cyrilzakka/clinical-trials huggingface dataset:
Lynch Syndrome Integrative Epidemiology and Genetics

The vision of the "Lynch syndrome INtegrative Epidemiology And GEnetics" (LINEAGE) Consortium is to collaboratively improve the lives and longevity of individuals and families with Lynch syndrome.

The mission of the LINEAGE Consortium is to collaboratively improve Lynch syndrome care through high-quality research. This consortium will provide intellectual and infrastructure support to facilitate development of research questions, collection of standardized data and biospecimens, support of grant applications, and generation of collaborative manuscripts.

Our aims are to:

I. Establish a prospective cohort of individuals with Lynch syndrome II. Collect standardized longitudinal clinical and biosample data to elucidate Lynch Syndrome epidemiology and gene-host interactions III. Promote intervention trials to improve cancer prevention and early detection in Lynch Syndrome

The main objective of this consortium is to build a shared resource to drive research in critical areas necessary to understand LS-related neoplasia risk and improve early detection and prevention of LS-associated cancers. This consortium will provide intellectual and infrastructure support to facilitate development of research questions, collection of standardized clinical data and biospecimens, support grant applications, and generate collaborative manuscripts.

Data and samples collected for LINEAGE will allow the consortium to address a variety of topic areas including but not limited to:

I. Risk of prevalent and incident colorectal neoplasia among PV/LPV carriers. II. Estimate risk of prevalent and incident extra-colonic neoplasm among PV/LPV carriers.

III. Characterization of post-colonoscopy colorectal cancer among PV/LPV carriers.

IV. Risk factors for prevalent and incident neoplasia.

The LINEAGE Consortium is an observational prospective cohort study, with baseline and annual electronic health record (EHR) abstraction, and electronic participant and provider surveys. The consortium may also collect single or serial biosamples from identified and enrolled LS patients at participating centers.

Eligibility Criteria:
Inclusion Criteria:

* • Adults age over 18 years

  * Eligible patients must have at least one variant of uncertain significance (VUS), pathogenic or likely pathogenic variant (PV/LPV) in MLH1, MSH2, MSH6, PMS2, or EPCAM, which will be confirmed by genetic testing results (obtained as part of routine care) and a review of the variant in ClinVar (https://www.ncbi.nlm.nih.gov/clinvar/).
  * Individuals who are an obligate carrier of a LS PV/LPV that is confirmed in the family.

Exclusion Criteria:

* Age under 18
Vitamin A Replacement in Patients Undergoing HSCT and Its Role on MBI-LCBI Rates

The primary objective of this study is to establish that single dose vitamin A supplementation is feasible and safe in pediatric and young adult bone marrow transplant recipients until day +30 (± 7 days) after hematopoietic stem cell transplantation.

The investigators' preliminary data suggest that low levels of vitamin A directly impact risk of mucosal barrier injury laboratory-confirmed bloodstream infection (MBI-LCBI), likely via decreased gut permeability, and they hypothesize supplemental vitamin A at the time of HSCT can reduce the risk of MBI-LCBI and gastrointestinal graft versus host disease (GI GVHD). A 3x3 dose escalation/de-escalation study design will be used to determine the safety and dosing required to maintain vitamin A levels in the upper quartile of normal range for age at day +30 (± 7 days) with single dose vitamin A supplementation prior to hematopoietic stem cell transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Any patient undergoing HSCT.

Exclusion Criteria:

* Vitamin A hypersensitivity or allergy.
* Age less than 1 year at time of transplant.
* Baseline pre-HSCT vitamin A levels higher than the upper quartile of normal range for age.
* Enteral feeding or medication intolerance.
* Pregnancy.
A Relative Bioavailability Study of Bupropion HCI 150 mg Sustained-Release Tablets Under Fasting Conditions

The purpose of this study is to demonstrate the relative bioequivalence of Bupropion HCI 150 mg SR Tablets under fasting conditions.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.
Study of the Evolution Profile of the Renal Doppler in the Perioperative Hepathic Transplantation

Liver transplantation is associated with a modification of the perfusion pressures of the abdominal organs (preoperative portal hypertension in connection with liver pathology, and normalization of the perfusion pressures during surgery). This abrupt change in the infusion regime is probably responsible for an alteration in renal function in some patients, and the identification of renal vascular profiles using Doppler could point to pathological profiles, which should be diagnosed early.


Eligibility Criteria:
Inclusion Criteria:

* Patient of full age (≥18 years)
* Patient operated on at the HUS for a liver transplant, between July 1, 2019 and June 30, 2020.
* Patients having undergone an evaluation of hepatic and renal vascular profiles perioperatively.
* Patients hospitalized in the surgical intensive care unit after hepatic transplant surgery.
* Patient not having expressed, after information, the reuse of his data for the purposes of this research

Exclusion Criteria:

* Patient who expressed his opposition to participating in the study
* Patient with suspected obstructive acute renal failure
* Stenosis of renal arteries known at the time
* End-stage renal disease on dialysis
* Impossibility of giving the subject informed information (difficulties in understanding the subject, etc.)
* Subject under safeguard of justice
Comparison of Efficacy, Safety and Costs of Recombinant FVIII Products Between On-demand and Secondary Prophylaxis Groups in Haemophilia A Patients

The project is an observational, multi-central, prospective, non-interventional and open-label data collection study on secondary prophylaxis with recombinant FVIII products in adolescents and adults with severe hemophilia A (FVIII \< 1%).

It will be a controlled observation of patients on secondary prophylaxis versus on-demand treatment regimen. Patients will be enrolled preferably on a 1:1 basis with regards to prophylaxis and on-demand treatment.

The patient enrollment period will be 2 years with a follow-up (observation period) of 2 years for each patient. Based on the primary effectiveness parameters (joint bleeds and overall bleeds per year) an observation period of 2 years is considered sufficient although it has to be admitted that it is rather short to assess the progression of orthopedic status. Previously treated prophylaxis patients with at least 50 exposure days and patients with continuing prophylaxis treatment will be included.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Severe hemophilia A (FVIII\<1%) diagnosis
* Prior treatment or ongoing treatment with on-demand or prophylaxis regimens according to Turkish guidelines and requirements
* Previously treated patients with at least \>50 exposure days
* Written informed consent signed by patient/legal representative

Exclusion Criteria:

* Currently on immune tolerance treatment
* Platelet count \< 75,000/mm3
* Participation in another study
* Existence of inhibitors in the past and in the last currently available blood sample prior to study start (Bethesda titer \< 0.6 BU/ml)
* Existence of inhibitor history in family members who also are diagnosed with hemophilia A
* Having been on primary prophylaxis as defined in the introduction
* Participation in another study
Determination of the Prevalence and Prognostic Importance of Unrecognized Non-Q-wave Myocardial Infarction by MRI

The first aim of this study is to determine how often unrecognized myocardial infarction occur in patients using a magnetic resonance imaging (MRI) technique (known as delayed enhancement MRI), as compared to the electrocardiogram. The second aim of this study is to determine the severity of coronary heart disease of the patients with unrecognized myocardial infarction. The final aim is to determine how the presence of unrecognized myocardial infarction detected by the MRI affects lifespan.

Unrecognized myocardial infarction (MI) is known to constitute a substantial portion of lethal coronary heart disease. However, since the diagnosis of unrecognized MI is based on the appearance of incidental Q-waves on 12-lead electrocardiography, the syndrome of unrecognized non-Q-wave MI has not been described. Delayed-enhancement cardiovascular magnetic resonance (DE-CMR) can accurately identify non-Q-wave MI. The aims of this study are three-fold: 1. to determine the prevalence of unrecognized non-Q-wave and Q-wave MI, 2. to define predictors of unrecognized non-Q-wave MI, 3. to determine the prognostic significance of unrecognized non-Q-wave MI.

Eligibility Criteria:
Inclusion Criteria:

* Patients with suspected coronary artery disease referred for invasive coronary angiography

Exclusion Criteria:

* Clinical history of myocardial infarction
* Percutaneous coronary intervention
* Coronary artery bypass surgery
* Known uncured malignancy
* History of hypertrophic cardiomyopathy, myocarditis, or infiltrative heart disease
* Contraindication of magnetic resonance imaging
Reliability of Different FOT Devices to Measure the Human Respiratory Impedance

The objective of the study is to evaluate the reliability of the impedance data in adult subjects measured with five different FOT devices.

The purpose of the study is to evaluate the reliability of the respiratory impedance measured with different FOT (=Forced Oscillation Technique) devices. To this end, the respiratory impedance of fifty adult subjects will be measured in random order with five different forced oscillation devices. As there is no "gold standard" FOT-device, each setup will be compared to all other setups.

Secondary study questions are: 1) is there a specific comfort (or discomfort) associated with the different measuring devices 2) Guidelines state that full chin and cheek support should be applied when measuring the human respiratory impedance. What is the influence of a partial cheek support?

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult subjects
* Adult patients with obstructive lung disease

Exclusion Criteria:

* Inability to perform lung function tests
* Patients with respiratory failure
* Patients on BIPAP-therapy
* Patients on supplemental oxygen.
Comparison Of Outcomes After Knee Arthroplasty Using Posterior-Substituting Versus Cruciate-Retaining Prostheses

Total knee replacement is used in the treatment of patients with knee arthritis, rheumatoid arthritis and other knee disorders. Today, there are basically two designs; It cuts the posterior cruciate ligament (PS) and protects the posterior cruciate ligament (CR). Although there is no clear study suggesting which design is better, research on this subject has increased recently. the investigators aim is to define the superiority of these two designs over each other. Preoperative and postoperative joint range of motion examinations were performed on both knees separately. WOMAC and OXFORD scores were examined separately for both knees.

Total knee arthroplasty is used to treat patients with osteoarthritis, rheumatoid arthritis, and other knee disorders. Today, there are basically two primary designs; posterior cruciate Substituting (PS) and protects the posterior cruciate -Retaining (CR). However, it is still controversial which approach is good, as both CR and PS have advantages and disadvantages. Proponents of the posterior cruciate retaining system argue that it provides natural stability, wider joint range of motion, better proprioception, and better knee kinematics. In addition, proponents of the posterior cruciate substituting system argue that it provides more harmonious articulation and a wider flexion range.

As a result, although there is no clear study suggesting which design is better, research on this subject has increased recently. Our aim is to define the superiority of these two designs over each other.

Patients with the same stage of knee osteoarthritis in both knees were selected. Total knee arthroplasty was performed in the same session by making the appropriate design for the appropriate knee simultaneously. Preoperative and postoperative joint range of motion examinations were performed on both knees separately. WOMAC and OXFORD scores were examined separately for both knees.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with primary osteoarthritis of both knees
2. Patients with secondary osteoarthritis of both knees

Exclusion Criteria:

1. Patients with primary osteoarthritis in both knees and undergoing unilateral knee prosthesis
2. Patients with secondary osteoarthritis in both knees and who underwent unilateral knee prosthesis
3. Patients with primary osteoarthritis in both knees and who underwent bilateral knee prosthesis in different sessions
4. Patients with secondary osteoarthritis in both knees and who underwent bilateral knee prosthetics in different sessions.
Effect of Pulsed Electromagnetic Field Stimulation on Localized Pediatric Osteomyelitis

This study will be applied to evaluate effect of pulsed electromagnetic field on pediatric localized osteomyelitis.

Twenty (11 girls, 9 boys) patients will participate in this study. Their ages ranged from 5 to 16 years. They will randomly divide into two groups. Group A ( study group) will receive pulsed electromagnetic field in addition to medical treatment three times per week for two months , Group B(control group ) will receive medical treatment only.

Eligibility Criteria:
Inclusion Criteria:

1. All patients suffering from localized osteomyelitis in one or both lower limbs
2. All patients will be assessed by a physician before starting the study procedures.

Exclusion Criteria:

1. Patients with immune disorders .
2. Patients who suffer from any systemic diseases that may interfere with the objectives of the study.
Observational Study in Cystic Fibrosis Patients Using TOBI® PODHALER® or Other FDA Approved Inhaled Antipseudomonal Antibacterial Drugs

This is a multicenter, prospective, two cohort, observational study over a 5-year period in Cystic Fibrosis (CF) patients with chronic Pseudomonas aeruginosa infection.The study will collect data over 1 year on respiratory function, antibacterial effectiveness, and clinical outcomes of treatment with inhaled antipseudomonal antibiotics and data over 5 years on microbiological and safety assessments.

This study will include CF patients chronically colonized with P. aeruginosa enrolled in the Cystic Fibrosis Foundation (CFF) PortCF registry and using TOBI® PODHALER® or another FDA-approved inhaled antipseudomonal antibiotic. No therapeutic intervention will be assigned and physicians will use their discretion in choosing a treatment regimen for their patients.

Sputum samples (primarily collected during routine clinical follow-up) from patients able to spontaneously produce sputum will be sent to a central laboratory for analysis.

In addition, this study will include two optional sub-studies for qualifying patients in the first study year - Sputum microbiology sub-study and TOBI® PODHALER® sputum pharmacokinetics (PK) sub-study.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 6 years of age.
* Documented FEV1 ≥ 25% predicted in the previous year.
* Diagnosis of cystic fibrosis.
* Established diagnosis of chronic P. aeruginosa infection of the lungs defined as two or more positive P. aeruginosa cultures in the previous year as documented in the subject's medical history (this may include a history of one positive culture in the year prior to enrollment and one positive culture from the specimen collected at the baseline visit).
* Prescribed and initiated chronic treatment with FDA-approved inhaled antipseudomonal antibiotic for chronic P. aeruginosa infection (e.g. TOBI® PODHALER®, TOBI®, Cayston® and Bethkis®).
* Actively enrolled or willingness to enroll in PortCF registry.
* Willing and able to provide written informed consent or, parent/guardian consent and where applicable pediatric assent, for participation and use of relevant clinical data previously captured in PortCF.
* Anticipated to have good adherence to routine visits, defined as the investigator having good knowledge that the patient has been to at least 2-3 routine visits in the previous year.

Exclusion Criteria:

* Documented FEV1 \< 25% predicted in the previous year.
* Current participation in an interventional clinical study with an inhaled antibiotic treatment.
* Treatment with compounded tobramycin (e.g. the use of tobramycin IV solution adapted for use by inhalation).
* Treatment with inhaled antipseudomonal antibacterial drug(s) that are not FDA approved.
* Patients undergoing an early eradication regimen for CF (first line therapy).
Study of Specific Allergen Immunotherapy in Grass Pollen Allergic Subjects With Epicutanoeus Allergen Administration

Seasonal rhinoconjunctivitis or hay fever is a common atopic condition that is frequently seen in clinical practice. Grass pollen is the major cause of pollinosis in many parts of the world. Immunotherapy is the only treatment that may affect the natural course of allergic diseases, and it may also prevent the development of asthma in patients with allergic rhinitis. With conventional subcutaneous desensitization the duration of treatment is around 3-5 years and usually comprises around 30-100 allergen injections. As high allergen doses have to be injected, allergic side effects may occur and patients must stay under medical supervision for at least 1 hour. Transcutaneous immunization (TCI) is a needle -free technique that delivers antigens and adjuvants to potent epicutaneous immune cells. The aim of the new epicutaneous route of desensitization is to more specifically target the immune system by loading Langerhans cells with the allergen. Lower antigen doses can be applied, such that side effects are reduced.


Eligibility Criteria:
Inclusion criteria: Written informed consent History of grass pollen allergic rhinitis for at least two years Male and female between 18 years to 65 years Positive skin-prick test to grass pollen Positive conjunctival provocation test

Exclusion criteria: Eczematous skin lesions on the upper arms Perennial rhinitis due to perennial allergies or anatomical reason (polyps, septal deviation) Symptoms of infectious disease with rhinitis in between the last week Surgical intervention in between the last 30 days Pregnancy or nursing History of HIV or AIDS History of mastocytosis (cutaneous or systemic) History of significant cardiovascular disease Uncontrolled Hypertension (blood pressure \> 160 / 95) History of significant pulmonary, renal and/or hepatic disease History of significant hematological disorder Moderate or severe asthma History of malignancy Significant neurological or psychatric disease History of active autoimmune disease Antihistamines with longed half-lives in the last week Systemic or topical steroids for 5 days Depot corticosteroids for the last two months Active infectious disease Adipositas per magna

Contraindicated medications:

* immunosuppressive agents
* Betablockers
* ACE-inhibitors, AT 2 Antagonists
* tricyclic antidepressants
* daily use of Beta-agonists or steroid inhalers
* Participation in another clinical trial /study at the moment or within the last 60 days
Clinical Management With SPM System and Validation of the SPM 5 Hour Cutoff in Patients With Symptoms of Gastroparesis

This protocol is designed to validate use of the SPM for diagnosis of delayed gastric emptying in patients with symptoms of gastroparesis and assess impact of a SmartPill study on patient management in the gastroparetic populations. Patients with symptoms of gastroparesis will be recruited.

Patients will undergo concurrent gastric scintigraphy and SPM testing to determine the presence or absence of delayed gastric emptying based on predetermined diagnostic cutoffs for each technique.


Eligibility Criteria:
Inclusion Criteria:

* Males and females between ages of 18-80 years of age with symptoms of gastroparesis for at least 12 weeks.
* Presenting with 2 or more of the following symptoms or signs which, in the opinion of the site investigator, are suggestive of a diagnosis of gastroparesis:

  * 1 Nausea, vomiting, or retching (dry heaves)
  * 2 Postprandial fullness or early satiety
  * 3 Bloating or visible abdominal distention
  * 4 Postprandial discomfort or pain
* Ability to stop proton pump inhibitors for 7 days and histamine2 receptor antagonists, prokinetic agents, narcotic agents, anticholinergic drugs, and cannabinoids 3 days prior to SPM and gastric scintigraphy testing.
* No evidence of metabolic disease (hypothyroidism, uncontrolled diabetes \[hemoglobin A1c \>10% within the past 6 months\], electrolyte imbalance).
* An upper endoscopy or upper gastrointestinal barium series within the past 2 years showing no organic disease that is potentially causative of symptoms.
* High probability of compliance and completion of study.

Exclusion Criteria:

* Participation in previous SmartPill clinical trials.
* Previous history of bezoars (the presence of retained liquid, bile, or small amounts of poorly organized food residue is permitted).
* Dysphagia to solid food or pills.
* Prior surgery involving the luminal gastrointestinal tract (cholecystectomy, appendectomy, and hysterectomy are permitted if performed \> 3 months prior to SPM test).
* Any abdominal or pelvic surgery within the past 3 months
* Known or history of inflammatory bowel disease.
* History of diverticulitis, diverticular stricture, and other intestinal strictures.
* Chronic daily use of nonsteroidal anti-inflammatory drugs (ibuprofen, naproxen, etc.)
* Tobacco or alcohol use within eight hours prior to capsule ingestion.
* BMI \> 40 kg/m2.
* Allergies to eggs, bread, or jam.
* Females of childbearing age who are not practicing birth control and/or are pregnant or lactating. (Urine pregnancy testing will be performed on female subjects of child-bearing potential prior to capsule ingestion and gastric scintigraphy).
* Use of cardiac medical devices such as pacemakers and defibrillators (gastric stimulators, bladder stimulators, spinal stimulators, medication infusion devices, insulin pumps, continuous glucose monitors are permitted).
* Uncontrolled diabetes with a hemoglobin A1c \>10%.
* Patient is expected to undergo MRI examination within 7 days after ingestion of the capsule