cyrilzakka/clinical-trials huggingface dataset:
Effects of Ethanol on Intestinal Permeability and Integrity

Alcohol consumption is a major health problem worldwide. It affects all systems of the body especially the gastrointestinal tract. Acute or chronic alcohol consumption has deleterious effects on the gastrointestinal mucosa vary from increased intestinal permeability, structural changes to sever destruction of the epithelial lining cells. Human data are still limited and most of the studies were performed in chronic alcohol abusers.

The investigators hypothesize that moderate alcohol drinking also may increase small intestinal permeability and contribute to the subsequent disruption of the tight junction complex. This study may provide more insight into the effects of moderate alcohol drinking on the small intestinal permeability.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form.
* Male gender to avoid the gender-related differences in ethanol metabolism.
* Between 18-45 years to avoid age-related changes in ethanol metabolism39.
* Normal medical history and physical examination.
* Normal liver function tests (i.e. ALT, AST, and γGT) according to the reference values for normal ranges of the liver enzymes at the laboratory of clinical chemistry of the Maastricht University Medical Center.
* Caucasian ethnicity.
* BMI=18 - 30 kg/m2.

Exclusion Criteria:

* History of gastro-intestinal disorders or abdominal surgery.
* History of alcohol abuse or current excessive alcohol consumption (\> 2 alcoholic beverages per day or \> 14 alcoholic beverages per week)40.
* Recent or chronic medications that may interact with ethanol metabolism or intestinal permeability i.e., NSAIDs, benzodiazepines and antidepressants.
* Smoking.
Effectiveness of Intensive Rehabilitation on Shoulder Function After Proximal Humerus Fracture

The fracture of the proximal humerus represents 4% of the fractures encountered in clinics and it must be treated surgically. Thus, the aim of the surgical treatment is to maintain bone alignment, articular congruity, vascularization of the humeral head and provide a painless shoulder with satisfactory function.

The objective of this study is to demonstrate the potential benefits of an early rehabilitation program on shoulder function.


Eligibility Criteria:
Inclusion Criteria:

* Male or female over 18 years
* Unstable fracture of the proximal humerus
* Two-part and three-part fractures according to the Neer classification
* Closed fracture
* Time between trauma and surgery less than or equal to 7 days
* Signing of consent form

Exclusion Criteria:

* Stable fracture of the proximal humerus (not requiring surgery)
* Four-part fracture on the Neer classification
* Fracture-dislocation or fracture involving the articular surface
* Isolated fracture of the large or small tuberosity
* Pathological fracture
* Fracture associated with neuro-vascular lesions
* Bilateral fractures
* Fracture associated with long bones fracture
* Polytrauma
* Previous history of fracture or surgery to the ipsilateral proximal humerus
* Severe COPD
* Severe neuromuscular disorders (Parkinson, hemiparesis, myasthenia gravis, muscular dystrophy, etc. ...)
* Remote location of patient's home which makes it difficult to come to facility for follow-up visits
* Any medical condition making it impossible for the patient to perform the exercise program (Alzheimer, dementia, etc. ...)
* Man or woman incapacitated sign consent form
* Any other condition which prevents the assessor from fully monitoring the patient during study.
Improving Early Reperfusion With Adjuvant Dornase Alfa in Large Vessel Ischemic Stroke (EXTEND-IA DNase)

Patients presenting to the emergency department with acute ischemic stroke, who are are eligible for standard intravenous thrombolytic therapy within 4.5 hours of stroke onset will be assessed for major vessel occlusion to determine their eligibility for the trial. All participants will receive intravenous tenecteplase (or alteplase due to manufacturer shortage) and endovascular thrombectomy as standard care. The trial is a Bayesian Optimised Phase 2 dose-finding umbrella trial (single arm versus objective performance criterion of 20% substantial reperfusion prior to endovascular thrombectomy based on the EXTEND-IA TNK trials NCT02388061, NCT03340493). The aim is to determine the optimal dose of intravenous dornase alfa (recombinant human DNase 1) with sufficient promise to take forward in a seamless phase 2b/3 design.


