cyrilzakka/clinical-trials huggingface dataset:
Aldosterone Antagonism and Microvascular Function

The prevalence of obesity and obesity-related complications is currently taking epidemic proportions. These complications increase the risk of type 2 diabetes and cardiovascular disease, which are important causes of morbidity and mortality worldwide.

It is important to gain insight in the mechanisms underlying obesity-related complications, because this may lead to the development of directed therapeutic strategies.

Currently, there is significant evidence that the cause of both insulin resistance and hypertension must be sought at the level of the microcirculation.

Over activity of the renin-angiotensin-aldosterone system is a potential cause of microvascular dysfunction. Angiotensin II was indeed found to be implicated in the pathogenesis of obesity-associated hypertension and insulin resistance, possibly through interference with the vascular effects of insulin.

Increased aldosterone levels have also been associated with resistant hypertension and insulin resistance, which is illustrated in patients with primary aldosteronism. Furthermore, aldosterone is known to exert several detrimental effects on the vasculature, some of which are offset by mineralocorticoid receptor antagonists.

In obese individuals, plasma aldosterone concentrations are increased as well. We hypothesize that increased aldosterone levels in adipose persons induce microvascular dysfunction, which contributes to the development of insulin resistance and hypertension, and mineralocorticoid receptor antagonism results in improved insulin sensitivity and decreased blood pressure by counteracting the adverse effects of aldosterone on the microvasculature.


Eligibility Criteria:
Inclusion Criteria:

* Age 40-65 years
* Caucasian
* Waist circumference \> 102 cm (men)/\> 88 cm (women)
* Triglycerides \> 1.7 mmol/L
* High-normal blood pressure (office blood pressure: 130/85 - 139/89 mm Hg) or stage I hypertension (office blood pressure: 140/90 mm Hg - 159/99 mm Hg; 24h ABPM: 125/80 - 149/89 mm Hg)

Exclusion Criteria:

* Cardiovascular disease (stroke, coronary artery disease, peripheral vascular disease, congestive heart failure, cardiac shunts, cardiac surgery, pulmonary hypertension, cardiac arrhythmias, family history of cardiac arrhythmias or sudden cardiac death)
* Diabetes mellitus/impaired glucose metabolism (fasting glucose values \> 5.6 mmol/L)
* Grade 2 or 3 hypertension (office blood pressure: \> 160/100 mm Hg; ABPM \> 150/90 mm Hg)
* Unstable or severe pulmonary disease
* Unstable or severe thyroid disorders
* Inflammatory diseases
* Alcohol use \> 2 U/day (women)/\> 3 U/day (men)
* Use of antihypertensive, lipid-lowering or glucose-lowering medications,
* Use of corticosteroids, medication known to inhibit or induce CYP3A4, lithium, and tricyclic antidepressants or antipsychotic medication, and regular use (weekly or several times a week) of NSAIDs
* Plasma potassium levels \< 3.2 mmol/L or \> 5 mmol/L
* eGFR \< 60 mL/min
* Impairment of hepatic function
* Pregnancy or lactation
The Effect of Cognitive Group Exercise Combined With Physical Exercise in MS

The aim of this study is to investigate the effect of cognitive rehabilitation in group with physical exercise in patients with Multiple Sclerosis. We assume that cognitive therapy is an effective treatment for multiple sclerosis.

The aim of this study is to investigate the effect of cognitive rehabilitation in group with physical exercise in patients with Multiple Sclerosis.

