cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Heterologous FMT by SQIMC-md Capsule in Mild-moderate Ulcerative Colitis Patients

This study aims to assess the safety and efficacy of heterologous fecal microbiota transplantation (FMT) by Standardized Quantitative multi-donor Intestinal Microbiota Capsule (SQIMC-md) in mild-moderate ulcerative colitis patients who fail to achieve clinical remission over 4 weeks after full dose 5-Aminosalicylic acid(5-ASA). Intestinal microbiota transplant for FMT will be prepared from multiple healthy donors and prepared by standardized procedure with fixed quantitative dosage. This strategy might offer a novel and safe therapeutic approach for these patients before step up to corticosteroid, immunosuppressant or biologics therapy.

All candidates for mild-moderate ulcerative colitis treated in Dept. Gastroenterology, Tongji Hospital, Tongji Medical College of HUST, the second Xiangya Hospital of central south university and the first affiliated Hospital of Zhengzhou University will be screened for study inclusion and exclusion criteria. All consenting patients will 2:1 randomized into SQIMC-md treatment group or Placebo group. Three dose of SQIMC-md capsule will be orally administrated on day1, day2 and day3. Follow-up will be performed every 4 weeks and last for 12weeks. Full dose of 5-ASA is orally administrated simultaneously during the study. Clinical data and outcome will be collected and documented in electronic case reported form (eCRF).

FMT DONORS:

Potential healthy adult stool donors (between 18 and 28 years of age) will be recruited by the research staff. They will be asked to volunteer for the screening and regularly supply stool samples according to the study protocol.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must have a diagnosis of ulcerative colitis based on clinical symptoms, as well as laboratory and colonoscopic findings, including histopathologic results of the intestinal mucosa.
2. Ulcerative Colitis complete Mayo score range from 4 to 10 \[mild-moderate activity\] and Mayo endoscopic score ≥2 as assessed within 4 weeks prior to enrollment and clinical symptoms that are at least stable.
3. Patients failed to acquire clinical remission after full dose and adequate course (4 weeks) of 5-ASA or precursors treatment.
4. Patients ≥ 18 and \< 70 years of age are eligible for this trial.
5. All patients must sign a written informed consent document. Assent, when appropriate, will be obtained according to institutional guidelines.

Exclusion Criteria:

1. Human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS) or other severe immunodeficiency
2. Patients with severe prior allergic reaction to food or supplementary material of placebo will be excluded from the protocol.
3. Patients who are pregnant or lactating will be excluded from the protocol.
4. Suspected as CMV or EBV colitis by endoscopic findings and proved by immunohistochemistry and biopsy PCR.
5. Decompensated life-threatening disease including but not restricted to liver cirrhosis (bleeding varices, ascites, encephalopathy or icterus), heart attack, malignancy and so on.
Biological MArkers of FRAilty in Elderly Subjects

Epidemiological data from Europe have shown that around 30% of subjects aged over 65 years of age are pre-frail, and 15% are frail. Recent research has demonstrated that identifying frailty and implementing preventive measures can help to slow cognitive decline. Screening and treating frailty seem to be a good start towards preventing dependency.

On the premise that this frailty is the result of more pronounced tissue alterations in certain elderly subjects, assessment of post-translational modification derived products (PTMDP) represents an innovative evaluation method. These include advanced glycation end-products (AGE), and carbamylation-derived products (homocitrulline). Indeed, the intensity of these modifications increases with ageing, and assessing the products resulting from these alterations could show the existence of differences according to frailty status. This would make it possible to adapt treatment accordingly in elderly subjects.


Eligibility Criteria:
Inclusion Criteria:

* With social security coverage
* Accept to participate in the study and sign informed consent for the study and for the collection of biological samples

Exclusion Criteria:

- \< 65 yo
Evaluation of Efficacy of Two Therapeutic Strategies for Cervical Maturation Before Medical Termination

Reducing the time patients spend in the labor and delivery room saves money and reduces patient discomfort as well and reducing complications. We will compare two methods for inducing cervical maturation in order to shorten the time taken between administration of drugs and delivery.


Eligibility Criteria:
Inclusion Criteria:

* The patient must have given their free and informed consent and signed the consent form
* The patient must be a member or beneficiary of a health insurance plan
* The patients is at least 18 years old
* Patient with a singleton pregnancy between 14 and 34 weeks gestation with an indication for medical termination due to maternal or fetal problem as validated by pluridisciplinary prenatal diagnosis center.

Exclusion Criteria:

* The subject is participating in an interventional study or is in a period of exclusion determined by a previous study
* The patient is under safeguard of justice
* The subject refuses to sign the consent
* It is impossible to give the subject informed information
* Patient has vaginismus
* Patient has a cervix permitting artificial rupture of membrane
* Patients taking one of the following treatments, contraindicated for mifepristone: ketoconazole, itraconazole, erythromycin, grapefruit juice, rifampicin, dexamethasone, St John's wort and certain anti-convulsants (phenytoin, phenobarbital, carbamazepine).

Patients contraindicated for oxytocine.
An Open-Label Extension Study to Evaluate the Safety and Tolerability of RWJ 333369 as Adjunctive Therapy in Patients 16 Years and Older With Partial Onset Seizures.

The purpose of this open-label extension study is to demonstrate that RWJ-333369 is safe as long-term add-on treatment of partial onset seizures.

333369EPY3004 is the open-label extension study that follows the double-blind studies 333369EPY3001 and 333369EPY3002 (NCT00425282 and NCT00433667, respectively). In an open label study such as 333369EPY3004, both the physician and the patient know the name of the assigned study medication. In a double blind study such as 333369EPY3001 and 333369EPY3002, neither the physician nor the patient knows the name of the assigned study medication. Patients who complete the double-blind treatment phase of studies 333369EPY3001 and 333369EPY3002 will be eligible to enter the open-label extension study 333369EPY3004 during which patients will transition through a blinded period to an open-label period with carisbamate (also referred to as RWJ-333369). There will be a blinded transition during which patients will take blinded study medication; after this, patients will then take unblinded, open-label study medication. No patients will receive placebo during the open-label extension. Safety assessments include the monitoring of the frequency, severity, and timing of adverse events, clinical laboratory test results, 12-lead electrocardiogram (ECG) recordings, vital signs measurements, physical and neurologic examinations, the Physician Withdrawal Checklist for symptoms of withdrawal for those patients who taper and/or discontinue study drug, and pregnancy tests for females of childbearing potential. Seizure counts will be obtained at every visit. A Quality of Life in Epilepsy questionnaire will be administered during the study. There is no statistical testing hypothesis for this study. Detailed Description update,5 Oct 2009. The Sponsor in conjunction with the DSMB agreed to amend the protocol to withdraw patients who develop signs of a drug hypersensitivity reaction. Open-label treatment with carisbamate 400 mg/day (up to a maximum of 1200mg/day) given in 2 equally divided doses BID for up to 1 year; study drug should be swallowed whole and not be chewed, divided, crushed, or dissolved.

Eligibility Criteria:
Inclusion Criteria:

* In order to enter the open label extension, the patient must have completed either Study 333369EPY3001 or Study 333369EPY3002.

Exclusion Criteria:

* Generalized epilepsy
* Currently experiencing seizures that cannot be counted accurately
* Unstable medical disease, such as a recent heart attack or uncontrolled diabetes
* Major psychiatric illness
* Recent drug or alcohol abuse
* Unable to swallow pills
Cardiac Steatosis in Cushing's Syndrome

This study aims at evaluating the myocardial triglyceride content and cardiac structure and function, using 1H magnetic resonance spectroscopy and cardiac magnetic resonance imaging, in patients with Cushing's syndrome before and after treatment and in age-, sex- and BMI-matched healthy volunteers. The investigators make the hypothesis that Cushing's syndrome patients compared to healthy subjects present with excess lipid storage in cardiac myocytes, reversible upon correction of hypercortisolism.

Despite skeletal muscle atrophy, Cushing's syndrome patients have an increased Left Ventricular mass, reversible upon correction of the hypercortisolism. This may be due to cardiac steatosis, previously demonstrated in patients with diabetes mellitus. This study aims at evaluating the myocardial triglyceride content and cardiac structure and function, using 1H magnetic resonance spectroscopy and cardiac magnetic resonance imaging (CMRI), in patients with Cushing's syndrome and in age-, sex- and BMI-matched healthy volunteers. The patients will be stratified into two groups in function of the presence or absence of diabetes mellitus or impaired glucose and will be evaluated twice: before and 6 months after efficient treatment of Cushing's syndrome. We make the hypothesis that Cushing's syndrome patients compared to healthy subjects have excess lipid storage in cardiac myocytes irrespectively of the glucose homeostasis status, and that this lipid content will decrease after the correction of hypercortisolism.

Eligibility Criteria:
Inclusion Criteria:

* group 1 and 2: patients with overt Cushing's syndrome, with 24-hour urinary free cortisol excretion over the two fold of the upper limit of the normal, with (group 1) or without (group 2) diabetes mellitus or glucose intolerance
* group 3: healthy volunteers matched for age, sex and BMI with the patients of the group 2

Exclusion Criteria:

* contraindication of MRI
* hypersensitivity to gadolinium
* acute myocardial ischemia
* renal insufficiency (creatinin clearance 30 mL/min/l,73m2)
* pregnancy
14 vs 24 Weeks HCV Treatment to Genotype 2/3 Patients With Rapid Virological Response

Patients with HCV genotype 2 or 3 infection who have a rapid virological response to treatment are randomised to either 14 or 24 weeks HCV treatment. Our hypothesis is that there is no important difference in effect between the two treatment effect.

Patients with HCV genotype 2 or 3 infection are currently recommended 6 months treatment with pegylated interferon alfa (2a or 2b) and ribavirin.Approximately 80% obtain sustained virological response (HCV RNA undetectable 6 months after treatment) to this approach. However, the treatment is associated with many and sometimes serious side effects. In addition, the treatment is costly also in econimical terms. Increasing the treatment duration beyond 6 months does not increase the response rate. Shorter treatment has only been assessed in small trials, but the results have been encouraging.

In this randomised, open label,multicenter phase 3 trial with acitive controls patients are treated with pegylated interferon alfa 2a (PegIntron (R), Schering Plough NJ)(1,5 mcg/kg)and ribavirin (Rebetol (R), Schering Plough, NJ) (800-1400mg based on weight)for 4 weeks. Those who are HCV RNA negative at week 4 (\<50 IU; Cobas Amplicor Monitor Test, Roche Diagnostic) are defined as rapid virological responders and randomised to either an additional 10 or 20 weeks combination treatment. Patients who are HCV RNA positive are all treated for 20 more weeks. The endpoint is sustained virological response defined as undetectable HCV RNA 24 weeks after end of treatment.

Our hypothesis is that there is no important difference in the effect in the two groups.

This is a non-inferiority trial. The smallest difference considered to be clinically important is 10%. Thus to state "non-inferiority" the 95% confidence interval of the observed difference between the groups shall not overlap 10%. Both intention to treat and and per protocol analyses will be published. Conclusion will be conservative and based on the analysis who detect the biggest difference.

Eligibility Criteria:
Inclusion Criteria:

HCV RNA positive Genotype 2 or 3 Treatment naive Raised ALT

-

Exclusion Criteria:

Active substance abuse Poorly controlled psychiatric disease Decompensated cirrhosis HBsAg positive Anti-HIV positive Suffering from other significant concurrent medical conditions including chronic liver diseases -
fMRI Feasibility Older Hip Fracture Surgery

An assessment of the feasibility of structural and functional magnetic resonance imaging (MRI) brain scans in older people who have recovered from and older people who never had delirium after hip fracture surgery

Postoperative delirium, an acute sate of confusion occurs with higher frequency in older people. Hip fracture surgery is a procedure associated with an increased risk of postoperative delirium.

In the study the feasibility of achieving structure and functional connectivity imaging of the brain, using magnetic resonance imaging, in older people who are recovering from hip fracture surgery will be assessed.

People who have recovered from post operative delirium and people who did not have postoperative delirium will be included.

Eligibility Criteria:
Inclusion Criteria:Age

* Age ≥ 65 years
* Cognitively intact
* primary admission for hip fracture surgery

Exclusion Criteria:

* Cognitive impairment
* Less than moderate level of activities of daily living
* History of neurosurgery/significant head trauma
* Acutely unwell/moribund
* Presence of neurological diseases including overt stroke, dementia, multiple sclerosis, Parkinson's disease, intracranial tumours and other significant neurologic disorders.
* Postural or movement disorders likely to impede MRI scan
* Contraindications to MRI
* Complex fractures/multiple injuries
Photo Biomodulation Therapy for Alveolar Osteitis Recovery in Oral Contraceptive Users

does laser effect on alveolar osteitis recovery in oral contraceptive users ?

photo biomodulation therapy for alveolar osteitis recovery in oral contraceptive users

Eligibility Criteria:
* Inclusion Criteria:

Female patients aged 25-40 years. Currently using oral contraceptives for at least 3 months prior to participation.

Diagnosed with dry socket (alveolar osteitis) based on clinical criteria.

* Exclusion Criteria:

Presence of systemic diseases (e.g., diabetes, immunodeficiency disorders). Smoking or tobacco use. Allergies to zinc oxide or other study materials. Use of antibiotics or anti-inflammatory medications within the last 2 weeks. Pregnancy or breastfeeding.
A Study of Absorption, Metabolism, Excretion and Mass Balance After a Single Dose Administration of MK-0941 (MK-0941-016)(COMPLETED)

A single dose, open label study to characterize the routes of elimination and determine the mass balance of MK-0941. A single 40 mg dose of MK-0941 will be given orally to male participants with type 2 diabetes. After drug administration, blood, urine, and fecal samples will be collected to determine relative quantities of 14C-labeled MK-0941.


Eligibility Criteria:
Inclusion Criteria:

* Subject has been diagnosed with type 2 diabetes, and is being treated with diet and exercise or with an oral anti-hyperglycemic agent
* Subject is willing to follow the American Heart Association diet and exercise program throughout the study
* Subject is a nonsmoker and/or has not used nicotine products for at least 6 months

Exclusion Criteria:

* Subject has a history of stroke, seizures, or major neurological disorder
* Subject has a history of neoplastic disease
* Subject has recently had abnormal bowel habits, such as diarrhea, loose stools or constipation
* Subject has a history of type 1 diabetes mellitus
* Subject has received insulin within the past 12 weeks
* Subject has a recent history of eye infection
* Subject has been diagnosed with glaucoma or is blind
* Subject consumes more than 3 alcoholic beverages per day
* Subject consumes more than 6 servings of coffee, tea, cola per day
* Subject has had major surgery, donated or lost blood in the past 4 weeks
* Subject has multiple or severe allergies to any food or drugs
Excess Skin and Physical Activity

Introduction: Currently, bariatric surgery appears to be the most effective treatment to improve the health of morbidly obese population. However, the massive weight loss induced by this intervention can create excess loose skin in various parts of the body contributing to the feeling of failure in their desire to feel better in some patients. Several studies show that people are once again disappointed and dissatisfied with their body appearance due to the mass of unsightly loose skin that disrupts their quality of life. However, very few studies have focused on the barriers that this excess skin could create in everyday physical activity. The aim of the investigators pilot study is to assess the impact of excess skin on the practice of physical activity in women who underwent bariatric surgery and evaluate if there is a relationship between physical activity and the level and location of excess skin. Also, the investigators will explore, the benefits of plastic surgery in patients who had this intervention.

Materials and methods: About twenty women who underwent bariatric surgery and a dozen who had subsequent plastic surgery will be included in this pilot study. Anthropometry, weight loss post bariatric and plastic surgery, motivational stage on the practice of physical activity, usual practice of physical activity, functional and physical ability, perceived benefits and barriers of physical activity, self-esteem and quality of life will be assessed. After analyzing the results, a group discussion will be established to further evaluate the impact of excess skin on the practice of physical activity. The evaluation will be identical for monitoring the effects of plastic surgery but the discussion group will also address the benefits and satisfaction related to plastic surgery.

Expected results: Excess skin could be a barrier to physical activity by limiting the functional and physical capacity. Thus, plastic surgery could improve the practice of physical activity with a direct improvement of functional discomfort, the subjects' motivation to be physically active, perceived benefits and barriers to physical activity, self-esteem and quality of life.

Issue project: This pilot project will generate data that will allow us, depending on the relevance of the results, to continue the investigators investigation with a larger cohort.


Eligibility Criteria:
Inclusion Criteria:

* have underwent bariatric surgery more than 1 year ago
* had a weight loss of at least 20% after bariatric surgery
* had a weight change of less than 5 kg in the last 3 months
* woman \> 18 years old
* have read and given consent

Inclusion Criteria for the group post-plastic:

* have underwent a plastic surgery at least 6 months ago

Exclusion Criteria:

* medical contraindication for physical activity
* major functional limitations : failure to realize different tests
* intellectual disability and/or neuropsychological disease
* not being able to speak or understand french
Recovery of Patients From COVID-19 After Critical Illness

Patients who are critically ill with COVID-19 requiring life support in an intensive care unit (ICU) have increased risk of morbidity and mortality. Currently the ICU community does not know what effect the disease, the ICU admission, physiotherapy interventions and life support have on their long-term quality of life and whether they can return to their pre-illness level of function following ICU.

COVID-Recovery will describe the physiotherapy interventions delivered to critically ill patients with COVID-19. In survivors, COVID-Recovery will utilise telephone follow-up of ICU survivors to assess disability-free survival and quality of life at 6 months after ICU admission. Additionally, COVID-Recovery will identify if there are predictors of disability-free survival. COVID-Recovery will aim to select up to 300 patients diagnosed with COVID-19 from ICUs in Australia. If they survive to hospital discharge, patients will be invited to receive a telephone questionnaire at 6 months after the ICU admission that aims to assess their long-term outcomes, including physical, cognitive and emotional function, quality of life, and whether they have been able to return to work following ICU discharge.

To describe the experience of critical illness in survivors of COVID-19 and their family members.

To explore and describe functional recovery, respiratory system function and respiratory health morbidity up to 6 months after ICU admission in persistently critically ill adults with COVID-19


Eligibility Criteria:
Inclusion Criteria:

1. COVID-19 patients who have been admitted to ICU for \> 24 hours
2. Patients aged over 17 years

Persistent critical illness cohort

1. As above
2. An ICU admission of at least 10 consecutive days

Exclusion Criteria:

* Previous enrolment in this study in a prior ICU admission
Early transfusIon of Convalescent Plasma in Elderly COVID-19 Patients. to Prevent Disease Progression.

Older age is an independent poor outcome predictor among COVID-19 hospitalized patients . Among 72,314 COVID-19 cases, case fatality rate (CFR) was 2.3% in total population, 8% in people aged 70 to 79, and 14.8% in those aged 80 and older. In the whole population, CFR was higher in people with comorbidities, ranging from 5-6% in persons with hypertension, chronic respiratory disease, diabetes or cancer, up to 10% in those with cardiovascular diseases. Sars-CoV-2 seems to be able to induce a functional exhaustion of specified T and NK lymphocyte subpopulations, breaking down antiviral immunity. One possible explanation is that the immune system of elderly people, might be exhausted by chronic stimulation associated with comorbidities and more susceptible to this Sars-CoV-2 effect. As a result, in these patients, the activation of the innate immune system might fail to produce an adequate adaptive response (i.e., virus-specific CD8+ T-cells). This results in persistent self-induced inflammation that eventually causes mortality.

The investigators hypothesize that transfusing convalescent plasma (containing neutralizing antibodies) at an early phase of COVID-19 infection could prevent or switch off the persistent inflammatory response elicited by the virus.

The objective of this study are:

* To demonstrate the superiority of COVID-19 convalescent plasma (CCP) plus standard therapy (ST) over ST alone
* To prevent progression of pneumonia in COVID-19 patients aged ≥65 with chronic comorbidities
* To decrease viral load
* To raise anti-SARS-CoV-2 antibody titer in recipients


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 65
* pneumonia at CT scan
* PaO2/FiO2 ≥300 mmHg
* Presence of one or more comorbidities (consider the list provided in Appendix A)
* Signed informed consent

Exclusion Criteria:

* Age \< 65
* PaO2/FiO2 \< 300 mmHg
* pending cardiopulmonary arrest
* refusal to blood product transfusions
* Severe IgA deficiency
* any life-threatening comorbidity or any other medical condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion