cyrilzakka/clinical-trials huggingface dataset:
ObServatory Children Acute RElated Therapy Leukemia

Acute Myeloid Leukemias (AML) of the child are a rare disease and its prognosis varies according to the subgroup. Secondary AMLs remain a subgroup of poor prognosis, whose cytogenetic and molecular characteristics and prognostic value differ in part from de novo AMLs. The purpose of this national observatory is to record scientific and medical information on cases of secondary AML that have occurred in France since 2013 in order to improve the treatment of children and adolescents with this disease in the years to come. This national observatory will contribute to better knowledge and progress in research into these diseases.

Therapy-related myeloid neoplasms (t-MNs) are a group of hematologic diseases that arise after chemotherapy and/or radiation therapy for a previous cancer or rarely autoimmune diseases. t-MNs had been included in the group of AMLs and remain as a distinct category also in the recent 2016 revision of the WHO classification of myeloid neoplasm and acute leukemia. The latency between exposition to anticancer drugs and development of t-MN may vary from some months up to 10 years, even considering the age at diagnosis of the primary malignancy, the kind of cytotoxic treatment previously used, and the cumulative dose and dose intensity. The prognosis of s-AML is generally considered to be poorer than that of de novo AML. The disease tends to be refractory to chemotherapy, and patients' tolerance of treatment generally is reduced because of prior therapies. 5-year event-free survival (EFS) and overall survival (OS) rates of pediatric t-AML/t-MDS have been reported to be 14% to 30%. However, the results are conflicting and overall lacking when compared with those in adults. The purpose of this national observatory is to record scientific and medical information on cases of secondary Acute Myeloid Leukemias that have occurred in France since 2013 in order to improve the treatment of children and adolescents with this disease in the years to come. The primary objective is to evaluate the association of potential prognostic factors (including clinical-biological factors) with the overall survival of children and adolescents aged 0-18 years diagnosed with secondary AML. The secondary objectives are to test the feasibility of setting up a French national database of secondary AMLs for children and adolescents as a first step towards European implementation, to assess the association of potential prognostic factors with event free survival and the occurrence of treatment-related toxicities, to characterize the molecular abnormalities associated with secondary AMLs in children and adolescents.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 0-18 years
* Patient with first cancer
* Diagnosis of secondary AML
* Patients treated in a SFCE (Société française des cancers de l'enfant) center
* For cases included in the prospective from March 2019 onwards: Consent of holders of parental authority and consent of the child of understanding age

Exclusion Criteria: None
Palatal Lengthening Using Buccinator Myomucosal Flaps with Furlow Z-plasty Technique for Primary Cleft Palate Repair

: Cleft palate is a congenital deformity caused by abnormal facial development during intra-uterine life. Worldwide, the prevalence of cleft lip/palate is about 1:1000 live births.

The levator vela palatini muscles are malpositioned sagittally, running postero-anteriorly and inserted onto the posterior edge of the hard palate in cleft palate patients . This configuration prevents the muscle from exerting its upward, backward, and lateral pull.

Various modalities have been described with major refinements over the past 30 years. Gradually, cleft surgeons began to appreciate the importance of dissection and retro-positioning of the levator muscle on improving speech outcomes.

Furlow was the first to describe the palatoplasty technique, in which the levator muscle is dissected and freely released from its abnormal position and retro-positioned in a Z-plasty lengthening technique without dissection on the hard palate. However , among the problems that have been raised concerning the Furlow palatoplasty is the limitation of the procedure in wide clefts. Furthermore, the possibility of higher fistula rate associated with the technique.

These considerations have led to modified palatal lengthening by buccinator myomucosal flaps which is this study working on.


Eligibility Criteria:
Inclusion Criteria:

* Patients in the age frame between 9 months and 18 months.
* Cleft palate alone or cleft lip and palate patients.
* Patients who have not done any previous palatal repair
* Haemoglobin level above 10 grams.
* Weight above 10 pounds.

Exclusion Criteria:

* Syndromic patients.
* Medically compromised patients contradicting operation.
Exercise-induced Collective Rhabdomyolysis

Rhabdomyolysis, which is a characteristic occurrence in associated with muscle cell necrosis, develops due to various causes.The investigators herein report a rare case of collective rhabdomyolysis after high intensity resistance training, including 35 teenagers（participants），in which markedly elevated levels of serum creatine kinase (CK) and serum myoglobin were observed. This high intensity resistance trainings is a part of Military Training(MT)，which all the middle school students must finish before admission。


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of rhabdomyolysis;
* Caused by military training;
* Informed consent；
* Must be able to cooperate with blood test.

Exclusion Criteria:

* Caused by drugs and other reasons;
* No hospitalization event
Impact of Perceptive, Executive and Emotional Factors on Decision-making of Pedestrian Face to Autonomous Vehicles.

The VASIS project aims to assess the impact of perceptual, executive and emotional factors on decision-making in the context of pedestrian crossing in an industrial environment involving autonomous vehicle traffic (forklift).


