cyrilzakka/clinical-trials huggingface dataset:
Evaluation the Safety and Efficacy of Lyophilized Fecal Microbiota Transplantation Administered Orally for Prevention of Relapse or Intestinal Inflammation in Adults With Ulcerative Colitis

The purpose of the study is to evaluate the efficacy and safety of lyophilized PRIM-DJ2727 capsules given orally in subjects with ulcerative colitis at remission stage. This study will also include longitudinal analyses of recipient's gut microbiota taxonomy and metagenomics to determine potential associations with clinical outcomes in context of active FMT or placebo administration.


Eligibility Criteria:
Inclusion Criteria:

1. Adult ≥18 years of age
2. History of active UC in the past 12 months based on standard clinical, endoscopic, or histologic criteria.
3. Remission of UC based on clinical grounds (partial Mayo score of ≤2 with each subscore ≤1), and on stable maintenance therapy.
4. Sexually active male and female subjects of childbearing potential must agree to use an effective method of birth control during the study.
5. Female subjects of childbearing potential must have a negative urine Qualitative HCG pregnancy test at enrolment and on the Week 1, Day 1 of the Treatment prior to administration of study drug.
6. Willing and able to sign an informed consent form and attend all study-related clinic visits, assessments, and follow-up phone calls.
7. Subject has an attending physician who will provide the non-FMT care.

Exclusion Criteria:

1. Unable to take multiple capsules orally.
2. Females who are pregnant, breastfeeding, or planning to become pregnant during the study.
3. Receipt of systemic non-topical antibiotics within 14 days of treatment day 1.
4. Positive results for active HIV, Hepatitis B, or Hepatitis C infections.
5. History of recurrent Clostridium difficile infection or FMT in the past 6-months.
6. History of other active gastrointestinal conditions such as irritable bowel syndrome, microscopic colitis, celiac disease, short gut syndrome, colostomy, colectomy, gastrointestinal fistulae or strictures, chronic parasitic infections, diverticulitis etc.
7. Known history of bile acid diarrhea
8. Compromised immune system (e.g. primary immune disorders or clinical immunosuppression due to a medical condition or medication e.g. taking oral prednisone \>20 mg a day or prednisone-equivalent)
9. History of active cancer and/or ongoing chemotherapy (superficial non-metastatic cancers and maintenance chemotherapy are permitted).
10. History of use of an investigational drug within 90 days prior to the screening visit.
11. History of significant uncontrolled systemic disease that in the opinion of the study investigator could interfere with study participation and/or objectives.
12. Life expectancy of \< 1 year.
13. In the opinion of investigator, subject for any reason, should be excluded from the study.
Single Embryo Transfer Versus Double Embryo Transfer

The aim of this project is to study the best number (1 or 2)and day (3 vs 5)of embryo transfer in good prognosis patient.


Eligibility Criteria:
Inclusion Criteria:G

* Good prognosis IVF patients

Exclusion Criteria:

* Bad prognosis IVF patients
An Observational Study of NeoRecormon (Epoetin Beta) in Cancer Patients With Anemia (FAST)

This observational study will evaluate the clinical benefit of NeoRecormon (epoetin beta) in daily routine practice in cancer patients with anemia. Data will be collected from patients who are receiving chemotherapy for a solid tumor or hematological malignancy. Patients will be followed for 28 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/=18 years of age
* Patients receiving myelosuppressive chemotherapy for a solid tumor, a hematological malignancy or an autograft for hematological malignancy
* Patients for whom treatment with epoetin beta is started at the inclusion visit
* Life expectancy \>/=6 months according to the physician
* Patients accepting and able to complete a French written questionnaire about his/her professional and social activities at each visit

Exclusion Criteria:

* Patients who received erythropoiesis-stimulating agents treatment, or red blood cell transfusion within 4 weeks before enrollment
* Participation in a clinical trial in onco-hematology
* Patients with myelodysplasia
* Patients with more than one active malignancy at the time of enrollment
Clinical Evaluation of Laminate Veneers With Coronal Post Versus Post and Core Foundation Restoration With Single Crown for Restoration of Endodontically Treated Anterior Teeth (Randomized Controlled Trial) "In-vivo Study"

Clinical evaluation of Laminate veneers with coronal post versus post and core foundation restoration with single crown for restoration of endodontically treated anterior teeth (Randomized Controlled Trial) "In-vivo Study"


Eligibility Criteria:
Inclusion Criteria:

1. From 18-60 years old, should be able to read and sign the consent document.
2. Ability to tolerate the restorative procedures (physical and psychological).
3. Patients with anterior endodontically treated teeth indicated for coronal restoration:

   1. Good oral hygiene
   2. Minimum remaining coronal tooth height of 4 mm
   3. Normal functional occlusal stresses within physiological limits.
   4. Adequate crown/root ratio
   5. No signs and symptoms related to active periapical pathosis or endodontic failure.
4. With no active periodontal or pulpal problems.
5. Willing to return for follow-up visits.

Exclusion Criteria:

1. Teeth not fully erupted as in young patients.
2. Poor oral hygiene and lack of motivation
3. Vital teeth
4. Psychiatric problems or unrealistic expectations
5. Excessive parafunctional stresses and bad habits like nail biting. 11
6. The absence of sound enamel margins for the preparation
7. Abnormally small teeth or with structural defects in enamel. 12
8. Tooth mobility or inadequate crown/root ratio.
Deferasirox in Treating Iron Overload Caused By Blood Transfusions in Patients With Hematologic Malignancies

RATIONALE: Deferasirox may remove excess iron from the body caused by blood transfusions.

PURPOSE: This clinical trial studies deferasirox in treating iron overload caused by blood transfusions in patients with hematologic malignancies.

PRIMARY OBJECTIVES: I. To determine the effects of the iron-chelating agent deferasirox on changes in: neutrophil function; macrophage function; lymphocyte function.

SECONDARY OBJECTIVES: I. To determine the effect of chelation on the incidence of bacterial, viral and fungal infections documented by clinical, microbiologically-proven versus radiologically-proven criteria. II. To determine the effect of iron chelation on mortality and morbidity with incidence of the following parameters: Need for hospitalization; Duration of hospitalization; Need for ventilatory support; Need for exchange transfusion/apheresis; Need for treatment with antifungals or antibiotics for documented infections.

OUTLINE: Patients receive oral deferasirox once daily for up to 6 months or until blood counts recover in the absence of disease progression or unacceptable toxicity.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have a pathology confirmed diagnosis of one of the following: myelodysplastic syndrome (MDS); acute leukemia; multiple myeloma; myelofibrosis; lymphoma; chronic anemia; sickle cell anemia
* Iron score \>= 2
* Absolute Neutrophil Count (ANC) \>= 1,000
* Platelets \>= 50,000
* Albumin \>= 2 g/dL
* Alkaline phosphatase =\< 5X Upper Limit of Normal (ULN)
* Total bilirubin =\< 1.5
* Creatinine =\< 2X age-appropriate Upper Limit of Normal (ULN) OR creatinine clearance \>= 40 ml/min
* Serum Glutamic Oxaloacetic Transaminase (SGOT) \[AST\] and Serum Glutamic Pyruvic Transaminase (SGPT) \[ALT\] =\< 5X Upper Limit of Normal (ULN)
* Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Patients with active disease undergoing chemotherapy treatment
* Patient who have been treated with rituximab or immunomodulating drugs =\< 1 month prior to enrollment
* HIV-positive patients
* Hepatitis-C positive patients
* Women who are pregnant or breastfeeding
* Patients on hemodialysis/patients with renal failure
* Patients with sepsis or acute illness
* Known hypersensitivity to deferasirox
* Patients with moderate or severe hearing loss as defined by audiogram
Parkdale Infant Nutrition Security Targeted Evaluation Project: Infant Feeding

In Toronto Ontario, the Parkdale Community Health Centre operates a community outreach program entitled Parkdale Parents' Primary Prevention Project (5P's). The 5P's provides weekly pre- and post-natal support and education programs for clients. This includes an infant feeding program for mothers with infants 0-6 months (Feeding Tiny Souls). The 5P's has a diverse client-base; the program is aimed at women who are in challenging life circumstances, therefore, clients may include low-income or single mothers and newcomers to Canada.

The aim of this project is to investigate the incidence, duration and exclusivity of breastfeeding and timely complementary feeding based on level of maternal participation in components of a pre and postnatal community outreach program. Exploring infant feeding practices is an evaluation component that will not only characterize infant feeding practices within a vulnerable population, but will elucidate whether there are areas of concern that need to be expanded upon within pre or postnatal programming. A prospective infant feeding questionnaire will be administered to participants at 2 weeks and at 2, 4 and 6 months postpartum. The study population will consist of women who enrolled in 5P's prenatally. The hypothesis is that exclusive breastfeeding rates will be low, but higher breastfeeding rates will be observed among women who utilize provided postnatal services more readily.


Eligibility Criteria:
Inclusion Criteria:

* Enrolled in Parkdale Parents' Primary Prevention Project (5P's) prenatally
* Enrolled prenatally in 5P's as of August 17, 2017 onwards

Exclusion Criteria:

* Only enrolled in Parkdale Parents' Primary Prevention Project (5P's) postnatally
* Unavailable to participate in infant feeding questionnaire by telephone or in-person during 5P's programming
Chemotherapy Combined With Targeted Therapy for High-risk HER2 Positive and Lymph Node Negative Early Breast Cancer

Human epidermal growth factor receptor 2 (HER2) positive breast cancer is a molecular subtype with high malignancy and easy recurrence and metastasis. The emergence of HER2 targeted drugs has greatly improved the prognosis and survival of such patients. At present, for HER2 positive breast cancer patients with negative lymph nodes, chemotherapy drugs combined with trastuzumab is the current standard treatment scheme, and in most cases, chemotherapy uses a combination of two drugs, while the main beneficiaries of the target treatment of trastuzumab and pertuzumab are concentrated in the group of patients with positive lymph nodes. Can the use of target therapy to de-escalation chemotherapy and further achieve a strategy of high efficacy and low toxicity. It is planned to explore the efficacy and safety of T1-T2, HER2 positive early breast cancer patients with negative lymph nodes to achieve chemotherapy reduction based on risk stratification.


Eligibility Criteria:
Inclusion Criteria:

* 1) Treated in Peking University People's Hospital and underwent radical resection with hospitalization records;
* 2) Postoperative pathology confirmed invasive breast cancer, pathological staging was T2, N0, HER2 positive, and accompanied by one of the high-risk factors (G3, or hormone receptor negative);
* 3) Has signed and agreed to participate in the PKUPH breast disease cohort study.

Exclusion Criteria:

* 1) Lack of clinical and pathological data (such as imaging data and pathological data);
* 2) Preoperative neoadjuvant therapy;
* 3) Patients with metastatic breast cancer or bilateral breast cancer;
* 4) Failure to perform radical surgery.
Efficacy and Safety of BiomatrixTM Stent and 5mg-Maintenance Dose of Prasugrel in Patients With Acute Coronary Syndrome

The purpose of this study is to evaluate the efficacy and safety of 5mg maintenance dose (MD) of prasugrel in patients with acute myocardial infarction (AMI) who underwent percutaneous coronary intervention (PCI) with BiomatrixTM stent.

About 1400 patients derived from Korean patients with acute coronary syndrome (ACS) receiving percutaneous coronary intervention (PCI) with BES(Biolimus-eluting stent, BiomatrixTM) in a routine manner will be enrolled in the investigators trial.

These patients will be randomized 1:1 to either prasugrel 5mg once daily MD or clopidogrel 75mg once daily MD after successful PCI with BES .

The investigators excluded the patients with age ≥75 years, body weight \<60 kg, or history of TIA (transient ischemic attack) or stroke. Follow-up data will be collected until 1-year after index procedure.

Primary efficacy end-point defined as the composite of cardiac death, non-fatal MI, stent thrombosis and ischemic driven target vessel revascularization and safety end-points as BARC (the Bleeding Academic Research Consortium) type ≥ 2 bleeding.

Eligibility Criteria:
Inclusion Criteria:

* Patients who can undergo percutaneous coronary intervention with Biomatrix stent with no history of TIA or stroke,
* 75 years old or younger,
* body weight of 60 kg or more and diagnosed with acute coronary syndrome

Exclusion Criteria:

* Patients with history of TIA or stroke,
* 75 years old or older,
* body weight of 60 kg or under,
* hypersensitivity to or contraindicated for heparin, aspirin, clopidogrel, prasugrel or contrast media
Fat Reduction Intervention Trial in African-Americans

To conduct a randomized controlled trial to evaluate the effectiveness of an intervention to reduce dietary fat.

BACKGROUND:

The African-American population of the United States continues to experience high rates of mortality from cardiovascular (CV) disease, including coronary heart disease, stroke and renal failure. The major syndromes which determine CV risk, including obesity, hypercholesterolemia, glucose intolerance, and hypertension, all occur more frequently among African Americans. Nutritional factors underlie many forms of CV disease and are an important focus of current prevention efforts. Very little is currently known, however, about specific nutritional patterns among African Americans that might lead to CV risk, or the applicability of structured interventions.

The study was conducted in response to an initiative on "Collaborative Projects on Minority Health" which was released in October 1992 after review and approval at the September 1992 National Heart, Lung, and Blood Advisory Council.

DESIGN NARRATIVE:

Given the growing recognition of the importance of total fat, from the point of view of both disease risk and eating patterns, the primary focus of the intervention was to reduce the percentage of calories in the diet from fat. Four hundred households were recruited and randomly assigned to either an active intervention or observation group for a period of 18 months. Dietary change consistent with specific recommendations made to the American public for reducing cardiovascular (CV) risk was encouraged, namely, reduction in total fat, saturated fat (SFA), and cholesterol (Chol). A practical, community-based program was developed which could be taken into households. Nutrition education and enhancement of skills helpful in making behavioral change formed the basis of the intervention. Lay educators, recruited from the target neighborhoods, worked under the close supervision of a community nutritionist. Changes in reported dietary intake, serum lipids/lipoproteins and body weights were measured. In addition to the formal evaluation of the trial outcome, an important secondary goal was to obtain detailed information about eating patterns in this community and characterize behavior associated with the achievement and maintenance of target nutrient goals.

The study was part of a collaborative project on minority health. Dr. Prewitt collaborated with Dr. Marian Fitzgibbon who was the principal investigator on R01HL51532.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Cardiovascular Protective Role of Laser Acupuncture in Systemic Lupus

Systemic lupus erythematosus is a chronic and multisystemic autoimmune disorder which predominantly affecting women. The most common cause of death in lupus patients affected by disease for more than 5 years is cardiovascular disease due to presence of some factors as oxidative stress, pro-inflammatory cytokines , dyslipidemia, diabetes, and hypertension.

laser acupuncture (active or sham) for one month (3 days/week ) on acupoint number 14 of GV meridian, acupoint number 4 and 11 of large intestine, acupoint number 34 of gall bladder meridian, acupoint number 3 of liver meridian, acupoint number 4, 12, and 9 of conception vessel meridian, acupoint number 40, 36, and 25 of stomach meridian, acupoint number 6 of spleen meridian, and acupoint number 5 of triple energizer meridian (laser will be applied for 1 min on every acupiont) in lupus females

Eligibility Criteria:
Inclusion Criteria:

* lupus females
* 60 patients

Exclusion Criteria:

* pregnancy
* cardiovascular diseases
* respiratory diseases
Relationship Between Folic Acid and Warfarin Metabolism and Effect

Folic acid supplementation has been shown previously to be associated with enhanced formation of p-HPPH from phenytoin, a metabolic pathway which is predominantly mediated through the activity of CYP2C9.

The metabolism of S warfarin, the more active enantiomer of warfarin, is also mediated predominantly through the activity of CYP2C9.

The purpose of the present study was to examine the relationship between folic acid concentration and warfarin pharmacokinetic as well as warfarin dose requirement among patients treated by warfarin. In addition the effect of folic acid supplementation (5 mg/d) for 3 weeks on warfarin pharmacokinetic and warfarin dose requirement will be evaluated in the second part of the study.


Eligibility Criteria:
Inclusion Criteria:

* Patients on chronic warfarin therapy

Exclusion Criteria:

* Refusal to participate in the study
CERAMENT G Device Registry

This is an Observational Device Registry Study of CERAMENT\|G in normal use in accordance with the IFU. It will run for a period of three years from enrolment of the first patient into the Study at each Site, before being subject to review. A Device Registry is a form of observational study that concerns the performance of a device in normal use. It is intended to collect data that is reflective of 'real world' device performance.


Eligibility Criteria:
Inclusion Criteria:

* 18 years and over (on the day of surgery)
* receive CERAMENT\|G as a component of their treatment at a participating, contracted centre or healthcare provider, in accordance with the IFU for the implanted product
* In receipt of patient information leaflet and have signed appropriately designed informed consent form.

Exclusion Criteria:

* Any exclusion criteria as per IFU for CERAMENT\|G
* Any off-label use
Propranolol for Treating Fibromyalgia Pain

The purpose of the study to evaluate the feasibility of using low dose propranolol for people with fibromyalgia.

The main purpose of this study is to collect pilot feasibility study data for the use of low dose propranolol for helping treat fibromyalgia. The investigators plan to compare 20mg twice a day dosage of propranolol and 10mg twice a day dosage of propranolol to placebo. The design is a 3 arm, double blind randomized control trial. The investigators will also test ECG and respiratory assessment as a part of the safety screening and the feasible assessment of respiratory sinus arrhythmia.

Propranolol is not indicated to treat pain. However, the previous studies showed that low dose propranolol can re-regulate the adrenergic dysfunction and reduce pain in people with chronic musculoskeletal pain. However, the investigators are not aiming to develop a new indication of the drug.

Eligibility Criteria:
Inclusion Criteria:

* Females with fibromyalgia (both meeting 1990 American College of Rheumatology (ACR) FMS criteria and 2010 ACR FMS criteria) age 18-65 with at least 1 year of symptoms and sedentary (exercising less than 120 min per week).

Exclusion Criteria:

* General Health Criteria:

  * Uncontrolled/unstable illnesses (physician diagnosed, self-report)
  * Pregnancy or planning to be pregnant in the next year
  * Having Asthma requiring medication treatment including inhaler
  * Type I diabetes or Type II diabetes requiring medical therapy that can lead to hypoglycemia
  * Having acute pain or neuropathic pain
  * Participation in exercise or psychological treatment studies in the past 2 years
  * Having known serious psychopathology: Psychosis, history of inpatient psychiatric admission in the past year, active suicidal intent, history of self-injurious behaviors in the past year, history of recreational IV drug use, substance abuse history in the past year)
* Cardiovascular Criteria:

  * Having known cardiovascular diseases (self-report, physician diagnosed)
  * Pacemaker
  * Bradycardia (resting heartrate of less than 55 bpm)
  * Resting diastolic BP \< 55 mmHG or systolic BP\<100 mmHG
  * ECG showing prolonged PR interval \> .2 sec
  * ECG showing irregular PR interval
  * ECG showing incongruence between P wave and QRS
* Medication Criteria

  * Allergy or intolerance of beta blockers
  * Current use of the following drugs:

    * Antihypertensive drugs
    * Neuroleptics
    * Monoamine oxidase inhibitors
    * Tizanidine
    * Amphetamine-based medications
    * Bupropion
    * Mirtazapine
    * Tricyclics: daily dose greater than 75mg amitriptyline or equivalent
    * Benzodiazepine: daily dose greater than 5mg diazepam or equivalent
    * Asthmatic medicine, including inhaler
  * Participants may be included after minimum of 4 weeks of physician prescribed termination of these drugs
Dose Escalation Study of Intravitreal 4D-110 in Patients With Choroideremia

This study will evaluate safety, tolerability, and preliminary efficacy of a single intravitreal (IVT) injection of a recombinant adeno-associated virus (AAV) gene therapy, 4D-110, in male patients with genetically-confirmed Choroideremia (CHM).

This is an open-label, Phase 1 study to evaluate safety and tolerability as well as preliminary efficacy of a single IVT injection of 4D-110 at three dose levels in male patients with genetically-confirmed CHM.

Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of CHM defined as a pathogenic mutation in the CHM gene, confirmed by genetic testing
* Both eyes must have ≥ 34 ETDRS letters (\~20/200)

Key Exclusion Criteria:

* Clinically significant, active ocular or peri-ocular infection or inflammation in the study eye
* Patient has previously received any AAV treatment
* Ocular conditions or ocular media opacity in either eye that would preclude the planned treatment (i.e. IVT injection) or interfere with the interpretation of study endpoints (e.g. significant lens opacity)