Eligibility Criteria:
Inclusion Criteria:

1. Patients presenting with acute ischemic stroke eligible, using standard criteria, to receive IV thrombolytics within 4.5 hours of stroke onset
2. Patient's age is ≥18 years
3. Intention to perform endovascular thrombectomy Imaging inclusion criteria
4. Arterial occlusion on CTA or MRA of the ICA, M1, M2 or basilar artery

Exclusion Criteria:

1. Intracranial hemorrhage (ICH) identified by CT or MRI
2. Rapidly improving symptoms at the discretion of the investigator
3. Pre-stroke mRS score of ≥ 4 (indicating previous disability)
4. Hypodensity in \>1/3 MCA territory or equivalent proportion of basilar artery territory on non-contrast CT
5. Contraindication to imaging with contrast agents
6. Any terminal illness such that patient would not be expected to survive more than 1 year
7. Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.
8. Pregnant or lactating women
Psychomotor Performance of Preterm Infants

The first part involved 120 children in grades II and III of elementary schools. From this group, children were qualified for the second part of the study - 35 randomly selected children born on time (BoT) and 35 children born before 35 weeks of pregnancy (PB). EUROFIT tests, Vienna Tests and postural stability tests were carried out in both groups.


Eligibility Criteria:
Inclusion Criteria:

* preterm born (PB): born before 35 weeks of gestation
* both groups: aged 7-9 y during the research project

Exclusion Criteria:

* musculoskeletal injuries
* neurological disorders or other CNS damage
OUT-OF-HOSPITAL CPAP STUDY

Evaluate efficacy and safety of CPAP in a randomised standard treatment controlled study, in out-of-hospital patients with acute cardiogenic pulmonary edema.

Acute cardiogenic pulmonary edema is a frequent medical emergency. Several studies have shown that continuous positive airway pressure is effective in acute cardiogenic pulmonary edema, through improvement in gas exchange, reduction in intubation rate and a trend towards reduced mortality. CPAP is usually obtained with a hermetic nasal or facemask witch has an expiratory valve to maintain a positive pressure at the end of the expiration. With this support, the patient does not receive any assistance with respiration.

The available data about CPAP concern patients hospitalised in cardiology intensive care units, in resuscitation areas or in emergency departments.

We will undertake a controlled prospective randomised trial to investigate whether the early use of CPAP would improve oxygenation and survival, as compared with standard medical therapy in patients with acute cardiogenic pulmonary edema.

This study will include 124 patients over 18 years of age, suffering of acute cardiogenic pulmonary edema, with a respiratory rate greater than 25 bpm and oxygen saturation less than 90 %. The patients will be include just after the beginning of the episode, in prehospital mobile intensive car unit (SAMU) and will be all admitted in resuscitation area in a central hospital. They will be randomly assigned to CPAP or conventional oxygen therapy. The randomisation sequence is generated by the random numbers table. Closed envelopes containing the allocated treatment will be stored in the emergency department and will be opened when the patient is included.

Oxygen saturation (by pulse-oxymetry), heart rate, respiratory rate, dyspnea, blood pressure will be measured every 15 min during the transport to the intensive care unit and every hour. The blood gazes will be measured at the arrival. The intubation rate, the duration of the hospitalisation and the mortality in the thirty days following initial treatment will be noted.

Eligibility Criteria:
Inclusion Criteria:

* patient with supposed acute cardiogenic pulmonary edema, defined as acute dyspnea associated with a past of cardiomyopathy ischemia and physical signs consistent with pulmonary edema.
* patient giving written informed consent

Exclusion Criteria:

* Glasgow score \< 10
* Acute myocardial infarction ; ventricular arrhythmia ; pneumothorax ; evidence of pneumonia ; immediate need for intubation ; heart failure or respiratory stop witch requires a reanimation ; cardiogenic shock (systolic blood pressure \< 90 mmhg)
* Any neurological impairment that would prevent the protocol compliance
* participation in another study throughout this one
* women pregnant or nursing
* vomiting
* patient with an history of gastric surgery (\< 8days)
Additional Effect of A Life Style Program on Antihypertensive Treatment With Telmisartan

This post-marketing surveillance study is designed to supplement the data on efficacy and tolerability of Micardis® and MicardisPlus® in patients at cardiovascular risk under general practice conditions.

