cyrilzakka/clinical-trials huggingface dataset:
Etude génétique Des Arméniens

This study aims at better understanding the genetic structure of the Armenians, an old population whose genetics has not been the subject of many studies. We will study 500 individuals whom grandparents originate from different regions of Armenia. Each individual will be genotyped using a large panel of genetic markers. Principal component analysis will be used to analyze the genetic structure of this population.


Eligibility Criteria:
Inclusion Criteria:

* Four grand-parents originating from Armenia

Exclusion Criteria:

* One or more grand-parents not originating from Armenia
Intravenous Mepolizumab In Subjects With Hypereosinophilic Syndromes (HES)

Hypereosinophilic syndrome (HES) is a rare disease with broad clinical signs and symptoms which is diagnosed based on a persistent blood eosinophil count of greater than 1500 cells, various end-organ damages (including skin, heart, lung, nervous system and digestive system etc.), and with exclusion of known secondary causes of hypereosinophilia.

HES has a high morbidity/mortality rate. The major treatment of HES has been systemic corticosteroid and other chemotherapeutic drugs (for example, hydroxyurea and interferon) with the intention to lower eosinophil counts and therefore to slow down the progression of disease. Even though corticosteroid and other therapies can effectively reduce eosinophilia in some patients, some may eventually become nonresponsive and intolerable to the amount of side effects of the long-term therapy with these medications.

Mepolizumab is a humanized monoclonal antibody that binds specifically to human interleukin 5 (hIL-5) and inhibits its activity. Previous human experience has shown it has been effective in reducing blood eosinophilia in atopic and HES patients and has alleviated some HES clinical signs and symptoms. This study intends to further evaluate the corticosteroid-sparing and clinical benefit of mepolizumab in HES.

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Phase III Study to Evaluate Corticosteroid-reduction and -sparing effects of Mepolizumab 750 mg intravenously in Subjects with Hypereosinophilic Syndromes (HES) and to evaluate the Efficacy and Safety of Mepolizumab in controlling the Clinical Signs and Symptoms of HES over Nine Months

Eligibility Criteria:
Inclusion criteria:

* Documented history of Hypereosinophilic Syndrome (HES)
* Eosinophil count greater than 1500 cells for 6 months
* Signs and symptoms of organ system involvement
* No evidence of parasitic, allergic or other causes of eosinophilia after comprehensive evaluation.
* Achieve and maintain a stable prednisone (corticosteroid) dose prior to starting study medication.
* Not pregnant or nursing.

Exclusion criteria:

* Churg-Strauss Syndrome
* Wegener's Granulomatosis
* Lymphoma, hematological malignancy, advanced and metastatic solid tumors
* Chemotherapy, radiotherapy or interleukin 2 treatment.
Insignia™ Hip Stem Outcomes Study

The objective of this study is to evaluate the safety and effectiveness of the Insignia™ Hip Stem for global market access and post-market clinical follow-up up to 10 years postoperative.

This study is a prospective, post-market, multi-center clinical investigation of the Insignia™ Hip Stem for primary and revision total hip arthroplasty (THA) in a consecutive series of patients who meet the eligibility criteria. The total enrollment goal for the study is a minimum of 313 cases, all of which will receive the Insignia™ Hip Stem.

Eligibility Criteria:
Inclusion Criteria:

* The subject has signed an Institutional Review Board (IRB)-approved, study specific Informed Consent Form (ICF).
* The subject is skeletally mature
* The subject has a diagnosis as listed in the instructions for use (IFU), which include non inflammatory degenerative joint disease (including osteoarthritis or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis, correction of functional deformity, treatment of nonunion, femoral neck and trochanteric fractures.
* The subject is a candidate for a primary or revision cementless THA.
* The subject is willing and able to comply with postoperative scheduled clinical evaluations.

Exclusion Criteria:

* The subject is pregnant or breastfeeding
* The subject has an active or suspected latent infection in or about the affected hip joint at the time of study device implantation.
* The subject has any mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care.
* The subject has bone stock compromised by disease, infection or prior implantation which cannot provide adequate support and/or fixation to the prosthesis.
* The subject is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. \> 30 days).
* The subject has a known sensitivity to device materials.
* The subject is involved in any ongoing legal matter, investigation, or dispute pertaining to the operative site.
* The subject is a prisoner.
Impact of Rifaximin Therapy on Intestinal Byproducts in End-Stage Renal Disease

The purpose of this study is to determine if rifaximin reduces serum trimethylamine-N-oxide (TMAO) levels in patients with end-stage renal disease.

Study participants will undergo 3 study visits: baseline, day 7 (immediately post-therapy), day 21 (2 weeks post-therapy). All participants will provide blood and stool samples at each visit.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of end-stage renal disease
* Receiving chronic intermittent hemodialysis

Exclusion Criteria:

* Patients with less advanced kidney disease
* Inability or unwillingness to provide informed consent
* Patients who may be pregnant
* Hemodynamically unstable patients
* Patients with liver failure, pancreatic insufficiency, or inflammatory bowel disease
* Patients with ongoing or recent infection and those with history of C-diff infection
* Patients with abnormal bowel structure secondary to surgical or anatomic variations
* Patients on certain medications, including immunosuppressants, antidiarrheal agents, or recent (within the last 2 months) use of antibiotics
The Influence of Peripheral Nerve Blocks in Patients Undergoing Limb Orthopedic Surgery

To investigate pre-op peripheral nerve block in reducing peri-op IL-6 level and post-op pain

In orthopedic surgery, peripheral nerve block can be used as an anesthesia adjuvant prior to surgery. In this study, we hypothesized that peripheral nerve blocks may alleviate inflammatory response and reduce the analgesics requirement. Sixty patients undergoing limb orthopedic surgery will be enrolled. Peripheral nerve block was injected with 0.25% bupivacaine under ultrasound guidance. 30 patients (Study group) underwent surgery with nerve blocks and another 30 patients (Control group) underwent surgery with morphine. The anesthetic protocol was standardized for both groups by experienced anesthesiologists. Surgical stress was assessed by blood pressure fluctuation and proinflammatory cytokine. Pain intensity was measured by numeric rating scale (NRS) score for 24 hours

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of limb fracture
* must receiving orthopedic surgery

Exclusion Criteria:

* With the comorbidity of chronic heart, lung, liver and renal disease, Chronic alcoholism, Allergy to bupivacaine
PATHWEIGH: Pragmatic Weight Management in Primary Care

The study examines patient weight loss and maintenance, associated predictors (patient health characteristics and demographics), and contextual factors in the practice environment that influence the intervention's adoption, implementation, and sustainability. This will be achieved through a mixed methods implementation study including collection and analysis of de-identified clinical data, surveys, observations, and interviews.

This study will investigate how PATHWEIGH, a weight management tool built into the EPIC electronic health record, in combination with clinician and staff training on the use of PATHWEIGH as a tool, education on effective weight management practices, and practice facilitation to support implementation can facilitate weight loss and maintenance for primary care patients. The study examines patient weight loss and maintenance, associated predictors (patient health characteristics and demographics), and contextual factors in the practice environment that influence the intervention's adoption, implementation, and sustainability. This will be achieved through a mixed methods implementation study including collection and analysis of de-identified clinical data, surveys, observations, and interviews.

This study is being conducted because despite obesity being the leading cause of preventable death in the U.S. and a major risk factor for disease, people with any degree of overweight or obesity are rarely offered anything other than lifestyle advice, rather than more rigorous and evidence-based weight management strategies. Poor reimbursement for weight-related visits, competing priorities, lack of appropriate tools, and limited time in visits also prevent more widespread use of weight management interventions. PATHWEIGH helps primary care clinicians and teams prioritize weight management with their patients when appropriate and ensures that they have the tools and knowledge handy to do so effectively. As part of the assessment of the PATHWEIGH intervention, the study will identify predictors of patient weight loss and weight loss maintenance using mediator and moderator analysis. Relevant factors (patient demographics, health metrics (e.g. vital signs, anthropometrics, comorbidities), behaviors and goals, provider age, sex, years and % time practicing, and clinic information (e.g. size, location, culture scale)) will be evaluated by including interaction terms between the treatment variable and possible moderating variables in outcome regression models .

Eligibility Criteria:
Clinician Inclusion Criteria:

* Affiliated with a participating primary care practice
* Provide care for adult patients (\>=18 years old)

Patient Inclusion Criteria:

* All adult patients (age \>18 years)
* BMI \>25 kg/m2
* Appointment at a primary care clinic participating in the study

Patient Exclusion Criteria:

* Unable to participate in weight loss treatment due to factors such as cognitive deficits, non-home residence, or limited life expectancy.
Effect of Caudal Nalbuphine on Postoperative Analgesia in Children

Nalbuphine as an adjuvant to bupivacaine caudal anesthesia for postoperative analgesia in children undergoing Hypospadias repair.

2 groups, 30 patients each


Eligibility Criteria:
Inclusion Criteria:

* Children undergoing elective Hypospadias repair
* with American Society of Anesthesiologists (ASA) physical status I
* age 2-10 years

Exclusion Criteria:

* Coagulation disorder
* allergy to study medications
* major malformations of the lower spine or meninges or any cutaneous or subcutaneous lesion at the site of injection.
Laparoscopic Revision Gastric Bypass for Inadequate Initial Weight Loss

The main aim of this study is to analyze and report traditional, patient-centered, and composite intermediate-term outcomes after laparoscopic revision Roux-en-Y gastric bypass surgery for inadequate initial weight loss.

There is lack of standardization of primary and revisional bariatric surgery compounded by a scant long-term outcome data. The treatment of inadequate weight loss, weight recidivism, and most severe technical complications after primary bariatric surgery remains refractory to non-operative treatment. Failure rates have been reported up to 20% and 35% for the morbidly obese (MO) and super obese (SO), respectively at 2 to 3 years after surgery. The indication for further surgical intervention remains controversial, as does what type of revisional procedure, both operative and endoscopic, to recommend. Furthermore, there is no standardization of the limb lengths, pouch size or the use of prosthetic reinforcement. Therefore the approach to these patients must be as individualized as their original operations. We formally analyze our experience with all laparoscopic revisional strategies for Inadequate Initial Weight Loss after failed Roux-en-Y gastric bypass(RYGB).

Eligibility Criteria:
Inclusion Criteria:

* laparoscopic revisional RYGB for failed RYGB with IIWL or non-responders pattern

Exclusion Criteria:

* failed RYGB with a WR pattern
* patients with prior major bariatric conversion or esophago-gastric surgeries
* RYGB patients revised by an open surgical approach
* RYGB patients who underwent laparoscopic revisional RYGB surgery somewhere else and continue their follow-up care with program
* missing records and/or unreachable patients with scan information for analysis
Assessment of Safety and Efficacy of Varenicline in Patients That Wish to Stop Smoking

The primary objective of this protocol is to evaluate 12 weeks of treatment of varenicline compared to placebo for smoking cessation. Abstinence from cigarette smoking and other tobacco products (e.g., pipe, cigars, chew, snuff.) use during non-treatment follow-up period will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Current male or female cigarette smokers who are motivated to stop smoking.
* Smoked an average of 10 cigarettes per day during past year and the month prior to first visit.

Exclusion Criteria:

* Patients who have used a nicotine replacement product, bupropion, clonidine or notriptyline within the past 6 months.
* Patients currently with depression or diagnosed with depression in past 12 months.
* Past or present history of psychosis, panic disorder, or bipolar disorder.
The Role of Peripheral and Tissue Chitinase 3-like 1 Protein Levels as a Bio-marker in IBD

The digestive system may be involved in various pathologic conditions, with different inflammatory, metaplastic and neoplastic aspects. As the therapeutic tool-box for digestive diseases grows and becomes more focused, at times targeting specific molecules, decision making in managing patients becomes more and more important, and must be evidence based.

Defining biomarkers with predictive value will theoretically allow physicians in making diagnosis, deciding on a suitable first line therapy (with specific endpoints suggesting response or indicating 2nd line therapy is indicated) and finally may suggest surgical intervention is warranted, thus forming an "individually tailored treatment" for each patient. These biomarkers may be located in the peripheral blood, in the gastrointestinal tract in general, or confined to specific intestinal lesions.

Chitinase 3-like 1 protein (YKL-40) is produced by different tissues (e.g. - synovium, smooth muscle, intestinal epithelium). Its specific action is unknown, but several reports have described it in different inflammatory conditions including those involving the gastrointestinal system. Chitinase 3 like-1 protein (YKL-40) has also been studied for its possible role in angio and onco-genesis.

This study aims to evaluate the diagnostic and prognostic value of peripheral and tissue Chitinase 3-like-1 (YKL 40) levels in gastrointestinal and liver diseases.

For periphery tests: 10 ml blood will be collected from all eligible subjects into SST tubes. Then serum will be separated and freeze at -80 degrees until analysis of Chitinase 3 like-1 protein by ELISA.

For tissue tests: biopsies will be taken from colons of eligible participants. One part of these biopsies will be freeze until analysis of Chitinase 3 like-1 protein by ELISA. The other part of the biopsies will be placed in dishes with appropriate media and will be incubated in 37 degrees in order to follow cytokine secretion for 24 h. Media will be collected after 24 h and then freeze until further analysis of Chitinase 3 like-1 protein by ELISA. The investigators will also measure mRNA levels of Chitinase 3 like-1 protein in collected biopsies.

The investigators will try to correlate between the Chitinase 3 like-1 protein levels in the blood and in tissue among various groups of participants and will compare between healthy participants and IBD participants. The investigators will also follow mRNA expression in tissue biopsies taken from all the participants.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Signed informed consent
* Any patient followed or treated by the digestive disease institute team (including ambulatory, hospitalized or undergoing procedure, endoscopy, surgery, endovascular or biopsy).

Exclusion Criteria:

* Pregnancy
* Inability to obtain informed consent
* Bleeding diathesis or any other condition precluding tissue biopsy.
Comparison of User Experience With Wheelsoft Wheels Intalled on a Wheelchair Compared With Normal Wheels.

Two groups of randomised rehabilitation patients will try a softwheels wheelchair and a regular one. One group will start with the softwheelsl and then change to the regular, and the other will start with the regular and then change to the softwheel.

The patients who are received to the rehabilitation ward and are confined to the use of a wheelchair are randomized to two groups. The first are given a wheelchair with wheelsoft wheels and the second group with regular wheels. The wheels of the chair are all covered to look similar to regular wheels (the regular wheels are also covered). All the patients will be taken once a day to a 10 minute trip with the wheelchair. After two days a questionnaire regarding their experience with the chair will be passed. On the third day the groups will change their wheels to the other kind. And again taken to daily trips and a final questionnaire on day four. We will collect additional data from the patients: age, sex, medical record, weight, height, ethnic background, marital status, working status.

Eligibility Criteria:
Inclusion Criteria:

* wheelchair bound for at least 4 days

Exclusion Criteria:

* not able to answer verbal questions
* over 95 kg of weight (wheel limit)
Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCH CD3-OLS)

This is a prospective, multicenter, open-label Phase 3 study of a microbiota suspension of intestinal microbes. Patients who have had at least one recurrence of CDI after a primary episode and have completed at least one round of standard-of-care oral antibiotic therapy or have had at least two episodes of severe CDI resulting in hospitalization may be eligible for the study. Subjects may receive a second RBX2660 enema if they are deemed treatment failures following the initial enema per the protocol-specified treatment failure definition.

This is a prospective, multicenter, open-label Phase 3 study of a microbiota suspension of intestinal microbes. The primary assessments for this study are (i) safety via assessment of treatment-emergent adverse events and (ii) efficacy of RBX2660 preventing recurrent episodes of CDI measured at 8 weeks after treatment. Follow-up office visits occur at 1 week and 8 weeks after completing the initial study treatment. Telephone assessments occur at 4 weeks, and 4 and 6 months after the study. Patients who have had at least one recurrence of CDI after a primary episode and have completed at least one round of standard-of-care oral antibiotic therapy or have had at least two episodes of severe CDI resulting in hospitalization may be eligible for the study. Subjects may receive a second RBX2660 enema if they are deemed treatment failures following the initial enema per the protocol-specified treatment failure definition.

Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years old.
2. Medical record documentation of either: a) a current diagnosis or history of recurrent CDI as determined by the treating physician, b) or has had at least two episodes of severe CDI resulting in hospitalization.
3. Is currently taking or was just prescribed antibiotics to control CDI related diarrhea at the time of enrollment. \[Note: Subject's CDI diarrhea must be controlled (\<3 unformed/loose stools/day) while taking antibiotics during screening.\]

Exclusion Criteria:

1. Has continued CDI diarrhea despite being on a course of antibiotics prescribed for CDI treatment.
2. Requires systemic antibiotic therapy for a condition other than CDI.
3. Fecal microbiota transplant (FMT) within the past 6 months.
4. FMT with an associated serious adverse event related to the FMT product or procedure.
5. Bezlotoxumab (CDI monoclonal antibodies) if received within the last year.
6. CD4 count \<200/mm\^3 during Screening.
7. An absolute neutrophil count of \<1000 cells/µL during Screening.
8. Pregnant, breastfeeding, or intends to become pregnant during study participation.
Phase2a Primaquine Dose Escalation Study

The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of low single-dose primaquine for gametocidal activity against P.falciparum among adult glucose-6-phosphate dehydrogenase (G6PD)-normal malaria patients.


Eligibility Criteria:
Inclusion Criteria:

* Male
* Age \>= 18 years and \< 50 years
* Malaria blood thick film positive
* Presence of gametocytes on thick blood film
* Agrees to admission to study ward for 26 hours post diagnosis and available for follow up visits
* No allergies to study drugs
* Hemoglobin \>= 8 g/dl
* No evidence of severe or chronic disease
* Written, informed consent
A Study of MK2578 in Patients With Chronic Kidney Disease Who Are Not on Dialysis (2578-002)

This study will define an effective starting dose for subcutaneous administration of MK2578 to correct anemia in erythropoiesis-stimulating agent (ESA)-naive patients with chronic kidney disease (CKD) who are not on dialysis while evaluating its safety.


Eligibility Criteria:
Inclusion Criteria:

* Patient is male or is a female who either cannot have children or who agrees to use appropriate contraceptive measures
* Patient has chronic kidney disease

Exclusion Criteria:

* Patient is morbidly obese
* Patient has used another erythropoiesis (red blood cell formation) stimulating agent within 12 weeks of screening
* Patient will require dialysis during the study or is planning to have a kidney transplant within the next 6 months
* Patient has had a blood transfusion within 12 weeks of screening
* Patient has had major surgery within the past 12 weeks or plans to have surgery
* Patient has Human Immunodeficiency Virus (HIV)
* Patient has a history of diseases other than CKD known to cause anemia
* Patient has severe congestive heart failure
* Patient has history of malignant cancer, except certain skin or cervical cancers
* Patient has a history of grand mal seizures within the last 6 months
* Patient is pregnant or breastfeeding
Genes That Affect Disease Outcome in Patients With Metastatic Colorectal Cancer

RATIONALE: Studying samples of blood and tumor tissue in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and help doctors understand how patients respond to treatment.

PURPOSE: This clinical trial is examining genes that affect disease outcome in patients with metastatic colorectal cancer.

OBJECTIVES:

* Collect blood samples for DNA extraction for genetic studies from patients receiving chemotherapy for metastatic colorectal cancer.
* Collect detailed clinical, pathological, and chemotherapy data from these patients.
* Identify genetic factors that relate to treatment response and outcome in these patients.

OUTLINE: Blood samples are collected and relevant genes and regions are amplified by PCR. PCR products are then sequenced or genotyped for known biological markers and single nucleotide polymorphisms. Tumor samples from surplus pathology specimens are analyzed for expression of candidate genes and mutation in the candidate genes.

Clinical and family history data is also collected by questionnaire.

PROJECTED ACCRUAL: A total of 800 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of metastatic colorectal cancer
* Currently receiving chemotherapy at Weston Park Hospital

PATIENT CHARACTERISTICS:

* Not Specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics