cyrilzakka/clinical-trials huggingface dataset:
Dairy Products and Metabolic Syndrome

The purpose of this trial is to investigate the effect of dairy products on the so called metabolic syndrome. Metabolic syndrome is a cluster of risk factors, such as high blood pressure and high cholesterol, for the development of diabetes and heart disease. Participants will be randomly assigned to either eat a portion of a Norwegian traditional cheese which is high in protein and low in fat (group 1), or eat a slightly higher than normal intake of regular Gouda-type cheese (group 2), or to limit their intake of cheese (group 3).

Dairy products are a significant source of bioactive peptides, small pieces of protein which may have an effect on our health. These effects may be antimicrobial, antioxidative, or blood pressure lowering. The traditional Norwegian cheese, Gamalost, which is naturally high in protein (50%) and low in fat (\<1%), has been found to be particularly high in these bioactive peptides. Specifically, the cheese was found to have a very high ACE-inhibitory activity, meaning it has the potential to lower blood pressure without the use of pharmaceuticals.

A pilot study was performed in May 2012. No intervention was given in this trial, but participants answered an extensive questionnaire about dietary habits and lifestyle. This trial found that the people who ate the most Gamalost had a slightly lower blood pressure than those that did not eat the cheese. Since that was just a point-in-time study with no intervention or control, the investigators are not able to say anything certain about cause and effect, which is why the investigators want to perform this larger controlled study.

In total, the investigators aim to recruit 300 people to participate in this trial, i.e. 100 in each group. The participants will be randomly placed in one of the groups and they will have to do the intervention for eight weeks. At inclusion, the investigators measure blood pressure, fasting blood glucose, weight, height, waist circumference, and the investigators draw a fasting blood sample to measure cholesterol. The same measurements will be repeated at the end of the eight weeks. At inclusion they will also fill out an extensive questionnaire about their diet and lifestyle. A shorter version of the same questionnaire will also be given at the end of the trial period.

The overall goal of the study is to assess the effect of dairy products on the metabolic syndrome, but the main hypothesis is to assess whether a high intake of Gamalost can reduce blood pressure in a group of people.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults
* Must be able to eat cheese evey day

Exclusion Criteria:

* Pregnant women
* Taking blood pressure lowering medication
* Not able to read Norwegian
Phase II Study of PG-102(MG12) Compared with Placebo in Obesity and Type 2 Diabetes

This phase 2 clinical trial aims to evaluate the safety and efficacy of PG-102 (MG12) in patients with type 2 diabetes and obesity. The study is a randomized, double-blind, placebo-controlled, multi-center trial. Participants will be randomly assigned to receive either PG-102 or a placebo over a 12-week treatment period. The primary goal is to investigate the therapeutic potential of PG-102 in improving clinical outcomes for type 2 diabetes and obesity, while closely monitoring the safety profile of the treatment.

The study will be conducted in two parts, A and B, with a total of six cohorts. Part A will involve two cohorts comprising patients with type 2 diabetes, while Part B will include four cohorts of patients with obesity.

Part A (T2DM): In Part A, subjects with type 2 diabetes will receive multiple doses of the study drug over a 12-week period, with varying dosing schedules across the two cohorts, to evaluate the safety and efficacy of PG-102 (MG12).

Part B (OB): In Part B, subjects with obesity will receive multiple doses of the study drug over a 12-week period, with varying dosing schedules across the four cohorts to evaluate the safety and efficacy of PG-102 (MG12) in this subgroup. Cohort B2 will include subjects who are both obese and have type 2 diabetes.

Eligibility Criteria:
Inclusion Criteria:

1. Adults aged 19 to 75 years who provide informed consent.

   \[Part A: Type 2 Diabetes Mellitus (T2DM) Specific Criteria\]
2. Diagnosed with type 2 diabetes for at least 6 months, with HbA1c between 7.0% and 10.0%, despite adherence to diet and exercise therapy according to diabetes treatment guidelines.
3. Stable on metformin monotherapy or metformin in combination with one oral hypoglycemic agent for at least 90 days.
4. BMI between 18.5 kg/m² and 30.0 kg/m², with a minimum weight of 55 kg for men and 50 kg for women.

   \[Part B: Obesity (OB) Specific Criteria\]
5. Failed at least one attempt at weight loss through diet and exercise.
6. Cohort B1: BMI ≥ 30 kg/m²
7. Cohort B2: BMI ≥ 27 kg/m² 8-1. Cohort B2: Diagnosed with type 2 diabetes for at least 6 months, with HbA1c between 7.0% and 10.0%.

8-2. Cohort B2: Received treatment with diet and exercise alone, OR stable on approved oral antidiabetic monotherapy or combination therapy for at least 90 days prior to screening.

Exclusion Criteria:

1. Participation in another clinical trial within 90 days.
2. Known hypersensitivity to study drugs or their components.
3. Inability to administer the drug in the abdomen.
4. History of severe gastrointestinal disorders, recent obesity-related surgeries, or conditions affecting gastric emptying.
5. Uncontrolled severe hypertension, hypertriglyceridemia, or severe cardiovascular disease.
6. History of acute pancreatitis, recent cancer, or endocrine disorders causing obesity.
7. Abnormal lab results, including eGFR \< 60 mL/min/1.73 m², AST/ALT \> 3x ULN, or abnormal ECG.
8. Substance abuse or significant psychiatric disorders within the last 2 years.
9. Pregnant, breastfeeding, or unwilling to use contraception during the study.
Effects of Standing at Different Angles on Transpulmonary Pressure

Effects of standing at different angles on transpulmonary pressure

Objective: To study the effect of different standing angles on cross-lung pressure.Background: Long-term bed rest in ICU patients leads to upward movement of diaphragm and increased intrathoracic pressure in mechanically ventilated patients, resulting in lower cross-lung pressure. If the end-expiratory cross-lung pressure is negative, lung tissue compression and atelectasis will occur.Standing can lower the diaphragm, improve the pressure across the lungs, and improve ventilation.Selection methods: patients with invasive mechanical ventilation in the ICU, on the premise of stable hemodynamics, with the aid of electric bed training in standing in different angles, start from 20 degrees, 5 degrees up every five minutes, the largest up to 80 degrees, each Angle across the pulmonary pressure, die cavity ratio, tidal volume and breathe out carbon dioxide at the end of the record, and record whether low blood pressure, an accident in the process of take off the tube and other adverse reactions.

Eligibility Criteria:
Inclusion Criteria:

* The age is ≥ 18 years old;
* the hemodynamics is stable;
* 50 \< heart rate \< 120 beats / min ;
* 90 \< systolic blood pressure \< 200mmHg ;
* 55 \< mean arterial pressure \< 120mmHg;
* do not increase the dose of pressor drugs for at least 2 hours;
* intracranial pressure is stable and there are no seizures within 24 hours;
* the respiratory state is stable;
* the patient's finger pulse oxygen saturation ≥ 88%;
* 10 \< respiratory frequency \< 35 beats / min.

Exclusion Criteria:

* Pregnancy;
* acute cardio-cerebrovascular events;
* spinal or limb fractures;
* active bleeding.
Genetic Variability in Taste Perception

This proposal describes a pilot study aimed at determining whether genetic variations in taste receptors determine differential taste tolerability of pediatric medications.

This is a cross-sectional call-back study of taste perception and the relationship between taste perception and taste receptor genotype.

Eligibility Criteria:
Inclusion Criteria:

* Adult females who were previously enrolled in Efficacy of Bitter Blockers on Taste Acceptance in Pediatric Populations Study (Protocol #809789)

Exclusion Criteria:

* Women who are pregnant
* Women on drugs with potential serious adverse effects that are mediated through cytochrome P450.
Creatine and Ubiquinol for Sperm Quality

This randomized controlled double-blind parallel-group interventional trial explores the impact of 8-week creatine supplementation, with or without ubiquinol, on sperm quality biomarkers in normospermic and oligospermic men. It aims to determine potential enhancements in sperm health to provide insights into male fertility and reproductive health improvement strategies.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 35 years
* Sperm quality test available (at least half will have low sperm quality)
* Informed consent
* Healthy BMI (18.5 - 24.9 kg/m2)

Exclusion Criteria:

* Major chronic disease and acute injuries
* History of dietary supplement use during the past 28 days
* No consent to randomization
* Participation in other studies
Lifespan Integration for Posttraumatic Stress Disorder From an Auto Accident

The purpose of this study is to evaluate if lifespan integration (LI) therapy reduces posttraumatic stress symptoms following a motor vehicle accident (MVA) trauma

Studies estimate a substantial proportion of MVA survivors, ranging from 9.4% to 59.9%, will develop PTSD following an accident (Blanchard \& Hickling, 2004). Based on conservative estimates, past research, indicates that MVA-related PTSD may affect 2.5 to 7 million persons in the United States (Blanchard \& Hickling). Furthermore, two seminal epidemiological studies (Kessler et al., 1995; Norris, 1992) that focused on causes of adult PTSD identified MVAs as the most frequent trauma resulting in PTSD. For these reasons, MVA-resultant PTSD represents a significant public health problem that needs not only to be thoroughly understood, but addressed with successful mental health treatment options (Beck \& Coffey, 2007; Blanchard \& Hickling, 1997, 2004; Bryant et al., 1998; Taylor et al., 1999; Taylor et al., 2001). Although there is empirical literature on the treatment of PTSD following an MVA, additional efficacious and rigorously conducted studies with statistical underpinnings are required to determine the results that can be expected from alternative models of care (Beck \& Coffey; Blanchard \& Hickling, 1997, 2004).

Eligibility Criteria:
Inclusion Criteria:

* Involved in or witnessed a car accident at least 6 months ago.
* PTSD or distress or impairment in important areas of functioning following the car accident

Exclusion Criteria:

* moderate or severe head injury
* current mental health treatment for the MVA-related problem
* severe chronic pre-injury mental health problems
Computed Tomography Perfusion Colorectal Cancer With Tumor Grade

Colorectal cancer is the third most commonly diagnosed cancer in the world. The 5-years survival rate depends on the tumor stage and grade at patient presentation. Individual treatment strategy based on the tumor stage and grade should be applied to improve the prognosis, So the pre-operative diagnostic evaluation and grading of colorectal cancer are important.

Diagnosis of cancer colon is usually based on colonoscopy which provides direct visualization of the lesions and allows for biopsies. However the pre-operative specimens from endoscopic biopsies sometimes fail to grade tumor because of the lack of sufficient tissue. Recent improvements in computed tomography have allowed for minimally invasive evaluation of cancer colon. Quantitative iodine density measurement can be used to differentiate low and high grade colorectal cancer. However, debate continues regarding the correlation between tumor grade and computed tomography perfusion parameters of colorectal cancer demonstrating the need for further investigation in this area of research.

Eligibility Criteria:
Inclusion Criteria:

* Any patient with primary colorectal mass

Exclusion Criteria:

* Colorectal mass pathologically proved to be benign Female patient at child bearing period with suspected pregnancy Raised renal chemistry Hypersensitivity to contrast.
Biomarkers in Retinitis Pigmentosa

The objective of this study is to discover biomarkers that demonstrate a correlation between the severity of retinitis pigmentosa (RP) and the thickness of the retinal pigment epithelium (RPE). These biomarkers will serve as prognostic indicators for various kinds of retinitis pigmentosa. The objective of this study is to find biomarkers that establish a correlation between the severity of retinitis pigmentosa and the thickness of the retinal pigment epithelium (RPE), which can serve as a prognostic indicator for Retinitis Pigmentosa.

After a genetic confirmation of RP and classification, the patients will undergo a comprehensive ophthalmological examination that includes the following tests: slit-lamp anterior segment, visual acuity direct and indirect ophthalmoscopy, intraocular pressure, and family history.In order to evaluate the potential role of RPE in the advancement of RP, HD-OCT and OCT angiography images of the outer retina using OCT devices will be performed.

Analysis of high-resolution images captured with an ultrawidefield system using a Zeiss Clarus device in order to determine the condition of the peripheral retina.Finally, Flicker Electroretinogram (fERG) performed on the central retina (macula), to assess the central macular function within an 18° field of view. This assessment involved measuring the response of the macula to a flickering stimulus with a frequency of 41 Hz, which is commonly done in routine clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are able to read and sign informed consent
* Patients with Retinitis pigmentosa confirmed by genetic test.
* Patients older than or equal to 18 years of age

Exclusion Criteria:

* Other retinal diseases such as macular hole, retinal detachment, macular neovascularization.
* Corneal surgery in the last 12 months
* Glaucoma with pressure above 25 mmHg in the last three months.
* Best Correct Visual Acuity below 1/10 in at least one eye.
Pragmatic Approach To Esophageal Dilation

The purpose of this study is to better understand the role of a technique called esophageal dilation in patients who complain of trouble swallowing. In patients with esophageal stricture we want to determine if the size of the esophageal dilator makes a difference in symptoms and outcomes. In patients who do not have an obvious esophageal stricture we want to determine if esophageal dilation is an effective therapy in these patients.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with esophageal dysphagia who are 18 years old or older.
2. Patients with dysphagia undergoing Esophagogastroduodenoscopy (EGD).
3. Patients who are able to provide consent for the study.
4. Patients with known esophageal stricture that may have or may not have been dilated before.

Exclusion Criteria:

1. Patients with malignant stricture.
2. Pregnant women.
3. Patients with a personal history of esophageal perforation.
4. Patients with achalasia, or globus sensation.
5. Any accessory procedures, like esophageal stenting, excision, steroid injection, or dysphagia treatment currently being done at outside facility.
A Phase 2 Trial of Neoadjuvant Modified FOLFIRINOX Chemotherapy for Resectable Pancreatic Adenocarcinoma

Within the next decade, pancreatic ductal adenocarcinoma (PDAC) is expected to rise to the second leading cause of cancer-related mortality. To increase the survival, various peri-operative treatments have been tested, and adjuvant FOLFIRINOX or gemcitabine plus capecitabine is now standard of care after surgical resection for localized PDAC. Even with superior survival among various disease extent of PDAC, resectable PDAC still shows poor outcomes with surgery followed by adjuvant chemotherapy. This phase II study is investigating the role of modified-FOLFIRINOX as neoadjuvant treatment for resectable PDAC.

This phase II study is designed to evaluate the efficacy and safety of modified FOLFIRINOX as neoadjuvant treatment for resectable pancreatic cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with pancreatic ductal adenocarcinoma confirmed by histological or cytopathological examination
2. Pancreatic adenocarcinoma patients evaluated as resectable according to the following criteria in imaging tests including CT or MRI (NCCN guideline criteria, if all of the following criteria are satisfied) A. No tumor contact with the major arterial structures of the Celiac axis \[CA\], superior mesenteric artery \[SMA\], and common hepatic artery \[CHA\].

   B. When there is no contact between the tumor and the major vein of the superior mesenteric vein (SMV) or portal vein (PV), or within 180° even if there is contact, and there is no venous atypicality.
3. Patients who have not undergone surgical resection and systemic chemotherapy for pancreatic cancer.
4. Patients whose ECOG activity ability index is 0 to 1
5. Patients who are willing and able to provide written informed consent for this study.
6. Patients over the age of 19 at the time of signing the subject consent form.
7. Patients with evaluable lesions according to RECIST 1.1.
8. Patients with adequate organ function.

Exclusion Criteria:

1. Histologic diagnosis other than pancreatic ductal adenocarcinoma (eg, neuroendocrine tumor, etc.)
2. Patients with distant metastases including central nervous system (CNS) metastases or peritoneal metastases
3. Patients with moderate acute or chronic medical conditions or abnormal findings on examination, which are judged to affect the results of this study
4. Patients who have participated in a study in which investigational drugs are used and are currently receiving investigational drugs or used investigational drugs or medical devices within 4 weeks prior to the first administration of this investigational drug.
5. Those who received chemotherapy, targeted small molecule agents, or radiotherapy within 2 weeks prior to Day 1 of the study, or who have not yet recovered (Grade 1 or lower or baseline level) from adverse reactions due to previously administered drugs patient.
6. Patients with known aggravation within the past 3 years or other malignant tumors requiring active treatment.
Comparison of Dehydrated Human Amnion-Chorion and Type 1 Bovine Collagen Membranes for Guided Bone Regeneration

The objective of this randomized clinical study was to evaluate the use of dehydrated human amnion-chorion membrane as an exposed barrier for guided bone regeneration (GBR) after tooth extraction and to determine whether intentional exposure of this membrane to the oral environment compromises ridge dimensions and bone vitality for implant placement.

Forty-three patients requiring extraction of at least one tooth and delayed implant placement were randomly assigned to either an experimental or a control group. For both groups, demineralized freeze-dried bone allograft was used to graft the socket. For the control group, Type I bovine collagen was used as a membrane; for the experimental group, human amnion-chorion membrane was used. For both groups, the barrier membranes were left exposed, and no primary closure was achieved. Patients returned for implant placement after a mean healing period of 19.5 weeks, at which time a core bone biopsy specimen 2 mm in diameter was obtained for histomorphometric analyses. Clinical ridge dimensions were measured at the times of extraction and implant placement.

Eligibility Criteria:
Inclusion Criteria: .

Patients included in the study were required:

* Not to be completely edentulous.
* To have at least 1 tooth that could not be saved and for which extraction and delayed implant placement were planned

Exclusion Criteria: Patients were excluded if they :

* Had received radiation therapy
* Were taking antiresorptive medication (i.e., bisphosphonate or denosumab)
* Had uncontrolled systemic disorders (such as uncontrolled diabetes, congestive heart failure, or acute odontogenic infections)
* Were smokers (more than 10 cigarettes per day)
* Were pregnant or breastfeeding.
Contact Lenses and Myopia

The objective of this study is to determine if multifocal contact lenses affect accommodation and/or binocular vision when worn by pediatric patients. This will be accomplished through subjective and objective accommodative and binocular experiments in children wearing single vision and multifocal soft contact lenses.


Eligibility Criteria:
Inclusion Criteria:

* 7 to 15 years of age
* Refractive error between -1.00 and -8.00 D sphere, with less than or equal to 1.00 D astigmatism
* Corrected visual acuity of 20/25 or better in each eye

Exclusion Criteria:

* Ocular or systemic disease known to affect accommodation or vision
* Convergence or accommodative disorder, or any strabismus
* Use of oral or topical medications known to affect accommodation
Evaluation of the Metabolic Surgery Technique for Glycemic Improvement in Type 2 Diabetes

Surgery is one of the management options for type 2 diabetes in patients with moderate obesity. This is a recent option because it has been part of the recommendations since October 2022.

The possible surgical techniques are the same as those for bariatric surgery:

* Sleeve,
* Bypass,
* Gastric band, but the main goal is not weight loss, it is remission of type 2 diabetes. It is called metabolic surgery.

The ring technique (gastroplasty) is practiced less and less in France because it is less effective in weight loss and is responsible for major discomfort.

Currently, metabolic surgery is one of the recommendations but no study has compared the effectiveness of the techniques with each other. One or other of the techniques can be chosen according to the preferences of the surgeon, the patient, the center, etc. but this choice is not made objectively, in the absence of comparative data.

This study would like to follow up on patients for whom metabolic surgery has been proposed by the doctor,.

If the surgery is accepted, this study would like to improve knowledge of the effectiveness of the different techniques, and thus demonstrate which metabolic surgery technique is preferred in terms of effectiveness and safety.


Eligibility Criteria:
Inclusion Criteria:

* adult patient and ≤ 65 years old
* T2D patient, with individualized glycemic objectives not achieved, despite medical care, in particular diabetological and nutritional, also including adapted physical activity, well conducted according to current good practice recommendations, for at least twelve months
* BMI between 30 and 34.9 kg/m²
* patient well informed beforehand about metabolic surgery and the study
* multidisciplinary evaluation (including a diabetologist) and decision on medical treatment by CM (date prior to inclusion)
* medical assessment of an acceptable surgical risk
* patient affiliated to or beneficiary of a social security system
* patient having freely signed the written informed consent

Exclusion Criteria:

* severe cognitive or mental disorders
* severe and unstabilized eating behavior disorders
* dependence on alcohol and licit and illicit psychoactive substances
* illnesses endangering life in the short and medium term
* contraindications to general anesthesia
* absence of identified prior medical care and foreseeable inability of the patient to participate in lifelong medical monitoring
* history of bariatric surgery
* pregnant or breastfeeding woman, or having a very long-term pregnancy plan short term (\&lt; 2 years)
* adult patient under guardianship or curatorship
* patient deprived of liberty or under judicial decision