The aim of the study is to investigate the effect of a six-month treatment with Micardis® / MicardisPlus® on blood pressure and the effect of the Lifestyle education tool for weight reduction on blood pressure control.

In addition, the post-marketing surveillance study will provide information on the effects on target measurement of the Lifestyle education tool and various laboratory parameters produced by treatment with Micardis® and MicardisPlus® in an unselected patient population under general practice conditions.


Eligibility Criteria:
Inclusion criteria:

1. Patients with essential hypertension (blood pressure (BP) higher or equal to 140/90 mmHg or higher or equal to 130/80 mmHg in case of diabetic patients)
2. Patients with hypertension under treatment with one or more antihypertensive drug

Exclusion criteria:

Patients are excluded according to the summary of product characteristics (SmPC).
Study Evaluating the Impact of Mesh Pore Size on Chronic Pain After Lichtenstein Hernioplasty

The aim of the present study is to determine whether usage of mesh with larger pores, compared with mesh with smaller pores, would result in decreased rate of chronic pain after open inguinal hernia repair.

The aim of the present study is to determine whether usage of mesh with larger pores, compared with mesh with smaller pores, would result in decreased rate of chronic pain after open inguinal hernia repair. The patients are randomized into two study gropus receiving mesh with different pore size. Clinical follow-up examination will be performed 1 week, 1 month, 6 months and 3 years after the operation.

Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years
* unilateral primary reducible inguinal hernia
* elective operation
* consent to participate in the study.

Exclusion Criteria:

* age \<18 years
* irreducible
* strangulated
* recurrent hernia
* inability to understand the questionnaire
* unwillingness to participate in the study
Weight Reduction with the Low-Insulin-Method - Self Monitoring of Breath Acetone

The goal of this clinical trial is to learn if lifestyle intervention with information about ketosis state supports weight reduction in overweight adults.

Researchers will compare an App-based lifestyle intervention with self-monitoring of breath acetone vs. lifestyle intervention alone.

Participants will:

Get a lifestyle intervention via the LIM-App for 12 months. Report body weight.

Background: Overweight and obesity are an increasing problem. Therefore, the Low-Insulin-Method was developed to support overweight and obese people in weight loss.

Method: In a randomized controlled clinical trial, the effect of the lifestyle intervention program 'Low-Insulin-Method', delivered by the Low-Insulin-App including low-carb diet, physical activity, self monitoring of weight, and self-monitoring of breath acetone (SMBA) is examined compared to a control group without information about ketosis level. Weight change will be compared after 3 and 12 months.

Objective: The aim is to develop a training and counseling program for overweight or obese individuals with diabetes risk or type 2 diabetes, which can be used both for primary and for tertiary prevention of overweight-related diseases.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index \> 25kg/m2

Exclusion Criteria:

-
Bladder Scan of Residual Urine With New Catheter

Male intermittent catheters (ICs) range from 340-500 mm long, with the European standard minimum length being 360 mm for a catheter without a balloon and 275 mm for one with a balloon. This length is defined by hospital standards although it is known that the male urethra has an approximate maximum length of 29 cmA new intermittent catheter developed by Coloplast A/S is a 30-cm-long sterile, ready-to-use, hydrophilic-coated male catheter. There is a lack of clinical data documenting that male ICs that are shorter and more or less flexible than standard catheters can sufficiently empty the bladder of male subjects. This will be tested using ultrasound to measure residual urine in the bladder following catheterisation with new product and standard length catheter.

See brief summary

Eligibility Criteria:
Inclusion Criteria:

1. Subject is a male IC user able to self-catheterise
2. Subject has used hydrophilic-coated ICs for at least 1 month
3. Subject is at least 18 years old.
4. Subject has provided informed consent.

Exclusion Criteria:

1. Subject has symptoms of UTI (ie, fever, autonomic dysreflexia, spasticity, discomfort or pain over the kidney or bladder, onset/increase in incontinence episodes, cloudy urine with increased odour, malaise, lethargy, or sense of unease).
2. Subject has known abnormalities in the lower urinary tract.
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VES001 in Healthy Participants

This is a Phase 1, randomized, placebo-controlled, double-blind study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple doses of VES001 in a two part followed by a multicenter, open-label Phase 1b study in asymptomatic GRN mutation carriers.

Part A will evaluate the safety, tolerability, PK, and PD of single doses of VES001 in healthy volunteers.

Part B will evaluate the safety, tolerability, PK, and PD of multiple doses of VES001 in healthy volunteers.

Part A will include six cohorts, with eight participants per cohort. Participants in each cohort will be randomised in a 6:2 ratio (VES001 vs. placebo).

Part B will include three cohorts, with ten participants per cohort. Participants in each cohort will be randomised in a 8:2 ratio (VES001 vs. placebo).

Eligibility Criteria:
Inclusion Criteria Part A \& B:

1. Healthy men or women aged 18 to 55 years.
2. Body Mass Index between 18 and 32 kg/m2, with a minimum weight of 50 kg.
3. Effective contraception required during the study and for at least 90 days after their last dose.
4. Participants in group 3, where the food effect is being investigated, must be able to eat a high-fat meal within 30 minutes for breakfast.

Exclusion Criteria Part A \& B:

1. Medical conditions or treatments that could interfere with the study.
2. History of any known neurologic disease, cognitive impairment, or a history of seizure, (significant) head trauma, or loss of consciousness.
3. History of active malignancy (active cancer cells or tumors) within the last 5 years.
4. Abnormal laboratory test results or infectious diseases (Hepatitis B, Hepatitis C, and/or HIV).
5. Recent medication or supplement use, unless allowed by the investigator.
6. Participation in other research studies involving study treatment or devices.
7. Positive tests for illegal drugs or alcohol at screening.
8. Heavy smoking or inability to abstain from smoking during the study.
9. Excessive consumption of caffeine (more than 8 cups per day).
10. History of severe allergic reactions to medication
11. Recent blood donation or significant blood loss.
12. Pregnancy, breastfeeding, or plans to become pregnant (for women).
A Smartphone Intervention for Relational and Mental Well Being

The primary aim of this study is to provide and evaluate a phone-based intervention to improve relational and mental well-being during the COVID-19 crisis. This information also will help us understand how individuals are responding to COVID-19 and have the potential to inform psychological and policy level interventions.

We conducted a randomized intervention trial of a mobile-based intervention that offered participants daily suggestions for 14 days on how to improve relational and mental well-being during the COVID-19 pandemic. A sample of 1765 adults residing in the United States participated in the study and were assigned to control or intervention conditions. To measure outcomes, all participants received a daily text message to their smartphones every evening for 28 days linking to a survey on relational and mental well-being. Participants also received a survey link on Days 56 and 72. Intervention participants received additional text messages in the mornings of Days 7 - 22 presenting the intervention suggestions.

Eligibility Criteria:
Inclusion Criteria:

* Age 18+
* Resides in United States
* Possesses smartphone
* Willing to share phone number and email to researchers

Exclusion Criteria:

* None
Effectiveness of Decision Support for Cardiovascular Risk Management in People With Cardiovascular Disease

This study aims to improve the way patients with cardiovascular diseases are informed about their treatment options. It explores methods to support shared decision-making between patients and doctors. In some cases, doctors will take extra time to discuss treatment options in detail. To assess the impact, some patients will be asked to complete questionnaires after their clinic visits.


Eligibility Criteria:
Inclusion criteria:

* Established ASCVD

  * At least 30 days since last CVD event and/or the diagnosis of ASCVD. If no CVD events have occurred, imaging confirming ASCVD must have been conducted at least 30 days prior.
  * Documented ASCVD (defined according to the 2021 European Society of Cardiology guideline), which includes ASCVD established clinically or demonstrated unequivocally by imaging:
* Clinically documented ASCVD includes previous myocardial infarction, acute coronary syndrome, coronary revascularization (Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Surgery (CABG)), and other arterial revascularization procedures, ischemic stroke or transient ischemic attack, and peripheral artery disease (from Fontaine stage II). Angina pectoris (stable) without imaging evidence of atherosclerosis does not qualify as ASCVD.
* ASCVD unambiguously identified through imaging, includes significant stenosis (\>50%) on coronary angiography, computed tomography angiography, or carotic ultrasound. It also includes aortic aneurysms measuring ≥3cm. Only Carotid Intima-Media Thickness measurements (cIMT), Coronary Artery Calcium scoring or abnormal ankle-brachial index scores without evidence of stenosis, do not qualify as ASCVD.
* Age 40-80 years (to allow for individual risk predictions with the SMART2 model
* Patient attending the Cardiology or Vascular Medicine outpatient clinic
* Sufficient understanding of the Dutch language (due to the questionnaires being administered in Dutch).
* Written informed consent must be provided. Although the proposed intervention is not subject to the WMO, informed consent is required for the collection and processing of data, including the distribution of questionnaires.

Exclusion criteria:

* Patients currently participating in other interventional medication studies, or studies that directly affect the therapy plan
* Remaining life expectancy of less than 2 years as assessed by a consulting healthcare professional (these patients have no indication for cardiovascular risk management)
* Patients for whom individual risk predictions with the SMART2 model are not feasible:

  * Systolic Blood Pressure (SBP) \<90 mmHg or \>200 mmHg
  * Total cholesterol \<2.5mmol/L or \>8 mmol/L
  * High-Density Lipoprotein (HDL) cholesterol \<0.6mmol/L or \>2.5 mmol/L
  * Low-Density Lipoprotein (LDL) \<0.1 mmol/L or \>7.4 mmol /L
  * Estimated Glomerular Filtration Rate (eGFR) \<30ml/min/1.73m2 or dialysis
  * Active treatment for malignity, pregnancy, history of organ transplantation, or liver failure
* Previous participation in 2-DECIDE
Is There a Microbiome Associated With Poor Growth in Preterm Infants?

This study evaluates the relationship between growth and stool microbiota in premature infants.

Preterm infants often require increased caloric intake to maintain appropriate growth while in the neonatal intensive care unit (NICU). While some infants will have a clear source of need for greater calories, it is often not obvious why others require increased available calories to maintain appropriate growth. Emerging evidence suggests that patterns of gut microbiota may play a role in infant and childhood growth. We hypothesize that differences in the microbial pattern in preterm infants is related to poor growth and need for increased caloric intake. This may ultimately represent a therapeutic target to improve the growth of preterm infants in the NICU. This study aims to describe the differences in microbiome which may vary with growth pattern.

Eligibility Criteria:
Inclusion Criteria:

All infants less than 28 weeks gestation who are admitted to the Parkland Hospital NICU.

Exclusion Criteria:

Infants \>27 weeks gestation. Infants with major congenital anomalies which may alter growth patterns.
A Study of Nivolumab Plus Ipilimumab, Ipilimumab Alone, or Cabazitaxel in Men With Metastatic Castration-Resistant Prostate Cancer (CheckMate 650)

The purpose of this study is to evaluate the effectiveness, safety and tolerability of nivolumab followed by ipilimumab, in subjects with metastatic castration resistant prostate cancer (mCRPC).


Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Current evidence of metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on computerized tomography/magnetic resonance imaging (CT/MRI).
* Ongoing androgen deprivation therapy (ADT) with a Gonadotropin-releasing hormone (GnRH) analogue or a surgical/medical castration with testosterone level of ≤1.73nmol/L (50ng/dL)

For crossover phase for participants originally randomized to Arm D3 or Arm D4 only:

* Previously randomized to Arm D3 or D4; had histologic confirmation of adenocarcinoma of the prostate and evidence of Stage IV disease (as defined by American Joint Committee of Cancer criteria (AJCC criteria) prior to randomization

Exclusion Criteria:

* Presence of visceral metastases in the liver
* Active brain metastases or leptomeningeal metastases
* Active, known, or suspected autoimmune disease or infection
* Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways

For crossover phase for participants originally randomized to Arm D3 or Arm D4 only:

* Prior radiation therapy within 14 days prior to first dose of nivolumab combined with ipilimumab
* Have received systemic anti-cancer therapy after the last dose of study treatment (ipilimumab or cabazitaxel)

Other protocol-defined inclusion/exclusion criteria apply