cyrilzakka/clinical-trials huggingface dataset:
Identification of Fecal Microbiota Biomarkers of Spondyloarthritis in Patients Suffering From Crohn's Disease.

The MICROSPA project aims to compare gut microbiota, serum cytokines, and PBMC of patients suffering from Crohn's disease (CD) associated or not to spondylarthritis (SpA). 3 groups of patients will be analyzed: patients suffering from CD alone, patients suffering from SpA alone, patients suffering from CD and SpA. One group of healthy controls will be analysed as a comparator. Fecal microbiota will be determined by bacteriome, virome and fungome NGS sequencing


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Patients will be recruited according to 3 groups:
* Patients with Crohn's disease and axial spondyloarthritis according to the criteria below.
* Patients with Crohn's disease (MC patients) with a diagnosis established according to clinical, biological criteria, radiological, endoscopic and / or histological studies for 3 months. With diagnosis of exclusion of a spondyloarthritis on criteria ASAS and / or New York modified.
* Patients with axial spondyloarthritis (SpA patients) with a diagnosis based on modified ASAS and / or New York criteria with exclusion diagnosis of Crohn's disease.
* Patient with the ability to give free and express informed consent.

Exclusion Criteria:

* History of colonic resection
* Taking antibiotics or colon preparation for colonoscopy within 8 weeks before stool collection (Temporary contraindication = removal possible before colic or first bowel preparation after the start of colonic preparation).
* Ostomy at the time of sampling
* BMI\> 30
* extreme diet
* unbalanced diabetes
* Pregnant woman
* Patient under guardianship, under curatorship or under the protection of justice Contacts/Locations Central Contact
HDL Acute Lipid Optimization in Homozygous Familial Hypercholesterolemia

Assess the effect on coronary atheroma of serial infusions of autologous selectively delipidated HDL/preβ enriched plasma following use of HDL Therapeutics PDS-2™ System

The PDS-2™ System is intended to reduce coronary atheroma in patients with Homozygous Familial Hypercholesterolemia (HoFH). Subjects will receive serial infusions of autologous selectively delipidated HDL/preβ enriched plasma following use of HDL Therapeutics' PDS-2 System.

Eligibility Criteria:
Key Inclusion Criteria:

* Clinical diagnosis of Homozygous Familial Hypercholesterolemia (HoFH) due to a defect in the LDL receptor, or the identification of a defect in apoB-100, or a gain of function of PCSK9, or a genetic defect resulting in the HoFH clinical phenotype
* No other condition that would preclude the subject from successfully completing the series of plasmapheresis visits in the investigator's opinion
* At least one (1) coronary artery study segment will be identified for each subject and all will remain constant throughout the study. The qualifying study segment(s) will have 20% to 40% stenosis.

Key Exclusion Criteria:

* Planned change in current lipid lowering therapy
* Use of oral anticoagulants, unless the dose has been stable for 4 weeks
* LDL or plasma apheresis within 1 week prior to enrollment and through 8-week primary endpoint
* New York Heart Association (NYHA) class III or IV or last known left ventricular ejection fraction \< 30%
* Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months of enrollment
Aniseikonia in Epiretinal Membrane Patients

Examination of aniseikonia in epiretinal membranes patients before and after surgery

Phakic patients woth epiretinal membranes are examined for aniseikonia and refractive status before and after surgery. Follow up is one year.

Eligibility Criteria:
Inclusion Criteria:

* Epiretinal membrane Phakic on both eyes

Exclusion Criteria:

* no previous eye surgeries
* refractive status +/- 2 seq
Melodi Matrix™ in Breast Reconstruction

Prospective, multicenter, randomized, controlled trial evaluating the safety and effectiveness of an absorbable antibacterial matrix device in two stage prepectoral alloplastic breast reconstruction.


Eligibility Criteria:
Inclusion Criteria:

* Female.
* Age 22 or older at the time of enrollment.
* Is scheduled to undergo unilateral or bilateral mastectomy (including prophylactic) with immediate two-stage post-mastectomy alloplastic prepectoral breast reconstruction.
* Is able to and willing to comply with the study requirements and providing informed consent.

Exclusion Criteria:

* Has prior history of neoadjuvant radiotherapy.
* Has had prior history of failed tissue expansion or breast implantation at the intended reconstruction site.
* Has an active abscess or infection requiring antibiotics anywhere in their body within 30 days.
* Has a Body Mass Index (BMI) \< 14 or \> 40.
* Is pregnant or is nursing; or plans to become pregnant during the course of the study.
* Has any connective tissue/autoimmune disorder or rheumatoid disease.
* Has known allergies to study device materials.
* Is participating in another interventional research study that may interfere with study endpoints.
* Has limited life expectancy or co-morbid conditions, social/psychological problems, or cognitive impairments that precludes participation.
* Has a medical condition or is taking medications that would result in elevated risk and/or affect the validity of the study.
* Intraoperative assessment demonstrates unfavorable conditions (i.e., poor mastectomy skin flap thickness or viability) for immediate, two-stage post-mastectomy alloplastic prepectoral reconstruction in any breast.
Effect of Perioperative Clopidogrel Responsiveness on Ischemic Outcome in Patients With Acute Coronary Syndrome Undergoing Off-pump Coronary Artery Bypass Surgery

The whole blood Thrombelastograph (TEG®) Platelet Mapping™ assay measures clot strength, maximal amplitude (MA), reflecting maximal platelet function, and detects the reduction in platelet function, presented as percentage inhibition, by both aspirin and clopidogrel. A study reported that the TEG® can be used as routine monitoring of the variability in ADP receptor inhibition and of antiplatelet therapy. Therefore, using TEG Platelet Mapping assay, we could find out the perioperative clopidogrel responsiveness of the patients with ACS undergoing OPCAB.

The purpose of this study is to determine whether the rate of the major adverse cardiac events (MACE, a combined endpoint of MI, revascularization and cardiac death) is higher in the patients with high degree of clopidogrel resistance, who are scheduled to undergo the OPCAB due to ACS.


Eligibility Criteria:
Inclusion Criteria:

1. the patients with ACS undergoing OPCAB
2. the patients over 20 years of age
3. the patient who have been taking \[100 mg of Aspirin\] and \[75 mg of clopidogrel or 180 mg of ticagrelor\] for more than one week and who continue within 3 to 5 days prior to surgery

Exclusion Criteria:

1. re-operation or emergency operation
2. the patients with bleeding tendency of decreased liver function
3. Left ventricular ejection fraction \< 40% by echo
4. preoperative hematocrit \< 33% or platelet count \< 100,000/mm3 or creatinine \> 1.4 mg/dL
5. abnormal preoperative prothrombin time or activated partial thromboplastin time
6. preoperative use of other PO antiplatelet drugs or PO anticoagulants
Adenomyosis: Genomic Mechanisms and Biological Response

Examination of genomic and biologic responses to LNG-IUS in patients with adenomyosis.

Examination of genomic and biologic responses to LNG-IUS in patients with adenomyosis.

Eligibility Criteria:
Inclusion Criteria:

* Abnormal bleeding in the presence of Adenomyosis as demonstrated by MRI

Exclusion Criteria:

* Other causes of abnormal bleeding such as fibroids, endometrial polyps, malignancy
* Presence of endometriosis
Methadone Maintenance Treatment Outcome Study in Taiwan

Opioid abuse is a complex problem, which not only impacts on the affected individuals' physical and psychological health, but also threatens public security and the productivity of the society. Further, through needle sharing and sexual contacts, injecting drug users (IDUs) have become laden with HIV and HIV related health problems, representing a serious public health threat all over the world. In Taiwan, since the identification of the first HIV-infected IDU in 1987, the incident cases have continued to increase, reaching a height of 2,461 in 2005. In order to contain the epidemics of HIV among IDUs, and to prevent its spread to the population in general, the Center for Disease Control (CDC) collaborated with the Department of Justice to initiate and implement a number of harm reduction programs in 2005. The fact that opioid addiction is officially treated as a health rather than a legal issue itself represents a remarkable milestone in Taiwan. Among these harm reduction programs, including needle and syringe exchange for IDUs as well as substitution treatment approaches for opioid dependence, methadone maintenance treatment (MMT) perhaps represents the most most important and most crucial component. Remarkably, in a relatively short time span, more than 60 MMT programs were established, which enrolled more than 15,000 heroin addicts. This notwithstanding, the overall and differential effectiveness of these MMT service delivery systems, as well as the characteristics of these programs and the patients that might contribute toward treatment response or failure remain largely unknown. Such knowledge base is crucial for establishing standardized and feasible outcome evaluation processes for opioid addicts receiving MMT programs, as well as for the further improvement of the efficacy and effectiveness of these programs, in Taiwan.

In order to address some of these issues, this study adopts a multi-site, prospective clinical follow-up design. It aims at establishing a research network for examining MMT outcome, developing standardized MMT outcome assessment instruments and procedures, and identifying predictors of MMT outcome. The findings may contribute to the better understanding of the characteristics of opioid addicts, the effectiveness of MMT and remaining service needs for opioid addicts in Taiwan.


Eligibility Criteria:
Inclusion Criteria:

* Be 18 years or older.
* Be fulfilling the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria of opiate dependence.
* Be agree to and capable of signing informed consent form that has been approved by an Institution Review Board.

Exclusion Criteria:

* Have ever participated in the study at one of the collaborative hospitals/clinics.
* Be expecting to discontinue methadone treatment for any reason (leaving the methadone clinic's geographic area, pending legal action, etc.) in the following 3 months.
Phenylephrine for Spinal Induced Hypotension

This study is designed to determine the ED90 for a single dose of phenylephrine for the treatment of spinal induced hypotension in parturients presenting for an elective CD. The ED90 is the effective dose at which 90% of subjects will have a "positive" response to phenylephrine. The primary outcome measure is the ED90 for bolus phenylephrine. Secondary outcomes include the need for additional vasopressors, glycopyrolate to treat bradycardia, and the presence of hypertension following administration of phenylephrine.


Eligibility Criteria:
Inclusion Criteria:

1. Non-emergent cesarean delivery with planned regional anesthesia (i.e. elective planned cesarean delivery for malposition, patient choice, cervical pelvic disproportion, previous cesarean delivery and other diagnosis that require a predetermined cesarean delivery)
2. American Society of Anesthesia physical status class I \& II (ASA I - Healthy, ASA II - mild and controlled systemic disease, eg. controlled essential hypertension)
3. Age ≥ 18 years (Standard within the obstetrical literature)
4. Term gestational age
5. English-speaking

Exclusion Criteria:

1. Morbid Obesity (Body Mass Index ≥ 45 kg/m2) (Morbidly obese parturients require a dose of local anesthetic less than the standardized dose in this study, typically have an exaggerated response to vasopressors, and the blood pressure cuff occasionally needs to be replaced by an intraarterial catheter due to limitations in size)
2. Height \< 5'0" (Women \< 5'0" are likely to require a dose of local anesthetic less than the standardized dose in this study)
3. Laboring women
4. Urgent or emergency cesarean delivery
5. Severe hypertensive disease of pregnancy defined as systolic blood pressure (SBP) \> 160mmHg, diastolic blood pressure (DBP) \> 110mmHg and/or requiring antihypertensive treatment or associated with significant proteinuria
6. Severe maternal cardiac disease
7. Diabetes type I
8. Subjects on monoamine oxidase inhibitors (MAOI's) or tricyclic antidepressants
9. Fetal anomalies
10. Failed spinal anesthesia
11. Subject enrollment in another study involving a study medication within 30 days of CD
12. Any other physical or psychiatric condition which may impair their ability to cooperate with study data collection
A 2-Year Study of an Investigational Drug in Obese Patients (0557-011)

This is a 2-year study to assess the safety, tolerability, and efficacy of an investigational drug in obese patients.


Eligibility Criteria:
Inclusion Criteria:

* Obese men and nonpregnant women at least 18 years of age with a specific body mass index (height and weight ratio) required by the study

Exclusion Criteria:

* Patients with uncontrolled high blood pressure and/or diabetes mellitus (high blood sugar)
Rosuvastatin on Diabetic Patients Treated With Glimepiride/Metformin

study effects of rosuvastatin on markers of atherosclerosis, thrombosis, in diabetic patients treated with glimepiride/metformin without coronary artery disease.

This effect will be investigated especially on sortilin ,fetuin-A

A randomized controlled trial on 70 patients with DM type 2 will be recruited from Damanhour national medical institute.

* Subjects will be divided into two group (one arm is DM-type 2 patients who will receive rosuvastatin -metformin-glimepiride combination (40 patients) and another arm is DM-type 2 patient who will receive glimepiride-metformin combination (30 patients).
* Determination of serum levels of fetuin A and Sortilin
* Blood samples will be collected after 3-month after active treatment.
* Outcomes measurement : Sortilin ,fetuinA, Atherogenic index (AI) and coronary risk index (CRI) .

Methodology

* Sortilin, fetuinA will be determined by ELISA.
* Lipid profile.
* FBG and Hb A1C will be measured.
* Atherogenic index (AI = LDL-C/HDL-C) and CRI (CRI = TC/HDL-C) will be calculated for all subjects.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus on oral therapy.
* Age 21-65 years
* Life expectancy \>1 year.

Exclusion Criteria:

* Documented CVD
* Planned surgical intervention.
* Hypersensitivity to either of the study drug components.
* Type I diabetes.
* Current Insulin treatment.
* Hepatic impairment known hepatic failure.
* Inability to comply with study protocol.
* Active malignancy.
* Chronic inflammation (i.e. inflammatory bowel disease, lupus, inflammatory arthritis, rheumatoid arthritis) or chronic infection (i.e. chronic diabetic foot infection).
* Pregnancy, lactation or child-bearing potential.
* Chronic renal disease
Digital Support for People With Cognitive Impairment

Cognitive impairment may cause problems in planning and initiating daily activities, as well as remembering to do what is scheduled. This study investigates the effectiveness of an interactive web-based mobile reminder calendar, (RemindMe). The calendar sends text messages to the user's mobile phone as support in everyday life, for persons with cognitive impairment due to neurological injury/diagnoses. The study has a randomized controlled trial design with data collection at baseline and at follow-up sessions after two and four months. Data collection started in October 2016 and continued until February 2018. RemindMe may give the needed support to remind the person and thus increase the ability to perform activities and to become independent in everyday life.


Eligibility Criteria:
Inclusion Criteria:

* Participants with cognitive impairment after stroke or other neurological diseases/injury
* Participants experiencing the need for support in planning, organizing and remembering to do activities in everyday life
* Participants having access to a computer and mobile phone/smartphone
* Participants having linguistic ability to participate in assessments

Exclusion Criteria:

* Participants with palliative care needs
* Participants with reduced vision and/or hearing loss that affects the ability to use a mobile phone/smartphone
* Participants with depression or psychiatric illness
Pregabalin for the Prevention of Chemotherapy Induced Nausea and Vomiting

phase II randomized, double-blind, placebo-controlled trial to investigate whether pregabalin can improve the complete control of nausea and vomiting (primary end point)

chemotherapy-naive patients, scheduled to receive moderately and highly emetogenic chemotherapy.

All patients will receive IV ondansetron 8 mg, dexamethasone 10 mg and ranitidine 50 mg before chemotherapy on day 1 and oral dexamethasone 4 mg, bd, on days 2 and 3.

Patients will be randomly assigned to take pregabalin 75 mg or placebo, bd, from the night before chemotherapy to day 5.

Eligibility Criteria:
Inclusion Criteria:

* patients scheduled to receive their first cycle of moderately to highly emetogenic chemotherapy;
* 18 years or older;
* Eastern Cooperative Oncology Group \< 2

Exclusion Criteria:

* Nausea or vomiting 24h before randomization
* aspartate aminotransferase / alanine aminotransferase above 3 times the upper limit
* Severe cognitive compromise;
* regular use of corticosteroids, opioid, benzodiazepines, tricyclic antidepressant, or cannabinoids within 30 days before randomization;
* brain metastasis;
* chronic alcoholism;
Somatosensory Tinnitus Study

Somatosensory tinnitus is suspected when the tinnitus perception changes following head, neck, or jaw maneuvers. The prevalence of this type of tinnitus in Veterans in unknown. The Cleveland Clinic evaluates all tinnitus patients for this condition and when detected, prescribes individualized physiotherapy. Cleveland Clinic's novel approach to tinnitus assessment and management provides the framework for this proof of concept pilot study.

Phase 1A involves adapting Cleveland Clinic's assessment and treatment approach for somatosensory tinnitus to make it feasible for a VA population.

Phase 1B involves screening Veterans with tinnitus to evaluate and describe the prevalence of somatosensory tinnitus (in Veterans with tinnitus).

Phase 2 involves Veterans with somatosensory tinnitus receiving 3 individualized physical therapy sessions using the adapted approach developed during Phase 1A.

Phase 3 will evaluate the feasibility and tolerability of the adapted treatment approach.

Eligibility Criteria:
Inclusion Criteria:

* Veteran
* chronic tinnitus
* positive screen for somatosensory tinnitus

Exclusion Criteria:

* Non-Veteran
* participation in new (\< 1 month) tinnitus management or treatment
* current participation in tinnitus research involving an intervention
Spontaneous Intracranial Hypotension Treatment "SIHT"

Spontaneous intracranial hypotension (SIH) is an infrequent disease, related to a leak of cerebrospinal fluid. There are not controlled studies for this treatment.The main of this study is to demonstrate the superiority of the Trendelenburg position compared to supine position during 24 hours after an epidural blood patch for a spontaneous intracranial hypotension

Various treatments have been used for patient with spontaneous intracranial hypotension, but there is not definite approach. Some patients, fortunately, improve spontaneously. Bed rest and increased fluid intake have been advocate. The effectiveness of the caffeine has been shown in some studies, but durable beneficial effect is doubtful. The efficacy of steroids has not been established. However, although there have been no controlled studies, autologous epidural blood patch (EBP) can be considered the treatment of choice for patients. The success rate of EBP for a post lumbar puncture headache is about 90%, but for SIH, is very less about 50% after the first one and 77% after the second. The amount of blood injected must be sufficient. On the other hand, the leak is usually located on dorsal, above the prolonged rest must be respected. One study, have demonstrated, without randomization, a success rate of 90% with a prolonged Trendelenburg after EBP. We decided to do this study, to confirm a superiority of a 24 hours prolonged Trendelenburg position.

It's a monocentric study of parallel randomized open blind groups. Patients will be recruited by investigators in our headache emergency room. If the diagnose of SIH is confirmed (orthostatic headache from more than 5 days and less than 28 days with a normal MRI or with sign of SIH) study will be proposed.

After a signed information, the patients will be randomized in 2 groups, the investigator is blind of the randomized arm of patient

1. EBP with 24 hours bed rest
2. EBP with 24 hours Trendelenburg position

V1: inclusion V2 : 24 hours before EBP (headache, associated symptoms, HIT6) V3 : randomization and EBP V4 : first evaluation 30 minutes after standing (headaches, associated symptoms) V5 : phone evaluation (safety) D7 V6 : Evaluation at D15 (headache, associated symptoms, safety) V7 : Evaluation at D30 (headache, associated symptoms, control cerebral MRI, HIT6, safety) V8 : last evaluation D60 (headache, associated symptoms,HIT6 safety)

Collection of 2nd EBP, 3rd EBP, 4th EBP throughout the study up to J 92 maximum

Eligibility Criteria:
Inclusion Criteria:

* 18 years or more
* No contraindication for BPE
* Severe or moderate headache within 15 min standing, mild or no headache after 15 min bed rest
* Headache from 5 to 28 days
* Normal or evidence of low CSF on MRI
* Signed informed consent

Exclusion Criteria:

* Known dural leak in the previous 2 months the onset of headache
* Abnormal MRI
* First BPE for SIH
* The patient has participated in another clinical trial than can interact with the evaluation
* Contraindication of Trendelenburg position
Evaluation of an Acceleration-Based Prosthetic Knee Locking Mechanism for Reducing the Risk of Falling in Transfemoral Amputees

The investigators hypothesize that a new automatic prosthetic knee locking mechanism will improve gait characteristics during an induced controlled trip and reduce fear of falling.


Eligibility Criteria:
Inclusion Criteria:

* transfemoral amputees
* Independent ambulation with a prosthesis
* Full cognitive and cooperative ability to follow simple instructions
* No orthopaedic or neurologic impairments present, that are unrelated to the amputation at the time of the trial

Exclusion Criteria:

* Cognitive disorders preventing the subject from understanding the trial protocol, signing a consent form or following the researcher's instructions
* Orthopaedic or neurologic impairment, un-related to the amputation
* Pregnant woman
* Weight exceeding 100 kg