cyrilzakka/clinical-trials huggingface dataset:
Validation of Strasbourg Environmental Exposure Chamber ALYATEC in Cat Allergic Subjects With Asthma

This is a randomized, double blind, cross-over study designed to determine the concentration of airborne cat allergen inducing bronchial response in asthmatic subjects allergic to cat, during allergen exposures in the Alyatec environmental exposure chamber (EEC).

The study was also designed to validate the specificity of the asthmatic reaction induced by exposure to airborne cat allergen in Alyatec EEC.


Eligibility Criteria:
Inclusion Criteria:

* Subjects having signed the informed consent
* Subjects affiliated to a social security scheme
* Non-specific bronchial hyperreactivity (HRBNS) assessed by a positive methacholine test
* FEV1 value \> 70% of theoretical FEV1 value
* Asthma Control Test (ACT) ≥ 20/25 in 4 weeks prior to EEC exposure
* Women of childbearing potential should have a negative pregnancy test throughout the study period with effective contraception.

Group A:

* Cat allergic asthma (GINA 1, 2) associated with rhinitis and / or conjunctivitis symptoms triggered during an exposure to a cat.
* Positive skin prick-test to cat allergen extract (wheal diameter \>3 mm compared to the negative control) Specific immunoglobulin E (IgE) for cat allergen \> 0.7 kU/L

Group B:

* Mild allergic asthma (GINA 1 or 2) not sensitized to cat allergen with associated rhinitis and/or conjunctivitis.
* Negative skin prick-test and specific IgE for cat allergen
* Positive skin prick-test and specific IgE for another allergen.

Exclusion Criteria:

* Uncontrolled asthma, ACT asthma control questionnaire less than 20, in the last 4 weeks
* Uncontrolled asthma 2 weeks after interruption of LABA
* Long-term treatment by LABA, within 2 weeks prior to inclusion
* Existence of a severe obstructive syndrome with FEV1 \<70% of the theoretical value
* Obstruction triggered by spirometric evaluations
* Hospitalization for asthma or exacerbation in the last 4 weeks
* Subjects treated with oral corticosteroids in the 4 weeks prior to inclusion in the study
* History of severe acute asthma requiring hospitalization in intensive care or intubation
* Subjects treated with biotherapy in the 4 months prior to inclusion in the study
* Presence of a cat at home, or daily exposure to cat allergens
* Desensitization to cat allergens in the last 6 months
* Active tobacco: plus 10 cigarettes / day or tobacco history plus 10 PA
Fecal Transplantation in Patients With IBS

The study will characterize the biology of FMT in the context of IBS prior to wider clinical application of the method. Given the ethical concerns of unknown and long-term adverse effects of FMT therapy, the study will include patients only with moderate to severe symptoms. IBS is a heterogenous disorder and it is important to characterize the patients, and study as homogeneous patient populations as possible. Therefore the study will only include post-infectious IBS patients after the Giardia outbreak.

Primary aims:

Detailed characterisation of donor and recipient microbial community composition (by means of 16S rRNA profiling) and determination of the kinetics of changes following FMT

Secondary aims:

* Determination of interactions of importance to persisting recipient gut microbiota.
* Evaluate safety of FMT in an IBS population
* To evaluate the efficacy of FMT in relieving symptoms in selected patients with IBS in an open pilot trial in order to have the possibility to calculate number of patients needed when planning future controlled studies.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18-and 70 years
* IBS-SSS (IBS-Symptom Severity Scale) score \>175 (175 - 300 represents moderate, \> 300 represent severe IBS).
* All patients are required to have symptoms for at least 12 months, fulfilling the Rome III criteria with either diarrhoea-predominant irritable bowel syndrome (IBS-D) or alternating constipation and diarrhoea (IBS-A) with bloating or flatulence as predominant symptoms. Only IBS considered post-infectious after the Bergen Giardia outbreak will be included. The severity of global IBS symptoms has to be either moderate ("cannot be ignored but do not influence daily activities") or severe ("influence daily activities"). A decrease of 50 points on the IBS-SSS has been shown to correlate with improvement in clinical symptoms. All patients will undergo appropriate investigations to exclude organic disease.

