cyrilzakka/clinical-trials huggingface dataset:
BREATHE ALD: A Shared Decision-Making Intervention for Adults With Advanced Lung Disease

This study aims to:

1. Develop the BREATHE-ALD intervention for adults with Advanced Lung Disease, multiple chronic conditions, and palliative care needs and their caregivers using interviews with 10 advanced lung disease (ALD) adults and their caregivers
2. To evaluate the feasibility and acceptability of intervention procedures; and
3. To explore intervention effects on ALD outcomes

This study addresses the important problem of adults with symptomatic advanced lung disease (ALD) who are at high risk for poor outcomes. Palliative care (PCare) improves the quality of life of individuals and their caregivers through the prevention and relief of suffering by identifying, assessing and treating the physical, psychosocial and spiritual problems associated with life-threatening illness. However, pulmonary clinicians rarely refer adults with ALD to PCare because of time demands, a lack of confidence in PCare and the perceived threat PCare poses to the relationship they have established with the ALD adult. Therefore, we are developing BREATHE-ALD (BRief intervention to Enhance Adherence to Treatment and HEalth advice in Advanced Lung Disease \[ALD\]), a novel shared decision-making (SDM) intervention to improve outcomes for adults with ALD.

The study includes two phases: (1) a development phase to develop BREATHE-ALD using interviews with 10 ALD adults and their caregivers with expert review to adapt BREATHE, and (2) a pilot validation phase conducting a pilot trial in which 10 adults with ALD receive BREATHE-ALD. We will follow adults with ALD for 3 months post-intervention to assess the impact of BREATHE-ALD on self-management and patient outcomes.

Eligibility Criteria:
Pre-trial

Inclusion Criteria:

* Patient participants with symptomatic advanced lung disease (ALD) followed at Weill Cornell Medicine (WCM).
* Caregiver participants who care for adults with symptomatic ALD followed at Weill Cornell Medicine.

Exclusion Criteria:

* Patients that have serious mental health conditions that preclude completion of study procedures or confound analyses.
* Caregivers that have serious mental health conditions that preclude completion of study procedures or confound analyses.

Trial

Inclusion Criteria:

* Patient participants with symptomatic advanced lung disease (ALD) followed at Weill Cornell Medicine (WCM).
* Nurse practitioner must manage a panel of adult ALD patients.

Exclusion Criteria:

* Patients that have serious mental health conditions that preclude completion of study procedures or confound analyses.
* Patients anticipated to have less than 3-month survival.
The Effect of Kinesiology Tape Application on Functional Level and Respiratory Function in Intensive Care Unit Patients

Investigation of the effects of respiratory muscles on the early functional system and respiratory function in the kinesiological period in intensive care patients.

Weakness of respiratory muscles delays weaning from the ventilator, prolongs hospital stay and increases treatment costs. Conventional treatments for respiratory muscles reverse these negative effects. Kinesiology taping has effects that support the muscle to which it is applied, increase circulation and improve its function. Studies have shown positive effects of kinesiology taping applied to COPD patients, and in light of this, it has been predicted that its application to intensive care patients will be beneficial. The results of our study will shed light on the rehabilitation of patients in intensive care and contribute to the literature.

In this study, the investigators aimed to increase the activation of respiratory muscles by taking advantage of the benefits of kinesiology taping in addition to conventional treatment.

Our study, which included a total of 48 participants will consist of 4 groups. Only conventional treatment will be applied to the 1st group, diaphragmatic kinesiology taping will be applied to the 2nd group in addition to conventional treatment, kinesiological taping to the accessory respiratory muscles will be applied to the 3rd group and sham taping will be applied to the 4th group.

Eligibility Criteria:
Inclusion Criteria:

* Individuals receiving inpatient treatment in intensive care who volunteer to participate in the research or who are allowed by their first-degree relatives if they are unconscious,
* Being over 18 years of age
* Being eligible to receive physiotherapy and rehabilitation from an intensive care physician
* Are in clinically stable condition

Exclusion Criteria:

* Patients with coagulation disorders (PT (Prothrombin Time); INR (International Normalized Ratio) value higher than 1.5 and platelet amount less than 50,000 m³)
* Patients with signs of increased intracranial pressure
* Skin wounds, ulcerations, allergic reactions
* Patients in contact isolation due to infection
* In shock
* Having malignancy
* Having multiple organ failure
* Having visual impairment
* Patients who are unconscious
The Effects of External Counter Pulsation Therapy on Circulating Endothelial Progenitor Cells

The objectives of the study are to test the hypothesis that external counter pulsation therapy (ECPT) provides clinical benefit by improving the number and function of endothelial progenitor cells (EPCs) in peripheral blood of patients with angina pectoris.

ECPT is a non-invasive approach for increasing blood flow to the heart in patients with myocardial ischemia. ECPT produces beneficial effects in coronary artery disease (CAD) patients. However, the exact mechanisms of ECPT action are not defined yet. Evidence has now accumulated that bone marrow-derived cells with angiogenic capability, termed EPCs, circulate in the blood of adults. EPCs possess the ability to home to sites of ischemia and contribute to neoangiogenesis.

We prospectively study CAD patients \[Canadian Cardiovascular Society (CCS) angina class II-IV\], before and after ECPT , and compare them with age- and sex-matched controls. Peripheral blood CD34+ cells, EPCs (CD34/VEGFR2+ cells), EPC colony forming units (CFUs) and brachial artery endothelial function is assessed prior to and after ECPT. Percent improvement in endothelium-dependent brachial artery flow-mediated dilatation (%FMD) is assessed using high-resolution ultrasound.

Eligibility Criteria:
Inclusion Criteria:

* coronary artery disease
* CCS angina class II-IV

Exclusion Criteria:

* aortic regurgitation
* acute myocardial infarction \<3 months
* systemic hypertension \>180/110 mm
* atrial fibrillation
* deep vein thrombosis
* phlebitis and hemorrhagic diathesis
* pregnancy
* abdominal aortic aneurism
* metastatic tumor
Bladder Suture in Uterus-Sparing Surgery and Hysterectomy for Placenta Percreta

This study aimed to evaluate the short-term and long-term complications of placenta percreta with bladder invasion. This evaluation focuses on cases where bladder dissection and ACAR-style bladder sutures were applied in cases of placenta percreta with bladder invasion that underwent uterine-sparing surgery or hysterectomy.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women
* Clinical diagnosis of PAS
* PAS with bladder invasion

Exclusion Criteria:

* Cases with incomplete or inadequate medical records
* Cases with other types of placental invasion (e.g., placenta accreta, placenta increta),
* Cases with missing key data points.
A Short Term Evaluation of a Structured Weight Loss Plan in Overweight and Obese Adults

The present study is designed to examine the effect of changes in body weight and related parameters associated with a commercially-available, low-carbohydrate diet plan. A parameter proposed to be studied here is the impact of fructose restriction and weight loss on serum uric acid concentrations and arterial stiffness.

It is well know that consumption of a calorically-restricted diet helps people lose weight. Such a diet with low carbohydrate lowers the serum uric acid concentration which is a factor associated with obesity and also represents a particular metabolic risk in women compared to men. The present weight loss study will determine whether women benefit more than men to short-term weight loss occurring during restriction of simple sugars.

Specifically, this study is designed to cause weight loss acutely through consumption of a diet that is restricted in calorie and simple sugars. Both men and women will be studied and their results compared to determine whether women benefit more with respect to arterial stiffness. Upon finishing the four-week diet intervention, body weight and blood lipids will be assessed two and four weeks later to compare the longer term effect on blood pressure.

