cyrilzakka/clinical-trials huggingface dataset:
Efficacy Assessment of Systematic Treatment With Folinic Acid and Thyroid Hormone on Psychomotor Development of Down Syndrome Young Children

Evaluation of the following in very young children with Down syndrome:

* the efficacy of systematic treatment with L-thyroxine at controlled doses (clinically and by ultrasensitive thyreostimulating hormone (TSH) assay),
* the efficacy of systematic folinic acid treatment at a dose of 1 mg/kg/o.i.d,
* any interaction between these two treatments.


Eligibility Criteria:
Inclusion Criteria:

* patient with a karyotype demonstrating homogeneous, free or Robertsonian translocation trisomy 21
* patient having undergone a cardiac ultrasound not demonstrating any severe heart disease
* patient aged 6 to 18 months at inclusion

Exclusion Criteria:

* congenital hypothyroidism
* hypothyroidism demonstrated by laboratory tests (TSH \> 7mUI/l)
* presenting or having presented hyperthyroidism
* presenting or having presented leukaemia
* presenting or having presented West syndrome or any other form of epilepsy or unstable neurological disease
* presenting or having presented signs of central nervous system distress: stroke, postoperative hypoxia, meningitis)
* presenting severe heart disease on cardiac ultrasound, with haemodynamic effects
* presenting non-controlled cardiac arrhythmia
* Apgar \< 7 to 5 min at birth
* Gestational age \< 231 days (33 gestation weeks)
A Central Preservation and Assessment Service to Optimize Donor Kidney Allocation

This is a study to collect information to assess if transporting hard-to-place (HTP) donor kidneys to a central preservation and assessment facility with dedicated organ assessment capabilities increases allocation success to transplant hospitals.

This is an Observational study of a centralized kidney assessment facility providing brief sub-normothermic machine perfusion (SNMP) to HTP donor kidneys to provide transplant centers additional information for accepting HTP kidneys.

This study is intended to collect data to evaluate the feasibility of a dedicated central service to determine if additional assessment data helps increase allocation to transplant centers. Transplantation will follow standard-of-care at each transplant center, including required post-transplant data collection, which must be reported to the OPTN registry by the center.

Eligibility Criteria:
Donor Kidney Inclusion Criteria:

* Be considered HTP, by receiving refusals from every transplant center within the 250 nm allocation radius or similar definition by the local OPO.
* From a Male or female deceased donor, aged 16- 75 years old.
* Kidney initially procured, preserved, and packaged with intent to transplant.
* LAP provides informed consent for organ donation for transplant and research purposes.
* The HTP donor kidney must be allocated to a participating transplant center by a participating OPO, and the transplant center makes the decision to send kidney to Sponsor's central preservation and assessment facility for SNMP assessment and preservation prior to determining suitability for allocation.

Donor Kidney Exclusion Criteria:

* From a Donor with pre-admission diagnosis of end stage renal failure.
* Obvious surgical damage to artery(s), vein(s), or ureter(s) preventing machine perfusion.
* From a donor with confirmed HIV (+), HBVSAg (+) and/or HCV NAT (+) serology results.
* No LAP consent for both transplant and research purposes.
* Cannot arrive to Sponsor's central preservation and assessment facility before reaching 24 hours of cold ischemic time (CIT).
Study of Occipital Nerve Stimulation for Drug Refractory Migraine

The purpose of this study is to evaluate the safety and effectiveness of an implantable device to treat migraine. There are a significant number of patients who have drug refractory migraine and alternative therapies are needed.


Eligibility Criteria:
Inclusion Criteria:

* Be diagnosed with multiple migraines per month of moderate to severe intensity;
* Be refractory to medication;
* Be an appropriate candidate for the surgical procedures required fo this study;
* Be willing and able to comply with all study related procedures;
* Be capable of reading and understanding patient information materials and giving written informed consent.

