cyrilzakka/clinical-trials huggingface dataset:
Food Effects on the Gut Microbiota

This is a small-scale study of the effects on microbes in the human gut of adding high-fiber snack foods to usual diet. The snack foods are being provided by Mondelez International, Inc. Eight pairs of dizygotic twins, discordant or concordant for obesity, will participate in the study. They will complete 3 successive experiments in which their regular diet is supplemented by consumption, over a 6-week period, of high-fiber snack foods. Each experiment will involve (i) two weeks consuming regular diet (fecal sample collected weekly); (ii) one week consuming one snack food per day (approximately 7 g fiber, collection of all fecal samples), (iii) one week consuming two snack foods per day (approximately 14 g fiber, collection of all fecal samples), (iv) four weeks consuming three snack foods per day (approximately 20 g fiber, collection of all fecal samples); and (v) two weeks consuming only regular diet (weekly collection of fecal sample). For each experiment, participants will also provide a fasting blood sample during the free diet phase at the end of the week just before initiation of snack consumption, and a fasting blood sample at the end of the last week of snack consumption. Participants will also collect one first morning urine sample weekly throughout the study. During week 2, participants will also collect first morning urine samples for 3 consecutive days. Similarly, they will collect first morning urine samples for the last 3 consecutive days of the last week of snack consumption. The study will test the effects of the different fiber-rich snacks on the composition and metabolic properties of the gut microbial community in lean and obese subjects.


Eligibility Criteria:
Inclusion Criteria:

\* member of female dizygotic twin pair discordant or concordant for obesity

Exclusion Criteria:

* pregnant or trying to get pregnant
* inflammatory bowel disease
* gastrointestinal cancer
* hepatitis
* HIV
* renal failure
* food allergies
Comparison Of The Effects Of Kinesiotape Application And Foam Roller Exercises

Low back pain is an important health problem that is common worldwide, with a lifetime prevalence of up to 80%.

Low back pain that lasts less than 6 weeks is called acute low back pain, if it continues for 6-12 weeks it is called subacute low back pain, and if it continues for more than 12 weeks it is called chronic low back pain. The majority of low back pain (97%) is of mechanical origin.

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic low back pain
* Individuals aged 18-60 years
* Patients without verbal communication barriers
* Patients without cognitive impairment (delirium, dementia, amnesia)

Exclusion Criteria:

* Exercise contraindication (uncontrolled medical conditions)
* Patients with previous spinal surgery
* Patients who develop an allergic reaction to the kinesiotape tape to be applied
Effect of Mental and Physical Training on Blood Pressure

Elevated blood pressure or prehypertension is highly associated with increased risk of developing hypertension, cardiovascular event, and type II diabetes. Many physically inactive young adults, particularly in Malaysia have blood pressure higher than normal range, therefore it is important to control the blood pressure within normal range as prophylactic measure. This experimental research will be carried out to study the effect of physical training (aerobic exercise) and mental training (mindfulness meditation) with diet as a control group on the systolic blood pressure, diastolic blood pressure and resting heart rate among young adult with elevated blood pressure living a sedentary lifestyle. Participant will be divided into 2 experimental groups (mental and physical training) and 1 control group (Dietary Approaches to Stop Hypertension -DASH diet plan) who need to complete the prescribed intervention for 6 weeks. Results will be analysed by repeated measures ANOVA followed by post-hic test.


Eligibility Criteria:
Inclusion Criteria:

* Male adults aged 18-25 years
* Normal BMI (18.5-24.9)
* Physically inactive
* SBP between 120-139 mmHg and/or DBP between 60-89 mmHg
* No hearing abnormalities
* Willing to participate

Exclusion Criteria:

* Participants who have cardiovascular, musculoskeletal, and neurological disorders or any other medical condition that would restrict them to participate in the exercise
* Those who are taking antihypertensive medications or other medications that will affect their BP and heart rate
* Participants who are currently engaging in any form of relaxation techniques such as yoga or meditation
* Individuals who are actively engaged in physical activities
Chronic Transplant Glomerulopathy and Regulation of Expression of Ephrin B1

The principal purpose is the study of the regulation of the expression of ephrin-B1 by immunofluorescence in kidney biopsies of patients with Chronic transplant glomerulopathy (CTG) compared to biopsies prior to the CTG, in same patients. Level of fluorescence in CTG biopsy will be the experimental reference value.

Chronic transplant glomerulopathy (CTG) is a specific lesion of kidney transplantation and a poor prognostic factor affecting transplant survival. Diagnosis remains only microscopic and lesions are irreversible. Recent studies prove that there is a strong correlation between CTG and antibody mediated rejection (AMR) with a possible link with chronic aggression of the endothelial cell. However, for unknown reason, all AMR does not lead to a CTG. Our recent data on mice demonstrated that ephrin-B1 is expressed in the glomerular endothelial cells and knockout mice for the gene encoding ephrin-B1 develop progressively ultrastructural glomerular lesions close to modifications observed in CTG, as well as proteinuria and chronic renal failure, suggesting that ephrin B1 could participate to CTG. Moreover, in a preliminary study on human kidney transplant biopsy we observed decrease in ephrin-B1 immunofluorescence on glomerulus when CTG, even in low grade. These data, and ultrastructural modifications in Knock Out (KO) mice suggest that early regulation of kidney expression of ephrin-B1 in the glomerulus may occur during the process leading to the CTG as antibody-mediated kidney rejection (AMR).

The purpose of the study is to determinate if ephrin-B1 expression is modified in CTG.

Eligibility Criteria:
Inclusion Criteria:

* Kidney transplant patient for whom renal biopsies are stored in the "collection of the University Hospital Toulouse" (collection N° DC-2009-989) and who received information on the purpose of the study, use of biopsies and who has not manifested any opposition.
* Kidney transplant patient with iterative biopsies with at least: post-surgery biopsy D0 (or early post-transplant biopsy D7 and at least one biopsy protocol. - Age\> 18 years Case group: - Kidney transplant patient, followed up by "organ transplant unity" of CHU Toulouse, with antecedent of CMR progressing to CTG between 2006 and 2013. Control group: - Kidney transplant patient, followed up by "organ transplant unity" of CHU Toulouse, with antecedent of CMR without progressing to CTG between 2006 and 2013

Exclusion Criteria:

* patient with uncontrolled hypertension - patient with diabetes mellitus -
* patient treated or who was treated with mTOR inhibitor - recurrence of the initial glomerular pathology - de novo glomerulopathy - patient including in another study with an exclusion period still going
Gabapentin for Postoperative Pain Management After Cardiac Surgery With Median Sternotomy

In this study we will focus on the postoperative recovery. A successful postoperative recovery should bring the patient to at least to the pre-surgical level. This can probably be achieved by a multimodal approach where at least postoperative pain and PONV are managed.

The surgical injury results in immobilisation which again can result in impaired cardiac, respiratory and musculoskeletal system. Pain relief is a prerequisite for mobilisation and an early return to the pre-surgical level. The preferred drugs for postoperative pain management are opioids. Although opioids are known to be an effective analgesia, they have a series of side effects: nausea, vomiting, constipation, respiratory deficiency, delirium among others.

Gabapentin has been tested for post operative pain. Randomized Clinical Trials have reported a significant better pain scores with Gabapentin in several studies -most of them restricted to the postoperative period in the post-anaesthesia care unit in many different kind of surgeries.

We want to test if Gabapentin can be used instead of opioids for treatment of postoperative pain after heart surgery by median sternotomy.


Eligibility Criteria:
Inclusion Criteria:

1. Patients scheduled for elective cardiac surgery with median sternotomy at the department of cardiac surgery, Aarhus University Hospital, Skejby.
2. Patients older than 18 years.

Exclusion Criteria:

1. Patients unable to cooperate.
2. Known allergy for Gabapentin or opioids.
3. Acute pancreatitis
4. History of gastric or peptic ulcer.
5. History of alcohol or drug abuse.
6. Chronic pain or daily intake of analgesics or corticosteroids.
7. Gastrointestinal obstruction
8. Impaired liver function.
9. Impaired kidney function.
10. Previous operation with median sternotomy
11. Pregnant women
Beta-1,3/1,6-D-Glucan Ganoderma Lucidum on Ulcerative Colitis

The aim of this study is to determine the efficacy and safety of Beta-1,3/1,6-D-Glucan from mycelium extract of Ganoderma lucidum on ulcerative colitis


Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years old
* ulcerative colitis patients who are treated by 5-aminosalicylic acid (5-ASA) 3x500 mg
* agreed to participate in this study

Exclusion Criteria:

* ulcerative colitis patients who are treated by corticosteroid, immunosuppressive agents and biologic agents
* allergic to Ganoderma lucidum
* could not be randomised and participate in this study by clinical judgement
Institut Fuer Diabetes-Technologie Surveillance Program

Assessment of the system accuracy of different blood glucose monitoring systems available in Europe

A variety of blood glucose monitoring systems (BGMS) are available on the European market. For many of these BGMS, the system accuracy is unknown or it has not yet been assessed in manufacturer-independent studies. The IDT surveillance program aims at assessing the system accuracy of different BGMS that are available in Europe in a manufacturer-independent, investigator-initiated study. The initial study will cover 18 BGMS from 18 different manufacturers. Per BGMS, one test strip lot will be assessed based on procedures stated in the international standard ISO 15197:2013 / EN ISO 15197:2015.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, with type 1 diabetes, type 2 diabetes or subjects without diabetes
* Signed informed consent form
* Minimum age of 18 years
* ubjects are legally competent and capable to understand character, meaning and consequences of the study.
* If blood glucose values \< 80 mg/dl or \> 300 mg/dl shall be measured after short term alteration in insulin therapy:
* Male or female with type 1 diabetes and intensified insulin therapy or insulin pump therapy.
* Signature of subjects to document consent with these procedures on informed consent form.

Exclusion Criteria:

* Pregnancy or lactation period
* Severe acute disease (at the study physician's discretion)
* Severe chronic disease with potential risk during the test procedures (at the study physician's discretion)
* Current constitution that compromises the subject's capability to participate in the study (at the study physician's discretion)
* Being unable to give informed consent
* \< 18 years
* Legally incompetent
* Being committed to an institution (e.g. psychiatric clinic)
* Language barriers potentially compromising an adequate compliance with study procedures
* Dependent on investigator or sponsor
* If blood glucose values \< 80 mg/dl shall be measured after short term alteration in insulin therapy, subjects with type 1 diabetes, suffering from:
* Coronary heart disease
* Condition after myocardial infarction
* Condition after cerebral events
* Peripheral arterial occlusive disease
* Hypoglycemia unawareness
Repair Versus Non-repair of the Aortic Arch in Type A Aortic Dissection

Acute Stanford type A aortic dissection (TAAD) is a life-threatening clinical status requiring surgery that is usually performed as a salvage procedure.We planned a multicenter study to evaluate the balance between the patient's condition and those therapeutic strategies that may limit the risk of late adverse events in patients who will be underwent surgery for appropriate management of TAAD

Substantial evidence has suggested a decrease of early mortality during the last years, however recently the Nordic Consortium for Acute Type A Aortic Dissection registry recorded 18% of 30-day mortality after surgery for ATAAD. Similarly, the prospective German Registry for Acute Aortic Dissection Type A confirmed this data reporting a 30-day mortality of 16.9%. Again, results from recent analysis of the Society of Thoracic Surgeon database that report 7353 procedures from 2014 and 2017 for acute TAAD revealed a 30-day mortality of 17%. Understanding the balance between the patient's conditions which may not allow extensive procedure and those treatment strategies which may limit the risk of late adverse events in patients who remain alive long after the surgery is essential for an appropriate management of ATAAD. The best treatment option in patients with ATAAD is dictated by the balance between patient conditions that may not allow for extensive procedures and those more conservative treatment strategies that limit the risk of late adverse events in patients who remain alive long after surgery. surgery. However, previous evidence from large series of patients do not provide information on the long-term durability of these procedures.

Here investigators planned a multicenter study to evaluate the contemporary early outcomes and duration of different surgical strategies for 15-year acute ATAAD in a large study population.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged \> 18 years
* TAAD or intramural hematoma involving the ascending aorta
* Symptoms started within 7 days from surgery
* Primary surgical repair of acute TAAD
* Any other major cardiac surgical procedure concomitant with surgery for TAAD.

Exclusion Criteria:

* Patients aged \< 18 years
* Onset of symptoms \> 7 days from surgery
* Prior procedure for TAAD
* Concomitant endocarditis;
* TAAD secondary to blunt or penetrating chest trauma.
Patients Visit Prior to Hospital Admission & Intensive Care Unit

The present study evaluates the effects of the visit prior to hospital admission on anxiety, depression and satisfaction of patients in an intensive care unit.


Eligibility Criteria:
Inclusion Criteria:

* Patient at hospital admission for surgery

Exclusion Criteria:

* Cognitive impairment
Effects of Antihypertensive Drug Treatment on Brain Blood Flow, Cognition, and Regulation of Nervous System in Older Adults with Hypertension.

High blood pressure (BP) is a public health problem worldwide. Nearly three-quarters of older adults (age \~60 years) in the United States have high BP. High BP links to many health problems, like stroke. Drug treatments are typically used in clinics to reduce high BP and the risk of associated health problems. However, these drug treatments may not always benefit brain health. For example, drug treatment may reduce brain blood flow, which may reduce cognitive function in older adults with high BP. Alternatively, reduced brain blood flow may cause high BP due to increased nervous system activity (the so-called "fight or flight response"). Thus, monitoring brain blood flow may help to manage high BP during drug treatment.

It is unknown if brain blood flow and its control will be altered by drug treatment in older high BP patients. Therefore, study team will recruit older adults with high BP, who receive either drug treatment or a placebo for 2 weeks and will assess brain blood flow, cognitive function, and nervous system control before and after treatment.

Results from this study will provide novel and clinically relevant information on the impact of drug treatment for high BP on brain health. Investigators expect these results will suggest that it is crucial to measure brain blood flow, which may be a therapeutic new target for BP control and brain health.


Eligibility Criteria:
Inclusion Criteria:

* Older men and women with mild-to-moderate essential hypertension (60-85 years, clinic systolic BP 130-159 and/or diastolic BP 80-109 mmHg)

Exclusion Criteria:

* Any evidence of cardiovascular or pulmonary disease by medical history or by physical examination
* Severe hypertension (systolic BP ≥160 and/or diastolic BP ≥110 mmHg; for safety reasons) or secondary hypertension
* Being on ≥3 antihypertensive agents
* Chronic kidney disease (an estimated glomerular filtration rate \&gt;45 mL/min) or renal failure
* Diabetes mellitus (fasting glucose ≥126 mg/dL or 2-hour oral glucose tolerance test, glucose level ≥200 mg/dL) or other systemic illness
* Any history of substance abuse (other than tobacco)
* Current cigarette smokers
* History of gouty arthritis
* Taking hormonal replacement therapy
* Endurance-trained athletes
* Diagnosed Alzheimer's disease and related dementias
A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated With Metformin With or Without an SGLT2 Inhibitor

This study will look at how well CagriSema helps people with type 2 diabetes lower their blood sugar and body weight. CagriSema is a new investigational medicine. Doctors may not yet prescribe CagriSema. CagriSema will be compared to a medicine called tirzepatide that doctors may prescribe in some countries. Participants will get either CagriSema or tirzepatide. Which treatment participant get is decided by chance like flipping a coin. Participant will have an equal chance of receiving either drug. For each participant, the study will last for up to one and a half years.


Eligibility Criteria:
Inclusion Criteria:

* Male or female (sex at birth).
* Age 18 years or above at the time of signing the informed consent.
* Diagnosed with type 2 diabetes ≥ 180 days before screening.
* Stable daily dose(s) ≥ 90 days before screening of any of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose as judged by the investigator: metformin with or without an sodium-glucose co-transporter-2 (SGLT2) inhibitor.
* HbA1c 7.0-10.5% (53-91 mmol/mol) (both inclusive) as determined by central laboratory at screening.
* Body mass index (BMI) of ≥ 30.0 kilogram per square meter (kg/m\^2) at screening. BMI will be calculated in the electronic case report form (eCRF) based on height and body weight at screening.

Exclusion Criteria:

* Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method.
* Renal impairment with estimated Glomerular Filtration Rate \< 30 milliliter per minute per 1.73 square meter (mL/min/1.73 m\^2) as determined by central laboratory at screening.
* Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed.
* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by an eye examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
Study Evaluating Bifeprunox in Bipolar Depression

The purpose of the study is to investigate whether eight weeks of treatment with flexible doses of bifeprunox is superior to treatment with placebo in depressed patients with bipolar disorder.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of bipolar disorder
* Experiencing a depressive episode
Three-Arm Study of the Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis

The objectives of this study are to assess the safety and efficacy of treatment with pirfenidone 2403 milligrams per day (mg/d) compared with placebo in patients with idiopathic pulmonary fibrosis (IPF), to assess the safety and efficacy of treatment with pirfenidone 1197 mg/d in patients with idiopathic pulmonary fibrosis and to characterize the pharmacokinetic disposition of pirfenidone in patients with idiopathic pulmonary fibrosis.

This is a Phase 3, randomized, double blind, placebo-controlled, three-arm, safety and efficacy study of pirfenidone in patients with idiopathic pulmonary fibrosis. Approximately 400 patients at approximately 70 centers will be randomly assigned (2:2:1) to receive either 2403 milligrams (mg) of pirfenidone, placebo equivalent, or 1197 mg of pirfenidone administered in divided doses three times per day (TID) with food. Patients will be randomized by geographic region.

Patients will receive blinded study treatment from the time of randomization until the last patient randomized has been treated for 72 weeks. A Data Monitoring Committee (DMC) will periodically review safety and efficacy data to ensure patient safety.

After week 72, patients who meet the Progression of Disease (POD) definition, which is a ≥ 10% absolute decrease in percent predicted FVC or a ≥ 15% absolute decrease in percent predicted carbon monoxide diffusing capacity (DLco), will be eligible to receive permitted IPF therapies in addition to their blinded study drug. Permitted IPF therapies include corticosteroids, azathioprine, cyclophosphamide and N-acetyl-cysteine (with restrictions).

Eligibility Criteria:
Primary Inclusion criteria:

* diagnosis of idiopathic pulmonary fibrosis
* 40 to 80 years of age
* Forced Vital Capacity greater than or equal to 50% predicted value
* Carbon monoxide diffusing capacity greater than or equal to 35% predicted value
* either Forced Vital Capacity or Carbon monoxide diffusing capacity less than or equal to 90% predicted value
* no improvement in past year
* able to walk 150 meters in 6 minutes and maintain saturation greater than or equal to 83% while on no more than 6 liters per minute (L/min) supplemental oxygen

Primary Exclusion criteria:

* unable to undergo pulmonary function testing
* evidence of significant obstructive lung disease or airway hyper-responsiveness
* in opinion of investigator patient is expected to need and be eligible for a lung transplant within 72 weeks after randomization
* active infection
* liver disease
* cancer or other medical condition likely to result in death within 2 years
* diabetes
* pregnancy or lactation
* substance abuse
* personal or family history of long QT (Q wave,T wave) syndrome
* other IPF treatment
* unable to take study medication
* withdrawal from other IPF trials
Enteropathogenic Escherichia Coli (EPEC): Does it Have a Role in Colorectal Tumourigenesis?

Despite the characterization of many aetiologic genetic changes. The specific causative factors in the development of sporadic colorectal cancer remain unclear. This study was performed to detect the possible role of Enteropathogenic Escherichia coli (EPEC) in developing colorectal carcinoma.

Fresh biopsy specimens have been obtained from the colonic mucosa overlying the colorectal cancer as well as from the colon of the healthy controls. Culture, genotyping and virulence of EPEC were done using (nutrient broth culture, and PCR). Strains biochemically identified as E. coli were selected from the surface of a MacConkey's plate and were serogrouped by slide agglutination tests

Eligibility Criteria:
Inclusion Criteria:

* patients with colorectal carcinoma after have been diagnosed

Exclusion Criteria:

* Patients with inflammatory bowel disease (IBD) or macroscopic signs of inflammation were excluded.