Eligibility Criteria:
Inclusion Criteria:

1. Men and premenopausal women
2. 30-55 years of age
3. Sedentary lifestyle, defined as less than three sessions of activity per week, or sessions less than 20 minutes per occasion, or less than 5000 steps per day
4. Must be able to speak, read, and write English (due to the small sample size and pilot nature of this study)
5. Overweight/obese subjects with BMI 27.0 - 40.0 kg/m2 and any one of the following characteristics of the metabolic syndrome:

A. Serum HDL cholesterol \<40 mg/dL (1 mmol/L) in men and \<50 mg/dL (1.3 mmol/L) in women B. Blood pressure ≥130/85 mmHg C. Fasting plasma glucose ≥100 mg/dL (5.6 mmol/L) D. Waist circumference in men of \>102 cm (40 in) and in women of \>88 cm (35 in) E. Serum triglycerides (TG) ≥150 mg/dL (1.7 mmol/L).

Exclusion Criteria:

1. Abnormal thyroid function or known liver disease
2. Diabetes or fasting glucose ≥ 125 mg/dL
3. Use of medications that interfere with protein, carbohydrate or lipid metabolism (e.g., fish oil capsules)
4. Occasional or regular tobacco use
5. History of gout
6. Uncontrolled hypertension
7. Pregnant or peri-menopausal
8. Vegetarian food restrictions (the diets consumed contain some meat, eggs and dairy)
9. Alcohol intake: females \> 70 g/wk, males \>140 g/wk
10. Moderate or vigorous-intensity physical activity, defined as more than 150 minutes per week of moderate-intensity, or 75 minutes a week of vigorous-intensity aerobic physical activity, or an equivalent combination of both.
A Study Comparing Drug Availability Of Methylprednisolone In Liquid Form Versus Methylprednisolone In Tablet Form

A new formulation of methylprednisolone is being developed. A study is needed to determine the drug availability using the new formulation, a powder for reconstitution into a suspension, versus the current commercially available tablet formulation in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2;
* a total body weight \>45 kg (99 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease;
* Any condition possibly affecting drug absorption (eg, gastrectomy).
The Study of Automated Telephone Programs for the Maintenance of Dietary Change

The purpose of this study is to test two different approaches to helping individuals who have recently starting eating a healthful diet maintain those healthy changes. This study will deliver a health program using an automated telephone system. The programs will be designed to help individuals maintain a healthy diet change for a lifetime.

RCT is completed. However, the eligibility was 18 y/o or greater and living in Greater Boston area. The participants used an evidenced based dietary intervention for 3 months and then were randomized to 1 of 3 arms. Those in the experimental arm received a 6 mo intervention based on social cognitive theory or goal systems theory. The intervention was designed to help the participants maintain previously achieved changes in the their diet, e.g., fruits and vegetables. The outcome measures are fruit and vegetable consumption as measured by servings on multiple dietary measures as well as a 24 hr dietary recall.

Eligibility Criteria:
Inclusion Criteria:

* Consume fewer than 5 fruits and vegetables per day.
* Understand conversational English
* Have the ability to use a telephone without assistance

Exclusion Criteria:

* Under 18 years of age
* Diagnosis of a health condition for which dietary recommendations in the would be contraindicated,
* Have cognitive impairment
* Have a terminal illness, recent myocardial infarction, current or former diagnosis of an eating disorder, pregnancy
* Consume \> 5 servings of fruit and vegetable per day, or
* Plan to move away from the Boston area in less than 30 months.
Motivational Interviewing for HCV Elimination

This study addresses a difficult barrier to hepatitis C elimination, specifically development and maintenance of a productive relationship between the health care provider and patient to ensure both treatment success and engagement in harm reduction services. Improvements in these domains may be observed through the use of a technique called "Motivational Interviewing" (MI). The aim of this study is to determine whether a customized motivational interviewing curriculum by general primary care and addictions medicine primary care providers changes rates of curative hepatitis C therapy completion.