Exclusion Criteria:

* History of inflammatory bowel diseases, gastrointestinal malignancy, blood in stool or antibiotic use within 1 month prior to FMT, immunocompromised patient defined as taking immuno-suppressive medications, history of opportunistic infections within 1 year prior to FMT, oral thrush, or disseminated lymphadenopathy.
* Patients who are scheduled for abdominal surgery, pregnant women or patients taking probiotics or taking antibiotics within 4 weeks prior to installation are also excluded from the protocol.
Preliminary Study of CA-008 (Vocacapsaicin) in Patients Undergoing Ventral Hernia Repair

A Three-Part, Phase 1/2, Randomized, Double-blind, Placebo-Controlled, Adaptive Safety, Pharmacokinetics, and Preliminary Efficacy Study of CA-008 (Vocacapsaicin) in Patients Undergoing Ventral Hernia Repair


Eligibility Criteria:
Inclusion Criteria:

* Scheduled elective, primary, open laparotomy with VHR, with retromuscular, preperitoneal mesh placement, with midline fascial reconstruction
* ASA physical class 1, 2, or 3
* BMI \</= 40 kg/m2
* Aged 18-80 years old

Exclusion Criteria:

* Concurrent condition requiring analgesic treatment during study period
* Opioid tolerant
* Known allergy to capsaicin or other study medication
* Use of prohibited medications
Effects of Exercise Oncology Intervention in Fitness Capacity and Body Composition in Breast Cancer Survivals

The goal of this interventional study is to analyze the impact of a supervised oncological exercise intervention in surviving breast cancer patients. The main questions it aims to answer are:

* Evaluate the efectivity of a supervised individualized and adapted oncological physical exercise program in the cardiovascular fitness of the participants.
* Analyze the impact of this intervention in the body composition, functionality and quality of life of the parcitipants

Participants will perform a controlled and adapted program, supervised by an especialized professional during 16 weeks.

Researchers will compare this intervention group, where the supervised program will take place, with a control group, where the patients will perform regular physical activity (non-supervised) to see the changes in the efectivity and impact in cardiovascular fitness, body composition and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Women diagnosed with primary, type I to III A/B cancer, with hormonal positive (ER+ and PG+), triple positive (ER+, PG+ y HER2+) or triple negative subtype.
* Women with chemotherapy and radiotherapy phase complete.
* Women with post-surgery phase complete.
* Women that are within 5 years from diagnostic.
* ECOG Score above or equal to 0 or 1.

Exclusion Criteria:

* Submit medical contraindications to physical exercise by their reference doctor.
* Women in state IV o methastasis.
* Pregnant women.
* Meet any of the criteria of the American Thoracic Society (ATS) to perfrom a cardiovascular fitness test.
Skeletal Fragility in Type 1 Diabetes: Glycemic Control and Bone Strength

The purpose of this research study is to find out how bones are affected in children and adolescents with type 1 diabetes (T1D) as compared to children and adolescents without type 1 diabetes.

T1D is primarily associated with decrements in bone strength due to disrupted microarchitecture occurring during peak bone mass accrual, and this disruption arises from hyperglycemia and glycemic variability. Impaired bone development during this period likely predisposes to an increased fracture risk across the lifespan.

The investigators will compare baseline, 12 month and 24 month changes in High-resolution peripheral quantitative computed tomography/micro-finite element analysis (HR-pQCT/μFEA)-based estimates of bone strength and bone turnover by biochemical measurements in 40 T1D children at the onset of peak bone mineral accretion (n=40) versus sex and puberty-matched healthy controls (n=40). The investigators will determine relationships between changes in bone strength (including trabecular and cortical components) and measures of glycemic control and variability by continuous glucose monitoring (CGM).

Eligibility Criteria:
Inclusion Criteria (T1D and Controls):

- Children within 2 years preceding the onset of the pubertal growth spurt

Inclusion Criteria (T1D participants):

- documentation of β-cell autoimmunity and need for insulin replacement

Exclusion Criteria:

* Estimated glomerular filtration rate (eGFR)\< 60 ml/mim
* 25(OH)D level \< 20 ng/ml.
* Celiac disease
* Autoimmune thyroid disease
* Addison's disease
* History of pathological fractures

  -- Disorders associated with altered skeletal structure or function
* Bone active drugs in past year
* Diabetes of other or unclear etiology
Evaluating Pharmacogenomic Variants for Cardiology Therapeutics

Cipherome's Lighthouse is a clinical decision support tool that incorporates a patient's pharmacogenetic information to determine therapeutic strategy, including determining appropriate dosage or assessing the likelihood of toxicity of a therapeutic regimen.

The Lighthouse tool incorporates pharmacogenetic (PGx) variants from well-established, evidence-based guidelines to provide personalized drug response profile(s) to guide treatment decisions.

The patient specimen is genotyped using a proprietary, carefully curated pharmacogenetic variant panel to determine the individual's phenotype. The Lighthouse report (PGx findings) are provided to the clinician, and a notification is generated when the patient has a genotype with a deleterious drug-metabolizing phenotype.

Evaluating the South Texas community for the pilot project will enhance the understanding of the impact of genetic variants on individuals of Hispanic/Latino ancestry, especially as the variants pertain to the efficacy and safety of medications.

Eligibility Criteria:
Inclusion Criteria:

* Subjects over 18 years of age, who are:
* On clopidogrel, prasugrel or ticagrelor after percutaneous stent
* Completed informed consent

Exclusion Criteria:

* Failure to provide informed consent.
* Lost to follow-up prior to 60 days.
A Non-significant Risk Clinical Study of Therapeutic Ultrasound for Patients With Diabetic Foot Ulcers.

This study is evaluating whether a therapeutic ultrasound device can improve blood flow to the leg with diabetic foot ulcer (DFU).

The VibratoSleeve TUS will be used on to assess its acute vasodilatory and perfusion effects in diabetic subjects with PAD and DFU. Each subject will receive one 90-minute TUS treatment in each of 3 treatment sessions. All post-treatment acute assessments will take place immediately following each day's treatment and no follow-up assessments will be required in this study.

Eligibility Criteria:
Inclusion Criteria:

1. Presence of at least one DFU (grade 0 or 1 by University of Texas classification)
2. Diagnosis of diabetes mellitus
3. Diagnosis of PAD that meets at least one of the following conditions:

   1. Ankle-brachial index (ABI) of \< 0.9 in the same limb as the DFU
   2. Toe Brachial Index (TBI) ≤ 0.6 OR Toe Blood Pressure ≤ 50 mmHg
   3. Documented history of PAD for a minimum of 3 calendar months prior to time of enrollment
4. Aged ≥ 22 years

Exclusion Criteria:

1. Rutherford 6 stage PAD
2. Active DFU infection
3. End-stage renal disease on dialysis
4. HbA1c \> 13%.
5. Planned PAD revascularization.
6. Prior stenting in posterior tibial artery.
7. Re-vascularization procedure within 25 days prior to enrollment in the study. (Note: Patients who had re-vascularization procedure earlier than 25 days prior to enrollment are eligible for enrollment if they meet all other criteria).
8. History or diagnosis of severe chronic venous insufficiency or mixed arterio-venous disease.
9. Acute limb ischemia within 30 days prior to treatment.
10. History or diagnosis of deep venous thrombosis below the knee in treatment leg.
11. Any conditions that, in the opinion of the investigator, may render the patient unable to complete the study or lead to difficulties for patient compliance with study requirements, or could confound study data.
12. Patient's enrollment in another investigational study that has not completed the required primary endpoint follow-up period (Note: Patients involved in a long-term surveillance phase of another study are eligible for enrollment in this study).
The Effect of Rifapentine on Raltegravir

The aim of this study is to study the effect of rifapentine on plasma concentrations of raltegravir.

Primary Objective

To compare the pharmacokinetics parameter values (geometric mean Cmin and AUC) of raltegravir at 400 mg q12h alone to raltegravir at 400 mg q12h co-administered in combination with rifapentine 900 mg once weekly, and to raltegravir at 400 mg q12h co-administered in combination with rifapentine 600 mg per day, 5 days per week.

Secondary Objective

To assess the tolerability and safety of concomitant administration of raltegravir and rifapentine in healthy volunteers.

Design

This study is a three-period, one-sequence, open label, pharmacokinetic study of the raltegravir-rifapentine interactions in healthy, male and female volunteers. Up to 21 subjects may be enrolled to achieve the estimated sample size of 16 completing subjects. All study medication will be self-administered except on the days of pharmacokinetic sampling. All subjects will participate in three sampling periods and be studied in a day clinic or be admitted overnight to a hospital.

Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant, non-nursing female age \> 18 years in good health
* Provision of informed consent for the study.
* HIV-uninfected. A prior negative HIV test (ELISA) must be obtained before enrollment.
* Willingness to have PK sampling in a day clinic or to be admitted overnight to a hospital on three occasions.
* Women of child-bearing potential must agree to practice an adequate method of birth control during the study and for 30 days after the last dose of study medication. Barrier methods of contraception or abstinence from sexual activity are satisfactory methods of birth control.
* Karnofsky score ≥ 90.
* Laboratory screening before enrollment:

  * Hematocrit \> 30 percent (most recent value)
  * AST \< 2 times the upper limit of normal
  * ALT \< 2 times the upper limit of normal
  * Bilirubin \< 2 times the upper limit of normal
  * Creatinine \< 1.5 times the upper limit of normal
  * Negative urine drug screen

Exclusion Criteria:

* Pregnancy or breast-feeding.
* Use of a medication or food that has the potential to alter the concentrations of raltegravir or rifapentine, within the 14 days prior to or during the periods of pharmacokinetic monitoring.
* Known intolerance to raltegravir or rifamycin antibiotics or prior use in the last 30 days.
* Weight less than 46 kg or greater than 102 kg.
* Prior gastrointestinal surgery.
* Infection with Hepatitis B or Hepatitis C by serologies.
* Co-morbidity for which concomitant, current medications are taken regularly. If concomitant medications are taken intermittently, these medications should not have potential to alter the concentrations of raltegravir or rifapentine.
* Current imprisonment
The Criteria for Lymph Node Sorting for Pathological Examination in Gastric Cancer

The aim of this study is intending to provide the optimal procedures of lymph node sorting for pathological examination after curative surgery for gastric cancer, which can discriminate the differences of the status of lymph node metastasis, pTNM classification and prognostic outcome of gastric cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* 1) Physical conditions compliance with the requirements for curative gastrectomy
* 2) Consent to undergo the D2 lymphadenectomy
* 3) Comply with the protocol during the whole study period
* 4) No neoadjuvant therapy administration
* 5) Sign informed consent and permission of withdraw in the whole study period
* 6) Consent to provide the tissue specimens after surgery for this study
* 7) Pathological examination confirmation the adenocarcinoma of stomach before surgery
* 8) Estimation the overall survival after surgery no less than 6 months
* 9) No anesthesia or operation contraindication disease
* 10) cTanyNanyM0 stage demonstration by CT and endoscopic ultrasonography examinations
* 11) Negative cytological detection in operation
* 12) No seriously concomitance's diseases
* 13) Karnofsky Performance Scores (KPS) more than 60

Exclusion Criteria:

* 1) Women during pregnant stage and breast-feed stage
* 2) Women of childbearing age without any contraceptive measures
* 3) Severe congestive heart failure, frequent arrhythmia, or myocardial infarction within 12 months
* 4) Immunosuppressive therapists for organ transplantation
* 5) Seriously uncontrolled recurrent infection
* 6) other malignant tumors
* 7) No abilities of self-knowledge or mental disorders
* 8) Participating in other clinical trials
* 9) Siewert I and II esophagogastric junction tumors
* 10) Serious internal diseases obstruction surgery
LAPAS Study: Insulin Glargine in Type 2 Diabetes Mellitus

The objective of this protocol is to confirm the efficacy and safety profile of Lantus in every day medical practice, in type 2 diabetic patients, have been treated with any other insulin but who did not reach the target of A1c = 7%.


Eligibility Criteria:
Inclusion Criteria:

* Patients with type 2 diabetes mellitus,
* Having been treated with any other insulin, but who did not reach the target of A1c=7%.
* Ability and willingness to perform Self Monitoring Blood Glucose measurement

Exclusion Criteria:

* Will follow the prescribing information (Summary of Product Characteristics).

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Post-marketing Registration Study of Nifekalant Hydrochloride (NIF) Injection

Retrospective and Prospective single arm, observational study to evaluate efficacy and safety of NIF in the treatment of ventricular tachycardia and ventricular fibrillation. The information registration of the target population will be collected with the hospital HIS system or LIS system.

Subjects enrolled in the retrospective study may be enrolled in a prospective study if the study drug is re-used, but in the end only the most-registered case of the subject would be collected.

The recommended treatment plan for this study is from the usage and dosage of NIF. The clinician can make appropriate adjustments to the specific usage and dosage according to the patient's condition.

Load dose: Adults usually use 0.3mg/kg each time, under continuous ECG monitoring, the injection should be completed within 5 minutes, and the maximum dose should not exceed 0.5 mg/kg.

Maintenance dose: After load injection, the adult routine dose is 0.4 mg/kg/h under continuous ECG monitoring. The dosage could be appropriately increased or decreased according to the patient's reaction, but the maximum dose should not exceed 0.8 mg/kg/h.

Eligibility Criteria:
Inclusion Criteria:

* Patients with life-threatening ventricular tachycardia or ventricular fibrillation in cases where other drugs are ineffective or inoperable.
* Patients who have received or are about to receive Nifekalant Hydrochloride for treatment according to the instructions.

Exclusion Criteria:

-
A Study to Assess RAD011 (Cannabidiol Oral Solution) for the Treatment of Participants With Prader-Willi Syndrome

This was a study investigating RAD011 in participants diagnosed with Prader-Willi Syndrome (PWS). The primary objective of the Phase 2 part of this study was to assess the safety and tolerability of multiple dose levels of RAD011 in order to select 1 or 2 dose level(s) for further evaluation in the Phase 3 part of the study. In Phase 3, the primary objective was to assess the effect of RAD011 on hyperphagia-related behavior in participants with PWS.


Eligibility Criteria:
Inclusion Criteria:

* Males and females between 8 and 65 years of age (inclusive) at Screening.
* Genetically confirmed diagnosis of PWS. Documentation of genetically confirmed diagnosis of PWS is acceptable.
* The same caregiver is available to complete the questionnaire throughout the duration of the study.
* After completion of the Tolerability period, participants will have a mean Hyperphagia Questionnaire for Clinical Trials (HQ-CT) score ≥13 and a decrease of HQ-CT score no more than 7 during Tolerability (run-in) period.
* If receiving growth hormone, psychotropic therapy, metabolic treatments that could affect appetite (including metformin), and other treatment including thyroid hormone, must be on the same medication and dose for at least 90 days prior to consent/assent

Exclusion Criteria:

* Known use of cannabis or cannabinoid containing products (including topical products) within 90 days prior to consent/ assent.
* Use of prescription or over-the-counter weight loss agents within 90 days prior to consent/assent.
* Implementation of new food or environmental restrictions within 90 days of consent/ assent.
* If living in a group home, participant spends less than 25 waking hours with their caregiver per week.
* Uncontrolled chronic conditions (diabetes, sleep apnea, etc.) as determined by the Investigator.
Role of the Chemical Environment in the Pathogenesis of Inflammatory Bowel Disease

Inflammatory Bowel Diseases (IBD) including Crohn's disease and ulcerative colitis are multifactorial diseases leading to chronic inflammation of intestinal mucosa. Their etiology is still unknown. Recently, major advances in the understanding of their pathophysiology have allowed to define them as heterogenic polygenic diseases, occurring in genetically susceptible patients. However, the whole genetic susceptibility does not explain the development of IBD and several data argue in favor of the involvement of environmental factors, which remain to be identified.

The aims of this clinical trial are:

1. As main objective: To determine the effects of environmental pollutants on intestinal homeostasis and particularly on inflammatory process and endoplasmic reticulum stress.
2. As secondary objective, to assess in human the genetic susceptibility of intestinal mucosa to environmental chemical compounds (I.e. xenobiotics), its interindividual variability, and its potential involvement in the pathogenesis of IBD.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who are at least 18 years old
2. Has Crohn's disease or ulcerative colitis, diagnosed, confirmed by radiological and / or endoscopic examination within 4 years or "Control" patient not suffering from inflammatory bowel disease (patient with abdominal pain and / or persistent diarrhea, or patient requiring coloscopy for cancer of the digestive tract diagnosis)
3. Patients requiring coloscopy as part of their medical follow-up
4. Social insured.

Exclusion Criteria:

1. Pregnant women
2. Breastfeeding women
3. People in emergency
4. Persons unable to understand, read and / or sign informed consent
5. Patients who recently had an intercurrent episode (eg recent diarrhea ...)
6. Persons deprived of their liberty
7. Persons protected by a legal protection status