Exclusion Criteria:

* Have onset of headache after age 50;
* Are current substance abusers (including alcohol and illicit drugs);
* Have a significant psychiatric disorder;
* Have previously been treated with occipital nerve stimulation (either temporary trial or permanent implant);
* Have had nerve stimulation for pain relief.
* Have had an injection of botulinum toxin in the head or neck within 6 months prior to enrollment;
* Have previously undergone destructive ganglionectomy affecting C2/C3 occipital and/or trigeminal distribution or have an occipital blockade or radiofrequency procedure currently in effect.
* Have a condition currently requiring or likely to require the use of MRI or diathermy;
* Have an active implantable device;
* Are pregnant or lactating or planning to become pregnant in the next 14 months;
* Have participated in any drug or device trial in the last 4 weeks or plant to participate in any other study during the next 14 months.
Anesthesia and Circulating Tumor Cells in Breast Cancer

Serious concern about the role of anesthesia in tumor recurrence has considerably risen over years, but the lack of surrogate markers for tumor spreading made trials addressing this issue difficult to realize. In breast cancer patients CTC positivity has been recently recognized as an independent prognostic factor. In this respect, we postulated that in a first step changes in the number of CTC after general anesthesia would help to determine the effect of anesthesia on this tumor marker.

Patients with primary breast cancer will be randomized to either propofol or sevoflurane anesthesia for curative surgery. CTC will be determined in the pre- as well as postoperative phase and the kinetic of CTC in the two groups will be compared.

Eligibility Criteria:
Inclusion criteria: \> Female

* Age 18 to 85
* ASA I-III
* Primary breast cancer (TNM stage = T1-3, N0-2, M0)
* Primary surgery
* Written informed consent

Exclusion criteria:

* Metastatic breast cancer
* Other than primary surgery (recurrence, reconstruction)
* Pre-operative chemotherapy or radiotherapy
* Auto-immune disease, HIV, other active cancer, age\>85, ASA IV or V
* Concomitant regional anesthesia
* Chronic opioids medication
* Any systemic immunosuppressive therapy
* Known hypersensitivity or suspected allergy to propofol, soya or egg proteins
* Known hypersensitivity to volatile anesthetics (malignant hyperthermia)
* Pregnancy
* Breast feeding
* Non German-speaking patients
* Enrollment in any other clinical trial during the course of this trial, 30 days prior to its beginning or 30 days after its completion
An Expanded Access Protocol for a Single Subject Who Has Completed 24-Weeks of Treatment in PR0140_CD02 Study

The primary objective is to provide continued access to PRO 140 to a subject who has completed participation in PRO140_CD02.

This is an open label, single center study designed to provide continued access to PRO 140 to a subject who have completed participation in PRO140_CD02 and continue to receive clinical benefit.

The subject will receive weekly PRO 140 SC injection along with oral ART regimen during the Treatment Phase. The study treatment (PRO 140 SC injections) will be administered by a qualified medical professional or self-administered by the subject.

Eligibility Criteria:
This study will recruit one treatment-experienced, HIV-1 infected patient with CCR5-tropic virus, who has participated in PRO 140_CD02 clinical trial and is continuing to derive clinical benefit from PRO 140 treatment.
Prevention And Treatment Of Chemotherapy-Induced Peripheral Neuropathy In Subjects With Advanced Colorectal Cancer

Prevention and treatment of the severity of symptoms of chemotherapy-induced peripheral neuropathy.

This study was terminated on July 15, 2008. The results of an interim analysis showed that the conditional power to detect a difference in treatment groups was insufficient to warrant study continuation and therefore termination of the trial was recommended. The decision to terminate the trial was not based on safety concerns.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cytological confirmed carcinoma of the Colon Stage III (Dukes C) or metastatic Colorectal Cancer (Dukes D)
* Independent of this protocol, the patient has decided to receive standard of care for the treatment of cancer with oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA) for a minimum of 9 cycles

Exclusion Criteria:

* Presence of neuropathic pain or peripheral polyneuropathy or identified causes of painful paresthesia including radiotherapy-induced or malignant plexopathy, lumbar or cervical radiculopathy existing prior to baseline
* Any patients who are not suitable to be treated with either Oxaliplatin and/or 5-FU/FA or pregabalin according to the respective local labeling
Histopathological Changes in Mycosis Fungoides

Patients with mycosis fungoides stage 1A disease have patch and plaque lesions less than %10 of body skin area. Aim of the study is to compare lesional and non-lesional skin of mycosis fungoides patients, and to decide if the systemic treatment is better or local treatment is better for them. Two biopsies for each patient were taken from lesional and non-lesional skin area.

Patients with mycosis fungoides stage 1A disease have patch and plaque lesions less than %10 of body skin area. Aim of the study is to compare lesional and non-lesional skin of mycosis fungoides patients, and to decide if the systemic treatment is better or local treatment is better for them. Two biopsies for each patient were taken from lesional and non-lesional skin area.

Biopsies will be taken from lesional and non-lesional skin of the patients in the dermatology clinic and sent to laboratory for histopathologic examination.

Eligibility Criteria:
Inclusion Criteria:

* Histopathologically confirmed mycosis fungoides stage 1A patients

Exclusion Criteria:

* Mycosis fungoides patients with other stages
Prevention of COVID-19 Complications in High-risk Subjects Infected by SARS-CoV-2 and Eligible for Treatment Under a Cohort ATU ('Autorisation Temporaire d'Utilisation') OR or Authorisation for Early Access (AAP). A Prospectvie Cohort.

This is a prospective, multicentric, non comparative study aiming to evaluate the clinical and virological evolution of high-risk patients infected with SARS-CoV-2 treated withtin the framework of a cohort ATU ('Autorisation temporaire d'utilisation') or authorisation for early access (AAP) delivered by the French drug agency (ANSM).


Eligibility Criteria:
Inclusion Criteria:

* Adults with the criteria for COVID-19 treatment within the French compassionate program (ATU/AAP)
* Adults covered by the French social health coverage
* Adults who signed the informed consent form

Exclusion Criteria:

* Exclusion criteria described in the French compassionate program (ATU/AAP)
* Patient participating in another biomedical research with an exclusion period ongoing at inclusion
* Vulnerable patient (adults legally protected: under judicial protection, guardianship, or supervision, persons deprived of their liberty)
* Pregnant or breastfeeding woman
Double-blind Randomized Clinical Trial of Transcranial Magnetic Stimulation in Chronic Migraine

The purpose of this study is to determine whether active repetitive transcranial magnetic stimulation of the left dorsolateral prefrontal cortex is safe and effective for preventive treatment of chronic migraine, compared to placebo repetitive transcranial magnetic stimulation.

Patients with chronic migraine according to the criteria of the International Headache Society will be randomized to either active repetitive transcranial magnetic stimulation of the left dorsolateral prefrontal cortex or placebo repetitive transcranial magnetic stimulation, in a total of 23 sessions of treatment (15 sessions in the first month and 8 sessions in the second month of treatment). Outcomes will be evaluated at baseline, after one, two months after treatment, and one month after end of treatment

Eligibility Criteria:
Inclusion Criteria:

* chronic migraine according to the criteria of the International Headache Society
* no change in prophylactic medication in the past 3 months

Exclusion Criteria:

* other neurological disorders
* bipolar disorder
* alcohol or drug dependence in the past 2 months
* suicidal ideation, psychotic symptoms
* contraindications to transcranial magnetic stimulation (cardiac pacemaker, implanted electronic devices, metal in the skull, skull fractures, history of seizures)
* use of antidepressants in the past 4 weeks
* pregnancy or lack of birth-control method in women of childbearing age
The Effect of High Reality Simulation Environment on the Skills of Midwifery Students, in Newborn Heel Blood Collection

The researchers gave midwifery students theoretical training on how to take heel blood on a newborn model. Students were asked to take heel blood on the model in the high-reality simulation environment and simulation room. The student's ability to take heel blood before and after taking heel blood in a high-reality simulation environment or on a newborn model in a simulation environment, satisfaction with learning, anxiety and self-efficacy levels were compared.

The population of the research consisted of 4th grade midwifery students studying in the fall semester of the 2022-2023 academic year (N = 98). 6 students could not continue studying. No sample selection was made and an attempt was made to reach the entire universe. The sample of the research consisted of a total of 92 midwifery students, n=46 in the control group and n=46 in the experimental group. Verbal and written permission was obtained from the students included in the research. Both the experimental and control groups were given theoretical training on heel blood collection on a model using the show-and-tell technique.Then, those in the experimental group were asked to take heel blood on a newborn model in a high-reality simulation environment. The control group was asked to take heel blood on a newborn model in the simulation laboratory. Self-Efficacy-Efficacy scale for both the experimental group and the control group. State and Trait Anxiety Scale was applied as pre-test and post-test. Student Satisfaction and Self-Confidence in Learning Scale was applied only as a posttest. The heel prick skill evaluation form was filled out by a researcher. Pre-test and post-test results, Student tudent Satisfaction and Self-Confidence in Learning scores , and Heel Blood Skill scores were compared between the experimental and control groups.

Eligibility Criteria:
Inclusion Criteria:

* 4th grade students (n=49) who took the Maternal and Child Health Practice course of the Midwifery Department and agreed to participate in the study voluntarily were included in the study.

Exclusion Criteria:

* Students in younger grades who did not take the Maternal and Child Health Practice course were excluded.
Efficacy Study of Tripterygium Glycoside Combined With Enteral Nutrition in the Treatment of Crohn's Disease for Induction Remission

The purpose of this study is to assess the effect of Tripterygium Glycosides Combined with enteral nutrition in the treatment of Crohn's disease for induction remission and compare the therapeutic effect with patients who only received Tripterygium Glycosides or enteral nutrition.

Crohn's disease is characterized by inflammation and ulceration of the small intestine and colon. Patients commonly experience abdominal pain, diarrhea，malnutrition and malaise which result in decreased quality of life and an increased risk of chronic disability and unemployment.

Tripterygium Glycosides(T2) is a chloroform/methanol extract Tripterygium wilfordii Hook F (TWHF), the traditional Chinese medicine,used in rheumatoid arthritis and nephritis. It has both immunomodulatory and anti-inflammatory activities.Our previous animal studies have revealed that the major component of T2, triptolide, could prevent the development of chronic colitis in interleukin-10 deficient mice. The phase I clinical trial in our institute also demonstrated that T2, or combined with enteral nutrition, is efficient for induction of remission in patients with active Crohn's disease.The common adverse effects of T2 are leucopenia,liver renal toxicity,oligospermia and amenorrhea.

The purpose of this study is to assess the effect of Tripterygium Glycosides Combined with enteral nutrition in the treatment of Crohn's disease for induction remission and compare the therapeutic effect with patients who only received Tripterygium Glycosides or enteral nutrition.

Eligibility Criteria:
Inclusion Criteria:

* Subjects should have a definitive diagnosis of Crohn's disease, based on WHO criteria
* Males and females ≥ 18 years old, including women who are not pregnant or lactating at the time of enrollment.
* Subjects should have a CDAI score ≥ 150 at week 0
* Able to swallow tablets
* Are capable of providing written informed consent and obtained at the time of enrollment
* Willing to adhere to the study visit schedule and other protocol requirements.

Exclusion Criteria:

* Bacterial,viral or other microbial infection(including HIV)
* Needing orally administered corticosteroids for the treatment of other diseases. Inhaled or dermatologic preparations are acceptable.
* Previous or current use of infliximab. current use of prescription doses or chronic/frequent use of NSAIDs
* Treatment with narcotic pain medications. (Anti-diarrheal agents such as loperamide and diphenoxylate are permitted)
* History of pancreatitis, except for subjects with a known but removed cause(such as gallstone pancreatitis)
* History of abnormal liver function tests, including AST or ALT \>1.5 times upper limit of normal, alkaline phosphatase \>2 times upper limit of normal, total bilirubin \>2.5 mg/dL at screening (or within the previous 6 months, if known)
* History of malignancy
* Women who are pregnant or lactating at the time of enrollment, or who intend to be during the study period.
* Participation in other clinical trial within the past 6 months
Study to Examine the Effect on Glucose Control and Safety/Tolerability of Exenatide Given Two Times a Day to Subjects With Type 2 Diabetes

This open label study is designed to assess long term glucose control, as measured by hemoglobin A1c (HbA1c) and to evaluate long term safety and tolerability in subjects with type 2 diabetes mellitus who receive subcutaneously injected exenatide administered twice a day.


Eligibility Criteria:
Inclusion Criteria:

* The subject has an HbA1c value \<=11.0%
* The subject has a body mass index (BMI) of 25 kg/m\^2 to 45 kg/m\^2, inclusive

Exclusion Criteria:

* Is currently treated with certain medications, including exogenous insulin
Prediction of Outcomes With a Miniaturized Transesophageal Echocardiography Probe in Patients With Acute Respiratory Distress Syndrome

The Superior Vena cava Respiratory Collapse Index (cVCS) is a haemodynamic parameter measured exclusively by transoesophageal ultrasound (TEE), which is used to assess cardiac precharge-dependence status. This may be an important prognostic factor in ARDS because it is a sign of hypervolemia and right heart failure.


Eligibility Criteria:
Inclusion Criteria:

* Patients hospitalized in Resuscitation, Emergency or Intensive Care Units at the Roger Salengro Hospital at Lille University Hospital.
* With acute respiratory distress syndrome of intermediate or severe severity (1) for less than 24 hours.
* Mechanical ventilation with tracheal intubation or tracheostomy, in controlled assisted ventilation (VAC) mode.
* Patient adapted to mechanical ventilation (no triggering of spontaneous ventilation cycle in VAC mode verified by the equality between the respiratory rate prescribed on the ventilator and the actual respiratory rate of the patient).

Exclusion Criteria:

* Patient under extracorporeal respiratory assistance at the time of inclusion.
* Anomalies or pathologies that make it dangerous or impossible to introduce an ETO probe:

  * Fistula, perforation, stenosis, varicose vein or diverticulum of the esophagus and / or stomach
  * History of esophageal and / or gastric surgery
  * Caustic lesions of the esophagus and / stomach
  * Tumor or history of oropharyngeal surgery
  * Unstable lesions of the cervical spine
  * Coagulopathy (thrombocytopenia \<50 109 / L and / or TP \<50%).
* Impossibility of measuring the diameter of the superior vena cava and cVCS in ETO due to poor echogenicity.
* Pregnant woman.
* Therapeutic limitation measures limiting the treatment of organ failure.
Oral Multiple-dose Study in Patients With Major Depressive Disorder

A study was to evaluate the safety and plasma concentration changes of quetiapine after repeated administration of FK949E (extended-release formulation of quetiapine) in patients with major depressive disorder (MDD).

The objective of the study was to evaluate the safety and pharmacokinetics of multiple oral doses of FK949E (extended-release formulation of quetiapine) of three doses in patients with major depressive disorder (MDD).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of major depressive disorder by the M.I.N.I. according to the DSM-IV-TR
* Female patients of childbearing potential with a negative serum pregnancy test result and who were willing and able to use a reliable method of birth control during the study.
* Patients who could understand and comply with the requirements of the study, as judged by the investigator/sub-investigator.

Exclusion Criteria:

* A current or past history of a DSM-IV-TR Axis I disorder other than major depressive disorder within 6 months prior to provision of written informed consent.
* Diagnosis of a DSM-IV-TR Axis II disorder that was considered to have a major impact on the patient's current psychiatric status.
* A history of substance or alcohol abuse or dependence excluding caffeine and nicotine.
* Patients who were unable to abstain from drugs that induce or inhibit the drug-metabolizing enzyme CYP3A4 from 14 days prior to screening assessment and throughout the study period.
* Patients showing evidence or signs of renal or hepatic failure, serious heart disease, cerebrovascular disease, viral hepatitis B or C, or acquired immunodeficiency syndrome (AIDS) (carrier).
* Patients being treated for hypertension or patients with clinical finding that in the opinion of the investigator/sub-investigator could be negatively affected by the study or that would affect the study results (e.g., hypertension, unstable angina).
* Patients with concomitant hypotension or orthostatic hypotension (hypotension is defined as systolic blood pressure of less than 100 mmHg)
* Conditions that could affect absorption and metabolism of the study medication (e.g., malabsorption syndrome, liver disease)
* A current diagnosis of malignant tumor unless in remission for at least 5 years (except basal or squamous cell skin carcinoma).
* A history of transient ischemic attack (TIA).
* A history of seizure disorder, except for febrile convulsions
* Application of electroconvulsive therapy within 90 days prior to the start of study drug administration
* Use of a depot antipsychotic injection and inability to be off the drug for a period of twice the dosing interval prior to screening assessment and throughout the study period
* A score of ≥ 3 on the HAM-D17 Item (suicide) or a suicide attempt within the past 6 months. Patients judged to be at serious suicidal or homicidal risk in the opinion of the investigator/sub-investigator.