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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 prevalence of metabolic syndrome (MetS) is a health concern among Asians. Growing evidence indicates that Korean Americans had higher MetS prevalence compared to non-Hispanic Whites, but a culturally and linguistically appropriate lifestyle intervention has not been developed for Korean American middle-aged and older women. Thus, the investigators propose to develop a 4-week lifestyle intervention (Women's Active Living for Koreans (WALK) Study) to increase physical activity (PA) and reduce sedentary behavior for Korean American women.

INTERVENTION 1: <TYPE: Behavioral; NAME: WALK; DESCRIPTION: Walking program, >;

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

Participants are initially randomized to receive tildrakizumab 200 or 100 mg once weekly at Weeks 0, 4, and every 12 weeks thereafter; or placebo at Weeks 0 and 4. At Week 12, participants initially randomized to placebo will be re-randomized to receive either tildrakizumab 200 or 100 mg at Weeks 12 and 16. At Week 28, all participants enrolled will be assessed for their improvement in PASI score from baseline. RESPONDERS: Participants initially randomized to tildrakizumab who achieve at least a 75% improvement from baseline PASI will be re-randomized to either continue on their initial treatment or to receive placebo at Week 28. - Participants who are re-randomized to continue on their initial treatment will continue tildrakizumab 200 or 100 mg every 12 weeks through Week 64. - Participants who are re-randomized to placebo will receive placebo every 4 weeks until relapse (reduction in maximum PASI response by 50%). If relapse occurs, the tildrakizumab dose that the participants was originally randomized to at baseline will be re-initiated (tildrakizumab 200 or 100 mg). Participants will be dosed tildrakizumab at the visit when the relapse occurs, and subsequent dosing of tildrakizumab will be given 4 weeks after treatment re-initiation, and every 12 weeks thereafter through Week 64. PARTIAL RESPONDERS: Participants initially randomized to tildrakizumab who achieved a PASI response of ≥50% but <75% improvement from baseline will be assigned a treatment regimen as described below, with their first dose started at Week 28. - Participants initially randomized to tildrakizumab 200 mg will remain on tildrakizumab 200 mg every 12 weeks. - Participants initially randomized to tildrakizumab 100 mg will be re-randomized to either remain on tildrakizumab 100 mg every 12 weeks or to receive tildrakizumab 200 mg every 12 weeks. - Participants initially randomized to placebo who achieved ≥50% improvement from baseline in PASI will receive tildrakizumab (200 or 100 mg) according to their re-randomized treatment assignment at Week 12 and continue on this treatment every 12 weeks through Week 64. NON-RESPONDERS: Participants who did not achieve at least 50% improvement from baseline PASI at Week 28 will be discontinued from the study. EXTENSION: Participants will receive tildrakizumab 200 mg or 100 mg every 12 weeks through Extension Week 192, depending on the treatment received at the time of completion of the base study.

Inclusion Criteria: - Clinical diagnosis of moderate-to-severe plaque psoriasis for at least 6 months prior to study enrollment - A candidate for phototherapy or systemic therapy - For the extension study: must have completed Part 3 of the base study - For the extension study: must have achieved at least a PASI-50 response by the end of Part 3 of the base study - For the extension study: must have received active tildrakizumab (MK-3222) treatment within 12 weeks prior to the end of Part 3 of the base study - Premenopausal female participants must agree to abstain from heterosexual activity or use a medically accepted method of contraception or use appropriate effective contraception as per local regulations or guidelines - If enrolled at a Japanese site, participants with psoriatic arthritis using non-steroidal anti-inflammatory drugs (NSAIDs) must be on a stable dose for at least 4 weeks prior to the first dose of study drug and must not be expected to require an increase in dose over the course of the study Exclusion Criteria: - Has erythrodermic psoriasis, predominantly pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis - Current or history of severe psoriatic arthritis and is well-controlled on current treatment - Women of child-bearing potential who are pregnant, intend to become pregnant within 6 months of completing the trial, or who are breast feeding - Expected to require topical treatment, phototherapy, or systemic treatment during the trial - Presence of any infection - History of recurrent infection requiring treatment with systemic antibiotics within 2 weeks of screening - Previous use of tildrakizumab (MK-3222) or other IL-23/Th-17 pathway inhibitors including P40, p19, and IL-17 antagonists - Evidence of active or untreated latent tuberculosis (TB) - Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) - At Japanese sites, positive test for HBs antibody and hepatitis B virus (HBV) deoxyribonucleic acid (DNA) - At Japanese sites, positive test for the Hepatitis B core (HBc) antibody and HBV DNA - For the extension study: women of child-bearing potential who are pregnant, intend to become pregnant within 6 months of completing the trial, or who are breast feeding - For the extension study: active or uncontrolled significant organ dysfunction or clinically significant laboratory abnormalities - For the extension study: expected to require topical treatment, phototherapy, or systemic treatment during the extension study - At Japanese sites, abnormal for Beta D Glucan and/or KL-6 test result(s) at the screening visit.

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

RATIONALE: Pomalidomide and bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bortezomib may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving pomalidomide and bortezomib together with dexamethasone may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of bortezomib when given together with pomalidomide and dexamethasone and to see how well it works in treating patients with relapsed or refractory multiple myeloma.

INTERVENTION 1: <TYPE: Drug; NAME: pomalidomide; DESCRIPTION: Given orally, >; INTERVENTION 2: <TYPE: Drug; NAME: bortezomib; DESCRIPTION: Given IV, >; INTERVENTION 3: <TYPE: Drug; NAME: dexamethasone; DESCRIPTION: Given orally, >; INTERVENTION 4: <TYPE: Other; NAME: laboratory biomarker analysis; DESCRIPTION: Optional correlative studies, >; INTERVENTION 5: <TYPE: Other; NAME: gene expression analysis; DESCRIPTION: Optional correlative studies, >;

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.

There is both a poor life expectancy and a poor prognosis of limb salvage in those patience with stenoses or occlusions of the lower limb (TASC Consensus). To date only a small number of these patients could be helped through medication or surgery. In fact within the first year following diagnosis of a critical limb ischemia 25% of patients lose their leg and 90% have to undergo a percutaneous transluminal angioplasty (PTA) or bypass surgery. Using PTA for treatment of long infrapopliteal artery lesions, stenosis reoccurs in 70% to 80% of cases 3 months after index procedure. Even the use of drug-eluting balloons leads only to 1-year primary patency rates up to 30%. The primary objective of this study is to compare the performance of atherectomy followed by a drug-coated balloon angioplasty over drug-coated balloon angioplasty alone in long de-novo infrapopliteal lesions in a prospective, single-center, randomized clinical trial.

PRIMARY OUTCOME: <MEASURE: primary patency; TIME_FRAME: 6 months; DESCRIPTION: Primary patency of the target lesion 6 months after index procedure measured by duplex ultrasound (PVR>2.4) and angiography (core lab analysis).; > SECONDARY OUTCOME 1: MEASURE: target lesion revascularisation (TLR); TIME_FRAME: 6 and 12 months; DESCRIPTION: Need for target lesion revascularisation from baseline to 6 months after index procedure.; >;

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 a 20 patient pilot open-label study of the efficacy of adalimumab in inflammatory osteoarthritis of the knee. Primary endpoint is at 12 weeks and primary outcome is the OARSI responder index.

Inclusion Criteria: - Patient is 40 years of age or older. - If female, patient is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one of the following methods of birth control: condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD) contraceptives (oral or parenteral) for three months prior to study drug administration),a vasectomized partner, total abstinence from sexual intercourse - If patient is female and of childbearing potential, the results of a serum pregnancy test performed at Screening, prior to the first dose of adalimumab, must be negative. - Patient has a diagnosis of OA of the index knee according to American College of Rheumatology criteria, including radiological evidence of OA (Kellgren-Lawrence grades 2 or 3). - Patient has had continual pain for at least 6 months prior to inclusion in the study. This includes pain that has persisted despite conventional treatment, defined as any one of the following medications taken daily during the preceding month:acetaminophen (2- 4 grams per day)maximum tolerated and recommended doses of an NSAID, acetaminophen/codeine combination (i.e. Tylenol No 2, 3, 4) taken at least 3 times daily - Patient has had daily knee pain for the month preceding study enrolment. - Patient has a summed pain score of 125-400mm (visual analog scale) on the WOMAC pain sub-scale in the index (more symptomatic) knee. - Patient has clinical evidence of a knee effusion in the index (more symptomatic) knee at Screening and Baseline. Exclusion Criteria: - Subject has a history of an allergic reaction or significant sensitivity to constituents of Adalimumab. - Patient has a history of proven systemic arthritis such as rheumatoid arthritis. - Patient has a concurrent medical or arthritic condition that could confound evaluation of the index joint e.g. post-traumatic or any secondary form of knee OA - Patient has predominant patellofemoral disease

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

Single arm, phase II study, MR (Magnetic Resonance Imaging) - based IGRT (Image-guided radiotherapy) of prostate cancer. Primary endpoint: Grade 2+ GI (gastrointestinal) and genitourinary (GU) toxicity after 2 years.

Inclusion Criteria: - histologically proven prostate cancer - indication for curative treatment - ECOG performance scale 0-2 - Informed consent Exclusion Criteria: - contraindications for curative treatment - age<18year - previous pelvic radiotherapy or prostatic treatment like TURP (transurethral resection of prostate), HIFU (high intensity focused ultrasound) - serious comorbidity leading to inability for IGRT (image-guided radiotherapy) - contraindications for MRI (Magnetic Resonance Imaging)

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

Part A of this trial will evaluate the safety and tolerability of a single unilateral administration of one of two dose levels of AAVAnc80-hOTOF and will evaluate the Akouos delivery device to safely achieve the intended product performance.

INTERVENTION 1: <TYPE: Combination Product; NAME: AAVAnc80-hOTOF via Akouos Delivery Device; DESCRIPTION: AAVAnc80-hOTOF is a sterile suspension intended to be administered via a one-time unilateral intracochlear administration using the Akouos Delivery Device., >;

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

Monitoring of Allergic and Asthmatic Symptoms in Patients Taking Dietary Supplements Joalis Bambi Bronchi and Joalis Bambi Analerg

Reduction of the total IgE antibody, improved vital capacity and lung volume measured by spirometry. Improving quality of life observed in the visual analogue scale (VAS).

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

A growing body of research has highlighted the importance of frontal regions, at both the functional and structural levels, in age-related declines in attentional and cognitive processing. However, the underlying neurobiological pathophysiological changes in the brain that contribute to these declines are still largely unclear. The objective of this proposal is to investigate neural mechanisms of age-related attentional distractibility, focusing on the neural circuit initiated from the locus coeruleus (LC). In the current proposal, the investigators will test the hypothesis that the neural dysconnectivity of LC with the salience network (SN) drives failures of ignoring distractors in older adults. The investigators will examine how LC-SN connectivity is associated with selective attention performance, and how improved LC-SN connectivity through a cognitive training program may lead to improved attentional performance.

INTERVENTION 1: <TYPE: Behavioral; NAME: Tablet based adaptive multimodal attention practice program; DESCRIPTION: An adaptive at-home tablet-based program that includes variants of the Flanker Task, the Stroop Task, and a Visual Tracking Task. Each session of practice will include up to ten minutes with each of these task types, and the tasks will increase in difficulty in a way that further taxes attention (such as through more distractors or more incongruent trials) as participant performance improves., >; INTERVENTION 2: <TYPE: Behavioral; NAME: Tablet based adaptive criterion task practice program; DESCRIPTION: An adaptive, at-home tablet-based variant of the criterion task, that is, the selective attention/distraction task used during the scanning portion of the human participant portions of the study, that takes up to 25 minutes to complete each session., >;

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

This study aims at Optimizing measured parameters to reflect underlying pathology in dyssynchronous hearts. This is an experimental study in patients were bioimpedance measurements are performed during implantation.

INTERVENTION 1: <TYPE: Diagnostic Test; NAME: Impedance measurements in Cardiac Resynchronization therapy; DESCRIPTION: Bioimpedance measurements, >;

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

The Relative Effects of Androgen, Estrogen, and the Combination of Androgen and Estrogen on Growth Rate, GH Binding Protein, IGF-I, and Cognitive Function in Growth Hormone-Treated Girls With Turner Syndrome

Turners Syndrome is a genetic condition in females that is a result of abnormal chromosomes. Patients with Turner syndrome are typically short, have abnormal physical features, and lack the physical changes normally associated with puberty. In addition, some patients with Turner syndrome have low bone density (osteoporosis) and differences in learning abilities. This study will research the effects of steroid hormones on patients with Turner syndrome. It will look closely at how taking steroid hormones effects the patient's rate of growth as well as the patient's ability to learn. In addition the study will investigate how different hormones (androgen and estrogen) work when given together as a combination. All patients asked to participate in this study will receive growth hormone injections. However, half of the patients will receive an additional sex steroid hormone (oxandrolone) in the form of a pill. The other half of the patients will receive a placebo or "sugar pill". This will allow the researchers to determine if the combination of the hormones produces different results than growth hormone alone. The study will last approximately 2 years. After 2 years of research the patients may qualify for an additional 2 years of treatment. Patients may benefit directly from this research with increased growth and improved ability to learn.

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

Termination reason: On February 23rd 2009, a decision to terminate further development for PD 0332334 was communicated to investigators in this study. The decision to terminate this study was not based on any safety concerns.

This is a 10-week trial that evaluates the efficacy and safety of PD 0332334 in subjects, ages from 18 to 65, with generalized anxiety disorder.

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

Assessing the safety and effectiveness of a 11-βhydroxysteroid dehydrogenase type 1 inhibitor (AZD4017), in a placebo controlled trial, in acute idiopathic intracranial hypertension (IIH) IIH is a condition of young, overweight women with characteristic raised intracranial pressure (pressure around the brain) leading to papilloedema (swelling of the nerve supplying the eye), visual loss and headaches. Medical literature (Cochrane review) demonstrates there is little evidence for the treatments used for IIH. Weight control appears the most effective method of improving symptoms but weight loss is difficult to maintain. 11β-hydroxysteroid dehydrogenase type 1 (11β-HSD1) is an enzyme which regulates local steroid levels and our previous research suggests it may influence the production of brain fluid(cerebrospinal fluid or CSF). 11β-HSD1 levels fall with weight loss and this is associated with with decreased intracranial pressure. Our primary outcome is to determine whether AZD4017, an inhibitor of 11β-HSD1, will reduce the pressure in the brain and as a consequence improve IIH. Patients are eligible to enter the study if they are between 18-55 years old with acute (<6 months) IIH, signs of active disease (papilloedema and raised CSF pressure (>25 cmH20)), no other major illnesses and have no plans for pregnancy during the study period. This is an MRC funded single centre, phase II, double-blinded, randomised control drug trial. It will be conducted at the University Hospital Birmingham and the University of Birmingham will act as Sponsor. Eligible participants will be randomly assigned to AZD4017 or a placebo ('dummy' with no active drug) for 3 months with a follow up a month later. Investigations during the study will include bloods, urine samples, pregnancy tests, lumbar punctures, DXA scans and small fat/skin biopsies. Participants will benefit from increased monitoring and a potential improvement in their condition. We hypothesise that specific inhibition of 11β-HSD1 will decrease intracranial pressure and consequently treat patients with IIH, thus opening a new and entirely novel therapeutic avenue.

INTERVENTION 1: <TYPE: Drug; NAME: AZD4017; >; INTERVENTION 2: <TYPE: Other; NAME: Placebo; DESCRIPTION: Matched placebo (matched to AZD4017 arm), >;

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

After being informed about the study and potential risks, all patients giving written informed consent will receiving injection of indocyanine greenat 8 points around the primary tumor with gastroscope 1 day before surgery. During the operation, laparoscopic gastrectomy and perigastric lymph node dissection were performed under ICG imaging equipment. After the surgical specimens were isolated, under the fluorescent illumination of the ICG imaging equipment, the lymph nodes that showed fluorescence and the lymph nodes that did not show fluorescence were collected from each LN station.

Inclusion Criteria: 1. Age from 18 to 75 years 2. Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy 3. Clinical stage tumor T1 (cT1), N0/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Eighth Edition. Preoperative staging was made by conducting mandatory computed tomography (CT) scans and an optional endoscopic ultrasound 4. No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby in the preoperative examinations 5. Tumor located in the lower third of the stomach, expected to receive radical distal gastrectomy 6. Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG) 7. American Society of Anesthesiology score (ASA) class I, II, or III 8. Written informed consent Exclusion Criteria: 1. Women during pregnancy or breast-feeding 2. Severe mental disorder 3. History of previous upper abdominal surgery (except laparoscopic cholecystectomy) 4. History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection 5. Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging 6. History of other malignant disease within past five years 7. History of previous neoadjuvant chemotherapy or radiotherapy 8. History of unstable angina or myocardial infarction within past six months 9. History of cerebrovascular accident within past six months 10. History of continuous systematic administration of corticosteroids within one month 11. Requirement of simultaneous surgery for other disease 12. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer 13. Forced expiratory volume in 1 second (FEV1)<50% of predicted values 14. Rejection of laparoscopic resection 15. Preoperatively confirmed tumors invading the dentate line or duodenum 16. History of allergy to iodine agents 17. Tumor located in the upper third of the stomach, expected to receive radical total gastrectomy

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

This project was a pilot randomized trial conducted to compare the effects of Kendall exercise and Gong's mobilization on pain, range of motion, function and strength in text neck syndrome so that we can have best treatment option for patients with neck pain

INTERVENTION 1: <TYPE: Other; NAME: Kendall exercise; DESCRIPTION: consist of stretch of pectoralis major and neck extensor strengthening of deep neck flexors and scapular retractor, >; INTERVENTION 2: <TYPE: Other; NAME: Gong's mobilization; DESCRIPTION: it is combination of glide along the facet joint and concurrent movement of cervical spine, >;

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

Among patients early following ST-segment (ST) elevation myocardial infarction, transcutaneous vagus nerve stimulation is associated with a reduce of the burden of premature ventricular contractions in the first 40 days post-myocardial infarction (MI). The above hypothesis will be tested with a randomized, prospective, parallel, single-blind clinical trial. The expected study duration is approximately 12 months from the time the first subject is enrolled (planned for June 2023) to the time of study's termination date (December 2024). Patient enrollment is planned to take place at two major centers in Greece. The researchers will obtain approval by the institutional review board (IRB).

INTERVENTION 1: <TYPE: Device; NAME: Parasym device (active, current (mA) < discomfort threshold); DESCRIPTION: Active transcutaneous Vagal Nerve Stimulation (tVNS) (Parasym device, Parasym Health, Inc, London, UK) will be performed with a clip attached to the ear at 20 hertz (Hz), 250 microseconds (ms) at a current just below discomfort threshold for 30 minutes twice a day, starting on post-MI day 0. Stimulation will continue until 7 days post-MI or discharge., >; INTERVENTION 2: <TYPE: Device; NAME: Parasym device (sham, current (mA) = 0); DESCRIPTION: Parasym device will be attached to the ear twice a day, turned on but current set to 0 milliamp (mA), starting on post-MI day 0. Stimulation will continue until 7 days post-MI or discharge., >;

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

1. Determine preoperative and postoperative levels of anxiety for pediatric patients ages 6-17 related to outpatient surgical intervention using the validated Psychosocial Risk Assessment in Pediatrics (PRAP) assessment tool, the State-Trait Anxiety Inventory for Adults(STAI-AD), and the State-Trait Anxiety Inventory for Children (STAI-CH) 2. Determine preoperative and postoperative levels of anxiety for parent/guardian of pediatric patients ages 6 - 17 related to outpatient surgical intervention using the validate PsychosocialRisk Assessment in Pediatrics (PRAP) assessment tool and the State-Trait Anxiety Inventory for Adults (STAI-AD). 3. Assess if additional Child Life intervention offered pre-operatively to one group demonstrates differences in PRAP scores compared to control group

INTERVENTION 1: <TYPE: Behavioral; NAME: Child Life; DESCRIPTION: For patients randomized to the intervention group, the Child Life specialist will reach out via telephone to offer support and expertise in helping prepare their child and themselves for outpatient surgery to help decrease anxiety and increase coping. Concepts covered will include: developmentally appropriate language for explaining surgery and related procedures, potential coping skills to ease separation for caregivers and pediatric patients. Additionally, written materials (attached) covering the same information will be sent via mail or email covering the same information discussed in the phone conversation to serve as a refresher and resource before the day of surgery. On the day of surgery, the patient will receive standard of care (SOC) Child Life Services available to all patients., >;

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

Vaccine-preventable diseases such as hepatitis A and meningitis, as well as cancers caused by human papillomavirus (HPV) disproportionately impact young Black men who have sex with men (YBMSM). Traditional techniques of vaccination promotion have been unable to address the racial disparities in vaccination rates. One promising method for influencing behavior change within YBMSM networks is diffusion of information through Popular Opinion Leaders (POLs). The POL model engages persons who are leaders within their own networks/communities to promote behavior change. The objective of this project is to develop and pilot test a POL intervention to increase routine HAV, HPV and meningococcal conjugate vaccination among YBMSM, ages 18-26. research (PAR) framework to facilitate community support and ensure intervention strategies are salient. PAR includes community members as equal collaborators in the research process. Outcomes from these aims are expected to have an impact on health outcomes by identifying effective strategies for increasing vaccination and routine healthcare engagement among YBMSM.

INTERVENTION 1: <TYPE: Behavioral; NAME: POL arm; DESCRIPTION: A popular opinion leader intervention designed to increase routine vaccination among young black men who have sex with men., >; INTERVENTION 2: <TYPE: Behavioral; NAME: Comparison arm; DESCRIPTION: A popular opinion leader intervention designed to increase routine vaccination among young black men who have sex with men., >;

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

Rationale for ambulatory hospitalization is based on increased demand of hospital care, hospital budgets constraints and patients who ask for a prompt recovery. Consequently, physicians should find ways to optimize the resources' allocation, without compromising quality, safety and efficiency of patient care. Several studies and routine practice have shown that ambulatory hospitalization was safe but we are still lacking evidence to demonstrate the cost-utility of this kind of management.

The purpose of this study is to assess the efficiency of outpatient surgery compared to conventional hospitalization in endovascular treatment of occlusive arterial disease. A cost-utility analysis will be conducted from a societal perspective. Patients referred for peripheral arterial disease (PAD) will be randomized in two arms and a 3 months follow-up will be performed.

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

This study protocol presents the design of a randomized pragmatic trial. This study aims to determine the effectiveness of virtual shared medical appointments (SMAs) lifestyle approach in improving glycaemic control, compared to usual care in type 2 diabetes (T2D) subjects.

INTERVENTION 1: <TYPE: Behavioral; NAME: Virtual SMAs; DESCRIPTION: 18 weeks lifestyle approach for type 2 diabetes program: Session 1 (week 0): Introduction; Session 2 (week 3): Behaviour change process; Session 3 (week 6): Medical nutrition therapy recommendations - Part 1; Session 4 (week 9): Medical nutrition therapy recommendations - Part 2; Session 5 (week 12): Medical physical Activity recommendations; Session 6 (week 15): Smoking cessation: tobacco and E-cigarettes; Session 7 (week 18): Diabetes distress., >;

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.

Head injury is a frequent motive of consultation in paediatric emergency units and the first cause of mortality in infants of more than one year old in developped countries. The indication of performing cerebral CT scans currently depends on clinical decision based on recommendations used in adults. In this way, 60 to 90% of scans are normal in children with head injury. CT scan is expensive and irradiating with the risk of increasing the cancer in children. Protein S100B and copeptin are biomarkers which have shown their ability to detect cerebral lesion in children with head injury. (protein S100B and /or in adults protein S100B and copetin). It is the first clinical biological evaluation of severity of head injury based on dosing of copeptin alone or associated with protein S100B. Furthermore, the evaluation of the biomarkers GFAP, NFL, Tau and UCHL-1 is today necessary from a scientific point of view and to optimize the diagnostic and prognostic value of these biomarkers which can be combined. Indeed, these protein biomarkers are biologically linked to the protein S100B and copeptin, and will allow a more specific and more thorough evaluation of the presence of brain damage at the cellular level. More specifically, the measurement of the S-100B and GFAP proteins will allow evaluation of gliovascular damage while those of copeptin, NFL, Tau and UCHL1 proteins will allow evaluation of neuronal damage. The assay of these different biomarkers will also be carried out on a control population, without head injury or neurological or inflammatory pathologies, in order to establish the standards of these biomarkers on a pediatric population of similar age.

PRIMARY OUTCOME: <MEASURE: Copeptin dosage; TIME_FRAME: At the inclusion; DESCRIPTION: Dosage of copeptin to determine the copeptin's performance in diagnostic of traumatic brain injury; > SECONDARY OUTCOME 1: MEASURE: S100B protein dosage; TIME_FRAME: At the inclusion; DESCRIPTION: Dosage of protein S100B to determine this protein's performance in diagnostic of traumatic brain injury; >; SECONDARY OUTCOME 2: MEASURE: GFAP protein dosage; TIME_FRAME: At the inclusion; DESCRIPTION: Dosage of GFAP protein to determine this protein's performance in diagnostic of traumatic brain injury; >; SECONDARY OUTCOME 3: MEASURE: NFL protein dosage; TIME_FRAME: At the inclusion; DESCRIPTION: Dosage of NFL protein to determine this protein's performance in diagnostic of traumatic brain injury; >; SECONDARY OUTCOME 4: MEASURE: Tau dosage; TIME_FRAME: At the inclusion; DESCRIPTION: Dosage of Tau protein to determine this protein's performance in diagnostic of traumatic brain injury; >; SECONDARY OUTCOME 5: MEASURE: UCHL-1 dosage; TIME_FRAME: At the inclusion; DESCRIPTION: Dosage of UCHL-1 protein to determine this protein's performance in diagnostic of traumatic brain injury; >; SECONDARY OUTCOME 6: MEASURE: Combinaison of Copeptine, PS-100B, GFAP, Tau and UCHL-1 protein dosage; TIME_FRAME: At the inclusion; DESCRIPTION: Combination of these biomarkers to improve early discrimination of patients with brain injury secondary to CT.; >;

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

Lower extremity orthopaedic surgery and malignancy are both known major risk factors for venous thromboembolism (VTE). Guidelines from high quality data exist with regards to VTE prophylaxis in patients undergoing orthopaedic surgery, particularly joint arthroplasty. Far fewer data are available regarding the efficacy of various methods of pharmacologic VTE prophylaxis in patients undergoing surgery for primary or metastatic musculoskeletal malignancies as malignancy itself is known to confer a hypercoagulable state. The existing data, including published data from our institution, are almost exclusively from retrospective studies. Given the limited external validity of existing guidelines and limitations inherent in applying data from retrospective studies, a randomized, prospective study comparing two of the most common methods of pharmacologic VTE prophylaxis would help to guide clinical care of this patient population. In addition, large dead spaces susceptible to hematoma formation are often created from tumor resections in orthopaedic oncology. Our retrospective data suggest that hematoma formation may be an independent predictor of infection. An important risk of chemical VTE prophylaxis is an increased incidence of bleeding into these dead spaces, leading to hematomas. This illustrates the complexity of selecting a method of VTE prophylaxis in patients at both high risk of VTE and hematoma formation and the need for high quality data to guide clinical decision-making in this patient population. The specific aim of this study is to compare the post operative incidence of symptomatic deep vein thrombosis (DVT) and pulmonary embolus (PE) between patients who receive low molecular weight heparin (LMWH) versus aspirin for prophylaxis after having undergone pelvic or lower extremity orthopaedic oncology surgery (primary bone sarcomas, soft tissue sarcomas, and metastatic osseous disease). Our secondary aim is to compare the incidence of hematoma formation and wound complications between these methods of pharmacologic prophylaxis in the aforementioned patient population. Our hypothesis is that there is no significant difference in the incidence rate of symptomatic DVT/PE in patients administered LMWH versus aspirin for prophylaxis; however there may exist a difference in the rate of wound complications between these prophylaxis methods.

Inclusion Criteria: - Patients with metastatic osseous disease of the lower extremities or pelvis treated with endoprosthetic reconstruction, curettage and cement packing with intramedullary nail fixation and/or plate and screws, or intramedullary nail fixation only. - Patients with primary bone sarcomas of the lower extremities or pelvis treated with wide resections and amputations or reconstruction with endoprosthesis, allografts, or allograft prosthetic composites. - Patients with soft tissue sarcomas of the lower extremities or pelvis measuring more than 8 cm in size, deep to the fascia levels, treated with preoperative or postoperative radiation, plus/minus preoperative and/or postoperative chemotherapy, receiving surgery with wide margins, followed by primary closure, closure with free or rotational, and/or skin graft. (478 patients per arm) Exclusion Criteria: - Documented prior history of VTE - Pre-operative use of therapeutic or prophylactic chemical anti-coagulation at the time of surgery (not including ASA 81 mg) - Documented allergy/adverse reaction to either of the two study drugs - Presence of an inferior vena cava (IVC) filter - Known diagnosed hypercoagulable state (other than malignancy) - Inability to receive chemical anticoagulation - Pre-operative use of full strength aspirin 325 milligrams (mg) daily - Inability for the patient him/herself to give informed consent due to delirium, dementia, or any other reason. - Pregnancy - Fear of needles - Inability to administer medications via needles themselves - Situation in which the attending surgeon does not feel that randomization of a subject would be appropriate

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 R0 resection rate of gastrointestinal stromal tumor (GIST) with high recurrence risk was relatively low, and the relapse-free survival rate was relatively low, which needed to be further improved. A few retrospective analyses and a small sample of prospective studies have found that neoadjuvant therapy with imatinib mesylate can improve R0 resection rates. Whether neoadjuvant therapy prolongs long-term survival remains unclear. The primary objective of this study was to evaluate 5-year progression-free survival (PFS) for GIST patients with high recurrence risk after neoadjuvant treatment with imatinib mesylate.

PRIMARY OUTCOME: <MEASURE: Progression free survival（PFS）; TIME_FRAME: 5 years; DESCRIPTION: Progression free survival（PFS）; > SECONDARY OUTCOME 1: MEASURE: Overall survival（OS）; TIME_FRAME: 5 years; DESCRIPTION: Overall survival（OS）; >; SECONDARY OUTCOME 2: MEASURE: Objective Response Rate （ORR）; TIME_FRAME: Up to 1 year; DESCRIPTION: Rate of complete and partial response according to Choi criteria; >; SECONDARY OUTCOME 3: MEASURE: R0 resection rate; TIME_FRAME: Up to 1 year; DESCRIPTION: complete resection rate with microscopically negative margin; >;

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.

Rhomboid intercostal block is used to block lateral cutaneous branches of intercostal nerves between T3 and T9 dermatomes. RIB has been reported to be successful in attenuating acute pain following breast surgeries. However, it's effect on chronic pain has not been evaluated yet. The primary hypothesis of the study is that the incidence of chronic pain of the patients who will receive Rhomboid intercostal block (RIB) following breast cancer surgery will be lower than the patients who will receive no block intervention at the postoperative 3rd month. The secondary hypothesis is that the incidence ofchronic pain of the patients who will receive Rhomboid intercostal block (RIB) following breast cancer surgery will be lower than the patients who will receive no block intervention at the postoperative 6th month. An other secondary hypothesis is that the total BPI-SF scores will be lower in the RIB group than control group at the postoperative 3rd and the 6th months.

PRIMARY OUTCOME: <MEASURE: 3rd month chronic pain; TIME_FRAME: At the postoperative 3. month; DESCRIPTION: The presence of chronic pain will be evaluated by using the 5. question of Brief Pain Inventory Short Form at the postoperative 3rd month. The question ranges from 0 (which means no pain) to 10 points (which means worst pain). The score equal to or over 4 points indicates the presence of chronic pain. Primary outcome of the study is the difference in the incidence of chronic pain between study and control groups at the postoperative 3rd month.; > SECONDARY OUTCOME 1: MEASURE: 6th month chronic pain; TIME_FRAME: At the postoperative 6. month; DESCRIPTION: The presence of chronic pain will be evaluated by using the 5. question of Brief Pain Inventory Short Form at the postoperative 6th month. The question ranges from 0 (which means no pain) to 10 points (which means worst pain). The score equal to or over 4 points indicates the presence of chronic pain. Secondary outcome of the study is the difference in the incidence of chronic pain between study and control groups at the postoperative 6th month.; >; SECONDARY OUTCOME 2: MEASURE: 3rd month total Brief Pain Inventory Short Form Score; TIME_FRAME: At the postoperative 3. month; DESCRIPTION: Total score of Brief Pain Inventory Short Form of all patients will be recorded at the postoperative 3rd month. The form ranges from 0 point (best score) to 120 (worst score) points. The 3rd outcome of the study is the difference in total Brief Pain Inventory Short Form scores of patients in the study and control groups at the postoperative 3rd month.; >; SECONDARY OUTCOME 3: MEASURE: 6th month total Brief Pain Inventory Short Form Score; TIME_FRAME: At the postoperative 6. month; DESCRIPTION: Total score of Brief Pain Inventory Short Form of all patients will be recorded at the postoperative 6th month. The form ranges from 0 point (best score) to 120 (worst score) points. The 3rd outcome of the study is the difference in total Brief Pain Inventory Short Form scores of patients in the study and control groups at the postoperative 6th month.; >; SECONDARY OUTCOME 4: MEASURE: 3rd month neuropathic pain; TIME_FRAME: At the postoperative 3. month; DESCRIPTION: The presence of neuropathic pain which will be evaluated by using Douleur Neuropathique 4 (DN4) which ranges from 0 point (no pain) to 10 points (worst pain). Score equal to or over 4 points indicates the presence of neuropathic pain. The 5th outcome of the study is the difference in the incidence of neuropathic pain between the study and control groups.; >; SECONDARY OUTCOME 5: MEASURE: 6th month neuropathic pain; TIME_FRAME: At the postoperative 6. month; DESCRIPTION: The presence of neuropathic pain which will be evaluated by using Douleur Neuropathique 4 (DN4) which ranges from 0 point (no pain) to 10 points (worst pain). Score equal to or over 4 points indicates the presence of neuropathic pain. The 6th outcome of the study is the difference in the incidence of neuropathic pain between the study and control groups at the postoperative 6th month.; >; SECONDARY OUTCOME 6: MEASURE: acute pain; TIME_FRAME: Postoperative 15. minute, 30. minute, 1.hour, 2nd hour, 6th hour, 12th hour, 24th hour; DESCRIPTION: Postoperative acute pain of the patients will be evaluated by using Numerical Rating Scale which ranges between 0 point (no pain) and 10 points (worst pain). The 7th outcome of the study is the difference in numerical rating scale scores between study and control groups.; >; SECONDARY OUTCOME 7: MEASURE: opioid consumption; TIME_FRAME: Postoperative 24th hour.; DESCRIPTION: Total opioid consumption of the patients will be recorded at the postoperative 24. hour.; >;

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

The objective of this study is to test the hypothesis that liraglutide (commonly known as Victoza) can promote an anti-inflammatory macrophage phenotype in human adipose tissue and blood, thereby reducing localized and systemic inflammation which are risk factors for cardiovascular disease and may contribute to hyperglycemia. This will be done after 4 weeks of treatment during which weight will remain stable, and again after 12 weeks, during which liraglutide-related weight loss occurs.

INTERVENTION 1: <TYPE: Drug; NAME: Victoza (liraglutide) with dietician monitoring; DESCRIPTION: Victoza (liraglutide), an FDA-approved medication, is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Subjects with this intervention will be followed by the MD and dietician throughout the study to monitor progress through 4 week period of weight maintenance and 8 week period of weight loss., >; INTERVENTION 2: <TYPE: Other; NAME: Placebo with dietician monitoring; DESCRIPTION: Subjects will not receive the study drug, but will be followed by the MD and dietician throughout the study to monitor progress through 4 week period of weight maintenance and 8 week period of weight loss., >;

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

The proposed research intends to randomize 50 abstinent pregnant Black or Hispanic smokers to receive either the attentional retraining (AR) or control VP task. Participants will be asked to carry around a smartphone as they go about their daily lives for 2 weeks in their last month of pregnancy (Phase 1). The smartphone will sound an alert randomly during the day, at which time participants will be asked to respond to a short set of questions assessing subjective states; this will be followed by a request to complete the AR (or control) procedures. This same procedure will be repeated for 2 weeks immediately after delivery (Phase 2). Women will undergo a follow-up visit 3 months after the end of Phase 2, and complete an unmodified VP and follow-up assessments.

PRIMARY OUTCOME: <MEASURE: Attentional Bias- Smoking Related Stimuli; TIME_FRAME: Up to 8 months; DESCRIPTION: Attentional bias (AB) is assessed using the standard (unmodified) visual probe task on the smartphone and study visits, and measured by the reaction time (RT) in milliseconds, i.e. the time it takes a participant to identify the location of the probe after presentation of the stimulus. The AB scores will be computed as the difference in RTs on trials where the probe replaced the smoking picture vs. trials where the probe replaced the neutral picture.; > SECONDARY OUTCOME 1: MEASURE: Self-reported craving; TIME_FRAME: Up to 8 months; DESCRIPTION: Self-reported craving is a single item that assesses craving to cigarettes on a 7-point Likert scale in the daily assessments delivered on the smartphone and at study visits. Higher scores on the 7-point Likert scale are indicative of higher cravings.; >; SECONDARY OUTCOME 2: MEASURE: Self-reported stress; TIME_FRAME: Up to 8 months; DESCRIPTION: Self-reported stress is assessed using the Perceived Stress Scale, modified to ask about daily stress, in the daily assessments delivered on the smartphone and at study visits. The mean score will be computed. Higher scores on the scale are indicative of higher stress.; >; SECONDARY OUTCOME 3: MEASURE: Smoking relapse; TIME_FRAME: Up to 6 months; DESCRIPTION: Relapse is defined as any smoking on 7 consecutive days or smoking at least once each week over 2 consecutive weeks. Smoking history is collected with the timeline follow-back at each study visit. This is a binary yes/no outcome.; >;

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 correct prasugrel dosage to be given to children with sickle cell disease (SCD).

PRIMARY OUTCOME: <MEASURE: Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of Prasugrel Active Metabolite (Pras-AM); TIME_FRAME: Parts A and B: 0.5, 1, 1.5, 2, 4 hours postdose; DESCRIPTION: AUC of Pras-AM from time 0 up to the last sampling time of 4 hours postdose [AUC(0-tlast)] is reported by dose administered [0.03, 0.05, 0.07, 0.09, 0.11, 0.13, 0.15, 0.2, 0.25, 0.3, 0.35, 0.4, 0.45, 0.5, 0.55, and 0.6 milligrams per kilogram (mg/kg)] during Part A (single-dose range finding phase) and is reported for doses administered on site (0.06, 0.08, and 0.12 mg/kg) during Part B (once-daily repeated dosing phase) of the study. Four participants received the same dose at multiple visits where pharmacokinetic samples were collected.; > SECONDARY OUTCOME 1: MEASURE: Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of Prasugrel Inactive Metabolite; TIME_FRAME: Part A: 0.5, 1, 1.5, 2, 4 hours postdose; DESCRIPTION: AUC of prasugrel inactive metabolite(s) from time 0 up to the last sampling time of 4 hours postdose [AUC(0-tlast)]. Improvements in bioanalytical methodology enabled direct measurement of Pras-AM from plasma, obviating the need to estimate its concentration from inactive downstream metabolite(s). Thus, the AUC of prasugrel inactive metabolite(s) was not analyzed.; >; SECONDARY OUTCOME 2: MEASURE: Number of Participants With Pain; TIME_FRAME: Part B: Baseline and Day14 ± 4 days postdose in each dosing period; DESCRIPTION: The number of participants who answered "yes" to the first question in the Sickle Cell Disease Pain (SCD) Questionnaire is reported. Question 1: In the past 2 weeks, did you experience any sickle cell pain?; >; SECONDARY OUTCOME 3: MEASURE: Number of Participants With Hemorrhagic Events Requiring Medical Intervention; TIME_FRAME: Part B: Baseline up to Day 36; DESCRIPTION: Hemorrhagic events were determined by the study investigator. Medical intervention was defined as any medical attention resulting in therapy or further investigation, as determined by a trained medical professional.; >;

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

This first in human study is a multi-center, randomized, double-blind, placebo-controlled single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of intravenous PNT001 in healthy adult participants.

INTERVENTION 1: <TYPE: Biological; NAME: PNT001; DESCRIPTION: PNT001 diluted in 5% dextrose, >; INTERVENTION 2: <TYPE: Drug; NAME: Placebo; DESCRIPTION: 5% dextrose, >;

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

The Influence of Vasopressin on Observational Learning of Placebo Analgesia

The feeling of pain is not just a sensory experience, but is also influenced by emotions, beliefs and expectations, making pain a highly subjective experience. This is evident in clinical practice, where the behavior of the physician and the treatment context can strongly influence the pain experience of patients. Research has shown that patients' expectation that a treatment will reduce pain influences individual perception of pain, even if the treatment has no active ingredient. The expectancy-induced analgesia emerges due to a modulation of the individual pain experience of patients by an engagement of endogenous inhibitory systems in the central nervous system. The development of expectancy-induced analgesia can be generated in several ways. The investigators have previously demonstrated that social information and observational learning (e.g. the patient observes analgesia in another person receiving a treatment) can lead to expectancy-induced analgesia and pain reduction. However, the neural mechanisms (mechanisms in the brain) of how these expectancies are acquired and the neural mechanisms of analgesia induced by observational learning are unknown. The investigators recently established a procedure to investigate neural mechanisms of observational learning in placebo analgesia. Here the investigators propose to investigate the influence of vasopressin, a neurotransmitter that is important for social interaction, on observational learning. The investigators will use functional magnetic resonance imaging (fMRI), a non-invasive method, to investigate neural activity in humans. Participants will either receive vasopressin or saline with a nasal spray. During fMRI scanning, participants will then undergo an observational learning phase, where the study participants will learn the experience of analgesia in another person through a video, and a testing phase, where participants will perceive painful stimulations with the same cues as the observational phase. The comparison of the vasopressin group and the saline group will allow us to investigate how vasopressin influences behavioral effects of observational learning on pain perception as well as its effect on the neural processing of observational learning. A better understanding of how the human brain processes observationally-induced analgesia would allow us to improve the therapeutic context of pain treatments by increasing the contextual factors which help patients cope with pain.

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

Efficacy and Safety of Profile HaloTM Dual-wavelength Fusion Fractional Laser on the Treatment of Facial and Neck Photoaging: a Self-controlled Trial.

1. Fractional laser has become an important laser modality in management of a number of skin conditions and photoaging. Fractional photothermolysis is the fractional emission of light into microscopic treatment zones, creating small columns of injury to the skin in a pixilated fashion. Epidermal and dermal disruptions occur in these focal zones of thermal injury, stimulating dermal collagen production and elastic tissue formation. Fractional laser has been used successfully to treat photodamage and overall dyschromia in the Caucasian population. However, there is not much improvement in Asian population. 2. Photoaging refers to the skin caused by intense and chronic exposure to sunlight. The visible effects of photoaging are fine wrinkles, mottling, pigmentation and roughness of the skin. These changes are usually associated with chronologic aging. However, photoaging is not a good indicator of chronologic age. It just makes a person look older than his or her chronologic age. Skin ageing may be divided into two processes: intrinsic ageing and extrinsic ageing (or photoageing). Both are accompanied by changes in the morphological and biomechanical properties of skin. 3. Profile HaloTM dual-wavelength fusion fractional laser is the first hand tool in the world that integrates ablative and non-ablative fractional lasers. It includes a non-ablative fractional laser with a wavelength of 1470nm and an ablative fractional laser with a wavelength of 2940nm. A day after treatment, new epithelial tissue began to appear, and the necrotic epidermis formed microepidermal necrotic debris (MENDs). MENDs were surrounded by keratin 2-7 days after treatment, and collagen sequence in MTZs was changed 7 days later. The 2940 ablative fractional laser can be added with 20-100 micron lattice stripping, ensuring safety while enabling MENDs to be peeled off 2 days earlier and reducing the risk of side effects. This makes the laser safe and effective compared with the single fractional laser and reduces the downtime.

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

This study evaluates the safety and efficacy of lefamulin, a pleuromutilin, for the treatment of adults with moderate to severe community-acquired bacterial pneumonia.

PRIMARY OUTCOME: <MEASURE: Early Clinical Response (ECR); TIME_FRAME: ECR was assessed 96 +/- 24 hours after the first dose of study drug.; DESCRIPTION: ECR was defined as survival with improvement in at least 2 signs and symptoms of CABP (relative to baseline), no worsening of any CABP sign or symptom, and no use of concomitant antibiotics (other than adjunctive linezolid, as allowed by the study protocol) for the treatment of CABP through the ECR assessment.; > SECONDARY OUTCOME 1: MEASURE: Investigator's Assessment of Clinical Response (IACR); TIME_FRAME: IACR was assessed at the Test-of-Cure visit; 5-10 days after the last dose of study drug.; DESCRIPTION: IACR was defined as resolution or improvement of a subject's clinical signs and symptoms such that no additional antibacterial therapy was administered for the treatment of the current episode of CABP; >; SECONDARY OUTCOME 2: MEASURE: Investigator's Assessment of Clinical Response (IACR); TIME_FRAME: IACR was assessed at the Test of Cure visit, 5 - 10 days after the last dose of study drug.; DESCRIPTION: IACR was defined as resolution or improvement of a subject's clinical signs and symptoms such that no additional antibacterial therapy was administered for the treatment of the current episode of CABP.; >;

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

This study is a side protocol/extension of 10 years of ClinicalTrials.gov ID: NCT02492555. Among 2.500 IBD patients the investigators have consecutively from the Gastroenterology out-patient clinic at North Zealand University Hospital recruited in total 120 in the study. At the out-patient consultation IBD patients has been informed about the project and the IBD eHealth nurse has ensured that no exclusion criteria was met by the patients. Inclusion criteria: IBD patients in remission, SCCAI ≤ 2 (Simple Clinical Colitis Activity Index )) or HBI < 5 (Harvey & Bradshaw Activity Index ) or in mild to moderate disease activity ( SCCAI 3-4, HBI < 16) IBD patients who can read, speak and understand Danish. IBD patients that can take advantage of the Internet and wireless network. 18 years or older. Exclusion criteria: IBD patients with severe disease activity HB > 16 SCCAI ≥ 5 IBD patients with social, medical or psychological issues of a more complex character. IBD patients with particularly complex issues such as drug and alcohol problems, severe mental / psychiatric disorders and / or serious social impact.IBD patients who cannot attend due language barrier or cognitive disorder. Age less than 18. When the patient has agreed to participate in the study, randomized to either OD or 3. Months (This has been done ClinicalTrials.gov ID: NCT02492555) Patients log in to www.noh.constant-care.dk at least once every 3rd months throughout the project period of 11 years in total (2015-2026). When the patient log in to the telemedicine platform the following scorings must be filled out: 1. - Disease activity (DA), respectively SCCAI or HBI. 2. - Quality of life assessment, s-IBDQ 3. - FACIT (Fatigue score) 4. - MARS ( Medical Adherence Rating Scale) 5. - FC, fecal calprotectin mg / kg measured by the patient's own SMART phone, rapid home test. If the patients prefer to send the fecal samples for test, it will be analyzed in the ehealth gastro lab. at the hospital with a SMART phone as well. The results of the scoring systems will appear to the health care professionals and patients in a traffic light manner (red, yellow and green). If the patient experiences a recurrence of the disease, it moves from green to either yellow or red area in the traffic graph, and patient will further be instructed to contact Gastro medical clinic project nurse for an early consultation and decision on further treatment initiative. This will also be indicated at the patient's website. If alarm symptoms occurs patients are instructed to contact the project nurse. Thus patients are treated in accordance to national and international guideline. By screening of the inflammation burden (web algorithm), the decision is moving forward. Patients logging in on demand, indicate disease activity, quality of life and FC at the start, and subsequently when needed and at the end of the study (after 11 years from inclusion). At relapse, disease activity score and FC is settled and repeated no later than 7 days here after. When the patient has reached remission (green) a new DA and FC test should be performed to verify the remission. The purpose of this study is to determine if the IBD patients doing home monitoring have relative reduced rates of colectomies, resections, mortalities and cancer after 11 years of web monitoring. Relative reduced rates of colectomies etc. means - relative to standard care but also if there is a difference between the two web screening procedures on these endpoints.

This study is a side protocol/extension of 10 years of ClinicalTrials.gov ID: NCT02492555. The purpose of this study is to determine if the IBD patients doing home monitoring (screening themselves on demand (OD) or every 3 months) have relative reduced rates of colectomies, resections, mortalities and cancer after 11 years of web monitoring. The IBD patients are self-monitoring by web apps consisting of a short disease activity questionnaire (DA) and fecal calprotectin (FC) on any smart phone.

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

A Phase I/II Study of Romidepsin (Depsipeptide) in Combination With Gemcitabine in Patients With Pancreatic and Other Advanced Solid Tumors.

This was a phase I dose escalation trial designed to determine the maximum tolerated dose (MTD) for the combination of romidepsin (depsipeptide) and gemcitabine. The study was originally planned as a Phase I/II; however only Phase I of the study was conducted.

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 total joint replacement, no previous open surgery on the same joint 2. Age 50~80 y/o, Pre-operative diagnosis: degenerative osteoarthritis 3. Pre-operative deformity: varus <15°, valgus <15°, flexion contracture <15°. 4. Patients with normal heart function 5. Willing to receive post-operative questionnaire and outpatient clinic follow-up Exclusion Criteria: 1. Allergy to Patient-Controlled Analgesia or LevoBupivacaine 2. Mental or cognitive illness that couldn't well response to questionnaire 3. American Society Anesthesiologist more than III degree 4. Liver cirrhosis, chronic renal insufficiency, heart disease or arrhythmia, insulin-dependent diabetes mellitus, and previous narcotic abuse history. 5. Not suitable for using patient-controlled analgesia pump by evaluation of anesthesiologist

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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.

Hypoglycaemia is a well-known complication of insulin treated diabetes. The counterregulatory response to hypoglycaemia, with glucagon as the most important mediator, is initially diminished within a few years of onset of Type 1 diabetes and subsequently lost and thus increasing the risk of hypoglycaemia. Dipeptidyl Peptidase (DPP)-4 inhibitors augment the glucagon response to insulin-induced hypoglycaemia in type 2 diabetes. The investigators hypothesize that treatment with a DPP-4 inhibitor in patients with type 1 diabetes will recover the alpha cell response to hypoglycaemia.

PRIMARY OUTCOME: <MEASURE: Glucagon Response to Acute Hypoglycaemia; TIME_FRAME: Change from initialisation phase to 40 minutes after onset of hypoglycaemia; DESCRIPTION: Change in glucagon concentration from the initialisation phase to 40 minutes after occurrence of the autonomic reaction to hypoglycaemia; > SECONDARY OUTCOME 1: MEASURE: Intact and Total Glucagon Like Peptide-1 (GLP-1), Intact and Total Gastric Inhibitory Peptide (GIP) Response to Acute Hypoglycaemia; TIME_FRAME: 0, 10, 20, 40 minutes; DESCRIPTION: Area under the curve (AUC) from onset of the autonomic response to hypoglycaemia to 40 minutes after onset of the autonomic response. AUC values were calculated by the trapezoid method.; >; SECONDARY OUTCOME 2: MEASURE: Epinephrine Response to Acute Hypoglycaemia; TIME_FRAME: 0, 10, 20, 40 minutes; DESCRIPTION: Area under the curve (AUC) from onset of the autonomic response to hypoglycaemia to 40 minutes after onset of the autonomic response. AUC values were calculated by the trapezoid method.; >; SECONDARY OUTCOME 3: MEASURE: Norepinephrine Response to Acute Hypoglycaemia; TIME_FRAME: 0, 10, 20, 40 minutes; DESCRIPTION: Area under the curve (AUC) from onset of the autonomic response to hypoglycaemia to 40 minutes after onset of the autonomic response. AUC values were calculated by the trapezoid method.; >; SECONDARY OUTCOME 4: MEASURE: Growth Hormone Response to Acute Hypoglycaemia; TIME_FRAME: 0, 10, 20, 40 minutes; DESCRIPTION: Area under the curve (AUC) from onset of the autonomic response to hypoglycaemia to 40 minutes after onset of the autonomic response. AUC values were calculated by the trapezoid method.; >; SECONDARY OUTCOME 5: MEASURE: Cortisol Response to Acute Hypoglycaemia; TIME_FRAME: 0, 10, 20, 40 minutes; DESCRIPTION: Area under the curve (AUC) from onset of the autonomic response to hypoglycaemia to 40 minutes after onset of the autonomic response. AUC values were calculated by the trapezoid method.; >; SECONDARY OUTCOME 6: MEASURE: Symptomatic Hormone Responses to Acute Hypoglycaemia.; TIME_FRAME: Change from baseline symptomatic response at hypoglycaemia and 30 minutes after hypoglycaemia; DESCRIPTION: The symptomatic responses to hypoglycaemia were assessed using a standard validated symptom questionnaire adapted for experimental hypoglycaemia (McCrimmon et al (2003) Diabet.Med. 20: 507-509). A 7-point Likert scale (1=symptom absent; 7=symptom experienced with great intensity) was used to score presence and intensity of autonomic and neuroglycopenic symptoms of hypoglycaemia. Symptom scores were obtained during the initialisation phase, at occurrence of autonomic reaction and again 30 minutes later. For analyses the scale was considered as a continuous variable.; >;

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 investigate the safety and effectiveness of a nitric oxide releasing solution, delivered as a footbath, to act as an antimicrobial treatment for participants presenting with a diabetic foot ulcer.

PRIMARY OUTCOME: <MEASURE: To measure the number of participants discontinued or lost to follow-up in the NORS compared to hypotonic saline in participants with diabetic foot ulcers (DFU); TIME_FRAME: 28 days; DESCRIPTION: Proportion of participants lost-to-follow-up, discontinuing study treatment due to intolerance or adverse events, or initiating new medications or treatments, or leaving/discontinuing the study for any other reason; > SECONDARY OUTCOME 1: MEASURE: To measure the efficacy of NORS compared to placebo on the change in pathogen load in participants with DFU; TIME_FRAME: 29 days; DESCRIPTION: Mean change in pathogen density as measured by colony forming units per milliliter (cfu/mL) compared to control; >; SECONDARY OUTCOME 2: MEASURE: To measure the efficacy of NORS compared to placebo on the change in bacterial load (CFU/mL) in participants with DFU; TIME_FRAME: 29 days; DESCRIPTION: Proportion of participants with a reduction in bacterial load as compared to control; >; SECONDARY OUTCOME 3: MEASURE: To measure the efficacy of NORS compared to placebo on the reduction of the number of clinical signs of infection in participants with diabetic foot ulcers (DFU); TIME_FRAME: 29 days; DESCRIPTION: Proportion of participants with Clinical Response defined as resolution of one or more clinical signs of infection reported compared to control; >; SECONDARY OUTCOME 4: MEASURE: To measure the efficacy of NORS compared to placebo on the change in wound bacterial microbiota (species) in participants with DFU; TIME_FRAME: 29 days; DESCRIPTION: Mean changes in percentage of bacterial microbiota (species) will be determined by comparing to control; >; SECONDARY OUTCOME 5: MEASURE: To measure the efficacy of NORS compared to placebo on the change in wound area in participants with DFU; TIME_FRAME: 29 days; DESCRIPTION: Mean % change in wound area calculated for DFU compared to control; >;

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.

PRF110 is new extended release oily solution formulation of ropivacaine that is intended for local infiltration into surgical wounds. The purpose of this study is to determine the safety and early efficacy of PRF110 in bunionectomy surgery, to measure the pharmacokinetic profile of PRF110 over 72 hours and evaluate the duration of analgesia witnessed in the surgical setting.

PRIMARY OUTCOME: <MEASURE: Incidence of treatment emergent adverse events; TIME_FRAME: 10 days; DESCRIPTION: All adverse events (AE) reported by the subjects will be recorded throughout the trial period; > SECONDARY OUTCOME 1: MEASURE: Time to first rescue medication; TIME_FRAME: 72 hours; DESCRIPTION: Time to first rescue medication; >; SECONDARY OUTCOME 2: MEASURE: Total amount of rescue medication used during the study; TIME_FRAME: 10 days; DESCRIPTION: Total amount of rescue medication used during the study; >; SECONDARY OUTCOME 3: MEASURE: Pain intensity recorded at rest; TIME_FRAME: 72 hours; DESCRIPTION: Pain intensity which will be recorded at rest at Hours 1, 2, 4, 6, 8, 10, 12, 18 (optional) 24, 28, 32, 36, 48, 52, 56, 60 and 72.; >; SECONDARY OUTCOME 4: MEASURE: Subject global assessment of PRF110; TIME_FRAME: 72 hours; DESCRIPTION: Subject global assessment which will be recorded at Hours 24, 48 and 72.; >;

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

To address the health disparities in SLE outcomes for minorities, targeted intervention will be used to address the common barriers to care among patients; a comprehensive patient navigator approach will be utilized based on evidence from prior studies is the purpose of this research. The navigator services most commonly provided include facilitation and coordination of care, practical support, including scheduling transportation and referrals to financial assistance programs, appointment scheduling and reminders, education and psycho-social support. The most effective patient navigators address both health system and patient barriers.

INTERVENTION 1: <TYPE: Behavioral; NAME: Patient Navigator Services; DESCRIPTION: The navigator services most commonly provided include facilitation and coordination of care, practical support, including transportation and financial assistance, appointment scheduling and reminders, education and psychosocial support, >;

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 overall objective of this study is to compare knowledge, decisional conflict, preferences, and caregiver burden over time caregivers of Alzheimer's Disease and Related Dementias (ADRD) patients by comparing the effectiveness of a video decision aid intervention and enhanced usual care.

PRIMARY OUTCOME: <MEASURE: Change from Baseline in percent correct and in response confidence on Knowledge of Advanced Dementia Questionnaire.; TIME_FRAME: Baseline and immediately post-intervention; DESCRIPTION: The Knowledge of Advanced Dementia Questionnaire is a verbally administered self-reported instrument assessing knowledge with six true/false questions with a total possible score of 6 (1 point for each correct T/F), with high scores indicating better knowledge. A confidence rating scale with possible scores from 1 (not at all confident) to 5 (extremely confident). Change = (post Knowledge score - pre Knowledge score) Change = (post Confidence score - pre Confidence score); > SECONDARY OUTCOME 1: MEASURE: Change and Retention of Change in Decisional Conflict Scale; TIME_FRAME: Baseline and immediately post-intervention Post-intervention and 3 Month Follow Up Post Intervention and 6 Month Follow Up; DESCRIPTION: The Decisional Conflict Scale is a validated, self-reported instrument assessing 5 dimensions of decision-making feelings (uncertain, uninformed, unclear about values, unsupported; ineffective decision making). Possible scores range from 1 (strongly disagree) to 5 (strongly agree). Change = (Post intervention score - baseline score) Retention = (3 Month Follow Up - Post Intervention) Retention = (6 Month Follow Up - Post Intervention); >; SECONDARY OUTCOME 2: MEASURE: Response Rate and Retention of Response Rate for Limited Medical Care and Comfort Care; TIME_FRAME: Baseline and immediately post-intervention Post-intervention and 3 Month Follow Up Post Intervention and 6 Month Follow Up; DESCRIPTION: The ACP Preferences Survey is a self-reported instrument asking a one multiple choice question with 3 options; Life Prolonging Care, Limited Medical Care and Comfort Care. Change = (Post intervention response rate - baseline response rate) Retention = (3 Month Follow Up response rate - Post Intervention response rate) Retention = (6 Month Follow Up response rate - Post Intervention response rate); >; SECONDARY OUTCOME 3: MEASURE: Response Rate for Advanced Care Planning (ACP) Documents Survey; TIME_FRAME: Baseline and Month 3 Follow Up Baseline and Month 6 Follow Up; DESCRIPTION: The ACP Documents Survey is a self-reported instrument asking 3 yes/no/unsure questions assessing the completion of ACP documents with a total possible score of 3 (1 point for each yes answer). A higher score indicates a higher amount of documents completed. Change = (3 month follow up score - baseline score) Change = (6 month follow up score - baseline score); >; SECONDARY OUTCOME 4: MEASURE: Response Rate of Satisfaction Survey on Video Rating Survey post-intervention; TIME_FRAME: Immediately post-intervention; DESCRIPTION: Responses from the Video Rating Survey, a self-reported instrument asking 5 questions assessing perception of ACP Video: Goals of Care: Advanced Dementia. Possible scores range from 1 (strongly disagree) to 5 (strongly agree) for knowledge, comfort, desire to learn more and recommend to others with a higher summary score indicating a positive response except for comfort, where a higher response indicating more discomfort. Importance to learn about this topic was measured on a 5-point scale; 1 (Not at all important) to 5 (Very Important) with a higher summary score indicating higher importance.; >;

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

The study schedule is comprised of a 14-day Screening Period, a treatment period and an observation period. All eligible subjects will be randomized into one of 3 treatment groups (1 of 2 dose levels or matched placebo). Study drug CR845 will be administered intravenously prior to surgery, and at specific time intervals post surgery. Additional rescue pain and anti-nausea medication will be made available. Post surgical changes in pain intensity, nausea and vomiting will be assessed.

INTERVENTION 1: <TYPE: Drug; NAME: CR845 IV 1 mcg/kg; DESCRIPTION: CR845 IV 1 mcg/kg will be administered as an IV bolus 2x loading dose one hour prior to anesthetic induction for surgery, then a dose within 30 minutes of the patient being considered stable in the post operative recovery room. Subsequent dosing will be administered at 6, 12 and 18 hours. Antinausea rescue medication (ondansetron 4 mg IV) may be requested, as well as analgesic rescue medication (morphine 5mg IV), post surgery, as needed. Saline infusion (IV 0.45%) for fluid replenishment will be provided., >; INTERVENTION 2: <TYPE: Drug; NAME: CR845 IV 0.5 mcg/kg; DESCRIPTION: CR845 IV 0.5 mcg/kg will be administered as an IV bolus 2x loading dose one hour prior to anesthetic induction for surgery, then a dose within 30 minutes of the patient being considered stable in the post operative recovery room. Subsequent dosing will be administered at 6, 12 and 18 hours. Antinausea rescue medication (ondansetron 4 mg IV) may be requested, as well as analgesic rescue medication (morphine 5mg IV), post surgery, as needed. Saline infusion (IV 0.45%) for fluid replenishment will be provided., >; INTERVENTION 3: <TYPE: Drug; NAME: Placebo IV; DESCRIPTION: Placebo IV will be administered as an IV bolus 2x loading dose one hour prior to anesthetic induction for surgery, then a dose within 30 minutes of the patient being considered stable in the post operative recovery room. Subsequent dosing will be administered at 6, 12 and 18 hours. Antinausea rescue medication (ondansetron 4 mg IV) may be requested, as well as analgesic rescue medication (morphine 5mg IV), post surgery, as needed. Saline infusion (IV 0.45%) for fluid replenishment will be provided., >;

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 primary objectives of the study are to evaluate the safety, tolerability, and efficacy of voxilaprevir (VOX) plus sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) in adults with chronic non genotype 1 hepatitis C virus (HCV) infection.

PRIMARY OUTCOME: <MEASURE: Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12); TIME_FRAME: Posttreatment Week 12; DESCRIPTION: SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study treatment.; > SECONDARY OUTCOME 1: MEASURE: Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24); TIME_FRAME: Posttreatment Weeks 4 and 24; DESCRIPTION: SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study treatment, respectively.; >; SECONDARY OUTCOME 2: MEASURE: Percentage of Participants With HCV RNA < LLOQ on Treatment; TIME_FRAME: Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable); >; SECONDARY OUTCOME 3: MEASURE: HCV RNA Change From Baseline; TIME_FRAME: Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable); >; SECONDARY OUTCOME 4: MEASURE: Percentage of Participants With Virologic Failure; TIME_FRAME: Up to Posttreatment Week 24; DESCRIPTION: On-treatment virologic failure: Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment) Virologic relapse: Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.; >;

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

Phase II Study Of Arsenic Trioxide In Patients With Refractory Germ Cell Malignancies

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating men who have germ cell cancer that has not responded to previous treatment.

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

Phase I Study of the Safety and Preliminary Efficacy of Intracerebral Transplantation of HuCNS-SC® Cells for Connatal Pelizaeus-Merzbacher Disease (PMD)

The purpose of this study is to determine the safety and preliminary effectiveness of human central nervous system stem cells (HuCNS-SC®) transplantation in patients with Connatal Pelizaeus-Merzbacher Disease (PMD).

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

This trial will assess chemosensitivity differences of the carotid bodies in individuals with T2DM, compared to healthy controls. During baseline and hyperinsulinemia.

INTERVENTION 1: <TYPE: Diagnostic Test; NAME: Hyperinsulemic-Euglycemic Clamp & Hypoxic Ventilatory Response (HVR); DESCRIPTION: Hyperinsulemic-Euglycemic Clamp as described by deFronzo et al., >;

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 objectives of this proposed study are: 1) to evaluate feasibility and acceptability of a novel intervention, Regulation of Cues (ROC), and Cognitive Behavior Therapy (CBT), and 2) to evaluate the efficacy of both treatments on reduction of binge eating and weight loss among 120 Veterans with subclinical or clinical Binge Eating Disorder (BED) with comorbid overweight/obesity (OW/OB).

PRIMARY OUTCOME: <MEASURE: Attendance; TIME_FRAME: Post-Treatment (5 months following baseline); DESCRIPTION: The number of treatment visits attended; > SECONDARY OUTCOME 1: MEASURE: Satiety Responsiveness; TIME_FRAME: Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks; DESCRIPTION: Self-reported satiety responsiveness measured by the Adult Eating Behavior Questionnaire (AEBQ); >; SECONDARY OUTCOME 2: MEASURE: Food Responsiveness; TIME_FRAME: Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks; DESCRIPTION: Self-reported food responsiveness measured by the Adult Eating Behavior Questionnaire (AEBQ); >; SECONDARY OUTCOME 3: MEASURE: Reward-Based Eating; TIME_FRAME: Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks; DESCRIPTION: Scales to evaluate reward-related eating measured by the Reward-Based Eating Drive Scale (RED-13); >;

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

This is an open-label, multicenter, phase 2 clinical trial to evaluate the antitumor activity of brentuximab vedotin as a single agent in patients with CD30-positive nonlymphomatous malignancies.

INTERVENTION 1: <TYPE: Drug; NAME: brentuximab vedotin; DESCRIPTION: 1.8 mg/kg every 3 weeks by intravenous (IV) infusion, >; INTERVENTION 2: <TYPE: Drug; NAME: brentuximab vedotin; DESCRIPTION: 2.4 mg/kg every 3 weeks by intravenous (IV) infusion, >; INTERVENTION 3: <TYPE: Drug; NAME: brentuximab vedotin; DESCRIPTION: 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion, >;

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

Clinical Outcome of Zirconia Versus Lithium Di-silicate Overlays Restorations for Restoring Vital Young Permanent First Molar Teeth Affected With Moderate Form of Molar Incisor Hypomineralization: Randomized Clinical Trial

the study evaluate the clinical outcome of zirconia versus lithium disilicate overlays restorations for restoring vital young permanent first molar teeth affected with moderate form of molar Incisor hypomineralization: randomized clinical trial.

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

Objectives: To compare the effectiveness of erector spinae plane block (ESPB) and rectus sheath block (RSB) in providing postoperative analgesia after supraumbilical surgery in adult patients and their impact on the patient's outcomes. Background: Supraumbilical surgery for hernia repair is the second-most-popular after surgical inguinal hernia repair and is accompanied by moderate to severe postoperative pain, so patients always require large doses of opioids within the first postoperative day. Because opioids have several adverse effects such as drowsiness, pruritus, nausea, and vomiting, regional analgesic techniques are an essential component of postoperative opioid-sparing analgesia. Previous studies have shown that regional analgesic techniques after abdominal wall surgeries can be an essential element of a postoperative pain management strategy with minimal adverse effects and hemodynamic responses. ESPB provides both somatic and visceral analgesia to the abdominal wall, through the blockade of the anterior rami of spinal nerves and the rami communicants involving sympathetic nerve fibers. RSB provides analgesia to the anterior abdominal wall from the xiphoid process to the symphysis pubis, through the blockade of the anterior rami of the 7th to 12th intercostal nerves. The dermatomal distribution of ESPB and RSB makes them ideal regional analgesic techniques after abdominal surgery, and to our knowledge, there were no previous trials that studied the difference between them. Patients and Methods: This was a prospective, randomized (1:1), double-blind clinical trial; carried out on 60 patients scheduled for elective supraumbilical surgery under general anesthesia at our hospital. Patients will be randomly allocated into two equal groups (30 patients each) and will receive: in group E; general anesthesia with postoperative bilateral ultrasound-guided ESPB, whereas in group R; general anesthesia with postoperative bilateral ultrasound-guided RSB.

INTERVENTION 1: <TYPE: Procedure; NAME: Erector Spinae Plane Block (ESPB); DESCRIPTION: Postoperative Bilateral Ultrasound-guided ESPB, >; INTERVENTION 2: <TYPE: Procedure; NAME: Rectus Sheath Block (RSB); DESCRIPTION: Postoperative Bilateral Ultrasound-guided RSB, >;

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

As the ADAPT-trials have clearly shown, pCR after 12 weeks of therapy, independent of the specific de-escalated neoadjuvant regimen and independent of further use of systemic chemotherapy, is an independent predictor of excellent prognosis4,19, also in patients treated by an antibody-drug conjugate alone (T-DM1), or in those receiving pertuzumab+trastuzumab+/-weekly paclitaxel. In contrast to the adjuvant setting, none of the neoadjuvant trials so far has focused on HER2+ patients with a low-intermediate risk profile (e.g., node-negative patients with cT1-2 tumours). The ADAPT-HER2-IV trial aims to close this evidence gap. Since there is some uncertainty about the optimal treatment duration in intermediate- to high-risk HER2+ EBC (e.g., tumour size >3 cm), we recommend using a longer 18-week taxane-based treatment (+/- carboplatin, at investigator´s decision) due to a large body of evidence for taxane + carboplatin combinations in patients in locally advanced stages. Antibody-drug conjugates appear to be ideal candidate drugs for a "de-escalated" treatment due to their favourable safety (reduced alopecia, polyneuropathy rates, etc.) and a high efficacy profile (e.g., comparable pCR rates after 18 weeks of T-DM1 and taxane+pertuzumab+trastuzumab in the PREDIX HER2 trial20). Similarly to the classical chemotherapy landscape, optimal duration of antibody-drug conjugate-based neoadjuvant therapy remains unclear. pCR rates of around 40% to 60% were observed after 12 and 18 weeks of T-DM1 treatment (+/-pertuzumab) in the ADAPT TP, KRISTINE and PREDIX HER2 trials in HR+/HER2+ disease21,22. Moreover, long-term survival seem to be comparable between T-DM1+pertuzumab and older chemotherapy-containing regimens (docetaxel+carboplatin+trastuzumab+pertuzumab) despite of higher local progression rates and lower pCR in one study22. Trastuzumab-deruxtecan (T-DXd) has shown promising activity in a small cohort of metastatic patients, including both HER2+ and HER2-low BC, pre-treated with several lines of therapy. Doi et al. reported overall response rates (ORR) of 58% and a disease control rate of 100% with overall survival at 12 months at in HER2+ disease pre-treated by T-DM1+/-pertuzumab in a late line setting23. T-DXd-therapy was associated with a manageable safety profile. Recently, clearly higher efficacy of T-DXd vs. T-DM1 was shown in second line metastatic breast cancer (MBC) in the DESTINY-03 trial24. Median progression free survival was not reached in T-DM1-arm vs. 6.8 months in the T-DXd-arm. This effect was independent of hormone receptor status, prior pertuzumab treatment, visceral metastases, number of prior therapy lines and presence of brain metastases. ORR was doubled (34.2 vs. 79.7%), favouring the T-DXd arm.

Inclusion Criteria: Patients eligible for inclusion in this study must meet all the following criteria: 1. Female patients with invasive, untreated HER2+ breast cancer (as assessed by local pathology) maximum 6 weeks before registration (standard-of-care diagnostic biopsy according to current AGO guidelines) 2. Age ≥18 years 3a. Cohort 1: low- to intermediate-risk for recurrence as per investigator´s decision (recommendation: cT1c - cT2 (1 - ≤3cm), cN0; cT1a/b excluded), OR 3b. Cohort 2: intermediate- to high-risk for recurrence as per investigator´s decision (recommendation: cT2 (>3 - ≤5cm), cN0) 3c. Elderly patients (≥ 65 years) may be assigned to any cohort as per investigator's decision 4. Written informed consent 5. LVEF ≥ 50% within 28 days before randomisation 6. Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1 7. Adequate organ and bone marrow function within 14 days before randomisation 8. Adequate treatment washout period before randomisation (refer to protocol for detailed information) 9. Evidence of post-menopausal status or negative serum pregnancy test for females of childbearing potential (refer to protocol for detailed information) 10. Female subjects must not donate, or retrieve for their own use, ova from the time of randomisation and throughout the study treatment period, and for at least 7 months after the final study drug administration. (refer to protocol for detailed information) Exclusion Criteria: Patients eligible for inclusion in this study must not meet any of the following criteria: 1. Non-operable breast cancer including inflammatory breast cancer 2. cT1a/b breast cancer 3. Any previous history of invasive breast cancer 4. Primary malignancies within 5 years, with the exception of adequately resected non-melanoma skin cancer, curatively treated in-situ disease 5. Any evidence for existing metastatic disease (confirmed by CT Thorax/Abdomen, bone scan, or other methods according to clinical practice 6. Previous or concurrent treatment with cytotoxic agents for any reason (except non-oncological reasons) 7. Concurrent treatment with other experimental drugs and participation in another clinical trial with any investigational drug within 30 days prior to study entry 8. Severe and relevant co-morbidity that would interact with the application of cytotoxic agents or the participation in the study/inadequate organ function 9. Reasons indicating risk of poor compliance 10. Woman of child-bearing potential defined as a woman physiologically capable of becoming pregnant, and not using highly effective methods of contraception during the study treatment and for 3 months after stopping the treatment. 11. Use of oral (oestrogen and progesterone), transdermal, injected, or implanted hormonal methods of contraception as well as hormonal replacement therapy. 12. Has substance abuse or any other medical conditions such as clinically significant cardiac or psychological conditions, that may, in the opinion of the investigator, interfere with the subject's participation in the clinical study or evaluation of the clinical study results. 13. Patients with a medical history of myocardial infarction (MI) within 6 months before randomisation, symptomatic congestive heart failure (CHF) (New York Heart Association Class II to IV), Subjects with troponin levels above ULN at screening (as defined by the manufacturer), and without any myocardial related symptoms, should have a cardiologic consultation before enrolment to rule out MI. 14. Corrected QT interval (QTcF) prolongation to > 470 msec (females) based on average of the screening triplicate12-lead ECG. 15. History of (non-infectious) ILD / pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening. 16. Lung criteria: Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder; Any autoimmune, connective tissue or inflammatory disorders (e.g., Rheumatoid arthritis, Sjogren's, sarcoidosis etc.) where there is documented, or a suspicion of pulmonary involvement at the time of randomisation; Prior pneumonectomy (complete); Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals 17. Active primary immunodeficiency, known human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA. Patients should be tested for HIV prior to randomisation if required by local regulations or ethics committee (EC). 18. Receipt of live, attenuated vaccine (mRNA and replication deficient adenoviral vaccines are not considered attenuated live vaccines) within 30 days prior to the first dose of trastuzumab deruxtecan. Note: Patients, if enrolled, should not receive live vaccine during the study and up to 30 days after the last dose of IMP. 19. Known allergy or hypersensitivity to study treatment (T-DXd) or any of the study drug excipients. 20. History of severe hypersensitivity reactions to other monoclonal antibodies. 21. Pregnant or breastfeeding female patients, or patients who are planning to become pregnant.

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

Participants will be randomized 1:1:1:1 and dosed with either of the 4 treatments: A, B, C, or D; followed by review of safety and tolerability data during and after the infusion. The study will proceed with treatments A, and C unless one or more of these treatments shows poor tolerability; in which case the study may proceed with treatment B or D in the follow-up cohorts. Additional participants will be randomized equally to each of the treatments the study will proceed with.

Main Objective of this study is to compare the single intravenous (IV) infusion pharmacokinetics (PK) of BMS-986231 and its metabolites (BMT-284730, BMT-279554, and CAR-000463) following of up to 2 test formulations of BMS-986231 relative to the reference formulation.

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

Preparation for colonoscopy is perceived as a major impediment to participate in CRC screening colonoscopy. Hence, inadequate bowel preparation is reported in up to 25% of all patients undergoing colonoscopy. Although the quality of bowel preparation is influenced by various factors, it largely depends on patient´s compliance regarding instructions on purgatives and diet. Therefore reinforced education and guidance is a valuable tool to improve bowel preparation. A rapidly increasing number of individuals worldwide use smartphones in their daily life. Application of this new technology into patient education could facilitate and empower the patient guidance. In this study patients either receive regular information on colonoscopy preparation (paper-based) or download a SPA for reinforced reminding of the steps of colonoscopy preparation. Objective of this study is to measure the impact of a SPA on quality of bowel preparation.

This study evaluates the impact of a SPA on Quality of bowel preparation for colonoscopy. Half of the patients receive regular paper based information on colonoscopy preparation (control), while the other half will use an additional SPA for colonoscopy preparation (coloprAPP).

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

The Impact of Mindful Meditation on Mobility, Cognition and Fall Risk in the Older Adult.

Falls have significant consequences for older adults, including fracture, disability, and death (1). Risk factors for falls include both impaired physical and cognitive function (1). Thus, older adults with chronic stroke are at significant risk for falls (2). Exercise is an evidence-based approach for reducing falls risk, even among those who are living with stroke-related impairments (3,4). More recently, mindfulness based meditation is gaining recognition for its positive impact on both physical and cognitive health (6,7). Thus, the investigators hypothesize that combining exercise with mindful meditation may be greater impact on falls risk reduction as compared with exercise alone. To begin exploring our hypothesis, we will conduct a 12-week proof-of-concept study among 20 older adults with chronic stroke (i.e., suffered their first clinical stroke > or = 12 months prior to study entry). Participants will be randomly allocated to either: 1) exercise; or 2) exercise + mindfulness based meditation. Outcomes will include measures of mobility, balance, and cognitive function. 1. Rubenstein, L.. Falls in older people: epidemiology, risk factors, and strategies for prevention. Age and Ageing 2006; 35-S2: ii37-ii41. doi:10.1093/ageing/afl084 2. Tyson et al. Balance disability after stroke. Physical Therapy January 2006: 86 (1):30-38 3. Thomas S, et al.Does the 'Otago Exercise Programme' Reduce Mortality and Falls in Older Adults?: A Systematic Review and Meta-analysis. Age Ageing. 2010; 39(6): 681-687. 4. Verheyden G, et al. Interventions for preventing falls in people after stroke. The Cochrane database of systematic reviews, 2013(5). 5. Baer R. Mindfulness Training as a Clinical Intervention: A Conceptual and Empirical Review. Clinical Psychology: Science and Practice 2003; 10(2): 125-143. 6. Grossman P, et al. Mindfulness-based stress reduction and health benefits. A meta-analysis. Journal of Psychosomatic Research, 2004;57(1) 35.

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.

ABSTRACT: In patients with obstructive jaundice, multi-organ dysfunction may develop. The aim of this study is to evaluate the effect of ursodeoxycholic acid on liver functional restoration on patients with obstructive jaundice after surgical or endoscopic treatment. Patients with obstructive jaundice will be divided into two groups: (A) test group in which will be administered ursodeoxycholic acid twenty-four hours after endoscopic or surgical procedure and will last fourteen days, and (B) control group. Serum-testing will include determination of bilirubin, alanine transaminase, aspartate transaminase, gama-glutamyl transpeptidase, alkaline phosphatase, albumin, and cholesterol levels. These parameters will be determined one day prior endoscopic or surgical procedure, and on the third, fifth, seventh, tenth, twelfth and fourteenth days after endoscopic or surgical intervention. Our hypothesis is that patients with obstructive jaundice under treatment with ursodeoxycholic acid will have better outcome than patients in control group.

PRIMARY OUTCOME: <MEASURE: Liver functional restoration; TIME_FRAME: Within 14 days after treatment with ursodeoxycholic acid; DESCRIPTION: Serum-testing in patients with obstructive jaundice will include determination of bilirubin (total and direct fractions), alanine transaminase (ALT), aspartate transaminase (AST), gama-glutamyl transpeptidase (GGT), alkaline phosphatase, albumin, and cholesterol levels.; > SECONDARY OUTCOME 1: MEASURE: To assess that in which functional parameters of the liver, treatment with UDCA will have greater impact; TIME_FRAME: within 14 days after treatment with ursodeoxycholic acid; DESCRIPTION: determination of bilirubin (total and direct fractions), alanine transaminase (ALT), aspartate transaminase (AST), gama-glutamyl transpeptidase (GGT), alkaline phosphatase, albumin, and cholesterol levels. These parameters will be determined one day prior endoscopic or surgical intervention, and on the third, fifth, seventh, tenth, twelfth and fourteenth days after endoscopic or surgical intervention.; >;

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

RSV is a common virus that affects all human age groups. Typical RSV illness is identified by symptoms such as runny nose, stuffy nose, sneezing, sore throat, earache, malaise or tiredness, cough, shortness of breath, headache, muscle ache, joint ache or stiffness, chilliness and feverishness. RSV spreads easily from person to person through the eyes, nose or mouth when droplets containing the virus, such as those from coughing or sneezing, are inhaled or passed to others. Adults with risk factors, like another illness or disease, may experience an RSV illness that is more severe or lasts longer. RSV may also start a worsening of health in frail adults, people with weak immune systems, and those with chronic cardio-pulmonary disease. No treatment or vaccine to treat or prevent RSV disease is available in the UK. Vaccination against RSV has the potential to be a highly beneficial and effective approach to reduce RSV disease in older adults as well as other high-risk adult and paediatric populations. The use of RSV human viral challenge model provides an important tool to evaluate the effectiveness of new RSV vaccines. Specifically, a RSV human viral challenge in 60 to 75-year-old individuals would enable measuring the effectiveness of RSV vaccines in a population that is thought to be less responsive to vaccines than the 18-45-year-old population. The purpose of this study is to infect up to 74 healthy subjects aged 60 to 75 years old with RSV in a controlled quarantine environment to confirm how safe and well tolerated the use of an experimental RSV virus infection is in a population that has not previously received the virus. Additionally, the investigators will also look at various components of the subjects' blood, the lining of their noses and other samples in order to measure the effects of the virus on the body, in particularly the immune system before, during and after viral infection. The study will consist of 3 phases: 1) Screening, 2) Quarantine and 3) Follow-up. The enrolment of the subjects will be staggered with safety data reviews performed between groups. Each volunteer will be in the study for approximately 3 months from screening to their last scheduled clinic visit.

The purpose of this study is to infect healthy volunteers aged 60-75 years old with Respiratory Syncytial Virus (RSV) to confirm how safe and well tolerated the use of an experimental RSV virus is in a population that has not previously received the virus. Additionally, this study will also look at various components of the volunteers' blood, the lining of their noses and other samples in order to measure the effects of the virus on the body, in particularly the immune system before, during and after viral infection.

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

Feasibility Study of Stereotactic Body Radiation Therapy Followed by Wedge Resection for Peripherally Located Early Stage Non-small Cell Lung Cancer

This pilot clinical trial studies the side effects and how well stereotactic radiosurgery followed by wedge resection works in treating patients with early stage non-small cell lung cancer that is located in the outer, or peripheral, areas of the lung. Stereotactic radiosurgery, also known as stereotactic body radiation therapy, is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue. Wedge resection is a less invasive type of surgery for removal of the tumor and a small amount of normal tissue around it. Giving stereotactic radiosurgery followed by wedge resection may be a safe treatment option for patients who cannot receive standard treatment with lobectomy.

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

Study of the Effect of Sitagliptin on the Hormonal Responses to Macronutrient Ingestion in Healthy Volunteers

The regulation by DPP-4 inhibition after ingested of different individual macronutrients is not known. Therefore, this study examines the influence of ingestion of fat, protein, glucose or mixed meal on the concentrations of incretin hormones and insulin secretion with or without concomitant administration of a DPP-4 inhibitor (sitagliptin).

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

Efficacy of a Web-Based Emotion Regulation Training in a Transdiagnostic Sample: A Randomized Controlled Trial

This two-armed randomized controlled trial investigates the efficacy of a web-based emotion regulation intervention in a transdiagnostic sample. The sample includes participants diagnosed with anxiety disorders, depression, eating disorders, borderline personality disorder, and healthy controls without a current psychiatric diagnosis. Participants will be randomly assigned to either the intervention group, receiving a web-based emotion regulation program, or a waitlist control group, which will have delayed intervention access after eight weeks. The intervention is grounded in cognitive-behavioral therapy (CBT), featuring everyday emotion regulation exercises, and psychoeducation delivered through video and audio files. Outcome measures include emotion regulation abilities, well-being, anxiety, depression, eating disorder symptoms, personality pathology, and self-esteem, evaluated at four and eight weeks post-baseline.

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

Histological studies suggest that HS is a disease of the follicles with apocrine involvement as a secondary event. The investigators have identified in a previous study that the Nd Yag laser is highly effective for decreasing the inflammation, pain, suppuration and frequency of recurrence of HS. Oral antibiotic therapy with Clindamycin and Rifampin has also been reported in previous studies to be a highly effective treatment regimen for HS and is commonly used by physicians in medical management of HS. The investigators would like to compare the efficacy of NdYag laser treatment combined with antibiotics versus treatment with antibiotics alone. The goal is to evaluate the success of these two treatment regimens on existent HS lesions as well as prevention of recurrence. There will be approximately 18 people in this research study at Henry Ford Health System (HFHS).

The purpose of this research study is to further evaluate the efficacy of two treatment regimens for the treatment of hidradenitis suppurativa. This is a randomized controlled study. Patients will be randomly assigned to an arm of the study.

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

This study is a single arm clinical study to observe the safety ，dose tolerance and pharmacokinetic characteristics of CAR NK-CD19 in patients with recurrent or refractory CD19 positive acute lymphoblastic leukemia, and preliminarily evaluate the effectiveness, the immunogenicity of the product and the correlation between the changes of cytokines after infusion and CRS , ICANS.

INTERVENTION 1: <TYPE: Biological; NAME: CAR-NK-CD19 Cells; DESCRIPTION: CAR-NK-CD19 Cells, 1-3×10^7 /KG, treatment follows a lymphodepletion. Drug: Fludarabine Recommendation: 25-30 mg/m2 (D-5~D-3), determined by tumor burden at baseline. Drug: Cyclophosphamide Recommendation: 250-300 mg/m2 (D-5~D-3), determined by tumor burden at baseline., >;

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

This study hopes to: 1. explore whether an increase in the dosage of distress tolerance intervention corresponds to greater effectiveness of mindfulness intervention in alleviating emotional distress. 2. explore whether distress tolerance mediates the effects of mindfulness intervention on alleviating emotional distress.

PRIMARY OUTCOME: <MEASURE: Changes of Five Facet Mindfulness Questionnaire-short form during the intervention; TIME_FRAME: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups; DESCRIPTION: The Five Facet Mindfulness Questionnaire is a self-reported questionnaire measuring mindfulness levels. Scores range from 39 to 195, with higher scores indicating higher levels of mindfulness.; > SECONDARY OUTCOME 1: MEASURE: The Paced Auditory Serial Addition Task-Computerized (PASAT-C); TIME_FRAME: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups; DESCRIPTION: PASAT-C In this task, participants were presented with a series of numbers and were given the task of adding the last two numbers. They were given points for correct answers and unpleasant vocal feedback for incorrect answers. The task consists of four stages: (1) simple stage, which is the control condition of cognitive and motor function; (2) Latency test stage to determine the level of completion of the addition test; (3) distress induced stage, used to induce emotional pain; (4) distress tolerance stage, used to measure distress tolerance (i.e., the time before task termination).; >;

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

Long-term Prognosis of Interventional Therapy in Patients With Lower Extremity Arterial Occlusive Disease and Its Risk Factors

Along with the improvement of living standard, the prevalence of Lower extremity arterial occlusive disease (LEAOD) is also increasing, which has become an important cause of lower extremity amputation and greatly affected the patients' life quality. Currently, percutaneous transluminal angioplasty (PTA), including balloon dilatation and stent implantation, has been regarded as the most widely applied and accepted treatment for LEAOD. The therapeutic effects of lower extremity interventional treatment, varied in different reports. It was reported that the therapeutic effects were influenced by some traditional risk factors, including age, gender, smoking, and so on. More risk factors are still unknown. The difference of therapeutic effects, the endpoint events were compared between interventional and conventional treatment group to analyze the effect of interventional treatment on LEAOD and explore its risk factors.

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: - Early and late perimenopausal women (≥38 years; early: experienced menstrual bleeding in the previous 3 months with a decrease in cycle regularity in the past year; late: no menstrual bleeding in the previous 3 months with some bleeding in the previous year). - Overweight and obese: body mass index (BMI) of 28 - 40 Kg/m^2 and percent body fat (%BF) ≥ 30%. - Healthy, non-smokers. Exclusion Criteria: - Have current and/or history of cardiovascular disease, diabetes, metabolic, thyroid, pulmonary, renal, hepatic, gastrointestinal, musculoskeletal disorders or medical or surgical events, such as bariatric surgery, heart surgery, or any joint or musculoskeletal injuries or surgeries occurring in the 6-months prior to enrollment, that may significantly influence study outcomes or prevent safe participation. - Gained or lost >5 kg in the previous 2 months - Have a self-identified or clinically diagnosed eating disorder - Undergone a full or partial hysterectomy for treatment of menopausal symptoms - Have uncontrolled hypertension or an abnormal electrocardiogram. - Have an ongoing diagnosed mental disorder with a change in medication in the previous 6 months. - Taking metabolism-altering drugs or medications outside of estrogen replacement therapy that may influence study outcomes (i.e. corticosteroids, stimulants, insulin, thyroid medications) or phytoestrogens. - Diagnosed with polycystic ovarian syndrome (PCOS). - Participating in more than 75 minutes per week of moderate exercise per week. - Currently pregnant or planning to become pregnant (determined from urine pregnancy test) - Currently nursing or have had a child within the previous 6 months - Has participated in another clinical trial within four weeks prior to enrollment that in the opinion of the PI would influence the results. - Has severely impaired hearing or speech or inability to speak English. - Unwilling or unable to comply with the study protocol, including abstaining from caffeine, tobacco, alcohol, and physical activity before testing days.

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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 goal is to further investigate the cerebrovascular hemodynamic consequences of cervical spine positions, including rotation and manipulation in-vivo under clinically relevant circumstances using two advanced forms of MRI technology on the VA and posterior cerebral vessels. According to the knowledge of the investigators, a study utilizing MRI and functional blood oxygen level dependent (fBOLD) imaging to examine blood flow and perfusion, turbulence and evidence of micro-trauma within these vessels has yet to be conducted.

Inclusion/Exclusion Criteria 1. Enrolled and matriculated as a student in the Canadian Memorial Chiropractic College. 2. Healthy asymptomatic male patients who would otherwise receive cervical manipulation on a regular basis as a part of their normal learning experience and will have had a cervical manipulation in the last 3 months. 3. Sufficient English language ability to complete study questionnaires (see appendix). 4. No history of disabling neck, arm or headache pain within the last 6 months. 5. No current or prior history of neurological symptoms including, facial or extremity weakness, abnormal sensation to the face, body or extremities, uncontrolled movements, abnormal gait, dizziness, unexplained nausea/vomiting, difficulty with speaking or swallowing. 6. Subjects will have had no prior history of head trauma or prior history of surgery to the neck region. 7. No history of claustrophobia, metallic implants or tattoos to ensure compatibility with MRI requirements.

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

The real linear measurement will be measured in millimeter (mm) on the mandibles using digital caliper in the chosen areas. CBCT images will be viewed by OnDemand3D™ viewer software and linear measurements using 2D ruler on multiplanar slices and 3D ruler on 3D volumetric rendering to assess for the dimension in the chosen areas.

study target is assessment of the accuracy of linear measurement obtained from CBCT images on 3D volumetric rendering and multiplanar slices with different voxel sizes

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

Atrial fibrillation (AF) and atrial flutter (AFL) are common cardiac arrhythmias associated with an increased incidence of stroke in patients with additional risk factors. Oral Anticoagulation (OAC) reduces stroke risk, but because these arrhythmias are frequently intermittent and asymptomatic, start of OAC therapy is often delayed until electrocardiographic documentation is obtained. Technological advances in implanted dual-chamber cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) devices allow early detection and real time verification of AF/AFL with intracardiac electrograms (IEGM) automatically transmitted to the clinicians. Such remote diagnostic capability might be particularly relevant in patients with asymptomatic AF by allowing timely treatment. Compared to conventional periodic, (e.g., quarterly) office device evaluation, daily remote monitoring may prove superior for diagnosis of AF and prophylactic treatment of thromboembolism. The start, stop and restart of OAC based on a predefined atrial rhythm-guided strategy in conjunction with a standard risk-stratification scheme could lead to better clinical outcomes compared with conventional clinical care. The study is designed to demonstrate a risk reduction of both thromboembolism proximate to episodes of documented AF/AFL and bleeding potentiated by chronic OAC in the absence of AF. Verification of this premise would impact the clinical practice, providing evidence to physicians for the use of HM to guide OAC in patients with AF/AFL. The results of this study should demonstrate the clinical value of wireless remote surveillance of the cardiac rhythm and may define the critical threshold of AF/AFL burden warranting OAC or antiarrhythmic drug therapy in patients at risk of stroke

The IMPACT Study will investigate the potential clinical benefit of the combined use of BIOTRONIK Home Monitoring (HM) technology and a predefined anticoagulation plan compared to conventional device evaluation and physician-directed anticoagulation in patients with implanted dual-chamber defibrillators or cardiac resynchronization therapy devices.

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: Diagnosed with Parkinson's Disease, Exercise less than 3x per week. Exclusion Criteria. Describe which potential participants will be excluded from participation, and list the criteria for their exclusion. 1. atypical Parkinson syndrome (progressive supranuclear palsy, multiple system atrophy, drug-induced etc.); 2. significant osteoporosis or arthritis; 3. other neurological disease/complications (e.g. myopathy, stroke, brain lesion, MS); 4. self-reports claustrophobia; 5. history of cancer within 5 years of study participation; 6. high dose of radiation from other procedures within the year; 7. not able to tolerate being off PD medication for up to 24 hours; 8. a female subject who is breast-feeding or pregnant. 9. Subjects who regularly use anti-inflammatories (only excluded for PBR scans). Exclusion criteria for MRI scanning and magnetic stimulation from repetitive Transcranial Magnetic Stimulation (rTMS) scanning includes: 1. artificial heart valve; 2. brain aneurysm clip; 3. electrical stimulator for nerves or bones; 4. ear or eye implant; 5. implanted drug infusion pump; 6. coil, catheter, or filter in any blood vessel; 7. orthopedic hardware (artificial joint, plate, screws); 8. other metallic prostheses; 9. shrapnel, bullets, or other metal fragments; 10. surgery or tattoos (including tattooed eyeliner) in the last six weeks; 11. brain surgery 12. have a cardiac pacemaker, wires or defibrillator; 13. have had an injury where a piece of metal lodged in the eye or orbit; 14. have a ferromagnetic aneurysm clip; and 15. have a history of seizures/epilepsy 16. history of severe or uncontrolled headaches/migraines 17. taking medications that lower seizure threshold (e.g. amitryptiline, haloperidol) Subjects may be excluded following study enrollment if they meet any of the following exclusion criteria: 1. significant cognitive impairment or depression; 2. significant or unstable cardiovascular or respiratory disease - all subjects will undergo a screening exercise bicycle stress test; or 3. failure to comply with the exercise or stretching intervention program by not completing at least 30 of the 36 exercise classes. 4. Severe/multiple head trauma(s)

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

The World Health Organization (WHO) estimates that approximately 2.3 billion people are infected with Mycobacterium tuberculosis. Approximately 1.7 million people die of TB each year, the second most common infectious cause of death in the world. In order to improve TB control worldwide, an affordable, effective, short course treatment for latent TB infection (LTBI) is a global priority. Candidates for LTBI treatment are those persons with a positive TST or IGRA, particularly if they also have risk factors for progressing to active TB, including individuals likely to be recently infected. The Prevent TB Study (TBTC Study 26) was an open-label, randomized, phase III controlled clinical trial with over 8,000 high risk TST reactors enrolled. The study compared rifapentine and INH (3RPT/INH) given once-weekly by directly observed treatment (DOT) for 3 months (12 doses) compared with 9 months of daily, self-administered INH. The results demonstrated the safety and efficacy of the shorter regimen. Moreover, the once weekly therapy had significantly higher treatment completion rates than the standard 9 INH regimen. One of the most effective strategies for assuring adherence with therapy is to have each dose of medication directly administered by a health care worker who observes and records the ingestion of the drugs. DOT for active TB has been successfully used in many settings to improve treatment completion, however cost and logistical constraints of DOT remain. The estimated cost of giving 12 weekly DOT doses to all LTBI patients is likely prohibitive for TB control programs worldwide. This may lead to a decreased uptake of the new regimen or implementation using SAT where adherence has not been studied. Therefore, to apply the Prevent TB study results more broadly, a new study evaluating treatment completion of 3 RPT/INH given as SAT is conducted. Medication adherence is defined by whether patients take a treatment as prescribed. The effectiveness of any treatment is determined largely by adherence. In clinical practice and research, indirect measures of adherence are commonly used. Indirect measures of adherence include patient self-report, evaluation of pharmacy dispensation records, pill counts, and the use of electronic prescription bottle monitors. Patient self-reported adherence is accurate when non-adherence is reported but tends to overestimate true adherence. Self-report is not discerning enough to be utilized as a sole measure of adherence in research settings where adherence is the primary outcome. Pill counts have been utilized successfully in research and clinical settings for real-time assessment but also tend to overestimate adherence. Electronic drug monitors such as the Medication Event Monitoring System (MEMS) are the best available tools to assess the timing and patterns of adherence. This study uses a combination of indirect measures including MEMS, pill counts, and self-report to provide the most accurate assessment of adherence to once weekly, self-administered RPT/INH. The number of cellular phone users globally has increased dramatically in the last decade. Cell phones and SMS reminders have been used successfully in randomized controlled clinical trials to improve adherence to vaccines, HIV medications, and asthma treatment. SMS appear to be cost-effective ways to reach patients in remote locations. This study examines effect of SMS on medication adherence. The goal of this open label clinical trial is to compare the adherence to 3RPT/INH given by DOT versus SAT or SAT with a weekly SMS reminder. The primary assessment of adherence will be treatment completion which is defined as taking at least 90% of the doses (11/12 doses of each drug) within 16 weeks of initiation. Secondary objectives include evaluating the patterns of adherence in participants who fail to complete, determining the feasibility and impact of using SMS reminders on treatment completion with SAT, evaluating the tolerability and any adverse events associated with each treatment arm, monitoring for the development of active TB, determining the drug susceptibility for participants who develop active TB, and measuring important patient-related expenditures associated with each study arm. The trial will be conducted in patients diagnosed with LTBI and recommended for treatment.

The study is an open label, multicenter, randomized (three arms: DOT (standard control), SAT, SAT with SMS reminders) controlled clinical trial. The trial is conducted in patients diagnosed with latent tuberculosis infection (LTBI) who are recommended for treatment. The primary objective is to evaluate adherence to a three-month (12-dose) regimen of weekly rifapentine and isoniazid (3RPT/INH) given by directly observed therapy (DOT) compared to self-administered therapy (SAT). The secondary objectives: - To compare the treatment completion rates between participants randomized to SAT without reminders versus SAT with weekly SMS reminders - To evaluate the timing of doses and patterns of adherence to once weekly RPT/INH among participants who complete treatment and those who discontinue therapy prior to completion. - To determine the availability and acceptability of using SMS reminders among all patients consenting to participate in the study. - To determine the toxicity and tolerability by comparing the rates of any drug-related grade 3 or 4 adverse events or death between the DOT arm and the SAT arms (both combined and individually) - To compare the frequency, timing, and causes for failure to complete treatment between the DOT arm and the SAT arms - To collect patient-specific cost data related to the 3 treatment arms - To describe the pattern of antituberculosis drug resistance among Mycobacterium tuberculosis strains cultured from participants who develop active TB.

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.

Objective: Acute urinary retention (AUR) is a common problem in hospitalized patients. Either indwelling urethral catheterization or clean intermittent catheterization (CIC) can be the choice of treatment. In chronic urinary retention, most physicians prefer CIC to chronic indwelling urethral catheter on the basis of the claim that the rate of catheter-associated urinary tract infection (CAUTI) is lower. Method: The patients were randomized into indwelling urethral catheter and CIC groups. The primary outcomes of the study were catheter-associated asymptomatic bacteriuria and CAUTI. The secondary outcomes were pain, hematuria, cloudy urine, and quality of life.

PRIMARY OUTCOME: <MEASURE: Catheter-associated urinary tract infection (CAUTI); TIME_FRAME: up to 12 months; DESCRIPTION: the presence of symptoms or signs compatible with UTI and no other identified source of infection, along with ≥103 CFU/mL of ≥1 bacterial species in a single catheter urine specimen or in a midstream voided urine specimen from a patient whose urethral catheter has been removed within the previous 48 hours.; > SECONDARY OUTCOME 1: MEASURE: Pain; TIME_FRAME: up to 12 months; DESCRIPTION: Using visual analogue scales; >; SECONDARY OUTCOME 2: MEASURE: Hematuria; TIME_FRAME: up to 12 months; >; SECONDARY OUTCOME 3: MEASURE: Cloudy urine; TIME_FRAME: up to 12 months; >; SECONDARY OUTCOME 4: MEASURE: Quality of life; TIME_FRAME: up to 12 months; DESCRIPTION: assessed on the basis of social functioning (SF) that was derived from SF-36 questionnaire; >; SECONDARY OUTCOME 5: MEASURE: Catheter-associated asymptomatic bacteriuria; TIME_FRAME: up to 12 months; DESCRIPTION: the presence of ≥105 CFU/mL of ≥1 bacterial species in a single catheter urine specimen from a patient without symptoms compatible with UTI.; >;

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: - Adult patients - With obstructive sleep apnea confirmed by polysomnography - Surgical indication for surgically maxillary expansion Exclusion Criteria: - - Patients refusing to participate in the survey having formulated their opposition - Diabetes, - Obesity (BMI> 30) - Failure to provide informed written consent - Refusal or inability to return to all follow-up visits and sleep studies - Patient pregnant or planning to become pregnant in the next 12 months or breastfeeding - Surgical resection or radiation therapy for cancer or congenital malformations of the larynx, tongue or throat (Note that some previous surgeries, such as uvulopalatopharyngoplasty (UPPP), tonsillectomy or adenoidectomy, to remove obstructions related to obstructive sleep apnea are allowed) - Obvious obstructions of the fixed upper airways (tumors, polyps or nasal obstruction) - Patients who have undergone previous surgery on the mandible and / or maxilla, other than dental treatment. - Patients included in another clinical study (excluding registers). - Patients taking medicines such as opiates which may affect sleep, alertness or breathing

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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.

Patients referred to an tertiary otorhinolarynglogical clinic due to dizziness will be invited to participate in the study. The aims are to examine the prevalence, extent and distribution of musculoskeletal pain in patients with prolonged dizziness, and to investigate the associations between musculoskeletal pain, dizziness symptoms, psychological and physical function and health-related quality of life. Furthermore, the aim is to monitor the natural course of the dizziness symptoms and functional status in these patients, and examine risk factors for prolonged disability after 6 and 12 months. The hypothesis is that muscle pain and distress at baseline may be independently associated with prolonged complaints at follow-up. Finally, patients who still are dizzy and have pain after 12 months will be invited to participate in one of two group interventions a) modified vestibular rehabilitation and b) virtual reality / exergaming. The interventions will be feasibility studies with a pre-post design.

Inclusion Criteria: - Patients referred to an otorhinolaryngological university clinic due to suspected vestibular disorders (dizziness) - Patients must be bothered with dizziness at the time of consultation Exclusion Criteria: - Patients uable to fill in questionnaires due language barriers - Patients not able to undergo diagnostic and testing procedures - Patients with vestibular Schwannoma - Patients with diving-related inner ear injuries

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

The present trial is split into two successive parts: - Study Part I is a double-blind, randomized, placebo-controlled study designed to obtain safety, tolerability and pharmacokinetic (PK) data after 14-day multiple oral administrations of once-daily increasing doses of GFT505 (300 and 360 mg) in healthy male subjects. The starting dose of 300 mg/day has been selected on the basis of the results of previous clinical trials and corresponds to the highest dose given in healthy subjects according to a single dose regimen (study GFT505-111-7). A total of 24 male subjects will be included, 12 for each cohort (a cohort corresponding to a dose level). In each cohort, 9 subjects will receive GFT505 and 3 will receive placebo. A Safety Review Committee (SRC) will have a formal meeting after full completion of at least 10 out of 12 subjects of each dose level to review under blinded conditions all safety data and to conclude on the safety and tolerability of a given dose level. Between the first and the second dose level, the SRC will give its agreement on the dose escalation, and at completion of the second level the SRC will define the supra-therapeutic dose to be administered in Study Part II. - Study Part II will be a parallel group, randomized, placebo-controlled study, with stratification by gender. The study is designed to investigate the potential impact of 14-day multiple oral administrations of once-daily GFT505 on QT/QTc prolongation under conditions of maximal GFT505 exposure, i.e. by administering the expected therapeutic dose of 120 mg/d and a supra-therapeutic dose (defined according to the results of Study Part I), to healthy male and female subjects. A single oral dose of 400 mg moxifloxacin will be used as a positive control in order to document the sensitivity of the experimental conditions. The study treatment administration will be double-blind for placebo and GFT505 and open for moxifloxacin. The ECG readings will be performed under blinded conditions. A preliminary sample size of 128 subjects to have at least 124 evaluable subjects has been fixed by formal justification on a theoretical basis. ECG data collected during Study Part I will support a formal determination using observed data and thus will lead to a final sample size. In all cases, it is anticipated that the sample size could not be less than 124 evaluable subjects. Each gender will represent at least 40% of the study population. Both sub-groups will be balanced between the 4 treatment groups.

Inclusion Criteria: Part I: - Healthy males aged 18 to 45 years inclusive - Body Mass Index (BMI) ≥ 18 ≤ 30 kg/m² - No clinically relevant abnormalities in blood pressure (BP) or heart rate (HR) - No clinically relevant abnormalities in 12-lead ECG results Part II: - Healthy males and females aged 18 to 45 years inclusive - For female subjects of childbearing potential, use of double contraception method - Body Mass Index (BMI) ≥ 18 ≤ 30 kg/m² - No clinically relevant abnormalities in blood pressure (BP) or heart rate (HR) - No clinically relevant abnormalities in 12-lead ECG results Exclusion Criteria: Part I: - Evidence of clinically relevant cardiovascular, renal, hepatic, hematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological, urogenital or psychiatric diseases - A history of risk factors for "Torsades de Pointe" (e.g., heart failure, hypokalemia, family history of Long QT Syndrome) - Any condition requiring regular concomitant medication, including herbal products and over-the-counter (OTC) medication or predicted need of any concomitant medication during the study - Current drug or alcohol abuse [including regular alcohol drinking of more than 21 units per week (1 unit = 4 cL spirits or equivalent)] or a history of drug or alcohol abuse within 1 year before screening - Current use of nicotine containing products, i.e., more than 5 cigarettes or equivalent/day and the inability to stop using nicotine containing products during confinement in the clinical center - Use of caffeine containing beverages exceeding 500 mg caffeine/day (5 cups of coffee) and the inability to refrain from the use of caffeine containing beverages during confinement in the clinical center - Blood donation or loss of significant amount of blood within 2 months prior to the first dosing - Any other condition that in the opinion of the Investigator would interfere with the evaluation of the results or constitute a health risk for the subject. Part II: - Evidence of clinically relevant cardiovascular, renal, hepatic, hematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological, urogenital or psychiatric diseases - A history of risk factors for "Torsades de Pointe" (e.g., heart failure, hypokalemia, family history of Long QT Syndrome) - The use of concomitant medications that prolong the QT/QTc interval - Any condition requiring regular concomitant medication, including herbal products and over-the-counter (OTC) medication or predicted need of any concomitant medication during the study - Current drug or alcohol abuse [including regular alcohol drinking of more than 21 units (for male) or 14 units (for female) (1 unit = 4 cL spirits or equivalent)] or a history of drug or alcohol abuse within 1 year before screening - Current use of nicotine containing products, i.e., more than 5 cigarettes or equivalent/day and the inability to stop using nicotine containing products during confinement in the clinical center - Use of caffeine containing beverages exceeding 500 mg caffeine/day (5 cups of coffee) and the inability to refrain from the use of caffeine containing beverages during confinement in the clinical center - Blood donation or loss of significant amount of blood within 2 months prior to the first dosing - For women: Positive pregnancy test at screening or on Day -2; Pregnancy or trying to become pregnant; Breastfeeding - Any other condition that in the opinion of the Investigator would interfere with the evaluation of the results or constitute a health risk for the subject.

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

In phenotypic animal models of Parkinson's Disease (PD), chronic physical exercise has produced nigrostriatal neuroprotection and symptom improvement, provided training was of high-intensity and prolonged duration (>3 months in rodent models). Conventional physical therapy in Parkinson's disease (PD) has traditionally avoided fatigue and high intensity workouts. Yet, in PD controlled studies have shown that: (i) an acute aerobic stress produces endogenous dopamine immediately after the exercise and (ii) short term (a few weeks) high intensity aerobic training enhances D2 striatal receptor density and cortical excitability and clinically improves walking, upper limb and executive functions; (iii) long-term (six months) high intensity aerobic treadmill training is associated with less deterioration of subjective UPDRS III score compared to a waiting list. Long-term high intensity aerobic training has not been compared to low or medium intensity training in PD patients for its objective motor, cognitive and putative neuroprotective effects.

INTERVENTION 1: <TYPE: Behavioral; NAME: High Intensity Aerobic program; DESCRIPTION: Three sessions a week of hospital-based exercise on a stationary bicycle, all in presence and with the guidance of a physical education teacher, for nine months, >; INTERVENTION 2: <TYPE: Other; NAME: Conventional Physical Therapy; DESCRIPTION: Three sessions a week of hospital-based exercise on a stationary bicycle, all in presence and with the guidance of a physical education teacher, for nine months, >; INTERVENTION 3: <TYPE: Behavioral; NAME: Medium Intensity Aerobic program; DESCRIPTION: Three sessions a week of hospital-based exercise on a stationary bicycle, all in presence and with the guidance of a physical education teacher, for nine months, >;

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

NOTIFY (New Observations Taking Information From Yesterday)

This trial will investigate whether notifying patients and their clinicians of the presence of moderate or severe coronary artery calcium on a low-dose CT scan performed for lung cancer screening results in a lower incidence of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke as compared with usual care informed by clinical practice guidelines.

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

This study will examine whether, compared to a standard, low-fat, calorie-restricted diet intervention, the clinic-supported Ideal Protein weight loss method will result in greater weight loss and improvement in cardiometabolic risk factors over 3 months among obese adults with cardiovascular disease (CVD) risk factors.

PRIMARY OUTCOME: <MEASURE: Change in weight; TIME_FRAME: Baseline and three months; DESCRIPTION: Change in weight at follow-up; > SECONDARY OUTCOME 1: MEASURE: Body Composition; TIME_FRAME: Baseline and three months; DESCRIPTION: Change in waist and hip circumference; >; SECONDARY OUTCOME 2: MEASURE: Body Composition; TIME_FRAME: Baseline and three months; DESCRIPTION: Change in lean and fat mass; >; SECONDARY OUTCOME 3: MEASURE: Lipid parameters; TIME_FRAME: Baseline and three months; DESCRIPTION: Change in lipid parameters; >; SECONDARY OUTCOME 4: MEASURE: Fasting glucose; TIME_FRAME: Baseline and three months; DESCRIPTION: Change in fasting glucose; >; SECONDARY OUTCOME 5: MEASURE: Continuously measured glucose; TIME_FRAME: Baseline and three months; DESCRIPTION: Change in continuously measured glucose; >; SECONDARY OUTCOME 6: MEASURE: Systolic Blood Pressure; TIME_FRAME: Baseline and three months; DESCRIPTION: Change in systolic blood pressure; >; SECONDARY OUTCOME 7: MEASURE: Diastolic Blood Pressure; TIME_FRAME: Baseline and three months; DESCRIPTION: Change in systolic blood pressure; >; SECONDARY OUTCOME 8: MEASURE: Appetite; TIME_FRAME: Baseline and three months; DESCRIPTION: Change in appetite as measured by self-report questionnaires; >; SECONDARY OUTCOME 9: MEASURE: Satiety; TIME_FRAME: Baseline and three months; DESCRIPTION: Change in satiety as measured by self-report questionnaires; >;

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 was to evaluate the magnitude and durations of the antihypertensive effects of losartan using ambulatory blood pressure monitoring (ABPM), and to evaluate the safety of losartan 50 and 100 mg doses compared to placebo.

PRIMARY OUTCOME: <MEASURE: Mean Change From Baseline in 24-hour Diastolic Ambulatory Blood Pressure Monitoring (ABPM) at Week 4; TIME_FRAME: 24 hour period at Baseline and Week 4; > SECONDARY OUTCOME 1: MEASURE: Mean Change From Baseline in Sitting Diastolic Blood Pressure (siDBP) 24 Hours After Morning Dose at Week 4; TIME_FRAME: Baseline and 24-hours after morning dose at Week 4; >; SECONDARY OUTCOME 2: MEASURE: Mean Change From Baseline in Sitting Diastolic Blood Pressure (siDBP) After Adding HCTZ 24 Hours After Morning Dose at Week 6; TIME_FRAME: Baseline and 24-hours after morning dose at Week 6; >; SECONDARY OUTCOME 3: MEASURE: Mean Change From Week 4 in Sitting Diastolic Blood Pressure (siDBP) Adding HCTZ 24 Hours After Morning Dose at Week 6; TIME_FRAME: Baseline and 24-hours after morning dose at Week 6; >;

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

The recurrent or refractory ovarian cancer tends to recur repeatedly at increasingly short intervals, making treatment more and more difficult.Patients often have limited physical capacity to undergo repeated systematic treatment. Currently, NCCN（ national comprehensive cancer network ）guidelines recommend palliative radiotherapy in patients with local recurrence of ovarian cancer. With the progress of IMRT（ intensity modulated radiation therapy ）, SBRT ( stereotactic body radiation therapy ) and other radiotherapy technologies, better local tumor control rate can also be achieved, while minimizing the damage to surrounding normal tissues. In this study, the patients will be divided into groups according to their wishes: group A (drug therapy alone), group B (radiotherapy alone), and group C (radiotherapy plus drug therapy).The researchers sought to explore the the efficacy and safety of involving field radiotherapy in the oligo-metastatic/recurrent/refractory ovarian cancer patients in different groups after treatment by inviting multiple centers to participate in the study.

In this study, The researchers sought to explore the efficacy and safety of involving field radiotherapy in the oligo-metastatic/recurrent/refractory ovarian cancer patients among different groups which include drug therapy alone, radiotherapy alone, and drug therapy plus radiotherapy by inviting clinical multi-center participation.

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

This randomized clinical trial research experimental design was performed with pediatric burn patients on May 2018-May 2019. Routine treatment of any child was not interfered with during the data collection phase of the study. Sample The minimum sample size in each intervention and control group was considered 36 using G power formula with a = 0.05, power of 80%, 95% confidence interval (Gpower 3.1.9.2., Germany). Allocation to the groups was performed using the Stratified Randomization. The absence of differences in age, vital signs and pain levels between groups prior to the intervention was achieved using Stratified Randomization method. Intervention Protocols In the clinic where the study was conducted, all children are routinely given hydrotherapy treatment for the examination of the burn area as of 10 am every morning and then dressings are applied. Besides routine care, the Control Group was treated with jojoba oil (Simmondsia Chinensis- produced by Arifoğlu, obtained from jojoba fruits by cold squeezing method) inhalation aromatherapy 15 minutes before Hydrotherapy. Jojoba oil was used as a placebo because it had no specific odour. Besides routine care, Intervention-15 Group received lavender oil (Lavandula angustifolia Miller Oleum-produced by Arifoğlu, obtained from lavender flowers by water vapour distillation method) inhalation aromatherapy 15 minutes before Hydrotherapy and besides routine care, Intervention-60 Group received lavender oil inhalation aromatherapy 60 minutes before Hydrotherapy. 0.5 ml (8.44 minim-imperial) of aromatherapy oil, which had been dripped into 7.5x7.5 cm gauze 15 or 60 minutes before the start of Hydrotherapy, was placed 20 cm (7.87 inches) away from the child's nose by the clinical nurse. To conceal the allocation, the group in which the child belongs is only known to the clinical nurse who has placed the aromatherapy oil-soaked gauze in the child's room and this clinical nurse did not carry out any assessment of the child's outcomes. Data Collection Before randomization, the characteristics of all participants were collected using the Turkish version of the FLACC Pain Scale, Demographic Data Collection Form, and the Vital Signs Follow-up Form which were developed by the researchers. By the clinical nurse 0.5 ccs of aromatherapy oil, which had dripped into the gauze, was placed 20 cm away from the child's nose. The child who inhaled the oil was then taken to hydrotherapy and then dressing. The pain and vital signs of the child were evaluated and recorded 1 minute and 30 minutes after the child returned to bed by a researcher who was blind to the study groups.

Inclusion Criteria: - aged 2 months-7 years, - having a second degree of superficial burn, - willing to participate in the study, - receiving hydrotherapy application (wet dressing), - dressing the child with the same dressing material, - having no chronic pain, - having scalding burn, - having no surgery record to treat burns, - having no pathogen reproduction at the burn area, - having no stage of epitheliazation, - having analgesic therapy containing the same active substance. Exclusion Criteria: -

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

The aim of this study is to investigate whether the activity in brain areas controlling the bladder is different among children suffering from Overactive Bladder (OAB) and Daytime Urinary Incontinence (DUI) compared to age- and gender-matched healthy children without bladder symptoms. Moreover, the aim is to investigate if sacral transcutaneous electric nerve stimulation (TENS) has a central mechanism of action. Children with OAB and DUI will be recruited from involved pediatric departments, and functional magnetic resonance imaging (fMRI) will be performed before and after 10 weeks of sacral TENS. In healthy children without bladder symptoms, only the baseline fMRI will be performed.

INTERVENTION 1: <TYPE: Device; NAME: Sacral TENS; DESCRIPTION: Sacral TENS applied two hours daily for 10 weeks, >;

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 randomized controlled pilot trial is to develop and test mobile app, Intensive Care Unit-Caregiver Activation Response, and Engagement (ICU-CARE). ICU-CARE provides a simulated learning environment to encourage family caregivers of mechanically ventilated patients to assess two patient symptoms, thirst and anxiety, and perform specific nonpharmacologic comfort measures to help alleviate patient symptom burden.

PRIMARY OUTCOME: <MEASURE: Enrollment Feasibility of ICU-CARE; TIME_FRAME: Through study completion, estimated 3 years.; DESCRIPTION: Total subjects screened, approached, consented and refused; > SECONDARY OUTCOME 1: MEASURE: Influence of ICU-CARE on Caregiver Process Characteristics - Caregiver Activation; TIME_FRAME: At study enrollment, 24-48 hours after study enrollment, and 2-4 weeks after ICU discharge; DESCRIPTION: Caregiver activation as measured by Patient Activation Measure for Family Caregivers (CG-PAM). Minimum score = 1; Maximum Score = 4. Higher score indicates greater activation.; >; SECONDARY OUTCOME 2: MEASURE: Influence of ICU-CARE on Caregiver Process Characteristics - Caregiver Self-efficacy; TIME_FRAME: At study enrollment, 24-48 hours after study enrollment, and 2-4 weeks after ICU discharge; DESCRIPTION: Caregiver self-efficacy as measured by the Caregiver Self-Efficacy Scale (CaSES). Scale contains four sub-scales that are scored separately. Minimum Score =1; Maximal Score = 5. Higher scores indicate greater self-efficacy.; >; SECONDARY OUTCOME 3: MEASURE: Influence of ICU-CARE on Caregiver Process Characteristics - Caregiver Preparedness; TIME_FRAME: At study enrollment, 24-48 hours after study enrollment, and 2-4 weeks after ICU discharge; DESCRIPTION: Caregiver Preparedness as measured by the Preparedness for Caregiving Scale (Prep Scale). Minimum score = 0; Maximum score = 32. The higher the score the more prepared the caregiver feels for caregiving.; >; SECONDARY OUTCOME 4: MEASURE: Influence of ICU-CARE on Proximal Caregiving Outcomes - Symptom Assessment; TIME_FRAME: Once every 24 hours from the date the patient is enrolled in the trial to the date the patient is discharged from the ICU, an average of 2 weeks.; DESCRIPTION: Rate of symptom assessment behaviors - the number of times in a 24 hour period that the subject records a patient symptom assessment in the ICU-CARE app; >; SECONDARY OUTCOME 5: MEASURE: Influence of ICU-CARE on Proximal Caregiving Outcomes - Symptom Management; TIME_FRAME: Once every 24 hours from the date the patient is enrolled in the trial to the date the patient is discharged from the ICU, an average of 2 weeks.; DESCRIPTION: Rate of symptom management behaviors - the number of times in a 24 hour period that the subject records a patient symptom management technique in the ICU-CARE app; >; SECONDARY OUTCOME 6: MEASURE: Influence of ICU-CARE on Proximal Caregiving Outcomes - Caregiver Anxiety; TIME_FRAME: Once every 24 hours from the date the patient is enrolled in the trial to the date the patient is discharged from the ICU, an average of 2 weeks.; DESCRIPTION: Caregiver anxiety as measured by the State-Trait Anxiety Inventory (STAI-State). Minimum score = 0; Maximum score = 6. Higher scores indicate greater anxiety.; >; SECONDARY OUTCOME 7: MEASURE: Influence of ICU-CARE on Proximal Caregiving Outcomes - Patient Thirst; TIME_FRAME: Once every 24 hours from the date the patient is enrolled in the trial to the date the patient is discharged from the ICU, an average of 2 weeks.; DESCRIPTION: Patient thirst as measured by a 0-100 visual analogue scale for thirst (VAS-Thirst); >; SECONDARY OUTCOME 8: MEASURE: Influence of ICU-CARE on Proximal Caregiving Outcomes - Patient Anxiety; TIME_FRAME: Once every 24 hours from the date the patient is enrolled in the trial to the date the patient is discharged from the ICU, an average of 2 weeks.; DESCRIPTION: Patient anxiety as measured by a 0-100 visual analogue scale for anxiety (VAS-Anxiety); >; SECONDARY OUTCOME 9: MEASURE: Influence of ICU-CARE on Distal Caregiving Outcomes - Caregiver Global Health Status; TIME_FRAME: At study enrollment and 2-4 weeks after ICU discharge; DESCRIPTION: Caregiver Global Health Status as measured by the Patient-Reported Outcome Measure (PROMIS-10). 5 questions each on 2 (1-5) subscales (Global Physical Health, Global Mental Health). Once every 24 hours from the date the patient is enrolled in the trial to the date the patient is discharged from the ICU, an average of 2 weeks. Higher scores indicate a healthier patient.; >; SECONDARY OUTCOME 10: MEASURE: Influence of ICU-CARE on Distal Caregiving Outcomes - Caregiver Anxiety & Depressive Symptoms; TIME_FRAME: At study enrollment and 2-4 weeks after ICU discharge; DESCRIPTION: Caregiver anxiety and depressive symptoms as measured by the Hospital Anxiety and Depression Scale (HADS). Two sub-scales (Anxiety & Depression) scored separately. Minimum Score = 0; Maximum Score = 21. Higher score = higher anxiety and/or depression.; >; SECONDARY OUTCOME 11: MEASURE: Influence of ICU-CARE on Distal Caregiving Outcomes - Caregiver Satisfaction; TIME_FRAME: At study enrollment and 2-4 weeks after ICU discharge; DESCRIPTION: Caregiver satisfaction as measured by the Critical Care Family Satisfaction Survey (CCFSS). Minimum Score = 5; Maximum score = 25. Higher scores indicate greater satisfaction.; >; SECONDARY OUTCOME 12: MEASURE: Influence of ICU-CARE on Distal Caregiving Outcomes - Caregiver ICU Experience; TIME_FRAME: At study enrollment and 2-4 weeks after ICU discharge; DESCRIPTION: Overall impact of ICU experience for caregivers as measured by the Impact of Events Scale-Revised. Minimum Score = 0; Maximum Score = 88. Higher score indicates great impact of life event.; >; SECONDARY OUTCOME 13: MEASURE: Influence of ICU-CARE on Distal Caregiving Outcomes - Patient Agitation; TIME_FRAME: Once every 24 hours from the date the patient is enrolled in the trial to the date the patient is discharged from the ICU, an average of 2 weeks.; DESCRIPTION: Nurse documentation of patient agitation in the electronic health record; >; SECONDARY OUTCOME 14: MEASURE: Influence of ICU-CARE on Distal Caregiving Outcomes - Patient Pain; TIME_FRAME: Once every 24 hours from the date the patient is enrolled in the trial to the date the patient is discharged from the ICU, an average of 2 weeks.; DESCRIPTION: Nurse documentation of patient pain in the electronic health record; >; SECONDARY OUTCOME 15: MEASURE: Influence of ICU-CARE on Distal Caregiving Outcomes - Duration of Ventilation; TIME_FRAME: Once every 24 hours from the date the patient is enrolled in the trial to the date the patient is discharged from the ICU, an average of 2 weeks.; DESCRIPTION: Duration of mechanical ventilation; >; SECONDARY OUTCOME 16: MEASURE: Influence of ICU-CARE on Distal Caregiving Outcomes - Sedative Exposure; TIME_FRAME: Through study completion, estimated 3 years.; DESCRIPTION: Sedative exposure (sedation intensity and sedation frequency); >;

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

The primary objective of this phase IIb/III, prospective, randomized clinical trial is to compare the efficacy of irreversible electroporation (IRE) with stereotactic body radiotherapy (SBRT) in patients with perivascular or peribiliary colorectal liver metastases (CRLM), that are not amenable for surgical resection or thermal ablation. Efficacy is assessed in terms of local control at 2 years.

INTERVENTION 1: <TYPE: Procedure; NAME: Irreversible electroporation; DESCRIPTION: Percutaneous (CT-guided) irreversible electroporation of 1-3 perivascular and peribiliary colorectal liver metastasis., >; INTERVENTION 2: <TYPE: Radiation; NAME: Stereotactic body radiotherapy; DESCRIPTION: Stereotactic body radiotherapy (CT- or MRI-guided) of 1-3 perivascular and peribiliary colorectal liver metastases., >;

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 the study is to estimate what effect 4 different doses of AZD3355 will have on the number of reflux episodes, in patients who have GERD and still experience symptoms despite proton pump inhibitor (PPI) treatment.

PRIMARY OUTCOME: <MEASURE: Total Number of Reflux Episodes During 24 Hours; TIME_FRAME: Measured during 24 hours at 4 different visits with a 7-28 days interval between; DESCRIPTION: Number of reflux episodes assessed during ambulatory impedance-pH recording (defined as starting with a drop in impedance to below 50% of baseline and ending when impedance recovers to above 50% of baseline); > SECONDARY OUTCOME 1: MEASURE: Number of Acid Reflux Episodes; TIME_FRAME: Measured during 24 hours at 4 different visits with a 7-28 days interval between; DESCRIPTION: Number of reflux episodes as defined for the primary outcome measure with an intraesophageal pH <4 (or a drop of at least 1 pH unit if pH is already <4) lasting more than 5 s.; >; SECONDARY OUTCOME 2: MEASURE: Number of Weakly Acidic Reflux Episodes; TIME_FRAME: Measured during 24 hours at 4 different visits with a 7-28 days interval between; DESCRIPTION: Number of reflux episodes as defined for the primary outcome measure with an intraesophageal pH 4.0-6.5 lasting more than 5 s.; >; SECONDARY OUTCOME 3: MEASURE: Number of Weakly Alkaline Reflux Episodes; TIME_FRAME: Measured during 24 hours at 4 different visits with a 7-28 days interval between; DESCRIPTION: Number of reflux episodes as defined for the primary outcome measure with an intraesophageal pH ≥6.5 lasting more than 5 s.; >;

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

This study is a 2-arm randomized controlled trial to evaluate the feasibility, acceptability and preliminary efficacy of an MI-based program for weight loss in young adults.

PRIMARY OUTCOME: <MEASURE: Feasibility; TIME_FRAME: 12 weeks; DESCRIPTION: Primary Aims Include: Primary Aim 1: To determine the feasibility of an MI-based approach to weight loss in young adults. Specifically, to demonstrate that we can: 1) recruit 18-25 year olds into the proposed program, 2) keep them engaged, as evidenced by achieving >80% attendance and >80% completion of tracking / reporting activities, and 3) retain them for assessments, as evidence by achieving >80% retention at 12 and 24 week visits.; > SECONDARY OUTCOME 1: MEASURE: Weight Loss; TIME_FRAME: 12 weeks; DESCRIPTION: To explore whether the MIBWL arm is a viable approach to weight loss in this age group. Specifically, within group, we will examine mean weight change and proportion of participants achieving a clinically significant weight loss (>5%). Although not powered to detect differences, we will also explore differences in mean weight change between the MIBWL and BBWL groups.; >;

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

Background Premature ventricular contraction (PVC), also known as premature ventricular beat, is one of the most common symptomatic arrhythmias in clinical practice. PVCs may cause serious harm to patients as follow: 1. PVCs with considerable load can increase the incidence of cardiomyopathy; 2. Some recurrent malignant arrhythmias, such as ventricular tachycardia and ventricular fibrillation, can be induced by PVCs; 3. cardiac resynchronization therapy-pacing/defibrillator non-responders may be due to frequent PVCs, which reduce the proportion of biventricular pacing; 4. For structural heart disease patients, PVCs may make their damaged heart function further deteriorated. At present, the clinical treatment of PVCs is still based on drugs, such as beta-blockers, mexiletine, propafenone, etc., and their effectiveness varies greatly among individuals. The status of catheter ablation in the treatment of ventricular premature beats continuous improvement, but this is an invasive operation and relatively expensive, which limits its wide application in clinical practice. Recent studies have shown that the autonomic nervous system plays an important role in the occurrence and maintenance of ventricular arrhythmia. Relevant studies have confirmed that the onset of ventricular arrhythmia is related to sympathetic nerve excitement. Moreover, inhibiting sympathetic nerve activity, including anesthesia, sympathetic nerve block, sympathetic nerve denervation, etc., can effectively reduce the onset and burden of ventricular arrhythmia. On the other hand, in patients with myocardial ischemia-related ventricular arrhythmia, atrial arrhythmia, and heart failure, the safety and effectiveness of the treatment of vagus nerve stimulation have also been verified. Low-level tragus stimulation (LLTS) is an emerging method of regulating autonomic nerves. Functional cardiac magnetic resonance studies have confirmed that by stimulating the auricle branch of the vagus nerve distributed in the tragus of the outer ear, the central projection of the vagus nerve in the brainstem and other higher centers can be activated. It is worth noting that LLTS has been used in clinical practice to treat tinnitus and epilepsy. Moreover, recent studies have confirmed that LLTS can reduce sympathetic nerve activity, inhibit inflammatory factors, and reduce the atrial fibrillation burden in patients with paroxysmal atrial fibrillation. Aim of the Study The current trial is designed to explore the effect of low-level tragus stimulation in patients with frequent premature ventricular contractions. Study Design This is a randomized, prospective, parallel, single-blind multicenter design. The enrollment target for this investigation is 100 patients. Patients are randomized in a 1:1 fashion into one of the investigation arms: active and sham LLTS group. Active LLTSs are performed using a transcutaneous vagus nerve stimulation device (Parasym device, Parasym Health, London, United Kingdom) with an ear clip attached to the tragus of the right ear. In the sham group, the clips are attached to the ear lobe and regarded as effectless to vagus nerve. At baseline, 3 months, and 6 months, patients underwent noninvasive continuous ECG monitoring for 10 days to evaluate their PVC burden (defined as the percentage of premature ventricular beats in total heart beats) using an adhesive continuous ECG patch. Heart rate variability, quality of life, skin sympathetic nerve activity and serum cytokine measurement are evaluated at baseline and follow-up.

Inclusion Criteria: - Age >18, <80 of age - Symptomatic PVCs refractory to ≥1 antiarrhythmic drugs (including β-blockers and calcium-channel blockers). - PVC burden ≥ 10%, with or without prior ablation - Arrhythmias originated from any focus (foci) in the right ventricular or left ventricular. Exclusion Criteria: - Left ventricular ejection fraction (LVEF) < 45% unless proven to be PVC-mediated cardiomyopathy (history of improving LVEF by >15% when PVC burden was reduced by pharmacological agents or ablation) - EF continues to decrease in the past 4 months regardless of the etiology - Unwilling to continue current pharmacological therapy during the study period - Severe heart failure with New York Heart Association Class ≥ III - Ventricular arrhythmias attributed to underlying structural heart disease, known myocardial scar or myocarditis - Change of anti-arrhythmic drug dosing, including β-blockers and calcium channel blockers, within 2 months prior to enrollment - < 3 months after prior unsuccessful ablation: - Patients on amiodarone - Patients with known thyroid issues, on renal-dialysis - life expectancy of < 12 months - Sustained ventricular tachycardia

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

Pegaspargase is the cornor stone for the treatment of ENKTCL, and gemcitabine has been shown to be active in ENKTCL. For several patients with relapsed/refractory or advance ENKTCL, hemophagocytic sysdrome (HPS) occurs, and the prognosis is very poor. Studies have found that etoposide and dexamethasone may be effective in controlling HPS. Thus, this study aims to evaluate the role of gemcitabine, pegaspargase, etoposide, and dexamethasone (GPED) in the treatment of relapsed/refractory or advance ENKTCL, wishing to improve the prognosis for these patients.

The purpose of this study is to evaluate the efficacy and safety of gemcitabine, pegaspargase, etoposide, and dexamethasone (GPED) in the treatment of Relapsed/Refractory or advanced NK/T-cell lymphoma patients (ENKTCL).

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

The duration of the study per participant was approximately 2 years. Each participant was treated until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment, and each participant was followed after completion of study treatment until death, study cut-off date, or withdrawal of participant consent.

Inclusion criteria : Histologically confirmed prostate adenocarcinoma. - Metastatic disease. - Effective castration with serum testosterone levels less than (<)0.5 ng/mL. If the participant has been treated with Luteinizing hormone-releasing hormone agonist (LHRH) agonists or antagonist (i.e., without orchiectomy), then this therapy should be continued. - Progressive disease defined by at least one of the following: - Progression in measurable disease (RECIST 1.1 criteria). - Appearance of 2 or more new bone lesions (PCWG2). - Rising Prostate Specific Antigen (PSA) (PCWG2). - Having received prior docetaxel for at least 3 cycles (before or after an AR-targeted therapy). Docetaxel administration in combination with androgen deprivation therapy (ADT) in metastatic hormone-sensitive disease was considered a prior exposure. Docetaxel rechallenge was allowed. - Having progressive disease (PD) while receiving AR-targeted therapy with abiraterone acetate or enzalutamide within 12 months of AR treatment initiation (<=12 months), even if treatment duration was longer than 12 months. Participants treated with Abiraterone Acetate + ADT in metastatic hormone-sensitive setting were eligible in the study if they have progressed within 12 months with the AR-targeted agent. Participants having PSA progression only (as per PCWG2) within 12 months were eligible. - A PSA value of at least 2 ng/mL was required at study entry. - Prior AR-targeted therapy (abiraterone acetate or enzalutamide) must be stopped at least 2 weeks before study treatment. - Signed informed consent. Exclusion criteria: - Prior chemotherapy other than docetaxel for prostate cancer, except estramustine and except adjuvant/neoadjuvant treatment completed >3 years ago. - Less than 28 days elapsed from prior treatment with chemotherapy, immunotherapy, radiotherapy, or surgery to the time of randomization. - Adverse events (excluding alopecia and those listed in the specific exclusion criteria) from any prior anticancer therapy of Grade >1 (National Cancer Institute Common Terminology Criteria [NCI CTCAE] v4.0) at the time of randomization. - Eastern Cooperative Oncology Group performance status (ECOG PS) >2 (ECOG 2 must be related to prostate cancer, not to other comorbidities). - Prior malignancy. Adequately treated basal cell or squamous cell skin or superficial (pTis, pTa, and pT1) bladder cancer were allowed, as well as any other cancer for which treatment has been completed >=5 years ago and from which the participant has been disease-free for >=5 years. - Participation in another clinical trial and any concurrent treatment with any investigational drug within 30 days prior to randomization. - Acquired immunodeficiency syndrome (AIDS-related illnesses) or known human immunodeficiency virus (HIV) disease requiring antiretroviral treatment. - Participants with reproductive potential who do not agree, in conjunction with their partner, to use accepted and effective method of contraception during the study treatment period and up to 6 months after the last administered dose. The definition of "effective method of contraception" described hereafter: oral contraceptives, combined hormonal intravaginal, transdermal, intra uterine device or condoms was based on respective study treatment labelling and country-specific regulatory requirements, and were documented in the Informed Consent Form. - Known allergies, hypersensitivity or intolerance to prednisone or excipients of abiraterone acetate, enzalutamide, docetaxel, or polysorbate 80. - Known history of mineralocorticoid excess or deficiency. - History of seizure, underlying brain injury with loss of consciousness, transient ischemic attack within the past 12 months, cerebral vascular accident, brain arteriovenous malformation, brain metastases, or the use of concomitant medications that may lower the seizure threshold. - Unable to swallow a whole tablet or capsule. - Inadequate organ and bone marrow function as evidenced by: - Hemoglobin <10.0 g/dL; - Absolute neutrophil count <1.5 * 10^9/L; - Platelet count <100 * 10^9/L; - Aspartate aminotransferase/serum glutamic oxaloacetic transaminase and/or alanine aminotransferase/serum glutamic pyruvic transaminase >1.5 * the upper limit of normal (ULN); - Total bilirubin >1.0 * ULN; - Potassium <3.5 mmol/L; - Child-Pugh Class C. - Contraindications to the use of corticosteroid treatment. - Symptomatic peripheral neuropathy Grade >=2 (NCI CTCAE v4.0). - Uncontrolled severe illness or medical condition including uncontrolled diabetes mellitus, history of cardiovascular disease (uncontrolled hypertension, arterial thrombotic events in the past 6 months, congestive heart failure, severe or unstable angina pectoris, recent myocardial infarction within the last 6 months, or uncontrolled cardiac arrhythmia). - Concomitant vaccination with yellow fever vaccine. The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

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

Background: Herbal remedies can have the role of prevention and control of bad breath Since in the previous studies, therapeutic and antibacterial effect of green tea and peppermint had been proven .we studied and compared the effects of green tea and peppermint mouthwashes on halitosis. Materials and Methods: This single-blind clinical trial study with cross over design total of 88 volunteer dental students who complained bad breath and had organoleptic score (>= 2) and higher average test scores were enrolled. The students were divided randomly into two groups Green Tea - Peppermint were assigned. Organoleptic test in the baseline, on the 7 day, 14 and 21 measured after rinsing the mouthwashes .As well as the satisfaction of both plants on the last day was considered. Data analysis was performed using tests; Wilcoxon signed rank test, Mann Whithney u, GEE (Generalized Estimating Equation -ordinal logistic regression).

INTERVENTION 1: <TYPE: Other; NAME: mouthwash; DESCRIPTION: mouthwash containing herbal peppermint or green tea, >;

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

Study name: Sacubitril Valsartan in Preventing the Recurrence of Atrial Fibrillation After Ablation in Elderly Hypertensive Patients With Atrial Fibrillation. Medicine: sacubitril/valsartan (100mg) and valsartan (80mg). Rationale: The latest guidelines represent an intensified management approach to reduce or prevent morbidity associated with atrial fibrillation. They provide stronger and more specific recommendations for catheter ablation (CA) use. However, not all patients maintain sinus rhythm after CA and both early and late relapses of AF can occur in many patients. Objective: To evaluate the efficacy and safety of sacubitril/valsartan in preventing atrial fibrillation recurrences after ablation in elderly hypertensive patients with atrial fibrillation. Study design: This is a 12-month prospective, randomized, active-controlled, open-label, multi-center study, with two treatment groups: sacubitril/valsartan (100mg tablet) and valsartan (80mg tablet). Study population: Men or women aged between 65 and 79 years will be screened for hypertension. Eligible patients should be untreated and treated atrial fibrillation patients with clinic systolic/diastolic blood pressure ≥130/80 mmHg, who are going to receive catheter ablation procedure. Patients should have abilities to understand the study requirements and provide informed consent. Randomization and treatment: After screening period by centers, eligible patients will be randomly divided into 2 groups, taking one pill of sacubitril/valsartan (100mg tablet) or valsartan (80mg tablet). Follow up: After meeting the inclusion criteria, there will be 1-week screening period. Clinic blood pressure, ambulatory blood pressure, echocardiography, concomitant medication records and adverse event records will be collected at randomization period. Then patients will be randomly assigned into sacubitril/valsartan group and valsartan group. The treatment will be observed for 12 months. There will be 4 visiting points in the treatment period, which will be the 1st month, 3rd month, 6th month and 12th month. Sample size: A total of 300 patients should be enrolled in total. Timeline: After obtaining the approval of Ethics Committee of Ruijin Hospital, recruitment will start. Patients enrollment and follow-up are expected to be performed from October 2022 to December 2024. Organization: The Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai, China.

Study name: Sacubitril Valsartan in Preventing the Recurrence of Atrial Fibrillation After Ablation in Elderly Hypertensive Patients With Atrial Fibrillation. Medicine: sacubitril/valsartan (100mg) and valsartan (80mg). Rationale: The latest guidelines represent an intensified management approach to reduce or prevent morbidity associated with atrial fibrillation. They provide stronger and more specific recommendations for catheter ablation (CA) use. However, not all patients maintain sinus rhythm after CA and both early and late relapses of AF can occur in many patients. Objective: To evaluate the efficacy and safety of sacubitril/valsartan in preventing atrial fibrillation recurrences after ablation in elderly hypertensive patients with atrial fibrillation. Study design: This is a 12-month prospective, randomized, active-controlled, open-label, multi-center study, with two treatment groups: sacubitril/valsartan (100mg tablet) and valsartan (80mg tablet). Study population: Men or women aged between 65 and 79 years will be screened for hypertension. Eligible patients should be untreated and treated atrial fibrillation patients with clinic systolic/diastolic blood pressure ≥130/80 mmHg, who are going to receive catheter ablation procedure. Patients should have abilities to understand the study requirements and provide informed consent. Randomization and treatment: After screening period by centers, eligible patients will be randomly divided into 2 groups, taking one pill of sacubitril/valsartan (100mg tablet) or valsartan (80mg tablet). Follow-up: After meeting the inclusion criteria, there will be 1-week screening period. Clinic blood pressure, ambulatory blood pressure, echocardiography, concomitant medication records and adverse event records will be collected at randomization period. Then patients will be randomly assigned into sacubitril/valsartan group and valsartan group. The treatment will be observed for 12 months. There will be 4 visiting points in the treatment period, which will be the 1st month, 3rd month, 6th month and 12th month. Sample size: A total of 300 patients should be enrolled in total. Timeline: After obtaining the approval of Ethics Committee of Ruijin Hospital, recruitment will start. Patients enrollment and follow-up are expected to be performed from October 2022 to December 2024.

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

Critically ill patients receiving mechanical ventilation (MV) in the Intensive Care Unit (ICU) have been reported to suffer due to their sense of dependency on technical medical equipment and from severe emotional responses such as hopelessness, anxiety, high levels of frustration and stress. The administration of sedatives is intended to reduce and/or prevent these negative experiences and to facilitate nursing care. Dexmedetomidine is a highly selective α2 receptor agonist with 1600-fold affinity to α1 receptor. The use of dexmedetomidine before anesthesia has a positive effect on hemodynamic stability, which has been associated with reduced postoperative mortality and reduction of unpleasant postoperative complications . Dexmedetomidine has been shown to provide good patient comfort during MV; it also has a satisfactory safety profile and reduces time to extubating. Salivary alpha amylase (SAA) will be considered as a suitable biomarker of sympathetic nervous system activity in recent years. SAA is locally produced by the highly differentiated epithelial acinar cells of the exocrine salivary glands, mostly of the parotid glands and plays an important role in carbohydrate hydrolysis.

Inclusion Criteria: - Age 18 to 65 years old. - Both sexes. - Newly mechanically ventilated. Exclusion Criteria: - Patients who used inhaled steroids. - Patients who used any medication that could affect salivary glands (such as antihypertensive, antidepressants or antipsychotic drugs). - Those with smoking and drinking habits. - Patients on adrenoreceptor agonist or antagonist therapy. - Pregnant female. - Known hypersensitivity to the study drugs. - Women using oral contraceptive or were in their menstrual cycle.

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: - Known diagnosis of histologically-confirmed diagnosis of BE with either no dysplasia, indefinite for dysplasia or low-grade dysplasia as defined by the presence of specialized columnar epithelium on histology and >= 2 cm of involvement on endoscopy - Adequate Barrett's mucosa, which is defined as >= 1 out of 4 research samples (i.e. >= 25 %) with >= 50% intestinal metaplasia in biopsies required to satisfy the endpoints of the study - Participants are on proton pump inhibitors (PPI) therapy for >= 1 month duration - Age >= of 18 years. Because no dosing or adverse event (AE) data are currently available on the use of OCA in participants < 18 years of age, children are excluded from this study but will be eligible for future pediatric trials, if applicable - Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%) - Hemoglobin >= 10g/dL - Leukocyte count >= 3,500/microliter - Platelet count >= 100,000/microliter - Absolute neutrophil count >= 1,500/microliter - Creatinine clearance (calculated if measured is not available) >= 30mL/min/1.73m^2 - Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 1.5 X institutional upper limit of normal (ULN) - Total bilirubin =< 1.0 X ULN - Alkaline phosphatase =<1.5 X ULN - Gamma-glutamyl transferase (GGT) =< 1.5 X ULN - The effects of OCA on the developing human fetus are unknown. For this reason, all men and women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, throughout the duration of study participation, and for at least 6 months after receiving the last dose of study drug. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately - Ability to understand the study procedures, benefits and risks, and sign a written informed consent document. Non-English speaking participants are allowed to enroll even if they skip answering quality-of-life (QOL) questionnaires. Special efforts will be made through community advisory boards at participating sites to reach Spanish speaking participants - Willing to undergo testing for human immunodeficiency virus (HIV) testing if not tested within the past 6 months - Willing to undergo hepatitis B and C screening - Willing and able to adhere to the prohibitions and restrictions specified in the approved protocol - Willingness to moderate alcohol intake (consuming no more than 1 or 2 alcoholic drinks per day for women and men, respectively) - Participants must have no evidence of active or recurrent invasive cancer for 6 months prior to screening and must be at least 6 months from any prior cancer-directed treatment (such as surgical resection, chemotherapy, immunotherapy, hormonal therapy or radiation) Exclusion Criteria: - History of prior ablative therapy such as radiofrequency ablation, cryotherapy or argon plasma coagulation (APC) in BE segment - Prior use of OCA - Prior history or presence of high-grade disease (HGD) or cancer on pre-intervention endoscopy - Cutaneous diseases manifesting with severe pruritus - Individuals with active, known or suspected chronic liver disease including cirrhosis, nonalcoholic steatohepatitis (NASH) with fibrosis or cirrhosis, primary sclerosing cholangitis, biliary atresia - Individuals with cholelithiasis or choledocholithiasis; acute cholecystitis (defined by a syndrome of right upper quadrant pain, fever, and leukocytosis associated with gallbladder inflammation diagnosed within the prior 6 weeks) or biliary obstruction (defined by extrahepatic cholestasis) - Individuals with a history of pancreatitis or pancreatic abnormalities - Individuals with hepatic steatosis and velocity > 1.7 as determined by liver ultrasound elastography - Individuals with hyperlipidemia not well controlled with the use of pharmacotherapy and/or dietary modifications - History of severe, progressive, or uncontrolled renal, genitourinary, hepatic, hematologic, endocrine, cardiac, vascular, pulmonary, rheumatologic, neurologic, psychiatric, or metabolic disturbances, or signs and symptoms thereof - Known hypersensitivity, allergies, or intolerance to the study drug or compounds of similar chemical or biologic composition - Any serious and/or unstable pre-existing medical disorder (aside from malignancy exception above), psychiatric disorder, or other conditions that could interfere with participant's safety, obtaining informed consent, or compliance to the study procedures - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements - Individuals with active and untreated hepatitis C virus (HCV) and/or or hepatitis B virus (HBV) infection - Individuals with HIV infection are eligible for participation if: - CD4+ count >= 300/uL - Viral load is undetectable - Receiving highly active antiretroviral therapy (HAART) without known or suspected drug interactions with OCA - Consultation with the participant's infectious disease specialist may be obtained - Pregnant, breast-feeding, or women of childbearing potential unwilling to use a reliable contraceptive method. Pregnant women are excluded from this study because OCA is an agent with unknown effects on the developing human fetus. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with OCA, breastfeeding should be discontinued if the mother is treated with OCA - Individuals taking the drugs listed below may not be randomized unless they are willing to stop the medications (and possibly change to alternative non-excluded medications to treat the same conditions) no less than 5 half-lives days prior to starting OCA or placebo on this study. Consultation with the participant's primary care provider may be obtained but is not required. - The use of the following drugs or drug classes is prohibited during OCA/placebo treatment - Investigational agents; - Bile acid sequestrants (bile acid binding resins): cholestyramine, colestipol, or colesevelam; - Bile salt efflux pump (BSEP) inhibitors; - Clozapine; - Theophylline derivatives; - Tizanidine; - Warfarin; - Hepatotoxic drugs such as amiodarone, sodium valproate, certain herbal/dietary supplements, and long-term doxycycline or tetracycline - Participants may not be receiving any other investigational agents

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

Blood loss in hepatic surgery is the main factor of postoperative morbidity. The use of the most effective possible tool for hemostasis allows a bleeding decrease during liver transection and thus could reduce postoperative morbidity. In the past decade, the improvement of techniques of transection of the hepatic parenchyma was one of the most important factors to ensure the hepatectomy safety. But the clinical performances of these technological innovations (ultrasound dissectors, monopolar radiofrequency probes and dissection devices using pressurized water) remain still unclear. The medical device of hemostasis Aquamantys® (Salient company, Innopath) use the technology of "transcollation" combining a source of radiofrequency associated with a conductive liquid (NaCl 0.9% solution). The system consists of a specific generator (Aquamantys Pump Generator®) and single-use probes (Aquamantys 2.3 BipolarSealer®). The energy of radiofrequency is delivered by two bipolar electrodes. The innovative aspect of this device consists in maintaining the tissue to a temperature of 100°C, while using a conductive liquid which acts as process of cooling and avoids the drying out of tissues, smoke, risks of electric arc and overheating met with conventional electrosurgery. This device allows the coagulation of blood vessels but also bile ducts. The Aquamantys® system could decrease the postoperative morbidity and mortality due to a decrease of blood loss and biliary leak. These clinical benefits could be translated by an improvement of the direct and indirect costs associated to the surgery. However the Aquamantys® technology has not been scientifically validated in the context of the hepatic surgery, and this technology is expensive due to the purchase of single-use bipolar probes (Aquamantys 2.3 BipolarSealer®) and to the investment in a generator (Aquamantys Pump Generator®). Consequently, it is essential to realize a study measuring the clinical and medical economic impact of the transcollation technology (Aquamantys® device) in the hepatic surgery.

INTERVENTION 1: <TYPE: Device; NAME: standard bipolar coagulation; >; INTERVENTION 2: <TYPE: Device; NAME: Aquamantys® probe for liver hemostasis; >;