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You are given the full description of a clinical trial. Please summarize it.

Post-natal growth restriction has become a problem yet to be solved and studied in most neonatal units. Newborns with very low birth weight grow at a rate lower than expected, thus culminating with delayed extra-uterine growth, be it in the term assessment, be it at the time of discharge from the hospital, and this makes the search for adequate nutrition a critical issue. Although there are intrinsic risk factors related to prematurity, the nutritional approach of the neonatal unit staff plays a decisive role on the prevalence of malnutrition. Although the importance of appropriate nutritional management of premature infants has been clearly recognized, the necessary nutrient requirements of most nutrients have not been well established yet and these uncertainties may contribute to a limited intake of nutrients (Hay et al, 1999). When fresh and extracted mother´s own milk, human milk has been considered the preferred feed for premature newborns, because of its digestibility, balanced chemical composition, capacity to provide immunity and prevention of future diseases (AAP, 2003). In addition, human milk has been associated to lower energy expenditure to be used in comparison with preterm formula, and this may promote the newborn's growth (Lubetzky et al, 2003). However, many of its advantages can be lost when human milk comes from a pool and is pasteurized, and its use has been associated to inadequate weight gain and a nutritional deficit during hospital stay. Thus it is sometimes necessary to use human milk with fortifier or preterm formula, to feed the preterm infant, in order to increase caloric-protein supply and weight gain. Milk formulas for premature babies have currently high caloric density and are better digested, but they do not have the capacity to provide immunity. In face of this problem, several studies are in progress to know and discuss the best nutritional approach for premature newborns during hospital stay. Among the factors that may have an impact on this approach is energy expenditure originated from the type of diet newborns have and on how its caloric constituents (macronutrients) are metabolized. In face of the aforesaid, the following question remains: Will individually adjusting the caloric density of human and formula milk fed to newborns with very low birth weight actually have any impact on energy expenditure? 2 - OBJECTIVES 2.1 - GENERAL: - To compare energy expenditure of preterm infants fed with fortified human milk versus preterm infant formula 2.2 - SPECIFIC: - To analyze the caloric content and macronutrients (fat, protein, and lactose) present in human milk fed to the newborn with very low birth weight at the time of the indirect calorimetry test; - To analyze the impact of the caloric density of the milk fed to each newborn on energy expenditure; - To compare the chemical composition of the milks offered to newborns with very low birth weight and their use in energy expenditure - To analyze the impact of energy substrates on respiratory coefficient; - To elaborate a pre and post-prandial energy expenditure curve of newborns with very low birth weight for each type of milk fed 3- MATERIALS AND METHODS 3.1 - Participants: Inclusion criteria: Newborns admitted to the Intensive Care Unit of Fernandes Figueira Institute with birth weight under 1500g, In order to be included in the study, newborns shall be in room air, with stable growth, without electrolytic unbalance, fed by gavage, with 160/ml/ky/day fluids, alternating human milk and formula for prematurity. Newborns must be tolerating the whole diet, without significant gastric residue (>5% of the total diet). For ethical reasons, newborns who are exclusively breastfeeding will not be included. 3.1.1 - Exclusion criteria: Newborns that present the following in their exams shall be excluded: significant gastric residue, signs and symptoms of sepsis, repeated apnea events which required the use of respiratory stimulants. 3.2 - Sample Size Calculation: Sample size of 25 newborns with very low birth weight was calculated based on the results obtained by Lubetzky et al (2003), considering a 10% difference between energy expenditure of human milk and preterm formula. The level of significance was 95% with a power of the test of 99%. MedCalc software was used in this calculation. 3.3 - Study place The study will be carried out at the Neonatal Intensive Care Unit of Fernandes Figueira Institute (IFF) / Oswald Cruz Foundation (FIOCRUZ), in Rio de Janeiro - RJ. This research was authorized by the Head of the Neonatology Department of this unit. 3.4 - Main Endpoint Energy expenditure adjusted by caloric density of milk in both groups measured by open system indirect calorimetry pre and pos feed. 3.5 - Study design A randomized, controlled, crossover, double blind clinical trial will be carried out in which the newborn will be its own control. Randomization will be according to the type of diet at the beginning of the study. Half of the participants will be randomly assigned to begin the study using one type of milk (for example, human milk) and later another type of milk (preterm infant formula) and the other half will do the opposite. 3.6 Randomization and blinding Newborns with very low birth weight included in the study will be randomized using a computer generated random numbers table, to initially get human milk and then milk formula or vice-versa. This study will be carried out by researchers whom have been trained to handle all necessary equipment and techniques, as well as to perform the procedures. Initially the Human Milk Bank will be requested to supply human milk with a caloric value above 65 Kcal/100ml. When it is sent to the Milk Bank for distribution, it will be assessed again by a researcher of the staff, who will be in charge of analyzing the caloric content and macronutrients contained in the milk and of randomization as well. After getting "diet A" for 24 hours, another researcher, who will be "blind", that is, who will not know which diet was given, will perform the indirect calorimetry test, which will be repeated 24 hours after the other type of diet. The researcher in charge of analyzing the results will also be "blind", that is, he will not know which milk belongs to "diet A" and to "diet B". 3.7 - Study protocol Energy expenditure assessment Energy expenditure assessment will be performed by indirect calorimetry, using the Deltatrac II Metabolic Monitor (Datex-Ohmeda, Helsink, Finland. This equipment is based on open circuit principle, which allows measuring oxygen consumption (VO2) and carbon dioxide production (VCO2), using a continuous flow generator. The indirect calorimetry test will be performed between the 21st and the 28th day of life, period in which the newborn reaches good metabolic stability. The newborn will be kept inside the incubator, in a thermoneutral zone, with the hood covering its face, without clothing or accessories such as socks, gloves and caps, with clean diapers, in prone position, sleeping or in a state of sleepiness. Temperature will be recorded by a thermometer attached to the infant's skin. The choice of prone position is based on the fact that it is in this position that premature newborns remain quietest, in addition to the many benefits it provides related to the respiratory function. Body movements will be recorded before and during the indirect calorimetry test, following a scale proposed by Thureen (1998), which associates activity and energy expenditure. Measurement will be interrupted when the infants are awake and active or crying. Deltatrac II has software and a printer connected to it, which provides the average value and standard deviation of the following parameters: baseline energy expenditure, expired CO2 volume, inspired CO2 volume and percentage of use of carbohydrates, proteins and fat, at the end of the test. The indirect calorimetry test will take place at the following times: 60 minutes before diet administration, 30 minutes during diet through gastroclysis and 90 minutes after diet administration, in a total of 180 minutes. After having had one type of diet for 24 hours, the indirect calorimetry test will be carried out and right after that the infant will be fed the other type of diet for 24 hours, at the end of which another indirect calorimetry test will be performed. It is necessary to observe a 24 hour washout period to make sure there is no interference of the nutrients from the previous diet, because studies have shown that the thermal effect of food may last for about 18 hours. The feasibility of obtaining a baseline status of the newborns, that is, a status in which infants remain still for a long period of time, can be assured by the fact that most newborns sleep about 60% of their time and they are in a calm awake state 25% of their time - when metabolism is low. On the other 15% of the time, newborns are either being fed or crying. Milk analysis In order to assess human milk ingested by the newborn, at the time of the test a 9 ml sample of the milk will be collected - 2ml will be analyzed using creamatocrit and the remaining 7 ml will be sent for qualitative analysis of protein, fat, lactose and total caloric content, dosed by spectrophotometry technique - using INFRARED ANALYSIS (Milko-Scan Minor 104, which has already been validated for human milk analysis. The human milk that will be fed to the newborn, at the time of the test, shall have a caloric value of at least 65 Kcal/100ml. Formula milk will be calculated using the information provided on the product label, considering volume and dilution and the most commonly used formula is Pré-Nan. The values of preterm formula constituents are Carbohydrate 8,6g/100 ml, protein 2,3g/100 ml, fat 4,2g/100 ml and total kcal is 80 Kcal/100 ml. Population characteristics The following anthropometric data will be collected to characterize the population: weight, length, as well as variables related to birth - nutritional status and neonatal practices. 3.8 - Analysis Data will be entered into a data base created using STATA and the analyses will be performed with STATA software. The analysis of the results will be carried out by variance analysis (ANOVA) for data with normal distribution or Kruskal-Wallis and Wilcoxon for non-parametric data on continuous variables or by chi-square for categoric variables. The regression model will be used for the analysis of association of the variables set considered with the energy expenditure. The choice of variables that will be used in the regression model will be defined based on bivariate analyses. The result will be considered statistically significant if p value is < 0.05. 3.9- Presentation of results Results will be presented in conformity with the standards suggested by CONSORT, using a flow diagram formed by four phases: selection, assignation, follow-up and analysis, as shown in the scheme below. 4.0- Ethical issues This project has been approved by the Institutional Review Board for Research with Human Beings of the Fernandes Figueira Institute, under protocol number 0057.0.008.000-06. The Term of free and informed consent will be requested from the newborn's legal representative, and they will only be included in this research work after the term has been signed. 5 - REFERENCES American Academic Pediatrics Committee On Nutrition (AAP). Pediatric Nutrition Handbook - 5th Edition. Edited by Ronald E. Kleinman., 2003. Hay W, Lucas A, Heird WC, Ziegler E, Levin E, Grave GD et al. Workshop Summary: Nutrition of the Extremely Low Birth Weight Infant. Pediatrics 1999; 104 (6):1360-1368. Lubetzky R, Vaisman N, Mimouni FB, Dollberg S. Energy expenditure in human milk- versus formula-fed preterm infants. J Pediatr 2003; 143(6):750-753. Thureen PJ, Phillips R, Baron KA. Demarie MP; Hay WWJr. Direct measurement of the energy expenditure of physical activity in preterm infants. J Appl Physiol 1998; 85(1):223-230.

The goal of this study is verify if the energy expenditure in preterm infant fed with human milk is different from preterm formula. A randomized, controlled, crossover, double blind clinical trial will be carried out in which the newborn will be its own control. Randomization will be according to the type of diet at the beginning of the study. Half of the participants will be randomly assigned to begin the study using one type of milk (for example, human milk) and later another type of milk (preterm infant formula) and the other half will do the opposite.

You are given a short description of a clinical trial. Please generate one or multiple interventions that fit the description.

To investigate the effect and safety of intracoronary autologous bone morrow mesenchymal stem cells (BM-MSCs) transplantation in patients with ST-segment elevation myocardial infarction（ STEMI） .

INTERVENTION 1: <TYPE: Biological; NAME: Bone marrow mesenchymal stem cells transfer; DESCRIPTION: Inject the BM-MSCs into the infarct-related arterial hypertension through the central cavity of the guide wire balloon catheter under the complete blockage of the target blood vessel. Each time the balloon continues to fill for 2 minutes to block blood flow, then resume perfusion for 2 minutes. The above process is repeated 6 ~ 8 times, >; INTERVENTION 2: <TYPE: Drug; NAME: Best medical treatment; DESCRIPTION: Refer to the latest medication guidelines and give the best medication to the patients, >; INTERVENTION 3: <TYPE: Procedure; NAME: Percutaneous coronary intervention; DESCRIPTION: Percutaneous coronary intervention, >;

You are given the title of a clinical trial. Please write a brief description that matches the trial title.

Does Aerobic or Resistance Exercise Training Improve Walking Ability in Chronic Stroke Patients?

This study will investigate the efficacy of aerobic exercise and progressive resistance training (PRT), singularly and combined, on changes in walking endurance for mildly-to-moderately affected chronic stroke patients. Specifically, we will determine the relative importance of training induced changes in muscle strength versus aerobic fitness on increases in gait velocity and 6-min walking distance, and assess the concomitant functional and psychosocial impact of increased muscle strength, aerobic fitness and improved gait. This longitudinal study will be conducted as a double blinded factorial randomized controlled trial of exercise training for chronic stroke patients.

You are given the title of a clinical trial. Please write a brief description that matches the trial title.

Phase IV Study of Oral Prednisone Taper vs. Placebo Following Intravenous Steroids for the Treatment of Acute Relapses in Multiple Sclerosis Within the Ticino Cohort

The management of MS-patients requires treatment with immune-modifying or immune-suppressive agents to prevent new relapses and progression of disability. Several studies have evaluated the effect of steroid treatment on clinical recovery after an acute relapse. An important unanswered clinical question is, whether or not an oral tapering dose of corticosteroids offers any additional advantage over intravenous methylprednisolone alone in improving neurologic recovery as well as safety and tolerability after a relapse. This study aims to compare the efficacy, tolerability and safety of tapering doses of oral prednisone and placebo after short-term high-dose i.v. methylprednisolone on the recovery from an acute relapse in patients with clinically isolated syndrome (CIS), relapsing-remitting multiple sclerosis (RR-MS) and primary (PP-MS) or secondary progressive multiple sclerosis (SP-MS) with superimposed relapses. Patients will be treated during 25 days with de-escaling doses of prednisone or placebo. The primary analysis will test whether placebo is equivalent to oral prednisone taper on the recovery status as measured by EDSS change from baseline to 3 months after baseline.

You are given a short description of a clinical trial. Please design one primary outcome for the trial and if needed one or more secondary outcomes.

This research study is for people who have been waiting for a kidney transplant for at least one year, and who have a cPRA of 99.5% or higher. Having a cPRA of 99.5% or higher means that your immune system would reject 99.5% of kidneys available for transplant. The study will test whether new products called Chimeric Antigen Receptor T Cells (CAR T Cells), when given with chemotherapy, is safe and will reduce cPRA. The main study will last up to 2 years: Participants will have up to 30 clinic or hospital visits over a one-year period. If a transplant takes place, there will be 9 more visits after transplant. Long term follow up is required by the Food and Drug Administration (FDA) for 15 years after receiving CAR T cell. The primary objective is to evaluate the safety and feasibility of administering CART BCMA + huCART-19 following lymphodepletion, including determination of optimal tolerated regimen (OTR) and/or recommended phase 2 regimen, according to the incidence of dose limiting toxicity (DLT) in highly sensitized patients awaiting kidney transplant.

PRIMARY OUTCOME: <MEASURE: The timing of adverse events after infusion of Chimeric antigen receptor T - B cell maturation antigen (CART-BCMA) with CD19 Targeted Humanized CAR T Cell (huCART-19); TIME_FRAME: From time of lymphodepletion to 12 months; DESCRIPTION: Adverse events will be categorized and described according to CTCAE v5.0. Specific safety outcomes will include but are not limited to: Cytokine release syndrome, as defined by ASTCT consensus grading Neurotoxicity (ICANS), as defined by ASTCT consensus grading Delayed hematopoetic recovery: proportion of subjects achieving ANC >1,000/microL and Platelets >75,000/microL at 60 days after first CART cell infusion Dose limiting toxicity; > SECONDARY OUTCOME 1: MEASURE: The proportion of subjects meeting the predefined Calculated Panel Reactive Antibody (cPRA) reduction criteria after the infusion of CART-BCMA + huCART-19; TIME_FRAME: 26 weeks after the infusion; >; SECONDARY OUTCOME 2: MEASURE: Duration of Calculated Panel Reactive Antibody (cPRA) response; TIME_FRAME: From time of infusion to 12 months; >; SECONDARY OUTCOME 3: MEASURE: For subjects who are transplanted, the proportion of subjects experiencing acute cellular rejection or antibody mediated rejection, delayed graft function (as well as AKI), graft loss OR De Novo donor specific antibody; TIME_FRAME: 3 years after transplantation; >; SECONDARY OUTCOME 4: MEASURE: The proportion of subjects with opportunistic infections; TIME_FRAME: From time of infusion to 12 months or 3 years after transplantation; >;

You are given a short description of a clinical trial. Please design one primary outcome for the trial and if needed one or more secondary outcomes.

The investigators propose a multicenter randomized controlled trial in South Korea and Taiwan to observe the clinical effects of REBOA on nontraumatic out-of-hospital-cardiac-arrest (OHCA) patients. While REBOA has been traditionally used in trauma for hemorrhage control, it has also shown promising results in nontraumatic cardiac arrests by rerouting circulation to increase perfusion in the coronary and brain.

PRIMARY OUTCOME: <MEASURE: Number of Participants Who Achieved ROSC (return of spontaneous circulation); TIME_FRAME: 24 hours; DESCRIPTION: Number of patients who achieves ROSC regardless of sustained time; > SECONDARY OUTCOME 1: MEASURE: Number of Participants Who Achieved Sustained ROSC; TIME_FRAME: 24 hours; DESCRIPTION: Number of participants who achieves sustained ROSC (ROSC maintained more than 20 minutes); >; SECONDARY OUTCOME 2: MEASURE: Survival to Admission; TIME_FRAME: 48 hours; DESCRIPTION: Whether patients who achieve sustained ROSC survives until admission; >; SECONDARY OUTCOME 3: MEASURE: Survival to Discharge; TIME_FRAME: 30 days; DESCRIPTION: Whether patients survive until hospital discharge.; >; SECONDARY OUTCOME 4: MEASURE: Neurological Outcome; TIME_FRAME: 1 month, 3 months, 6 months since ROSC; DESCRIPTION: The cerebral performance category (CPC) and modified Rankin Score (mRS) of each patient at 28 days, 3 months, and 6 months after achieving ROSC. CPC is measured on a scale of 1 to 5, with 1 being the best neurological performance, and 5 indicating brain death. MRS is measured on a scale of 0 to 6, with 0 indicating no neurological deficit, and 6 indicating death.; >; SECONDARY OUTCOME 5: MEASURE: Changes in Arterial Blood Pressure; TIME_FRAME: ABP 2 minutes and 1 minute before REBOA insertion, ABP 1 minute / 2 minutes / 4 minutes / 10 minutes after REBOA insertion.; DESCRIPTION: Arterial blood pressure measured before and after REBOA inflation in the experimental group. Both systolic and diastolic pressures will be used.; >;

You are given a short description of a clinical trial. Please generate one or multiple interventions that fit the description.

This phase II trial studies the effect of selpercatinib given before surgery in treating patients with thyroid cancer whose tumors have RET alterations (changes in the genetic material [deoxyribonucleic acid (DNA)]). Selpercatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving selpercatinib before surgery may help shrink the tumors and help control the disease.

INTERVENTION 1: <TYPE: Other; NAME: Quality-of-Life Assessment; DESCRIPTION: Ancillary studies, >; INTERVENTION 2: <TYPE: Other; NAME: Questionnaire Administration; DESCRIPTION: Ancillary studies, >; INTERVENTION 3: <TYPE: Drug; NAME: Selpercatinib; DESCRIPTION: Given PO, >; INTERVENTION 4: <TYPE: Procedure; NAME: Therapeutic Conventional Surgery; DESCRIPTION: Undergo standard of care surgery, >;

You are given a short description of a clinical trial. Please design one primary outcome for the trial and if needed one or more secondary outcomes.

The study is intended to characterize the clinical benefit regarding safety and efficacy of a long term treatment with Lucentis in comparison with Ozurdex over an additional 6 months and a 3-month follow-up period, following the initial 6-month treatment in the respective core studies CRFB002EDE17 (NCT01396057) and CRFB002EDE18 (NCT01396083).

PRIMARY OUTCOME: <MEASURE: Number of Participants With Adverse Events as a Measure of Safety and Tolerability; TIME_FRAME: 6 months; DESCRIPTION: The number of participants who experienced Adverse events, serious AE and death; > SECONDARY OUTCOME 1: MEASURE: Raw Mean Best Corrected Visual Acuity (BCVA) by Treatment Group; TIME_FRAME: Baseline, 6 months and 12 months; DESCRIPTION: Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. The range of BCVA (EDTRS) is 0 to 100 letters. A positive change from baseline of BCVA indicates improvement; >; SECONDARY OUTCOME 2: MEASURE: Percentage of Patients Gaining / Losing ≥ 15 / 10 / 5 Letters at Month 12 Compared to Baseline; TIME_FRAME: 12 month; DESCRIPTION: BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who were gaining/losing ≥15, 10 or 5 more letters of visual acuity at month 12 as compared with baseline; >; SECONDARY OUTCOME 3: MEASURE: Change in Central Subfield Thickness (CSRT) From Baseline to Month 12; TIME_FRAME: Baseline , Month 12; DESCRIPTION: High Resolution OCT was performed at every study visit by Spectral Domain OCT (if not available Time Domain OCT was acceptable) and the images were transferred to a digital video disc. These assessments were performed by trained and adequately qualified experts at the sites and prior to any study drug administration. CSFT is the average retinal thickness of the circular area with 1 mm diameter around the foveal center.; >; SECONDARY OUTCOME 4: MEASURE: Change of Foveal Center Point Thickness (FCPT) From Baseline to Month 12; TIME_FRAME: Baseline, Month 12; DESCRIPTION: FCPT (foveal center point thickness) was assessed by central reading center to ensure error- corrected measurements of retinal thickness and volumes,; >; SECONDARY OUTCOME 5: MEASURE: Change in Mean Visual Function Questionnaire (VFQ-25); TIME_FRAME: Baseline, 12 months; DESCRIPTION: The VFQ-25 composite and subscale scores range from 0 to 100, a higher score indicating better functioning. The 12 subscales in the VFQ-25 are general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. The scores on the subscales were added together for a total score, which ranged from 0 to 100. A higher score indicated improvement in quality of life due to vision function.; >; SECONDARY OUTCOME 6: MEASURE: Change in SF-36 Summary Scores; TIME_FRAME: Baseline, month 12; DESCRIPTION: The SF-36 measures the impact of disease on overall quality of life and consists of eight subscales (physical function, pain, general and mental health, vitality, social function, physical and emotional health) which can be aggregated to derive a physical-component summary score and a mental-component summary score. Scores for each subscale range from 0 to 10, and the composite scores range from 0 to 100, with higher scores indicating better health. A positive change from Baseline score indicates improvement in quality of life.; >; SECONDARY OUTCOME 7: MEASURE: Change in Euro Quality of Life Questionnaire (EQ-5D) VAS Summary Scores; TIME_FRAME: Baseline, month 12; DESCRIPTION: The Euro Quality of Life Questionnaire (EQ-5D) standardized instrument was utilized to measure health outcomes related to mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Participants self-rate their health on a visual, vertical analogue scale from 0 to 100 where the endpoints are labeled "Best imaginable health state" (100) and "worst imaginable health state" (0).; >; SECONDARY OUTCOME 8: MEASURE: Time to the First Retreatment of Both Treatment Arms; TIME_FRAME: 6 months; DESCRIPTION: Time to the first retreatment; >;

You are given the title of a clinical trial. Please write a brief description that matches the trial title.

Role Of Angiogenic Factors In The Development Of Hepatorenal Syndrome

This Study will look at the effect of substances called "angiogenic factors"(development of new blood vessels) have on the development of severe liver disease. The results may help to understand the factors involved in the repair and regeneration of liver tissue and to see if different types of liver disease are associated with different types of factors, especially in the severe liver disease called hepatorenal syndrome.

You are given the full description of a clinical trial. Please summarize it.

Runner's knee or patellofemoral pain syndrome (PFPS) is a common cause of anterior knee pain in young active individuals. Patellofemoral pain (PFP), or anterior knee pain (AKP), is a common musculoskeletal disorder. It involves dysfunction in mechanical forces between the patella and the femur. The worldwide PFP prevalence has been reported as 15-45% of population. Females are at two times higher risk of PFP than males, especially young active females. The aim of this study is to determine the effects of Mulligan mobilization with and without dry needling in Runner's Knee in a randomized clinical trial. The study will be randomized clinical trial. The study will be conducted at Johar Pain Relief Center, Lahore. The study will be completed within eight months after synopsis approval from ethical committee of Riphah College of Rehabilitation and Allied Health sciences. Sample size will be 40 (20 in each group). Non-probability convenience sampling technique will be used to recruit the Runner's Knee patients in the study and then they will be divided into two groups by simple randomization through sealed opaque envelope. Mulligan mobilization with dry needling will be given to group A. Mulligan mobilization without dry needling will be given to group B. Outcome measures will be pain, knee range of motion, flexibility, functional disability and muscle strength measured through Numeric pain rating scale (NPRS), goniometer, Kujala Patellofemoral Scale and Modified Sphygmomanometer Test (MST) respectively. Data will be analyzed by SPSS version 25.

The aim of this study is to determine the effects of Mulligan mobilization with and without dry needling on pain, range of motion, flexibility, functional disability and muscle strength in patients with Runner's Knee.

You are given the inclusion and exclusion criteria for participant selection in a clinical trial. Please tell me how many participants we will find that fit these criteria.

Inclusion Criteria: 1. The patients were 18-80 years old and diagnosed as malignant solid tumor by pathology; 2. Patients with persistent cancer pain and NRS score ≥ 7 during previous 24 hours; 3. Patients who did not receive radiotherapy, chemotherapy or targeted therapy within 7 days before randomization and trial； 4. Patients or his/her caregivers who are able to fill out the questionnaire forms ; 5. Ability to correctly understand and cooperate with medication guidance of doctors and nurses ; 6. Without psychiatric problems; 7. ECOG performance status ≤3; 8. Patients who did not receive the trial drug within 14 days before the trial； 9. The subjects voluntarily signed the informed consent. Exclusion Criteria: 1. The pain is confirmed not due to cancer; 2. Patients with severe post-operative pain; 3. Patients with paralytic ileus; 4. Patients with brain metastasis; 5. Patients hypersensitive to opioids; 6. Patients with abnormal lab results that have obvious clinical significance, such as creatine ≥ 2 fold of upper limit of normal value, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2.5 fold of upper limit of normal value, or liver function of Child C grade; 7. Patients who cannot take drugs orally; 8. Patients with an incoercible nausea or vomiting; 9. Those who have received monoamine oxidase inhibitor (MAOI) within two weeks before randomization; 10. Patients who are pregnant or in lactation, or who plan to be pregnant within one month after the trial; 11. Alcoholic patients; 12. Patients with other conditions or reasons causing the patients unable to complete the clinical trial.

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You are given a short description of a clinical trial. Please generate one or multiple interventions that fit the description.

In patients with heart failure, elevated filling pressures may contribute to symptoms while not improving cardiac output. The current study is focused on evaluating the relationship between exercise capacity, pulmonary pressures, cardiopulmonary parameters, and symptoms of dyspnea in patients with heart failure during exercise.

INTERVENTION 1: <TYPE: Procedure; NAME: Preventing pulm HTN during exercise; DESCRIPTION: Balloon catheter is inflated within the IVC to maintain pulmonary pressures during exercise., >;

You are given the full description of a clinical trial. According to this description, please design inclusion and exclusion criteria for selecting participants.

The study will be conducted in two parts: Part 1: Volunteers representative of pregnancy test users will use a range (4 of 7 different tests being evaluated) in their own home to gain usability data. All products will be used according to their instructions for use which, where required, will be translated into English prior to the study start. A study questionnaire will be completed after each test is used. Part 2: The volunteers will attend the study site soon after completing their last home test and be required to read randomised results of tests conducted by study technicians (pregnant and not pregnant) to gain an understanding of their ability to correctly read results of the tests. The technician will also read and record the test results to enable both the laboratory agreement (technician read) and the consumer readability to be determined and compared for each product. Each volunteer will be required to provide a urine sample for determining pregnancy status and quantitative urinary hormone measurement (this is done to confirm the result obtained at home using the HPTs). At the end of the testing period the volunteers will also be asked to rank the four products they have used in the study, based on a series of statements regarding usability and readability of the tests

Inclusion Criteria: - Female - Aged 18-45 years - Willing to give informed consent - Willing to conduct a personal home pregnancy test and reveal their pregnancy status Exclusion Criteria: - Currently or previously employed by SPD, Alere, Unipath, P&G, Abbott, or affiliates - Has an immediate relative* currently or previously employed by SPD, Alere, Unipath, P&G, Abbott or affiliates - Taken a hormonal preparation containing hCG in the last month, e.g. Pregnyl® - Recently miscarried and yet to have 2 complete menstrual cycles before study start

You are given a short description of a clinical trial. Please design one primary outcome for the trial and if needed one or more secondary outcomes.

ZYIL1 is a novel oral selective NLRP3 inflammasome inhibitor which prevents NLRP3-induced ASC oligomerization, thus inhibiting NLRP3 inflammasome pathway. ZYIL1 is expected to show benefit in patients demonstrating cytokine, like IL1β flare, including those exhibiting cytokine storm related to COVID-19 and other viral inflammatory diseases.

PRIMARY OUTCOME: <MEASURE: Incidence and Severity of Adverse event of ZYIL1 following a single oral dose in healthy subjects; TIME_FRAME: Baseline to Day 3; DESCRIPTION: The Common Terminology Criteria for Adverse Event (CTCAE) (Version 5.0 or higher) system will be used for reporting and grading; > SECONDARY OUTCOME 1: MEASURE: Maximum plasma concentration (Cmax); TIME_FRAME: Predose; 0.5 hour; 1 hour; 1.5 hour; 2 hour; 3 hour; 4 hour; 5 hour, 6 hour; 8 hour; 12 hour, 24 hour and 48 hour; DESCRIPTION: At each dose level, blood samples will be withdrawn for the evaluation of pharmacokinetic.; >;

You are given the inclusion and exclusion criteria for participant selection in a clinical trial. Please tell me how many participants we will find that fit these criteria.

Inclusion Criteria: - Histologically or cytologically proven urothelial carcinoma of the urinary bladder in stage T2b-T3, N0/Nx, M0. - Patients must have measurable disease. Response assessment will be evaluated according to RECIST criteria. Measurable lesions with clearly defined margins will be evaluated by X-Ray, Transvesical Ultrasound, CT-Scan or MRI, cystoscopy. - Lesions serving as measurable disease must have the longest diameter of greater than or equal to 20 mm as measured with conventional techniques or greater than or equal 10 mm with spiral CT scan. Lesions measured by physical examination must have a longest diameter of greater than or equal 20 mm. Exclusion Criteria: - Patients with prior or concomitant malignant diseases (other than appropriately treated basal cell carcinoma of the skin or carcinoma of the cervix) - PSA greater than 5.0 ng/mL - Concurrent administration of any other tumor therapy, including radiotherapy, cytotoxic chemotherapy, immunotherapy, molecular target therapy.

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You are given the full description of a clinical trial. Please summarize it.

Patients with an indication for spondylodesis are included according to the inclusion criteria and exclusion criteria. Subsequently, randomization into the MySpine and conventional group is performed. Patients remain blinded to the randomization. On the basis of a computed tomography, the surgeon plans the entry points, the screw size and length, as well as the angle of the screws in two planes (sagittal and axial) on the computer. In the MySpine group, a three-dimensional, digital reconstruction of the spine is made using Medacta International SA software. On the basis of these planning files, three-dimensional templates with guide channels (guides) are produced for each individual vertebra. These guides can be applied dorsally to the bony anatomy and thus specify the entry points as well as the direction of the screw. Also, replicas of the individual vertebra are produced in the 3D printer. The patients are operated in a prone position via a dorsal approach. After preparation of the dorsal process, vertebral arches and vertebral joints as well as the transverse process, the screws are implanted with one of the following methods depending on the randomization: 1. Freehand (fluoroscopically controlled) 2. MySpine System Postoperatively, all patients undergo computed tomography of the operated area. On the basis of this computed tomography the number of pedicle perforations as well as their extent should be determined according to the simplified Laine classification. These results are to be statistically evaluated with the question of whether there are significant differences between the two techniques with respect to the absolute and individual number of pedicle perforations, as well as their extent. It is also to be examined whether these results show a dependence on the level of experience of the surgeon. In addition to the individual radiation exposure (cumulative irradiation time in seconds and irradiation dose in cGy), the time for the dorsal instrumentation for each of the two systems per surgeon is also to be measured and evaluated. In the follow-up, the outcome is also recorded by means of pain registration, ODI score and complication detection (infections, pedicle fractures, implant loosening, pseudoarthrosis, re-operations). The follow-up assessments 6 weeks, 6 months, 1 year and 2 years after surgrey are peformed according to institutional standards.

The clinically already tested and approved MySpine system is compared to the free-hand dorsal instrumentation, which is the gold standard in spondylodesis surgery. The aim of this study is to investigate whether or not the pedicle screw can be inserted anatomically more accurately by the MySpine system than by the conventional free-hand method using intraoperative fluoroscopy.

You are given the inclusion and exclusion criteria for participant selection in a clinical trial. Please tell me how many participants we will find that fit these criteria.

Inclusion Criteria: - Age 18-80 years old Exclusion Criteria: - Ongoing atrial fibrillation - Arm circumference incompatible with the blood pressure cuffs for all devices (<18 cm or > 50 cm) - Incapacity to give consent

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You are given the inclusion and exclusion criteria for participant selection in a clinical trial. Please tell me how many participants we will find that fit these criteria.

Inclusion Criteria: - 1. Outpatients, males and females, 21-55 years of age. - 2. Principal diagnosis of OCD according to the DSM-5 with duration of ≥2 years. - 3. Subjects with at least moderate OCD, defined by Yale-Brown Obsessive Compulsive Scale (YBOCS) (27) score of >19. - 4. Had trials of at least two SSRIs or one SSRI and clomipramine. 1. Treatment failure/non-response: As per the MGH-TRQ-OCD, minimal or no meaningful clinical benefit despite an adequate dose and duration of treatment; 2. Adequate duration: At least 8 weeks of treatment with SSRI or clomipramine 3. Adequate dose: Defined by the USPI labeling - 5. If on medication, must be maintained on SRI medications at a stable therapeutic dosage for at least 2 months prior to study entry and for the duration of the trial. - 6. If subjects are currently undergoing Exposure and Response Prevention (ERP) treatment, they must be in the maintenance stage with stable ERP "dosing" for at least 2 months. - 7. Willing and able to adhere to the study schedule, which requires 6 sonication/scan visits over two weeks and follow up visits for up to 6 months. Exclusion Criteria: - 1.Subjects will be excluded with a history of more than four (4) previous failed treatment trials of SSRIs or clomipramine (not including any current medication trial) given for an adequate duration at an adequate dose. - 2. Experimental therapy, either medication or device, within past 30 days. - 3. TMS in last 30 days. - 4. Present suicidal risk as assessed by the investigator using the Columbia Suicide Severity Rating Scale (28) or a history of attempted suicide in the past year. - 5. History of epilepsy or seizure (except febrile) or increased risk of seizure. (N.B. We are not aware of evidence that LIFU can induce seizures; however, we decided to incorporate similar safeguards to those used in TMS studies. - 6. Contraindications for MRI, including any metal in the head, metallic particles in the eye, implanted cardiac pacemaker or any intracardiac lines, implanted neurostimulators, intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or implanted medical pumps. - 7. Subjects with significant neurological disorder or insult, ablative surgery or DBS. - 8. History of substance abuse including alcohol use disorder within the past 6 months (except nicotine and caffeine). - 9. Unstable medical or neurological condition - 10. Women of childbearing potential and not using a medically accepted form of contraception such as: the consistent use of an approved hormonal contraception (birth control pill/patches, rings); an intrauterine device (IUD); Contraceptive injection (Depo-Provera); double barrier methods (diaphragm with spermicidal gel or condoms with contraceptive foam); Sexual abstinence (no sexual intercourse) or sterilization. - 11. Taking regular dose of benzodiazepines in excess of equivalent to clonazepam 4 mg per day. - 12. Mini-Mental State Exam (MMSE) less than 24 - 13. Current or prior history, per DSM-5 criteria, of bipolar I disorder, schizophrenia or other psychotic disorders, autism or autistic spectrum disorders, borderline PD, antisocial PD, body dysmorphic disorder, hoarding disorder (symptoms of hoarding disorder as part of the OCD diagnosis are allowed, a current diagnosis of Tourette's disorder. Co-morbid depression is allowed as long as OCD is considered primary.

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You are given the full description of a clinical trial. Please summarize it.

The measurement of blood pressure during anesthesia is commonly performed by the inflation of a brachial cuff providing only intermittent blood pressure measurements. In some case, it is required to add a continuous invasive monitoring of blood pressure, via the insertion of an arterial catheter. Unfortunately, the related morbidity is not negligible. To limit the consequences of such a gesture, some developments have been done in the past to allow for continuous non-invasive measurements of blood pressure during anesthesia. Unfortunately, most of these devices are subject to important limitations and constraints of use. A new system has been designed by CSEM consisting of an optical system fixed on patient's skin, absolutely non-invasive and easy to use. In order to study the reliability of this device, the investigators plan to compare its blood pressure estimates against gold-standard arterial catheter measurements during induction of general anesthesia on: - 40 patients wearing the optical system at the chest. - and 40 patients wearing the optical system at the fingertip

Comparison of an optical method to continuously measure blood pressure against an invasive arterial catheter.

You are given the full description of a clinical trial. Please summarize it.

Tinnitus is the phantom auditory perception of sound in the absence of an external or internal acoustic stimulus. It is a frequent problem which can interfere significantly with the ability to lead a normal life. Treatment is difficult. Most available therapies focus on habituation rather than treating the cause. Tinnitus is thought to be generated in the brain, as a result of functional reorganization of auditory neural pathways and tonotopic maps in the central auditory system, following damage to the peripheral auditory system. Low-frequency rTMS has been investigated for the treatment of hyperexcitability disorders such as auditory hallucinations and tinnitus. Pilot data indicate that the beneficial effect of low-frequency rTMS can be enhanced by high frequency rTMS of the left dorsolateral prefrontal cortex (DLPFC). In the proposed study we investigate whether high frequency rTMS of the DLPFC improves therapeutic efficacy of low-frequency rTMS on tinnitus in a controlled trial.

Transcranial Magnetic Stimulation is used to modulate the auditory neural pathways caused by hearing loss and leading to the phantom auditory perception of sound in the absence of an external or internal acoustic stimulus.

You are given a short description of a clinical trial. Please generate one or multiple interventions that fit the description.

Objective: To assess whether adjunctive therapy of COVID-19 infection with atorvastatin reduces the deterioration in hospitalized patients and improves clinical outcome.

INTERVENTION 1: <TYPE: Drug; NAME: Atorvastatin; DESCRIPTION: Atorvastatin 40 mg tablet, >;

You are given the title of a clinical trial. Please write a brief description that matches the trial title.

To Evaluate the Efficacy and Safety of Combination Therapy of AGT and AGZ Versus Monotherapy of AGT in Patients With Primary Hypercholesterolemia

To Evaluate the Efficacy and Safety of Combination Therapy of AGT and AGZ Versus Monotherapy of AGT in Patients With Primary Hypercholesterolemia.

You are given a short description of a clinical trial. Please design one primary outcome for the trial and if needed one or more secondary outcomes.

This study evaluated the safety and efficacy of 26 weeks treatment with indacaterol, placebo or salmeterol in patients with chronic obstructive pulmonary disease.

PRIMARY OUTCOME: <MEASURE: Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment; TIME_FRAME: Week 12; DESCRIPTION: Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 hour 10 minute and 23 hour 45 minute post-dose FEV1 readings. Mixed model used baseline FEV1, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and 1 hour post inhalation of ipratropium as covariates.; > SECONDARY OUTCOME 1: MEASURE: St. George's Respiratory Questionnaire (SGRQ) Total Score After 12 Weeks of Treatment; TIME_FRAME: Week 12; DESCRIPTION: SGRQ is a health related quality of life questionnaire consisting of 76 items in three sections: symptoms, activity and impacts. The total score is 0 to 100 with a higher score indicating poorer health status. The mixed model used baseline SGRQ total score, FEV1 prior to and 30 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and one hour post inhalation of ipratropium as covariates.; >; SECONDARY OUTCOME 2: MEASURE: Percentage of COPD "Days of Poor Control" During 26 Weeks of Treatment; TIME_FRAME: Up to 26 weeks; DESCRIPTION: Participants rated their symptoms on a scale of 0=none to 3=severe. A Chronic Obstructive Pulmonary Disease (COPD) "day of poor control" was defined as any day in the participants diary with a score >=2 (moderate or severe) for at least 2 of 5 symptoms (cough, wheeze, production of sputum, color of sputum, breathlessness). The mixed model used baseline percentage of "days of poor control", FEV1 prior to and 30 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and one hour post inhalation of ipratropium as covariates.; >;

You are given a short description of a clinical trial. Please design one primary outcome for the trial and if needed one or more secondary outcomes.

The purpose of this study is to test the safety and tolerability of an investigational inhaled flu medication, CS-8958. Study participants will include 38 elderly males and females, age 65 and older. Participants will be divided into 1 of 4 possible treatment groups (Groups A, B, C and D) to receive the study drug or placebo (substance containing no medication). Group A will receive 5 mg CS-8958, Group B will receive 10 mg CS-8958, Group C will receive 20 mg CS-8958 and Group D will receive 40mg CS-8958. Safety information will be reviewed prior to administering a higher dose of treatment. Study procedures will include blood and urine samples, ECGs (measure of heart activity), and a 7 day clinic stay. Participants will be involved in study related procedures for up to 6 weeks.

PRIMARY OUTCOME: <MEASURE: Safety and tolerability: treatment-emergent AEs, changes in vital signs including BP and PR, SpO2, oral body temperature, ECG, spirometry, PEFR, physical examinations, psychological assessments and laboratory parameters.; TIME_FRAME: Duration of study; > SECONDARY OUTCOME 1: MEASURE: Pharmacokinetic parameters for CS-8958 and R-125489.; TIME_FRAME: Days 1-7; >;

You are given the inclusion and exclusion criteria for participant selection in a clinical trial. Please tell me how many participants we will find that fit these criteria.

Inclusion Criteria: 1. Elective surgery patients 2. Aged 55 to 75 3. New York Heart Association class II or III cardiac functions 4. Median sternotomy approach for coronary artery bypass grafting or heart valve replacement procedures. Exclusion Criteria: 1. With a history of benzodiazepine allergy 2. Significant liver or kidney insufficiency 3. Coagulation dysfunction 4. Neurological or psychiatric disorders 5. Undergone major surgery within the past three months.

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You are given a short description of a clinical trial. Please design one primary outcome for the trial and if needed one or more secondary outcomes.

The proposed study is to evaluate the safety and initial efficacy of MRgFUS for patients with treatment-refractory OCD. This study is designed as a prospective, single arm, nonrandomized study. Assessments will be made before and after MRgFUS for adverse events related to treatment, for clinical symptom relief, and quality of life (QoL). The target in the brain chosen for ablation will be the anterior limb of the internal capsule (ALIC) (i.e 'capsulotomy'). Safety will be assessed prospectively in radiologic and clinical terms. Post-procedural imaging will be evaluated for evidence of swelling, hemorrhage, and the evolution of the lesion in the anterior limb of the internal capsule. Patients will be clinically followed up at Day 1, Month 1, Month 3, Month 6 and Month 12 post-procedure. At every follow-up visit, patients will be evaluated for general health, neurological changes, as well as for device/procedure related adverse events. Imaging will also be performed with positron emission tomography (PET) and MRI, as per the Month 3 and Month 12 post-procedure. Feasibility will be evaluated by determining the rate of patient accrual, the tolerability of the procedure for patients, and the technical ability of heating the ALIC to lesional temperatures.

PRIMARY OUTCOME: <MEASURE: Incidence of Treatment-Emergent Adverse Events [Safety]; TIME_FRAME: 12 months; DESCRIPTION: Adverse events (AE) will be recorded and categorized according to severity and relationship to procedure; > SECONDARY OUTCOME 1: MEASURE: Clinically meaningful reduction in symptoms [Efficacy]; TIME_FRAME: 12 months; DESCRIPTION: Primary effectiveness will be evaluated using validated scores and subscales related to the symptom being treated (i.e., Yale-Brown Obsessive Compulsive Scale). Efficacy is defined as a clinically meaningful reduction in symptoms at 12 months post-treatment. A patient with OCD is considered to have a treatment response if their YBOCS is reduced by 35% compared to baseline.; >;

You are given the inclusion and exclusion criteria for participant selection in a clinical trial. Please tell me how many participants we will find that fit these criteria.

Inclusion Criteria: - Male or Female, age ≥ 19 years - Stage III non-small cell lung cancer(NSCLC) patient who without surgical treatment - Patients scheduled for curative concurrent chemoradiotherapy - chemotherapy : paclitaxel and carboplatin - radiation therapy : IMRT, total 60~70Gy - Eastern Cooperative Oncology Group(ECOG) performance status of 0 to 2 at the screening visit - Subject whose remaining life expectancy is more than 6 months according to the judgment of investigator - Volunteer, be willing and able to provide written informed consent for the trial Exclusion Criteria: - Subjects with pleural effusion - Subjects with a weight loss of 10% or more within the last 6 months from the screening visit - Subjects with a history of thoracic or neck radiotherapy or chemotherapy prior to screening visit - Subjects with distant metastases - Subjects with liver/renal dysfunction according to the following criteria on the screening test - Total Bilirubin >1.5 mg/dL - ALT or AST level is 2.0 times higher than the upper limit of normal (based on the institution) - Serum Creatinine >1.5 mg/dL - Subjects with serious cardiovascular disease within 3 months prior to the screening visit (ex. arrhythmia, congestive heart failure, infarction, unstable angina etc) - Subjects with serious systemic infection (≥ Grade 3, evaluated by CTCAE v5.0) - Patients with chronic or interstitial lung disease (excluding patients with chronic obstructive pulmonary disease (COPD)), patients with chronic bronchitis, patients with pneumonia - Subjects with thyroid dysfunction as present illness at the screening visit - Subjects who administered systemic steroids within 4 weeks prior to the date of randomization (except for cases when administered to prevent hypersensitivity reaction of paclitaxel) - Subjects who are hypersensitive to investigational products and standard anticancer treatments - Subjects who participate in other clinical trials within 30 days prior to the screening visit and administer investigational drugs or apply clinical trial medical devices - Women of childbearing age or men who do not agree to use a medically accepted method of contraception during the clinical trial - Pregnant or breast-feeding - Subjects who have clinical significance that is considered inappropriate for this clinical trial as judged by the investigator

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You are given the full description of a clinical trial. According to this description, please design inclusion and exclusion criteria for selecting participants.

Obstructive Sleep Apnea-Hypopnea Syndrome (OSAHS) is a condition characterized by intermittent partial collapse and closure of the upper airway (UA). This leads to sleep fragmentation, oxygen desaturation, hypercarbia, and activation of the sympathetic nervous system. OSAHS is also associated with excessive daytime sleepiness, as well as other behavioral, functional, cardiovascular and cognitive dysfunction. Continuous Positive Airway Pressure (CPAP) is the most effective treatment for the OSAHS. CPAP stabilizes the airway and prevents instability and collapse. With a stable airway, breathing continues in a normal manner, gas exchange is improved, and there is no disruption of sleep related to disturbed breathing. CPAP is applied to the upper airway via a mask that covers the nose or the nose and mouth and reduces/eliminates sleep disordered breathing. The period of maximum susceptibility to airway collapse is at the end of exhalation and during early inhalation. During inhalation, negative pressures are generated in the airway by the normal process of ventilation (increase of thoracic volume and reduction of intra-thoracic pressure). The constant pressure of CPAP supports the airway throughout the ventilatory cycle. In the sleep laboratory, titration of positive airway pressure is performed to determine effective CPAP pressures. During the procedure, the patient is instrumented for full polysomnography (PSG). Therapy is applied and pressure is adjusted during the course of the night to stabilize the upper airway and the breathing pattern. With conventional CPAP, a single pressure level is applied to the airway. While adequate for a majority of patients with obstructive sleep apnea, this static prescription will present challenges in certain patients and conditions. Other forms of positive airway pressure that are approved for the treatment of OSAHS include automatically adjusting CPAP (Auto CPAP), Bi-level Positive Airway Pressure (BiPAP), and automatically adjusting BiPAP. Auto CPAP evaluates the airflow pattern and adjusts pressure to optimize airflow. Auto CPAP accommodates patients presenting with highly variable pressure requirements (e.g., sleep stage or body position dependent sleep apnea). The automatic adjustment can be used in patients for whom in-laboratory therapy titration is either delayed or impossible. The REMStar Auto algorithm is proactive and flow-based. It evaluates the inspiratory flow and determines impending or actual flow limitation. This occurs in concert with a program of pressure adjustments designed to evaluate the pressure at which the airway is susceptible to collapse and maintains pressures slightly above the critical pressure. The patient is protected from "break-through" events with a full complement of intelligent responses to airflow events and snoring. BiPAP therapy is another alternative. With BiPAP therapy, the patient's breathing pattern is monitored to identify the inspiratory and expiratory phases. Pressure is increased during inhalation and decreased during exhalation. The expiratory pressure (EPAP) is adjusted to prevent airway collapse and the inspiratory pressure (IPAP) is adjusted to prevent airflow limitation, hypopnea, snoring or arterial desaturation not associated with complete airway obstruction. BiPAP therapy differs from CPAP therapy, in that in addition to stabilizing the airway, inspiratory effort is assisted by the difference between the inspiratory and expiratory pressure. Patients with OSAHS may be prescribed BiPAP therapy if CPAP therapy is not tolerated. BiPAP therapy may also be prescribed for patients with other respiratory disorders or for patients with both sleep and respiratory-related dysfunction. Patients experiencing reduced ventilation from lung disease, neuromuscular disorders, or problems with the control of the breathing can experience nocturnal hypoventilation that is worse during sleep than it is during wakefulness. These patients are typically more complex and require more extensive evaluation and follow-up than patients suffering only from OSAHS. Patients may also be more vulnerable to loss or interruptions in treatment and often require more advanced modes and features such as alarms and timed back-up breaths. OSAHS patients may respond to increases in CPAP or BiPAP therapy by demonstrating a shift in the nature of the apnea from obstructive to central. In these cases, patients may not receive adequate treatment with CPAP since lower pressure levels do not manage the instability of the airway leaving residual airway obstruction, while higher pressure levels are associated with CPAP emergent events. This condition is referred to as CPAP Emergent Complex Apnea. Auto SV (Auto Servo Ventilation) is a mode of positive airway pressure used to treat obstructive and complex central sleep apnea. Its main features include: - Normalization of ventilation by automatically adjusting IPAP pressure to achieve a target ventilation. - Provision of timed, back-up breaths during central apneas. The optimal back-up rate is automatically determined by the device based on the patient's breathing. - Automatic control of EPAP pressure to treat obstructive events. Several manufacturers produce these types of devices. The algorithms used to determine the IPAP, EPAP and minimum respiratory rate are different. The largest number of these devices currently in use are the BiPAP AutoSV Advanced System One (Philips Respironics, Murrysville PA), Dreamstation BiPAP AutoSV and the VPAP (variable positive airway pressure) Adapt S7 (ResMed Corp., San Diego CA). Adaptive Servo Ventilation (ASV) is a mode of positive airway pressure used to treat central sleep apnea and complex sleep apnea. The main features of the Auto SV mode include; normalization of ventilation by automatically adjusting IPAP to achieve and stabilize a target ventilation; provision of timed, back-up breaths during central apneas wherein the optimal back-up rate is automatically determined by the device based on the patient's breathing; and automatic control of EPAP to treat obstructive events. The older version of the VPAP Adapt (S7) was found to lead to increased risk for all-cause mortality when compared to control group that involved medical management in patients with heart failure with reduced ejection fraction and predominantly central sleep apnea in a recent study (SERVE-HF). An accompanying editorial by Magalang and Pack suggested that the device algorithms may have played a role -- specifically, greater levels of pressure assist and associated increase in minute ventilation. This was supported by the measurements of minute ventilation delivered by the S7 device in the trial which was found to be greater than other servo-ventilation devices. Such increased levels of ventilation could potentially cause respiratory alkalosis which, in turn, could lead to QT interval prolongation and cardiac arrhythmias. The investigators recently performed a study of patient-ventilator interaction in patients with complex sleep apnea and preserved cardiac contractility (left ventricular ejection fraction > 45%) in order to determine the performance of various ASV devices on respiratory parameters - such as minute ventilation and apnea-hypopnea index. In order to facilitate feasibility and promote safety, the investigators avoided performing the study in the target population of the SERVE-HF trial, viz., patients with predominant central sleep apnea and heart failure with reduced ejection fraction (HFreF). The investigators performed the study only on patients with preserved ejection fraction (LVEF > 45%). In the current proposal, the investigators propose to perform the study on patients with predominantly obstructive sleep apnea and HFreF who need ASV therapy due to PAP-emergent central apneas. In the prior study, in order to avoid intolerance to device therapy, the investigators preferred study patients who were already adherent in using servo ventilation therapy at home. The investigators will do the same in the currently proposed study. In the prior study, the investigators found that S7 device led to greater minute ventilation than other devices and that such greater levels of minute ventilation was attributable to a greater tidal volume, higher respiratory rate, and greater pressure assist. Interestingly, there was prolongation of QTc interval and a tendency for greater premature ventricular contractions in the same patients during the nights that they were exposed to the S7 device. Although the mechanistic basis for this finding is potentially attributable to excessive ventilation and related pro-arrhythmic effects of hypocapnia, the investigators had not performed measures of partial pressure of CO2 (PaCO2) in this prior study. Specifically, it is unclear whether therapy with the S7 device leads to lower PaCO2 levels than other devices and whether such effects are augmented in individuals with high loop gain (complex sleep apnea in the setting of HFreF). Increases in minute ventilation (Ve) during wakefulness causes hypocapnia (respiratory alkalosis), which, in turn, could cause hypokalemia. Hypokalemia due to nighttime intracellular shifts in potassium ions can prolong QT interval. Conceivably, nighttime alkalosis due to excessive ventilation may lead to daytime hypokalemia and QTc prolongation through renal loss of potassium at night with consequent effects on QTc prolongation during the daytime. The observed QTc prolongation during S7 therapy was small in magnitude (~ 20 msec), but such effects may be magnified in patients with heart failure who develop metabolic alkalosis due to loop diuretics.The investigators did not, however, measure serum potassium levels which was a study limitation. In the current proposal, the investigators will ascertain the effects of nocturnal ASV therapy on serum potassium levels. Lastly, the investigators will explore the inter-individual variability in susceptibility in measured Ve or QTc interval.

Inclusion Criteria: - Ability to provide consent - Currently prescribed servo ventilation therapy at home - At least two weeks of recent adherence and efficacy data from PAP device demonstrating adequate use of therapy (at least 4 hours of use per night and use on at least 10 of 14 nights) - Individuals with complex sleep apnea (obstructive sleep apnea with central apneas) and preserved left-ventricular ejection fraction (LVEF > 45%) and/or heart failure with preserved ejection fraction (HFrEF) who are currently on ASV therapy. - Individuals with complex sleep apnea (predominantly obstructive sleep apnea with central apneas) and reduced left-ventricular ejection fraction (LVEF < 45%) and/or heart failure with reduced ejection fraction (HFrEF) who are currently on ASV therapy. Exclusion Criteria: - Participants who are acutely ill, medically complicated or who are medically unstable - Participants in whom PAP therapy is otherwise medically contraindicated - Participants who are claustrophobic - Symptomatic ("Symptomatic" defined as hospitalized for heart failure or a change in cardiac medications, within the last two months) chronic heart failure (NYHA 2-4) AND moderate to severe predominant central sleep apnea - Participants with previously diagnosed respiratory failure or respiratory insufficiency and who are known to have elevated arterial carbon dioxide levels while awake (PaCO2 ≥ 55mmHg). - Participants requiring any kind of oxygen therapy - Participants who have had surgery of the upper airway, nose, sinus, eyes, or middle ear within the previous 90 days.

You are given a short description of a clinical trial. Please design one primary outcome for the trial and if needed one or more secondary outcomes.

AZITHROMYCIN VERSUS SULPHADOXINE-PYRIMETHAMINE FOR PROPHYLAXIS AGAINST MALARIA IN PREGNANCY IN OWO, SOUIHWESTERN NIGERIA: A RANDOMISED CONTROLLED TRIAL OBJECTIVE: This study is to compare the efficacy of Azithromycin versus sulphadoxine-pyrimethamine as options of chemoprophylaxis against malaria in pregnancy. METHOD: This is a randomized controlled trial with parallel assignment that will be conducted in the Obstetrics and Gynaecology department of the Federal Medical Centre. One hundred and sixty four (164) pregnant women who are eligible will be randomly allocated to 2 groups (A and B) of 84 each, using computer generated random numbers. Group A will receive sulfadoxine-pyrimethamine for malaria prophylaxis while Group B will receive azithromycin. All other aspects of antenatal care till delivery will be the same for all the women recruited. Maternal venous blood samples for malaria parasitaemia will be collected on recruitment and repeated at follow-up visits at any gestation there are symptoms of malaria; maternal peripheral blood film, placental and cord blood samples will be collected at delivery. All data will be documented in the data collection sheet. The results obtained will be subjected to statistical analysis using statistical package for social sciences (SPSS) version 21, Armonk, NY:IBM. The level of significance will be set at 5%. Outcomes will be compared across groups using Chi-square.

PRIMARY OUTCOME: <MEASURE: malaria parasitaemia during pregnancy; TIME_FRAME: through study completion, an average of 6 months; DESCRIPTION: number of pregnant women with maternal peripheral blood parasitaemia during pregnancy among pregnant women who use sulfadoxine pyrimethamine and azithromycin for malaria prevention in pregnancy; > SECONDARY OUTCOME 1: MEASURE: malaria parasitaemia at the point of delivery; TIME_FRAME: at the time of delivery; DESCRIPTION: number of pregnant women with maternal peripheral blood and placental parasitaemia, number of new born with cord blood parasitaemia at birth among pregnant women who use sulfadoxine pyrimethamine and azithromycin for malaria prevention in pregnancy; >;

You are given the title of a clinical trial. Please write a brief description that matches the trial title.

Post-operative Pain Relief in Laparoscopic Cholecystectomy Using a Combination of Intraperitoneal Bupivacaine Morphine, Bupivacaine Fentanyl and Bupivacaine Ketamine: A Comparative Study

compare the analgesic efficacy of the combination of bupivacaine and morphine, bupivacaine and fentanyl and bupivacaine and ketamine in alleviating post operative pain following laparoscopic cholecystectomy.

You are given a short description of a clinical trial. Please design one primary outcome for the trial and if needed one or more secondary outcomes.

This study will assess the impact of the novel oral hormonal agents (abiraterone acetate or enzalutamide) among elderly metastatic prostate cancer patients. This study will assess the influence of treatments on patients' cognitive functions on a longitudinal basis and evaluate the quality of life and the adherence of patients who had or develop cognitive disorders.

PRIMARY OUTCOME: <MEASURE: The proportion of elderly patients who will experience a decline in cognitive performances (at least for one cognitive function) by questionnaires; TIME_FRAME: 3 months after initiation of treatment by new generation hormono-therapies for a metastatic castration-resistant prostate cancer; > SECONDARY OUTCOME 1: MEASURE: The quantitative score of cognitive functions by questionnaires; TIME_FRAME: Within 12 months after initiation of treatment by new generation hormono-therapies for a metastatic castration-resistant prostate cancer; >; SECONDARY OUTCOME 2: MEASURE: the quantitative score of quality of life by questionnaires for evaluate impact of cognitive impairment on quality of life to treatment; TIME_FRAME: Within 12 months after initiation of treatment by new generation hormono-therapies for a metastatic castration-resistant prostate cancer; >; SECONDARY OUTCOME 3: MEASURE: the quantitative score of anxiety/depression by questionnaires for evaluate impact of cognitive impairment; TIME_FRAME: Within 12 months after initiation of treatment by new generation hormono-therapies for a metastatic castration-resistant prostate cancer; >; SECONDARY OUTCOME 4: MEASURE: the quantitative score of fatigue by questionnaires for evaluate impact of cognitive impairment; TIME_FRAME: Within 12 months after initiation of treatment by new generation hormono-therapies for a metastatic castration-resistant prostate cancer; >; SECONDARY OUTCOME 5: MEASURE: the quantitative score of autonomy by geriatric evaluation for evaluate impact of cognitive impairment; TIME_FRAME: Within 12 months after initiation of treatment by new generation hormono-therapies for a metastatic castration-resistant prostate cancer; >; SECONDARY OUTCOME 6: MEASURE: the quantitative score of observance of treatment by questionnaire; TIME_FRAME: Within 12 months after initiation of treatment by new generation hormono-therapies for a metastatic castration-resistant prostate cancer; >;

You are given a short description of a clinical trial. Please generate one or multiple interventions that fit the description.

It is reported that more than 90,000 patients died of lung cancer and more than 20% of them were older than 80 years in North America. Therefore a less invasive but effective treatment is required for patients with lung cancer of advanced age, diminished pulmonary functions, and chronic diseases. Stereotactic body radiation therapy (SBRT) is an effective and well-tolerated treatment for early stage lung cancer in medically inoperable patients. On the other hand, accurate mediastinal and hilar lymph node staging is one of the most important factors that determine the outcome and indications for SBRT. Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is a novel, minimally invasive modality that enables the assessment of mediastinal and hilar lymph nodes with a high sensitivity. Accurate lymph node staging by EBUS-TBNA will allow opportunities for high-risk patients with lung cancer to undergo minimally invasive treatment.

INTERVENTION 1: <TYPE: Procedure; NAME: EBUS-TBNA; DESCRIPTION: Currently EBUS-TBNA is performed in patients with CT and/or PET positive lymph nodes in the mediastinum or hilum. In this study, all patients being considered for SBRT will undergo EBUS-TBNA for the lymph node staging prior to SBRT., >;

You are given the full description of a clinical trial. Please summarize it.

Introduction. After observing the inefficient pelvic control and the difficulty in identifying the musculature used when performing the different dance positions, it was decided to carry out a core strengthening and lumbo-pelvic stabilization exercise intervention with dancers of the Dance Conservatory of Murcia. Approximately 40 students in the 6th year of professional dance of the 4 specialties taught will participate in this study. Objectives. To improve core musculature, lumbo-pelvic stability, dance technique and proprioception, to favor the correct integration of the dancer's body scheme and muscular synergies, to reduce the risk of injury and to avoid muscular compensations in the specific Arabesque dance position. Methods.For the development of the study, two individual and specific evaluations of the dancer will be performed, pre and post intervention. In them, data and personal history will be collected, assessing joint ranges and asymmetries in the movement of upper and lower limbs, and a musculoskeletal assessment of the spine, hip and knee will be performed by orthopedic tests. Flexibility of the ischiosural muscles will be evaluated by means of the toes-floor test and the popliteal angle test, and muscle strength in the abdominal and lumbar region of the muscles most involved in the arabesque movement. In addition, core stability will be evaluated by specific tests and hip and knee extension range along with hyperlordosis when performing the Arabesque. The intervention will be carried out through group sessions of 4 to 6 participants, and exercises aimed at muscle strengthening and improving lumbo-pelvic stability will be taught. The intervention will be performed 1 hour per week, with each group, for 2 months and they will be instructed to work this routine two hours per week at home.

Introduction. After observing the lack of lumbo-pelvic control and the difficulty in identifying the musculature used when performing the different dance positions, it was decided to carry out an exercise intervention to strengthen the abdominal musculature and lumbo-pelvic stabilization with dancers of the Dance Conservatory of Murcia. Approximately 40 students in the 6th year of professional dance of the 4 specialties taught will participate in this study. Objectives. To improve abdominal musculature, lumbo-pelvic stability, dance technique and proprioception, to favor the correct integration of the dancer's body scheme and muscular synergies, to reduce the risk of injury and to avoid muscular compensations in the specific Arabesque dance position. Methods. In order to develop the study, two individual and specific assessments of the dancer will be performed, pre and post intervention. In these, data and personal history were collected, assessing joint ranges and asymmetries in the movement of upper and lower limbs, and musculoskeletal assessment of the spine, hip and knee was performed by orthopedic tests. Flexibility of the ischiosural muscles will be evaluated by means of the toes-floor test and the popliteal angle test, and muscle strength in the abdominal and lumbar region for the muscles most involved in the Arabesque movement. In addition, core stability will be assessed by specific tests and hip and knee extension range along with the increase in lumbar curve when performing Arabesque. The intervention will be carried out through group sessions of 4 to 6 participants, and exercises aimed at muscle strengthening and improving lumbo-pelvic stability will be taught. The intervention will be performed 1 hour per week, with each group, for 2 months and they will be instructed to work this routine two hours per week at home.

You are given the title of a clinical trial. Please write a brief description that matches the trial title.

An Open Label Study to Allow Patients Continuous Use of the HemoCare™ Hemodialysis System for Home Hemodialysis Prior to Market Authorization

This study is designed to monitor and assess the safety of continued access to the HemoCare™ Hemodialysis System used during the review of the pre-market notifications for the devices in the HemoCare™ Hemodialysis System.

You are given the title of a clinical trial. Please write a brief description that matches the trial title.

An Exploratory Pilot Study Assessing the Efficacy of Fecal Microbial Transplantation for Clinical and Endoscopic Characteristics of Ileal Pouch Anal Anastomosis Patients

The investigator is hypothesize that an intensive FMT regimen will have superior efficacy the treatment of inflammatory disorders of the pouch (pouchitis and CLDP).

You are given a short description of a clinical trial. Please generate one or multiple interventions that fit the description.

Fructo-oligosaccharides are known as prebiotic ingredients to modulate the composition of the intestinal microbiota and particularly to stimulate the growth of Bifidobacteria. Imbalance of the intestinal microbiota such as reduction of Bifidobacteria is implicated in Irritable Bowel Syndrome (IBS). Thus the objective of the study is to evaluate the effect of fructo-oligosaccharides to improve IBS score and to explore which modifications of the microbiota are responsible of this improvement.

INTERVENTION 1: <TYPE: Dietary Supplement; NAME: Fructo-oligosaccharides; DESCRIPTION: Dietary supplementation for 4 weeks, >; INTERVENTION 2: <TYPE: Dietary Supplement; NAME: Maltodextrins; DESCRIPTION: Dietary supplementation for 4 weeks, >;

You are given a short description of a clinical trial. Please generate one or multiple interventions that fit the description.

This study will evaluate the long-term safety and tolerability of tezacaftor in combination with ivacaftor (TEZ/IVA) in subjects with cystic fibrosis (CF) aged 6 years and older, homozygous or heterozygous for the F508del mutation.

INTERVENTION 1: <TYPE: Drug; NAME: TEZ/IVA; DESCRIPTION: Fixed-dose combination tablet for oral administration., >; INTERVENTION 2: <TYPE: Drug; NAME: IVA; DESCRIPTION: Tablet for oral administration., >;

You are given a short description of a clinical trial. Please generate one or multiple interventions that fit the description.

This study will evaluate the effect of various degrees of renal function on the pharmacokinetics and safety of ALKS 5461.

INTERVENTION 1: <TYPE: Drug; NAME: ALKS 5461; DESCRIPTION: Single dose, given orally, >;

You are given a short description of a clinical trial. Please design one primary outcome for the trial and if needed one or more secondary outcomes.

Task shifting of less complex healthcare tasks to lay health workers (LHWs) is increasingly employed strategy to address the global shortage of skilled health workers. Despite availability of effective treatment, tuberculosis (TB) remains an important cause of mortality with 1.3 million lives lost globally to TB in 2012. The greatest proportion of new TB cases occurs in Africa and over 95% of TB deaths occur in low income countries (LICs). In response to the combined high TB burden and severe healthcare worker shortages in these settings, outpatient TB care is among the tasks commonly shifted to LHWs. LHWs are community members who have received some training but are not healthcare professionals. Randomised trials show LHWs improve access to basic health services and TB treatment outcomes, however, insufficient training and supervision are recognized barriers to their effectiveness. The investigators' goal is to improve TB care provided by LHWs in Malawi by implementing and evaluating a knowledge translation (KT) strategy designed to facilitate incorporation of evidence into LHW practice. The investigators will employ a mixed methods design including a pragmatic cluster randomized controlled trial to evaluate effectiveness of the strategy and qualitative methods to understand barriers and facilitators to scalability and sustainability of the program.

PRIMARY OUTCOME: <MEASURE: Proportion of Cases Successfully Treated, Defined as the Total Number of Cases Cured and Completing Treatment.; TIME_FRAME: 1 year; DESCRIPTION: primary outcome =proportion of cases successfully treated, defined as the total number of cases cured and completing treatment.; > SECONDARY OUTCOME 1: MEASURE: Proportion of Default Cases (Treatment Interrupted >= 2 Consecutive Months); TIME_FRAME: 1 year; DESCRIPTION: secondary outcome =proportion of default cases (treatment interrupted >= 2 consecutive months); >; SECONDARY OUTCOME 2: MEASURE: Proportion of Successes Among HIV Co-infected Cases; TIME_FRAME: 1 year; DESCRIPTION: secondary outcome = proportion of successes among HIV co-infected cases; >;

You are given a short description of a clinical trial. Please design one primary outcome for the trial and if needed one or more secondary outcomes.

This is an open pilot trial of web-based parent training for tantrums and disruptive behavior in children. Parents will be asked to complete a battery of tests to assess their children' behaviors before and after the intervention. Children will undergo a psychiatric evaluation as part of screening. The intervention will be delivered online via an app over a period of 6 weeks. It consists of 8 self-guided courses that take approximately 10 minutes to complete and include text and animated parent-child simulations. Parents will also complete 3 one-hour videoconferencing sessions with a study clinician. During the intervention, parents will be taught various strategies for managing situations that can be anger provoking for their child. This study is conducted to examine whether a digitally-delivered version of parent-management training can be used to reduce behavioral problems including anger outbursts, irritability, aggression and noncompliance.

PRIMARY OUTCOME: <MEASURE: Feasibility measured by Program completion; TIME_FRAME: Endpoint- Week 6; DESCRIPTION: Measured by completion of 80% or more of the modules; > SECONDARY OUTCOME 1: MEASURE: Disruptive Behavior Rating Scale; TIME_FRAME: Baseline (Week 0) and End-point (Week 6); DESCRIPTION: 16-item rating scale used to assess inattention, hyperactivity-impulsivity, and oppositional defiant behavior among school-aged children. It includes two 8 question subscales, one of which assesses the frequency of these constructs while the other assesses the interference of these constructs in different parts of the child's life. Each item is graded between 0-3 so that each sub-scale has a maximum score of 24 and a minimum score of 0 with a total range of 24. The two subscales are not combined in any way. Higher values are a worse outcome as they either represent a greater frequency or interference (depending on the sub-scale).; >; SECONDARY OUTCOME 2: MEASURE: MAP-DB- Multidimensional Assessment of Preschool Disruptive Behavior; TIME_FRAME: Baseline (Week 0) and End-point (Week 6); DESCRIPTION: A developmentally sensitive questionnaire that includes ~74 items, to assess frequency of temper loss in terms of tantrum features and anger regulation in preschool-aged children. Will perform a preliminary evaluation of intervention effectiveness by assessing change in pre-post scores. Each item is rated on a 6-point likert scale ranging between "never" to "many times each day". The scoring system for this measure is not published, but the authors of this novel tool have agreed to assist in the scoring of this scale.; >; SECONDARY OUTCOME 3: MEASURE: SNAP-Swanson, Nolan and Pelham Questionnaire (SNAP); TIME_FRAME: Baseline (Week 0) and Endpoint (Week 6); DESCRIPTION: Parent and teacher questionnaires with 18 scored items. Items 1-9 assess inattention in children, while items 11-19 assess hyperactivity in children. Each item ranges between 0-3. Items 10 and 20 are not scored. The higher the score, the worse the outcome as the higher scores reflect greater frequency in the child's inattention or hyperactivity. The two sub-scales are not combined.; >; SECONDARY OUTCOME 4: MEASURE: CBCL - Child Behavior Checklist; TIME_FRAME: Baseline (Week 0) and Endpoint (Week 6); DESCRIPTION: The Child Behavior Checklist is a parent rating of child psychopathology that has factor-analytically derived scales of anxiety, depression, and disruptive behavior. It includes 7 general questions about the child's preferences and activities, and 113 items to assess childhood behavior. We will use it to obtain a more detailed characterization of psychopathology in children.; >; SECONDARY OUTCOME 5: MEASURE: ARI-Affective Reactivity Index; TIME_FRAME: Screening (Week 0) and Endpoint (Week 6); DESCRIPTION: ARI is a 7-item measure of irritability in children and adolescents. Items are rated between 0-2, except for the last item (Number 7) which is not used for scoring. The scale has a minimum score of 0 and a maximum score of 12. An "Affective Reactivity Index Average Score" will be calculated, which is the total score divided by 6. The higher the score, the worse the outcome as this represents greater problems related to irritability. There are no subscales in this measure.; >;

You are given the full description of a clinical trial. Please summarize it.

OBJECTIVES: I. Determine the safety and efficacy of monoclonal antibody HuG1-M195 as demonstrated by frequency of complete remission (CR) in patients with acute myelogenous leukemia with regimen failure on the control arm of PDL Study 195-301. II. Determine additional evidence of clinical benefit of this treatment as demonstrated by frequency of partial remission (PR), durations of CR and PR, and progression free and overall survival in these patients. OUTLINE: This is a multicenter study. Patients receive monoclonal antibody HuG1-M195 (MOAB HuM195) IV over 4 hours on days 1-4 every 2 weeks for 4 courses. Patients without disease progression after completion of course 4 continue to receive MOAB HuM195 as above. Treatment repeats every month for a maximum of 8 additional courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: A maximum of 100 patients will be accrued for this study.

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody in treating patients who have acute myelogenous leukemia that did not respond to standard treatment given in clinical trial PDL 195-301.

You are given the full description of a clinical trial. According to this description, please design inclusion and exclusion criteria for selecting participants.

An estimated 20-65% of women treated with breast surgery for breast cancer experience chronic pain in the treated breast. Patients will be randomize between: infiltration with chlorhydrate of ropivacaine at the time of breast surgery for cancer versus placebo.Intra-operative analgesia will be standardized as well as peri-operative pain management.

Inclusion Criteria: - Breast cancer patients treated by conservative surgery with axillary node dissection or treated by mastectomy with or without axillary node dissection or sentinel lymph node biopsy. - ASA physical status 1, 2 or 3 - With a minimum life expectancy of 2 years - Written informed consent Exclusion Criteria: - Any previous cancer other than breast cancer - Allergies to local anesthesic and morphine - Reported history of drug - Pregnancy - Homolateral breast surgery during the last 3 years - Analgesic use pre-operatively - Renal, pulmonary or liver major dysfunction - Active malignant disease - Unable to follow the protocol for any reason

You are given a short description of a clinical trial. Please design one primary outcome for the trial and if needed one or more secondary outcomes.

Provoked vestibulodynia (PVD) is one major subtype of vulvar pain, affecting close to one in ten women and resulting in pain during attempts at vaginal intercourse and/or attempts to insert a digit, device or tampon into the vagina. Management involves a multidisciplinary approach, through physicians, psychologists, sex therapists and physiotherapists. Low Level Laser Therapy (LLLT) is a therapeutic modality involving irradiation of injured or diseased tissue with a combination of red and infrared light. This process is thought to initiate a series of physiological reactions within the cells exposed to light at these wavelengths, leading to the restoration of normal cell structure and function. The investigators hypothesize that LLLT will be effective at reducing pain and improving sexual function among women with PVD. The purpose of this double-blind randomized controlled trial is to assess the feasibility of using a LLLT intervention for the management of PVD in women. The aim is to determine whether there is evidence of a positive effect of LLLT, delivered using a BioFlexTM laser system (Health Canada Licence No. 7931) and a semi-standardized protocol, in terms of self-reported pain and sexual functioning, physiological responses to pressure applied at the vulvar vestibule, tonic and phasic activation of the PFM and/or corticomotor excitability to the PFMs in women with PVD with or without concurrent vaginismus (VAG) when compared to an identical treatment schedule where sham LLLT is delivered. Women will be recruited from among eighty women with confirmed PVD and PVD+VAG who participate in a cross sectional study investigating pelvic floor muscle involvement in PVD. If they are interested in participating in this intervention study, they will be asked to consent to having their data from the cross sectional study used for the purposes of this concurrent study. Women will be evaluated before the intervention using a battery of physical assessments and questionnaires, re-evaluated on primary outcome measures 3 weeks after initiating the intervention and then re-evaluated using the complete battery of physical assessment and questionnaires at the end of the intervention period. If we secure further funding, a medium term (12 weeks later) follow-up will be added. Physical assessment will include evaluation of pressure-pain threshold, temporal summation of pain, electromyographic (EMG) evaluation of PFM activity, responses of the PFMs to pressure applied at the vulvar vestibule using a custom electronic vulvalgesiometer, motor evoked potential threshold, amplitude, latency and the duration of cortically mediated silent period recorded from the PFMs following transcranial magnetic stimulation. The questionnaires will include the The Vulvar Pain Assessment Questionnaire (VPAQ), the Female Sexual Functioning Index, the Pain Catastrophizing Scale, the Depression Anxiety Stress Scales and the Central Sensitization Inventory. Three weeks and 12 weeks after the first start of treatment, the Global Perception of Improvement and Global patient satisfaction with treatment questionnaires will be administered. These will be repeated 12 weeks after completing treatment if funding becomes available.

PRIMARY OUTCOME: <MEASURE: Global perception of improvement; TIME_FRAME: 3 weeks (during intervention); DESCRIPTION: The Global perception of improvement is a single question through which participants provide a ordinal rating based on their overall perception of improvement attributed to the intervention. Much Better, Better, About the same, Worse, Much worse. Higher ratings is associated with better outcomes.; > SECONDARY OUTCOME 1: MEASURE: Global Patient satisfaction with treatment; TIME_FRAME: 3 weeks (during intervention); DESCRIPTION: Global patient satisfaction with treatment is a single question through which participants provide a ordinal rating based on their satisfaction with the intervention. Completely, Somewhat, Not at all. Higher ratings is associated with better outcomes.; >; SECONDARY OUTCOME 2: MEASURE: Global Patient satisfaction with treatment; TIME_FRAME: 12 weeks (following intervention); DESCRIPTION: Global patient satisfaction with treatment is a single question through which participants provide a ordinal rating based on their satisfaction with the intervention. Completely, Somewhat, Not at all. Higher ratings is associated with better outcomes.; >; SECONDARY OUTCOME 3: MEASURE: Global Patient satisfaction with treatment; TIME_FRAME: 12 weeks after intervention (if funding becomes available); DESCRIPTION: Global patient satisfaction with treatment is a single question through which participants provide a ordinal rating based on their satisfaction with the intervention. Completely, Somewhat, Not at all. Higher ratings is associated with better outcomes.; >; SECONDARY OUTCOME 4: MEASURE: Female Sexual Function Index (FSFI); TIME_FRAME: Baseline; DESCRIPTION: This is a 19-item validated questionnaire for assessing the key dimension of sexual function in women, considered a gold standard for evaluation of sexual function. It assesses six domains: desire, arousal , lubrification, orgasm, satisfaction, and pain. All scores are totaled for a maximum of 36. Higher scores represents better sexual function. A score ≤26.55 has been set as a cutoff to identify those at risk for sexual dysfunction.; >; SECONDARY OUTCOME 5: MEASURE: Female Sexual Function Index (FSFI); TIME_FRAME: 12 weeks (following intervention); DESCRIPTION: This is a 19-item validated questionnaire for assessing the key dimension of sexual function in women, considered a gold standard for evaluation of sexual function. It assesses six domains: desire, arousal , lubrification, orgasm, satisfaction, and pain. All scores are totaled for a maximum of 36. Higher scores represents better sexual function. A score ≤26.55 has been set as a cutoff to identify those at risk for sexual dysfunction.; >; SECONDARY OUTCOME 6: MEASURE: Female Sexual Function Index (FSFI); TIME_FRAME: 12 weeks after intervention (if funding becomes available); DESCRIPTION: This is a 19-item validated questionnaire for assessing the key dimension of sexual function in women, considered a gold standard for evaluation of sexual function. It assesses six domains: desire, arousal , lubrification, orgasm, satisfaction, and pain. All scores are totaled for a maximum of 36. Higher scores represents better sexual function. A score ≤26.55 has been set as a cutoff to identify those at risk for sexual dysfunction.; >; SECONDARY OUTCOME 7: MEASURE: Motor evoked potential (MEP) peak to peak amplitude (µV); TIME_FRAME: Baseline; DESCRIPTION: Transcranial magnetic stimulation outcome will be determined for all participants and compared among groups. A Magstim® 200 system coupled with a double coil (96 mm loops, P/N 9902) will be used to probe the corticospinal projections to PFMs. MEPs will be ensemble averaged to generate estimates of MEP peak to peak amplitude (µV).; >; SECONDARY OUTCOME 8: MEASURE: Motor evoked potential (MEP) peak to peak amplitude (µV); TIME_FRAME: 12 weeks (immediately after the intervention); DESCRIPTION: Transcranial magnetic stimulation outcome will be determined for all participants and compared among groups. A Magstim® 200 system coupled with a double coil (96 mm loops, P/N 9902) will be used to probe the corticospinal projections to PFMs. MEPs will be ensemble averaged to generate estimates of MEP peak to peak amplitude (µV).; >; SECONDARY OUTCOME 9: MEASURE: Motor evoked potential (MEP) peak to peak amplitude (µV); TIME_FRAME: 12 weeks later (if funding becomes available); DESCRIPTION: Transcranial magnetic stimulation outcome will be determined for all participants and compared among groups. A Magstim® 200 system coupled with a double coil (96 mm loops, P/N 9902) will be used to probe the corticospinal projections to PFMs. MEPs will be ensemble averaged to generate estimates of MEP peak to peak amplitude (µV).; >; SECONDARY OUTCOME 10: MEASURE: Cortical silent period (ms); TIME_FRAME: Baseline; DESCRIPTION: Transcranial magnetic stimulation outcome will be determined for all participants and compared among groups. A Magstim® 200 system coupled with a double coil (96 mm loops, P/N 9902) will be used to probe the corticospinal projections to PFMs. MEP cortical silent period (cSP) will be measured from individual trials and then averaged.; >; SECONDARY OUTCOME 11: MEASURE: Cortical silent period (ms); TIME_FRAME: 12 weeks (immediately after the intervention); DESCRIPTION: Transcranial magnetic stimulation outcome will be determined for all participants and compared among groups. A Magstim® 200 system coupled with a double coil (96 mm loops, P/N 9902) will be used to probe the corticospinal projections to PFMs. MEP cortical silent period (cSP) will be measured from individual trials and then averaged.; >; SECONDARY OUTCOME 12: MEASURE: Cortical silent period (ms); TIME_FRAME: 12 weeks later (if funding becomes available); DESCRIPTION: Transcranial magnetic stimulation outcome will be determined for all participants and compared among groups. A Magstim® 200 system coupled with a double coil (96 mm loops, P/N 9902) will be used to probe the corticospinal projections to PFMs. MEP cortical silent period (cSP) will be measured from individual trials and then averaged.; >; SECONDARY OUTCOME 13: MEASURE: Pain Catastrophizing Scale; TIME_FRAME: Baseline; DESCRIPTION: This is a reliable and valid scale to measure of catastrophizing. The scores from this questionnaire is predictors of intensity of physical and emotional distress. It is a self-report measure, consisting of 13 items scored from 0 to 4, resulting in a total possible score of 52. The higher the score, the more catastrophizing thoughts are present.; >; SECONDARY OUTCOME 14: MEASURE: Pain Catastrophizing Scale; TIME_FRAME: 12 weeks (after the intervention); DESCRIPTION: This is a reliable and valid scale to measure of catastrophizing. The scores from this questionnaire is predictors of intensity of physical and emotional distress. It is a self-report measure, consisting of 13 items scored from 0 to 4, resulting in a total possible score of 52. The higher the score, the more catastrophizing thoughts are present.; >; SECONDARY OUTCOME 15: MEASURE: Pain Catastrophizing Scale; TIME_FRAME: 12 weeks later (if funding becomes available); DESCRIPTION: This is a reliable and valid scale to measure of catastrophizing. The scores from this questionnaire is predictors of intensity of physical and emotional distress. It is a self-report measure, consisting of 13 items scored from 0 to 4, resulting in a total possible score of 52. The higher the score, the more catastrophizing thoughts are present.; >; SECONDARY OUTCOME 16: MEASURE: Depression Anxiety Stress Scale (DASS); TIME_FRAME: Baseline; DESCRIPTION: This is a 42-item self report instrument designed to measure the three related negative emotional states of depression, anxiety and tension/stress. Each one contains 14 items, divided into subscales of 2-5 items with similar content. The DASS have been shown to have high internal consistency and to yield meaningful discriminations in a variety of settings. A higher score on the DASS indicates greater severity or frequency of these negative emotional symptoms. The maximum score is 126.; >; SECONDARY OUTCOME 17: MEASURE: Depression Anxiety Stress Scale (DASS); TIME_FRAME: 3 weeks (during the intervention); DESCRIPTION: This is a 42-item self report instrument designed to measure the three related negative emotional states of depression, anxiety and tension/stress. Each one contains 14 items, divided into subscales of 2-5 items with similar content. The DASS have been shown to have high internal consistency and to yield meaningful discriminations in a variety of settings. A higher score on the DASS indicates greater severity or frequency of these negative emotional symptoms. The maximum score is 126.; >; SECONDARY OUTCOME 18: MEASURE: Depression Anxiety Stress Scale (DASS); TIME_FRAME: 12 weeks (after the intervention); DESCRIPTION: This is a 42-item self report instrument designed to measure the three related negative emotional states of depression, anxiety and tension/stress. Each one contains 14 items, divided into subscales of 2-5 items with similar content. The DASS have been shown to have high internal consistency and to yield meaningful discriminations in a variety of settings. A higher score on the DASS indicates greater severity or frequency of these negative emotional symptoms. The maximum score is 126.; >; SECONDARY OUTCOME 19: MEASURE: Depression Anxiety Stress Scale (DASS); TIME_FRAME: 12 weeks later (if funding becomes available); DESCRIPTION: This is a 42-item self report instrument designed to measure the three related negative emotional states of depression, anxiety and tension/stress. Each one contains 14 items, divided into subscales of 2-5 items with similar content. The DASS have been shown to have high internal consistency and to yield meaningful discriminations in a variety of settings. A higher score on the DASS indicates greater severity or frequency of these negative emotional symptoms. The maximum score is 126.; >; SECONDARY OUTCOME 20: MEASURE: Central sensitization index; TIME_FRAME: Baseline; DESCRIPTION: The Central Sensitisation Inventory (CSI) is a self-report outcome measure designed to identify patients who have symptoms that may be related to central sensitisation (CS) or central sensitivity syndromes (CSS). Part A includes 25 questions related to common CSS symptoms. Part B determines if the patient has been diagnosed with certain CSS disorders or related disorders, such as anxiety and depression. CSI severity levels have been established for part A: subclinical = 0 to 29; mild = 30 to 39; moderate = 40 to 49; severe = 50 to 59; and extreme = 60 to 100.; >; SECONDARY OUTCOME 21: MEASURE: Central sensitization index; TIME_FRAME: 12 weeks (after the intervention); DESCRIPTION: The Central Sensitisation Inventory (CSI) is a self-report outcome measure designed to identify patients who have symptoms that may be related to central sensitisation (CS) or central sensitivity syndromes (CSS). Part A includes 25 questions related to common CSS symptoms. Part B determines if the patient has been diagnosed with certain CSS disorders or related disorders, such as anxiety and depression. CSI severity levels have been established for part A: subclinical = 0 to 29; mild = 30 to 39; moderate = 40 to 49; severe = 50 to 59; and extreme = 60 to 100.; >; SECONDARY OUTCOME 22: MEASURE: Central sensitization index; TIME_FRAME: 12 weeks later (if funding becomes available); DESCRIPTION: The Central Sensitisation Inventory (CSI) is a self-report outcome measure designed to identify patients who have symptoms that may be related to central sensitisation (CS) or central sensitivity syndromes (CSS). Part A includes 25 questions related to common CSS symptoms. Part B determines if the patient has been diagnosed with certain CSS disorders or related disorders, such as anxiety and depression. CSI severity levels have been established for part A: subclinical = 0 to 29; mild = 30 to 39; moderate = 40 to 49; severe = 50 to 59; and extreme = 60 to 100.; >; SECONDARY OUTCOME 23: MEASURE: The Vulvar Pain Assessment Questionnaire - Supplemental Domains; TIME_FRAME: Baseline; DESCRIPTION: Supplemental Domains Pain Descriptors (VPAQdesc). This pain descriptor scale contains the most common words used to describe chronic vulvar pain. Burning/stinging pain Incisive pain Sensitivity Coping Strategies (VPAQcope). This scale addresses some common coping strategies that are utilized by women with vulvar pain. Distraction/relaxation strategies Problem-solving strategies Partner Factors (VPAQpartner). This 24-item scale encompasses how romantic partners/spouses may be impacted by/respond to vulvar pain experienced by one partner. Negative response Support seeking Impact on relationship Sexual communication Each subscale is scored separately and is the average of the items. The lowest possible score is 0 (Not at all) and the highest is 4 (very much). Higher score means worse symptoms; >; SECONDARY OUTCOME 24: MEASURE: The Vulvar Pain Assessment Questionnaire - Supplemental Domains; TIME_FRAME: 3 weeks (during intervention); DESCRIPTION: Supplemental Domains Pain Descriptors (VPAQdesc). This pain descriptor scale contains the most common words used to describe chronic vulvar pain. Burning/stinging pain Incisive pain Sensitivity Coping Strategies (VPAQcope). This scale addresses some common coping strategies that are utilized by women with vulvar pain. Distraction/relaxation strategies Problem-solving strategies Partner Factors (VPAQpartner). This 24-item scale encompasses how romantic partners/spouses may be impacted by/respond to vulvar pain experienced by one partner. Negative response Support seeking Impact on relationship Sexual communication Each subscale is scored separately and is the average of the items. The lowest possible score is 0 (Not at all) and the highest is 4 (very much). Higher score means worse symptoms; >; SECONDARY OUTCOME 25: MEASURE: The Vulvar Pain Assessment Questionnaire - Supplemental Domains; TIME_FRAME: 12 weeks (following intervention); DESCRIPTION: Supplemental Domains Pain Descriptors (VPAQdesc). This pain descriptor scale contains the most common words used to describe chronic vulvar pain. Burning/stinging pain Incisive pain Sensitivity Coping Strategies (VPAQcope). This scale addresses some common coping strategies that are utilized by women with vulvar pain. Distraction/relaxation strategies Problem-solving strategies Partner Factors (VPAQpartner). This 24-item scale encompasses how romantic partners/spouses may be impacted by/respond to vulvar pain experienced by one partner. Negative response Support seeking Impact on relationship Sexual communication Each subscale is scored separately and is the average of the items. The lowest possible score is 0 (Not at all) and the highest is 4 (very much). Higher score means worse symptoms; >; SECONDARY OUTCOME 26: MEASURE: The Vulvar Pain Assessment Questionnaire - Supplemental Domains; TIME_FRAME: 12 weeks after intervention (if funding becomes available); DESCRIPTION: Supplemental Domains Pain Descriptors (VPAQdesc). This pain descriptor scale contains the most common words used to describe chronic vulvar pain. Burning/stinging pain Incisive pain Sensitivity Coping Strategies (VPAQcope). This scale addresses some common coping strategies that are utilized by women with vulvar pain. Distraction/relaxation strategies Problem-solving strategies Partner Factors (VPAQpartner). This 24-item scale encompasses how romantic partners/spouses may be impacted by/respond to vulvar pain experienced by one partner. Negative response Support seeking Impact on relationship Sexual communication Each subscale is scored separately and is the average of the items. The lowest possible score is 0 (Not at all) and the highest is 4 (very much). Higher score means worse symptoms; >;

You are given the title of a clinical trial. Please write a brief description that matches the trial title.

Will Perceptual Learning Via Video Game Playing Improve Visual Acuity, Stereopsis and Fixation Stability in Mild Amblyopes? Part 2 Study

Contrast balanced dichoptic videogame training has been found to improve sensory functions in adults with amblyopia; best corrected distance visual acuity (BCVA) and stereopsis, but its effect on motor function, namely amblyopic eye fixation stability, is unknown. Furthermore, the effect of treatment in cases of mild amblyopia is not well understood. The aim of this study is to find out the difference on fixation stability, BCVA and stereopsis in mild amblyopes after 6 weeks' contrast balanced dichoptic video game training.

You are given a short description of a clinical trial. Please generate one or multiple interventions that fit the description.

This is a double blind single site vehicle controlled study. The following activities will be conducted at each visit. Baseline Research Center Visit Obtain a signed and dated, written ICF prior to any study-related procedures.· Obtain demographic data· Assign subject number based on the order in which subjects present to the research center· Obtain medical/surgical history· Obtain concomitant medications· Assess eligibility based on inclusion/exclusion criteria· Collect blood and urine samples for clinical laboratory tests and send to the central laboratory· Perform serum pregnancy test in all women of child bearing potential (WOCBP)· Obtain vitals· Assess IGA, inflammation, erythema· Perform facial lesion counts· Perform local signs and symptoms assessments· Perform Columbia Suicide Severity Rating Scale (C-SSRS) for baseline visit· Randomize subject and dispense Investigational Study Medication and use instructions along with compliance diary· Schedule return visit Week 2 Phone Call· Reassess medical/surgical history· Reassess concomitant medications· Assess adverse events· Assess compliance Weeks 4, 8 Research Center Visit Reassess medical/surgical history· Reassess concomitant medications· Assess adverse events· Collect a urine sample from female subjects of childbearing potential for a urine pregnancy test· Obtain vitals· Assess IGA, inflammation, erythema· Perform facial lesion counts· Perform local signs and symptoms assessments· Perform Columbia Suicide Severity Rating Scale (C-SSRS) for return visits· Assess compliance diary and Investigational Study Medication, collect used Investigational Study Medication and redispense as necessary· Schedule return visit Week 12 Research Center Visit· Reassess medical/surgical history· Reassess concomitant medications· Assess adverse events· Collect a urine sample from female subjects of childbearing potential for a urine pregnancy test· Collect blood and urine samples for clinical laboratory tests and send to the central laboratory· Obtain vitals· Assess IGA, inflammation, erythema· Perform facial lesion counts· Perform local signs and symptoms assessments· Perform Columbia Suicide Severity Rating Scale (C-SSRS) for return visits· Assess compliance diary and Investigational Study Medication· Collect diary and Investigational Study Medication· Release subject from study participation

INTERVENTION 1: <TYPE: Drug; NAME: Roflumilast Cream; DESCRIPTION: Topical Cream, >;

You are given the full description of a clinical trial. Please summarize it.

Liver transplantation (LT) has recently been proposed as alternative treatment for definitively unresectable colorectal liver metastases in selected patients with a 60% estimated survival at 5 years in a recent prospective Norwegian study. However, disease free survival (DFS) in this preliminary study has been poor with 90% of recurrence after LT. The objective of our study is to validate LT as a therapeutic option on a large multicentric scale throughout a highly strict policy selection in term of survival, disease free survival and quality of life. In order to reduce selection bias, unresectability criteria and theorical indication to LT will be confirmed by an independent Steering Committee including HPB surgeons, oncologists, radiologists and hepatologists.

This is a multicentric randomized parallel group open trial comparing 5-year survival of chemotherapy followed by LT (Group LT+C) versus chemotherapy alone (Group C) in patients with confirmed unresectable liver-only metastases, well controlled by chemotherapy (no progression) and extensively explored by modern imaging techniques. The primary objective of the trial is to validate in a large multicentric cohort of selected patients the possibility to obtain at least 50% 5-years survival with LT combined to chemotherapy compared to around 10% with chemotherapy alone.

You are given the full description of a clinical trial. According to this description, please design inclusion and exclusion criteria for selecting participants.

In recent years most industrialized nations have been confronted with a dramatic increase in cases dealing with back pain; in Germany, back pain belongs to the major individual and societal health problems with associated costs that have put a strain not only on health care systems. Besides frequent demand for medical services, loss of production (due to temporal sick leave) and disability allowances are important economic factors. In total, the estimated annual costs caused by back pain range between 16 and 22 billion Euros. Population based studies revealed high life-time prevalence with 80% report having ever experienced back pain. The point prevalence lies between 30 and 40%. Approximately one-fourth to one-third of those affected suffer from clinically significant back pain. Epidemiological evidence for the prevalence of back pain, its severity, course and associated risk factors is extensive; however, little systematic knowledge is available about treatment of back pain especially about return-to-work interventions. This study is designed as a quasi-experimental study to evaluate benefits of return-to-work interventions during medical rehabilitation. Positive effects are expected for low back pain related functional limitations and subsequently job performance. The intervention tested is based on the biomechanical model of chronic pain that assumes a relationship between external strain, body posture, muscle activity, and intravertebral pressure. According to this model, chronic low back pain is partially caused by overexertion and poor postural habits. The intervention aims at lowering the impact of biomechanical stress by training an adequate body posture while performing activities of daily living or job-related activities. Additionally, performing job-related activities target fear-avoidance beliefs especially assumptions about the connection between pain and work activities. The experimental group training good postural habits while performing activities of daily living or job-related activities (additionally to standard rehabilitation activities such as physiotherapy or education and counselling) will be compared with participants receiving a standard rehabilitation only. Outcome measures are assessed at baseline, post-intervention, and 6 month post-intervention.

Inclusion Criteria: - Chronic low back pain - Undergoing inpatient rehabilitation - Working age Exclusion Criteria: - Receiving or applying for retirement pension - Diagnostic findings that require surgery

You are given the full description of a clinical trial. According to this description, please design inclusion and exclusion criteria for selecting participants.

PRIMARY OBJECTIVES: I. Evaluate disease control rate (DCR) at 4 months. II. Evaluate tumor-based biomarkers in paired pre and post treatment biopsies (10 in each arm, 30 total) that may correlate with treatment or prospectively identify patients likely to respond to treatment with danvatirsen (AZD9150) in combination with durvalumab (MEDI4736) (may include PD-L1 expression, phosphorylated or total STAT3 expression, tumor genetics, characterization of immune infiltrates, or other stratification markers). III. Explore the relationship between PD-L1 protein levels in the membrane of circulating tumor cells obtained by peripheral blood draws prior to, during, and after treatment with clinical endpoints including treatment efficacy and toxicity. SECONDARY OBJECTIVES: I. Evaluate the frequency of dose limiting toxicities. II. Evaluate frequency of objective response (as defined as partial response [PR] or complete response [CR] according to Response Evaluation Criteria in Solid Tumors [RECIST] 1.1 criteria). III. Evaluate duration of response (DOR) measured from the time measurement criteria are first met for CR or PR, whichever is first recorded, until the first date that recurrent or progressive disease (PD) is objectively documented. IV. Evaluate best overall response (including CR, PR, stable disease [SD], and PD, according to RECIST version 1.1 criteria). V. Evaluate progression free survival (PFS) from allocation to the first documentation of PD as determined by the investigator or death from any cause, whichever occurs first. EXPLORATORY OBJECTIVES: I. Explore the relationship between radiologic metrics (radiomics) prior to, during, and after treatment with clinical endpoints including treatment efficacy and toxicity. OUTLINE: Patients receive danvatirsen intravenously (IV) over 1 hour on days 7, 5 and 3 prior to cycle 1, then on days 1, 8, 15 and 22. Patients also receive durvalumab IV over 1 hour on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days, 1-3 months, then every 2 months thereafter.

Inclusion Criteria: - The patient/legal representative must be able to read and understand the informed consent form (ICF) and must have been willing to give written informed consent and any locally required authorization (e.g., Health Insurance Portability and Accountability Act in the United States of America [USA]; European Union Data Privacy Directive in the European Union [EU]) before any study-specific procedures, including screening evaluations, sampling, and analyses - Has a histological confirmation of pancreatic cancer, mismatch deficient colorectal cancer, or non-small cell lung cancer (NSCLC) that is refractory to standard therapy or for which no standard of care regimen currently exists - Has an Eastern Cooperative Oncology Group (ECOG) performance score (PS) score of 0 or 1 - Has measurable disease, defined as at least 1 lesion that can be accurately measured in at least 1 dimension (longest diameter to be recorded) with a minimum size of 10 mm by computerized tomography (CT) scan, except lymph nodes which must have minimum short axis size of 15 mm (CT scan slice thickness no greater than 5 mm in both cases). Indicator lesions must not have been previously treated with surgery, radiation therapy, or radiofrequency ablation unless there is documented progression after therapy - Transfusions intended to elevate any parameters below solely for the intent of meeting study eligibility are not permitted - Leukocytes >= 3000 mcL - Absolute neutrophil count >= 1500 mcL - Platelets > = 100 000 mcL - Hemoglobin >= 9 g/dL - Total bilirubin =< 1.5 x upper limit of normal (ULN) - Total bilirubin =< 3 x ULN in patients with documented Gilbert's syndrome (unconjugated hyperbilirubinemia) or in the presence of liver metastases - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x ULN if no demonstrable liver metastases or =< 5 x ULN in the presence of liver metastases - Creatinine within normal limits OR, for patients with levels above institutional normal: creatinine clearance measured by 24-hour urine collection >= 60 mL/min, OR calculated corrected creatinine clearance >= 60 mL/min/1.73 m^2 using the Cockcroft-Gault formula (Cockcroft and Gault 1976) corrected for the body surface area - Women of childbearing potential and men who are sexually active with a female partner of childbearing potential must be surgically sterilized, practicing abstinence, or agree to use 2 birth control methods before study entry, for the duration of study participation, and for 20 weeks after the final dose of study drug; cessation of birth control after this point should be discussed with a responsible physician. Women of childbearing potential are defined as those who are not surgically sterile (i.e., bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause). Two methods of contraception which are considered accurate per protocol must be combined. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control - Women of childbearing potential also may not be breast feeding and must have a negative serum or urine pregnancy test within 72 hours before the start of study treatment - The patient/legal representative must be willing to provide written consent for collection of formalin fixed paraffin-embedded blocks or slides from archival diagnostic histology samples, where available Exclusion Criteria: - Has a spinal cord compression unless asymptomatic, radiographically stable over the last 4 weeks, and not requiring steroids for at least 4 weeks before the start of study treatment - Presently has a second malignancy other than squamous cell carcinoma of the head and neck (SCCHN), or history of treatment for invasive cancer other than SCCHN in the past 3 years. Exceptions are: - Previously treated in-situ carcinoma (i.e., noninvasive) - Cervical carcinoma stage 1B or less - Noninvasive basal cell and squamous cell skin carcinoma - Radically treated prostate cancer (prostatectomy or radiotherapy) with normal prostate-specific antigen, and not requiring ongoing antiandrogen hormonal therapy - Patients must have completed previous cancer-related treatments before enrollment. Any concurrent chemotherapy, radiotherapy, immunotherapy, or biologic, or hormonal therapy for cancer excludes the patient (concurrent use of hormones for noncancer-related conditions [e.g., insulin for diabetes or hormone replacement therapy] is acceptable). The following intervals between end of the prior treatment and first dose of study drug must be observed: - Port-a-cath placement: no waiting required - Minor surgical procedures: >= 7 postoperative days - Major surgery: >= 4 weeks - Radiotherapy: >= 4 weeks - Chemotherapy: >= 4 weeks - Immunotherapy or investigational anticancer therapy with agents other than monoclonal antibodies (mAbs): >= 4 weeks - Immunotherapy or investigational anticancer therapy with mAbs: >= 6 weeks - Immunosuppressive medication: >= 4 weeks with the exceptions of intranasal or inhaled corticosteroids or systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent - Is still experiencing toxicity related to prior treatment and assessed as Common Terminology Criteria for Adverse Events (CTCAE) grade > 1. Exceptions are alopecia and/or anorexia. The eligibility of patients who are still experiencing irreversible toxicity that is not reasonably expected to be exacerbated by the study drugs in this study (e.g., hearing loss) must be reviewed and approved by both the principal investigator and medical monitor - Has experienced immune-related adverse events (AEs) (irAEs) while receiving prior immunotherapy (including anti-CTLA4 treatment) and assessed as CTCAE grade >= 3 - Has active or prior documented autoimmune disease within the past 2 years with the exceptions of vitiligo, Grave's disease, and/or psoriasis not requiring systemic treatment - Has active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis) - Has a history of primary immunodeficiency - Has undergone an organ transplant that requires use of immunosuppressive treatment - Has a history of interstitial lung disease or pneumonitis from any cause - Has a history of allergic reactions attributed to the study treatments (AZD9150 or MEDI4736), their compounds, or agents of similar chemical or biologic composition (e.g., antibody therapeutics) - Suffers from a comorbidity that in the opinion of the investigator renders the patient unsuitable for participation in the study. Such comorbidity may include, but is not limited to, uncontrolled intercurrent illness such as active infection, severe active peptic ulcer disease or gastritis, myocardial infarction within 6 months before entry, congestive heart failure, symptomatic congestive heart failure, active cardiomyopathy, unstable angina pectoris, cardiac arrhythmia, uncontrolled hypertension, or psychiatric illness/social situations that would limit compliance with study requirements - As judged by the investigator, has any evidence of severe or uncontrolled systemic diseases such as active bleeding diatheses, is positive for human immunodeficiency virus (HIV), or has active hepatitis B virus (HBV) and/or hepatitis C virus (HCV) - Has a known history of tuberculosis - Has a condition that, in the opinion of the investigator, would interfere with the evaluation of the study drugs or the interpretation of patient safety or study results - Has received a live attenuated vaccine within 28 days before the first dose of study drug - Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements - Patients with clinically active brain metastases (known or suspected) are excluded unless the brain metastases have been previously treated and are considered stable. Stable brain metastases are defined as no change on CT scan or magnetic resonance imaging (MRI) scan for a minimum of 2 months AND no change in steroid dose for a minimum of 4 weeks, unless change due to intercurrent infection or other acute event - Female subjects who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control

You are given a short description of a clinical trial. Please generate one or multiple interventions that fit the description.

Genomic analysis for metastatic breast cancer(MBC) patients - Participant (Inclusion criteria) 1. Patients who diagnosed metastatic/stage IV breast cancer 2. Patients who were not received treatment for metastatic breast cancer on palliative setting - Process (1) Tissue/ Blood sample - At diagnosis, MBC tissue / blood sample (20cc) will be obtained. - At disease progression after 1st line treatment for MBC, blood sample (20cc) will be obtained (tissue; optional) (2) WES, RNASeq, ctDNA, Exosome - We will analyze genomic characteritics using WES, RNASeq, ctDNA, Exosome.

INTERVENTION 1: <TYPE: Diagnostic Test; NAME: Genomic analysis; DESCRIPTION: WES, RNASeq, ctDNA, Exosome, >;

You are given the title of a clinical trial. Please write a brief description that matches the trial title.

Understanding Pasta Formulations and Portion Size on Satiety in Healthy Weight Women

Investigators are interested in learning how appetite responds to pasta containing different amounts of protein and fiber when provided in two different portion sizes. In this research study, subjects will be asked to eat an entire pasta serving containing different amounts of protein and fiber mixtures. Subjects will be asked to do this on six separate occasions. One time subjects will not receive pasta, only water. After the pasta serving, there will be a buffet of deli style lunch items and subjects may eat as much they desire. Thereafter subjects will describe their feelings of hunger, fullness and desire to eat for 3 hours. In addition, blood will be taken throughout the study period to determine how eating pasta servings in different portion sizes impacts certain hormones released from the intestine, and therefore how they influence appetite. All study visits will take approximately 4 ½ - 5 hours.

You are given the full description of a clinical trial. Please summarize it.

Aim: to clarify the efficacy and safety of acupuncture for patients with functional dyspepsia Design: A single blind randomized controlled trial will be performed in Chengdu, Hunan and Chongqing province. Two hundred participants will be randomly assign to acupuncture and sham acupuncture group. Each participants will receive 20 sessions of acupuncture in 4 weeks, with a duration of 30 minutes in a session. The primary outcome is Patients' global assessments of efficacy in 16 weeks after inclusion. Secondary outcomes include validated Leeds Dyspepsia Questionnaire, Nepean dyspepsia index, etc.

Hypothesis: Acupuncture is efficacious and safe for patients with functional dyspepsia Design: - A single blind randomized controlled trial - 200 participants will be included - Two arms: acupuncture and sham acupuncture group

You are given a short description of a clinical trial. Please generate one or multiple interventions that fit the description.

Early detection of pulmonary exacerbations (PEx) in Cystic Fibrosis (CF) patients is important to quickly trigger treatment and reduce respiratory damage. The investigators hypothesize that using home-based connected devices (CDs) in educated patients applying Cumulative sum charts (CUSUM) to monitor physiological parameters (PP) and patients' perception reported (PRP), will allow early detection of PEx. Objective: to study clinical validity of using CDs and evaluate adherence and satisfaction in CF patients and teams Design: 3 phase multicenter study in 36 CF patients aged >=12 years. Phase 1, patients are equipped during 3 months with CDs. PP and PRP to estimate CUSUM parameters are collected. In phase 2, patient's personalized educational plan to manage alerts is built. In phase 3, PP and PRP are collected during 12 months. Clinical validity, change in patients clinical data, quality of Life/Anxiety-Depression/Satisfaction, patients and teams' acceptance and adherence are assessed.

INTERVENTION 1: <TYPE: Device; NAME: Connected Devices for 3 months; DESCRIPTION: Inclusion will be proposed at a follow-up visit by the child's or adult's referring doctor. A written informed consent form will be obtained. Quality of Life and Anxiety-Depression will be collected. Then, each included patient will be equipped with CDs-spirometer, oxymeter, scale and watch during 3 months for base-line., >; INTERVENTION 2: <TYPE: Behavioral; NAME: Educationnal Intervention; DESCRIPTION: After a first statistical analysis and interpretation (5 months), alert parameters for each patient are then fixed. An educational visit will be scheduled with patients and a personnalized action plan will be defined.., >; INTERVENTION 3: <TYPE: Device; NAME: Connected Devices for 12 months; DESCRIPTION: Each included patient will be re-equipped with CDs-spirometer, oxymeter, scale and watch during 12 months. If alerts occur, patients will be informed by email or SMS, with data transmission to the medical team who will not interfere. Patients should apply the shared action plan they learned. Quality of Life and Anxiety-Depression will be collected., >; INTERVENTION 4: <TYPE: Other; NAME: Interviews; DESCRIPTION: At the end, semi-structured interviews will be completed to explore confidence on the CDs, impact on the doctor-patient relationship, change in the workload of medical team…etc., >; INTERVENTION 5: <TYPE: Behavioral; NAME: Refusal Questionnaires; DESCRIPTION: Clinic staff will email all patients or parents (pediatric settings) to introduce the study. A qualitative interview with 10 patients who declined to participate in the study will be conducted to identify the reason of refusal, >;

You are given a short description of a clinical trial. Please generate one or multiple interventions that fit the description.

The purpose of this study is to assess the extent of and sources of variation in the glycaemic index values of foods measured by different laboratories around the world.

INTERVENTION 1: <TYPE: Drug; NAME: Test Meal: Reference food (glucose or white bread); >; INTERVENTION 2: <TYPE: Drug; NAME: Test Meal: Pirate's Booty; >; INTERVENTION 3: <TYPE: Drug; NAME: Test Meal: Ceaprove wafer; >; INTERVENTION 4: <TYPE: Drug; NAME: Test Meal: Stretch Island Strawberry Fruit Leather; >;

You are given a short description of a clinical trial. Please design one primary outcome for the trial and if needed one or more secondary outcomes.

This is a feasibility study that will assess the efficacy of using autologous blood to treat moderate to severe dry mouth. Dry mouth has been estimated to affect up to 64.8% of the general population (Navazesh et al., 2009) and many patients that are affected by Sjögren's syndrome or have had radiation therapy to combat head or neck cancer (Navazesh et al., 2009). The blood will be applied to the interior of the mouth by means of a mouthwash. This research poses the first potential curative treatment for dry mouth - all other current dry mouth treatments are either symptomatic or lifestyle-based. Autologous blood has been shown to be effective in treating the epithelial surface of dry eyes. This has been attributed to the analogous growth factors in the blood to that of tears - and potentially in this case, saliva - in healing the oral epithelial surface (Herbst et al., 2004).

PRIMARY OUTCOME: <MEASURE: Improvement of signs of clinical dry mouth; TIME_FRAME: 6 months; DESCRIPTION: To assess improvement of signs of dry mouth using the Challachombe scale for visual identification and quantification of dry mouth; > SECONDARY OUTCOME 1: MEASURE: Adherence Self Report Questionnaire to assess patient compliance; TIME_FRAME: 12 months; DESCRIPTION: We will create a questionnaire to assess patient adherence to apply fresh autologous blood during the study and after the study period has ceased. There will also be questions on patient comfort and thoughts on the application process.; >;

You are given the full description of a clinical trial. Please summarize it.

This is a cross-sectional diagnostic accuracy study with up to 250 participants with a goal of obtaining 20 deficient and 20 intermediate samples. The clinic will recruit and consent study participants. Clinic staff will draw 3 whole blood samples and obtain finger stick capillary blood. G6PD activity is reported in terms of grams of hemoglobin (Hb), hence the hemoglobin concentration must be measured. Clinic staff will perform the investigational Standard Diagnostics (SD) Biosensor point-of-care (POC) test for glucose-6-phosphate dehydrogenase (G6PD) deficiency and a HemoCue® hemoglobin test on finger stick capillary blood and on the venous blood samples. Another venous blood sample will be sent to a clinical laboratory improvement amendments (CLIA)-certified laboratory for reference testing by the gold standard assays: - G6PD measurement by spectrophotometry using the Pointe Scientific G6PD reference assay - hemoglobin measurement by a hematology analyzer Individuals identified as G6PD deficient with the reference test will be notified of their results by the clinic and referred to their physician for follow-up.

The primary objective of this study is to assess the accuracy of the SD Biosensor STANDARD G6PD Analyzer in measuring G6PD activity when used by trained health care workers.

You are given a short description of a clinical trial. Please generate one or multiple interventions that fit the description.

Wild-type transthyretin cardiac amyloidosis is an underdiagnosed depository disease in which fibril monomers of misfolded amyloid protein accumulates in various tissues, including the heart, and cause tissue dysfunction. Before onset of cardiac symptoms, many patients will have undergone surgery for idiopathic carpal tunnel syndrome since the protein also deposits in the transversal carpal ligament of the hand. This study investigates patients previously operated for idiopathic carpal tunnel syndrome to determine if they display signs and symptoms of cardiac amyloidosis.

INTERVENTION 1: <TYPE: Diagnostic Test; NAME: DPD Scintigraphy; DESCRIPTION: Confirms/Refutes diagnosis of cardiac amyloidosis., >;

You are given the title of a clinical trial. Please write a brief description that matches the trial title.

Pharmacodynamic Response to Exercise Treatment and Plant-Based Diet in Overweight/Obese Postmenopausal Women With Primary Hormone Receptor Positive Breast Cancer: A Phase 2 Randomized Control Trial

The purpose of this study is to find out what effects, if any, exercise and a plant-based diet have on aromatase levels in postmenopausal women who are overweight and being treated with an aromatase inhibitor for their HR+ breast cancer. The study will also look at other ways diet and exercise may affect your body (for example, changing the way your breast tissue expresses or makes genes) and your quality of life.

You are given the full description of a clinical trial. Please summarize it.

Women with overweight/obesity will follow a 12-week dietary intervention supplemented with a cereal-based biscuit enriched with plant proteins or a common isocaloric wheat biscuit as a daily snack. At the beginning and at the end of the dietary intervention postprandial metabolic responses, body weight reduction and subjective appetite ratings will be examined.

Biscuits enjoy high popularity in the human diet and can be excellent snack alternatives and potential carriers of ingredients with appetite regulating properties. In the present study, the effects of a wheat biscuit enriched with plant proteins originated from legumes and seeds on gastrointestinal hormone responses of women with overweight/obesity after a hypocaloric dietary intervention will be examined.

You are given the full description of a clinical trial. Please summarize it.

The majority of breast cancer patients discontinue today's standard adjuvant treatment (endocrine therapy) due to side effects and reduced quality of life. Thereby, most side effects are unspecific, thus, not related to the specific pharmacological action of the drug, but to the individual treatment context and patients´ expectations (nocebo effects). The aim of this study is to evaluate a side effect prevention training (SEPT) that optimizes patients' response expectations before the start of pharmacotherapy to prevent nocebo side effects during longer term drug intake. Using a randomized trial, we will study the time course of response expectations and side effects in breast cancer patients receiving either SEPT, standard medical care or an attention-control intervention ("supportive therapy") before the start of adjuvant endocrine therapy. We will analyze the effects of changing pre-treatment expectations on cancer-treatment related side effects, quality of life and adherence 3 and 6 months after the start of endocrine therapy. Moderator analyses will be used to determine predictors of non-specific medication side effects and patients that are at high risk of experiencing them. Furthermore, we will explore the mediating influence of coping behaviours, thereby providing insights into pathways of clinical nocebo effects. The study findings promise significant advances in the clinical application of nocebo research with strong implications for clinical and research practice.

The purpose of this study is to evaluate a side effect prevention training (SEPT) that optimizes patients' response expectations before the start of adjuvant endocrine treatment (AET) to prevent nocebo side effects and enhance quality of life during longer term drug intake.

You are given the full description of a clinical trial. According to this description, please design inclusion and exclusion criteria for selecting participants.

Study PCYC-1112-CA is a randomized, multicenter, open-label, phase 3 study of the Bruton's Tyrosine Kinase (BTK) inhibitor Ibrutinib (PCI-32765) versus Ofatumumab in patients with Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma. Patients randomized to the ofatumumab arm may be considered to receive next subsequent therapy with ibrutinib.

Inclusion Criteria: - ECOG performance status of 0-1. - Diagnosis of CLL or SLL that meets IWCLL 2008 criteria. - Active disease meeting at least 1 of the IWCLL 2008 criteria for requiring treatment. - Must have received at least one prior therapy for CLL/SLL. - Considered not appropriate for treatment or retreatment with purine analog based therapy. - Measurable nodal disease by CT. - Patients must be able to receive outpatient treatment and laboratory monitoring at the institution that administers study drug for the entire study. Exclusion Criteria: - Known CNS lymphoma or leukemia. - No documentation of cytogenetic and/or FISH in patient records prior to first dose of study drug. - Any history of Richter's transformation or prolymphocytic leukemia. - Uncontrolled Autoimmune Hemolytic Anemia (AIHA) or idiopathic thrombocytopenia purpura (ITP). - Prior exposure to ofatumumab or to ibrutinib. - Prior autologous transplant within 6 months prior to first dose of study drug. - Prior allogeneic stem cell transplant within 6 months or with any evidence of active graft versus host disease or requirement for immunosuppressants within 28 days prior to first dose of study drug. - History of prior malignancy, with the exception of certain skin cancers and malignancies treated with curative intent and with no evidence of active disease for more than 3 years. - Serologic status reflecting active hepatitis B or C infection. - Unable to swallow capsules or disease significantly affecting gastrointestinal function. - Uncontrolled active systemic fungal, bacterial, viral, or other infection. - History of stroke or intracranial hemorrhage within 6 months prior to the first dose of study drug. - Requires anticoagulation with warfarin.

You are given the inclusion and exclusion criteria for participant selection in a clinical trial. Please tell me how many participants we will find that fit these criteria.

Inclusion Criteria: - Completion of the CGMMDI trial. - Written informed consent. Exclusion Criteria: - Pregnancy, planned pregnancy for the study duration or pregnancy during the last six months - Severe cognitive dysfunction or other disease, which is adjudicated by a physician as not suitable for inclusion. - Required continuous use of paracetamol. Paracetamol must not have been used the week before the study and shall not be used during CGM-use because it disturbs the interpretation of blood glucose levels estimated by the Dexcom. However, other pain killers can be used throughout the study duration. - History of allergic reaction to any of the CGM materials or adhesives in contact with the skin, or to chlorhexidine or alcoholic anti-septic solution. - Abnormal skin at the anticipated glucose sensor attachment sites (excessive hair, burn, inflammation, infection, rash, and/or tattoo). - Other investigator-determined criteria making patients unsuitable for participation.

100

You are given the title of a clinical trial. Please write a brief description that matches the trial title.

A Feasibility Study of a Step-goal Based Physical Activity Intervention in People With Epilepsy

The purpose of this research study is to evaluate the feasibility of a 12-week, telehealth delivered, step-goal based physical activity intervention in people with epilepsy. The study team will also evaluate the physical activity profiles of people with epilepsy both at rest and when engaged in physical activity and gather information on the effect of the intervention on epilepsy and epilepsy associated comorbidities.

You are given the title of a clinical trial. Please write a brief description that matches the trial title.

The CABG or PCI in Patients With Ischemic Cardiomyopathy (STICH) 3.0 International Trial Consortium

The primary objective of the STICH 3.0 Study is to determine whether CABG is superior to PCI in terms of all-cause mortality at 5 years in patients with severe CAD and iLVSD. Individual patient data from similar national RCTs independently powered for different efficacy endpoints will be pooled, harmonized, and analyzed. The primary endpoint is all-cause mortality.

You are given a short description of a clinical trial. Please generate one or multiple interventions that fit the description.

The primary objective of this study is to demonstrate that investigation medication (Bowklean) is not less effective than the active comparator (Klean-Prep with Dulcolax), with regards to the overall quality of bowel preparation in subjects undergoing colonoscopy. An additional objective of this study is to collect subject's response to the acceptability and tolerability about bowel preparation and safety information. After bowel preparation, independent evaluator who is blinded to subject's treatment will evaluate the overall colon cleansing based on Aronchick and Ottawa scale. A total of 600 eligible subjects scheduled to a colonoscopy will be randomly assigned with equal allocation to 1 of 2 treatment groups: "Bowklean" or "Klean-Prep" with Dulcolax. Each subject's participation is expected to be maximally 4 weeks in study duration (up to 3-week screening period followed by one week post colonoscopy).

INTERVENTION 1: <TYPE: Drug; NAME: Picosulfate sodium, magnesium oxide, citric acid; >;

You are given the full description of a clinical trial. Please summarize it.

This is a Phase 1 non-randomized, open-label, parallel cohort, multi-site study to investigate the effect of renal impairment on the pharmacokinetics, safety and tolerability of PF-06651600 after multiple oral doses of 50 mg daily. Subjects will be selected and categorized into normal renal function or renal impairment groups based on their estimated glomerular filtration rate. Part 1: A total of approximately 16 subjects will be enrolled; approximately 8 subjects with severe renal impairment and approximately 8 with normal renal function. After statistical evaluation of results from Part 1, Part 2 may be conducted with approximately 8 subjects each with moderate and mild renal impairment. The total duration of participation from Screening visit to Day 11 will be a maximum of 39 days and from Screening visit to Follow-up/Contact Visit will a maximum of 73 days.

This is a Phase 1 non-randomized, open-label, parallel cohort study of PF-06651600 in subjects with severe renal impairment and subjects without renal impairment (Part 1) and in subjects with mild and moderate renal impairment (Part 2).

You are given the title of a clinical trial. Please write a brief description that matches the trial title.

Patient-reported Outcomes in the Bergen Early Cardiac Rehabilitation Study

An intervention study with longitudinal follow-up of patients with coronary artery disease undergoing early cardiac rehabilitation is designed.

You are given the full description of a clinical trial. According to this description, please design inclusion and exclusion criteria for selecting participants.

Study Objectives: - Primary objectives o To determine the overall success of effectiveness (clinical and radiographic success) and safety (lack of serious product-related AEs and lack of secondary intervention) of OIF/beta-TCP within 30 weeks after bone graft implantation in subjects with open tibial fractures in need of bone grafting. - Secondary objectives - To determine radiographic union in different treatment groups; - To determine clinical union in different treatment groups; - To assess the safety of OIF - To assess the immunogenicity of OIF; - To determine the pharmacokinetics of OIF.

Inclusion Criteria: - Exclusion Criteria: 1. Skeletally mature, male and female subjects who are > 21 years old; 2. Females of non-childbearing potential or who have a negative result on pregnancy test within 72 hours prior to surgery, or males; 3. Isolated open tibial fractures, which is classified as below and within 3 months of initial fracture, and soft tissue stable without any sign of active infection; 1. Gustilo type II with fracture gap at least 0.5 cm in length or severe damage to the periosteum after debridement or 2. Gustilo type IIIA with fracture gap at least 0.5 cm in length or IIIB with fracture gap at least 0.5 cm in length; 4. Subjects with unilateral open tibial fractures; 5. Willing to provide signed informed consent form (ICF) prior to participation in any study-related procedures and adhere to the study requirements for the length of the trial. Exclusion Criteria: Subjects will be excluded if ANY of the following exclusion criteria apply: 1. Patients with a Glasgow Coma Scale less than 15 (less than fully awake) at the time of informed consent. 2. Purulent drainage from the fracture, or evidence of active osteomyelitis; 3. Compartment syndrome; 4. Inadequate neovascular status; 5. Pathological fractures; history of Paget's disease or other osteodystrophy; or history of heterotopic ossification; 6. Endocrine or metabolic disorder that affects osteogenesis (e.g., hypo- or hyper-thyroidism or parathyroidism, renal osteodystrophy, Ehlers-Danlos syndrome, or osteogenesis imperfecta) 7. Has abnormal renal and/or hepatic functions, with Creatinine or ALT value >5 times the upper normal limit; 8. History of malignancy, radiotherapy, or chemotherapy for any malignancy within the last 5 years. History of malignancy may include: Multiple exostoses syndrome ((also known as multiple osteochondromas syndrome), an inherited condition associated with bumps of cartilage on the bones, has been associated with an increased risk of chondrosarcoma), any cancer prone syndrome, such as Li-Fraumeni; 9. Any autoimmune disease (e.g. Systemic Lupus Erythematosus or dermatomyositis); 10. Subjects with major psychiatric disorders, defining such disorders using standard criteria such as the DSM-V 11. Subjects with Insulin-dependent Diabetes mellitus. 12. Subjects with substance and alcohol abuse; 13. Current smokers* (*CDC: An adult who has smoked 100 cigarettes in his or her lifetime and who currently smokes cigarettes.); 14. Previous exposure to rhBMP-2; 15. Hypersensitivity to protein pharmaceuticals, e.g, monoclonal antibodies, gamma globulins, and tricalcium phosphate; 16. History of hypersensitivity or allergy to kanamycin or aminoglycosides. 17. Treatment with any investigational therapy within 28 days of implantation surgery; 18. Treatment with prednisone for 7 days or more within previous 6 months (cumulative dose> 150 mg or other steroids with equivalent dose, refer to Appendix 2 in the protocol); calcitonin (within previous 6 months); bisphosphonates (for 30 days or more within previous 12 months); or therapeutic doses of fluoride (for 30 days within previous 12 months); 19. A female that is currently pregnant or breastfeeding at time of enrollment, or have plans to become pregnant with the next one year; or female subjects of childbearing potential and male subjects with partners of childbearing potential that do not agree to use protocol approved methods of contraception throughout the study. 20. Individuals who have undergone a bone marrow transplant for the treatment of another condition; 21. Any condition that is not suitable to participate in the study based on the physician's judgement

You are given a short description of a clinical trial. Please design one primary outcome for the trial and if needed one or more secondary outcomes.

The purpose of this study is to evaluate the effect of cemdisiran on proteinuria in adults with immunoglobulin A nephropathy (IgAN), who excrete >1 gram (gm) of protein per day despite standard of care, which includes treatment with angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARB). These participants are at high risk for progression of kidney disease, which can result in end-stage renal failure.

PRIMARY OUTCOME: <MEASURE: Percent Change From Baseline in UPCR as Measured in 24-hour Urine at Week 32; TIME_FRAME: Baseline to Week 32; DESCRIPTION: UPCR is a way of assessing the amount of protein in the urine. The primary analysis for UPCR was performed using Mixed-Effect Model Repeated Measures (MMRM) approach. Geometric mean (GM)ratios were obtained by exponentially back-transforming the arithmetic mean of change in log-transformed 24h UPCR. Standard error of the mean (SEM) was calculated as exponential (mean of change in log-transformed data) * (standard error of change in log-transformed data). Adjusted GM ratio to baseline and 90% confidence interval (CIs) were calculated by exponentially back-transforming the model-based least square (LS) mean and the corresponding 90% CI.; > SECONDARY OUTCOME 1: MEASURE: Percent Change From Baseline in 24-hour Proteinuria at Week 32; TIME_FRAME: Baseline to Week 32; DESCRIPTION: Proteinuria is high levels of protein in the urine. 24-hour proteinuria assessment included 24-hour urine collections to assess total protein excretion per 24 hours. Analysis was performed using the MMRM model. GM ratios were obtained by exponentially back-transforming the arithmetic mean of change in log-transformed 24h urine protein (UP). SEM was calculated as exp (mean of change in log-transformed data) *(standard error of change in log-transformed data). Adjusted GM ratio to baseline and 90% CIs are calculated by exponentially back-transforming the model-based LS Means and the corresponding 90% CI.; >; SECONDARY OUTCOME 2: MEASURE: Percentage of Participants With Partial Clinical Remission at Week 32; TIME_FRAME: Week 32; DESCRIPTION: Partial clinical remission was defined as having UP <1.0 g/24-hours.; >; SECONDARY OUTCOME 3: MEASURE: Percentage of Participants With >50% Reduction in 24-hour Proteinuria at Week 32; TIME_FRAME: Week 32; >; SECONDARY OUTCOME 4: MEASURE: Change From Baseline in UPCR as Measured in a Spot Urine at Week 32; TIME_FRAME: Baseline to Week 32; DESCRIPTION: UPCR was calculated by dividing the level of protein in a spot urine test by the creatinine level. Analysis was performed using MMRM model. GM ratios were obtained by exponentially back-transforming the arithmetic mean of change in log-transformed spot UPCR. SEM was calculated as exp (mean of change in log-transformed data) *(standard error of change in log-transformed data). Adjusted GM ratio to baseline and 90% CIs are calculated by exponentially back-transforming the model-based LS Means and the corresponding 90% CI.; >; SECONDARY OUTCOME 5: MEASURE: Number of Participants With Change From Baseline in Hematuria at Week 32; TIME_FRAME: Baseline to Week 32; DESCRIPTION: Hematuria is the presence of blood in the urine. Hematuria from spot urine collections was evaluated to assess the effect of cemdisiran on disease course in participants. The degree of hematuria was assessed by microscopic examination of the spun urine sediment (red blood cell (RBC)/ high power field [hpf]) and by urine dipstick.; >; SECONDARY OUTCOME 6: MEASURE: Number of Participants With Adverse Events (AEs); TIME_FRAME: Baseline up to 240 weeks; DESCRIPTION: AE is any untoward medical occurrence in a participant or clinical investigational subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.; >;

You are given the title of a clinical trial. Please write a brief description that matches the trial title.

Relief-Hybrid: A Behavioral Intervention for Depression and Chronic Pain in Primary Care

Chronic pain and depression frequently co-exist in late and mid-life and contribute to increased disability, high health care costs, psychiatric comorbidity, and suicide. Older and middle-aged depressed-pain patients: a) are mainly treated in primary care practices; and b) are often prescribed medication, which increases the risk for addiction to opioids and benzodiazepines. Despite the need and desire by the patients and providers for primary care behavioral intervention, behavioral interventions are scarce in primary care. To address this need, Relief-Hybrid was created. Subjects are randomized to either the Relief-Hybrid intervention or to Referral to Mental Health/Usual Care. Subjects in both arms will complete research assessments at 6, 9, and 12 weeks. Subjects in the Relief-Hybrid arm will receive 5 weekly sessions with the study therapist (licensed social workers, LCSWs) and 4 self-administered, mobile technology-assisted sessions.

You are given the full description of a clinical trial. According to this description, please design inclusion and exclusion criteria for selecting participants.

Teduglutide is an analog of naturally occurring human glucagon-like peptide-2 (GLP-2), a peptide secreted by L-cells of the distal intestine. GLP-2 is known to increase intestinal and portal blood flow, and inhibit gastric acid secretion. Teduglutide binds to the glucagon-like peptide-2 receptors located in intestinal subpopulations of enteroendocrine cells, subepithelial myofibroblasts and enteric neurons of the submucosal and myenteric plexus. Activation of these receptors results in the local release of multiple mediators including insulin-like growth factor (IGF)-1, nitric oxide and keratinocyte growth factor (KGF). This multicenter, double-blind, international, Phase III trial will have a treatment period of 28 weeks. Subjects in this study are those who received teduglutide or placebo in protocol CL0600-004 (NCT00081458). These subjects will receive daily subcutaneous injections of 0.05 milligrams or 0.10 milligrams of teduglutide per kilogram of body weight. Subjects will have visits every 4 to 6 weeks and will be assessed for parenteral nutrition (PN) reduction with a follow-up period of 4 weeks duration for those subjects who do not complete this protocol, or do not enter into the long-term safety extension protocol CL0600-010.

Inclusion Criteria: At dosing week 24 of protocol CL0600-004 (NCT00081458), subjects will be reviewed for their participation in this study. Subjects who meet all of the following criteria can be enrolled in this study: - Signed and dated informed consent form (ICF) to participate before any study-related procedures are performed - Completion of protocol CL0600-004 (NCT00081458) Exclusion Criteria: - History of cancer or clinically significant lymphoproliferative disease with fewer than 5 years documented disease-free state - History of alcohol or drug abuse (within previous year) - Prior use of native glucagon-like peptide 2 (GLP-2) within 3 months of screening visit - Pregnant or lactating women - Any condition or circumstance, which in the investigator's opinion would put the subject at any undue risk, prevent completion of the study, or interfere with analysis of the study results

You are given the inclusion and exclusion criteria for participant selection in a clinical trial. Please tell me how many participants we will find that fit these criteria.

Inclusion Criteria: - Age 12 years or older at the time of study enrollment; - SCD diagnosis (all genotypes) confirmed by hemoglobin electrophoresis; - Own or have access to a smartphone or a tablet; and - Speak and read English. Exclusion Criteria: - Patients or caregivers with cognitive impairment; - Patients or caregivers physical impairment; and - Patients or caregivers who will not be able to complete study assessments.

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You are given a short description of a clinical trial. Please generate one or multiple interventions that fit the description.

This is a dose escalation study using the CyberKnife radiotherapy device for small surgical or medically untreatable renal tumors. Patients with renal tumors 5cms or less in diameter will be accrued onto this study. The ability of CyberKnife to ablate these renal tumors and maintain renal function with dose escalation will be assessed.

INTERVENTION 1: <TYPE: Radiation; NAME: Stereotactic radiation; DESCRIPTION: Dose escalation three consecutive treatments, >; INTERVENTION 2: <TYPE: Device; NAME: CyberKnife Robotic Radiosurgery System; >;

You are given a short description of a clinical trial. Please design one primary outcome for the trial and if needed one or more secondary outcomes.

The purpose of this study is to evaluate the safety and efficacy of NIC5-15 in the treatment of Alzheimer's Disease.

PRIMARY OUTCOME: <MEASURE: Change in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)Score; TIME_FRAME: Over 6 months, measured at visits 2 (week 2), 6 (week 12), 8 (week 24); DESCRIPTION: A psychometric instrument that evaluates memory, attention, reasoning, language, orientation, and praxis.; > SECONDARY OUTCOME 1: MEASURE: Change in Alzheimer's Disease Cooperative Study Clinician's Global Impression of Change (ADCS-CCGIC) Score; TIME_FRAME: Over 6 months, measured at visits 2 (week 2), 6 (week 12), 8 (week 24); DESCRIPTION: A systematic method for assessing clinically significant change in a clinical trial as viewed by an independent skilled and experienced clinician . The ADCS-CGIC focuses on clinician's observations of change in the subject's cognitive, functional, and behavioral performance since the beginning of a trial. It relies on both direct examination of the subject and an interview of an informant. Unlike a targeted symptom scale, it takes into account a subject's overall function in the cognitive, behavioral, and functional activity domains.; >; SECONDARY OUTCOME 2: MEASURE: Change in Mini-Mental State Examination (MMSE) Score; TIME_FRAME: Over 6 months, measured at visits 2 (week 2), 6 (week 12), 8 (week 24); DESCRIPTION: A frequently used screening instrument for Alzheimer's disease drug studies. It evaluates orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons; >; SECONDARY OUTCOME 3: MEASURE: Change in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) Score; TIME_FRAME: Over 6 months, measured at visits 2 (week 2), 6 (week 12), 8 (week 24); DESCRIPTION: ADCS-ADL assesses functional performance in subjects with Alzheimer's disease. In a structured interview format, informants are queried as to whether subjects attempted each item in the inventory during the prior 4 weeks and their level of performance. The ADCS-ADL scale discriminates well between normal controls and mild AD patients. It has good test-retest reliability. The ADCS-ADL includes some items from traditional basic ADL scales (e.g., grooming, dressing, walking, bathing, feeding, toileting) as well as items from instrumental activities of daily living scales (e.g., shopping, preparing meals, using household appliances, keeping appointments, reading).; >; SECONDARY OUTCOME 4: MEASURE: Change in Neuropsychiatric Inventory (NPI) Score; TIME_FRAME: Over 6 months, measured at visits 2 (week 2), 6 (week 12), 8 (week 24); DESCRIPTION: The NPI is a well-validated, reliable, multi-item instrument to assess psychopathology and behavior in AD based on interview with the informant.; >; SECONDARY OUTCOME 5: MEASURE: Changes in AD Biomarkers; TIME_FRAME: Blood collected at visits 2 (week 2), 6 (week 12), 8 (week 24); DESCRIPTION: Plasma beta-amyloid proteins will be collected from blood samples obtained at visit 2 (week 2), visit 6 (week 12), and visit 8 (week 24).; >; SECONDARY OUTCOME 6: MEASURE: APO-E genotyping; TIME_FRAME: Collected at visit 2 (week 2); DESCRIPTION: APOe e4 is an important genetic risk factor for AD. In this trial, as in many studies of AD and memory and cognition in aging, the APOe e4 allele will be analyzed as a predictor of clinical change over time.; >;

You are given a short description of a clinical trial. Please generate one or multiple interventions that fit the description.

The objective of our study is to evaluate safety, tolerability, and immunogenicity of COVID-19 preventive DNA vaccine in healthy volunteers.

INTERVENTION 1: <TYPE: Drug; NAME: GX-19N; DESCRIPTION: DNA vaccine expressing SARS-CoV-2 S-protein antigen including the Nucleocapsid protein (NP) antigen, >; INTERVENTION 2: <TYPE: Drug; NAME: Placebo; DESCRIPTION: Normal saline, >;

You are given the full description of a clinical trial. According to this description, please design inclusion and exclusion criteria for selecting participants.

This study examines how skin-to-skin contact between father and newborn affects the attachment relationship. A randomized controlled trial was conducted at a regional teaching hospital and a maternity clinic in northern Taiwan. The study recruited 83 first-time fathers aged 20 years or older. By block randomization, participants were allocated to an experimental (n=41) or a control group (n=42). With the exception of skin-to-skin contact (SSC), participants from each group received the same standard care. Both groups also received an Early Childcare for Fathers nursing pamphlet. During the first three days postpartum, the intervention group members were provided a daily SSC intervention with their respective infants. Each intervention session lasted at least 15 minutes in length. The outcome measure was the Paternal Attachment Questionnaire (PAQ). Four field experts of clinical obstetrics and pediatrics validated the developed father-neonate SSC intervention. A description of the intervention used in this study is as follows: The researchers facilitated initial SSC between intervention-group participants and their infants within 24 hours of birthing under conditions that did not adversely affect spontaneous mother-infant SSC nor interfere with the early initiation of breastfeeding. Because it is standard practice to discharge vaginal-birth mothers on the third postpartum day, this study implemented the intervention during the first three postpartum days for both vaginal and cesarean birth cases. Meanwhile, intervention-group participants were provided with the nursing pamphlet, Early Childcare for Fathers, and briefed on its contents at hospital admission. Upon delivery, each newborn infant received immediate SSC with the mother and was then provided neonatal nursing before being placed temporarily into an incubator for observation. After the infant was confirmed as being in a "quiet alert" state, defined as eyes open and bright, breathing normal, and sensitive and responsive to stimuli, a researcher led the father into the nursery, helped him hold his infant, and facilitated initial SSC. Immediately afterward, the researcher - in accordance with each participant's expressed preference - either withdrew from the room or observed the infant from an appropriate distance. Two further father-infant SSC sessions were held on day 2 and day 3, respectively, in either the nursery or maternity ward. The sessions took place in a secluded section of the nursery or ward about two hours after one of the daily feedings and only after the infant had been bathed, towel dried, and fitted with a diaper. The session space included a comfortable armchair, a footrest, a partition screen, a pillow, and a towel or blanket. The ambient temperature was held at a constant 25~27°C. Prior to touching their infant, participants wore a loose-fitting, front-button shirt or hospital smock and washed their hands. They then sat in the provided armchair and exposed their chest. A pillow and footrest were also made available for use. After the researcher confirmed the safety of all preparations, participants were given their infant to hold. The infant was cradled on the participant's chest in a fetal position, with the head held upwards either vertically or at a 30~60° angle. The exposed back of the infant was then covered by a blanket or clothing. The participant supported the infant with his hands placed on the infant's shoulder and back. Next, he made eye contact with the infant. Touch and soft voice contact commenced only after the infant was appropriately relaxed, as indicated by relaxed eyebrows, forehead, and chin muscles; slightly curled hands; a comfortably curled body position; and calm smile.18 Previous studies found that infants feel most at ease within 15 minutes of SSC with their parents and that verbal and non-verbal communication typically commences within this time period as well.16, 20 Thus, the researchers defined the minimum duration of SSC sessions as 15 minutes, with sessions longer than this duration allowed to continue until either consciously ended by the father or interrupted by other infant-care priorities. After receiving institutional review board (IRB) approval for this study in November 2012, a random allocation computer program generated a random stratified allocation table that was used to direct participant recruitment.23 Upon hospital admission, participants in both the intervention and control groups received the Early Childcare for Fathers nursing pamphlet in order to promote understanding of early infant care and complete the pretest PAQ instrument. Afterward, intervention-group participants were orally briefed on pamphlet contents and shown how to successfully perform father-infant SSC. These participants subsequently engaged in at least one >15-minute SSC session with their infant on each of the first three postpartum days. On the other hand, control-group participants received only standard nursing care after receiving the pamphlet. After the 3-day study period, all participants completed and submitted the demographic survey form and post-test PAQ.

Inclusion Criteria: - older than 20 years; - be at the hospital daily until discharge; - be a nonsmoker; - not have an alcohol addiction or be diagnosed with a psychological disorder; and - sign an informed consent agreement. Exclusion Criteria: - the neonate gestational age less than 37 weeks; - the neonate vital signs unstable; and - the neonate with congenital abnormalities or diseases.

You are given the full description of a clinical trial. According to this description, please design inclusion and exclusion criteria for selecting participants.

This prospective randomized controlled clinical trial included all patients who developed the manifestations of low output recurrent colonic fistula or leak after colonic anterior resection for rectal cancer at Zagazig University hospital between (December 2020 to August 2022). The study was prospectively approved by Zagazig University Faculty of Medicine Institutional Review Board (Approval Number: 10027/26-10-2022).The investigators performed the study under the code of ethics of the World Medical Association (Declaration of Helsinki) for studies involving human subjects. They got written informed consent from all participants after explaining to them all the study procedures with its benefits and hazards. Patients with recurrent low output colo-cutaneous fistula (less than 500cc/24h) or leak after anterior resection due to rectal cancer , patients who subjected to conservative measures but failed , patient with good general condition (ASA I&II), patients with size of fistula less than 15mm and patients with good nutritional status were included and eligible for randomization. The investigators excluded patients who were with bad general condition (ASAIII&IV&V), patients with high output fistula , patients with recto-vaginal or recto-vesical fistula, patients with size of fistula more than 15mm and patients were treated with conservative measures. Included eligible patients were simply randomized at a 1:1 ratio to "Endoscopic (SG)" or "Surgical Group (EG)" via the drawing of sealed envelopes containing computer-generated random numbers prepared by a third party before the start of the intervention. The sample size was calculated by using an open Epi program depending on the following data; confidence interval 95%, power of the test 80%, ratio of unexposed/ exposed 1, the success rate of endoscopic management of low output colonic fistula after anterior resection of rectal cancer versus surgical management was 60.2% versus 90% respectively . Odd ratio 0.17, and risk ratio 0.67, so the calculated sample size equal 78 patients divided into two equal groups. Primary and secondary outcomes were success rate in managing the fistula , postoperative hospital stay, and complications and mortality in each group after the intervention during the 3-months follow-up period, respectively. Diagnosis After full history taking and complete physical examination, low output colonic fistula or leak after anterior resection for rectal cancer was clinically suspected and then confirmed by laboratory investigations (complete blood picture, liver and kidney functions, coagulation profile), radiological imaging (abdominal US to exclude any abdominal collection, CT abdomen with oral and I. V contrast, MRI in some situations and virtual colonoscopy to exclude any distal obstruction , distal narrowing or recurrence of the cancer ). Intervention: Patients involved in endoscopic group were firstly subjected for Interventional Radiology to drain any intra-peritoneal collection present in preoperative radiology then were subjected either to Clips application (OTSC, OVASCO Endoscopy AG. Tubingen, Germany) or Endo-suturing (Overstitch, Apollo Endo-Surgery , TX, United states) to close the low output fistula or leak after anterior resection for rectal cancer. The endoscopy was done under sedation, not general anesthesia after colonic preparation (chemical & mechanical preparation) firstly, to detect size of fistula . Clips were used in cases with fistula's size less than 10 mm, while Endo-suturing devices were used in cases with fistula's size more than 10mm till 15mm. Patients involved in surgical group were subjected to either redo of resection anastomosis manually or by circular stapler or primary repair of the defect with ileostomy. This was done under general anesthesia after colonic preparation. Follow up after endoscopy and discharge from the hospital: All patients were subjected for clinical examination & laboratory investigation during the hospital stay. Any suspected colonic leak or fistula post intervention mandated CT scan with oral and I.V contrast and lower GI endoscopy. Patients were followed-up for at least 3 months post repair. Statistical analysis Analysis of data was done by IBM computer using SPSS (statistical program for social science version 23): description of quantitative variables as Mean, SD, median and IQR, Shapiro test of normality used to check the data distribution, description of qualitative variables as number and percentage, Chi-square test was used to compare qualitative variables between groups, Fisher exact test was used when one expected cell or more are less than 5, Mann-Whitney test was used instead of unpaired t-test in non-parametric data (SD>30% mean). I considered the results statistically important when the important probability was less than 0.05 (P < 0.05). P-value < 0.001 was considered highly statistically important (HS), and P-value ≥ 0.05 was considered statistically insignificant (NS) (10).

Inclusion Criteria: - Patients with recurrent low output colo-cutaneous fistula (less than 500cc/24h) or leak after anterior resection due to rectal cancer - patients who subjected to conservative measures but failed - patient with good general condition (ASA I&II), - patients with size of fistula less than 15mm - patients with good nutritional status Exclusion Criteria: - patients with bad general condition (ASAIII&IV&V), - patients with high output fistula , - patients with recto-vaginal or recto-vesical fistula, - patients with size of fistula more than 15mm - patients were treated with conservative measures.

You are given the full description of a clinical trial. Please summarize it.

This randomized, single blind trial will compare outcomes from a 6-month FFT-CHR intervention and a control condition (enhanced care, or EC) matched to the FFT-CHR in duration (6 months) and access to a clinician. Participants families in FFT-CHR are provided 18 family sessions augmented by a therapy app with content and surveys, while participants in the EC condition are provided three family sessions plus five monthly individual support and case management sessions. Duration of therapy sessions is one hour. Main Goals of FFT-CHR (Experimental Treatment) 1. To assist young clients and their family in: developing a common understanding of CHR symptoms; recognizing early signs of escalating symptoms; practicing individual and family coping strategies; and pre-planning family responses to any escalation in symptoms. When families have poor understanding of CHR symptoms and strategies for their management, this can fuel stressful home dynamics and contribute to youth withdrawal and decompensation. 2. For the youth and their family members to learn to express more constructive messages during their interactions, particularly regarding highly charged topics such as curbing risky behaviors and management of the offspring's symptoms. 3. For youth and family members to practice skills for resolving family or extrafamilial conflicts (usually those related to the youth's functioning) through effective communication and problem solving The control condition, Enhanced Care (EC) shares the psychoeducation goal of FFT-CHR but is more oriented toward skill-training for the individual patient. Whereas it does not offer the same level of opportunity for families to build communication and problem-solving skills, the family is actively involved in helping the individual develop a relapse prevention plan. Monthly individual sessions focus on the development of individual coping skills such as symptom tracking and problem-solving. Both conditions require families to submit real-time mobile app surveys to assist with progress tracking. Study Aims The primary clinical outcomes are prodromal positive symptom scores examined immediately after treatment (6 months) and at 18 months. Secondary outcomes are time to remission of positive symptoms and psychosocial functioning over 18 months. Temporal relationships between early changes in treatment targets and later changes in symptoms or psychosocial functioning will also be examined. Primary Hypotheses 1. FFT-CHR (vs. EC) will be associated with greater improvement in positive symptoms by end of therapy and follow-up (6 and 18 months), and greater high-risk syndrome remission and better psychosocial functioning at 18 months 2. FFT-CHR (vs. EC) will be associated with greater improvement in family communication and problem solving at 6 months 3. FFT-CHR (vs. EC) will be associated with greater improvement in youth-perceived parental criticism at 6 months. In turn, improvements in family communication, problem-solving and youths' perceptions of criticism will be associated with downstream improvements in the youths' primary outcomes (positive symptoms) and secondary outcomes (time to remission and psychosocial functioning) over 18 months. Thus, improvements in family functioning are hypothesized to mediate the relationship between treatment condition (FFT-CHR, EC) and changes in primary and secondary outcomes in the individual with CHR syndrome. 4. CHR individuals with higher baseline risk of conversion are hypothesized to improve more on family communication over 6 months and primary and secondary outcomes over 18 months in FFT-CHR than in EC.

The present study is a confirmatory efficacy trial of Family Focused Therapy for youth at clinical high risk for psychosis (FFT-CHR). This trial is sponsored by seven mature CHR clinical research programs from the North American Prodrome Longitudinal Study (NAPLS). The young clinical high risk sample (N = 220 youth ages 13-25) is to be followed at 6-month intervals for 18 months.

You are given the title of a clinical trial. Please write a brief description that matches the trial title.

Analgesic Efficacy of Fascia Iliaca Compartment Block With Bupivacaine Versus Bupivacaine With Dexamethasone or Magnesium Sulphate for Dynamic Hip Screw Surgeries Randomized Double Blinded Comparative Study

The aim of this study is to evaluate the analgesic efficacy of fascia iliaca compartment block using bupivacaine versus bupivacaine with dexamethasone or magnesium sulphate for dynamic hip screw surgery under spinal anesthesia. The primary outcome will be the duration of effective analgesia from FICB till the first analgesic dose is required,the secondary outcomes will be the severity of postoperative pain as will be assessed by the visual analogue scale and the total dose of pethidin for rescue analgesia.

You are given a short description of a clinical trial. Please generate one or multiple interventions that fit the description.

A prospective, multicenter, interventional study to collect confirmatory evidence on the safety and effectiveness of the TactiCath® percutaneous ablation catheter in the post approval setting for the treatment of symptomatic paroxysmal atrial fibrillation using contact force assisted irrigated radiofrequency ablation.

INTERVENTION 1: <TYPE: Device; NAME: TactiCath Quartz treatment; >;

You are given a short description of a clinical trial. Please generate one or multiple interventions that fit the description.

The current study will examine the relationship between brain responses and a guided imagery exercise in overweight and obese individuals. Results of this work are highly relevant to public health because they employ neuroimaging methods to understand food decision-making. Findings from this study will inform health decision making and holds great potential for future translation across multiple health behaviors and scalable interventions to impact population health

INTERVENTION 1: <TYPE: Behavioral; NAME: Guided Imagery; DESCRIPTION: The guided imagery exercise asks participants to think about positive associations with healthy foods and imagine their future healthy selves., >;

You are given the title of a clinical trial. Please write a brief description that matches the trial title.

A Multi-center, Double-blind, Randomized, 24-month Study, to Compare the Efficacy of Doxycycline Once Daily for 6 Weeks Versus Placebo in Improving Filarial Lymphedema Independent of Active Filarial Infection

Current lymphedema management protocols are based on the use of simple measures of hygiene (regular washing with soap and water, skin and nail care), use of topical antibiotics or antifungal agents, exercise and footwear. This is considered the "standard of care" in most endemic countries in the absence of any structured treatment programs. Previous controlled clinical trials and extensive field experience have shown the benefit of these measures in reducing the frequency of attacks of acute dermato-lymphangio-adenitis (ADLA) that drive the progression of lymphedema. In the present study, the progression of lymphedema in a group of patients who receive a six-week course of doxycycline will be compared with that of a group who receives doxycycline "look-alike" placebo tablets. However, both groups will be enrolled into a standardized "regimen of hygiene" described above. Thus, patients enrolled in the "placebo" group also will receive the current standard of care, and the placebo used in the study will help to identify the benefits of doxycycline on a background of simple hygiene measures. The regimens will be explained to all participants who will be trained to use established standardized methods of hygiene and be effectively applying it prior to the initiation of the drug treatment. In addition, patients will be evaluated at 3, 6, 12 and 24 months.. A common, generic SOP with handouts that describes methods and the training schedule will be used so that similar methods are employed across all sites.

You are given a short description of a clinical trial. Please generate one or multiple interventions that fit the description.

The purpose of this study is to confirm the safety and efficacy of Soluble Ferric Pyrophosphate (SFP) dialysate solution in maintaining iron delivery for erythropoiesis in anemic adult patients with chronic kidney disease (CKD) receiving hemodialysis. Efficacy will be measured primarily by the change from baseline in hemoglobin (Hgb).

INTERVENTION 1: <TYPE: Drug; NAME: Soluble Ferric Pyrophosphate (SFP); DESCRIPTION: Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 18 months., >; INTERVENTION 2: <TYPE: Device; NAME: Standard dialysate; DESCRIPTION: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week., >;

You are given the inclusion and exclusion criteria for participant selection in a clinical trial. Please tell me how many participants we will find that fit these criteria.

Inclusion Criteria:Type 2 diabetic obese pateints - Exclusion Criteria:patients age above 65 or below 18 years old, history of upper laparotomy, unfit for anesthesia or laparoscopy, major psychological instability and drug abuse. -

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You are given the title of a clinical trial. Please write a brief description that matches the trial title.

Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST)

This ALCHEMIST trial studies genetic testing in screening patients with stage IB-IIIA non-small cell lung cancer that has been or will be removed by surgery. Studying the genes in a patient's tumor cells may help doctors select the best treatment for patients that have certain genetic changes.

You are given the inclusion and exclusion criteria for participant selection in a clinical trial. Please tell me how many participants we will find that fit these criteria.

Inclusion Criteria: - Age from 50 to 60 years - Patients undergoing elective upper abdominal surgery with an abdominal incision longer than 5 cm that is above or extending above the umbilicus. - Non-smoker patients Exclusion Criteria: - Patients developing cancer - Patients with rib fractures - Inability to comprehend and follow instructions. - Pre-existing obstructive sleep apnea - Current hospital patient for a separate episode of care. - Patients requiring esophageal surgery or organ transplant.

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You are given the title of a clinical trial. Please write a brief description that matches the trial title.

Continuous Glucose Monitoring With a Subcutaneous Sensor During Critical Illness and Surgery

We hypothesize that measurements of interstitial fluid (ISF) glucose by the FreeStyle Navigator (Abbot Diabetes Care), a continuous glucose monitoring system, will correlate with blood glucose (BG) values in surgical and ICU patients with a clinically useful degree of accuracy.

You are given a short description of a clinical trial. Please generate one or multiple interventions that fit the description.

The aim of this study is to gain knowledge about effects of high flow transnasal insufflation on various breathing parameters like intratracheal pressure conditions, CO2 elimination, breathing frequency and tidal volume.

INTERVENTION 1: <TYPE: Procedure; NAME: High flow therapy; DESCRIPTION: Each patient is treated with nasal high flow at different flow rates (15, 30, 45L/min). The order of flow rates is randomized. Each flow rate will be used for 15 minutes. A wash out time of ten minutes is planned after each phase, during which the patient uses his his individual oxygen flow., >;

You are given the full description of a clinical trial. According to this description, please design inclusion and exclusion criteria for selecting participants.

Monoclonal antibodies, alone or in combination with chemotherapeutic agents, have been proven to be effective treatment for many malignant diseases in human. Antibodies can mediate cytotoxicity through complement dependent cytotoxicty (CDC), antibody dependent cell mediated cytotoxicity (ADCC) or apoptosis. AbGn-7 was identified based on its direct killing (apoptosis-inducing) activities towards cancer cells expressing its epitope. In vitro data also demonstrated its ability to elicit CDC and ADCC. The in vivo xenograft study of AbGn-7 demonstrated that AbGn-7 alone or in combination with chemotherapeutic agents successfully suppressed the growth of gastric, pancreatic, and colorectal tumours. The NHP study proved the safety profile of AbGn-7. The present Phase 1 clinical study is designed to evaluate the safety and tolerability of AbGn-7 alone in patients with solid tumors of epithelial origin (Phase 1a) and in combination with a current chemotherapeutic regimen FOLFOX7 in patients with recurrent, locally advanced or metastatic gastric carcinoma (Phase 1b).

Inclusion Criteria: 1. must provide written informed consent. 2. must be ≥18 years of age, either sex and of any race/ethnicity. 3. Phase 1a: must have a histologically or cytologically confirmed advanced malignant solid tumor of epithelial origin and must have failed on previous chemotherapy. Phase 1b: must have a histologically or cytologically confirmed, recurrent, locally advanced or metastatic gastric cancer with measurable disease; must be chemo-naïve or must have failed on previous chemotherapy; must not have received an oxaliplatin-based chemotherapeutic regimen or monoclonal antibody therapy. 4. must have an Eastern Cooperative Oncology Group Performance Status of ≤2. 5. must have adequate hematological, renal and liver functions within 3 weeks prior to first study drug administration as evidenced by: a) Absolute neutrophil count ≥1.5 x 109/L, b) Hemoglobin ≥90 g/L (≥80 g/L for patients with documented renal cell carcinoma), c) Platelet count ≥100 x 109/L, d) Serum creatinine ≤1.5 x upper limit of normal ULN or a calculated creatinine clearance ≥60 mL/minute, e) Total bilirubin <1.5 x ULN, except for patients with documented Gilbert's disease, f) AST/SGOT and ALT/SGPT < 2.5 x ULN, or, in the presence of documented liver metastases, ≤5 x ULN. 6. must be able to adhere to dose and visit schedules. 7. Each female patient of childbearing potential must agree to use a medically accepted method of contraception or to abstain from sexual intercourse and each male patient must agree to use a medically accepted method of contraception or to abstain from sexual intercourse during the study and for 60 days after stopping the study drug. 8. A life expectancy of at least 3 months. 9. Available tumor tissue in the form of unstained slides for determination of AbGn-7 epitope expression (optional for Phase 1a, obligatory for Phase 1b). Patients without archival/banked tumor tissue obtained at the time of initial diagnosis must have a biopsy performed according to institutional guidelines prior to the initiation of treatment. Exclusion Criteria: 1. No current treated or untreated leptomeningeal metastasis or a metastatic CNS lesion. 2. For Phase 1a, patients should not have received chemotherapy within 30 days prior to initiation of AbGn-7 therapy. For Phase 1b, patients should not have received oxaliplatin-based chemotherapy or monoclonal antibody therapy for their gastric cancer prior to enrollment. 3. Have note received radiation therapy within 3 weeks prior to first study drug administration and must have adequately recovered from any associated toxicity and/or complications of this intervention. 4. Have not undergone major surgery within 3 weeks prior to the first study drug administration and must have adequately recovered from the toxicity and/or complications of these interventions. 5. No current human immunodeficiency virus (HIV) infection or a current HIV-related malignancy. 6. No current active hepatitis B or C. 7. No any serious or uncontrolled infection. 8. No uncontrolled diabetes mellitus, defined as a HbA1c of ≥7.5% in a patient with documented diabetes mellitus. 9. No any of the following within 6 months prior to first study drug administration: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, clinically significant cardiac dysrhythmia or clinically significant ECG abnormality, cerebrovascular accident or transient ischemic attack, or seizure disorder. 10. No persistent, unresolved NCI CTCAE Grade ≥2 drug-related toxicity associated with previous chemotherapy. 11. Not participating in any other clinical study with a potentially therapeutic agent, or have not received another investigational product within 21 days. 12. No any clinically significant condition or situation which would interfere with the study evaluations or optimal participation in the study.

You are given the inclusion and exclusion criteria for participant selection in a clinical trial. Please tell me how many participants we will find that fit these criteria.

Inclusion Criteria: - All patients admitted for diagnostic flexible bronchoscopy in the endoscopy department Exclusion Criteria: - Bronchoscopy outside the endoscopy unit - Tracheal stenosis - SpO2 <90% in the open air - Bradycardia <55 per minute - Atrioventricular block - Heart failure known (EF <40%) - Alcoholism (> 5 drinks per week)

162

You are given a short description of a clinical trial. Please design one primary outcome for the trial and if needed one or more secondary outcomes.

The purpose of this study is to assess the effectiveness of vestibular rehabilitation for an individual who has chronic central vestibular deficits due to cerebellar dysfunction. Due to the lack of treatment for chronic cerebellar dysfunction with Physical Therapy, the investigators hope to produce a protocol for chronic cerebellar dysfunction utilizing balance training, vestibular rehabilitation, or any other rehabilitation technique that may alleviate or eliminate symptoms.

PRIMARY OUTCOME: <MEASURE: Activity Specific Balance Confidence Scale; TIME_FRAME: 2-6 months; DESCRIPTION: Perceived self confidence with balance. 16 items are scored on a 0-100% scale. Items are totaled and then averaged. The higher the average score the higher the confidence with balance and the less likely risk there is for falling.; > SECONDARY OUTCOME 1: MEASURE: Dizziness handicap inventory; TIME_FRAME: 2-6 months; DESCRIPTION: Perceived handicap from dizziness. Items are scored on a 0, 2 or 4 point scale with adding up the total number of the 26 items. The lower the score, the less perceived amount of handicap is present.; >; SECONDARY OUTCOME 2: MEASURE: Functional Gait Assessment; TIME_FRAME: 2-6 months; DESCRIPTION: Gait and balance test. 10 item test rated on each item from 0-3. total score is calculated of 10 items. the higher the score the less likely risk for falling is present.; >; SECONDARY OUTCOME 3: MEASURE: Motion Sensitivity Quotient; TIME_FRAME: 2-6 months; DESCRIPTION: Motion sickness indicator. 16 items are scored based on symptom severity and duration. positive items are calculated together to receive a percentage. the lower the percentage the less motion sensitivity a person has.; >; SECONDARY OUTCOME 4: MEASURE: Modified Clinical Test for Sensory Integration in Balance; TIME_FRAME: 2-6 months; DESCRIPTION: balance test for sensory system inputs. 6 item test to check for sensory integration with balance. each of the 6 items is calculated for length of time and amount of sway. the less the sway, the lower the score and the better the balance.; >;

You are given the full description of a clinical trial. According to this description, please design inclusion and exclusion criteria for selecting participants.

BACKGROUND/SCIENTIFIC RATIONALE: Functional impairment after a stroke often includes slowed gait velocity and increased fall risk attributed to foot drop (the inability to dorsiflex the ankle during the swing phase of gait) and lower limb muscle weakness. Damage in the motor cortex or corticospinal tract often results in significant, persistent distal muscle weakness including the sensorimotor control of the ankle joint, typically because of a combination of weakness of the agonist ankle dorsiflexor muscles and spasticity of the antagonist plantarflexor muscle. This results in slower and abnormal gait which leads to gait compensation strategies such as hip hitching, excess circumduction during gait, reduced foot clearance, and high energy expenditure, all of which are factors which could increase the risk of falls in individuals with stroke. Electrical stimulation, particularly functional electrical stimulation (FES), has become widely used in the field of rehabilitation. FES is defined as the electrical stimulation of muscles that have impaired motor control to produce a contraction to obtain a functionally useful movement. In the last few years, FES systems have been used as neuroprosthetic devices in rehabilitative interventions such as gait training. Stimulator triggers, implemented to control stimulation delivery, range from open-to closed-loop controllers. Finite-state controllers trigger stimulators when specific conditions are met and utilize preset sequences of stimulation. Thus, wearable sensors provide the necessary input to differentiate gait phases during walking and trigger stimulation to specific muscles. This technology has been largely used to improve gait and balance parameters in people with chronic stroke. Home-based rehabilitation is a powerful option to increase frequency of exercises, therapy adherence, amount of training per week, and self-confidence. Home-exercise using FES is an option which can help reduce the sequelae of sensorimotor disorders and lends itself as an exciting way for people suffering from various conditions to exercise their muscles. Additionally, it has been well described that extending the use of home-based FES to elderly could increase its impact and beneficiate this population significantly. One of the most complex issues to wider adoption of FES is its ease of use in the home context. There is a marked difference in the use of a technological and medical device in laboratory or clinical facilities compared to home or other more ecological environments. Software able to include easy training programs based on well-established therapeutic protocols may reduce this gap between laboratory and ecological environments and benefit the use of technological medical devices such as FES. A FES system would allow the participant to easily adjust the type and location of their exercise on a daily basis. On the other hand, any device with currents as low as those used by a FES system should be safe to use in any context, and especially in an unsupervised setting. Most of the tele rehabilitation platforms lack a medium to provide external physical assistance. Incorporating an actuation modality such as FES or other technological devices at the patient's end, which mimics a therapist in a remote clinic, may be effective for therapeutic purposes until the patient's recovery is maximized. Although a robot-guided rehabilitation intervention or online supervision by the therapist could be a feasible option, it might be more therapeutically beneficial to include FES. This is a treatment where a skeletal muscle can be activated by passing low-level electric currents across the motor neurons. This treatment can be administered by applying transcutaneous electrodes over the surface of the skin. The reason why FES is helpful is because it can strengthen muscle, prevent muscle atrophy, and increase bone density. Moreover, FES has neuroplastic effects as it helps to retrain active motor units and rebuild the weak connections between the brain and the motor neurons. Hence, the inclusion of FES to telerehabilitation programs could increase the efficacy of the therapy and contribute to the recovery process of persons with partial or complete loss of limb function. This project aims to determine whether home-based use of a platform that enables FES exercises is safe and beneficial to individuals with chronic stroke. It also aims to see if 8-weeks of home-based FES and task-specific training can result in improvements in spatio-temporal parameters of gait, mobility, balance and general health. OBJECTIVE/AIMS: The purpose of this study is to examine the feasibility, safety, efficacy and effect of 12 weeks of home-based combined FES and task-specific training program in people with chronic stroke. Aim 1: To investigate the feasibility, safety and efficacy of 12-weeks of home-based FES and task-specific training in adults with chronic stroke. H1: 12-weeks of home-based FES training program will be safe, feasible and will not result in any adverse events during the training program. Aim 2: To examine the effect of 12-weeks of home-based FES and task-specific training on gait, mobility and balance in adults with chronic stroke. H2: Post intervention, adults with chronic stroke will demonstrate improvements in spatial and temporal parameters of gait (gait speed, cadence and gait asymmetry), mobility (physical activity and muscle strength) and balance (anticipatory and reactive balance components).

Inclusion Criteria: 1. Age group: 18-90 years. 2. Presence of unilateral hemiparesis. 3. Onset of stroke (> 6 months). 4. Ability to walk independently with or without an assistive device for at least 300 ft. 5. Can understand and communicate in English and can verbalize discomfort or pain in English 6. Use of smartphone on a daily basis 7. Availability of internet/Wi-Fi at home Exclusion Criteria: 1. Body weight more than 250 lbs. 2. Heel bone density measurement using an ultrasound device. Individuals classified as osteoporotic (i.e., with a T-score < -2) will be excluded. 3. Cognitive impairment (Montreal Cognitive assessment score <26/30) 4. Verbal Aphasia (i.e <71% score on Mississippi Aphasia Screening) 5. Severe depression (> 15 points on geriatric depression scale) 6. Any neurological condition other than stroke. 7. Uncontrolled and/or untreated hypertension/hypotension, uncontrolled and/or untreated diabetes and any musculoskeletal, neuromuscular or systemic diagnosis . 8. Recent major surgery (< 6 months) or hospitalization (< 3 months). 9. Deep venous thrombosis. 10. Past or current history of any type of active cancer 11. Peripheral nerve injury or neuropathy in the affected limb with motor disability. 12. Uncontrolled high blood pressure/angina. 13. Skin condition not tolerant with FES therapy. 14. Past or current history of uncontrolled/controlled epilepsy or any other types of seizure disorders 15. Botox treatment within the last 5 months. 16. Pacemaker users. -

You are given the inclusion and exclusion criteria for participant selection in a clinical trial. Please tell me how many participants we will find that fit these criteria.

Inclusion Criteria: - 1) aged 60 or above, - 2) with at least two risk factors of accelerating aging based on their health screening results. Exclusion Criteria: - Any who is not at or at only one risk factor of accelerating aging.

1000

You are given a short description of a clinical trial. Please generate one or multiple interventions that fit the description.

This trial assesses the quality of life in patients with high grade glioma and their caregivers using a questionnaire called the Beacon Patient Related Outcomes Quality of Life (PROQOL). Knowledge gained from this trial may help researchers find out if early integration of palliative care will lead to improvement in quality of life for both patients and caregivers.

INTERVENTION 1: <TYPE: Other; NAME: Palliative Therapy; DESCRIPTION: Visit with palliative care team, >; INTERVENTION 2: <TYPE: Other; NAME: Quality-of-Life Assessment; DESCRIPTION: Ancillary studies, >; INTERVENTION 3: <TYPE: Other; NAME: Supportive Care; DESCRIPTION: Visit with neuro-oncologist, >; INTERVENTION 4: <TYPE: Other; NAME: Survey Administration; DESCRIPTION: Complete survey, >;

You are given a short description of a clinical trial. Please design one primary outcome for the trial and if needed one or more secondary outcomes.

The purpose of this study is to see if giving pramlintide and insulin before a meal would lower high blood sugar and if a glucagon (a naturally made hormone in the body but reduced in diabetes and its role is in prevention of low blood sugar) shot given in the late "after meal" time would prevent low blood sugar. The studies outlined in this proposal might help in developing new treatment options to target "after meal" high blood sugar and before meal low blood sugar in children. This would possibly help improve overall blood sugar control and prevent the long-term complications of diabetes.

PRIMARY OUTCOME: <MEASURE: Area under the curve for glucose; > SECONDARY OUTCOME 1: MEASURE: Glucagon and gastric emptying; >;

You are given the full description of a clinical trial. According to this description, please design inclusion and exclusion criteria for selecting participants.

Fat tissue obtainment: Subjects will undergo liposuction under local anesthesia. In this procedure, Ringer's solution with the anesthetic lidocaine and vasoconstrictor adrenaline infused into the adipose compartment to minimize blood loss and contamination of the tissue by peripheral blood cells. 15 minutes later a hollow blunt-tipped 3 mm cannula introduced into the subcutaneous space through small (0.5 cm) incision. The cannula attached to syringe and under gentle suction moved through the adipose compartment, mechanically disrupting the fat tissue. Aspirate volume - approximately 150-200 cc. Procedure time - 30 minutes. ADRC isolation: Aspirated fat tissue placed into sterile vessel which inserted into Celution 800/CRS System (Cytori Therapeutics Inc) - closed system for automated and standardized extraction and concentration of ADRC. Celution 800/CRS System drains excess of fluid from fat tissue and estimate it's volume After that lipoaspirate washed extensively with equal volumes of Ringer's solution to remove blood. At the end of this process System indicates required volume of enzyme reagent (Celase®) which should be added immediately by operator. After enzyme treatment Celution 800/CRS System automatically transfers isolated ADRC into washing compartment where ADRC washed and concentrated in 5 mL suspension. Tissue processing time - approximately 60 minutes. ADRC suspension match all requirements listed in technical documentation for Celution 800/CRS System. Obtained ADRC divided into 2 portions. First portion (0.2-0.5 mL) used for counting, viability and sterility assessment. Second portion placed into sterile insulin syringes with needle size 30 G for injection. Intracavernosal injection of ADRC: Tourniquet applied immediately prior to injection at the base of the penis. Penis and surrounding skin treated with antiseptic solution. The injection performed on lateral surface of penis bilaterally proximally into the middle and distal parts of corpus cavernosum. Needle is inserted into the corpus cavernosum at the depth of 5-7 mm. Up to 1.0 ml of ADRC suspension injected per single injection. Equal portions of ADRC suspension injected into both corpora cavernosa. Tourniquet removed 20 minutes after ADRC injection.

Inclusion Criteria: - Patient suffers from erectile dysfunction - IIEF-5 score less than 21 - Endothelial dysfunction confirmed by EndoPAT measurements - Patient is familiar with Participant information sheet - Patient signed informed consent form Non-inclusion Criteria: - Contraindications to the local anesthesia or medical history of allergic reactions to local anesthetics - Patient prescribed for systemic corticosteroids, immunosuppressive drugs, nonsteroidal antiinflammatory drugs, phosphodiesterase-5 inhibitors - Medical history of penile prosthesis implantation - Peyronie's disease - Subcompensated or decompensated forms of chronic diseases of internal organs - Clinically significant abnormalities in results of laboratory tests - Any conditions limiting compliance (dementia, neuropsychiatric disease, drug and alcohol abuse etc.) - Participation in other clinical trials (or administration of investigational drugs) during 3 months prior inclusion - Patients with malignant tumors including postoperative period, patients receiving chemotherapy and/or radiotherapy. - Patient's activated partial thromboplastin time exceeds normal levels more than 1,8 times - Patients prescribed for anticoagulants treatment or patient received anticoagulants at least one hour prior liposuction - Medical history of heterotopic ossifications - Patients prescribed for glycoprotein inhibitors treatment - Patients with infections or septic condition Exclusion Criteria: - Patient's refusal from the further participation in trial - Chronic kidney disease IV- V stages (creatinine clearance < 30 mL/min estimated by Cockcroft-Gault formula) - Confirmed syphilis, HIV, hepatitis B or C infections - Patients with hypogonadism Dropout Criteria: - Direct indications on immediate initiation of treatment with drugs that have proven effect on erectile function

You are given the full description of a clinical trial. Please summarize it.

HB-201 and HB-202 are study drugs which are designed to train the body to recognize and fight substances found in HPV 16+ cancer. This trial studies the safety and anti-cancer effect of HB-201 and HB-202 in people. The trial is enrolling patients with metastatic/recurrent head and neck cancer who have not yet received treatment in this setting (1L, first line) and who are eligible to receive pembrolizumab as part of their standard of care. This trial is also enrolling patients with metastatic/recurrent head and neck who have received prior treatment in this setting (2L+, second and later line) who are eligible to receive pembrolizumab as part of their standard of care. Patients will receive the study drugs in addition to their pembrolizumab standard of care regimen.

This is a First in Human (FIH) Phase I/II, multinational, multicenter, open-label study of HB-201 single vector therapy and HB-201 & HB-202 two-vector therapy in patients with HPV 16+ confirmed cancers comprising two parts: Phase I Dose Escalation and Phase II Dose Expansion.

You are given a short description of a clinical trial. Please design one primary outcome for the trial and if needed one or more secondary outcomes.

Prospective, open-label, randomized crossover assignment, multi-center non-inferiority study conducted in the United States

PRIMARY OUTCOME: <MEASURE: Apnea-Hypopnea Index (AHI); TIME_FRAME: 1 sleep night; DESCRIPTION: The mean combined number of apnea and hypopnea events per hour of sleep; > SECONDARY OUTCOME 1: MEASURE: Oxygen Desaturation Index (ODI); TIME_FRAME: 1 sleep night; DESCRIPTION: The number of oxygen desaturations ≥ 4% per hour of sleep; >;

You are given the inclusion and exclusion criteria for participant selection in a clinical trial. Please tell me how many participants we will find that fit these criteria.

Inclusion Criteria: - Participants ≥ 50 years old - On the deceased donor kidney waiting list at Johns Hopkins Hospital - Awaiting a first kidney transplant - No available living kidney donors - On hemodialysis or peritoneal dialysis or stage 5 chronic kidney disease (CKD) defined as a glomerular filtration rate < 15 ml/min for ≥ past 90 days - HCV-uninfected (by both antibody and RNA PCR) and without any behavioral risk factors for contracting HCV other than being on hemodialysis. - Calculated panel reactive anti-human leukocyte antigen (HLA) antibody (cPRA) below 20 percent - Female who is: - practicing total abstinence from sexual intercourse (minimum 1 complete menstrual cycle) - sexually active with female partners only - not of childbearing potential: defined as postmenopausal for at least 2 years prior to screening defined as amenorrheic for longer than 2 years, age appropriate, and confirmed by a follicle-stimulating hormone level indicating a postmenopausal state, or surgically sterile: defined as bilateral tubal ligation, bilateral oophorectomy or hysterectomy or has a vasectomized partner(s); - of childbearing potential and sexually active with male partner(s): currently using at least one effective method of birth control at the time of screening and agree to practice two effective methods of birth control while receiving study drug (as outlined in the participant information and consent form starting with Study Day 1 and for 30 days after stopping study drug, or for 6 months after stopping study drug if receiving RBV (Note: Estrogen-containing hormonal contraceptives, including oral, injectable, implantable, patch and ring varieties, may not be used during study drug treatment). - Males who are not surgically sterile and are sexually active with female partner(s) of childbearing potential must agree to practice two effective forms of birth control (as outlined in the participant information and consent form) throughout the course of the study, starting with starting with Study Day 1 and for 30 days after stopping study drug, or for 6 months after stopping study drug if receiving ribavirin (RBV) Exclusion Criteria: - Plan to receive a multi-organ transplant - Plan to receive a dual kidney transplant (including en bloc) - Prior solid organ transplant - Participating in another study that involves an intervention or investigational product - Plan to receive a blood type incompatible kidney - History of human immunodeficiency (HIV), hepatitis C (HCV), or active hepatitis B (HBV) infection defined as being on active antiviral treatment for HBV, detectable hepatitis B surface Ag or detectable hepatitis B DNA - Active or unresolved bacterial, viral, or fungal infection that is clinically significant - History of cirrhosis or pre-existing liver disease such as non-alcoholic steatohepatitis - History of illicit drug use or alcohol abuse within 12 months prior to screening - Psychiatric or physical illness that in the opinion of the investigator would make it unsafe to proceed with transplantation or interfere with the ability of the subject to participate in the study.

10

You are given a short description of a clinical trial. Please design one primary outcome for the trial and if needed one or more secondary outcomes.

The purpose of this study is to determine whether combination oral contraceptive pill of Norethindrone & Ethinyl estradiol is effective in the treatment of dysmenorrhea associated with endometriosis.

PRIMARY OUTCOME: <MEASURE: patient response to treatment for dysmenorrhea associated with endometriosis,as evaluated by VRS; > SECONDARY OUTCOME 1: MEASURE: changes in the VAS of dysmenorrhea.; >; SECONDARY OUTCOME 2: MEASURE: changes in the VRS of non-menstrual pain.; >; SECONDARY OUTCOME 3: MEASURE: changes in the VAS of non-menstrual pain.; >; SECONDARY OUTCOME 4: MEASURE: changes in the clinical evaluation of pelvic induration.; >; SECONDARY OUTCOME 5: MEASURE: changes in the size of ovarian endometrioma.; >;

You are given the full description of a clinical trial. According to this description, please design inclusion and exclusion criteria for selecting participants.

1. The research can be started only after approval by the Medical Ethics Committee of the Second Affiliated Hospital of Wenzhou Medical University. 2. According to the "Consensus on Diagnosis and Treatment of Inflammatory Bowel Disease" formulated by the Beijing Conference in 2018 as a standard, patients with clear diagnosis of CD are collected. Other diagnostic criterions include vitamin D deficiency (<= 20ng / ml) and treatment with infliximab. Exclusion criteria include pregnancy, breastfeeding, liver and kidney dysfunction, concurrent autoimmune diseases, and use of antiepileptic drugs or drugs metabolized by liver cytochrome P450 enzymes. 3. Assess disease activity of CD participants based on the "Simplified Crohn's disease Activity Score". 4. General information about participants with CD is collected. 5. Detection of Fok I gene polymorphism using Snapshot technology. 6. The level of serum 25 (OH) D of participants is detected. 7. Serum C-reactive protein, erythrocyte sedimentation rate, albumin, calcium and phosphorus levels are measured. 8. Develop a treatment plan for all participants. 9. Participants are divided into two groups, one group is given oral vitamin D drops 400IU/ d, and the other group do not intervene. 10. The disease activity is re-evaluated at 2, 6, 14, 22, 30, and 38 weeks, and the above serum indexes are re-evaluated. 11. Follow-up for 38 weeks. By comparing the above indicators, observe that in the Han population: 1. Can Vitamin D drops supplementation increase serum 25 (OH) D levels in patients with CD who are treated with infliximab? 2. Can Vitamin D drops supplementation improve the condition of patients with CD who are treated with infliximab? 3. Whether Fok I gene polymorphism affect the efficacy of Vitamin D drops supplementation therapy? 4. Whether the effects of Vitamin D drops on CD patients who are treated with infliximab is affected by factors such as disease site, disease activity, treatment, etc .. 12. Through statistical analysis, comprehensive analysis of the effectiveness and safety of Vitamin D drops supplementation in Han patients with CD who are treated with infliximab，and its relationship with Fok I gene polymorphism, providing a theoretical basis for further "precise treatment" intervention in inflammatory bowel disease.

Inclusion Criteria: - Clearly diagnosed patients with CD - Vitamin D deficiency (<= 20ng / ml) Exclusion Criteria: - Pregnancy, lactation - Liver and kidney insufficiency - Co-morbid with other autoimmune diseases - Use antiepileptic drugs or drugs metabolized by liver cytochrome P450 enzymes - Vitamin D level is normal or high - Receiving infliximab treatment