Eligibility Criteria:
Patient Inclusion Criteria:

* Willingness to participate and provide informed consent
* Positive HCV RNA Result
* ≥18 years of age

Patient Exclusion Criteria:

* Unwilling or unable to provide consent

Health Care Provider Inclusion Criteria:

* Willingness to participate and provide informed consent
* Has a hepatitis C care experience

Health Care Provider Exclusion Criteria:

* Unwilling or unable to provide consent
Safety and Efficacy in Adult Subjects With Acute Migraines

The purpose of this study is to compare the efficacy of BHV-3000 (rimegepant) versus placebo in subjects with Acute Migraines


Eligibility Criteria:
Key Inclusion Criteria:

1. Patient has at least 1 year history of migraines (with or without aura), consistent with a diagnosis according to the International Classification of Headache Disorder, 3rd Edition, Beta version\[1\] including the following:

   * Not more than 8 attacks of moderate or severe intensity per month within last 3 months
   * Consistent migraine headaches of at least 2 migraine headache attacks of moderate or severe intensity in each of the 3 months prior to the Screening Visit and maintains this requirement during the Screening Period
2. Less than 15 days with headache (migraine or non-migraine) per month in each of the 3 months prior to the Screening Visit and maintains this requirement during the Screening Period
3. Patients on prophylactic migraine medication are permitted to remain on therapy provided they have been on a stable dose for at least 3 months prior to study entry.
4. Patients with contraindications for use of triptans may be included provided they meet all other study entry criteria.

Key Exclusion Criteria:

1. Patient history of HIV disease
2. Patient history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. Patients with Myocardial Infarction (MI), Acute Coronary Syndrome (ACS),Percutaneous Coronary Intervention (PCI), cardiac surgery, stroke or transient ischemic attack (TIA) during the 6 months prior to screening.
3. Uncontrolled hypertension (high blood pressure), or uncontrolled diabetes (however patients can be included who have stable hypertension and/or diabetes for 3 months prior to being enrolled)
4. Patient has a current diagnosis of major depression, other pain syndromes, psychiatric conditions (eg, schizophrenia), dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion, might interfere with study assessments
5. Patient has a history of gastric, or small intestinal surgery, or has a disease that causes malabsorption.
6. The patient has a history or current evidence of any significant and/or unstable medical conditions (eg, history of congenital heart disease or arrhythmia, known suspected infection, hepatitisB or C, or cancer) that, in the investigator's opinion, would expose them to undue risk of a significant adverse event (AE) or interfere with assessments of safety or efficacy during the course ofthe trial
7. History of, treatment for, or evidence of, alcohol or drug abuse within the past 12 months or patients who have met DSM-V criteria for any significant substance use disorder within thepast 12 months from the date of the screening visit.
Study to Evaluate the Safety, Tolerability, Drug Levels and Drug Effects of BMS-986331 in Healthy Participants

The purpose of this study is to evaluate the safety, tolerability, drug levels and drug effects of single and multiple oral doses of BMS-986331 versus placebo in healthy participants and healthy Japanese participants.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant deviations in medical history, physical examination, ECGs, vital signs, and clinical laboratory determinations
* A body mass index of 18 - 32 kg/m2, inclusive
* Women and men must agree to follow specific methods of contraception, if applicable

For J-MAD Part 3

* Must be Japanese (both biological parents are ethnically Japanese)

Exclusion Criteria:

* Women who are of childbearing potential
* Women who are pregnant or breastfeeding
* Any significant acute or chronic medical illness
* Current or recent (within 3 months of study drug administration) gastrointestinal disease that could impact upon the absorption of study drug
* Any surgery within 12 weeks of study drug administration

Other protocol-defined inclusion/exclusion criteria apply
Demonstration of the Medical Interest of the VisioCyt® Artificial Intelligence Test

European, multicenter clinical trial with VisioCyt®, an in vitro diagnostic medical device. VisioCyt® is an innovative solution for the early diagnosis of bladder cancer.

VisioCyt® is based on a patented technology, combining bright-field imaging and artificial intelligence, from a simple urine sample from which the cells are extracted .

The main objective of the study is to demonstrate the medical superiority of the VisioCyt® test versus conventional cytology for detecting recurrence of bladder tumors, in patients monitoring non-muscle infiltrating bladder tumors at high and very high risk of progression

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old and autonomous
* Patient understanding national language well and able to understand the protocol.
* Patient information and informed consent signature before the start of the study
* Patients under surveillance of Non-muscle invasive bladder cancer (NMIBC) at high and very high risk of progression, whatever the stage on the basis of a histological result. The diagnosis (primary or recurrence) should be less than or equal to 24 months (the last histology result confirming a bladder cancer with high or very high risk of recurrence is taken into account).

Exclusion Criteria:

* Patients who have had total bladder resection or bladder reconstruction
* Age \<18 years old
* Person deprived of liberty or under guardianship (including curatorship)
* Bladder cancer outside of urothelial carcinoma
* Associated high urinary tract carcinoma
* Kidney transplant patient (BK virus)
* Pelvic radiotherapy patient (prostate cancer)
* Patients with or under surveillance of a muscle-infiltrating bladder tumor
Clinical, Morphological and Functional Aspects in Myocarditis.

Cardiac magnetic resonance (CMR) is accurate to identify acute myocardial damage (edema, hyperemia, and/or fibrosis) due to acute myocarditis (AM). Recently, two-dimensional strain echocardiography was also validated in order to provide important information on myocardial dysfunction in patients with AM, even if no wall motion abnormalities are detected. No data are available about incidence of longitudinal myocardial dysfunction and its prognostic role in AM.

In this study, the investigators will analyze the effect of acute myocarditis-induced damage on LV myocardial deformation and remodeling both in the acute myocarditis phase and follow-up period (about 2 years later). The investigators will use a combined approach including strain echocardiography to asses left ventricular myocardial deformation and late gadolinium enhancement (LGE)cardiac magnetic resonance for the assessment of left ventricular damage.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of clinical suspected acute myocarditis (AM)
* diagnosis of AM with cardiac magnetic resonance (CMR) according to Lake Louise criteria (myocardial edema, hyperemia, and LGE).
* absence of coronary artery diseases confirmed by coronary angiography or computed tomography in all patients with the exception of those younger than 30 years with a low risk of coronary artery disease.

Exclusion Criteria:

* Previous heart diseases
Efficacy and Safety of Quadruple Therapy in Eradication of H. Pylori: A Comparison to Triple Therapy

This study aims at evaluating efficacy and safety of quadruple therapy (bismuth, metronidazole, tetracycline and omeprazole: OBMT) vs triple therapy (amoxicillin, clarithromycin and omeprazole: OAC) in H. Pylori eradication. It is hypothesized that quadruple therapy will be comparable in efficacy to triple therapy. Subjects with confirmed H. pylori positive status will be randomized to one of the treatments described above. At week 6 and 10 follow-up visits, a urea breath test (UBT) will be performed to confirm eradication.

The study will include three phases: screening, treatment and follow-up. Screening: this phase will last a maximum of 30 days and subjects eligibility will be evaluated after informed consent signature. Endoscopy and Urea Breath test will be performed in addition to the baseline routine evaluations.

Treatment: Subjects assigned to OAC will be treated for 7 days. Those assigned to Pylera will be treated for 10 days. A randomization visit will take place on Day 0 and an end-of-treatment visit will take place between day 8 and 14.

Follow-up: includes two visits. approximately one and two months post-treatment. Eradication of H. Pylori will be confirmed through UBT, and resistance will be evaluated in case of treatment failure. These subjects will undergo an endoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Positive H. Pylori status;
* Presence of upper gastro-intestinal symptoms;
* Mental and legal ability to sign informed consent.

Exclusion Criteria:

* Previous surgery of the GI tract;
* Clinically significant impairment of renal or hepatic function;
* Severe unstable cardiovascular, pulmonary or endocrine disease;
* Barrett's oesophagus or high-grade dysplasia;
* Dysphagia or vomiting as major symptoms.