cyrilzakka/clinical-trials huggingface dataset:
Preliminary Efficacy of Different Exercise Training During Immunotherapy in Patients With Lung Cancer: The ENHANCE Trial

The purpose of this study is to examine the feasibility and effects of 12-week exercise training at different intensities among individuals with advanced lung cancer receiving immune checkpoint inhibitors.

The names of the study interventions involved in this study are:

This single-center, two-armed, pilot randomized controlled research study will assess feasibility and compare immune activities, cardiorespiratory fitness, physical function, and immunotherapy-related adverse events, and patient-reported outcomes between three groups - high-intensity exercise, moderate-intensity exercise, and usual care.

Participants in this study will be randomly assigned to one of three groups:

* High-intensity interval training (HIIT)
* Moderate-intensity continuous training (MICT)
* Usual care (UC) The HIIT and the MICT groups will receive virtually supervised home-based exercise training three sessions per week for 12 weeks. The UC group will be asked not to change their baseline exercise behavior and will be offered to receive one of the exercise programs at the end of the initial 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years.
* Histologically diagnosed with advanced non-small cell lung cancer (NSCLC).
* Having been receiving anti-PD-1 or anti-PD-L1 antibodies (i.e., single agent or combination) for at least one month with a plan to continue for at least 12 weeks prospectively at the time of recruitment.
* Medical clearance to perform exercise intervention and testing by their treating oncologist.
* No uncontrolled medical conditions that could be exacerbated with exercise (e.g., uncontrolled hypertension or diabetes).
* Ability to communicate and complete written forms in English.
* Participate in less than or equal to 60 minutes of moderate-to-vigorous aerobic exercise per week over the past month.
* Ability to understand and the willingness to sign informed consent prior to any study-related procedures.
* Willing to travel to DFCI for necessary data collection.

Exclusion Criteria:

* Participate in more than 60 minutes of moderate-to-vigorous aerobic exercise per week over the past month. This study targets insufficiently active persons to assess the effect of the described exercise intervention, where additional exercise done regularly will contaminate the intervention outcomes.
* Unstable comorbidities that prevent participation in moderate-to-vigorous intensity exercise. Patients with unstable comorbidities may develop unexpected adverse events from exercise. For the purpose of patients' safety, as well as because part of this study involves remote, home-based exercise where close supervision is not possible, patients with unstable medical conditions are excluded.
* Subjects who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study.
* Development of second malignancy (except for basal cell carcinoma or squamous cell carcinoma of the skin) that requires concurrent treatment, which would interfere with this study.
Cholesterol and Fatty Acid Synthesis in Islet and Liver Transplant Patients and Effect of Dietary Intervention

The purpose is to investigate possible mechanisms of increased blood lipid levels following transplantation, and also to see if a comprehensive dietary intervention is effective in reducing blood lipid levels in post-transplant patients.

Post-transplantation patients frequently have an increase in blood lipid levels presumed to be due to immunosuppressive agents, however it is currently unknown the mechanisms by which this occurs. Dietary interventions have frequently been unsuccessful in these patients, which may be due to single-nutrient interventions and lack of support and guidance. This research will use stable isotope methods to estimate cholesterol and fatty acid synthesis to determine if these pathways are affected by immunosuppression in patients before and after islet and liver transplant. In addition, it will be determined if a multi-nutrient dietary intervention will be implemented post-transplant can reduce blood lipid levels in to prevent further polypharmacy these patients.

Eligibility Criteria:
Inclusion Criteria:

* on islet or liver transplant list
* post-transplant \>3 months
* physically able to participate in study and intervention

Exclusion Criteria:

* \< 18 years of age
* family history of premature cardiovascular disease or familial hyperlipidemia (control subjects)
* cholestatic diseases (liver transplant patients)
* type 2 diabetes
Dutasteride 0.5mg For The Treatment Of Chinese Patients With Benign Prostatic Hyperplasia (BPH)

This randomized, double-blind, placebo-controlled, six-month parallel-group study assess efficacy and safety of dutasteride 0.5mg once daily in Chinese patients with Benign Prostatic Hyperplasia (BPH) , followed by a 12-month open-label treatment phase


Eligibility Criteria:
Inclusion:

* Clinical diagnosis of BPH
* AUA-SI \>=12 \[American Urological Association Symptom Index\]
* Qmax \> 5ml/sec and \<=15ml/sec and minimum voided volume of \>=125ml
* Prostate volume \>=30cm(3)

Exclusion:

* Post void residual volume \>250ml
* History or evidence of prostate cancer
* Total serum PSA \<1.5ng/ml or \>10.0ng/ml (Prostate specific antigen)
* Previous prostatic surgery or other invasive procedures to treat BPH.
* History of AUR (Acute Urinary Retention) within 3 months
* History of flexible/rigid cystoscopy or other instrumentation of the urethra within 7 days
* Any causes other than BPH, which may in the judgement of the investigator, result in urinary symptoms or changes in flow rate
* History of hepatic impairment or abnormal liver function tests
* Use of any 5a-reductase inhibitors ,any drugs with antiandrogenic properties or other drugs noted for gynaecomastia effects, or could affect prostate volume, within past 6 months and throughout the study
* Use of alpha-receptor blockers within 2 weeks and throughout the study.
* Use of phytotherapy for BPH within 2 weeks and/or predicted to need phytotherapy during the study.
* Concurrent use of anabolic steroids
* Use of any alpha-adrenergic agonists or cholinergics within 48 hours prior to uroflowmetry assessment.
* Hypersensitivity to any 5a-reductase inhibitor or other chemically-related drugs.
* Actively trying to procreate or unwilling to wear a condom during intercourse with a woman of childbearing potential for duration of participation in this study and 16 weeks following treatment.
* History or current evidence of drug or alcohol abuse within the previous 12 months.
* History of any illness that in the opinion of the investigator might confound the results of the study or poses additional risk to the patient.
* Any unstable, serious co-existing medical condition(s) including, but not limited to, myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, of cerebrovascular accident within 6 months prior to Screening visit; uncontrolled diabetes or peptic ulcer disease which is uncontrolled by medical management.
* History of renal insufficiency, or serum creatinine \>1.5xULN (Upper Limit of Normal )
* Participation in any investigational or marketed drug trial within 30 days and during the course of the study.
Early Weight Bearing Tarsometatarsal Fusion Study

A Prospective, Randomized, Controlled Trial Comparing Early Weight Bearing versus Non Weight Bearing Following Modified Lapidus Arthrodesis

The purpose of this prospective randomized control trial is to assess outcomes in patients who undergo modified Lapidus arthrodesis and whose postoperative management includes early weight bearing on heel (in a boot) and compare it to standard of care non weight bearing post operative management.

Eligibility Criteria:
Inclusion Criteria:

* Patient has signed the Institutional Review Board approved informed consent form specific to this study prior to enrollment
* Failure of conservative treatment (i.e. non-surgical action, consisting of footwear modification in the form of shoes with wide toe boxes, padded inserts, activity modifications and pain control medications)
* Patients who underwent Lapidus procedure with or without other procedures of the first ray (i.e., muscle-tendon procedures, distal metatarsal osteotomy, Akin procedure)
* Patient older than 18 years of age
* Patient is able to give informed consent
* Patient is independent, ambulatory, and agrees to comply with all postoperative visits

Exclusion Criteria:

* Patient has a pre-existing condition which may cause impairment of healing and bone fusion
* Any significant pathology that, in the opinion of investigator, makes the patient unsuitable for study
* Patients who underwent Lapidus arthrodesis in conjunction with other procedures that did not focus on the first pedal ray with the exception of harvesting autogenous ipsilateral calcaneal bone graft
Telehealth Integrated Care Model in Patients With Cardiometabolic Disease

The objective of this study is to evaluate the telehealth integrated care model for its clinical efficacy, medical resource utilization, health economics measurement, and satisfaction survey indicators in hyperlipidemia patients and other cardiometabolic diseases. The result of the study will provide evidence for the value of integrated model in the treatment of patients with cardiometabolic syndrome.

Efficacy evaluation is critical for understanding the practical application effect of telehealth integrated mode in the therapy of cardiometabolic disease patients. We can comprehend the influence of the combination of online and offline models on patients' clinical curative effect, medication compliance, medical cost, and satisfaction by analyzing the curative effect and finding a scientific basis for clinical practice and policy formation. As a result, the purpose of this study is to assess the curative effect of hyperlipidemia patients with other cardiometabolic disease using a telehealth integrated model, as well as to investigate the potential benefits and risks of this model in the management of cardiometabolic disease.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 16 years, and ≤ 85 years;
* Diagnosis as hyperlipidemia with at least one of the following disease: hypertension or type 2 diabetes mellitus;
* Agreed to be enrolled in this study.

Exclusion Criteria:

* Undergone percutaneous coronary intervention within one year in our hospital;
* Severe LV dysfunction, such as LV ejection fraction \< 35%, or congestive heart failure with New York Heart Association (NYHA) functional class IV or Killip class IV;
* Structural heart disease, or severe arrhythmia;
* Severe liver or kidney diseases, endocrinology diseases, hematologic diseases, rheumatic immune system diseases, and malignancy;
* could not complete at least one-year-followup.
Immunogenicity and Safety of COVID-19 Vaccine in Cancer Patients

Serum antibody titre against COVID-19 spike protein will be measured before, after the first dose, and after the second dose (when applicable) in cancer patients who are receiving or received anti-cancer drugs. Side effects of vaccination and actual incidence of COVID-19 will be monitored.