Eligibility Criteria:
Inclusion Criteria:

* Patients with an Mini Mental State Test score less than 24
* Patients with an Extended Disability Status Scale score less than 4
* Patients trained for at least 5 years
* Patients who have not received steroid therapy in the last 1 month

Exclusion Criteria:

* Patients who have not passed at least 3 months from the last Multiple Sclerosis attack
* Patients with hearing and vision problems that may interfere with communication
* The patients who Have other neurological and psychiatric disorder that will cause cognitive impairment
* Patients receiving medical treatment for spasticity, tremor, bladder disorder and fatigue
Long-term Outcome of TNF Alpha Therapy in IBD

The aim of this retrospective study is to assess the outcome of patients with inflammatory bowel disease (IBD) under TNF-alpha antibody therapy over a period of 20 years

Long-term results published so far show that over the years a large part of patients have to stop TNF Alpha antibody therapy in IBD. Reasons are mostly loss of effectiveness or intolerance or side effects. Reasons for the termination are usually poorly characterized with regard to the exact reason and time. As a consequence, the aim of this retrospective study is to assess the outcome of patients with inflammatory bowel disease under TNF-alpha antibody therapy over a period of 20 years

Eligibility Criteria:
Inclusion Criteria:

* Patients with a confirmed IBD diagnosis
* TNF Alpha antibody therapy in the last 20 years at our outpatient clinic

Exclusion Criteria:

* Not Meeting the inclusion criteria
* Lack of clinical data, no follow up available
Normal Values for Esophageal and Pyloric Impedance Planimetry Under General Anesthesia (NormaFLIP)

Impedance planimetry using Endoscopic Functional Lumen Imaging Probe (EndoFLIP) device is a promising diagnostic tool to assess esophageal, esophago-gastric junction and pylorus function. It allows the measurement of esophageal and pylorus distensibility as well as contractile activity in response to distension. Examination is useful performed under sedation. General anesthesia might affect distensibility values. The aim of this study is to normal values for esophageal, esophago-gastric junction and pylorus distensibility in controls during an upper gastro-intestinal endoscopy performed under general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Subject older than 18 years and younger than 80 years
* Subject referred for upper gastro-intestinal endoscopy under general anesthesia for anemia, intestinal metaplasia in the stomach, Helicobacter pylori screening, or submucosal dissection
* Subject with health insurance
* Written informed consent

Exclusion Criteria:

* Patient younger than 18 years or older than 80 years
* Pregnancy or breast feeding
* Previous history of esophago-gastric surgery or vagotomy
* Previous history of Parkinson disease or diabetes mellitus
* Contra-indication to upper gastro-intestinal endoscopy
* Esophageal varices
* Esophageal diameter smaller than 5 mm
* Contra-indication to general anesthesia
* Hiatal hernia greater than 3 cm on endoscopy
* Esophageal or gastric cancer otherwise than superficial lesion with indication of submucosal dissection
* Typical symptoms (heartburn, regurgitation) of gastro-esophageal reflux disease and/or gastroesophageal reflux disease (GERD)-Q score greater or equal to 8
* Nausea, vomiting or epigastric pain
* Dysphagia with Sydney score greater ou equal to 50
* Incapability to give consent
* No written informed consent
* Participation to another study at the same time
A Drug Interaction Study of Warfarin and Canagliflozin in Healthy Adult Volunteers

The purpose of the study is to assess the effect of multiple oral doses of canagliflozin on a single oral dose of warfarin.

This is an open-label (volunteers will know the names of treatments they are assigned) single-center study of canagliflozin (JNJ-28431754) and warfarin in healthy adult volunteers. Canagliflozin is a drug currently under development to lower blood sugar levels in patients with type 2 diabetes mellitus and warfarin is an approved anticoagulant (ie, a drug that stops blood from clotting). After an overnight fast (without eating food) of at least 10 hours, volunteers will receive Sequence 1 (canagliflozin 300 mg, orally, once daily on Days 1-12 with a single, oral 30 mg dose of warfarin on Day 6 \[Treatment A\] followed 14 days later by a single, oral 30 mg dose of warfarin on Day 1 \[Treatment B\]) OR Sequence 2 (Treatment B followed 14 days later by Treatment A).

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers with a body mass index between 18 and 30 kg/m

Exclusion Criteria:

* Any blood coagulation disorder determined to be clinically relevant by the Investigator
* Medications known to affect coagulation taken within 7 to 14 days of study entry
Combating Alzheimer's Through Sleep and Exercise

The purpose of this research is to see how sleep and exercise affects dementia risk over time.


Eligibility Criteria:
Inclusion Criteria:

1. Able to perform mild exercise
2. Able to wear DREEM 2 Headband
3. Able to wear a Fitbit wrist watch
4. Able to perform the Everlywell biomarker procedure
5. Able to Understand and Speak English
6. Able to operate a digital device like mobile phone, iPad, or computer
7. Self-reported history of problems with cognitive impairment: memory, concentration, and processing information
8. Only participants cognitively able and willing to provide consent will be included.

Exclusion Criteria:

1. Prohibited from or unable to perform mild exercise
2. Unable to wear wrist watch or headband devices, or unable to supply pinprick blood sample for any reason
3. Unable to speak or understand English
4. Unable to use mobile device/smartphone technology
5. Unable or unwilling to consent for any reason.
Bayer OA Knee Pain Pilot

The objective of this study is to investigate if MRI can be used to evaluated effect of knee artery embolization for knee osteoarthritis. Participants be evaluated in clinic, obtain a knee MRI, undergo embolization of the symptomatic knee, and follow up in clinic at 1, 6, and 12 months after embolization. A second MRI is obtained 6 months after embolization. Participants will keep a record of their pain level and treatment and answer questionnaires at each visit.

In addition, this study aims to determine the effects of knee artery embolization on the amount of opioid (pain reliever drugs) needed to manage osteoarthritis-associated pain and change in quality of life.


Eligibility Criteria:
Inclusion Criteria:

1. Age 25 to 90
2. Symptomatic osteoarthritis of one or both knees, with Kellgren-Lawrence grade 1-3 assessed by weight-bearing knee radiography, including post-traumatic osteoarthritis
3. One or more months of non-surgical therapy for knee pain such as joint injections, oral NSAIDs, or opioid analgesia
4. Subjects able to provide informed consent. As this is a study of pain, patients must be able to consent for themselves.
5. Patients without contraindication to MRI imaging with gadolinium-based contrast.

Exclusion Criteria:

1. Anaphylaxis to gadolinium or iodinated contrast media
2. Impaired renal function with GFR \<30ml/min
3. Severe atherosclerotic disease of the lower extremity precluding percutaneous angiographic access to the involved geniculate artery(ies)
4. Active septic arthritis of the symptomatic knee within 2 months of screening
5. Malignancy of the involved knee
6. Rheumatoid Arthritis or Gout
7. Prior knee surgery
8. Hemarthrosis
9. Females who are pregnant or plan to become pregnant during the study. All participants able to become pregnant will be administered a urine pregnancy test.
Movement-Based Pelvic Health Education for Women in Underserved Communities

It is essential to provide the community with evidenced-based care to optimize healthcare outcomes; more specifically, women in underserved communities undergoing health disparities in rehabilitation. To address this issue, a movement-based pelvic health education course was developed to assess women's knowledge and adherence of the exercises in an underserved region in Western Arkansas.The purpose of this research was to determine the effectiveness of a single movement-based pelvic health education session on general pelvic health knowledge, underactive pelvic floor, and overactive pelvic floor knowledge and adherence to performing pelvic exercises in women.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* female-identifying
* ability to speak English or provide own translator
* ability to complete the questionnaires
* clearance from physician if pregnant
* access to internet

Exclusion Criteria:

-Experiencing pelvic pain and/or pregnant and does not have physician clearance to participate
The Added Value of Quantification of Lung Function in Patients Undergoing Radiotherapy, Using Tc-99m-MAA SPECT-CT

Adult patients referred to radiotherapy treatment of primary or secondary malignant involvement of the lung parenchyma, who are not meeting the exclusion criteria, will be introduced to the study and suggested to participate in it by the radiotherapist, Dr Viacheslav Soyfer, M.D. from the Institute of Radiotherapy Tel Aviv (Sourasky) Medical Center.

They will sign an informed consent and the study will be conducted based on the agreement of the institutional ethical committee, prior to perfusion study.

Each patient will be evaluated three times: prior to treatment, a baseline evaluation mid-follow-up period 6 weeks post initiation of radiotherapy and a delayed follow up 6 months post treatment. Each SPECT/ Low dose CT assessment will take place within two weeks of the clinical and PFT assessment.

The study will take place within a duration of two years, from recruiting the participating patients to the completion of the study protocol by the last recruited patient. For the individual patient, the duration of participation is six months.

Perfusion SPECT/ Low dose CT studies with a non-diagnostic low dose chest CT will be performed after the I.V. injection of 4 mCi 99m-Tc-MAA. SPECT/ Low dose CT scan will be acquired immediately post injection on a GE OPTIMA NM/CT 640 camera. In order to obtain a better definition of the irradiated fields, we will co-register the SPECT/ Low dose CT with high-resolution CT provided from the Institute of Radiotherapy. In this procedure, the low dose chest CT is used as a bridge between high resolution CT and the functional imaging SPECT. Using the Q.Lung segmentation tool, individual whole lung function and lung subunits will be assessed, and will be correlated to irradiated fields. Calculated data for each study step will be compared in order to assess the extent of RT induced lung injury.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients both female and male above 18 years old referred to radiotherapy treatment of primary or secondary malignant involvement of the lung parenchyma.

Exclusion Criteria:

* Patients undergoing treatments that might induce lung toxicity other than the RT being assessed will be excluded.
* Patients suffering of lung illnesses as infection, pulmonary embolism, and congestive heart failure will be excluded.
* Special populations like pregnant women, children and legally incompetent patients will not be included in this study.
Cardiac Rehabilitation of Heart Failure Patients by Telemedicine

The purpose of the READ study is to compare the continuation of the cardiac rehabilitation at home with clinical follow-up, therapeutic education, and advice on the training at the stamina, via telemedicine with the classic strategy in day hospital.


Eligibility Criteria:
Inclusion Criteria:

* Patient with a dysfunction of left ventricle with ejection fraction of left ventricle \< 40 % appreciated by echocardiogram at hospital discharge for cardiac rehabilitation.

Exclusion Criteria:

* Patient non authorized to follow an effort training
* Therapeutic education impossible
* Pregnant woman or breast-feeding
* No assent
* Incapacity to use the terminal
* Minor patient or under supervision
Exploratory Study of Upper and Lower Endoscopic Fuse System

Single-Center, Exploratory Study of EndoChoice's Upper and Lower Gastrointestinal Endoscopic Systems Utilizing EndoChoice's Full Spectrum Optical Technology

The investigational devices are EndoChoice gastrointestinal endoscopic systems that are similar in their fit, form, and functions to the corresponding commercially available models with the exception of the EndoChoice's proprietary Optical system that enhances their field of view.

Eligibility Criteria:
Inclusion Criteria:

* Male and Female patients ages of 18-75
* The patient has been scheduled for routine screening upper or lower endoscopy, diagnostic endoscopic work up, or endoscopic surveillance.
* Signed informed consent form

Exclusion Criteria:

* Patients who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the patient's participation in this study.
* Patients who are unable to consent
* Pregnant female patients of any age.
Effect Of Percutaneous Electrical Nerve Field Stimulation on Symptom Control/Nervous System Activity in Patients w/Diabetes Types 1/2

The purpose of this study is to find out if we can stimulate the vagus nerve. The vagus nerve is a largely internal nerve that controls many bodily functions, including stomach function. We hope that electrically stimulating the nerve around the external ear will also stimulate the internal vagus nerve. If it does, then we hope that this will help our treatment of patients with nausea and vomiting and disordered stomach function.

Each participant will be randomized to receive Percutaneous Electrical Nerve Field Stimulation (PENFS) treatment with or without stimulation. The study involves 6 study visits. Study procedures include: removing and replacing the PENFS device, questionnaires, ECG, assessment use of galvanic skin response (GSR), pneumatic belt to assess breathing, physical examine, and blood draws.

Eligibility Criteria:
Inclusion Criteria:

* Wiling to have one teaspoon (5 ml) of blood drawn.
* Diagnosed with gastroparesis for twelve months or longer
* Diagnosed with diabetes either Type 1 or Type 2
* Documented delayed gastric emptying (\>10% retention of the test meal at four hours) on a standardized scrambled-egg scintigraphy gastric emptying test performed in the last two years.
* Upper GI endoscopy indicating no mechanical obstruction performed in the last five years.
* Symptoms of nausea and vomiting consistent with clinical diagnosis of gastroparesis (as opposed to other causes of nausea and vomiting such as mechanical obstruction, acute viral illness, chemotherapy, psychogenic vomiting.
* Documented Hb A1c within three months of screening or at the time of screening (\<=8.0)

Exclusion Criteria:

* Unable to provide consent
* Pregnant females
* Medical records indicate intestinal pseudo-obstruction
* Diagnosed with cardiac arrhythmia
* History of prior gastric surgery
* History of vagotomy
* History of organ transplantation
* History of seizures
* Diagnosed with primary swallowing disorders
* Subjects who are dependent on drugs like Marinol for their condition
* Those diagnosed with psychogenic vomiting and not related to gastroparesis
* Medically unstable subjects
* Those at high surgical risk
* Subjects taking narcotic analgesics daily.
* Those with poorly controlled diabetes mellitus (Hgb A1c\>8) within three months of screening or at the time of screening.
* Subjects diagnosed with hemophilia, psoriasis vulgaris are excluded
* Those having a cardiac pacemaker will be excluded from the study.
Antihypertensive Effectiveness of the Associations of Hydrochlorothiazide and Amiloride and Hydrochlorothiazide and Enalapril

The majority of hypertensive patients require antihypertensive associations to control their blood pressure. Most of clinical trials don't compare different associations using Hydrochlorothiazide 25 mg as the standard initial therapy and compare the associations using doses that are not equivalent.

This randomized trial where patients and investigators are blinded and compares the effectiveness two associations: Hydrochlorothiazide and Amiloride and Hydrochlorothiazide and Enalapril.


Eligibility Criteria:
Inclusion Criteria:

* patients who are using Hydrochlorothiazide 25mg/d at least in a four weeks treatment and had their office blood pressure not controlled (systolic or diastolic greater than 140 mmHg or 90 mmHg, respectively).

Exclusion Criteria:

* Established cardiovascular disease
* Diabetics in use of insulin
* Impairment renal in renal function
* Contraindications for the study medications
Positive Feedback vs. No-Feedback Games for Behavioral Change

We aim to investigate here whether we can develop a reinforcement learning game which provides game-based feedback to encourage positive actions (behaviors) both inside and outside of the game. Does providing positive reward when participants make decisions which are associated with value-based actions (like those in BA) result in different game decisions? We propose that it will increase positive actions in the game. And, secondly, how does it affect short-term behavior (in one week)? We propose that it will increase pro-health activities and may reduce depressive symptoms.

We know that behavior influences mood -- our best interventions to improve mood rely upon the relationship between these. Treatments like this are thought to work in part by helping individuals to increase value-derived behaviors; participants are given guidance which results in an increase of positive behaviors and a decrease of coping behaviors that don't help -- that is, their health-seeking behavior is reinforced while behaviors that diminish health are reduced. In past work, we showed that a text-based game could be used to explore what sort of decisions people would make in certain environments. That game showed associations between in-game behaviors and real-life depressive symptoms and actions. Such work focuses on low-level symptoms of depression -- increasingly common, especially after the onset of the covid-19 pandemic. We aim to investigate here whether we can develop a reinforcement learning game which provides game-based feedback to encourage positive actions (behaviors) both inside and outside of the game.

Thus, the experiment described below and proposed in this application would test the role of positive rewards (positive-feedback) in a dichotomous-choice game, compared to neutral (no-feedback).

Eligibility Criteria:
Inclusion Criteria:

* 18-34 years old
* Fluent in English
* Based in the United States

Exclusion Criteria:

* None