cyrilzakka/clinical-trials huggingface dataset:
Studies of Disorders in Antibody Production and Related Primary Immunodeficiency States

This study investigates gene abnormalities in Primary Immune Deficiency(PID) with a goal of improving the diagnosis and treatment of patients.

The specific disorders include:

1. X linked hyper IgM Syndrome which is caused by an abnormality in the CD40L gene.
2. NEMO associated immune deficiency which is caused by an abnormality in a gene called NEMO.
3. Common variable immunodeficiency (CVID) which has an unknown genetic basis.
4. Other disorders of immunoglobulin production.

This study will:

1. Better characterize the clinical features of CD40 L deficiency and NEMO associated immune deficiency and other related primary immune deficiency syndromes.
2. Determine the frequency of CD40 L and Nemo abnormalities.
3. Determine whether particular abnormalities in these genes are associated with more of less severe illness or with specific symptoms.
4. Explore the basic mechanism by which these altered genes cause immune dysfunction.
5. Identify other genes causing low immune globulin levels and related primary immune deficient states.

This protocol is designed to study the genetics and pathophysiology of Hyper-IgM syndrome, NEMO associated immune deficiency, patients with related primary immune deficiency disorders, and the blood relatives of immunodeficient patients. Patients will undergo evaluations that include history/physical, blood sampling, genetic testing, and possible tissue sampling. Among the aims of this protocol are to better understand genetic factors that lead to defects in host defense, and to use modern and evolving methods in molecular and cellular biology to elucidate the pathogenesis of these diseases. A better understanding of primary immunodeficiency could allow for the rational development of novel therapies for such diseases and to benefit future patients, but it might not benefit current patients directly. Routine follow-up may occur every six months - with evaluation and blood sampling. Under some circumstances, we may provide treatment that relates to the immune deficiency. These treatments will follow standard medical practice.

Eligibility Criteria:
* INCLUSION CRITERIA:

All patients must have a known or suspected immune defect with hyper-IgM syndrome and/or disorders of immunoglobulin production. There will be no limit on age, sex, race, or disability. Normal volunteers must be healthy adults between the age of 18 and 70 years. All study participants enrolled on to this study must agree to allow PI to store research samples. Refusal to let PI store samples may lead to withdrawal fro this specific study.

EXCLUSION CRITERIA:

The presence of an acquired abnormality, which leads to immune defects, such as HIV, chemotherapy, and malignancy are general exclusion criteria. Refusal to let us store samples may lead to withdrawal from this specific study. Other factors, which are in the judgment of the Principal Investigator PI that may interfere with patient evaluation or determine to pose an added risk for study participants are also criteria for exclusion.
Inactivation of Whole Blood With Mirasol

The purpose of this study is to evaluate radiolabeled recovery and survival of autologous red blood cells (RBC), derived from Mirasol-treated fresh whole blood (WB), stored as leukoreduced packed RBC (LR-pRBC), and re-infused in healthy adult subjects

This is a feasibility level study conducted to assess the recovery and survival of autologous, radiolabeled leukoreduced packed red blood cells (LR-pRBC) derived from fresh whole blood (WB) units that have been treated with the Mirasol System for Whole Blood (Mirasol System) and stored for 21 days at 1-6°C.1

Eligibility Criteria:
Inclusion Criteria:

* Eligible whole blood donor
* Age ≥ 18 years, of either sex
* Able to commit to the study follow-up schedule
* Subjects must have adequate bilateral antecubital venous access for WB collection and follow-up blood draws
* Negative screening test panel for infectious diseases
* Subjects of child-bearing potential (female or male) must agree to use effective contraceptive during the course of the study per site guidelines
* Subjects must agree to report adverse events (AEs) during the required reporting period
* Negative direct antiglobulin test (DAT) with subject's RBC
* Negative indirect antiglobulin test (IAT) with subject's serum

Inclusion for radiolabeled reinfusion of LR-pRBC on Day 21 (evaluated the day of, prior to, reinfusion):