Eligibility Criteria:
Inclusion Criteria:

* 20 years of age or older
* Patients who are receiving or received anti-cancer drugs
* Those who are not vaccinated against COVID-19 at the time of enrollment
* Written informed consent

Exclusion Criteria:

* Any contraindications to COVID-19 vaccines
* Those who were already vaccinated
* Those who are on immunosuppressants or infected with HIV
* Those who underwent organ transplantation
* Active infections (for example, pneumonia)
Incidence & Predictors of Mechanical Abnormalities of QuickSite® and QuickFlex® Left Ventricular Pacing Leads

On April 2, 2012 the manufacturer of the Quicksite® and Quickflex® leads, St. Jude Medical, released a voluntary medical device advisory regarding these leads' potential for problems with the silicone insulation covering one end of the lead, where it meets another section of the lead which is coated with a different insulating material (polyurethane). There has been a voluntary suspension of sales of these leads.

There are approximately 179,000 of the above leads implanted worldwide with an estimated 101,000 leads currently in service (59,000 in US). There have been 39 confirmed cases of the conductor portion of the lead becoming exposed from the silicone insulation (externalization), and the rate of occurrence of this type of problem is conservatively estimated at less than one percent. However, a review done by St. Jude Medical of returned Quicksite® and Quickflex® leads and available X-ray and fluoroscopic (x-ray movie) images of patients with these leads (from 1,219 patients) revealed a higher rate of 3-4%. It is presumed that there are patients whose leads have not yet been affected by this problem, but whose leads may show signs of structural changes on x-ray or fluoroscopy. This study seeks to determine what structural changes may be occurring in these leads, what signs might predict these changes, and what impact these changes may have on the lead and its performance.


Eligibility Criteria:
Inclusion Criteria:

* Patient that received Quicksite or Quickflex lead at the University of Kansas Hospital

Exclusion Criteria:

* Not willing to consent to data collection
Influence on Food Liking of Adding Spices to Replace Dietary Sugar

This study aims to reduce the amount of sugar in a particular food item and add spices to see if the food liking of that item rates as high or higher in a post meal survey. Through the weekly feeding and testing of the menu items the investigators will determine an opinion of the participants. Results of these surveys will determine whether participants enjoy the reduced sugar options as much as their full sugar counterparts.

The Investigators will determine the overall consumer acceptability of a breakfast meal (tea and oatmeal) and a dessert (apple crisp) using a randomized, three-period, within subjects, crossover design. The three test conditions will be (1) Full sugar ("FS"), (2) reduced sugar (and calorie) with no added spice ("RS") and (3) reduced sugar (and calorie) plus spice ("RSS"). The two reduced sugar meals will be matched for calories. Subjects will taste each condition of the item on a separate day; tastings will be one week apart.

Eligibility Criteria:
Inclusion Criteria:

* age 18-65 years

Exclusion Criteria:

* diagnosed taste or sensory disorders that would prevent subject from evaluating the food
* known eating disorders
* allergies to the test food/ingredients
* medical conditions that may adversely affect taste (e.g., dysgeusia)
* inability to complete the protocol
* personal dietary restrictions towards test meal items
* dislike of the particular food items to be served in the test meals
* Subjects who do not consume foods or beverages that contain sugar or to which they have added sugar will be excluded.
* Subjects who have not consumed or would not be willing to consume hot tea, oatmeal or baked apple products will be excluded.
* Subjects who are pregnant or trying to become pregnant will be excluded.
The Educational ARDS Diagnosis Study

Without rigorous, high-quality training materials, the results of the LUNG-SAFE study examining the global incidence and outcomes of severe lung failure (acute respiratory distress syndrome \[ARDS\]) could be confused by either under-recognition of patients with, or misclassification of patients without, ARDS. This problem has been previously identified with the use of the prior ARDS definitions, particularly in patients with milder severity of illness. Importantly, the chest x-ray criteria in the ARDS definition has demonstrated only moderate reliability when applied by experts, although this can be improved through the use of training radiographs (as will be used in this educational module). The investigators hypothesize that the training from the educational module will allow more accurate diagnosis of ARDS by data collectors/study coordinators participating in the LUNG-SAFE study.

In this LUNG-SAFE sub-study, the investigators will evaluate the effect of a brief online educational module on correctly identifying patients (i.e., standardized cases) with ARDS according to the Berlin Definition.

The investigators hypothesize that the training from the educational module will allow more accurate diagnosis of ARDS according to the Berlin Definition by participating data collectors/study coordinators.

Data collectors and study coordinators from ICUs participating in LUNG-SAFE would be randomized (by simple random number generator) to one of the following online educational streams:

1. Educational module completion followed by evaluation
2. Evaluation followed by educational module completion

Limited demographic data will be collected from the respondents, along with their responses to the 15 multiple choice test questions. Time spent viewing the educational module will also be collected.

Eligibility Criteria:
Inclusion Criteria:

* Study coordinators/data collectors for the LUNG-SAFE study

Exclusion Criteria:

* No informed consent to participate
MAVRIC VR ICD Registry

The purpose of this registry is to collect information on the health status of patients receiving Marquis/Maximo VR Implantable Cardiac Defibrillators (ICDs), how the devices are being programmed and how this correlates to clinical patient outcome.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age or older
* Patients implanted with a new or replacement Marquis VR or Maximo VR ICD

Exclusion Criteria:

* Patients enrolled in a device study that affects treatment and/or programming
Evaluating the El Camino Program

The goal of this randomized controlled trial is to evaluate the impacts of El Camino, a goal-setting sexual health promotion program targeted toward Latino adolescents. The primary research questions are:

* Research Question 1: Is participation in the El Camino goal setting program associated with greater abstinence (measured as never had sex, no recent sexual activity) relative to a comparison group that did not receive El Camino?
* Research Question 2: Is participation in El Camino associated with reduced unprotected sex (measured as sex without any method of contraception, sex without a condom) for the intervention group relative to the comparison group?

Researchers will compare those who received El Camino to a comparison group who received an alternative program that does not include sexual health components.

As part of the study, participants will be asked to:

* Attend approximately 11 hours of programming completed over 11 weeks
* Complete baseline, post-intervention, and 12-month follow-up surveys
* For select participants who received the El Camino program, participate in an optional focus group discussion


Eligibility Criteria:
Inclusion Criteria:

* High school student in Montgomery County, MD
* Have not previously received El Camino during pilot study
* Have parental consent (if under 18)
* Agree to be in study

Exclusion Criteria:

* Previously participated in pilot study and received El Camino curriculum
* No parental consent (if under 18)
* Do not agree to be in study
Synbiotic Treatment in Crohn's Disease Patients

The purpose of this study is to determine whether administration of a synbiotic, comprised on inulin and a bifidobacterial probiotic will colonise the gut wall and down-regulate TNF-alpha and other pro-inflammatory cytokines in the mucosa of Crohn's patients with active disease to reduce mucosal inflammation and induce remission.

Crohn's disease is one of the two main forms of idiopathic inflammatory bowel disease. The Th1-mediated inflammatory response in Crohn's disease is characterised by increased IL-18 and INF-gamma and especially TNF-alpha, which are formed by lamina propria mononuclear cells. The aim of this investigation is to determine whether a synbiotic comprised of inulin and a bifidobacterial probiotic, that we have previously shown to down-regulate TNF-alpha and other proinflammatory cytokines in the gut mucosa in ulcerative colitis patients with active disease, can colonise the bowel wall, reduce mucosal inflammation and induce remission in Crohn's disease patients with active disease, in a randomised controlled trial. Crohn's disease is associated with high mortality and incurs significant social, commercial and NHS costs. Many patients are refractile to standard treatments, which often have undesirable side effects. An inexpensive, effective and non-toxic treatment based on the synbiotic concept would contribute greatly to relieving the clinical and financial burdens of the disease.

Eligibility Criteria:
Inclusion Criteria:

* Crohn's disease of large bowel (+/- small bowel disease)
* 18-79 years old
* stable doses of medications
* CDAI \>150, \<450

Exclusion Criteria:

* short gut syndrome
* pregnancy
* lactation
* antibiotic therapy in last 3 months
* probiotic therapy in last 1 month
* \<18, \>79 years old
* CDAI \<150 or \>450
* indeterminate colitis, ulcerative colitis
* alterations to medications in last 3 months
Training Effects in Colonoscopy

Colon cancer is the second most common cause of death among cancer-related deaths in Germany. Precancerous lesions such as adenomas can be detected efficiently by colonoscopy. To provide high quality in colonoscopy several quality parameters have been postulated in the past. The adenoma detection rate (ADR) is one of those parameters. Empirical data suggest that a detection rate of 20% should be demanded. Detection rates are influenced by a multitude of circumstances such as bowel cleanness. The facts that detection rates vary between colonoscopists suggests that leaning effects may also play a role. It is not known how ADR and other quality parameters evolve while trainees improve their skills in colonoscopy. The investigators postulate that a learning curve exists. The investigators therefore plan to evaluate chronologically the findings of trainee colonoscopists. A particular performance in detecting adenomas shall be calculated in relation to the amount of examinations performed.


Eligibility Criteria:
Inclusion Criteria:

* colonoscopy performed at the Technical University Munich, Germany

Exclusion Criteria:

* colonoscopy performed for the purpose of polypectomy