cyrilzakka/clinical-trials huggingface dataset:
Imatinib TDM in GIST

Imatinib can lead to long recurrence free survival in patients diagnosed with gastrointestinal stromal tumors (GIST); however side effects can significantly hinder quality of life for our patients. This study will use therapeutic drug monitoring to improve quality of life and symptoms and assess how many patients maintain therapeutic levels. Free drug levels and pharmokinetics of imatinib will also be monitored.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed GIST with KIT mutation or PDGFRA mutation (non-D842V)
* Currently receiving imatinib initiated within the last 3 months or to be started in the next 1 month
* Prior systemic chemotherapy for other malignancy is allowed as long as it was completed within the past 6 months and there is no evidence of disease
* Age ≥18 years
* ECOG performance status of 0 or 1
* Normal organ function

Exclusion Criteria:

* Presence of PDGFRA D842V mutation
* Known allergy to imatinib or allergic reactions to compounds of similar chemical or biologic composition to the study drug
* Concomitant anticoagulation with oral warfarin.
* Use of strong inhibitors or inducers of CYP3A or CYP3A4, drugs metabolized by CYP3A4 or CYP2D6
* Uncontrolled intercurrent illness
* Concurrent malignancy
Registry for Vascular Anomalies Associated With Coagulopathy

PURPOSE The purpose of this study is to learn more about multifocal lymphangioendotheliomatosis with thrombocytopenia (MLT). MLT is a rare vascular disorder characterized by multiple congenital skin and visceral lesions, profound thrombocytopenia, and gastrointestinal bleeding. The skin lesions may appear red, brown or blue, often misdiagnosed as hemangiomas. The gastrointestinal tract, liver, and lungs are the most common internal organs involved. The severe thrombocytopenia (low platelets) is believed to be the result of platelet trapping within the skin and visceral vascular lesions. Severe and chronic gastrointestinal bleeding is common during infancy and early childhood. Although a relatively newly described entity, MLT was likely previously reported as hemangiomas, blue rubber bleb nevus syndrome, diffuse hemangiomatosis, Kasabach-Merritt phenomenon, and hereditary hemorrhagic telangiectasia. The term cutaneovisceral angiomatosis with thrombocytopenia is also a term used for this same disease. This study is a longitudinal cohort study of MLT to collect detailed clinical data on the distribution of disease, disease severity, and complications. This data will be used to create diagnostic criteria and an evaluation protocol for infants with this disease

After informed consent is obtained a detailed question will be mailed to participating patients and families. This questionnaire will also be available electronically through an educational website. Data collected will include photographs of skin lesions, video images of gastrointestinal lesions, demographic data, clinical information, therapeutic interventions, glass slides of tissue biopsies, and collection of DNA. Enrollment will be patient family driven and modeled after several successful registries of rare diseases.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with a vascular anomaly with coagulopathy

Exclusion Criteria:

* Subjects without a vascular anomaly with coagulopathy
Calcitriol and Dexamethasone in Patients With Myelodysplastic Syndromes

This is a study to determine the response rate in patients with myelodysplastic syndromes treated with calcitriol and dexamethasone.

Current therapeutic options for myelodysplastic syndromes (MDS) are limited and, aside from bone marrow transplantation, none have proven superior to supportive measures alone. Preclinical investigations have indicated the potential therapeutic role for vitamin D in the treatment of MDS. However, because of the dose-limiting toxicity of hypercalcemia, past clinical trials with vitamin D have been forced to utilize low doses, with promising but inconsistent results.

This study utilizes a dosing schema of dexamethasone (Dex) and calcitriol (the active form of vitamin D) that augments the therapeutic index of calcitriol, and allows for safe administration of 5-10 times higher dose of calcitriol than previously has been used in clinical trials for MDS. Patients will receive dexamethasone 4 times per week and calcitriol 3 times per week. This schedule will continue weekly until patients are off study. The dose of calcitriol will be increased until the maximum tolerated dose (MTD) is determined. History and physical examination, blood monitoring, urinary ultrasounds, and bone marrow aspirations and biopsies will be used to assess disease response.

Eligibility Criteria:
Inclusion criteria:

* Histologically confirmed refractory anemia (RA), RA with excess blasts (RAEB), RAEB in transformation (RAEB-IT), or ringed sideroblasts (RARS)
* Evidence of cytopenia affecting at least 1 hematological cell lineage
* Adequate liver and renal function
* ECOG 0-2
* Expected survival of at least 12 weeks

Exclusion criteria:

* Symptomatic coronary artery disease
* Uncontrolled diabetes mellitus
* Uncontrolled and symptomatic glaucoma
* History of dangerous reactions to steroid therapy
* Chemotherapy or any hematopoietic growth factor therapy within the past 8 weeks
* History of nephrolithiasis
* Children
* Chronic myelomonocytic leukemia (CMML)
Azacytidine Plus Chidamide in the Treatment of Relapsed and Refractory Angioimmunoblastic T-cell Lymphoma

This is a multicenter prospective single arm phase II study. The purpose of this study is to evaluate the safety and efficiency of azacytidine combined with chidamide in the treatment of relapsed/refractory angioimmunoblastic T-cell lymphoma.

Azacytidine was given subcutaneously at a dose of 75 mg/m2 on days 1-7. Chidamide was an oral tablet which was administered 20mg twice weekly. This regimen was repeated every 28 days. Treatment was given until disease progression, unacceptable toxicity, or patient/investigator discretion.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed angioimmunoblastic T-cell lymphoma according World Health Organization (WHO) classification;
* Age≥18years;
* ECOG≤2;
* Patients received at least one systemic treatment previously and achieved no remission or relapsed after first-line treatment;
* Adequate bone marrow hematopoietic function: ANC\>1.5 × 109/L，HGB\>90g/L，PLT\>80 × 109/L;
* Adequate organ function: ALT≤3 times ULN, TBil≤1.5 times ULN, SCr≥50ml/min/m2, cardiac function grade 0-2 (NYHA);

Exclusion Criteria:

* Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment;
* Any instability of systemic disease, including but not limited to severe cardiac, liver, kidney, or metabolic disease need therapy;
* Pregnant or lactating women;
RCT on LIFT Versus Modified Parks Technique Versus Two-Stage Seton

LIFT is a sphincter-saving procedure that is based on the concept of secure closure of the internal opening and concomitant removal of infected cryptoglandular tissue in the intersphincteric plane. Modified Parks technique involves adequate drainage of the intersphincteric space by extending the internal anal sphincterotomy. Placement of seton in the fistula track has been used for a long time and is still being currently used. Drainage two-stage seton is used to promote adequate drainage of infection and can be employed as a definitive treatment of anal fistula.

This present randomized study aimed to compare LIFT, modified Parks technique, and two-stage seton in treatment of complex anal fistula in terms of success of treatment and complication rates.


Eligibility Criteria:
Inclusion Criteria:

* Adult Patients of either sex aged less than 65 years presenting with complex anal fistula were included. Complex anal fistulas were defined as high trans-sphincteric (involving more than 30% of the external anal sphincter), extra-sphincteric, supra-sphincteric, horse-shoe fistulas and anterior fistulas in females

Exclusion Criteria:

* Patients with simple anal fistula (intersphincteric and low trans-sphincteric anal fistula)
* Patients with associated anorectal pathology such as anal fissure, hemorrhoids, rectal prolapse, neoplasm, solitary rectal ulcer, inflammatory bowel diseases.
* Patients on long-acting steroids or immunosuppressive drugs.
* Patients with fecal incontinence (FI)
* Patients with previous anorectal operations including surgery for previous anal fistula.
* Patients with ASA score (American society of anesthesiologists) of III and higher
Placebo Controlled Double-blind Dose Ranging Study of the Efficacy and Safety of SSR149744C 50, 100, 200 or 300 mg OD With Amiodarone as Calibrator for the Maintenance of Sinus Rhythm in Patients With Recent Atrial Fibrillation/Flutter

Double blind study to evaluate the efficacy and tolerability of SSR149744C and select a dose to be further investigated in the maintenance of sinus rhythm after electrical, pharmacological or spontaneous conversion of AF/AFL.

This is a dose-ranging multicenter, multinational, randomized, double-blind, placebo-controlled, parallel arm study with 4 SSR149744C dose regimens and amiodarone as a calibrator.To be eligible, patients must be in normal sinus rhythm for at least one hour at randomization and must have an electrocardiogram documented history of recent AF/AFL reverted to normal sinus rhythm by electrical, pharmacological or spontaneous conversion.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 21 years or more of either sex with documented sinus rhythm for at least 1 hour at the time of randomization with at least one ECG-documented AF/AFL episode in the last 3 months.

Exclusion Criteria:

* MAIN CRITERIA (non-exhaustive list):Women of childbearing potential without adequate birthcontrol, Pregnant Women, Breastfeeding women, contraindications to amiodarone, conditions which increase the risk of severe antiarrhythmic drug side effects, severe left ventricular dysfunction, severe associated conditions.
Impact of Atypical Antipsychotic Therapy on Health Outcomes and Costs Among Patients With Major Depressive Disorder

The primary objective is to examine changes in pre/post-augmentation healthcare costs and resource utilization in patients diagnosed with major depressive disorder (MDD) who augment their current antidepressant therapy with an atypical antipsychotic.


Eligibility Criteria:
Inclusion Criteria:

Patients who meet the following criteria will be included in the study:

* aged 18 to 64 years
* diagnosis of major depressive disorder during the study timeframe (ICD 9 codes 296.2, 296.3, 311)
* evidence of at least 6 consecutive claims for traditional antidepressant therapy with a 30 day supply or at least 2 claims with a 90 day supply (consecutive defined as ≤15 days gap)
* must be continually enrolled during the study timeframe and have both medical and pharmacy benefits
* evidence of at least 4 consecutive claims for an atypical antipsychotic prescription with a 30 day supply or 2 claims with a 90 day supply (consecutive defined as ≤15 days gap)
* evidence of antidepressant therapy for at least 60 consecutive days prior to the initiation of atypical antipsychotic
* After at least a 60 day trial of traditional antidepressant medications, patient augments with an atypical antipsychotic medication for at least 4 months.

Exclusion Criteria:

Patients are excluded if they:

* have any claims for a diagnosis of schizophrenia, schizoaffective or bipolar disorder during the study period
* have Electroconvulsive therapy (ECT) during the study period
* new augmentation with mood stabilizers, L-thyroxine (T4), L-Thyronine (T3), buspirone, stimulant, or others during the post-period (table 1)
* are pregnant during the study period
* patients with Medicare or Medicaid
Respiratory and Quadriceps Muscle Fatigability After an ICU Acquired Weakness

Muscle dysfunction can be lead to poor outcomes moreover ICU muscle weakness recovery are not correctly described.

The investigators aimed to assess the ability for quadriceps or respiratory muscles to repeat an effort at a maximal loading.


Eligibility Criteria:
Inclusion Criteria:

* Mechanically ventilated at least at 24 Hours
* Maximal inspiratory pressure \< 30 centimeter of water
* MRC score \< 48/60

Exclusion Criteria:

* Age \< 18 years
* Patients with neurological pathology or pre existing neuromuscular dysfunction
* Patient unable to walk 50 meters before ICU admission
* Patient with a thoracic or abdominal surgery
* Inability to carry out maximal voluntary contraction
Clinical-randomized Study of the Influence of Rehabilitation Therapy Using Strength and Blood Flow Restriction Training on Muscular Fitness and Regeneration After Elective Total Knee Arthroplasty

The present study investigates the effects of blood flow restriction training on muscular recovery during out-patient rehabilitation after elective total knee arthroplasty

The present study evaluated the impact of blood flow restriction training in the context of three-week outpatient rehabilitation following TKA, in accordance with the guidelines of the German Pension Insurance System. The in-rehabilitation and post-rehabilitation muscle status, strength, knee functionality, impairments in daily life and subjective pain perception were measured.

Eligibility Criteria:
Inclusion Criteria:

* Physical Fitness for Rehabilitation
* Primary TKA surgery
* BMI \< 35

Exclusion Criteria:

* Sickle Cell Anemia
* Vascular Intervention on the lower extremities
* Open Wounds
A Study of MK0431 in Patients With Type 2 Diabetes (0431-010)

A dose-ranging study of MK0431 in patients with type 2 diabetes who have inadequate control of their blood sugar.


Eligibility Criteria:
Inclusion Criteria:

* Age 21 to 70, You are a man or non-pregnant woman

Exclusion Criteria:

* Have a history of type I diabetes
* You are on a weight loss program with ongoing weight loss or taking weight loss medications
* You have a history of minor surgery
* You have received investigational drugs within 8 weeks of study start
* You have hepatitis B or C
Preliminary Neck Classification Study

The purpose of this study was to assess if pain and function in patients with neck pain is less when physical therapists use a classification system.

The purpose of this study was to prospectively assess pain and function scores in patients with neck pain, with therapists specifically trained to implement a treatment based classification and matched interventions system. This study consisted of two phases to determine whether implementing a classification changed patient outcomes. In phase one, baseline data was obtained while physical therapists continued with their current neck pain evaluation and intervention approaches. The second phase involved educating the therapists in the neck classification system with the matched interventions. Pain and function outcomes were analyzed for 2 phases. The overall goal was to prospectively determine if the implementation of this classification system with matched interventions could enhance patient outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Licensed physical therapists
* Treat patients with neck pain on a regular basis

Exclusion Criteria:

* Do not utilize interventions included in the study
Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis Subjects

Lung infections are a chronic problem for patients with cystic fibrosis (CF). Some patients with CF may have a type of bacteria called Pseudomonas aeruginosa in their lungs that can cause infections or make their symptoms worse. Tobramycin inhalation solution (TOBI) is an approved antibiotic, which is inhaled directly into the lungs, and can be used to manage these infections. Tobramycin inhalation powder (TIP) is a new, experimental powder formulation of tobramycin that is inhaled directly into the lungs using a T-326 inhaler. The purpose of this research study is to determine if TIP is safe and effective when compared to placebo (a powder with no medicine) treatment.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of cystic fibrosis patients with Pseudomonas aeruginosa infection.
* Male and female subjects between 6 and 21 years of age at the time of screening.
* FEV1 at screening must be between 25% and 80% of normal predicted values.

Exclusion Criteria:

* Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.
Outcomes of Neonates Born to Mothers With SARS-CoV-2 Infection in Shanghai

Since March 2022, there are an outbreak of SARS-CoV-2 infection (Omicron) in Shanghai. This cohort study aims to analysis the clinical outcomes of neonates born to mothers with SARS-CoV-2 infection.


Eligibility Criteria:
Inclusion Criteria:

* Neonates born to mothers with SARS-CoV-2 infections.

Exclusion Criteria:

* Parents who rejected to participate in this study.
A Pilot Study of Pulmonary Function in Dysphagic Infants

Infants less than 2 years old who have been newly diagnosed with problems swallowing will have pulmonary function tests performed to try to detect the presence of chronic lung disease. Six months later after the infants have received appropriate therapy for their swallowing problems, pulmonary function tests will be performed again to see if there has been any change in their chronic lung disease.

Twenty-five infants between the ages of 1 month and 24 months who have just been diagnosed with dysphagia via a modified barium feeding study will be recruited into the study. The infants will be sedated with chloral hydrate and have pulmonary functions measured (pre- and post-bronchodilator spirometry and lung volume) using the infant pulmonary laboratory. Treatment for the infants' dysphagia/chronic aspiration will be treated as determined by the primary care physicians. Six months later the infants will again be sedated and have pulmonary functions measured. Results of the two sets of tests will be compared statistically.

Eligibility Criteria:
Inclusion Criteria:

* infants between ages 1-24 months who have been newly diagnosed with dysphagia

Exclusion Criteria:

* cystic fibrosis
* obstructive sleep apnea
* seizures
* allergy or adverse reaction to chloral hydrate
* heart disease
* liver disease
* kidney disease
* pneumonia
* pleural effusion
* neuromuscular disease
* major congenital anomalies
* tracheoesophageal fistula
* vascular ring
* bronchopulmonary dysplasia
* pharyngeal anomalies
* Arnold-Chiari malformation
Multicentre Evaluation of Bucco-dental Health in Patients With Schizophrenia in Côte d'Or

The aim of this study is to know the bucco-dental status of patients with schizophrenia in Côte d'Or.

Participation in this study will last only as long as it takes to:

* carry out a bucco-dental examination: evaluation of dental plaque and calculus
* take a blood sample to assess needs in vitamin C (only for patients included at DIJON CHU and CHS Chartreuse)
* complete a 30-minute questionnaire: clinical data and answers to questions concerning dental hygiene and eating habits.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have provided consent
* Patients over 18 years of age
* Persons with schizophrenia according to the ICD 10 criteria and followed in hospital (complete or day hospital) in one of the hospitals taking part in the study

Exclusion Criteria:

* Adult under guardianship
* Patient not covered by national health insurance
* Pregnant or breast-feeding women
* Patients not stabilized from a psychiatric viewpoint
* Patients experiencing an acute psychiatric episode
* Impossibility to understand and /or poor understanding of French
Interest of FSL 2 in Recently Diagnosed Type 2 Diabetic Patients

Therapeutic patient education (TPE) is a key element in the management of people living with type 2 diabetes.

The benefit of therapeutic education (TPE) has been clearly established on glycaemic control.

Continuous interstitial glucose monitoring (CGM) can be considered as a TPE tool for people living with diabetes. A direct reading of the effects of diet and physical activity on glycaemic levels could have an impact on the initiation and maintenance of therapeutic lifestyle modifications.

The investigators therefore propose a prospective randomised study in 2 arms :

* a group of people living with diabetes receiving standard TPE vs
* a group of people living with diabetes receiving standard TPE + FSL 28 days Ourmain objective is to determine the benefit of CGM on HbA1c at 3 months between 2 arms

Main objective to the investigators is to determine the benefit of continuous interstitial glucose monitoring (by fresstyle 2) for 28 days coupled with standard TPE (Patient Therapeutic Education) vs standard TPE alone in newly diagnosed type 2 diabetics on HbA1c at 3 months.

The secondary objectives are to evaluate the effect of the TPE coupled with FSL vs TPE alone on :

* HbA1c at 6 months (assessment of persistence or not of a remote effect)
* weight change at 3 and 6 months
* other cardiovascular risk factors : variation in blood pressure, lipid profil at 3 and 6 months
* eating behaviour/ eating habits at 3 and 6 months
* treatment satisfaction, anxiety and quality of life scores

Eligibility Criteria:
Inclusion Criteria:

* recently diagnosed diabete mellitus (\<1 an) treated by non medical therapeutics and/or metformine
* \> 18 years old
* initial glycated hemoglobin between 7 and 8.5%

Exclusion Criteria:

* Person whose physical and/or psychological health is severely impaired
* Person deprived of his rights, person under guardianship or curatorship
* Person deprived of liberty (by judicial or administrative decision)
* Person who does not speak the French language
* Absence of affiliation to/Not beneficiary of a Social Security scheme
* Absence of written informed consent to participate in the study
* Unable to understand the nature, purpose and methodology of the study
* Bariatric surgery planned within 6 months of inclusion
Step Rate in Recreational Runners

This will be a pilot study to determine if a 6 week home training program can increase preferred step rate (cadence) in recreational runners. Increase in step rate has been correlated with decreased stress at lower limb joints in runners. This has the potential of decreasing overuse injuries in this population.

Research participants will have their preferred cadence evaluated at the beginning of the study. The athletes will be randomly assigned to two groups. One group will continue to train without intervention and the other group will train at a cadence of 10% higher than their preferred step rate.

At the end of 6 weeks the participants will have their preferred cadence reevaluated using the same method as pre-participation cadence was determined.

The investigators hypothesis the preferred running cadence of recreational runners following the intervention will be 5-10% greater than prior to the intervention and the increased cadence will be maintained for 6 months following the intervention.


Eligibility Criteria:
Inclusion criteria:

* healthy male or female runners
* 18 years of age or greater
* run two or more times per week most weeks of the year for at least 4 years
* cadence of 85 strides/min or less as determined at initial evaluation
* no musculoskeletal injuries or illnesses that would limit running in the last 6 months
* currently running at least 15 miles a week

Exclusion criteria:

* baseline running cadence greater than 85 strides/min
* inability to run
* cardiovascular disease
* greater than 2 cardiovascular risk factors
* peripheral vascular disease
* neurological disease
* musculoskeletal injury or disease that causes pain with running