* Maintenance of healthy status
* Negative direct antiglobulin test (DAT) with subject's RBC (fresh)
* Negative indirect antiglobulin test (IAT) with subject's serum (fresh) versus autologous stored LR-pRBC
* Negative serum or urine pregnancy test in females

Exclusion Criteria:

* Any serious medical illness and/or therapy, including: abnormal bleeding episodes, clotting or bleeding disorder, evidence of anemia, myocardial infarction, uncontrolled hypertension, heart disease, surgery with bleeding complications, epilepsy or any major surgery (with general or spinal anesthesia) within the last 6 months
* Pregnant or nursing females; For women of childbearing potential, negative serum or urine pregnancy tests at the time of WB donation and before the reinfusion are required
* Unable to give informed consent
* Participation currently, or within the last 12 months, in another investigational trial that would potentially interfere with the analysis of this investigation (e.g., pharmaceutical)
* Have received an accumulated radiation dose that would exclude them from the study according to the local radiation safety limits established by each institution
* Inability to comply with the protocol in the opinion of the investigator
Impact of a Gluten-free Diet on Quality of Life in Patients With Axial Spondyloarthritis.

Subclinical intestinal inflammation and gut dysbiosis have been reported in patients with spondyloarthritis (SpA). In common practice, rheumatologists are increasingly confronted with patients with inflammatory rheumatism who are on gluten-free diets (GFDs), despite the lack of reliable data from controlled studies. This study aims to determine the impact of a GFD on the quality of life of patients with axial SpA.

The GlutenSpA study is a 24-week, randomized, double-blinded, placebo-controlled, multicenter trial. Patients with axial SpA (n=200) will follow a 16-week GFD and be randomly assigned (1:1) to an experimental or control arm. In the experimental arm with receive at least 6 gluten-free breads per day + 200 g of gluten-free penne pasta per week + 6 rice flavor capsules per day. The control arm will receive at least 6 gluten-containing breads per day + 200 g of gluten-containing penne pasta per week + 6 vital gluten-containing capsules per day.

At baseline, the dietician will explain to the patients how to properly follow a GFD during a face-to-face interview. The patient's compliance to the GFD will be evaluated by the dietician at S2, S16, an S24 using an online 3-day alimentary questionnaire.

The bread and penne pasta were chosen for their visual resemblance and similar taste to maximize the blindness of the study. In order to reach the daily amount of gluten in a standard diet (estimated in France between 10 and 15 g/d) in the control arm, each day patients will have to ingest six capsules of vital gluten wheat made for the study. Vital gluten flour is an over-the-counter food supplement used to enrich a protein diet or as a base for making products, such as seitan. Capsules will be made using commercially available vital gluten and contain 0.35 g of gluten per capsule. The total amount of gluten in the control arm will be approximately 10.5 g/day.

After the 16-week GFD, patients will be offered to follow or not follow the GFD according to their own decision for an 8-week open-labelled follow-up period. The study duration for each patient is 24 weeks. The patient recruitment is expected to last 2 years

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of axial SpA defined by ASAS criteria
* Rheumatologist not wish to change the treatment within 4 months of inclusion,
* stable treatment (NSAID and/or DMARD) for at least 3 months but no corticosteroid infiltration in the month prior to inclusion,
* able to follow a GFD and to provide written informed consent and submit to the requirements of the study

Exclusion Criteria:

* Any diet at the time of inclusion or within 3 months prior to inclusion;
* have a history of celiac disease;
* received antibiotic treatment within 3 months of inclusion or are taking a probiotic;
* are pregnant, breastfeeding,
* not covered by social security;
* minors or adults under the protection of the law or under the protection of justice.
A Study in Healthy Male Subjects to Investigate Whether Administration of ACT-132577 Can Affect Rosuvastatin's Fate in the Body (Amount and Time of Presence in the Blood)

The primary purpose of this study is to investigate the effect of Aprocitentan (ACT-132577) at steady state on the pharmacokinetics of single-dose rosuvastatin in healthy male subjects


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent in the local language prior to any study mandated procedure;
* Healthy male subjects aged 18 to 45 years (inclusive) at screening;
* Body mass index of 18.0 to 28.0 kg/m2 (inclusive) at screening;
* Healthy on the basis of physical examination, cardiovascular assessments and laboratory tests;
* Hemoglobin ≥ 135 g/L at screening.

Exclusion Criteria:

* Known allergic reactions or hypersensitivity to ACT-132577, rosuvastatin, any drug of the same classes, or any of their excipients;
* Any contraindication for rosuvastatin treatment;
* History or clinical evidence of myopathy;
* Asian or Indian-Asian ethnicity;
* Known hypersensitivity or allergy to natural rubber latex;
* Previous exposure to ACT-132577;
* Treatment with rosuvastatin within 3 months prior to screening;
* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
Neurohormonal Parameters in Hypertrophic Cardiomyopathies

The primary purpose of this study is to demonstrate that changes in plasma levels of circulating neurohormones (mainly BNP and NT-proBNP), measured at rest and post-exercise correlate with exercise functional limitation (assessed by exercise peak VO2) and exercise ultrasonic parameters (as left ventricular filling, obstruction, and mitral regurgitation)

The secondary purposes are to study the kinetics of secretions of natriuretic peptides, and their relationships with extent of MRI myocardial fibrosis with the degree of exercise functional limitation.

Eligibility Criteria:
Inclusion Criteria:

* - Age 18 to 75 years
* Primary (sarcomeric) hypertrophic cardiomyopathy, obstructive or non obstructive, with studies of exercise peak oxygen consumption and cardiac MRI with gadolinium late-enhancement
* Informed consent
* Patient with a social insurance Patient at rest
* - Age 18 to 75 years
* Primary (sarcomeric) hypertrophic cardiomyopathy, obstructive or non obstructive
* Informed consent
* Patient with a social insurance

Exclusion Criteria:

* - Insufficient echogenicity
* Permanent atrial fibrillation
* Complete BBB on the ECG
* LVEF \< 35 %
* Previous septal ablation (surgical or percutaneous)
* Simultaneous participation to another biomedical research

If exercise needed:

* contraindication to exercise : hemodynamic instability, uncontrolled high blood pressure (\>220/120 mmHg), severe aortic stenosis
* Inability to exercise (muscular, pulmonary, elderly patient)
A Study to Compare the NexGen CR and CR-Flex Knee Implants

The purpose of this study is to test for significant differences in functional outcomes, specifically pre-operative ROM and post-operative ROM obtained by using a NexGen CR versus a NexGen CR-Flex knee implant. Specifically, it is predicted that an increase in post-operative range of motion will be experienced by patients treated with the NexGen CR-Flex knee implant.

This study will compare the clinical results of the NexGen CR femoral component with the higher flexion potential of the NexGen CR-Flex femoral component in all patients with degenerative joint disease that require total knee arthroplasty. The primary variable of interest is post-operative range of motion achieved with the two devices, which are implanted with slightly different surgical techniques in patients who may also be subjected to different rehabilitation programs depending on the device they are assigned.

Eligibility Criteria:
Inclusion Criteria:

* Age, 21-80 years
* Sex, Male and Females will be included
* BMI less than or equal to 39
* Stable Health, the patient would be able to undergo surgery and participate in a follow-up program based on physical examination and medical history.
* Patient is willing and able to cooperate in follow-up therapy.
* Patient exhibits pre-operative radiographic evidenced of joint degeneration consistent with TKA that cannot be treated in non-operative fashion.
* Patient has stable and functional posterior cruciate and collateral ligaments.
* Patient has potential to perform higher than average range of motion activities.
* Operative side range of motion flexion greater than or equal to 120 degrees.
* Severe knee pain and disability due to degenerative joint disease.
* Patient or patient's legal representative has signed the Informed Consent form.

Exclusion Criteria:

* Previous history of infection in the affected joint.
* Previously failed knee endoprosthesis of any kind.
* Charcot joint disease or other severe neurosensory deficits.
* Previous patellectomy
* Patient is skeletally immature.
* Grossly insufficient femoral or tibial bone stock.
* Patient is pregnant.
* Varus or valgus deformity greater than 20 degrees.
* Fixed flexion deformity greater than 15 degrees.
* Previous high tibial osteotomy.
* Previous femoral osteotomy.
* Patient is a poor compliance risk, currently treated for ethanol or drug abuse, physical or mental handicap, etc.
* Loss of musculature or absence of musculoligamentous supporting structures required for adequate soft tissue balance.
Hyaluronan Versus NaCl 20 Ml Versus Placebo in Knee Osteoarthritis

251 consecutive patients with knee arthrosis were randomized to one of three interventions: Four weekly injections of 2 ml isotonic saline (placebo), 2 ml sodium hyaluronate (hyaluronan) or 20 ml isotonic saline (excessive saline).

They all suffered from clinically and radiologically verified arthrosis of the knee with daily pain that did not respond to treatment with analgetics.

Results were evaluated at weeks 1,2,3,4,8,12,16 and 26. Biochemical markers for bone and cartilage degradation were measured in urine/blood.


Eligibility Criteria:
Inclusion Criteria:

* Patients, men/women age \> 60 years with clinical,
* Radiological and possible arthroscopical verified knee osteoarthritis.
* Knee pain on the day of examination scoring more than 20 mm on a visual analogue scale (VAS) at baseline.

Exclusion Criteria:

* Age below 60
* Unconsciousness
* Psychosis
* Demens
* Ingestion of drugs that may influence the results of the clinical examinations
* Inflammatory diseases of the joints
* Rheumatoid arthritis or other inflammatory arthritis as diagnosed by American College of Rheumatology criteria
* Contraindication to hyalgan treatment
* Previous intraarticular fracture of a knee joint
* Infection or skin disease located at the place of injection and invasive procedures done to the knee joint within previous two months inclusive intra-articular injections of steroids.
* Any other condition that might interfere with the efficacy assessment or completion of the trial.
Adjuvant CCRT vs CT in Minimal N2 NSCLC

This study propose adjuvant concurrent chemoradiotherapy vs chemotherapy alone in completely resected microscopic N2 NSCLC

Approximately 15% of patients with non-small cell lung cancer are diagnosed with stage IIIA-N2 disease. However, this subgroup is heterogeneous, with lymph nodes that are only microscopically invaded to those that are radiologically visible with bulky ipsilateral mediastinal lymph node involvement. Surgical resection in selected patients results in 5-year survival rates of 7-24%.

The standard treatment for locally advanced clinical N2 disease is definitive concurrent chemoradiotherapy or induction chemotherapy (± radiation) followed by operation. However, in some patients, N2 status could be confirmed only after curative operation without any evidence of N2 diseases through preoperative evaluation methods (CT, PET, mediastinoscopy). We usually define those N2 disease found only after curative operation as microscopic N2, and do adjuvant chemotherapy, radiotherapy or concurrent chemoradiotherapy. However, little data about the adjuvant therapy for completely resected N2 disease have been available, Hence, we propose a randomized phase II study of adjuvant concurrent chemoradiotherapy vs chemotherapy alone in completely resected microscopic N2 NSCLC.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed diagnosis of stage IIIA(N2) NSCLC that was completely resected by lobectomy, bilobectomy, pneumonectomy, or sleeve lobectomy through any incision (thoracoscopic or video-assisted thorascopic surgery approaches were acceptable)
2. "Pathologic N2" disease (involvement of N2 nodes can only be determined at the time of surgical exploration or postoperative pathologic analysis)
3. Age ≥18years
4. No known residual disease (negative resection margin and no extracapsular invasion of lymph node metastasis)
5. ECOG performance status of 0 to 1
6. No previous chemotherapy or RT
7. Adequate organ function as evidenced by the following; Absolute neutrophil count \> 1.5 x 109/L; platelets \> 100 x 109/L; total bilirubin ≤1.5 UNL; AST and/or ALT \< 5 UNL; creatinine clearance ≥ 50mL/min
8. Written informed consent form

Exclusion Criteria:

1. Patients with preoperative mediastinoscopic N2 positive disease
2. Uncontrolled systemic illness such as DM, CHF, unstable angina, hypertension or arrhythmia
3. Patients with post-obstructive pneumonia or uncontrolled serious infection
4. Pregnant or nursing women ( Women of reproductive potential have to agree to use an effective contraceptive method)
5. Prior history of malignancy within 5 years from study entry except for a adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer, well-treated thyroid cancer
tDCS for Fatigue in Sjogren's Syndrome

Sjogren's Syndrome (SS) is an autoimune disease of unknown etiology characterized by lymphocytic infiltration of the exocrine glands and other organs. patients usually presents with xerophthalmia, xerostomia, fatigue and other symptoms. Fatigue has often been reported as the biggest problem and the most difficult symptom patients have to deal with. Fatigue management in pSS is difficult. However, in other diseases such as Parkinson disease, post-polio syndrome and multiple sclerosis the use of Transcranial Direct Current Stimulation (tDCS) has recently been studied and has shown effectiveness. The overarching objective of this study is to examine the effect of a tDCS protocol in patients with pSS.


Eligibility Criteria:
Inclusion Criteria:

* Women
* Age between 18 and 65 years old;
* Diagnosis of primary Sjogren's Syndrome according to American-European Criteria;
* Stable pharmacological therapy for at least 3 months;
* Complaints of fatigue as assessed by Fatigue Severity Scale (FSS\>5).
* Complaints of fatigue for more than 3 months.

Exclusion Criteria:

* Heart, coronary, respiratory, renal, or hepatic uncompensated insufficiencies;
* Uncompensated systemic arterial hypertension;
* Unable to answer the questionnaires.
* Severe depression (with a score \> 30 in the Beck Depression Inventory)
* History of epilepsy or syncope
* Implanted brain metallic devices
* Established cognitive impairment
* Traumatic brain injury with residual neurological deficits
Effect of Seminal Fluid on the Colon Wall; Implications for HIV Transmission

This research is being done to learn how seminal fluid affects the lining of the colon, and whether this might make it easier for HIV to get into the body and cause infection.

Design of effective rectal microbicides to prevent HIV infection requires an understanding of rectal HIV transmission and the location within the lower gastrointestinal (GI) tract (luminal and mucosal) of HIV (cell-free and cell-associated) following exposure to infected seminal fluid. These basic details of HIV transmission have yet to be determined in human subjects, yet they are essential to select microbicide candidates if they are to be rationally designed to achieve effective concentrations at sites of HIV transmission. Rational development of a rectal microbicide also requires an understanding of those factors that may contribute to colonic mucosal injury - potential confounders of microbicidal effect. Such factors include exposure to seminal fluid which has been shown in animal and in vitro studies to cause histologic and permeability changes that might facilitate HIV transmission.

Eligibility Criteria:
Inclusion Criteria:

* Able to provide signed informed consent
* Men of 21 years or older.
* Prior history of receptive anal intercourse.
* Laboratory values within the last 28 days:
* Negative for HIV antibodies
* Lymphocyte count within normal limits
* Neutrophil count \> 1,000 cells/ml
* Cluster of Differentiation 4 (CD4) cell count \> 500 cells/ml
* Platelet count ≥ 150,000 cells/mm3
* Prothrombin Time (PT) within normal limits
* Partial thromboplastin time (PTT) within normal limits.
* No childbearing intentions.

Exclusion Criteria:

* Active anorectal disease or recent (3 months) anorectal surgery;
* Diarrhea, defined as three or more loose stools per day, for at least three days prior to admission.
* History of sleep apnea, or airway problems with previous sedation procedures.
* History of significant adverse reaction to sedation medications.
* Other history, including significant occupational radiation exposure, history of inflammatory bowel disease or any other diseases and lab results, such that, in the judgment of the investigator, study procedures are not considered safe for the subject's participation.
Post-Trial Access for Guselkumab in Participants With Familial Adenomatous Polyposis

The purpose of this post-trial access (PTA) program is to provide guselkumab to participants with Familial Adenomatous Polyposis (FAP) who are experiencing clinical benefit after completing 48 weeks of treatment in Study CNTO1959COR1001.


Eligibility Criteria: