cyrilzakka/clinical-trials huggingface dataset:
Effectiveness and Safety of Berberine Hydrochloride and Bifidobacterium in People With Abnormal Glucose Level

The aim of this study is to assess the beneficial effects of Bifidobacterium and Berberine Hydrochloride on lowering glucose and delaying progress to diabetes in patients with prediabetes and to detect the potential mechanism.

Gut microbiota may play an important role in patients with prediabetes. Berberine, which is usually used as an antibiotic drug, has been reported a potential glucose-lowering effect in vitro and in vivo studies. Bifidobacterium, as a familiar probiotics, can modulate gut microbiota and improve glucose and lipid metabolism in animal experiments. Therefore, the aim of this study is to assess the beneficial effects of Bifidobacterium and Berberine Hydrochloride on lowering glucose and delaying progress to diabetes in patients with prediabetes and to detect the potential mechanism.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before any trial-related activities.
* Male or female between 18 and 70 years of old.
* 19≤Body mass index(BMI)≤30kg/m\^2.
* No participate in any clinical trial at least 3 months.
* Diagnosed impaired fasting glucose(IFG) and impaired glucose tolerance(IGT) or Diabetes.
* In visit 1, 5.60mmol/L≤Fasting plasma glucose(FPG)\<8.0mmol/L; in visit 2, 6.1≤FPG\<8.0mmol/L or 7.8≤2-hour postprandial plasma glucose(2h-PPG) \<17mmol/L.
* Females in child-bearing period should be given birth control.
* No severe disease about heart, lung and kidney.

Exclusion Criteria:

* Type 1 diabetes
* Diabetes patients with previously treated or untreated FPG ≥ 8 mmol/L or 2-h PPG ≥ 17 mmol/L;
* Women of childbearing potential who are pregnant, breastfeeding or intend to become pregnant or are not using adequate contraceptive methods.
* Those who are allergic to study drugs
* Unable to cooperate
* Abnormal liver function, ALT and AST are more than 2 times of the normal upper limit
* Renal injury, blood creatinine ≥133 µmol/L
* Poor blood pressure control, systolic blood pressure SBP≥160mmHg and/or diastolic blood pressure DBP≥95mmHg
* Patients with chronic gastrointestinal diseases (pancreatitis, inflammatory bowel disease) and history of intestinal surgery
* Patients with severe heart disease, such as heart failure, unstable angina pectoris, acute myocardial infarction
* Chronic hypoxic diseases such as emphysema, pulmonary heart disease
* Having obvious diseases of the blood system
* Persons with tumor diseases
* Endocrine diseases, such as hyperthyroidism and hypercortisolism
* Mental illness, abuse of alcohol, drugs or other substances
* Persons with long-term oral or intravenous corticosteroid hormones therapy
* Having stress conditions such as surgery, severe trauma, etc.
Beta-Hydroxybutyrate Feasibility Treating IBD

This clinical trial aims to understand the feasibility of patients taking ketone body supplement beta-hydroxybutyrate (BHB) for 4 weeks with a confirmed diagnosis of Crohn's disease and starting new therapy for active disease.

The main questions it aims to answer are:

* BHB supplementation will be feasible and acceptable to patients.
* BHB supplementation will be associated with a reduction in systemic inflammation.
* BHB supplementation will be associated with a reduction in pro-inflammatory bacterial colonies.

Participants will:

* Take 3 capsules x 3 times per day for 4 weeks.
* Document food consumption using a 24-hour food recall questionnaire.
* Provide blood and fecal samples twice, at the beginning of the study and the 4-week mark.

Researchers will compare the group taking the ketone body supplement and the group not taking the supplement to see if the supplement provides relief of symptoms suffered from Crohn's disease.

A clinical trial designed to determine the feasibility of prebiotic supplementation with beta-hydroxybutyrate (BHB) in Crohn's patients in a prospective, open-label pilot trial and to assess the association between BHB supplementation and changes in the microbiome, inflammation, and markers of disease severity in Crohn's patients in a prospective pre-/post-study design.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years of age
* Confirmed diagnosis of Crohn's disease
* Active disease defined as either a fecal calprotectin \&amp;amp;gt;250 µg/g or active disease on endoscopy within the prior 3 months
* Starting a new therapy defined as a biologic (anti-TNF, anti-integrin, IL-12/23, or IL-23) or small molecule therapy (JAK inhibitor, S1P receptor modulator)
* Willing to provide consent for participation.
* Managed at UT Digestive Health Clinic.

Exclusion Criteria:

* Any current or recent (within 4 weeks) use of BHB supplement
* Currently or recently (within 4 weeks) following a ketogenic diet
* Currently or recently (within 4 weeks) following an intermittent fasting diet
* Any recent antibiotic use (within 3 months)
* Recent infection with C. difficile (within 6 months)
* Current or recent (within 4 weeks) daily use of acid-suppressing therapy (proton pump inhibitor or H2 receptor blocker)
* Current or recent use (within four weeks) of non-dietary probiotic supplements
* Unwilling to provide signed consent
IMPACT OF OPERATIVE POSITIONING ON THE DEVELOPMENT OF SHOULDER PAIN AFTER PULMONARY LOBECTOMY BY VATS

The investigators want to be able to show a 66% decrease in the incidence of shoulder pain in the "support" group compared to the "suspension" group.

The position currently used in cases of pulmonary lobectomies by videothoracoscopy is an extension associated with an abduction of the shoulder on the side operated by suspension of the thoracic limb in a trampoline-type arm support with an angulation of more than 90 ° of the shoulder in the saggital and frontal planes.

The investigators wish to prospectively and randomly compare this position currently used in the thoracic surgery service of the IUCPQ with a 2nd position which seems less restrictive for all the joints of the shoulder joint complex in which the patient's arm rests on a support placed in front of the patient's face. It follows from this position of the joint degrees less than or equal to 90 ° in all planes. This new position is not experimental, but not normally used in thoracic surgery at the IUCPQ.

Eligibility Criteria:
Inclusion Criteria:

* Any patient in whom the management of a bronchopulmonary cancer, or his strong suspicion, justifies a bilobectomy, a lobectomy or a segmentectomy by videothoracoscopy.

Exclusion Criteria:

* surgery extended to the chest wall, including extra-pleural resections,

  * Pleurectomy,
  * Chronic pain patient suffering from chronic pain preoperatively,
  * Fibromyalgia patient,
  * Chronic taking of analgesic or anti-inflammatory medications during the preoperative period, namely taking at least daily for more than 4 weeks,
  * Patient with a history of orthopedic surgery of the upper limb ipsilateral to the surgery,
  * Patient with mechanical limitation of the joint range of the upper limb ipsilateral to surgery,
  * Non-French speaking patient,
  * Pregnant woman,
  * Patient under 18-year-old,
  * Patient whose BMI is greater than or equal to 35 kg / m2
  * Glomerular filtration rate less than \<50 ml / min
Assessing GS500 in Functional Constipation

This study is designed to evaluate the safety, tolerability and efficacy of GS500 as a superabsorbent hydrogel for relief of constipation in subjects with functional constipation.

To evaluate the safety, tolerabilityand efficacy of GS500 as a superabsorbent hydrogel for relief of constipation in subjects with functional constipation.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 and ≤75 years old
* BMI ≥18.5 and \<35 kg/m2
* Rome IV criteria for FC
* Compliant with reporting during Baseline Run-in .
* Ability to record daily bowel habits, including frequency, stool consistency, straining, completeness of evacuation, and patient reported outcomes
* Ability to follow verbal and written instructions
* Consent obtained via signed ICF

Exclusion Criteria:

* Meeting Rome IV criteria for IBSat screening
* Missing \> 2 days of daily bowel habits reporting during either week of the Baseline Run-in period
* Patients reporting laxative, enema, and/or suppository usage for \>2 days or any usage of a prohibited medication during the Baseline Run-in
* Patients reporting watery stools for any SBM or loose stools for \>1 SBM in the absence of laxatives during Baseline Run-in
* Need for routine manual maneuvers in the last 6 months in order to achieve a BM
* History of significant GI lumen surgery at any time or other GI or abdominal surgery except cholecystectomy or appendectomy within 2 months prior to screening
* Documented GI obstruction
* History of laxative abuseas judged by investigator team
* Glycosylated hemoglobin (HbA1c) ≥8.5%
* Known history of Crohn's disease or ulcerative colitis
* Pregnancy in females of childbearing potential or lactation
* Absence of medically approved contraception in females of childbearing potential
* History of allergic reaction to carboxymethylcellulose, citric acid, sodium stearyl fumarate, HPMC, pectin, gelatin, maltotextrin or titanium dioxide
* Currently enrolled in another investigational device or drug study, or less than 3 months since ending another investigational device or drug study(s), or receiving other investigational treatment(s).
* Subjects anticipating surgical intervention during the study
* Angina, coronary bypass, or myocardial infarction within 6 months prior to Screening Visit
* History of swallowing disorders
* History of gastroparesis
* History of intestinal stricture (e.g., Crohn's disease)
* History of intestinal obstruction or subjects at high risk of intestinal obstruction including suspected small bowel adhesions
* History of maltodextrin intolerance
* Presence of metastatic cancer or current use of systemic anti-cancer treatments
* Anticipated requirement for use of prohibited concomitant medications
* Current use of prescribed or illicit opioids
* Use of intestinal secretagogues to treat constipation/IBS within 12 months of the screening visit
* Any other clinically significant disease or biochemical abnormality interfering with the assessments of GS500, according to the Investigator
Study of Mantle Cell Lymphoma Treatment by RiBVD

Study of First line mantle cell lymphoma treatment by Rituximab, Velcade, Bendamustine and Dexamethasone schema in patients older than 65 years or 18 to 65 years old who cannot or refuse receive conditioning regimen followed by autograft.

Demonstration of Improvement of progression-free survival (PFS) compared to literature data. 6 months prolongation equal 24 months compared to 18 months obtained whatever the current regimen and in particular compared to RCHOP regimen

Eligibility Criteria:
Inclusion Criteria:

* mantle cell Lymphoma CD20 positive
* Untreated patients
* 65 ans years old patients or 18 to 65 years old patients who can't or refuse receive conditioning regimen followed by autograft.
* Stages Ann Arbor II, III or IV,
* ECOG performance status of 0, 1 or 2
* Without history of neoplasm, except in situ cervix carcinoma and cutaneous basal cell epithelioma, or in complete remission since 3 years,
* Without drug contraindication used in the schema (Rituximab, benda-mustine, Velcade, Dexamethasone),
* Without heart insufficiency or stabilized,
* With the following biological values limits except if pathological values are due to Medullary invading or hypersplenism, hepatic involvement) :PNN more than 1 G/L, Platelets more than 50 G/L,Transaminases (SGOT and SGPT) and alkalin phosphatases alcalines less than 4 x normal,Bilirubin less than 3 x N,- Clearance creatinemia more than 20 mL/min
* Hepatitis B negative serology unless the seropositivity is clearly linked to a vaccination.
* Can be regularly followed
* Who signed the informed consent,
* Affiliated to a national insurance or such a same scheme .

Exclusion Criteria:

* Other type of lymphoma than mantle cell lymphoma according to OMS 2008 classification
* Patients in relapse, except those in relapse due to localized stade who only received locoregional irradiation or splenectomized,
* Central nervous system localization in particular meninge,
* Drug used in the schema contraindication Rituximab , Bendamustine , Velcade® or Dexamethasone
* Non stable diabetes,
* HIV positive or active hepatitis C or B
* ECOG performance status equal or more than 3
* Peripheral neuropathy, whatever its origin, rated more than 2 from NCI
* Non stabilized heart insufficiency,
* Patient who can't receive hyperhydration in order to treat tumoral lysis syndrome or in prophylaxis,
* Patient who can't, whatever the reason, be regularly followed,
* Major patient who are on legal protection, or can't give their consent
* Patient who has not signed the informed consent
A Bioelectric Dressing for Post De-Roofing Treatment of HS

The primary purpose of this study is to test if the use of a bioelectric dressing can improve healing after a surgical procedure called de-roofing.


Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years old and older.
* Have diagnosis of HS confirmed by a dermatologist
* Have at least two ancillary tunnels in separate anatomical sites
* Able to provide informed consent

Exclusion Criteria:

* Individuals who are not yet adults
* Subject is allergic to any of the materials and dressings involved in the procedures
* Women known to be pregnant
* Prisoners
* Subjects, who in the opinion of the PI, cannot comply with hope application of the treatment
Clinical Evaluation Of An X-Ray Bone Densitometer:Use Of DXA Technology For Precise Assessment Of Human Body Composition

The main objectives of this study are:

* to assess the concordance of body composition measures between two bone densitometry devices: the STRATOS by Diagnostic Medical Systems (DMS) and the Hologic QDR 4500 A by Hologic inc.
* to assess the concordance of body composition measures between two bone densitometry devices: the STRATOS by Diagnostic Medical Systems (DMS) and the Hologic HORIZON A by Hologic inc.

The secondary objectives of this study are:

* the assessment of the consistency of body composition measurements at local level (arms, trunk, legs) between the Stratos and Hologic 4500 A,
* the assessment of the consistency of body composition measurements at local level (arms, trunk, legs) between the Stratos and Hologic HORIZON A,
* Monitoring the evolution of body composition in patients receiving at least two evaluations of DXA Hologic QDR 4500A on: patients treated for obesity or anorexia nervosa, sports people and other patient with prescription DXA and the assessment the consistency of body composition measurements in terms,
* Monitoring the evolution of body composition in patients receiving at least two evaluations of DXA Hologic HORIZON A on: patients treated for obesity or anorexia nervosa, sports people and other patient with prescription DXA and the assessment the consistency of body composition measurements in terms.

Eligibility Criteria:
Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient is referred by a doctor for the performance of an osteodensitometry examination or sportsmen coming through a protocol where the nuclear medicine department is the investigator center

Exclusion Criteria:

* The patient is pregnant or nursing
* The patient is unable to sign or refuse to sign the informed consent
* The patient has a coronary stent or metal sutures in the heart
* The patient has any type of metal objects in the body such as an artificial joint, a pin or a metal plate
* The patient has a pacemaker or defibrillator
* Patient weighing more than 200 kg or more than 2 meters high by 65 centimeters wide
* The patient is using an insulin pump or with insulin-necked
* The patient has undergone X-ray examination using a contrast medium such as barium in the previous seven days visit,
* Patient who underwent an examination using x rays in the 15 days preceding the visit
* Patient suffering from generalized edema
Monitoring Resuscitation in Severe Sepsis and Septic Shock

Our hypothesis is that hemodynamic fluid resuscitation guided by dynamic parameters will improve outcome in patients with severe sepsis and septic shock, by limiting the deleterious effects of fluid overload.

To evaluate the efficacy of dynamic parameters versus static measures to guide fluid resuscitation we pretend to detect a 10% relative reduction in mortality. In addition, we pretend to observe an improvement on the length of resuscitation time, mechanical ventilation and vasopressor support-free days, ICU and hospital length of stay, organ failure and renal function.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Clinical evidence of sepsis (microbiology confirmation, radiological or direct view - pus in biological fluid or surgical direct view-).
* ≥ 2 SIRS criteria:

  * Temperature \< 36.0°C or \> 38.0°C
  * Heart rate \> 90 bpm
  * Respiratory rate \> 20 rpm or PaCO2 \< 32 mmHg or need of mechanical ventilation.
  * Leukocytes \> 12.0 x109/L or \< 4.0 x109/L
* Hemodynamic insufficiency defined as (at least one of the following):

  * Sustained systemic hypotension (systolic arterial pressure ≤ 90 mmHg or MAP \< 65 mmHg) or a decrease in MAP of \> 30 mm Hg in a hypertensive patient.
  * Need of vasopressors.
  * Tachycardia (HR \> 110 bpm) or bradycardia (HR \< 55 bpm)
  * Acute onset of oliguria, defined as a decreased urine output \< 0.5 ml/kg/hr for ≥ 2 hours
  * Serum lactate \> 2 mmol/l
  * Peripheral cyanosis, mottled skin, prolonged capillary refill
* Mechanical ventilation without any kind of inspiratory effort and Vt 7-10 mL/Kg, Pplateau \< 30 mmH2O. Those patients with ARDS under mechanical ventilation will need to tolerate a tidal volume of at least 7 mL/Kg during 30 seconds while the plateau pressure remains \< 30 mmH2O.
* Prior hemodynamic monitoring by arterial catheter.
* Central venous catheter.

Exclusion Criteria:

* Acute myocardial infarction \< 7 days.
* Pregnancy
* Prior request of limited code status or expected life length lower than 3 months.
* Shock \> 12h
* Cardiac arrhythmia
* Aortic valvular disease
* Inability to properly measure arterial pressure wave forms
Anxiety Sensitivity Program for Smoking Cessation

The purpose of this study is to develop and test a smoking cessation intervention for persons who are specifically sensitive to anxiety and anxiety-related bodily sensations.


Eligibility Criteria:
Inclusion Criteria:

1. Aged between 18 and 65 years old
2. Not pregnant
3. Regular smoker averaging 10 or more cigarettes per day for at least one year
4. Score of 25 or greater on 16-item Anxiety Sensitivity Index
5. Motivation to Quit score of 7 or greater (using Readiness to Quit Ladder)
6. Not currently using pharmacotherapy for smoking cessation (e.g., Zyban)
7. No use of other tobacco products (e.g., chewing tobacco, cigars)
8. No Axis-I or Axis-II diagnoses other than mood or anxiety disorders (intake interview required)
9. No suicidal or homicidal ideation
10. No current psychotropic medication use
11. No evidence of substance abuse or dependence (other than nicotine dependence)
12. No history of significant medical conditions (cardiovascular, neurological, etc.)
13. Ability to provide informed, written consent (no evidence of limited mental capacity)
14. Sufficient command of the English language (able to carry on interview conversation)
15. Plan to stay in Burlington VT area for at least next 6 months

Exclusion Criteria:

1. Not between 18-65 years old
2. Pregnant or currently trying to become pregnant
3. Regular smoker for less than one year OR smoke less than 10 cigarettes per day
4. ASI below cutoff level of 25
5. Motivation to Quit score of 6 or less (using Readiness to Quit Ladder)
6. Current or recent use of any pharmacotherapy for smoking cessation (e.g., patch, Zyban)
7. Current use of other tobacco products (e.g., chewing tobacco, cigars)
8. Axis-I disorders other than anxiety or mood disorders.
9. Endorsement of suicidality or homicidal ideation.
10. Any current psychotropic medication use (must have stopped at least 1 month prior).
11. Any evidence of substance abuse or dependence (other than nicotine dependence)
12. Any history of significant medical conditions (cardiovascular, neurological, etc.)
13. Inability to provide informed, written consent (evidence of limited mental capacity)
14. Insufficient command of the English language (unable to carry on conversation)
15. Plan to permanently leave Burlington area anytime during the next 6-12 months
Validation of DNA Methylation Biomarkers for Oral Cancer Detection-Follow up Study

This is a follow up study which aims to evaluate the correlation between several methylated genes (potential biomarkers) and oral cancers. A prospective case control trial is designed with sample size of at least 300 cases with estimated 200 subjects with precancerous lesion or oral cancer, and 100 subjects with normal oral mucosa. This study is approved by the National Taiwan University Hospital Research Ethics Committee. After signing the informed consent, all subjects will receive an intraoral examination and followed by epithelial cells collection with oral swab. The gDNA will be extracted from the oral swab collected cells and followed by bisulfite conversion procedures. Subsequently, bisulfite converted DNA will be subjected to methylated gene detection by Real-Time PCR. The methylation index (clinical sensitivity and specificity) of oral cancer related genes will be evaluated. For diagnosis confirmation, photos and biopsy specimens will be taken upon observation of abnormal lesion.


Eligibility Criteria:
Inclusion Criteria:

* Subject with age over 20.
* Subjects with oral mucosal findings (normal, oral mucosal lichen planus, precancerous lesion, and oral cancer) or subjects who have involved in the previous study (NCT01945697).
* Subjects agrees to sign the informed consent form.

Exclusion Criteria:

* Pregnant woman.
* Subject disagrees to sign the informed consent form.