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

OBJECTIVES: - Determine the antitumor activity of dacarbazine, mitomycin, doxorubicin, and cisplatin plus sargramostim (GM-CSF) in patients with advanced, persistent, or recurrent leiomyosarcoma of the uterus. - Determine the nature and degree of toxicity of this regimen in these patients. OUTLINE: Patients receive dacarbazine IV over 2 hours, followed by mitomycin IV over 2-5 minutes, doxorubicin IV over 2-5 minutes, and cisplatin IV over 2 hours on day 1. Patients also receive sargramostim (GM-CSF) subcutaneously (SC) once every 12 hours on days -6 to -3 before the first chemotherapy course and then on days 2-15 and 23-26 of all chemotherapy courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease receive a maximum of 4 courses. Patients achieving complete or partial response receive a maximum of 6 courses. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 12-43 patients will be accrued for this study within 12-28 months.

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus sargramostim in treating patients who have advanced, persistent, or recurrent cancer of the uterus.

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

Pilot Study of ONO-1101 in Patients Scheduled for Multi-slice Computed Tomography (CT) Due to Suspected Coronary Artery Disease

The purpose of this study is to evaluate the efficacy and safety of ONO-1101 in patients scheduled for multi-slice CT.

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: - Signed written-informed consent. - Subjects over 18 years of age, and less than 70 years old. - Subjects with a definite, possible, or probable diagnosis of ALS, according to the revised El Escorial criteria. - Subjects having experienced their first ALS symptoms within 18 months before recruitment/consent. - FVC > 70% - Subjects must be medically suitable for study participation and of complying with all planned aspects of the protocol including blood sampling at the time of inclusion in the study. Exclusion Criteria: - Subjects with a clinically significant preexisting lung disease not attributable to ALS. - Subjects with a diagnosis of other neurodegenerative diseases or diseases associated with dysfunction of the motor neurons that can confuse the diagnosis of ALS. - Participation in other clinical trials, or the reception of any other investigational drug in the six months prior to the start of the study. - Female subjects who are pregnant, currently breastfeeding, or attempting to conceive during the study. - Difficult peripheral venous access precluding plasma exchange and inability to implement a viable alternative catheter to make continued performing plasma exchange visits according to protocol - Any contraindication for plasma exchange or abnormal coagulation parameters according clinical criteria from apheresis team - A history of frequent adverse reactions (serious or otherwise) to blood products. - Hypersensitivity to albumin or allergies to any of the components of Albutein. - Subjects that can not interrupt treatment with acetylsalicylic acid or oral anticoagulants - Plasma creatinine > 2mg/dl. - Present a history of heart disease including ischemic heart disease or congestive heart failure. - Presence of prior conduct disorders requiring pharmacologic intervention, with less than 3 months of stable treatment - Any condition that complicates adherence to study protocol (illness with less than one year of expected survival, drug or alcohol abuse, etc.)

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

A Phase III Randomized Study to Evaluate the Efficacy of Zometa® for the Prevention of Osteoporosis and Associated Fractures in Patients Receiving Radiation Therapy and Long Term LHRH Agonists for High-Grade and/or Locally Advanced Prostate Cancer

RATIONALE: Zoledronate may prevent bone loss in patients with prostate cancer undergoing radiation therapy and hormone therapy. It is not yet known whether zoledronate is more effective than calcium and vitamin D alone in preventing osteoporosis and bone fractures in patients with prostate cancer. PURPOSE: This randomized phase III trial is studying zoledronate to see how well it works compared to calcium and vitamin D alone in preventing osteoporosis and bone fractures in patients with locally advanced nonmetastatic prostate cancer undergoing radiation therapy and hormone therapy.

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 evaluate pharmacodynamic drug interaction between cilostazol and statins (simvastatin as a CYP3A substrate and rosuvastatin as a non-CYP3A substrate) in healthy male subjects.

INTERVENTION 1: <TYPE: Drug; NAME: Cilostazol; DESCRIPTION: cilostazol bid for 7 days, >; INTERVENTION 2: <TYPE: Drug; NAME: Simvastatin; DESCRIPTION: simvastatin qd for 7 days, >; INTERVENTION 3: <TYPE: Drug; NAME: Rosuvastatin; DESCRIPTION: rosuvastatin qd for 7 days, >;

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. Pathologically confirmed soft tissue sarcoma. 2. Age ≥ 18. 3. ECOG 0-1. 4. Able to receive preoperative radiotherapy followed by surgical resection. 5. Able to provide treatment consent forms that conforms to federal and institutional guidelines. 6. Have adequate kidney function for safe administration of gadolinium contrast, as determined by current Department of Radiology MRI guidelines. 7. Creatinine clearance either by 24 hour collection or nomogram: Creatinine clearance (CC) > 50 ml/min is determined by 24 hour collection or nomogram: CC male = (140 - age) x (wt. in kg)/(Serum Cr mg/dl) x 72 CC female = 0.85 x (CC male) Exclusion Criteria: 1. Patients have claustrophobia, iron or metal in the MRI scan site or pacemaker which are contraindicated for MRI scan. 2. patients have pacemaker or defibrillator and contraindicated to MRI images 3. Patients are allergic to gadolinium IV contrast. 4. Patients have acute or chronic renal insufficiency and contraindicated to gadolinium contrast enhancing MRI. 5. Patient had previous radiation to the same disease site. 6. Patient had chemotherapy prior to preoperative radiotherapy. 7. Patients that are pregnant. Patients that may become pregnant must have a negative pregnancy test prior to enrolling.

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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 randomized controlled human exposure crossover study. Investigators aims to assess the acute effects of high temperature exposure and the underlying mechanisms.

INTERVENTION 1: <TYPE: Other; NAME: high temperature (32℃) group; DESCRIPTION: The exposure group will be exposed to high temperature (32℃) in a chamber for about 2 hours, resting during the whole periods., >; INTERVENTION 2: <TYPE: Other; NAME: moderate temperature (22℃) group; DESCRIPTION: The exposure group will be exposed to thermoneutral temperature (22℃) in a chamber for about 2 hours, resting during the whole periods., >;

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: 25 -70 years - (Body Mass Index) BMI≥30kg/m2 - Currently weight stable (+/- 3% in previous 6-12 months and not on any specific exercise or dietary program) - Elevated clinic systolic (Blood Pressure) BP ≥135 or diastolic BP ≥85mmHg, - on ACE inhibitor for at least 6 weeks prior to baseline assessment Exclusion Criteria: - Grade 2-3 hypertension (systolic office BP >160, diastolic office BP >100 mmHg) - Secondary causes of hypertension - CKD (Chronic kidney disease) stage 4-5 {(estimated glomerular filtration) eGFR<30ml/min} - Heart failure NYHA (New York Heart Association) class II-IV - Recent CV (cardiovascular) event (acute myocardial infarction, acute coronary syndrome, stroke or transient ischaemic attack within the previous six months) unstable psychiatric condition - medication such as corticosteroids, several antidepressants and antipsychotics - Female participants of childbearing potential must have a negative pregnancy test prior to treatment

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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 safety and efficacy of WAL 801 CL (epinastine hydrochloride) Dry Syrup in the treatment of atopic dermatitis in children was evaluated and plasma drug concentrations were measured.

PRIMARY OUTCOME: <MEASURE: Overall incidence of adverse events; TIME_FRAME: up to 12 weeks; > SECONDARY OUTCOME 1: MEASURE: Degree of pruritus; TIME_FRAME: at weeks 4, 8 and 12; >; SECONDARY OUTCOME 2: MEASURE: Degree of rash; TIME_FRAME: at weeks 4, 8 and 12; >; SECONDARY OUTCOME 3: MEASURE: Pruritus score obtained through the itching questionnaire; TIME_FRAME: at weeks 4, 8 and 12; >; SECONDARY OUTCOME 4: MEASURE: Impression on pruritus of the patient or the parent; TIME_FRAME: week 12; >; SECONDARY OUTCOME 5: MEASURE: Plasma concentration of epinastine hydrochloride; TIME_FRAME: pre-dose and 6, 12, 18, 24, 30, 36 hours post-dose; >;

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: - Aged ≥ 65 years - Admitted as residents at the study-site institutions (long-term care facilities) - Mini Mental Status Examination (MMSE) ≥ 13 - Able to communicate sufficiently Exclusion Criteria: - Open facial wounds - Problems with a finger, hand, or wrist and/or major visual or auditory impairment, making it difficult to deliver training scheme - Major neurological or psychiatric conditions that may affect cognition (e.g., stroke, dizziness, schizophrenia) - Unstable medical conditions - Were unable to comply with the intervention

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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.

The purpose of the study is to determine the influence of surface characteristics (different surfaces materials and textures) of gait training on kinematics gait parameters (step length, step width, double support time and cadence) and the functional walking capacity in children with diplegic CP.

Inclusion Criteria: 1. Their ages will range from 6 to 8 years old. 2. The degree of spasticity will range from grade 1 or 1+ according to Modified Ashworth Scale. 3. They will be at level II on GMFCS . 4. They will be able to follow verbal command or instructions. Exclusion Criteria: - 1. Fixed deformities of lower limbs. 2. Sever visual or auditory problems. 3. History of surgical interference in lower limbs less than one year. 4. Botulinum toxin injections to the lower limb during the previous 4 months.

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 research study is to find out what effects (good and bad) that omega-3 fatty acids has on schizophrenia.

PRIMARY OUTCOME: <MEASURE: Determine positive symptom treatment response in omega-3 fatty acid deficient first-episode schizophrenia patients augmented with omega-3 fatty acid supplementation vs. placebo.; TIME_FRAME: 12 months; > SECONDARY OUTCOME 1: MEASURE: Determine negative and cognitive symptom treatment response in omega-3 fatty acid deficient first-episode schizophrenia patients augmented with omega-3 supplementation vs. placebo.; TIME_FRAME: 12 months; >;

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

There is an unmet need for implementing a clinically superior behavioral therapy intervention for medication-assisted treatment of opioid use disorder. One strategy for fighting the opioid epidemic is to improve treatment and detoxification programs. In the United States, the Drug Addiction Treatment Act of 2000 requires that physicians combine medication-assisted treatment (MAT) with a behavioral intervention. However, there is no clear evidence regarding what form of therapy is most effective when coupled with MAT for opioid use disorder (OUD) management. This investigation will explore the impact of a novel skills-based psychosocial intervention called START NOW, which has been modified for the substance use disorder (SUD) patient population. The promising therapeutic potential of START NOW is evident in the growing data affirming the program's utility and the psychosocial techniques with substantial supportive evidence incorporated into the program. This investigation will attempt to prove through a number of clinical and behavioral parameters how START NOW with MAT may be an effective treatment program for patients undergoing OUD treatment. START NOW is an evidence-informed psychotherapy composed of a total of 32-skills-based-sessions, originally designed for inmates in correctional systems. A previous study of incarcerated individuals found that for each additional session of START NOW completed, a 5% reduction in the incident rate of disciplinary reports was noted. In fact, individuals with a higher overall security risk score also had a greater reduction in the number of disciplinary reports with more sessions attended, suggesting that START NOW is an effective behavioral intervention for those who need it most. A follow-up study on these same participants concluded that START NOW appears to have a beneficial clinical effect with each session completed being associated with a 5% decrease in subsequent psychiatric hospital days. Evidence continues to build in support for START NOW as a behavioral intervention as its implementation continues to grow. For example, START NOW is currently being used in correctional facilities in more than 10 states in the US. Using a randomized, controlled trial in Europe, investigators are evaluating START NOW's ability to enhance psychosocial adjustment and well-being and to reduce oppositional and aggressive behavior in 128 institutionalized female adolescents diagnosed with oppositional defiant disorder and/or conduct disorder. Investigators hypothesize that OUD patients who complete START NOW group therapy will show a statistically greater reduction in impulsivity, delay discounting, and illicit drug use compared to the OUD patients who complete the treatment-as-usual (TAU) because of START NOW's integrated model of care. For example, START NOW combines CBT, the most widely used evidence-based psychosocial intervention for treating mental disorders, with motivational interviewing, which in clinical trials has been shown to be an effective conjunction intervention for SUD. START NOW exercises psychosocial techniques similar to dialectical behavior therapy (DBT), a type of cognitive behavior therapy (CBT) with promising indications for treating SUD because it targets impulsive and self-destructive behaviors. A currently unpublished pilot study using START NOW in an office-based outpatient treatment setting with OUD yielded patient satisfaction data and detailed feedback; this data is being used to guide the modification process of START NOW's materials and delivery so that START NOW is more culturally sensitive and appropriate for the SUD patient population. This proposed investigation will use the revised START NOW participant workbooks and real-life exercises adapted specifically for SUD. Investigators believe that START NOW possesses many components that make it a particularly useful behavioral intervention for SUD. For example, the program is divided into four units, and Unit 1, while teaching focusing skills and functional analysis of behavior skills, tries to teach individuals how to develop self-control, cope with stressors, and become ready for change. Unit 2 focuses on understanding and coping with feelings and emotions. Unit 3 aims to teach individuals how to build positive relationships with others. Finally, Unit 4 focuses on setting and reaching personal goals. Investigators hypothesize that using START NOW's manual-guided approach will confer improved executive functioning skills and decreased delayed discounting, which will ultimately yield better clinical outcomes. This will be the first investigation evaluating an adapted START NOW for treating OUD with buprenorphine/naloxone MAT in the outpatient setting. The study aims to provide clinical utility for healthcare professionals in the field of addiction medicine and contributions to the understanding of addiction biology. Delayed discounting may be a useful biomarker for tracking and predicting clinical outcomes for patients undergoing rehabilitation Delayed discounting (DD) is a behavioral marker for impulsive decision-making and devaluation of delayed rewards. This investigation will use delayed discounting as an objective measure of cognitive executive functioning of its study participants before, during, and after treatment. Furthermore, we will compare DD values to clinical outcomes, clinician assessments, and self-report assessments in order to see if there is a correlation between all of these measures. Opiate addiction has consistently been found to correlate with delay discounting, especially during periods of active addiction and especially amongst intravenous heroin users. However, methadone treatment, even when it resulted in the avoidance of relapse or other drug use, did not significantly improve delay discounting, when compared to the treatment condition in which participants continued to abuse substances. The authors of this study suggest that this may be due to patients receiving effective drug treatment that does not involve prolonged substitution therapy may be forced to develop better self-control skills to remain abstinent. In a comparison between buprenorphine and methadone, a 2012 study found buprenorphine has a number of advantages over methadone for use in MAT. While methadone is a full agonist of opioid receptors, buprenorphine is a weak partial agonist, especially at the mμ opioid receptor, thereby causing less analgesia and euphoria. Investigators hypothesize that methadone, as a full agonist more prone to inducing euphoria and thereby enabling drug abuse, may prevent the improvement in cognitive executive functions theorized to be impaired by substance dependence. Moreover, the unique pharmacokinetics and pharmacodynamics profiles of buprenorphine may allow for more stable disease control, reduced harmful behavior, and thus improvements in cognitive executive functions (namely DD) for individuals undergoing concomitant buprenorphine MAT and an effective psychosocial intervention such as START NOW. Furthermore, previous studies found that DD decreases in individuals completing treatment for opioid dependence with buprenorphine MAT, but they failed to find any relationship between DD measures and abstinence outcomes. While DD might be a stable trait in some individuals, a technology of behavior that manipulates DD may not only impact DD but also reduce the impulsive choices that comprise behavioral patterns of addiction and poor health-decision-making. Studies have successfully shown reduced delay discounting (DD) when targeting cognitive skills such as learning to activate one's working memory for longer periods. The clinical trial proposed by this investigation not only utilizes MAT and START NOW as a unique approach for not only treating OUD and developing effective clinical practices, but also aims to enhance the understanding of DD in addiction treatment outcomes. Showing a correlation between DD and opioid addiction may enable clinicians and researchers alike with the ability to predict treatment success and to use DD as a biomarker for OUD disease regression or relapse. DD will be measured in both groups during the appointed time at the designated group sessions. Those in the START NOW group that have been randomized to have the fMRI will also perform DD before their fMRI scan. Neural correlates will be studied from before and after the START NOW treatment begins. Neural correlates in the TAU group will be not studied. The identification of the neural correlates of START NOW treatment response may lead to a number of potential future directions. First, understanding who is most likely to respond to treatment may help target treatment efforts. Second, this information will help elucidate the mechanisms of START NOW effects, allowing for refining and further development of the treatment approach. Third, future efforts could use knowledge gained in this proposal to directly target behavior change with techniques such as transcranial magnetic stimulation or real-time fMRI biofeedback. All of the information obtained through this investigation's outcome measures may help in the development of a superior behavioral intervention for OUD and improve our understanding of addiction biology. For participants in the START NOW group, those that are eligible and interested will be randomized to have an fMRI or not. Only 20 participants will complete the fMRI. These participants will perform delayed discounting tasks in fMRI sessions before and after behavioral intervention. Investigators expect the neural correlates of delayed discounting to predict START NOW treatment success. Depending on the results, the fMRI component of this investigation may elucidate the mechanisms of START NOW's effects, help create a model for predicting treatment success, or provide information on how to better target behavior change. Neural correlates will only be studied in the START NOW group, comparing before and after the treatment begins. Beyond capturing a participant's drug use and clinical disease course, this study aims to capture participants' personal satisfaction with one's livelihood and other measures to effectively compare START NOW with TAU. Moreover, investigators hypothesize that in the best-case scenario, individuals who maintain their sobriety, regardless of the behavioral treatment intervention they receive, will show improvements in other aspects of their lives. For example, individuals who remain sober throughout treatment (clean urine drug screens) will also show: decrease disease severity (CGI-S), increased disease improvement (CGI-I), reduced impulsivity (BIS), decreased aggression (AGQ), and fewer interpersonal problems (IIP). With all of these measures, investigators hope to offer a more compassionate, comprehensive view-one that extends beyond the disease and diagnosis-of the whole patient. Data Analysis For Specific Aim 1, the differences between START NOW and TAU utilizing an intent-to-treat model with a regression statistical approach will be evaluated. The specific regression model will be determined by the distribution of the data. For Specific Aim 2 and 3, self-assessment by the participants between START NOW and TAU will be compared in the stated domains using an analysis of variance model (ANOVA). For Specific Aim 4, neural correlates associated with delay discounting task performance will be compared between groups. For Specific Aim 5, variance / co-variance matrixes of SNAP compared to the BIS, AGQ, and IPP will be looked at to determine the factor structure and correlation between the instruments. Investigators hypothesize that activation of valuation networks (e.g., dopaminergic networks connecting midbrain to frontal cortices) will predict and change in response to START NOW treatment success.

This investigation involves a partially randomized clinical trial examining the effectiveness of combining buprenorphine/naloxone MAT with START NOW, a skills-based psychosocial intervention modified specifically for the ambulatory substance use disorder (SUD) patient population. START NOW is an integrated evidence-informed model based on an adapted form of dialectical behavior therapy (DBT), a type of cognitive behavior therapy (CBT) with promising indications for treating SUD as it targets impulsive and self-destructive behaviors. Furthermore, START NOW combines CBT, the most widely used evidence-based psychosocial intervention for treating mental disorders, with motivational interviewing, which in clinical trials has been shown to be an effective technique for engaging patients with SUD. In addition to tracking clinical outcomes such as abstinence rates through weekly urine drug screens, this investigation will use: clinician assessments of disease severity, researcher-evaluated tests of delayed discounting (DD) and demand tasks, and self-report surveys assessing impulsivity, aggression, interpersonal skills, and other measures to capture the patients' sense of progress in treatment in regards to their substance use, health, lifestyle, and community. By using DD and functional magnetic resonance imaging (fMRI), the identification of the neural correlates of START NOW treatment response will begin to elucidate the mechanisms of START NOW's effects and more. This investigation's outcome measures may not only compare the effectiveness between START NOW and treatment-as-usual (TAU), but also provide a more realistic, holistic view of patients and their well-being throughout the recovery process. DD will be performed by both START NOW group members and TAU group members at their group therapy meetings as per protocol. Additionally, START NOW group members randomized and consented to have an fMRI will also perform DD before the scan is initiated.

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

This is an open-label, multicenter, phase II study to evaluate the efficacy and safety of epcoritamab and rituximab for patients with untreated follicular lymphoma (FL). Epcoritamab brings T cells and follicular lymphoma cells close together and activates the T cells to kill the lymphoma cells. Rituximab activates the immune system to kill the lymphoma cells. The U.S. Food and Drug Administration (FDA) has not approved epcoritamab as a treatment for any disease. The U.S. Food and Drug Administration (FDA) has approved rituximab as a treatment option for follicular lymphoma (FL). The research study procedures include screening for eligibility, study treatment with evaluations, blood tests, bone marrow biopsies, and Computerized Tomography (CT) scans and Positron Emission Tomography (PET) scans. Participants will receive study treatment for approximately 9-10 months and will be followed for up to 10 years. It is expected that about 35 people will take part in this research study. Genmab and AbbVie are supporting this research study by providing one of the study drugs, Epcoritamab. Genmab is providing funding for the study.

Inclusion Criteria: - Histologically confirmed diagnosis of CD20+ FL (grade 1-3A) with review of the diagnostic pathology specimen at one of the participating institutions. Patients with current or prior histologic transformation are excluded. - No prior systemic therapy for FL. Prior treatment with radiation therapy or short course steroids is allowed. - Meets at least one criterion to begin treatment based on the modified GELF (Groupe d'Etude des Lymphomes Folliculaires) criteria: - Symptomatic adenopathy - Organ function impairment due to disease involvement, including cytopenias due to marrow involvement (WBC <1.5x109/L; absolute neutrophil count [ANC] <1.0x109/L, Hgb <10g/dL; or platelets <100x109/L) - Constitutional symptoms (defined as persistent fevers >100.4 F, shaking chills, drenching night sweats, or loss of >10% of body weight within a 6 month period) - Any nodal or extranodal tumor mass >7 cm in maximum diameter - >3 nodal sites of involvement >3 cm - Local compressive symptoms or imminent risk thereof - Splenomegaly (craniocaudal diameter > 16cm on CT imaging) - Clinically significant pleural or peritoneal effusion - Leukemic phase (>5x109/L circulating malignant cells) - Rapid generalized disease progression - Renal infiltration - Bone lesions - Patients cannot be in need of urgent cytoreductive chemotherapy (in the opinion of the treating investigator). - Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. (Appendix A) - Age ≥18 years. - Adequate hematologic and organ function: 1. Absolute neutrophil count > 1.0x109/L unless due to marrow involvement by lymphoma in which case ANC must be >0.5x109/L 2. Platelets > 75 x109/L, unless due to marrow involvement by lymphoma, in which case platelets must be >50 x109/L 3. Estimated CrCl (Cockcroft Gault) ≥ 45ml/min 4. Total bilirubin < 1.5 X ULN, unless Gilbert syndrome, in which case direct bilirubin must be < 1.5 x ULN 5. AST/ALT < 2.5 X ULN, unless documented liver involvement by lymphoma, in which case AST/ALT must be <5 x ULN - Ability to understand and the willingness to sign a written informed consent document. - Willingness to provide a pre-treatment tumor sample by core needle or excisional surgical biopsy. A fresh biopsy is strongly encouraged, but an archival sample is acceptable if the following provisions are met: 1) availability of a tumor-containing formalin-fixed, paraffin-embedded (FFPE) tissue block, 2) if the tumor containing FFPE tissue block cannot be provided in total, sections from this block should be provided that are freshly cut and mounted on positively-charged glass slides. Preferably, 25 slides should be provided; if not possible, a minimum of 15 slides is required. Exceptions to this criterion may be made with approval of the Sponsor-Investigator. - Willingness to remain abstinent or to use two effective contraceptive methods that result in a failure rate of <1% per year from screening until: (a) at least 3 months after pre-treatment with rituximab or 12 months after the last dose of epcoritamab, whichever is longer, if the patient is a male or (b) until at least 18 months after pre-treatment with rituximab or 12 months after the last dose of epcoritamab, whichever is longer, if patient is a female. Examples of contraceptive methods with a failure rate of <1% per year include: - Tubal ligation, male sterilization, hormonal implants, established proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. - Alternatively, two methods (e.g., two barrier methods such as a condom and a cervical cap) may be combined to achieve a failure rate of <1% per year. Barrier methods must always be supplemented with the use of a spermicide. Exclusion Criteria: - Patients who require systemic immunosuppressive therapy for an ongoing medical condition will be excluded. For corticosteroids, patients receiving a prednisone dose of >10 mg daily (or equivalent) will not be eligible. A short course of steroids (up to 14 days) for symptom palliation is allowed, in which case patients should be off steroids prior to treatment start. - Patients with bulky cervical adenopathy that is compressing the upper airway or could result in significant airway compression during a tumor flare event. - Patients with stage I follicular lymphoma - Patients who are candidates for radiation therapy with curative intent (in the opinion of the treating investigator) - Patients, who have had a major surgery or significant traumatic injury within 4 weeks of start of study drug, patients who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia). - Active HBV (DNA PCR-positive) or hepatitis C (RNA PCR-positive infection). Subjects with evidence of prior HBV but who are PCR-negative are permitted in the trial but should receive prophylactic antiviral therapy. Subjects who received treatment for HCV that was intended to eradicate the virus may participate if hepatitis C RNA levels are undetectable. - Known history of seropositivity for human immunodeficiency virus (HIV). Note: HIV testing is required at screening only if required per local health authorities or institutional standards. - Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at trial enrolment or significant infections within 2 weeks prior to the first dose of epcoritamab. - Prior history of another malignancy (except for non-melanoma skin cancer or in situ cervical or breast cancer) unless disease free for at least 2 years. - Patients should not have received immunization with attenuated live vaccine within one week of study entry or during study period. - Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study or limit adherence to study requirements. - Patients with any one of the following currently on or in the previous 6 months will be excluded: myocardial infarction, congenital long QT syndrome, torsade de pointes, unstable angina, coronary/peripheral artery bypass graft, cardiac arrhythmia (CTCAE grade 3 or higher), clinically significant ECG abnormalities, or cerebrovascular accident. - Patients with New York Heart Association Class III or IV heart failure or known ejection fraction of <45%. - Inability to comply with protocol mandated hospitalizations and restrictions. - Patients who are pregnant, breast-feeding, or intending to become pregnant during the study. - Prior solid organ or allogeneic stem cell transplantation. - History of known or suspected hemophagocytic lymphohistiocytosis (HLH). - History of autoimmune disease, including but not limited to myocarditis, pneumonitis, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. • Patients with a remote history of, or well controlled, autoimmune disease who meet above criteria may be eligible to enroll after consultation with the Sponsor-Investigator. - History of severe allergic or anaphylactic reactions to anti-CD20 mAb therapy or known allergy or intolerance to any component or excipient of epcoritamab. - Vaccination with live vaccines within 28 days prior to the first dose of epcoritamab. - Active CNS lymphoma - Neuropathy > grade 2. (CTCAE) - Treatment with CAR-T therapy within 100 days prior to first dose of epcoritamab. - Treatment with an investigational drug within 4 weeks or 5 half-lives, whichever is longer, prior to the first dose of epcoritamab. - Chemotherapy and other non-investigational anti-neoplastic agents (except CD20 mAbs) within 4 weeks or 5 half-lives (whichever is shorter) prior to the first dose of epcoritamab. - Screening 12-lead ECG showing a baseline QTcF >470 msec.

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: - ICU patients with ECMO: - Hemodynamic support with vasopressors - Procalcitonin level ≥ 1 ng/ml - Invasive hemodynamic monitoring - Written informed content ICU patients with the septic shock of medical origin: - Signs of hypoperfusion: serum lactate >2 mmol/L, low central venous oxygen saturation (ScvO2) (<70%) or high ScvO2 (>85%), metabolic acidosis, oligo-anuria, high venous-to-arterial CO2-gap (dCO2 >6 mm Hg) - Hemodynamic support with vasopressors - Procalcitonin level ≥ 1 ng/ml - Invasive hemodynamic monitoring - Written informed content Exclusion Criteria: - ICU patients with ECMO: - age < 18 years - acute liver or kidney failure straight before transplantation - the patient declines to participate in the study ICU patients with the septic shock of medical origin: - Patients under 18 years - Pregnancy (bHCG test positivity) - Surgical intervention in context with the septic insult New York Heart Association IV heart failure - Acute coronary syndrome - Acute hematological malignancies - Immunosuppression, systemic steroid therapy (>10mg prednisolone/day) - Human immunodeficiency virus infection (HIV) and active AIDS - Patients with donated organs - Thrombocytopenia (<20.000/ml) - More than 10%-of body surface area with third-degree burn

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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 clinical study is designed to evaluate the theoretical prediction of a lower glucose absorption in optimized automated peritoneal dialysis regimes. Patients will receive both a standard 6 x 2L 1.36% glucose regime or an optimized 7 x 2 L 2.27% glucose + 5 x 2 L 0.1% glucose regime in a crossover fashion.

INTERVENTION 1: <TYPE: Procedure; NAME: Automated peritoneal dialysis (APD); DESCRIPTION: Automated peritoneal dialysis (APD) using the Baxter HomeChoice Pro Cycler., >;

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

REGONIVO is a Phase Ib study to explore the efficacy and safety of regorafenib in combination with nivolumab in the treatment of gastric cancer and colorectal cancer with MSS. The study enrolled 50 patients with advanced disease, including 25 cases of gastric cancer, 25 cases of colorectal cancer, except for one case of colorectal cancer with MSI-H, and others were MSS type. The results of the study showed that patients with colorectal cancer had an objective response rate (ORR) of 36% and a progression-free survival (PFS) of 6.3 months. Based on the preliminary results of the REGONIVO study, the aim of this phase 2 study is to explore the safety and efficacy of regorafenib and PD-1 antibody with or without radiotherapy in previously treated metastatic colorectal cancer patients with pMMR/MSS.

INTERVENTION 1: <TYPE: Drug; NAME: Regorafenib and PD-1 antibody in Combination with Radiotherapy; DESCRIPTION: Regorafenib will be given 3 weeks on/1 week off (80 mg od po.) and PD-1 antibody, >; INTERVENTION 2: <TYPE: Radiation; NAME: Radiation therapy; DESCRIPTION: Radiation therapy is believed to increase the likelihood of response of immunotherapy, >;

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 and hearing sensitivity: - Younger listeners (18-40 years) with normal hearing; - Older listeners (65-80 years) with normal hearing; - Older listeners (65-80 years) with bilateral, mild-to-moderate sensorineural hearing loss. - High School Diploma, - native speaker of English (based on self-report) - normal middle-ear function (based on tympanometry) - normal cognitive function (based on score on Montreal Cognitive Assessment) - good-to-excellent word recognition scores (based on Northwestern University Test # 6 word recognition scores presented in quiet at suprathreshold levels). Exclusion Criteria: - non-native speaker of English, - motor and/or speech disorders that prevent participant from providing a time-locked response, - presence of middle ear disease or conductive hearing loss, - presence of severe or profound hearing loss, - presence of poor word recognition scores, - cognitive impairment.

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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 study is designed to investigate the absorption, distribution, metabolism and elimination of a single oral dose of radiolabeled [14C]-labeled RO5285119 in healthy male participants.

INTERVENTION 1: <TYPE: Drug; NAME: RO5285119; DESCRIPTION: Single oral dose of RO5285119 with approximately 2.1 MBq (56.6 uCi) [14C]-radiolabeled RO5285119 administered as a drinking solution under fasted conditions on Day -1, >;

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

OBJECTIVES: - Determine the toxicity of genistein in patients with localized prostate cancer treated with radical prostatectomy. - Determine the decrease, if any, of prostate-specific antigen-positive cells in the operative field of patients treated with this drug. - Determine the quality of life of patients treated with this drug. OUTLINE: Patients receive 1 of 2 treatment regimens. - Group A: Patients receive oral genistein once daily for 1-2 months, undergo radical prostatectomy, and then continue oral genistein once daily for 1-2 months afterward (for a total of 3 months of therapy). - Group B: Patients undergo radical prostatectomy. Beginning 1 month after surgery, patients receive genistein as in arm I for 3 months. Quality of life is assessed at baseline and at 1 and 3 months after surgery. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 88 patients (44 patients per treatment group) will be accrued for this study within 2 years.

RATIONALE: Genistein may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. PURPOSE: Phase II trial to study the effectiveness of genistein in treating patients with localized prostate cancer who are planning to undergo radical prostatectomy.

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: - perihilar cholangiocarcinoma - locally advanced disease (unresectable) - M1 (limted to 1 site) Exclusion Criteria: - refusal to sogn the ICF - poor performance status (ECOG >2) - surgically altered anatomy (i.e Bilroth II or Roux-en-Y interventions) - significant comorbidities - ASA score >3 - life expectancy <3 months

30

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: Subjects to be enrolled in this trial must fulfil all of these criteria: - Sex: male - Age: 18-60 yr old, both inclusive - Having a Body Mass Index (BMI) between 18.5-28 kg / m2 (both inclusive) and body weight not less than 45 kg - Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; and to comply with the requirements of the entire study - Voluntarily given written informed consent to participate in this study - Be of normal health as determined by the principal investigator from medical history, physical examination and laboratory investigations, 12- lead ECG and X-ray chest of the subjects performed within 10 days prior to the admission of the study - Ability and willingness to abstain from alcohol, methylxanthine-containing beverages or food (coffee, tea, coke, chocolate, "power drinks") and grapefruit (juice) from 48 h prior to each admission until study completion Exclusion Criteria: Subjects meeting any of these criteria will not be enrolled in the study: - Employees of FCRL or PBL - Not willing to use contraceptives (preferably condoms) during sexual activity for the period of 3 months from the date of check-in - History of hypersensitivity and / or intolerance to Dipeptidyl peptidase (DPP)-IV inhibitors or any other related compounds. - History of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers may affect the outcome of the study. - Clinically abnormal ECG and Chest X-ray. - Physical findings: clinically relevant abnormal physical findings (including body temperature) suggesting underlying pathologies or those which could interfere with the objectives of the study. - Gastrointestinal disorders likely to influence drug absorption including acute gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea, heart burn), preceding one week to admission. - Laboratory values that are significantly different than the normal reference range and/or are deemed to be of clinical significance by the investigator - Presence of reactive disease markers of HIV 1 and II, HBsAg,, HCV or VDRL. - Positive for alcohol breath test and/or urine drug screen (barbiturates, benzodiazepines, amphetamine, cocaine, opiates, tetra-hydro cannabinol). - Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations. - History of Diabetes Mellitus or intake of any anti-diabetic medication - Diseases: relevant history of renal, hepatic, cardiovascular, respiratory, skin, haematological, endocrine, neurological or gastrointestinal diseases. History of depression, psychosis, schizophrenia or any other severe psychiatric diseases, or epilepsy, or any other illness that may interfere with the aim of the study. History of any significant illness in the 4 weeks preceding the screening - Medications: history of intake of any medications including over the counter medications (OTC) during the 4 weeks period prior to dosing with the IMP. - Investigational drug trials: participation in the evaluation of any drug in the 3 months prior to the start of the study (dosing with IMP). - Blood donation: Subjects who, through completion of this study, would have donated and/or lost more than 300 mL of blood in the past 12 weeks Note: In case the blood loss is ≤ 200 mL; subject may be dosed 60 days after blood donation or last sample of the previous study - Regular smokers who smoke more than 10 cigarettes daily or have difficulty abstaining from smoking for the duration of each study period. - History of drug dependence or alcoholics

48

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. Body weight must be at least 50.0 kilograms (kg) and body mass index (BMI) within the range of 18.0 - 40.0 kg/meter squared (m^2) (inclusive) at the time of signing the informed consent. 2. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. 3. Must agree to receive prophylactic antibiotics to mitigate the potential risk of meningococcal infection. Participants with Impaired Renal Function 4. Aside from impaired renal function, sufficiently healthy for study participation based upon medical history, physical examination, neurological examination, laboratory tests, vital signs, and electrocardiograms (ECGs). 5. A clinical diagnosis of impaired stable renal function. 6. No clinically significant change in renal status at least 1 month prior to first dose of study intervention and is not currently or has not previously been on hemodialysis or did not have any history of peritoneal dialysis. 7. Stable creatinine clearance. 8. Must be on a stable medication regimen. Concomitant medications must be approved by Alexion unless presented in the list of common concurrent medications for participants with impaired renal function. Matched Healthy Control Participants with Normal Renal Function 9. Must match the sex and the race (similar ratio of white and non-white) of participants with impaired renal function, and at screening, age must be within ± 10 years and BMI must be within ± 20% of the matching participants with impaired renal function 10. Healthy as determined by medical evaluation, including medical history, physical examination, neurological examination, laboratory tests, vital signs, and ECGs, and who possess a baseline eGFR ≥ 90 mL/min/1.73 m^2, based on MDRD equation at screening. Exclusion Criteria: 1. History or presence of seizures, head injury, head trauma, or any other brain disorder. 2. History of procedures that could alter absorption or excretion of orally administered drugs. 3. History of meningococcal infection or a first-degree relative with a history of meningococcal infection. 4. Body temperature ≥38.0°Celcius at screening or check-in or history of febrile illness or other evidence of infection, systemic or otherwise, within 14 days prior to the first dose of study intervention. 5. Participants with CH50 results outside the reference ranges at screening, unless approved by Alexion 6. Significant blood loss or donation of blood within 3 months prior to the first dose of study intervention, donation of plasma within 30 days prior to the first dose of study intervention, receipt of blood products within 6 months prior to first dose of study intervention, or receipt of a vaccine within 30 days prior to the first dose of study intervention. 7. Current enrollment or past participation within the last 30 days (or 5 half-lives, whichever is longer) prior to the first dose of study intervention in the current clinical study or any other clinical study involving an investigational study intervention or any other type of medical research. 8. History or presence of drug or alcohol abuse within 1 year prior to the first dose of study intervention, current tobacco user, or positive results for alcohol and/or drug screen at screening or check-in. 9. Pregnant or lactating. 10. Does not produce sufficient urine output to permit urine sampling at screening and/or check-in or has a history of urinary incontinence prior to check-in. 11. History of kidney transplant or actively on a transplant waiting list prior to check-in. 12. Any acute or chronic non-renal condition prior to check-in that would limit the participant's ability to complete or participate in this clinical study.

40

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

Proposal to Evaluate the Impact of Point of Care Liat Influenza A/B Testing in the Emergency Department at Boston Medical Center

The purpose of the study is to compare Emergency Department patients who undergo influenza testing using an FDA-approved point-of-care device (Cobas Liat Influenza A/B assay) located in the ED, to patients whose samples are sent to the BMC central laboratory. Patients who agree to participate will have their samples randomly assigned to be tested on either at the core lab, or on the POC device. The current turnaround time for samples sent to the laboratory is approximately two hours; investigators expect that the point of care device can reduce this time. Investigators will determine if the time to disposition and the administration of antibiotics is different in the group undergoing POC influenza testing compared to those undergoing laboratory-based influenza testing

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

Abstract Aim: This study aimed to determine the effect of individualized nursing interventions based on the Roy Adaptation Model on the recovery of alcohol addicts. Method: This was an experimental study with pretest-posttest, follow-up, and a control group. It included 64 individuals who completed their detoxification process and met the inclusion criteria. The experimental group was provided with individualized care, and interventions were made in line with the Roy Adaptation Model. The personal behaviors that could be related to recurrence (physiological, self-concept, role function, and mutual commitment) and the stimuli that caused recurrence (focal and affecting) were assessed, objectives were determined, and nursing interventions were carried out in line with these objectives. The interventions planned for diagnosing ineffective coping were selected according to the patients' needs among the "support coping" interventions under the title of the behavioral area in the Nursing Intervention Classification (NIC). The data were collected using an introductory information form, the Recovery Assessment Scale (RAS), the Turkish Version of the World Health Organization Quality of Life Instrument (WHOQOL-BREF-TR), and the Penn Alcohol Craving Scale (PACS).

INTERVENTION 1: <TYPE: Behavioral; NAME: individualized nursing interventions based on the Roy Adaptation Model /experimental; DESCRIPTION: The personal behaviors that could be related to recurrence (physiological, self-concept, role function, and mutual commitment) and the stimuli that caused recurrence (focal and affecting) were assessed, objectives were determined, and nursing interventions were carried out in line with these objectives. The interventions planned for diagnosing ineffective coping were selected according to the patients' needs among the "support coping" interventions under the title of the behavioral area in the Nursing Intervention Classification (NIC). A total of 10 individual interviews were made twice a week for about 45 to 60 minutes. The interviews were evaluated by determining the area specific Nursing outcome classification (NOC) (self respect, social support, mood management, role performance)., >;

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: - VVF confirmed by dye test and clinical exam at least 3cm from the external urethral orifice (regardless of size), adequate vaginal capacity to accommodate the cup (per physician) - Willing to insert and remove cup/cup+ - Clear understanding of the study procedures - Willing to participate fully, not yet been repaired or previously failed surgical repair, at least 6mo post-surgery - If previous fistula repair, ≥3mo post-delivery - If recent birth, age 18+ or emancipated minor - Speak English or local language Exclusion criteria: - Any rectovaginal fistula - Women who are candidates for catheterization who could be healed without surgery will be excluded as they are <3mo post-delivery.

100

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.

Biomarkers that provide an early indicator of kidney stress could be useful in clinical practice to detect silent episodes of acute kidney injury (AKI) or for early identification of subjects at risk of AKI. Two urinary biomarkers have been identified as early indicators of AKI. The NephroCheck® test is a commercially available test that uses these biomarkers, and this study assesses the use of these in reducing negative clinical outcomes for patients with sepsis-associated AKI. The study will enroll subjects diagnosed with sepsis, including septic shock, who will be randomly assigned to either receive NephroCheck®-guided kidney-sparing and fast-tracking interventions; or to receive current Standard of Care assessment and treatment. NOTE: Participants are no longer being recruited to this study.

PRIMARY OUTCOME: <MEASURE: Number of deaths, dialysis or progression of AKI; TIME_FRAME: Enrollment to 72 hours; DESCRIPTION: Measured by composite number of deaths, dialysis or progression of AKI. Dialysis defined as any form of renal replacement therapy (RRT); progression of AKI defined as Stage 0 to 2/3 or Stage 1 to 3.; > SECONDARY OUTCOME 1: MEASURE: Number of participants with progression of AKI; TIME_FRAME: Enrollment to 48 and 72 hours; DESCRIPTION: Progression of AKI (Acute Kidney Injury) to Stage 2 or 3 during the time frame. Measured independently.; >; SECONDARY OUTCOME 2: MEASURE: Number of deaths; TIME_FRAME: Enrollment to 48 and 72 hours; DESCRIPTION: Number of deaths. Measured independently.; >; SECONDARY OUTCOME 3: MEASURE: Number of participants receiving dialysis; TIME_FRAME: Enrollment to 48 and 72 hours; DESCRIPTION: Dialysis defined as any form of renal replacement therapy (RRT). Measured independently.; >; SECONDARY OUTCOME 4: MEASURE: Number participants at Stage 2 or 3 AKI; TIME_FRAME: Enrollment to 72 hours; DESCRIPTION: Defined as highest stage of AKI during the time frame; >; SECONDARY OUTCOME 5: MEASURE: ICU length of stay; TIME_FRAME: Enrollment to hospital discharge or Day 60, whichever is sooner; >;

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

Safety, Tolerability and Immunogenicity of a Recombinant SARS-CoV-2 Vaccine (Sf9 Cell) in Chinese Healthy Population Aged 18 Years and Older: A Phase I, Single-center, Randomized, Placebo-controlled, Double-blind Study

This is a phase I, single-center, randomized, placebo-controlled, double-blind study, to evaluate safety, tolerability and immunogenicity of a recombinant SARS-CoV-2 vaccine (Sf9 cell) in Chinese healthy population aged 18 years and older. After randomization, the trial for each subject will last for approximately 13 months. Screening period is 1 week prior to randomization (Day -7 to Day -1), and each dose of either SARS-CoV-2 vaccine (Sf9 Cell) or placebo will be given intramuscularly (IM) on Day 0 and Day 28 for a two-dose regimen, or on Day 0, Day 14, and Day 28 for a three-dose regimen. Subjects who are ≥18 years old and ≤ 55 years old will be enrolled in adult group, and healthy elderly population who are >55 years old will be enrolled in elderly group. After adult group completes the follow-up 7 days after first vaccination, elderly group will be recruited.

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

Powered exoskeletons using robotic suits have recently been introduced for the rehabilitation of persons with spinal cord injury (SCI). Exoskeletons offer a unique opportunity for persons with SCI to experience standing and walking at a low metabolic cost. Evidence suggested that exoskeleton assisted walking can decrease spasticity and improve bowel movement. Training may also improve the level of physical activity as well as psychological parameters that are likely to interfere with rehabilitation outcomes. Previous studies reported that a frequency of 2-3 times per week or more for 1-2 hours may be beneficial in the rehabilitation of persons with SCI. Using exoskeletal-assisted walking to improve the level of physical activity may be appealing to persons with SCI. Exoskeleton training for 12 weeks may enhance energy expenditure, parameters of physical activity and result only on modest effects on both cardiovascular and body composition parameters. In other words, persons with tetraplegia may have greater cardiovascular and body composition adaptations compared to persons with paraplegia. Twenty subjects will participate in a powered exoskeleton (EKSO) for one or twice a week for 12 weeks. The program will involve walking with the robotic suits for 1 hour for persons with complete (n=10) and persons with incomplete (n=10) SCI.

The purpose of the current study is to investigate the effects of powered exoskeleton (EKSO) on cardiovascular performance as measured by resting blood pressure and heart rate, peak oxygen consumption during walking, energy expenditure, whole and regional body composition assessments. The effects of exoskeleton training on walking kinematics including stand-up time, walking time, distance covered and speed of walking will also be evaluated.

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

The Buckypaper (BP) is an innovative material that has attracted the attention of many research groups engaged in the study of its possible applications in various technological fields preliminary to human experimentation. In fact the experimentation, preliminary conducted on animal model, will be applicable to human, if the results in terms of toxicity and durability will be comfortable. The interesting material properties, such as good mechanical strength, electrical conductivity, low density, porosity adaptable, are closely associated to the intrinsic characteristics of carbon nanotubes (CNTs), of which BP is made . The high surface development of CNT, in addition to promoting their aggregation, allows the preparation of micro-and nano-porous membranes that exclude the passage of colloidal particles with a diameter greater than 50 nm. The microporous structure, also gives the BP high capacity to absorb liquids, such as water, for which the effect of capillarity, penetrates quickly in the mesh material . This could be a possible interpretation of the rapid and effective adhesion of BP to biological tissues observed in our studies on the effects of the material implanted in vivo. The bioadhesion of BP has been documented in ex vivo experiments mechanical peeling (bench surgery), conducted in advance using as substrate, guinea pig, rats, the abdominal muscle fascia of rabbits. The results showed that the force required the posting of BP from organic support is much greater than that required for the conventional prosthesis made from polymer networks, commonly used in hernia surgery fixed with glue and biological prosthetic material bioadhesive synthetic currently marketed . Based on these assessments and based on the potential offered by the use of BP in the field of prosthetic surgery, deductible by the intrinsic characteristics of the material in this project is expected to further research for the development of a new generation of prosthetic materials for use surgical -based BP, easily implantable by the surgeon without the need for sutures, graphs and / or biological glues . The reasons are: 1. stitches: they could tighten the knot vessels (ischemia-atrophy) or nerves (chronic pain); 2. graphs: placing blind and can cause bleeding or pain; 3. biological glues: derived from the plasma of donors and thus could transmit diseases unknown. It is still unknown if BP has the appropriate mechanical properties to withstand the stresses that occur on the abdominal wall and In any case is documented the good bio-adhesion on living tissues and anatomical preparations, but only if made humid. For this reason it was decided to prepare composite materials BP/polypropylene. Such materials, defined as "coupled", will be obtained by adhering on the smooth face of BP, a polymeric support which confers to the hybrid film, the correct mechanical resistance. Such a system may be subject to further changes. Indeed, exploiting the functional groups present or introduced into the crystalline structure of MWCNTs and/or on the polymer, it will be possible to implant on the muscle/muscular fascia surface, the composite material, to obtain gripping. Moreover, biologically active molecules, with functions antimicrobial, anti-adhesive, anti-inflammatory or analgesic, can be introduced into the crystalline structure of MWCNTs, for modulate the inflammatory response and the incorporation of the implanted material in the fibrous scar. The objective of this project is to obtain results that can direct the search for the ultimate realization of a prosthetic device for use in abdominal surgery appliable to humans. Our Research Group proposes that the present research program has all the skills to achieve all the objectives . It brings together researchers with proven expertise and experience in various fields of General Surgery and Prosthetic Surgery of abdominal wall and Experienced scientist of Materials Science especially of polymeric nature, also for biomedical uses, Organic Chemistry, and synthesis of bio-conjugates for the development of slow release systems of drugs, characterization of biological systems through techniques of nuclear magnetic resonance (NMR). The surgeon in the unit of search, in fact, for many years been engaged both in the resolution of issues related to surgical techniques, both in the assessment of the effects on the living organism of conventional prosthetic materials and innovative ones, in the proposed project, including through in vivo testing, conducted according to a protocol specially prepared and approved by the Ministry of Health. The protocol have been drawn in the respect of environmental policies, and ethical principles on experimentation on animal model, in accordance with the guidelines of the European Union (86/609/EEC-European Economic Community), and the Italian Law n° 116/92. Will be conducted systematic experiments in 30 New Zealand female rabbits (R1-R30), weighting about 3000 g (Harlan Laboratories). The "in vivo" investigations will be about the biocompatibility and the adhesion of BP in the abdominal scar and in the performing of the intervention of incisional hernia and plastic surgery of the inguinal hernia. The biocompatibility of the BP will be investigated by means of blood chemistry tests. Blood samples of 3 ml of whole blood will run to every beast after induction of general anaesthesia, from the ear vein, before surgery with prosthetic implant, and prior to euthanasia as indicated in the Time schedule. Methodology and technique of the experiment : These experiments are preliminar to human use and will be performed under general anesthesia with endotracheal intubation, then hair removal, disinfection and preparation of the surgical field. A midline incision of about 10 cm navel-pubis will be performed, splaying of the skin and subcutaneous layers, then will be incised the fascia plane, and muscles deep to enter in the peritoneum sac. The execution of the blood sampling coincident with the detection of the body weight and the execution of ultrasound of the abdominal region for the study of the implant site in search of signs of sepsis and incisional hernia. We will implant this kind of new matherials on humans but before to this we will try to study the tollerability and toxicity on an animal model so drawn: ten rabbits (hereafter defined as BPR1-BPR10) (Buckypaper Rabbit subject 1 to 10) will receive 2x2cm2 samples of BP (Buckypaper) and ten rabbits will receive 2x2cm2 samples of PR (polypropylene) (PRR11-PRR20) in a pocket created between muscular fascia and large muscles of the abdominal wall. In five rabbits (BPR21-BPR25), the surgical incision will carried out on the abdominal linea alba and performed deeply, for entering into the abdominal cavity. The control group (R26-R30) will not undergo to surgery. A 2x2cm2 BP sample will then be inserted with the rough side facing the parietal peritoneum surface and the smooth and brilliant surface facing to the visceral peritoneum (BPR21-BPR25). Five rabbits (R26-R30) will not be operated but will be used as control group. The animals will be monitored and controlled daily, during the entire studied period, in order to continually assess their state of health, and body weight. At the 35th day will be picked up a blood sample for examination. Finally the animals will be sacrificed under general anesthesia. The cases BPR1-BPR10 (group A) will be compared with the PRR11-PRR20 (control group B) comparing the effects of implants of BP and the same size in Parietene already in use in reconstructive surgery of healthy man . After the intervention, that will last about 60 minutes from the time of induction, the animal will be slowly awakened and then brought back in the room housing. At the time of sacrifice will be prepared anatomic samples of all the viscera and of the implantation site, to be studied histologically. Histopathological samples for microscopic examination will be prepared. Portions of BP implanted in BPR 1-BPR 10 will be excised with all the surrounding fascia, dermal and muscular tissues. The same procedures will be performed, also in PRR 11-PRR 20 group and BPR 21-BPR 25 group. The samples will be fixed in 10% buffered formalin, cut and stained with Haematoxylin and Eosin (H&E) for histological observation. The post-operative pain, as in the human, it will be mild, and will be treated with analgesics according to techniques standardized in humans. In our experience, the animals undergo to prosthetic surgery, both the experimental and the control group, will treated with prophylactic antibiotics and pain medication in the immediate post -operative, and will be closely watched. Even if in animal model, the sterility of all the surgical procedure prevents inflammation, edema and sepsis and abscesses and ensures a low level of postoperative pain. The days after the surgical procedure is expected a moderate appetite of the operated animals and mild clinical symptoms related to the post-operative . All treated animals will be observed daily to carefully control the amount of food that will be consumed and thus the potential loss of appetite. Will be look for evidence of possible inflammatory and degenerative processes affecting the skin of the abdominal wall, the symptoms of infection or rejection of the prosthesis. If weight loss will be excessive (eg more than 10% of the normal weight of an animal of the same race, the same age and in comparison to the control group), or the animal will show clinical symptoms of suffering more than a normal postoperative, will be subjected to general anesthesia and then deleted. The analgesic and antibiotic therapy performed in the postoperative period will be as follows : Antibiotic : enrofloxacin 2.5 mg /kg /day I.M. for 5-7 days; and anti-inflammatory analgesic : ketoprofen, Findol 10%, 0.3 ml/10kg/die i.m. for 3-5 days. If necessary will be given also tramadol, 2-4 mg /kg/day in the first 2 /3 days post-intervention . The surgical wound will be checked daily. The clinical-chemical parameters examined from blood samples of 3 ml will be: BUN (Blood Urea Nitrogen), blood glucose, creatinine, sodium, potassium, calcium, magnesium, albumin, total proteinemia and Blood protein level, SGOT(Serum Glutamic Oxaloacetic Transaminase), SGPT(Serum Glutamic PyruvateTransaminase), GGT(gamma glutamyl transferase), ALP(alkaline phosphatase) and fractionated bilirubin, PT(Prothrombin Time), APTT/PTT(Activated partial thromboplastin time), Fibrinogen, CBC(Complete Blood Count) formula, lymphocyte subpopulations, C-reactive protein, erythrocyte sedimentation rate. Will be performed ultrasound examination to evaluate morphologically the prosthesis' incorporation, the formation of seroma, bruises, abscesses. This procedure will be performed under sedation and followed by body weight check and the pick-up of a blood sample. The same procedure will be repeated twice at the intervention and after 35 days at the sacrifice.

Inclusion Criteria: animal model: New Zeeland female rabbits of 3000 gr of body weight - Exclusion Criteria: any kind of illness in rabbit subjects -

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

A Randomized, Open-labelled, Crossover Study Confirming Performance of a Single-use Intermittent Micro-hole Zone Catheter in a Population of Adult Male Intermittent Catheter Users

The goal of this randomized, controlled crossover study was to assess the performance of a new micro-hole zone catheter compared to a conventional 2-eyelet catheter in 42 male intermittent catheter users. The main objective of this study was to demonstrate superiority of the micro-hole zone catheter in terms of number of flow-stop episodes and residual volume at first flow-stop, with the catheterization performed by a health care professional in a hospital setting compared to a conventional two-eyelet catheter.

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.

A Study to Assess the Safety and Potential of Oral Insulin to Reduce Liver Fat Content in Type 2 Diabetes Patients with Nonalcoholic Steatohepatitis (NASH)

PRIMARY OUTCOME: <MEASURE: Number of participants with treatment-related adverse events.; TIME_FRAME: Week 12; DESCRIPTION: Safety of Oral Insulin will be measured by the number of treatment-related adverse events according to CTCAE version 5.0; > SECONDARY OUTCOME 1: MEASURE: Percent change in liver fat content; TIME_FRAME: Screening(Baseline) and Week 12; DESCRIPTION: The percent change in liver fat content measured by MRI-Proton Density Fat Fraction from baseline to week 12; >; SECONDARY OUTCOME 2: MEASURE: Percent change in liver fibrosis; TIME_FRAME: Screening, Week 0, and Week 12; DESCRIPTION: Percent change in liver fibrosis as measured by FibroScan Elasticity in units of kilo Pascals (kPa); >; SECONDARY OUTCOME 3: MEASURE: Percent change in liver steatosis; TIME_FRAME: Screening, Week 0, and Week 12; DESCRIPTION: Percent change in liver steatosis as measured by FibroScan Controlled Attenuation Parameter (CAP) in units of dB/meter; >;

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 must have histologic confirmation of advanced (metastatic, recurrent, and/or unresectable) squamous cell carcinoma of the head and neck (SCCHN), nonsmall cell lung cancer (NSCLC), or renal cell cancer (RCC) with measurable disease per RECIST 1.1 - Participants expected to have received standard of care therapies including an available PD-(L)1 inhibitor - Eastern cooperative oncology group performance status of 0 or 1 - Women of childbearing potential must agree to follow methods of contraception Exclusion Criteria: - Participants with active, known or suspected autoimmune disease - Participants with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications - Uncontrolled or significant cardiovascular disease - History of or with active interstitial lung disease or pulmonary fibrosis - Prior participation in anti-natural killer cell receptor (anti-NKG2A) clinical study - History of allergy or hypersensitivity to study drug components Other protocol-defined inclusion/exclusion criteria apply

308

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

Mortality from severe acute pancreatitis reaches 42%. The prognosis of acute pancreatitis is associated with the development of acute inflammatory response syndrome (SIRS) and multiple organ failure (MOF). Due to the lack of etiological therapy, the treatment of acute pancreatitis is predominantly symptomatic. Severity and mortality are associated with early systemic inflammatory response syndrome (SIRS) and septic complications in the later stages of the disease. In connection with a pronounced inflammatory reaction ("cytokine storm") in the early phase of endogenous intoxication of acute pancreatitis, a promising therapeutic approach is the extracorporeal removal of cytokines. This prospective study intends to study the effect of hemoperfusion (Efferon CT) in combination with high-volume hemofiltration (HVHF) on the severity of symptoms of endogenous intoxication and indicators of organ dysfunction in acute pancreatitis.

INTERVENTION 1: <TYPE: Device; NAME: Efferon CT; DESCRIPTION: Efferon CT (JSC Efferon, Moscow, RF) is a device for extracorporeal blood purification by direct hemoperfusion. Detoxification is carried out by sorption of cytokines and other products of endogenous intoxication with a molecular size of up to 55 kDa., >;

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

Plate osteosynthesis is the basic philosophy in maintaining skeletal stabilization in jaw surgery. Numerous branded osteosynthesis systems are available and most of them are made from pure titanium or titanium alloys with standard construction specifications. Usually these titanium plates should be bended and arched to better match the three-dimensional contour of anchored jaw bones. However the optimal bending of the titanium plate sometimes is difficult and time-consuming especially for the inexperienced surgeons and in complicated cases. Excessive bending could also initiate residual stress and potentially worsen the mechanical properties of titanium plates(1). The three-dimensional (3D) printing, or additive manufacturing, has been well developed in fabricating customized materials from the computer-generated digital files. In recent years, 3D printing of patient-specific medical implants has been evolving with the newly-emerged technology of powder bed fusion, which enabled the melting of metals and further shaping of devices(2). In September 2015, China's innovative 3D printed hip joint prosthesis was commercially certified by China's State Food and Drug Administration. In February 2016, the world's first 3D printed patient-specific titanium cranial/craniofacial plate implant got the U.S. Food and Drug Administration's approval. Beyond that, a number of other printed implants have showed excellent performance in clinical research. These printed medical implants are majorly from pure titanium or Ti6Al4V alloy, which exhibit good resistance to fatigue and corrosion and are considered the most biocompatible metal(3). Relying on individualized imaging data, the printed implants are patient-specific and adapt to the anatomical structures precisely. Since the additive manufacturing is ultimately different from the conventional multi-step production operations, it could reduce costs and lead times, especially in printing complex devices for individualized cases. While in clinical applications, 3D printing of customized implants are expected to facilitate surgical operation, reduce application duration and improve precise restoration(4). It is predicted the application of 3D printing technique in medical area may bring forward another major advance toward personalized medicine(5). Many more customized medical implants will be approved in the future across the world. With the advent of metal additive manufacturing, the 3D-printed patient-specific titanium plates have been successfully fabricated. In 2012, Per Derand et al. reported the first application of 3D-printed titanium plates with the established workflow from imaging, via virtual design, to manufacturing of cutting guide and customized titanium reconstruction plates, and its utility in the fibula-based mandibular reconstruction surgery. The pre-printed plates did facilitate the operation and reduced the operation duration about half an hour though the postoperative accuracy of the grafted bone was modest compared with the virtual planning(6). Simultaneously, Leonardo Ciocca et al. reported the computer-aided designing and manufacturing in guiding secondary mandibular reconstruction of a discontinuity defect involving the employment of the surgical guide and printed titanium reconstruction plate in surgical transferring of virtual planning(7). In 2013, Simona Mazzoni and Leonardo Ciocca et al. applied the same surgical protocol in a study group of seven mandibular reconstruction patients and compared its advantages with the standard pre-plating technique on stereolithographic models in a control group. The results revealed the computer-aided surgical protocol was viable in reproducing the patients' anatomical contour, giving the surgeon better procedural control and reducing procedure time(8). In 2015, Simona Mazzoni et al. further developed the computer-aided designing and manufacturing technique in fabricating surgical cutting guides and titanium fixation plates in upper maxilla repositioning surgery without an occlusal wafer. The study result confirmed the high accuracy in transferring the virtual planning by using the surgical guides and fixation plates(9). In reviewing the literature, the application of 3D printing of titanium fixation plates in jaw surgery are available only at two centers currently: the Maxillofacial Surgery Department of S Orsola Malpighi Hospital in Italy and the Oral and Maxillofacial Surgery Department of Lund University in Sweden(6,7). The published preliminary work have proved the prospect of 3D-printed titanium plates in promoting mandibular reconstruction surgery and upper maxilla orthognathic surgery though their printed titanium plates looked rather bulky and the sample sizes were small and there is still lack of qualified randomized controlled trials between the printed and the conventional titanium plates. To better benefit from the burgeoning use of 3D printing in health care, we will develop a new designing and manufacturing protocol in printing customized fixation plates, which will be designed in specific loading circumstances and will perfectly adapt to the anatomical structures of the jaw. It is imperative to conduct a feasibility study in exploring the application of 3D printing of titanium fixation plates in jaw surgery based on our patients.

Medical titanium plates are routinely used in fixing mobilized bone segments in jaw surgeries. Generally these plates are commercialized with standard construction specifications. Thus they should be repeatedly bended and arched to match the contour of anchored jaw bones before located in place and fastened by screws. To prevent stress fatigue induced by plate bending and improve structural design, we utilized the three-dimensional printing technique and developed a new production procedure in fabricating customized titanium plates according to each patient's specific skeletal contours and dimensions derived from medical imaging data. In general, the three-dimensional printing of customized implants are expected to facilitate surgical operation, reduce application duration and improve precise restoration. Up until now, the application of three-dimensional printing of titanium fixation plates in jaw surgery has been available only at two centers globally. The published preliminary work have proved the prospect of customized titanium plates in promoting mandibular reconstruction surgery and upper maxilla orthognathic surgery though their printed titanium plates looked rather bulky and the sample sizes were small and there is still lack of qualified randomized controlled trials between the printed and the conventional titanium plates. To better benefit from the burgeoning use of three-dimensional printing in health care, it is imperative to conduct a feasibility study in exploring the application of three-dimensional printing of titanium fixation plates in jaw surgery based on our patients. The aim of the study is to conduct a case series study focusing on the feasibility and safety of applying three-dimensional printed titanium plates in jaw reconstruction surgery and orthognathic surgery. The outcome measures include the success rate, potential adverse events and accuracy. A sample size of 48 subjects will be recruited prospectively. Considering the facts that titanium plates are widely used in jaw surgery and our unit is the largest oral and maxillofacial surgery center in Hong Kong, the well-designed customized titanium plate is therefore with great potential benefit for the patients in our population. Furthermore, the well-developed three-dimensional manufacturing protocol could also be applied in other relevant medical areas and push forward the personalized medicine era in the future.

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: - Patients older than 18 years old. - Chest imaging shows the presence of peripheral pulmonary lesions (surrounded by pulmonary parenchyma and located below the segmental bronchus/located at least 2 airway generations from the main carina as seen radiographically.) suspicious of malignancy, 0.8-5cm in greatest diameter in need of bronchoscopic biopsy for clinical purposes, and the investigators consider it possible to be biopsied with BF-UC290F (the bronchus adjacent or leading to the PPLs are ≥5mm in diameter, thus BF-UC290F is able to arrival/access). - Patients without contraindications of bronchoscopy. - Patients have good medical adherence and signed informed consent. Exclusion Criteria: - Peripheral pulmonary lesion is pure ground-glass opacity. - Visible lumen lesions during bronchoscopy - The lesions were adjacent to the central airway (trachea, left and right main bronchus, and right middle bronchus), and the biopsies by the Thin Convex Probe EBUS Scope BF-UC290F were conducted without leaf bronchus entry - The investigators believe that patient has other conditions that are not suitable for the study.

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

The study aims to examine the effectiveness of a psychotherapy approach called Facilitator-guided Acceptance and Commitment Bibliotherapy (FAB) in improving the psychological health of parents of young children with neurodevelopmental disorders (NDD) and reducing the emotional and behavioral symptoms of NDD children. The study will involve 154 Cantonese-speaking parents of children aged 2-6 years diagnosed with NDD in Hong Kong. The study hopes to find that FAB can improve parent-child dyads' health outcomes by enhancing psychological flexibility, parental psychological health, and mindful parenting skills.

INTERVENTION 1: <TYPE: Behavioral; NAME: Facilitator-guided Acceptance and Commitment Bibliotherapy (FAB); DESCRIPTION: The Facilitator-guided Acceptance and Commitment Bibliotherapy (FAB) is a 12-week self-help parenting program that integrates Acceptance and Commitment Therapy (ACT) principles with web-based modules and group-based sessions. The program includes a self-help workbook/manual and ACT protocols that cover various self-help exercises such as guided imagery, grounding, mindfulness, and values clarifications. To make the programme more relatable to Hong Kong parents caring for children with NDD, storytelling vignettes and therapeutic narratives will be included. Parents will work on each module at their own pace within 2-3 weeks and meet with trained facilitators in a video-conferencing format after completing each module to review their progress and learn positive parenting techniques., >; INTERVENTION 2: <TYPE: Behavioral; NAME: General Parenting Education and Advice; DESCRIPTION: Both the FAB group and the Control Group will receive routine family support services from collaborating NGOs, including education on managing the emotional and behavioral symptoms of children with NDD. To control for the interaction/social effect present in the FAB group, the Control Group will also receive four video-conferencing sessions guided by a trained research assistant over 12 weeks. These sessions will facilitate parents to discuss their parenting challenges, identify parenting traps, and provide general parenting advice as recommended by the Child Assessment Services, Department of Health under the HKSAR government., >;

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 goal of the study is to investigate, which of two antibiotic treatments - oral penicillin for 10 days or oral cefuroxim for 7 days - is more successful for patients (1-16 years of age) with perianal dermatitis caused by group A beta-hemolytic streptococci.

PRIMARY OUTCOME: <MEASURE: Resolving signs and symptoms of perianal dermatitis; > SECONDARY OUTCOME 1: MEASURE: microbiological cure (= negative culture for GABHS) at end of treatment; >;

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

To screen metastatic GC patients who failed or progressed on first-line chemotherapy. Patients will undergo biopsy of their tumor and will be analyzed using cancer panel/nanostring CNV and immunohistochemistry. This protocol is a screening protocol and informed consent form will be obtained again according to the biomarker profiled on this protocol if eligible. Informed consent will be obtained from patients with gastric adenocarcinoma and analysis of fresh tissue or archival FFPE at Samsung Medical Center will be performed. Patients who have prior to or completed or during the first-line chemotherapy (fluoropyramidine/platinum-based) will be eligible for screening. After the analysis, pathologic and molecular biologic verification process about validity of the result will proceed. The biopsies will be performed before or after or during first-line treatment for molecular analysis. The patients who are screened through this protocol will undergo baseline biopsy before or after or during first-line therapy. Study Objectives 1. Primary Objective: To screen metastatic GC patients who failed or progressed on first-line chemotherapy. Patients will undergo biopsy of their tumor and will be analyzed using cancer panel/nanostring CNV and immunohistochemistry. 2. Secondary Objective Planned subgroup analyses: 1. OS (biomarker negative vs biomarker postivie metastatic GC patients) 2. PFS (biomarker negative vs biomarker postivie metastatic GC patients) 3. OS/PFS (EBV negative vs positive metastatic GC patients)

This protocol is a screening protocol only. No drug intervention study will be included in this protocol. However, based on the molecular profiling, patients may be eligible for targeted agents. However, the molecular profiling doesn't guarantee the enrollment onto the clinical trial. Currently, the available drugs are AKT inhibitor, MEK inhibitor, Wee1 inhibitor, MET inhibitor. ATR inhibitor and other agents may be available in the context of clinical trials depending on the availability.

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

Type 2 diabetes (T2D) mellitus is a challenge for health care systems as the numbers increases constantly. In 2014, 422 million people had been living with diabetes worldwide. The absolute numbers of people with prediabetes have also grown substantially over 25 years worldwide. In Germany, about 10% of the population has T2D and another 21 % of the population has prediabetes.Overall, 16% of all deaths in Germany are attributable to type 2 diabetes. Macro- and microvascular complications of diabetes imply a significant threat for the patients and are already present in the prediabetic state. Short term and long term complications, the burden of treatment, and reduced quality of life are major burdens of the disease. Accumulating data indicate that currently recommended therapeutic diet regimens in patients with obesity and diabetes are not sustainable on the long term. Novel concepts are therefore urgently needed. T2D occurs when insulin secretion from pancreatic beta-cells cannot sufficiently be increased to compensate for insulin resistance. Causes of beta-cell dysfunction are heterogeneous. In addition, the most important determinants of diabetes remission are the extend of weight loss and restoration of beta-cell function. In the course of diabetes progression, the inability to recover insulin secretion might identify the state of no return to normal glucose tolerance. It is therefore crucial to improve insulin secretion in treatment and prevention of diabetes. Up to now lifestyle intervention trials in prediabetes or pharmacological intervention trials in diabetes did not show improvement of insulin secretion after intervention. However, one recent small human trial shows that intermittent fasting (early time restricted fasting) is able to improve insulin secretion.Currently, there are no trials that examine the effect of intermittent fasting in individuals with a broad range of impaired glucose metabolism (from prediabetes to diabetes). Recently novel subtypes of diabetes and prediabetes with high risk for the early manifestation of diabetes complications have been identified. Currently, prevention strategies for this high risk individuals have not been examined yet. We will study for the first time the effectiveness of 4 weeks intermittent fasting on changes in insulin secretion capacity in subphenotypes of diabetes and in prediabetes.

INTERVENTION 1: <TYPE: Behavioral; NAME: Intermittent fasting; DESCRIPTION: The intermittent fasting intervention consists of a decreased daily caloric intake of 400 kcal below individual requirements (Harris Benedict Formula) combined with early time restricted fasting according to the schema 16:8. fasting will be performed over 4 weeks., >; INTERVENTION 2: <TYPE: Behavioral; NAME: Control diet; DESCRIPTION: Control group will be advised to reduce daily caloric intake of 400 kcal below individual requirements (Harris Benedict formula), >;

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 nonrandomized, open-label, dosed escalation, safety activity, and PK study to determine the MTD and optimal dosing regimen of Eribulin ORA.

PRIMARY OUTCOME: <MEASURE: Dose Escalation: Maximum Tolerated Dose; TIME_FRAME: 3 weeks; DESCRIPTION: Occurrence of Dose-limiting toxicity (DLT) in all patients who received at lest one dose of Eribulin ORA.; > SECONDARY OUTCOME 1: MEASURE: Dose Escalation: Safety; TIME_FRAME: Up to 24 months; DESCRIPTION: Occurrence of adverse events in all patients who signed the informed consent .; >; SECONDARY OUTCOME 2: MEASURE: Dose Escalation: Bioavailability; TIME_FRAME: Up to 24 months; DESCRIPTION: Pharmacokinetic analysis of Area Under the Curve (AUC), Time to Maximum Effect (Tmax), and Peak Plasma Concentration (Cmax) will be done to determine bioavailability of Eribulin IV or Eribulin Ora in all patients who received at least one dose of Eribulin ORA.; >; SECONDARY OUTCOME 3: MEASURE: Dose Escalation: Tumor Response; TIME_FRAME: up to 24 months; DESCRIPTION: Evaluate objective tumor response rate for confirmed Partial, Stable, Complete Response, or Progression Disease in all patients who receive at lease one dose of Eribulin IV or Eribulin ORA.; >;

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

Background: On December 2019, a new human coronavirus infection (COVID-19) was detected in China. Its infectivity and virulence characteristics caused a rapid spread, being declared pandemic on March 2020. The mortality attributed to the infection ranges between 3 and 10%. Main risk factors are age, male sex, and chronic degenerative comorbidities. Due to the absence of therapeutic options, potential alternatives such as human immunoglobulin or plasma from convalescent patients have been administered. Due to the severity of the disease and the associated mortality, it is urgent to find therapeutic alternatives. Objective: To assess the safety and efficacy of the administration of Convalescent plasma vs human immunoglobulin in critically ill patients with COVID-19 infection. Material and methods: Randomized Controlled trial of patients diagnosed with respiratory infection by COVID-19, with severe respiratory failure without indication of mechanical ventilation, or those who due to their severity are intubated upon admission. Randomization will be performed 2:1 to receive plasma from convalescent patients or human immunoglobulin. Outcomes: The primary outcome will be time to discharge from hospital for improvement. The safety outcomes will be: Kirby index (PaO2/FiO2) evolution and dead.

INTERVENTION 1: <TYPE: Drug; NAME: Plasma from COVID-19 convalescent patient; DESCRIPTION: Infusion of 400 ml (2 units) of plasma. Plasma donated from convalescent patients will be extracted in strict compliance with the following criteria: History of a clinical event with symptoms attributed to COVID-19 and a positive PCR test for COVID-19 Further confirmation of a negative PCR test for COVID-19 In order to be eligible plasma donors must complete at least 14 days after the last negative PCR in the absence of any symptom attributable to COVID-19 infection IgG antibodies for COVID-19 must be confirmed POSITIVE when a qualitative assay is being used When quantification of IgG antibodies for COVID-19 is available a title > 1: 640 will be required for inclusion. Apheresis will be used as the only method for plasma extraction., >; INTERVENTION 2: <TYPE: Drug; NAME: Human immunoglobulin; DESCRIPTION: Human immunoglobulin 0.3 gr/kg/day (5 doses), >;

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

The Effects of a Mindfulness Based Intervention on IBD Disability

EMBODY (Effects of a Mindfulness Based interventiOn on ibD disabilitY) aims to evaluate the effects of a mindfulness based intervention on a broad number of disease related disability dimensions in patients with Crohn's disease (abdominal pain, regulation defecation, joint pain, energy, emotions, body image, interpersonal interactions, education and work, sexual function, sleep). Besides, the investigators will measure the effect of the intervention on depression, anxiety, stress, disease acceptance and perceived control as well as (biomarkers of) disease activity. It will be a prospective, randomized-controlled, monocentric, superiority trial using a waiting list with treatment as usual as control arm. Half of the patients will immediately start the mindfulness based intervention (early intervention group). In the other half, there will be a waiting time of 6 months before starting the mindfulness based intervention (late intervention or control group). Clinical disease activity (two-item patient reported outcome (PRO2)), faecal calprotectin and C-reactive protein (CRP) will be collected throughout the trial (pre-, during and post-intervention). The investigators will measure IBD-related disability through the IBD-Disk, a tool for assessing the impact of the disease on ten different dimensions of everyday life dimensions. Depression, anxiety and Stress will be investigated via the Depression Anxiety Stress Scale Short Form (DASS21). Disease acceptance and perceived control will be measured using the Subjective Health Experience (SHE) model. Evolution of the different variables will be compared between both groups (ANOVA).

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

Patient Osteoarthritis Care Plan To Inform Optimal Treatment

Knee and hip osteoarthritis (OA) is the most common cause of disability in the U.S. and affects more than 60% of adults over 65 years. As the burden of knee and hip OA increases among aging adults, more patients are deciding to have joint replacement surgery. However, no clear guidelines exist for patients to determine if or when to undergo total joint replacement (TJR). The investigators plan to develop a web-based system that will provide individualized patient OA Care Plans that will help patients make informed decisions about how to treat their arthritis. The investigators will be using this system with patients to see if they find it useful. The investigators believe that the OA Care plan will improve the process and quality of OA treatment decisions and the quality of OA care.

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

Changes in dyspnoea, coughing and/or sputum production often precede exacerbations but as symptoms vary within-same day and across days, patients cannot easily judge the significance of such changes with the result that exacerbations remain unreported and untreated. Furthermore due to heterogeneity amongst COPD patients, predictions must be personalised to be clinically meaningful. Remote monitoring and POC systems have evolved rapidly but none have yet convincingly demonstrated the capability to predict exacerbations and stratify episode severity. To address the above problem, COPDPredictTM has been created and developed. This System automatically processes information that is regularly sent by patients using COPDPredictTM), which connects to peripheral monitors via Bluetooth and uses intelligent software to determine a patient's health through a combination of wellbeing scores, lung function and measurements of key biomarkers in blood and saliva. The clinical team has access to a secure web portal (dashboard) which allows them to monitor patient data, case manage and make informed decisions on clinical practice. Depending on the degree of change from a given patient's 'usual health', timely alerts are sent to the individual, with sign-posting to an action plan. Alerts are also sent to clinicians who support and advise patients via App's secure messaging facility. If patients fail to improve with self-treat plan or if an episode triggers an 'at high risk alert' from the start, clinicians are prompted to be involved and intervene with escalated treatment The Clinician facing dashboard allows for "real-time" case management and the ability to remotely monitor the patients and facilitate interaction. Clinicians can choose to escalate treatments based on the results being transmitted by the patients. This clinical investigation asks if COPDPredictTM can be used by patients with COPD at home and the clinicians managing the patients to improve self-management and help them identify exacerbations, intervene promptly and avoid hospitalisation. The clinical investigation will randomise 384 patients, from 4 hospitals in the West Midlands. United Kingdom, who have frequent AECOPD to use either the SSMP and RM (if needed according to the SSMP) or the COPDPredict App and RM (if needed according to the App self-management plan or clinician input).

Inclusion Criteria: - Clinically diagnosed chronic obstructive pulmonary disease (COPD), confirmed by post-bronchodilator spirometry and defined as a ratio of Forced Expiratory VolumeFEV1 to Forced Vital Capacity <0.7 and <lower limit of normal for age post bronchodilator use - ≥2 Acute Exacerbations of COPD (AECOPD) in the previous 12 months according to the patient and/or ≥1 hospital admission for AECOPD - Exacerbation free for at least 6 weeks - An age of at least 18 years - Willing and able to comply with the data collection process out to 12 months from randomisation - Ability to consent - Ability to use intervention as judged by the investigator at screening, upon demonstration of the system to the patient Exclusion Criteria: - Life expectancy < 12 months - Patients with active infection, unstable co-morbidities at enrolment or very severe comorbidities such as grade IV heart failure, renal failure on haemodialysis or active neoplasia or significant cognitive impairment;

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

The goal of this clinical trial is to evaluate the capacity of implantable/remote technology for early evaluation of drug therapies in patients with pulmonary arterial hypertension (PAH). The main question it aims to answer is whether structured changes in clinical therapy will be detectable using implanted regulatory approved devices. Participants will will be implanted with approved medical devices and will enter into a study of approved drugs to assess physiology, activity and patient reported quality-of-life (QoL) outcomes. Researchers will compare two therapeutic strategies in each individual patient to see if the study design provides enough evidence to personalise drug treatment plans

INTERVENTION 1: <TYPE: Drug; NAME: Selexipag; DESCRIPTION: If Arm A - Up-titration to maximum tolerated dose followed by de-escalation If Arm B - Up-titration to maximum tolerated dose followed by observation, modification or transition at discretion of responsible care team where necessary., >; INTERVENTION 2: <TYPE: Drug; NAME: Riociguat; DESCRIPTION: If Arm A - Up-titration to maximum tolerated dose followed by de-escalation If Arm B - Up-titration to maximum tolerated dose followed by observation, modification or transition at discretion of responsible care team where necessary., >; INTERVENTION 3: <TYPE: Device; NAME: CardioMEMS pulmonary artery pressure monitor; DESCRIPTION: Implantation and remote monitoring established with patient initiated daily readings, >; INTERVENTION 4: <TYPE: Device; NAME: Confirm Rx; DESCRIPTION: Implantation and remote monitoring established with automated daily readings / downloads, >;

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 years - Confirmed G1, G2 or G4 HCV infection - Plasma HCV-RNA ≥1000 IU/mL - No history of HCV treatment of any kind - Willingness to use a birth control method (hormonal or intrauterine device for women, condoms for men), starting before HCV treatment initiation and continued until 4months (women) and 7 months (men) after end of treatment. - Weight ≥40 kg and ≤125 kg For patients infected with HIV : - Confirmed HIV-1 infection - Stable HIV treatment for at least 8 weeks with two NRTIs (tenofovir or abacavir, and lamivudine or emtricitabine) and a third agent (raltegravir, lopinavir/ritonavir, atazanavir/ritonavir, darunavir/ritonavir, efavirenz, nevirapine) - Current CD4+ lymphocytes count ≥100/mm3 - Current plasma HIV-1 RNA <200 copies/mL Exclusion Criteria: For each patient: - Cirrhosis classified Child-Pugh B or C - Co-infection by the Hepatitis B virus - Pregnant or breastfeeding ongoing - History of transplantation of organs or tissues - Progressive Cancer, including hepatocellular carcinoma - Epilepsy - Sickle Cell Disease - A history of myocardial infarction or other severe heart disease - Excessive consumption of alcohol or drug users, in the absence of substitution by methadone, a stable weaning for more than three months should be required - Ongoing Participation in another clinical trial - Contraindications to the Sofosbuvir as defined in the Summary of Product Characteristics - At least one of the following laboratory abnormalities: Haemoglobin <10 g / 100 ml (woman) <11 g / 100 ml (man) Platelet count <50,000 / mm3 polymorphonuclear neutrophils rate <750 / mm3 Creatinine clearance <50ml / min For patients infected with HIV: - Severe opportunistic infections in the last 6 months - Poor adherence to antiretroviral treatment history - Use of antiretroviral drugs other than those permitted in the test

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

A Pilot Study of AMP-224, a PD-1 Inhibitor, in Combination With Stereotactic Body Radiation Therapy (SBRT) in Patients With Metastatic Colorectal Cancer

Background: - T-cells are white blood cells that can find and kill germs and tumors. Cancer can keep T-cells from working. Researchers think a new drug called AMP-224 might help the T-cells in people with cancer. They think the drug might work even better when combined with a certain type of radiation therapy. Objective: - To study the safety and effectiveness of AMP-224 together with 1 or 3 days of stereotactic body radiation therapy (SBRT) directed to the liver. Eligibility: - People age 18 and older with metastatic colorectal cancer. Their cancer must have spread to the liver and not be responding to treatment. Design: - Participants will be screened with a medical history, physical exam, and blood and urine tests. Their tumors will be measured with computerized tomography (CT) scans or magnetic resonance imaging (MRI) of the chest, stomach, and pelvis. They will have an electrocardiogram (ECG) heart test. - Participants will have a small part of their tumor removed by needle (biopsy). - Participants will have 8 study visits over about 10 weeks. - At 1 visit, they will have another tumor biopsy. - At 1 visit, they will get a chemotherapy drug through a vein (intravenous (IV)). - At 6 visits, they will receive AMP-224 through an IV. - At 1 or 3 visits, they will have SBRT. Computed tomography (CT) scans will map the position of their tumor. Radiation beams of different intensities at different angles will be directed to the tumor. - At all visits, some screening procedures may be repeated. - After treatment ends, participants will have 7 follow-up visits over about 5 months. Blood will be drawn. Some screening procedures may be repeated.

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.

Stroke is the leading cause of disability in adults in the United States. Despite advances in hyperacute stroke care, advancements in stroke rehabilitation are lagging. We have previously shown that a non-invasive, cost-effective, easy to perform intervention, called ischemic conditioning (IC), can improve paretic leg strength, reduce muscle fatigue, and increase walking speed in chronic stroke survivors (>1 year post-stroke). The IC procedure makes the paretic leg transiently ischemic (5 minutes) using a cuff inflated to 225 mmHg, and repeats the occlusion 5 times with 5 minute periods of rest between cycles (45 total minutes). It is well accepted that the response to IC is complex and involves local, humoral and neural factors. The mechanism by which IC can confer motor benefit in stroke survivors is unknown. The aim of this study is to examine if IC can increase sympathetic nervous system (SNS) activity, which would promote an increased cardiovascular response to exercise and increased muscle strength. We hypothesize that plasma epinephrine and norepinephrine levels will increase more during a cold pressor test (a well-tolerated test to induce a sympathetic response) in chronic stroke survivors who undergo a single session of IC vs. IC-Sham. To accomplish the goals of this study, 15 chronic stroke survivors will each make two visits to the adult translational research unit at Medical College of Wisconsin (MCW) to have either IC or IC-Sham performed on their paretic leg in a counterbalanced order. Venous blood will be drawn before and after the IC or IC-Sham procedure and after a two-minute cold pressor test where the study participants submerge their hand into a bucket of ice water. This will cause an increased sympathetic response, which will be assessed by measuring blood pressure and the relative increase in the levels of circulating catecholamines (epinephrine and norepinephrine, assessed by high performance liquid chromatography).

PRIMARY OUTCOME: <MEASURE: Change in Plasma Norepinephrine Concentration; TIME_FRAME: Through study completion, an average of 1 year; DESCRIPTION: We will compare the absolute change in plasma norepinephrine from immediately after IC or IC Sham to immediately after the cold pressor test (i.e. the change in concentration from rest to immediately after the cold pressor test; comparison is deltaIC vs. deltaIC Sham).; > SECONDARY OUTCOME 1: MEASURE: Change in Plasma Epinephrine Concentration; TIME_FRAME: Through study completion, an average of 1 year; DESCRIPTION: We will compare the absolute change in plasma epinephrine from immediately after IC or IC Sham to immediately after the cold pressor test (i.e. the change in concentration from rest to immediately after the cold pressor test; comparison is deltaIC vs. deltaIC Sham).; >; SECONDARY OUTCOME 2: MEASURE: Change in Systolic Blood Pressure; TIME_FRAME: Through study completion, an average of 1 year; DESCRIPTION: We will compare the absolute change in systolic blood pressure from immediately after IC or IC Sham to immediately after the cold pressor test (i.e. the change in systolic blood pressure from rest to immediately after the cold pressor test; comparison is deltaIC vs. deltaIC Sham).; >;

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

A Feasibility Study of Gallium-68 Citrate PET to Detect Aberrant MYC Protein Expression in Diffuse Large B-Cell Lymphoma

This is a single center imaging study investigating the use of PET with 68Ga-citrate in patients with DLBCL or BCLU.

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. Ability to give signed informed consent and willing and able to comply with the protocol. 2. Patients aged 18 years and above. 3. Patients with newly diagnosed, pathologically confirmed pancreatic ductal adenocarcinoma who will undergo neoadjuvant chemotherapy following formal MDT assessment at St Vincent's University Hospital, specifically FOLFIRINOX or Gemcitabine with Nab-Paclitaxel (and/or any additional therapy regimen approved by NCCP). 4. Patients have CT scan available and suitable for body composition analysis within 8 weeks prior to randomisation. 5. Patients have adequate upper limb dexterity to allow assessment of hand grip strength. Exclusion Criteria: 1. Patients who are unable to consume oral diet and require prolonged enteral and/or parenteral nutritional support. 2. Patient with any significant history of non-compliance to medical treatments or with inability to grant reliable informed consent. 3. Patients who can/will not consume fish and pork products due to allergy, intolerance, religious beliefs, or dietary preferences. 4. Patients with known blood clotting disorders, e.g antiphospholipid syndrome, factor V Leiden syndrome, haemophilia /any liver disease which has progressed to liver cirrhosis where prolonged fish oil supplementation is unsafe. 5. Patients with uncontrolled hypertension (BP >180/110 mm Hg) which prohibits exercise. 6. Patients with muscle wasting disorders, e.g. paraplegia, motor neuron disease, Duchenne muscular dystrophy, multiple sclerosis. 7. Women who are pregnant or breastfeeding due to differing nutritional needs and macronutrient metabolism.

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

A Randomized Controlled Study Comparing Needle-Guided vs Free-Hand Technique in Performing Brachial Plexus Blockade

This is an openly randomized controlled parallel group study evaluating the effectiveness of using a guided approach and free-hand approach in performing upper extremity regional blocks. Potential subjects for this study are the patients who are scheduled for upper extremity surgeries requiring supraclavicular and interscalene brachial plexus blocks at Montefiore Medical Center. Rotating residents who are participating in the study will be randomly assigned either to perform block under guided approach (with the help of needle guidance) or free-hand without the needle guidance. All the blocks will be single injection blocks utilizing the in-plane technique for needle insertion which is the usual protocol in our institution. Each resident will be performing one interscalene block with the device and one without the device and one supraclavicular block with device and one without the device. An independent observer will be present during the case and will be responsible for recording the time taken to perform the block, number of times the needle has been redirected and the number of times the needle is reinserted. This observer will also administer the satisfaction questionnaire. Number of time needle is redirected and number of times reinserted is also a self reported assessment by the physician who is performing the block. Efficacy of the block will be assessed by the standard of care practiced at our center.

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

This project leverages Penn Medicine's and the investigative team's longstanding partnership with the Family Heart Foundation (FHF), a nonprofit research and advocacy organization, to test two promising approaches to implementing cascade screening. The study will test two patient-facing implementation strategies to increase reach of cascade screening with FH probands within Penn Medicine. This pragmatic randomized controlled trial (RCT) will test (a) a health system (Penn Medicine)-mediated strategy using automated text messages and emails, (b) an FHF-mediated strategy delivered by a navigator, and (c) the "usual care" approach. Both active strategies use centralized direct contact to relatives and behavioral economics. Specifically, we will conduct a 3-arm hybrid type III effectiveness-implementation RCT. Aim 1: Compare the effect of the three arms on effectiveness and implementation outcomes. - Reach (primary outcome): proportion of probands who have at least one family member who completes screening - Absolute number of family members screened - Absolute number of family members with a new FH diagnosis - Proband LDL-C levels 12 months post-randomization Aim 2: Use mixed methods to identify implementation strategy mechanisms with a focus on health equity. In Aim 2a, the researchers will conduct qualitative interviews to understand proband perspectives on mechanisms of the implementation strategies using the Consolidated Framework for Implementation Research, oversampling for populations at risk for disparities. In Aim 2b, the researchers will explore disparities quantitatively by evaluating differential strategy effectiveness by race/ethnicity and gender; and descriptively explore differential strategy effectiveness by income and medical mistrust.

Inclusion Criteria (probands): - Adults aged 18 years and older with clinically diagnosed FH who are treated within the Penn Medicine system - Have contact information for at least one living, first-degree biological relative - Have a cell phone with texting capabilities and/or access to email Exclusion Criteria (probands): - People under age 18 - Do not have contact information for at least one living, first-degree biological relative - Do not have a cell phone with texting capabilities nor access to email

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

Split-Face Tolerability Comparison Between MetroGel® (Metronidazole Gel) 1% Versus Finacea® (Azelaic Acid) Gel 15% in Subjects With Healthy Skin

The purpose of this study is to compare the tolerability of MetroGel® (metronidazole gel) 1% to Finacea® (azelaic acid) Gel 15% in subjects with healthy skin applied according to product labeling for three weeks.

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

A Two-arm, Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Study to Evaluate Safety and Tolerability and to Explore the Neuroprotective Effect of Atacicept as Assessed by Optical Coherence Tomography (OCT) in Subjects With Optic Neuritis (ON) as Clinically Isolated Syndrome (CIS) Over a 36-week Treatment Course

This study was intended to evaluate the efficacy, safety and tolerability of atacicept compared to placebo and to explore the neuroprotective effect of atacicept as assessed by OCT in subjects with ON as CIS. The study was randomized. Study medication was administered via subcutaneous (under the skin) injections.

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

The main objective of this multicentric, prospective and interventional study is to assess the feasibility of multimodal prehabilitation in patients aged 75 years or older with surgical indication for coxarthrosis or severe gonarthrosis

INTERVENTION 1: <TYPE: Behavioral; NAME: Multimodal geriatric prehabilitation; DESCRIPTION: Multimodal prehabilitation will be carried out over a period of 6 weeks in a day admission (once a week) and at home, and will include: Muscle rehabilitation developed with a physiotherapist or physical activity monitor Nutritional support (dietitian at the 1st, 3rd, and 6th day admission (DA)) Cognitive and physical stimulation "Exergame" Psychological support by a psychologist Information in the form of videos on the main risks and important points to know and prepare before and after surgery Assessment of patient satisfaction, any limitations encountered, the possible performance of exercises at home and the occurrence of any adverse effects. One session of adapted physical activity at home of one hour per week by a physical trainer from the Siel Bleu association, >;

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: - School-age Children and - Required needle procedures Exclusion Criteria: - Neurodevelopmental problems - Chronic disease - Taken Analgesic

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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. Age≥18 years old; 2. Pancreatic cancer was confirmed by pathology or cytology; 3. Liver-metastatic confirmed by pathology or clinical imaging; 4. Newly treated patients who have not received any systemic treatment for pancreatic cancer are allowed to enter the group for patients who have previously used fluorouracils (excluding gemcitabine and or taxanes) as adjuvant treatments for recurrence; 5. ECOG score of preoperative physical condition was 0-1; 6. Expected survival time ≥3months; 7. There is at least one measurable lesion under CT evaluation according to the RECIST 1.1 standard,; 8. The patient has sufficient hematological function (not receiving blood, platelet transfusion or growth factor supportive therapy within 14 days before the start of the study treatment), determined according to the following laboratory test values: 1. Absolute neutrophil count (ANC) ≥ 1.5 × 109/L; 2. Platelets ≥ 100 × 109/L; 3. Hemoglobin ≥ 9.0 g/dL; 9. The patient has sufficient liver and kidney function, which is determined according to the following laboratory test values: 1. Serum creatinine ≤ 1.5 × ULN; 2. If serum creatinine>1.5 × ULN, creatinine clearance rate ≥50ml/min; 3. Alanine aminotransferase (AST) and aspartate aminotransferase (ALT) in non-liver metastatic lesions ≤ 2.5 × ULN, and AST and ALT ≤ 5.0 × ULN in liver metastatic lesions; 4. Serum albumin ≥ 2.5 g/dL; 5. Total bilirubin ≤1.5 × ULN; 10. Men, women of childbearing age (postmenopausal women who must have been menopausal for at least 12 months to be considered infertile) and their partners voluntarily take it during treatment and at least six months after the last study drug is taken by the investigator. Effective contraceptive measures; 11. Able to understand and voluntarily sign a written informed consent form and voluntarily complete the research procedures and follow-up inspections. The informed consent form must be signed before the implementation of any research procedures specified by the trial Exclusion Criteria: 1. Received chemotherapy within 14 days before entering the study. 2. Received VEGFR signaling pathway therapy or other anti-cancer therapy within 14 days before enrollment. 3. Received radiotherapy within 14 days before enrollment, and received chest radiotherapy within 28 days before enrollment. 4. Active central nervous system involvement is known. 5. Oral anticoagulant is being used, or an inhibitor or inducer of potent cytochrome oxidase 3A4 (CYP3A4) is being used (see Appendix 1 for details). Allow the use of subcutaneous anticoagulants. 6. Patients who have participated in clinical trials of reagents or new drugs under investigation within 28 days before the first treatment administration (phase I-IV clinical trials). 7. Adverse reactions caused by previous anti-tumor treatments did not recover to grade 1 or below (hair loss and peripheral neuropathy did not recover to grade 2 or below). 8. Active infection or unexplained fever> 38.5°C occurred within 2 weeks before the first administration (according to the judgment of the investigator, the subject can be included in the group for fever caused by the tumor). 9. Various chronic active infections, such as hepatitis B virus (evidence of hepatitis activity such as HBV-DNA ≥104 copies/ml or 2000IU/ml), hepatitis C and HIV. 10. Patients with elevated serum troponin T or I (above the normal limit specified by the research center). 11. Pregnant or lactating (lactating) women, where pregnancy is defined as the state of a woman after conception until the end of pregnancy, and the result of a serum β-human chorionic gonadotropin (β-hCG) laboratory test is confirmed to be positive. 12. Any of the following cardiac standards: the average QTcF calculated according to Fridericia's formula during the rest period of the screening period [QTcF = QT/(RR1/3), RR is the standardized heart rate value, obtained by dividing 60 by the heart rate]: male> 450 milliseconds , Female> 470 milliseconds; any clinically important abnormalities in the rhythm, conduction or morphology of the resting electrocardiogram (ECG) (for example, complete left bundle branch block, third degree heart block, second degree heart block); Congenital long QT syndrome or family history of long QT syndrome. 13. According to the investigator's judgment, patients who have not fully recovered after surgery, patients whose wounds are in an active healing stage, patients who underwent major surgery within 28 days before the start of the study, and patients who underwent minor surgery within 14 days before the start of the study. 14. Severe and uncontrollable accompanying diseases that may affect protocol compliance or interfere with the interpretation of results, including active opportunistic infections or advanced (severe) infections, and diabetes that cannot be controlled after adequate clinical anti-hyperglycemia treatment according to guidelines , Uncontrollable hypertension, cardiovascular disease (Class III or IV heart failure as defined by the New York Heart Association classification, heart block above II, congestive heart failure (CHF), myocardial infarction in the past 6 months , Unstable arrhythmia or unstable angina, cerebral infarction within 3 months, etc.) or lung disease (history of interstitial pneumonia, obstructive lung disease and symptomatic bronchospasm). 15. Any other situation that the researcher considers inappropriate to participate in clinical research.

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

Re-engineering Precision Therapeutics Through N-of-1 Trials: Personalized Trials for Stress Management Against Standard of Care

The purpose of this study is to determine if an N-of-1 study design, or within-subject trials that the investigators are calling "Personalized Trials" can improve health outcomes over standard practice for common stress management techniques. This study uses three different stress management interventions to improve individual self-report of perceived stress: guided mindfulness meditation, guided yoga, and guided brisk walking. Arm 1 (n=53) and Arm 2 (n=53) of the trial will deliver the interventions using a Personalized Trial (within-subject, single N, cross-over trial) format. Participants in Arm 3 of the trial (N=106) will be offered the same number of interventions but will not be required to follow the established N-of-1 Personalized Trials framework. At the end of their Personalized Trial, participants in Arms 1 and 2 will receive a summarized report with personalized feedback. Participants in Arm 3 will also receive a report, but with summarized data . Both arms will receive 2 additional weeks of the stress management intervention of their choosing, while continuing to answer daily assessments and wear a Fitbit device. At the end of the study, a final survey will be sent assessing satisfaction with the study.

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

- The participants will be assessed for their eligibility based on inclusion and exclusion criteria. After obtaining the written informed consent, the eligible participants will be randomized to either an intervention or a control group. Psychiatric and personality disorders will be excluded before participation using the translated form of (Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders) I and II questionnaires. The participants in the intervention group will receive the education and training program in addition to the routine pharmacological treatment whereas the participants in the control group will receive only the routine pharmacological treatment (preventive treatment with stable dose for at least 3 months and not to change the dose through the study). For proper conduction of the study, three phases will be performed: Assessment phase: Each migraine patient in the intervention and control group will be interviewed individually before applying the planned program to collect socio-demographic data and clinical migraine evaluation using the clinical sheet of the clinic. Then base line measures of headache-related disability and migraine specific quality of life using migraine specific quality of life questionnaire before any intervention. Retrospective recording of 1 month past migraine attacks frequency will be recorded. This interview will take about 25-30 minutes. Implementation phase: - intervention group An intervention program will be implemented to the intervention group only after dividing them into small homogeneous groups. The program will be conducted in the clinic, it includes two parts educational and training part. The educational part will be done once in the first visit in about 30 minutes aiming to increase patient knowledge about migraine reduce the impact of migraine in daily life, the session will include concise messages about: 1. Basic migraine education. 2. Identify Common triggers to reduce and avoid migraine attacks. 3. Role of non-pharmaceutical therapies. 4. Steps for getting support from family, friends and at work. 5. Encourage use of the headache dairy. 6. How to prepare migraine emergency tool kit. 7. Explanation and demonstration of progressive muscle relaxation and deep breathing training (20-30min). Information and skills will be demonstrated and applied in the session through power point presentation, educational brochures, video lessons and guided home-based practice. The information will be in a simple language, relevant to the disease process and management as well as evidence-based (guidelines for controlled trial in migraine, 2012). The practical part: Appropriate relaxation training Program - Relaxation training comprises deep breathing exercises and progressive muscle relaxation, to perform them daily and to keep a record of them. - Group meeting sessions for training will be held every week for the 1st 4 weeks . - Video programs will be used as relaxation facilitators. - Patient will try these exercises for the first time in front of the researcher. - Patients will be advised to perform them daily for 8 weeks to achieve 60 sessions and to keep a record of them. Follow up of the intervention group adherence to instructions will regularly be done weekly by Telephone for the remainder of the study between educational, reinforcement and final evaluation sessions. Participants who will return for reinforcement sessions will receive mild compensation for study participation. The control group The control group will be advised to be adherent to the prescribed medications only and try not to change the treatment plan during the study period. Evaluation phase: Evaluation of both groups will be done using headache diary and migraine specific quality of life questionnaires. After another 4 weeks, the two groups' participants will be reevaluated. Final evaluation will be done after 3 month from base line by the researcher using the same tools. •Statistical Analysis /Statistical Package:- -The data will be collected, revised, coded and entered to personal computer, Statistical analysis by the appropriate statistical tests will be done using (statistical package for social science) program version 20.

Inclusion Criteria: - Aged 18-65 years old. - Diagnosed with migraine for at least 6 months duration. - Experiencing 4 or more migraine days/month with disability. - Willingness to practice relaxation exercises at home. Exclusion Criteria: - Secondary headache. - Patients with severe co-morbid psychiatric (depression, anxiety), personality or medical condition (liver or renal impairments).

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

Objective of the study is to assess the safety, tolerability, and PK of single and multiple intravenous administration of HM201. The study design consists of a SAD study of 4 cohorts, 8 subjects each cohort and a different dose level per cohort. In each cohort 2 will receive the placebo while rest of group will be administered with HM201. A total of 32 subjects are planned for the SAD study. MAD part will begin after cohort 1 and 2 of SAD is completed. MAD will consist of 8 subjects; 2 will receive the placebo while 6 will be administered with HM201. MAD will be conducted in a dose escalation manner with 4 weekly doses administered to all subjects. One randomization scheme will be produced for each cohort separately.

Key Inclusion Criteria: 1. Healthy male or non-childbearing potential female 2. BMI ≥18.0 and ≤32.0 kg/m2 3. Good health based on past medical history, medication use, vital signs and physical exam. 4. Normal renal and hepatic function. 5. Female partners of child bearing potential must agree to use contraception. Key Exclusion Criteria: 1. Clinically significant medical history. 2. Significant drug allergy. 3. Use of experimental drug within 3 months prior. 4. Previously received HM201, AM and other derivatives. 5. History of old myocardial infarction. 6. Diagnosed with malignant tumor or history of treatment for malignant tumor. 7. History of drug or alcohol abuse. 8. Use of omitted medicines or substance opposing objective of study. 9. COVID19 vaccine administered within 14 days of initiation of investigational product or if to receive additional dose within 30 days of investigational product administration. 10. Use of tobacco/nicotine in excess of ≥ 5 cigarettes a day and unable or unwilling to prohibit smoking during admission to site. 11. Daily consumption of more than 1L of caffeine/xanthine beverage which cannot be discontinued more than 24 hours prior to dosing of investigational product and/or ECG measurement. 12. Regular use of nutraceuticals (e.g., St. John's wort, ginseng, ginkgo biloba, Chinese herbs, and melatonin) within 1 week before administration of investigational product. 13. Donation of plasma or platelet or 200 mL of whole blood within 4 weeks or 400 mL whole blood within 3 months before administration of investigational product. 14. Clinically relevant findings in ECG. 15. Systolic blood pressure below 100 mmHg or above 140 mmHg at screening. 16. Diastolic blood pressure above 90 mmHg at screening. 17. Heart rate below 40 beats/min or above 100 beats/min at screening. 18. Symptom of orthostatic hypotension is found at screening or before investigational product administration (Day -1). 19. Hepatitis B virus surface antigen (HBsAg), hepatitis B virus core antibody (HBcAb) hepatitis C virus antibodies (anti-HCV) or human immunodeficiency virus (HIV) antigen and antibody at screening. 20. Positive to syphilis. 21. Positive to urine drug test. 22. Positive alcohol breath test.

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

It's well-known that the long-term outcome of adult acute lymphoblastic leukemia (ALL) lags far behind that of pediatric ALL,associated with different molecular cytogenetics make-up and treatment strategies. In search of an optimal regimen for pediatric ALL, comprehensive series of clinical trials of intensive chemotherapies have been conducted and lead to 80%-90% long-term survival. At the same time, pediatric-inspired chemotherapy protocol aslo yielded a charming result of 50-60% 3-year EFS in adolescent and young adult. In comparison with the leading role of intensive chemotherapy in pediatric ALL, allogeneic hematopoietic stem cell transplantation (allo-HSCT) plays an important role in treatment strategy of adult ALL. According to the state-of-art understanding of ALL, total therapy of ALL should consist of molecular-cytogenetics classification at diagnosis, minimal residual disease (MRD) monitoring and redefining risk classification during treatment, pediatric-inspired chemotherapy with high-dose Methotrexate/L-asparaginase during consolidation therapy,furthermore,risk/MRD-adapted allo-HSCT for high-risk and refractory/relapsed ALL.In pre-pediatric-inspired protocol era, allo-HSCT still represents the major role for improving the outcome of adult ALL, especially for high-risk and refractory/relapsed ALL. It's established that graft-versus-leukemia (GVL) effect was weak in ALL and patient shows poor response for donor-lymphocyte infusion (DLI). Intensified conditioning regimen allo-HSCT is based on a hypothesis of that intensifying condition with less-used drugs could overcome resistance,reduce tumor burden, and most importantly, spare enough time for slow-growing GVL effect following immune reconstitution to finally get rid of MRD and control the disease. Our previous trial of HDE-ALL-2011 (NCT01457040) have confirmed the role of intensified conditioning allo-HSCT in adult ALL, resulting in significantly improved OS and EFS in comparison with previous standard TBI/CY2 conditioning regimen(data not yet published). But at the same time, FA-TBI/CY2-VP16 conditioning regimen was associated with high transplantation-related mortality (TRM), which might be attributed to excessive suppression on both bone marrow and immune. TT-ALL-HIE-2013, substituting FA with idarubicin, is aimed at maintaining anti-tumor effect with less cross-resistance and immune suppression and reducing TRM.

Intensified conditioning regimen allo-HSCT is based on a hypothesis of that intensifying condition with less-used drugs could overcome resistance,reduce tumor burden, and most importantly, spare enough time for slow-growing GVL effect following immune reconstitution to finally get rid of MRD and control the disease. Our previous trial of HDE-ALL-2011 (NCT01457040) have confirmed the role of intensified conditioning allo-HSCT in adult ALL, resulting in significantly improved OS and EFS in comparison with previous standard TBI/CY2 conditioning regimen(data not yet published). But at the same time, FA-TBI/CY2-VP16 conditioning regimen was associated with high transplantation-related mortality (TRM), which might be attributed to excessive suppression on both bone marrow and immune. TT-ALL-HIE-2013, substituting FA with idarubicin, is aimed at maintaining anti-tumor effect with less cross-resistance and immune suppression and reducing TRM.

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 safety, effectiveness and tolerance of low doses of oral naltrexone along with buprenorphine to treat opioid use disorder prior to the first injection of VIVITROL.

INTERVENTION 1: <TYPE: Drug; NAME: NTX/BUP; DESCRIPTION: Daily doses, >; INTERVENTION 2: <TYPE: Drug; NAME: NTX/PBO-B; DESCRIPTION: Daily doses, >; INTERVENTION 3: <TYPE: Drug; NAME: PBO-N/PBO-B; DESCRIPTION: Daily doses, >;

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

The DRIVE program (Developing Relationships that Include Values of Eating and Exercise) is a home-based parent training program with 15 sessions focused on improve family nutrition and physical activity and promoting positive parent-child interactions. The aim of this study is to pilot-test the development of a childhood obesity program that includes parenting and health information. Participants in this study will be recruited through community organizations based upon their obesity health risk. Only families whose children's BMI percentile is greater than or equal to 75 will be eligible to participate in this study These participants will be randomly assigned to either the control group, in which participants will receive health information via mail only, or the experimental group that will participate in 15 DRIVE sessions focusing on parent-child interactions, health and nutrition, and physical activity. Both groups will complete a baseline assessment, mid-point assessment, and post assessment in their home, which will measure parent and child height, weight, and waist circumference; parent attitudes towards health and nutrition; and parent and child food consumption and physical activity levels. Results from this study will provide information regarding the feasibility of implementing the DRIVE curriculum as well as its impact on parent and child body mass indexes, and parents' knowledge, and attitudes related to nutrition.

Inclusion Criteria: - Child age 2-6 years old with a BMI percentile greater than or equal to 75 - Fluent in English - Parent has primary custody of the primary child participant in the study Exclusion Criteria: - Pregnant or currently breastfeeding (parent) - Planning to get pregnant while enrolled in the study (parent) - Have BMI greater than 45 (parent) - Chronic disease that affects body weight, appetite, or metabolism (for example, diabetes- type I or type II) (child) - Have HIV or AIDS (child) - Use prescription or over-the-counter medications or herbal products that affect appetite, body weight, or metabolism (child) - Plan to move out of the Atlanta/Baton Rouge area for the duration of enrollment (approximately 5 months) (family) - Plan to be out of the Atlanta/Baton Rouge area for more than 2 weeks for the duration of enrollment (approximately 5 months) (family)

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: - Women at risk of pregnancy and seeking contraception Exclusion Criteria: Exclusion criteria based on approved prescribing information in India: - Presence or history of venous thrombosis, with or without pulmonary embolism. - Presence or history of arterial thrombosis (e.g. cerebrovascular accident, myocardial infarction) or prodromi of a thrombosis (e.g. angina pectoris or transient ischemic attack). - Known predisposition for venous or arterial thrombosis, with or without hereditary involvement such as Activated Protein C (APC) resistance, antithrombin-III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant). - History of migraine with focal neurological symptoms. - Diabetes mellitus with vascular involvement. - The presence of a severe or multiple risk factor(s) for venous or arterial thrombosis (at the discretion of the doctors) - Pancreatitis or a history thereof if associated with severe hypertriglyceridemia. - Presence or history of severe hepatic disease as long as liver function values have not returned to normal. - Presence or history of liver tumors (benign or malignant). - Known or suspected malignant conditions of the genital organs or the breasts, if sex steroid-influenced. - Undiagnosed vaginal bleeding. - Known or suspected pregnancy. - Hypersensitivity to the active substances or to any of the excipients of NuvaRing. - Women who are breast feeding

252

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

A Phase 1 Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of MEDI-557 in Healthy Adults Intranasally Challenged With Respiratory Syncytial Virus (RSV)

The primary objective is to evaluate the suitability of the challenge model in measuring the efficacy of MEDI-557 compared to placebo in healthy adult participants for the reduction in the incidence of RSV through 12 days post-RSV challenge with the RSV Memphis-37 strain.

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

Pilot Study: Role of Dietary Fiber in PCOS Anovulation

The purpose of this study is to determine whether 6 months of fiber supplementation will improve ovulation in women with polycystic ovary syndrome (PCOS).

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

A Parallel-group Randomized Trial to Compare the Efficacy of Different Behaviour Change Techniques in the e- and M-health Intervention 'MyPlan 2.0'

The aim of this study is to investigate the effectiveness of intervention 'MyPlan 2.0' and the efficacy of the different behaviour change techniques that are included. Eight groups will be created that will receive a different version of the intervention, varying in three behaviour change techniques (action planning, coping planning, self-monitoring).

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. Primary unilateral total knee replacement 2. Suitable to have any one of the three test bearings 3. Over 35 years of age 4. Willing to take part 5. From one of the following NHS Scotland Health Boards: Ayrshire & Arran, Forth Valley, Greater Glasgow & Clyde, Highland, Lanarkshire or Lothian 6. Able to return for follow up sessions Exclusion Criteria: 1. Previous hip or knee replacement procedure if carried out in the previous twelve months 2. Unable to give written consent 3. Unable to attend the movement analysis sessions 4. Journey time from home to the university in excess of two hours 5. Previous ankle surgery 6. Any past neurologic history e.g. stroke, Charcot-Marie-Tooth disease

120

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

Pre-therapeutic MRI Assessment of Early Stage Rectal Cancer and Significant Rectal Polyps to Avoid Major Resectional Surgery: A New Approach to the Management of Early Stage Rectal Cancer.

This multicentre, prospective, randomised, feasibility trial aims to change UK practice by enabling more patients with early rectal cancer to safely undergo local excision rather than major surgery thus maintaining quality of life without compromising survival outcomes.

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

Heart failure (HF) affects 2-3% of the population, and is characterized by impaired sodium balance which results in fluid overload. Ejection fraction, a measure of systolic function, is reduced in only about half of all HF patients. Incidence of heart failure with preserved ejection fraction (HFpEF) has increased in the last 20 years making it a growing public health problem. Currently, most patients admitted to the hospital with heart failure have preserved rather than reduced ejection fractions. However, to date it remains unknown why patients with HFpEF retain salt and water. The hypothesis is that patients with clinical HFpEF have an impaired renal response to salt loading, intravascular expansion and diuretics. Characterization of the salt and water excretory renal response to intravascular salt, fluid and diuretic load in patients with HFpEF will provide insight into the pathophysiology of HFpEF, and may help in the development of novel strategies to target renal sodium handling in patients with HFpEF. This characterization is the primary objective of this pilot project.

INTERVENTION 1: <TYPE: Drug; NAME: 0.9% Sodium Chloride; DESCRIPTION: Intravenous infusion of 0.25ml/kg/min of 0.9% sodium chloride intravenously for a total of 60 minutes, >; INTERVENTION 2: <TYPE: Drug; NAME: Furosemide 40 mg; DESCRIPTION: Bolus intravenous injection of 40 mg furosemide, >;

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.

Principal hypothesis: A low suction drainage (-50 mmHg) reduce a 25% the blood loss with respect a standard closed drainage (-700 mmHg) following total knee arthroplasty.

PRIMARY OUTCOME: <MEASURE: total post-surgical blood loss (mL); TIME_FRAME: from the moment after surgery until drainage catheter removal; > SECONDARY OUTCOME 1: MEASURE: blood loss (mL) in the recovery unit; TIME_FRAME: 24-48 h; >; SECONDARY OUTCOME 2: MEASURE: Blood loss in the ward; TIME_FRAME: 5-10 days; >; SECONDARY OUTCOME 3: MEASURE: need for a blood transfusion according to the surgeon's criteria; TIME_FRAME: 10 days; >; SECONDARY OUTCOME 4: MEASURE: number of blood units required for transfusion; TIME_FRAME: 10 Days; >; SECONDARY OUTCOME 5: MEASURE: post-surgical pain (using a 100mm visual analogue scale); TIME_FRAME: 10 days; >; SECONDARY OUTCOME 6: MEASURE: incidence of hematomas; TIME_FRAME: 10 days; >; SECONDARY OUTCOME 7: MEASURE: infections; TIME_FRAME: 10 days; >; SECONDARY OUTCOME 8: MEASURE: suture dehiscence; TIME_FRAME: 10 days; >; SECONDARY OUTCOME 9: MEASURE: re-intervention due to complications in the surgical wound; TIME_FRAME: 10 dasy; >; SECONDARY OUTCOME 10: MEASURE: venous thrombosis; TIME_FRAME: 10 days; >; SECONDARY OUTCOME 11: MEASURE: hypotension; TIME_FRAME: 10 days; >; SECONDARY OUTCOME 12: MEASURE: mortality; TIME_FRAME: 10 days; >; SECONDARY OUTCOME 13: MEASURE: adverse reactions; TIME_FRAME: 10 days; >;

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

Osteonecrosis of the femoral head (ONFH) is difficult to treat as collapse frequently occurs after core decompression (CD). This may be due to the failure to provide structural support during revascularization and healing. Reports of polymethylmethacrylate (PMMA) packing of the femoral head after CD for ONFH have noted favorable results. This study was undertaken to determine whether the addition of PMMA packing to CD provides any benefit to progression-free survival (PFS) and conversion to total hip arthroplasty-free survival (CFS). Secondary objectives were to assess for differences in functional outcomes and predictive factors for progression of the disease.

INTERVENTION 1: <TYPE: Procedure; NAME: Core Decompression; DESCRIPTION: Core Decompression, >; INTERVENTION 2: <TYPE: Procedure; NAME: PMMA augmentation; DESCRIPTION: Polymethylmethacrylate (PMMA) augmentation, >;

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

This study is the first prospective randomized study assessing the patient-reported outcomes and safety outcomes between preoperative and postmastectomy radiotherapy in locally advanced breast cancer patients with immediate reconstruction of deep inferior epigastric perforator(DIEP) flap. Radiotherapy before mastectomy and autologous free-flap breast reconstruction can avoid adverse radiation effects on healthy donor tissues and delays to adjuvant radiotherapy. We aimed to explore the feasibility of preoperative radiotherapy followed by DIEP flap reconstruction in patients with breast cancer requiring mastectomy.

INTERVENTION 1: <TYPE: Radiation; NAME: Preoperative radiotherapy; DESCRIPTION: Radiotherapy followed by mastectomy and DIEP flap reconstruction, >; INTERVENTION 2: <TYPE: Radiation; NAME: Postmastectomy radiotherapy; DESCRIPTION: Radiotherapy after mastectomy and DIEP flap reconstruction, >;

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: - Mild to moderate male pattern baldness (androgenic alopecia) with ongoing hair loss for at least 1 year Exclusion Criteria: - History of Paget's disease, osteoporosis, or bone malignancy - History of bone fracture within the previous 12 months, except for metatarsal, metacarpal, or skull fractures - Patient is currently undergoing radiation therapy or anticipates undergoing radiation therapy at any time during the study - Drug or alcohol abuse within 12 months - HIV positive - Received hair transplants or had scalp reductions - Use of hair weaves, hair extensions or wigs within 3 months - Application of topical medications, minoxidil or nonsteroidal anti-inflammatory drugs (NSAIDs) to scalp within 4 weeks

53

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

EEG Based Brain Computer Interface in Chronic Stroke Survivors for Upper Limb Rehabilitation- A Pilot Study Using Motor Execution and Motor Imagery

Biomedical and Engineering approaches form a key element to neurological rehabilitation of upper limbs. Brain Computer Interface (BCI) using Motor execution and Motor Imagery are known to aid motor recovery in stroke. The purpose of this study is to demonstrate that Noninvasive Sensorimotor Rhythm (SMR) based EEG based BCI using motor execution and Motor Imagery tasks can aid in rehabilitation of upper limb movements in chronic stroke. The project aims to explore an SMR-based BCI system that can exploit the sensorimotor rhythm voluntary modulation to play a virtual game as neurofeedback using motor executory tasks and imagined hand movements by stroke patients, who suffer from upper limb disability.

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

A Phase II Study of MLN0128 in Metastatic Anaplastic Thyroid Cancer

This research study is studying a targeted therapy (ML0N128) as a possible treatment for anaplastic thyroid cancer. This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied. The FDA (the U.S. Food and Drug Administration) has not approved MLN0128 as a treatment for any disease. MLN0128 prevents tumor cells from dividing and growing by selectively and potently inhibiting a chemical, mTOR kinase, which regulates cell growth and survival. Patients with anaplastic thyroid cancer have been observed to sometimes carry genetic alterations in their tumor cells which may make the cancer more sensitive to inhibition by MLN0128. In this research study,the investigators are investigating usefulness of MLN0128 in metastatic anaplastic thyroid cancer cases.

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

The hypertension project will tailor improvement strategies to the problems identified as underlying underuse among treated but uncontrolled hypertensive patients in East and Central Harlem, New York City. Along with the communities' 6 major health providers, we will first combine qualitative and quantitative methods to identify specific patient, provider, and system problems, and customize interventions to address them. In a randomized controlled trial, we will then randomly assign 480 patients among 4 arms: nurse management, blood pressure monitors alone, usual care, and peer led chronic disease self-management course. During the 18-month trial, patients self-monitor their blood pressure or attend a self-management course, or nurse managers will assess patients' needs, counsel them, address any access barriers, and follow up with regular telephone contacts; convey information, including blood pressures from patients' self-monitoring, between patients and physicians to inform possible medication changes; and ameliorate any systems problems. We will assess differences in blood pressure reductions among the 4 arms as the primary outcome, and in quality of life, patient satisfaction, costs, and cost-effectiveness as secondary outcomes. The findings will provide new knowledge about the relationship between these changes and patient and clinician knowledge, attitudes, and behaviors. The educational course is designed to teach patients tools for managing their chronic illness which will empower them to improve their overall health and is specifically tailored for patients living with asymptomatic chronic illnesses and will emphasize communication with health care providers. In partnership with community organizations and the policymakers, we will disseminate successful findings within these communities and throughout the state and the nation.

Inclusion Criteria: Male and female, English or Spanish speaking African American and/or Hispanic patients with uncontrolled hypertension who have been seen in either the Cardiology clinic, Internal Medicine Associates (IMA) or Geriatric clinic at least twice in a given year at least 18 years of age. Exclusion Criteria: This study is about hypertension control among African Americans and Hispanics, these are the ethnic groups with disparities in CVD that we want to improve so other races are excluded. The study is for adults with hypertension; therefore, we are excluding anyone who is under 18 years of age.

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.

Atrial Fibrillation (AF) is a irregular heart rhythm associated with significant morbidity and mortality. Catheter ablation is a treatment where catheters are passed through the veins in the leg into the left atrium of the heart and lines of scar is delivered to disrupt tissue causing and maintaining atrial fibrillation. Current strategies involve isolating the pulmonary veins which have been shown to trigger and maintain AF. However, success rates for persistent AF lie in the region of 30-60% due to the drivers of AF residing elsewhere to the Pulmonary Veins antra. The ECG-I is a system which involves wearing a jacket with many ECG electrodes to record electrical activity from the surface of the body. A CT scan then shows where these electrodes are relative to the atria, and computer modelling is used to reconstruct the movements of electricity on the surface of the heart and therefore identifying where the drivers (tissue causing and maintaining AF) are located. Unfortunately, not all patients respond to PVI due to the drivers of AF being located in areas other than within the Pulmonary Veins. Identifying the drivers of AF is very difficult and the role they play has yet to be proved scientifically. PHENOTYPE AF is an ongoing clinical trial in which 100 patients with persistent AF are receiving cryoballoon pulmonary vein isolation for persistent AF (NCT03394404). Patients with recurrent AF or atrial tachycardia within 1 year following pulmonary vein isolation for AF within this trial will be recruited into this study. Up to 50 such patients who have failed Pulmonary Vein Isolation will be enrolled. These patients will undergo a second procedure at which time participants will undergo catheter ablation of drivers of AF and will then be followed up for 12 months.

PRIMARY OUTCOME: <MEASURE: Number of Participants free from Atrial Arrhythmia at 12 months; TIME_FRAME: 12 months; DESCRIPTION: Number of participants free from atrial arrhythmia (including both AF and atrial tachycardia) at 12 months following their procedure; > SECONDARY OUTCOME 1: MEASURE: Rates of termination of AF with ECGI guided ablation; TIME_FRAME: Intra-procedural (day 1); DESCRIPTION: The proportion of patients in whom AF terminates with ablation during the catheter ablation procedure; >; SECONDARY OUTCOME 2: MEASURE: Number of participants free from AF at 12 months; TIME_FRAME: 12 months; DESCRIPTION: Number of participants free from AF at 12 months following their procedure; >;

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

The objective of this study is to investigate the impact of regular home use of Lumoral device® as an adjunct treatment compared to non-surgical periodontal treatment alone on biofilm removal and host response in Stage III and Grade C smoking periodontitis patients at 6 months. Lumoral® is based on a dual-wavelength LED light that activates Lumorinse® (exocellular) and bacteria porphyrins (endocellular), resulting in the formation of reactive oxygen species (ROS). ROS and heat induce a series of photochemical and biological events that cause irreversible inactivation leading to the death of undesired bacteria. This device is designed for home use. Therefore it is hypothesized that its adjunct use in the treatment of periodontitis could lead to better outcomes compared to traditional periodontal treatment. In order to investigate this impact, clinical and microbiological measurements will be compared between patients who will be treated with conventional non-surgical periodontal treatment and patients who will receive the Lumoral device® as an adjunct to the periodontal treatment. The patients who receive the device will use it every day for four months. Both groups will be followed for 6 months.

Inclusion Criteria: - Periodontal disease Stage III and Grade C with at least 6 sites with probing depth (PD) and clinical attachment loss (CAL) ≥5 mm and bleeding on probing (BoP) ≥15 teeth - aged ≥35 - Smokers smoking ≥10 cigarettes per day Exclusion Criteria: - Patients allergic to indocyanine - Patients with active carious lesions - Need for prophylactic antimicrobial coverage - Scaling and root planing in the previous 6 months - Non-smoking status or smoking less than 10 cigarettes per day - Antimicrobial therapy in the previous 6 months - Immunomodifying conditions/ diseases (e.g. diabetes mellitus, rheumatoid arthritis, osteoporosis) - Long-term use of medication that could interfere with periodontal response (e.g. biphosphonates) - Pregnancy or lactation

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

This pilot study will examine esophageal manometry in patients emerging from routine general anesthesia. Manometry of the esophagus is not a standard part of surgery or general anesthesia. The investigators will be using standard solid state high resolution manometry. One of the authors (JPC) evaluates all routine manometry for patients undergoing such procedures at both UCSF and SFGH. The use of manometry in patients recovering from anesthesia will permit the investigators to assess the recovery of a normal swallowing mechanism. An adequate determination of return of normal swallowing sequence is likely to determine the safe time for extubation. The investigators propose to, as a research study, investigate esophageal motor function using standard high resolution esophageal manometry in 10 patients recovering from general anesthesia. These studies are likely to document that the return of normal pharyngoesophageal function will coordinate with verbal commands to initiate swallowing. This pilot study will help clarify the precise timing of the return of normal function in the oropharynx and the proximal esophagus and thus determine the safe time for removal of the endotracheal or nasotracheal intubation.

Inclusion Criteria: - Patients between 18 and 70 years of age (ASA I or II). - Already scheduled for routine general anesthetic procedure requiring an endotracheal tube for anesthesia administration. - Scheduled abdominal surgical procedure including endoscopy, colonoscopy, ERCP, cholecystectomy, appendectomy, colectomy or small bowel resection. - Willing and able to give informed consent in either English or Spanish. Exclusion Criteria: - Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study. - Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data. - Patients not meeting entry criteria above. - Refusal to give informed consent. - Coagulopathy (INR > 2 and/or platelet count < 100,000. - White Blood Cell count < 5,000/mm3 - Arrhythmia - Serum creatinine > 2 mg/dl - Prior known or suspected nasal obstruction. - Known or suspected Zenker's diverticulum of esophagus, esophageal stricture, head/neck radiation therapy, hereditary telangiectasis, esophageal varices, cirrhosis. - Anticoagulant usage such as heparin or Plavix

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: - Inclusion criteria of practices Practices inclusion criteria 1- General practices who are currently contributing part of the CPRD in England. - Inclusion criteria of children with asthma Inclusion criteria for the data extraction from CPRD: 1- School-aged children with asthma aged between 4 to 16 years old as of 1st September 2021 with a coded diagnosis of asthma who have been prescribed asthma medication in the last 12 months. Exclusion Criteria: - Practice exclusion criteria: 1. General practices that are not in England. 2. General practices that are not included in the CPRD. 3. Practices that cease to be part of the CPRD during the intervention time without contributing to the primary outcome. 4. Practices that merge during the intervention (where the merging practices were in different study arms). - Exclusion criteria of children with asthma: 1. School-aged children with asthma under 4 and over 16 years old as of 1st September 2021. 2. Children with no asthma diagnosis 3. Children with asthma who have not received a prescription for asthma medication. in the last 12 months

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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.

While evidence-based care for chronic obstructive pulmonary disease (COPD) and asthma can substantially reduce disease burden and prevent emergency visits and hospitalizations, it is estimated that 55% of patients with COPD do not receive all recommended care and that less than 50% of patients with asthma are well controlled. The proposed study will evaluate the effectiveness of a novel model for pulmonary specialist-health coach consultations (PuSHCon) in its ability to increase access to specialty recommendations and the provision of evidence-based care for patients with chronic obstructive pulmonary disease (COPD) and/or asthma receiving care at federally qualified health centers (FQHCs). The specific aims of the study are to compare the use of evidence-based care and of patient reported outcomes 4 months after the consultation. In addition, the study will evaluate the cost per patient in each model to determine the model's effectiveness in increasing access and lowering cost. The first aim of comparing the use of evidence-based care will be measured as the proportion of guideline-based recommendations that are ultimately received by the patients. The secondary endpoint for this aim will be measured through the proportion of patients receiving guideline-concordant medications at 4 months after consultation compared to baseline. The second aim of the study regarding patient-reported outcomes will be measured primarily through the change in COPD and/or asthma related quality of life measures from baseline to 4 months post consultation. The secondary measure for this aim will look at changes in COPD and/or asthma specific symptom scores. The third aim of the study is to assess the impact of this model on access to care and cost of care. Access will be measured by tracking the number of patients who successfully complete a consultation per month. Costs will be determined by calculating time spent per patients, as well as by health care utilization.

Inclusion Criteria: - English or Spanish speaking - At least 18 years of age - Diagnosed with asthma or COPD - Experiencing uncontrolled symptoms or exacerbations Exclusion Criteria: - Do not plan to attend primary care clinic for at least 3 months - Already engaged in pulmonary specialty care (defined as at least one visit in last 12 months) - Cognitive dysfunction that would prevent interaction with a health coach - Not having a phone at which the participant can be reached

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

This study is a prospective, longitudinal, multi-center, within patient evaluation of patients with articular cartilage defects of the knee who have had an inadequate response to a prior non-Carticel surgical treatment. Patients who met eligibility criteria were enrolled in the study. Subsequent to implantation with Carticel patients have follow-up every 6-months up to 48-months.

INTERVENTION 1: <TYPE: Biological; NAME: Carticel (autologous cultured chondrocyte) implantation; DESCRIPTION: Each Carticel vial of autologous cultured chondrocytes contains approximately 12 million cells implanted into the defect and secured with a periosteal flap, >;

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

Supplementation of Brown Seaweed on Insulin Resistance of NAFLD Patients With Pre- or Type 2-Diabetes

Investigators research team conducted a previous human clinical trial of brown algae and conducted liver and metabolic indicators of brown algae to improve nonalcoholic fatty liver disease, and found brown algae extract (LMF-HSFx, commodity In addition to reducing the liver function index, HbA1c in some patients with early stage diabetes or type 2 diabetes has an improved effect. In the mouse model of type 2 diabetes, comprehensive anti-hyperglycemia, anti-hyperlipidemia and hepatoprotective activity were studied using LMF-HSFx. Intake of LMF-HSFx reduced fasting blood glucose, increased adiponectin levels, reduced urine glucose, and improved hepatic glucose metabolism. LMF-HSFx can improve glucose and lipid metabolism in adipose tissue of diabetic mice, and inflammatory factors such as TNF-α and IL-6 can also be reduced. In this study,participants will be given Fuco-HiQ, and their effects on blood glucose and various metabolic indicators will be evaluated.

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. Age 7 - 80 years at time of screening. 2. Has a clinical diagnosis of type 1 diabetes: 1. 14 - 80 years of age: A clinical diagnosis of type 1 diabetes for 2 years or more as determined via medical record or source documentation by an individual qualified to make a medical diagnosis. 2. 7 - 13 years of age: A clinical diagnosis of type 1 diabetes for 1 year or more as determined via medical record or source documentation by an individual qualified to make a medical diagnosis. 3. Does not require a legally authorized representative to consent on their behalf due to mental or intellectual disability. 4. Subject or parent/caregiver is literate and able to read the language offered in the pump or pump materials. 5. Subject and/or legally authorized representative is willing to provide informed consent for participation. 6. Is willing to perform fingerstick blood glucose measurements as needed. 7. Is willing to wear the system continuously throughout the study. 8. Must have a minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units. 9. Has a Glycosylated hemoglobin (HbA1c) less than 10% (as processed by Central Lab) at time of screening visit. 10. Has thyroid-stimulating hormone (TSH) in the normal range OR if the TSH is out of normal reference range the Free T3 is below or within the lab's reference range and Free T4 is within the normal reference range. 11. Uses pump therapy for greater than 6 months prior to screening (with or without CGM experience). 12. Is willing to upload data from the study pump, must have Internet access, and a computer system, or compatible smartphone that meets the requirements for uploading the study pump. 13. Is willing to take one of the following insulins and can financially support the use of insulin preparations as required by the study: 1. Humalog (insulin lispro injection) 2. NovoLog (insulin aspart injection) 3. Admelog (insulin lispro injection) Exclusion Criteria: 1. Has a history of 2 or more episodes of severe hypoglycemia, which resulted in any the following during the 6 months prior to screening: 1. Medical assistance (i.e., Paramedics, Emergency Room [ER] or Hospitalization) 2. Coma 3. Seizures 2. Has been hospitalized or has visited the ER in the 6 months prior to screening resulting in a primary diagnosis of uncontrolled diabetes. 3. Has had DKA in the last 6 months prior to screening visit. 4. Will not tolerate tape adhesive in the area of sensor placement as assessed by a qualified individual. 5. Has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection). 6. Is female of child-bearing potential and result of pregnancy test is positive at screening. 7. Is sexually active female of child-bearing potential and is not using a form of contraception deemed reliable by the investigator. 8. Is female and plans to become pregnant during the course of the study. 9. Is being treated for hyperthyroidism at time of screening. 10. Has diagnosis of adrenal insufficiency. 11. Has taken any oral, injectable, or intravenous (IV) glucocorticoids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or IV glucocorticoids during the course of the study. 12. Is using hydroxyurea at time of screening or plans to use it during the study. 13. Is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study device in the last 2 weeks. 14. Has used a MiniMed 780G pump prior to screening. 15. Is currently abusing illicit drugs. 16. Is currently abusing marijuana. 17. Is currently abusing prescription drugs. 18. Is currently abusing alcohol. 19. Using pramlintide (Symlin), DPP-4 inhibitor, liraglutide (Victoza or other GLP-1 agonists), metformin, canagliflozin (Invokana or other SGLT2 inhibitors) at time of screening. 20. Has a history of visual impairment which would not allow subject to participate in the study and perform all study procedures safely, as determined by the investigator. 21. Has elective surgery planned that requires general anesthesia during the course of the study. 22. Has sickle cell disease, hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening. 23. Plans to receive red blood cell transfusion or erythropoietin over the course of study participation. 24. Is diagnosed with current eating disorder such as anorexia or bulimia. 25. Has been diagnosed with chronic kidney disease that results in chronic anemia. 26. Has a hematocrit that is below the normal reference range of lab used. 27. Is on dialysis. 28. Has serum creatinine of >2 mg/dL. 29. Has celiac disease that is not adequately treated as determined by the investigator. 30. Has had any of the following cardiovascular events within 1 year of screening: myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, or ventricular rhythm disturbances. 31. Has had history of cardiovascular event 1 year or more from the time of screening without 1. a normal EKG and stress test within 6 months prior to screening or during screening or 2. clearance from a qualified physician prior to receiving the study devices if there is an abnormal EKG or stress test. 32. Has 3 or more cardiovascular risk factors listed below without a normal EKG within 6 months prior to screening or during screening or clearance from a qualified physician if there is an abnormal EKG: - Age >35 years - Type 1 diabetes of >15 years' duration - Presence of any additional risk factor for coronary artery disease - Presence of microvascular disease (proliferative retinopathy or nephropathy, including microalbuminuria) - Presence of peripheral vascular disease - Presence of autonomic neuropathy 33. Is a member of the research staff involved with the study. 34. Is a Medtronic Diabetes employee or their immediate family member (excluding adult children and/or adult siblings).

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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.

A phase I clinical trial to compare and evaluate the safety and pharmacokinetic characteristics after administration of CKD-391 and co-administration of CKD-331 and D337 in healthy adult volunteers

Inclusion Criteria: 1. Healthy adult aged between 19 to 55 at screening 2. Weight ≥ 50kg(man) or 45kg(woman), with calculated body mass index (BMI) of 18 to 30kg/m2 3. Those who have no clinically significant congenital or chronic diseases and have no abnormal symptoms of findings 4. Those who are deemed suitable for clinical trials based on laboratory (hematology, blood chemistry, serology, urinalysis, urine drug test) and 12-lead ECG results at screening 5. Those who agree to contraception from the first IP dosing day till 14 days after the last dosing day and decide not to provide sperm during the participation of clinical trial 6. Those who voluntarily decide to participate in paper and agree to comply with the cautions after fully understand the detailed description of this clinical trial Exclusion Criteria: 1. Those who have used drugs that induce or inhibit drug metabolizing enzymes, such as barbiturates, within 1 month before the first dosing date, or who have used drugs that may interfere with this study within 10 days before the first dosing day 2. Those who exceed an alcohol, caffeine and cigarette consumption (caffeine> 5 cups/day, alcohol> 21 glasses/week(man), 14 glasses/week(woman), smoking> 20 cigarettes/day) and not able to stop on smoking, caffeine and alcohol 3. Those who received investigational products or participated in bioequivalence test within 6 months before the first administration of clinical trial drugs 4. Those who donated whole blood within 8 weeks before the first date of administration and donated ingredients within 2 weeks or received blood transfusion in 4 weeks 5. Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery 6. Patients with the following diseases - Patients with active liver disease or with elevated amino transferase levels with unknown cause increased by more than 3 times the normal upper limit - Patients with severe liver failure or biliary obstruction and bile congestion - Patients with muscular disease, rhabdomyolysis, or persons with a past history - Patients with hypothyroidism, patients with genetic muscle disease or their family history, and patients with history of muscle disability due to drugs - Patients with renal impairment or a history of in and patients with severe renal dysfunction - Patients with a history of muscle toxicity to other statin drugs or fibrate drugs 7. Those who have genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption 8. Those who have hypersensitivity to the main constituents or components of the investigational drug 9. Those who have a history of drug abuse within 1 year of screening or who have tested positive for urine drug tests 10. Woman who are pregnant or breastfeeding 11. Those who are deemed insufficient to participate in clinical study by investigators

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

A Randomized, Open Lable, Multi-center, Active Competitor Phase 2 Study for Evaluating Efficacy and Safety of Genakumab for Injection as First Line Therapy in Patients With Gout Flare

To evaluate the safety and efficacy of Genakumab for Injection in patients with gout flare as a first line therapy

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

The investigators are undertaking a parallel group, multicenter, randomized controlled trial of patients with ITP in China. Patients were tested for MSCs, and they were divided into MSC-C5b-9+ group and MSC-C5b-9- group according to the test results, and the two groups were randomized to ATRA + eltrombopag and eltrombopag monotherapy group. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.

Inclusion Criteria: - 1. Isolated thrombocytopenia (platelet count <30 × 109/L); 2. age > 18 years; 3. normal white blood cells and red blood cells on bone marrow examination; 4. increased number of megakaryocytes (bone marrow examination was performed in all patients except for myelofibrosis or other conditions that can cause thrombocytopenia disease); 5. the spleen was normal in size; 6. Eastern Cooperative Oncology Group status score (ECOG score) ≤ 2; 7. ineffective or relapsed after at least 1 course of full-dose full-course hormone therapy; 8. Failure of prior ITP therapy (eg, hormones, splenectomy, and cyclosporine) and at least 4 weeks from enrollment. Exclusion Criteria: - 1. Secondary ITP such as drug-related thrombocytopenia; 2. thrombocytopenia due to viral infection (HIV, hepatitis B virus, or hepatitis C virus); 3. severe cardiac, renal, hepatic, or respiratory insufficiency; 4. severe immunodeficiency; 5. pregnancy or lactation; 6. myelodysplasia or Myelofibrosis; 7. history of malignancy; 8. ongoing immunosuppressive therapy for other diseases; 9. patients previously treated with eltrombopag were excluded from this study.

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

Evaluation of the Ovarian Reserve in Patients Who Hypogastric Arteries and or Uterine Arteries Had Been Ligated

Patients who hypogastric arteries and/or uterine arteries had been ligated will be evaluated in terms of ovarian reserve markers such as anti-mullerian hormone levels, ovarian volumes, antral follicule count, follicule stimuli hormone and estrogen levels. Investigators will search their archives for finding suitable patients for study. Investigators will especially notice being at least 6 month time of interval between surgery and evaluation time. Ultrasound examination and taking blood sample will be performed on 2nd or 3th day of menstrual cycle. These results will be compared with normal postpartum women's results. It will be evaluated that there is or not any effect of the hypogastric arteries and/or uterine arteries on ovarian reserve

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.

Young men who have sex with men (MSM) in low- and middle-income countries often do not seek out HIV testing, are unaware of their HIV-positive status, and do not receive early medical care, compromising their health and contributing to downstream disease incidence. This situation is of great concern in post-socialist countries of Eastern Europe, where stigma about HIV/AIDS and same-sex behavior are great, HIV epidemics are still increasing, and the health needs of young MSM are rarely acknowledged or addressed. The planned research will be conducted in Sofia, Bulgaria, where MSM account for nearly half of HIV infections. The study will be conducted in two phases.

PRIMARY OUTCOME: <MEASURE: Change in Frequency of HIV Testing; TIME_FRAME: 6 months; 12 months; DESCRIPTION: Change in the number of HIV tests completed within the 6 months prior to baseline will be compared with the number of HIV tests completed 0-6 months post-intervention and 7-12 months post-intervention; > SECONDARY OUTCOME 1: MEASURE: Change in Medical Appointment Keeping; TIME_FRAME: 6 months; 12 months; DESCRIPTION: Changes in the number of medical appointments scheduled and kept relative to baseline will be compared at 6 and 12 months post-intervention; >;

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. Male and female participants at least 18 years of age. 2. Able to provide informed consent. 3. Able to ingest oral tablets for the anticipated treatment duration. If present at baseline, nausea and/or vomiting should have been mild or well-controlled with antiemetic therapy, in order to tolerate oral study drug. 4. Have a diagnosis of cUTI or AP as defined below: a. cUTI definition: At least Two of the following signs and symptoms: i. Chills, rigors, or fever; fever must be observed and documented by a health care provider (oral, tympanic, rectal or core temperature >38.0°C [>100.4°F]) ii. Dysuria, urgency to void, or increased urinary frequency iii. Nausea or vomiting, as reported by the participants iv. Lower abdominal, suprapubic, or pelvic pain And at least One of the following risk factors for cUTI: i. Implanted urinary tract instrumentation (e.g., nephrostomy tube, ureteric stents, or other urinary tract prosthetic material), ongoing intermittent bladder catheterization, or presence of an indwelling bladder catheter (Note: bladder catheters that have been in place for >24 hours prior to Screening must be removed or replaced prior to collection of the Screening urine for urinalysis and culture, unless removal or replacement is considered unsafe or contraindicated). ii. Current known functional or anatomical abnormality of the urogenital tract, including anatomic abnormalities of the urinary tract, neurogenic bladder, or post-void residual urine volume of ≥ 100 mL within the past 6 months. iii. Complete or partial obstructive uropathy (e.g., nephrolithiasis, tumor, fibrosis, urethral stricture) that is expected to be medically or surgically treated during study drug therapy (prior to end of the treatment [EOT]). iv. Known intrinsic renal disease with blood urea nitrogen (BUN) >20 mg/deciliter (dL), or blood urea >42.8 mg/dL, or serum creatinine (Cr) >1.4 mg/dL. v. Urinary retention, including urinary retention in men due to previously diagnosed benign prostatic hyperplasia (BPH). b. AP definition: Acute flank pain (onset within 7 days prior to randomization) or costovertebral angle tenderness on physical examination. And at least One of the following signs and symptoms: i. Chills, rigors, or fever; fever must be observed and documented by a health care provider (oral, tympanic, rectal or core temperature >38.0°C [>100.4°F]). ii. Peripheral white blood cell count (WBC) >10,000/mm3 or bandemia (≥15% immature polymorphonuclear neutrophils (PMNs), regardless of WBC count). iii. Nausea or vomiting, as reported by the participants. iv. Dysuria, urgency to void, or increased urinary frequency. Note: Participants who meet the definition for cUTI (Inclusion Criterion 4a) and also have flank pain or costovertebral tenderness should be randomized as cUTI rather than AP. 5. Have an adequate urine specimen for evaluation and culture obtained within 24 h prior to randomization with evidence of pyuria that includes at least one of the following: 1. At least 10 WBCs per high power field (hpf) in urine sediment. 2. At least 10 WBCs per cubic millimeter (mm3) in unspun (non-centrifuged) urine. 3. Positive leukocyte esterase (LE) on urinalysis. Note: Participants could be randomized and administered investigational product (IP) prior to knowledge of urine culture results. 6. Expectation, in the judgment of the Investigator, that the participant would survive with effective antibiotic therapy and appropriate supportive care for the anticipated duration of the study. 7. Willing to comply with all the study activities and procedures throughout the duration of the study. 8. Participants were required to use a highly-effective method of birth control; male participants were required to use an effective barrier method of contraception from Screening through LFU and for 90 days following the last dose if sexually active with a female of childbearing potential (FOCP); female participants must not have been pregnant or nursing, and were required to commit to either sexual abstinence or use at least two medically accepted, effective methods of birth control (e.g., condom, spermicidal gel, oral contraceptive, indwelling intrauterine device, hormonal implant/patch, injections, approved cervical ring) from Screening through LFU and for 90 days following the last dose. Exclusion Criteria 1. Presence of any known or suspected disease or condition that, in the opinion of the Investigator, may have confounded the assessment of efficacy, including but not limited to the following: 1. Perinephric or renal corticomedullary abscess. 2. Uncomplicated urinary tract infection (cUTI) - (acute cystitis that does not meet the cUTI disease definition, see Inclusion Criterion 4a). 3. Polycystic kidney disease. 4. Recent history of trauma to the pelvis or urinary tract. 5. Confirmed or suspected acute or chronic bacterial prostatitis, orchitis, or epididymitis. 6. Chronic vesicoureteral reflux. 7. Previous or planned renal transplantation. 8. Previous or planned cystectomy or ileal loop surgery. 9. Known or suspected non-renal source of infection (e.g., infective endocarditis, osteomyelitis, meningitis, pneumonia). 10. Confirmed or suspected infection that is caused by a pathogen that is resistant to either IP (e.g., carbapenem-resistant pathogen), including infection caused by fungi (e.g., candiduria) or mycobacteria (e.g., urogenital tuberculosis). 2. Gross hematuria requiring intervention other than administration of IP or removal/placement of urinary tract instrumentation. 3. Urinary tract surgery within 7 days prior to randomization or urinary tract surgery planned during the study period (except surgery required relieving an obstruction or placing urinary tract instrumentation). 4. Creatinine clearance (CrCl) of ≤30 mL/min, as estimated by the Cockcroft-Gault formula: estimated Creatinine Clearance (eC_Cr) [mL/min]=((140-Age [yrs]) × Body Weight [kg] × [0.85 if Female])/(72 × Serum Creatinine [mg⁄dL]). 5. Anticipated concomitant use of non-study antibacterial drug therapy between randomization and the LFU Visit that would potentially effect outcome evaluations of cUTI/ AP, including but not limited to antibacterials with potential activity versus uropathogens, antibacterial drug prophylaxis, and antibacterial bladder irrigation. 6. Anticipated concomitant use of gastric acid-reducing medications between randomization and end-of-treatment (EOT), including proton pump inhibitors, histamine-2 receptor antagonists, and antacids. 7. Receipt of more than a single dose of a short-acting potentially effective antibiotic started within 72 h prior to randomization. Exception: Participants who received more than a single dose of short-acting potentially effective antibiotic within 72 h prior to randomization may be eligible for enrollment if they meet all of the following criteria: 1. In the opinion of the Investigator they have failed the prior antibiotic therapy (e.g., have worsening signs and symptoms of cUTI/AP). 2. Had a documented uropathogen (growth in urine culture >10^5 CFU/mL) that is resistant to the prior antibiotic therapy. 3. Had a documented uropathogen that is carbapenem-susceptible. 4. Received approval from the Medical Monitor to enroll the participants. 8. Severe hepatic impairment at Screening, as evidenced by alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5x upper limit of normal (ULN) or total bilirubin >3x ULN, or clinical signs of cirrhosis or end-stage hepatic disease (e.g., ascites, hepatic encephalopathy). 9. Any signs of severe sepsis, including shock or profound hypotension defined as systolic blood pressure <90 mmHg or a decrease of >40 mmHg from baseline that is not responsive to fluid challenge. 10. Pregnant or breastfeeding women. 11. History of epilepsy or known seizure disorder (excluding a history of childhood febrile seizures). 12. Receipt of any investigational medication during the last 30 days or 5 half-lives, whichever is longer, prior to randomization. 13. Known history of human immunodeficiency virus (HIV) infection and or acquired immunodeficiency syndrome (AIDS)-defining illness, or known history of HIV infection and known CD4 count <200/mm^3 within the past year. 14. Presence of immunodeficiency or an immunocompromised condition including neutropenia (<1,000 neutrophils/mm^3 obtained from the local laboratory at Screening), hematologic malignancy, bone marrow transplant, or receiving immunosuppressive therapy such as cancer chemotherapy, medications for the rejection of transplantation, and long-term use of systemic corticosteroids (e.g., ≥20 mg/day of prednisone or systemic equivalent for at least 2 weeks). 15. A mean QT interval corrected using Fridericia's formula (QTcF) >480 msec based on triplicate ECGs at Screening. 16. History of significant hypersensitivity or allergic reaction to β-lactam antibiotics (e.g., cephalosporins, penicillins, carbapenems), product excipients (mannitol, microcrystalline cellulose, crospovidone, magnesium stearate, colloidal silicon dioxide, and Opadry®) or any contraindication to the use of ertapenem. 17. History of known genetic metabolism anomaly associated with carnitine deficiency (e.g., carnitine transporter defect, methylmalonic aciduria, propionic acidemia) 18. Requirement for concomitant use of valproic acid, divalproex sodium, or probenecid between randomization and EOT. 19. Unable or unwilling to comply with the protocol. 20. An employee of the Investigator or study center with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as a family member of the employee or the Investigator.

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

Cardiac arrythmias are the most common cardiac complications after thoracic surgery. They are made primarily of postoperative atrial fibrillation (POAF). They are associated with an increased risk of stroke, increased length of hospital stay and cost of care, and increased long-term mortality. Randomized , single-blind prospective study in the anesthesia and intensive care department of Abderrahmen Mami hospital Ariana Tunisia comparing the efficacy of Diltiazem versus Celiprolol in the prevention of postoperative cardiac arrythmias in patients proposed for pneumonectomy and bilobectomy.

INTERVENTION 1: <TYPE: Drug; NAME: Celiprolol; DESCRIPTION: receiving 1 tablet per day of Celiprolol 200 mg in the morning from the first postoperative day after pneumonectomy or bi lobecomty for 2 weeks., >; INTERVENTION 2: <TYPE: Drug; NAME: Diltiazem; DESCRIPTION: receiving 1 tablet per day of Diltiazem 200 mg in the morning from the first postoperative day after pneumonectomy or bi lobecomty for 2 weeks., >;

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: - Subjects who have completed their participation in a randomized "qualifying" study of CP-690,550 for the treatment of rheumatoid arthritis Exclusion Criteria: - Serious medical conditions that would make treatment with CP-690,550 potentially unsafe

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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.

It is hypothesized that reappraising intergeneration relationships through perspective-taking will enhance the well-being of adult-child caregivers. Incorporating both psychological and social perspectives, the study makes a unique contribution to address research gaps by evaluating an integrated model of intervention for dementia caregivers. The conceptual model involves the following components: 1) relational insights; 2) self-reflection to integrate the challenges and benefits in caregiving; 3) interpersonal empathy To test the incremental value of perspective-taking reappraisals, the study involves a two-arm randomized controlled trial of 12 weeks of intervention with two conditions: 1) Reappraisal through Perspective Taking and 2) Basic Skill Building. Telephone-administered sessions are integrated with group sessions and home visits to maximize sustainability and accessibility of the intervention. One hundred fifty-four participants will be recruited and randomized. Primary outcomes are reduced depressive symptoms and enhanced psychological well-being for the caregivers. Secondary outcomes include enhanced social support for caregivers and reduced behavioral problems in the care-recipients.

PRIMARY OUTCOME: <MEASURE: Change in Center for Epidemiological Studies-Depression Search Results Center for Epidemiological Studies Depression; TIME_FRAME: Week 1, 6, 12, 24; DESCRIPTION: 20-item measure that asks caregivers to rate how often over the past week they The scale rates experienced symptoms associated with depression.. Response options range from 0 to 3 for each item (0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time). Scores range from 0 to 60, with high scores indicating greater level of having depressive symptoms.; > SECONDARY OUTCOME 1: MEASURE: Change in Revised Memory and Problem Checklist; TIME_FRAME: Weeks 1, 6, 12 ,24; DESCRIPTION: The checklist is a 24-item caregiver-report measure provides a total score plus scores for three subscale memory-related problems, affective distress and disruptive behaviors. Scores are computed for the presence or absence of each problem first, and then for caregiver "reaction" or the extent to which caregivers were "bothered" or "distressed" by each behavior. The caregivers' reaction to each behavior, or the extent of distress experienced, were scored as follows: Reactions are assessed by asking how "upsetting" the behavior was on a Likert scale of 0 to 4 (0 = Not at all, 1= a little, 2 = moderately, 3 = very much, and 4 =extremely). Frequency of behaviors are assessed based on a Likert-scale of 0 to 4 (0 = never occurs, 1 = occurs infrequently and not in the last week, 2 = occurred 1-2 times in the last week, 3 = occurred 3-6 times in the last week, and 4 = occurs daily or more often). The range of score is from 0 to 96, higher scores suggesting greater disruption.; >; SECONDARY OUTCOME 2: MEASURE: Change in MacArther Social Support Scales; TIME_FRAME: Weeks 1,6, 12, 24; DESCRIPTION: The measure the levels of emotional and instrumental social support experienced by the caregivers. The scale consists of 12 items assesses the frequency of receipt of 3 categories of social support: emotional support, instrumental support and negative interaction involving conflict or excessive demands. The participants scored each item on a 5-point Likert Scale ranging from 0 (never) to 4 (frequently). The range of scores is from 0 to 48, with higher score indicating better social support.; >;

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

Delivering Evidence-Based Parenting Services to Families in Child Welfare Using Telehealth

The goal of this randomized controlled trial is to compare Promoting First Relationships - Home Visit (PFR-HV) to Promoting First Relationships - Telehealth (PFR-T) among parents of 6-12 month olds in the child welfare system. The main questions it aims to answer are: - Is PFR-T effective relative to PFR-HV and Usual Care with respect to observed parent sensitive and responsive care, parent knowledge of child social and emotional development, and child externalizing behavior? - Is PFR-T effective relative to PFR-HV and Usual Care with respect to child out-of-home placement in foster care relative to the control group? - How does PFR-T compare in a benefit-cost analysis to the cost-effectiveness relative to PFR-HV and Usual Care? - Are eligible families impacted by the lack of technology and Wi-Fi/cellular data to engage in PFR-T? - How does provider adherence and fidelity in delivery of PFR-T compare to adherence and fidelity of PFR-HV? What will participants be asked to do? 1. Participants will be asked to agree to randomization, resulting in their placement in one of three groups: PFR-HV, PFR-T, or the control group. 2. Participants will be asked to participate in three virtual research visits, over the course of approximately 12 months (families could be finished as early as 9 months, however in our experience, intervention sessions and research visits often need to be rescheduled, delaying completion of the study). The research visits take approximately 80 minutes, and families will be paid $75 for each visit they participate in. 3. During the research visit, the families will be asked to participate in videotaped research activities involving parent-child play and interaction. Parents will be asked to answer questions regarding their background, feelings, parenting opinions, and stress. 4. Families randomized to the PFR-HV intervention are asked to participate in a 10 week in home parenting program which includes videotaped caregiver-child interactions and feedback. 5. Families randomized to the PFR-T intervention are asked to participate in a 10-week parenting program that will occur over Zoom, which will include videotaped caregiver-child interactions and feedback. 6. Families randomized to the control group will be emailed a resource packet with some information about services or programs that might be helpful for them.

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

To determine, in previously healthy infants 6 weeks to 12 months of age, diagnosed with acute bronchiolitis and monitored by hourly oximetry, if the probability of hospitalization within 72 hours of arrival in those whose oxygen saturation display is manipulated 3 percentage points above the true measurements is significantly lower in comparison to those whose monitors display true saturations.

INTERVENTION 1: <TYPE: Other; NAME: True saturation values displayed; DESCRIPTION: Physicians will be presented with real saturations., >; INTERVENTION 2: <TYPE: Other; NAME: Altered saturation values displayed.; DESCRIPTION: Physicians will be presented with saturation measurements three percentage points above the true values., >;

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

Patients undergoing IVF treatment cycle at Queen Mary Hospital and Kwong Wah Hospital will be invited to participate in this study. Participating subjects will be randomized into either (i) vitamin D or (ii) placebo group in a 1:1 allocation ratio by computer-generated random numbers one month before IVF. Subjects allocated to the vitamin D group will take vitamin D 50,000IU per week from recruitment for 4 weeks, followed by 50,000IU once every 2 weeks throughout the IVF cycle until fetal viability is confirmed at 6 weeks (if pregnant), after which they will be switched to Materna. If not pregnant, they will continue Vitamin D 50,000IU once every 2 weeks until 6 months from randomization, during which they can undergo frozen-thawed embryo transfer. Subjects allocated to the placebo group will take placebo tablets which will be identical to the active drug. If pregnant and fetal viability is confirmed at 6 weeks, they will be switched to Materna. If not pregnant, they will continue the placebo tablets until 6 months from randomization, during which they can undergo frozen-thawed embryo transfer. The clinician and patients will both be blinded to the randomization throughout the course of treatment. The live birth rate of the two groups will be compared.

This is a randomized-controlled trial evaluating the effect of the use of vitamin D supplementation on the live birth rate in women undergoing in vitro fertilization (IVF). The hypothesis is that administration of vitamin D can increase the live birth rate for women undergoing IVF.

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

In 2016, the World Health Organization (WHO) issued guidelines for the use of a shorter treatment regimen (STR) for eligible patients with RR and multidrug-resistant tuberculosis (MDR-TB) which was adopted by the South African National Tuberculosis Program (SANTP) in 2017. The WHO then released guidelines in September 2018 regrouping the medicines for the treatment of MDR/RR-TB into three categories and ranking them based on the latest evidence about the balance of effectiveness to safety. BDQ, LNZ and fluoroquinolones were moved to Category A and should be included in all regimens as core drugs. CFZ and terizidone as Category B drugs, should be added to all regimens. The current short injectable-free treatment regimen for RR-TB in South Africa is based on these WHO recommendations. This South African standard of care, referred to as the Control Strategy, is given for a duration of 40 to 48 weeks and consists of BDQ, LNZ, Isoniazid (high dose), LVX, ethambutol, pyrazinamide and CFZ. Should a patient have resistance to the fluoroquinolones and/or the injectable, the patient is started on a strengthened regimen that may include BDQ, LNZ and DLM with other added agents depending on prior exposure and any other available resistance testing. In addition to the shorter RR-TB regimen recommended by the WHO, there are other shorter regimens currently being evaluated in clinical trials. Many of these regimens employ new or re-purposed medicines such as BDQ, DLM, and LNZ, which have each been shown to be effective in clinical trials. Some of the regimens forgo the use of a second-line injectable, which is associated with a high rate of adverse events and is programmatically difficult to administer. Although these regimens are currently undergoing testing in clinical trials, the programmatic use of these regimens under operational and pragmatic research conditions can also provide important data to the global TB community about their effectiveness and safety, while also providing more information about programmatic implementation and expanding access to their potential benefits. For this reason, BEAT Tuberculosis aims to be as pragmatic as possible, with broad eligibility criteria including almost all participants diagnosed with RR-TB. It aligns itself with the SANTP's goal to investigate an effective treatment regimen for RR-TB, while strictly adhering to the high standards of ethical conduct in clinical research. The primary objective of the trial is to evaluate the efficacy and safety of the Study Strategy, specifically to demonstrate that the intervention or Study Strategy has non-inferior efficacy to the Control Strategy. The principle behind the Study Strategy is to "hit early and to hit hard" with the agents most likely to be effective- it is common that upon the diagnosis of RR-TB, fluoroquinolone resistance is unknown. Therefore, the Study Strategy contains three novel agents as core drugs -BDQ, LNZ, and DLM against which there is no expected Mtb resistance in the community. In addition, there are two other support medications- LVX and CFZ. Treatment will be changed on receipt of the second-line line probe assay (LPA) results. The Study Strategy has been designed to cover all possible eventualities from rifampicin mono resistant TB to Extensively Drug Resistant (XDR-TB) with an all oral regimen. The Study Strategy is given for 24 weeks but if culture conversion has not occurred by week 16, the full treatment duration can be extended to 36 weeks. Participants include children from 6 years of age and adults diagnosed with RR-TB with or without resistance to isoniazid (INH) and/or fluoroquinolones. A total of 400 participants will be enrolled into the clinical trial. Participants will be randomized in a 1:1 ratio to receive either the Study Strategy or Control Strategy, with a stratification by clinical site and HIV status. All participants will be followed up for 76 weeks from randomization. All patients in South Africa who are diagnosed with RR-TB are managed by the SANTP. All study tests will therefore be performed by the National Health Laboratory Services, including mycobacteriology, blood screening and safety testing and point of contact testing. These tests will be done in line with the national programme's schedule of events. The trial will be open label, as blinding is not feasible. It is not possible to formulate placebos with multiple drugs and durations of treatment. However, the trial will be treated as if it were a blinded trial in all ways other than the physician and the participant having knowledge of the treatment assignment. Individuals assessing x-rays, cultures, ECGs and other participant information will be blinded to treatment assignment. BEAT Tuberculosis will be conducted in Port Elizabeth in the Eastern Cape, and in Durban, KwaZulu Natal, where there is a high burden of drug resistant TB (DR TB). The clinical trial sites are established DR-TB initiation and treating sites and have been approved by the national, provincial and district TB program with the capacity for long term follow up for safety evaluation. This trial will strengthen the drug resistant TB research capacity in an under-researched area such as the Eastern Cape. All participants will be offered an HIV test, as is standard in South Africa, and must be willing to take antiretroviral treatment, should they test positive. Wherever possible, participants who are co-infected with HIV will be managed in a joint treatment clinic to ensure close co-ordination of management of the two conditions, and to ensure that appropriate decisions can be made concerning the management of drug interactions and side effects. Additionally, there is a pharmacokinetics/pharmacodynamics (PK-PD) aspect to the trial. There are limited data describing the association of drug concentrations with efficacy and treatment related toxicities of many of the anti-TB drugs used in the treatment of RR-TB. Understanding these PK-PD relationships can result in dose optimization to improve outcomes in the relevant patient populations. BEAT Tuberculosis is a unique opportunity to explore these relationships.

BEAT Tuberculosis is a phase 3, open label, multi-centre, randomized controlled trial. The purpose of this trial is to compare the efficacy and safety of a Study Strategy consisting of 6 months of bedaquiline (BDQ), delamanid (DLM), and linezolid (LNZ), with levofloxacin (LVX) and clofazimine (CFZ) compared to the current South African Standard of Care (Control Strategy) for 9 months for the treatment of rifampicin resistant (RR-TB) Tuberculosis.

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 the effects of daily consumption of snacks with and without pea hull fiber on gastrointestinal function, gastrointestinal symptoms, food intake, appetite, changes in fecal and microbial composition and activity. Fifty maintenance hemodialysis hemodialysis and CKD patients in stage 4 or 5 will be recruited to participate in a randomized, blinded, 13-week cross-over study evaluating snack foods containing 15 g/d of pea hull fiber.

PRIMARY OUTCOME: <MEASURE: Uremic molecule - p-cresyl sulfate; TIME_FRAME: baseline, 5 weeks, 9 weeks, 13 weeks; DESCRIPTION: Change in serum levels of microbial metabolic product, p-cresyl sulfate; > SECONDARY OUTCOME 1: MEASURE: Uremic molecules (various); TIME_FRAME: baseline, 5 weeks, 9 weeks, 13 weeks; DESCRIPTION: Change in serum levels microbial metabolic products (e.g. indoxyl sulfate, TMAO, phenylacetyl glutamine etc.); >; SECONDARY OUTCOME 2: MEASURE: Fecal content of metabolites and minerals; TIME_FRAME: at baseline, week 5, week 9 and week 12.; DESCRIPTION: Change in fecal concentration of microbial metabolites and minerals; >; SECONDARY OUTCOME 3: MEASURE: Number of stools per week; TIME_FRAME: 13 weeks; DESCRIPTION: Change in number of stools per week and mean number of stools per week per period; >; SECONDARY OUTCOME 4: MEASURE: Stool form rating; TIME_FRAME: 13 weeks; DESCRIPTION: Change in stool form determined using Bristol Stool Form Scale; >; SECONDARY OUTCOME 5: MEASURE: Gastrointestinal symptom score; TIME_FRAME: at weeks 1 through 13; DESCRIPTION: Change in gastrointestinal symptom score determined by GSRS (Gastrointestinal Symptom Response Scale); >; SECONDARY OUTCOME 6: MEASURE: Fecal microbiota profile changes; TIME_FRAME: baseline, weeks 5, 9 and 13; DESCRIPTION: change at phylum and genus levels; changes in operational taxonomic units (OTUs); >; SECONDARY OUTCOME 7: MEASURE: Dietary intake; TIME_FRAME: baseline, weeks 5, 9 and 13; DESCRIPTION: Change in dietary energy, macronutrient and fiber intake; >; SECONDARY OUTCOME 8: MEASURE: Appetite; TIME_FRAME: at weeks 1 through 13; DESCRIPTION: Change in appetite determined by SNAQ questionnaire; >; SECONDARY OUTCOME 9: MEASURE: Quality of Life; TIME_FRAME: baseline, weeks 5, 9 and 13; DESCRIPTION: Change in Kidney Disease Quality of Life questionnaire (KDQOL®-36); >;