Eligibility Criteria:
Inclusion Criteria:

* subjects aged 18 to 45
* no objection following submission of a non-objection form indicating that the subject has understood the purpose and procedures of the study and agrees to participate in the study and to comply with the requirements and restrictions inherent in the study

Exclusion Criteria:

* legal incapacity or limited legal capacity
* subject unlikely to cooperate with the study and/or poor cooperation anticipated by the investigator
* pregnant or breast-feeding women
* color-blind subject
* history of cardiovascular disease
* current psychiatric or neurological disorders (including self-reported diagnoses of epilepsy)
* known vestibular disorders (prone to frequent dizziness or vertigo)
* headaches or migraines
* deafness
* subjects under the influence of psychotropic substances (alcohol, drugs)
* motor disorders likely to prevent crossing
Does Treatment With Alfuzosin Increase Success Rates of (SWL) Shock Wave Lithotripsy

In latest literature more evidence is available about the positive effect of alpha blocker on stone expulsion from the ureter. Patients benefit from less pain and shortening time to stone expulsion. Our study is design to evaluate whether alfuzosin improves the stone free out come following SWL.

All patients undergoing SWL are included in study. Exclusion criteria: Patient with radio-lucent stone, patients treated with calcium channel blockers, alpha blockers, steroids, patients with contraindication to alpha blocker treatment, postural hypotension patents with abnormal liver function tests.

Patient will be recruited to the study prospectively. Following signature on inform consent patients will be randomized into 2 groups. One group will be treated with alfuzosin 10mg a day and the control group with placebo. Treatment will be initiated following the lithotripsy treatment.

Parameters for investigation includes: demographic and personal data, stone size and location (obtained by CT or KUB), pain control medication and visual analogue scale assessment of pain, side effects, clinical squeals, stone free out come. Follow up evaluation will be at 1 week, 1 month, and 3 months post treatment. Success will be defined following CT evaluation at 3 months. Treatment ends at stone free achievement or at 3 months.

Endpoints:Stone free rate, time to stone free, side effect.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing shock wave lithotripsy treatment for urolithiasis.

Exclusion Criteria:

* patients with abnormal liver function, postural hypotension, alpha-blocker treatment, sensitivity to alpha-blockers, radio-lucent stone, calcium channel blocker treatment, steroids treatment.
TIII Over TI in Subjects With Myocardial Infarction

Study was performed to identify ECG criteria for unmasking of subjects with NSTEMI at elevated risk.

In the present study the investigators assessed the value of T wave changes in subjects with NSTEMI (TIII\>TI).

Eligibility Criteria:
Inclusion Criteria:

* NSTEMI and PCI

Exclusion Criteria:

* NSTEMI without percutaneous intervention
Comparison of Daily Single Dose Triple and Conventional Triple Therapies for Helicobacter Pylori Infection

This study is conducted to investigate whether the efficacy of single-dose triple therapy (Esomeprazole 40 mg, Tinidazole 1 g, and Levofluxacine 500 mg) for 14 days is superior to double-dose lansoprazole 30 mg, amoxicillin 1 g and clarithromycin 500 mg for 14 days in the treatment of H pylori infection.

Multiple regimens have been evaluated for H. pylori therapy in randomized controlled trials The treatment regimen that is selected must be effective, but considerations such as cost, side effects, and ease of administration should also be taken into account. Despite the number of studies, the optimal therapeutic regimen has not yet been defined.

The regimen most commonly recommended for first line treatment of H. pylori is triple therapy with a PPI, amoxicillin and clarithromycin for 14 days. However, the multi-drug application is associated with remarkable side effects and it is not uncommon not to be able to complete a treatment course. Thus, treatment failure is associated with H. pylori strains that are resistant to the commonly used antibiotics. This study is conducted to investigate whether the efficacy of single-dose triple therapy (Esomeprazole 40 mg, Tinidazole 1 g, and Levofluxacine 500 mg) for 14 days is superior to double-dose lansoprazole 30 mg, amoxicillin 1 g and clarithromycin 500 mg for 14 days in the treatment of H pylori infection.

Eligibility Criteria:
Inclusion Criteria:

* The patients who proved H. pylori infection following three methods

  * Positive rapid urease test
  * Histologic evidence of H. pylori by modified Giemsa staining
  * Positive stool Antigen Test

Exclusion Criteria:

* Patients who received eradication therapy for H. pylori infection, previously
* H. pylori eradication failure because of poor compliance
* The administration of antibiotics or the consumption of bismuth salts within 4 weeks or the administration of a proton pump inhibitor (PPI) within 2 weeks
* Advanced gastric cancer or other malignancy
* Abnormal liver function or liver cirrhosis
* Abnormal renal function or chronic kidney disease
* Other severe concurrent diseases
* Previous allergic reactions to the study drugs
* Pregnant or lactating women
Physical Activity and Cardiovascular Disease Prevention

To provide new scientific information regarding the role of physical activity in primary and secondary disease prevention, particularly coronary heart disease (CHD).

DESIGN NARRATIVE:

The long-term follow-up and data analysis of two epidemiologic studies, a general population study and a clinical trial provided the basis for the study. The first study assessed the long-term relationship between total physical activity (both during work and leisure time) and mortality in a random sample of 1,656 Black and white men and women residents of the City of Buffalo, New York. The study focused on participants (30+ years of age at baseline) of the Buffalo Health Study, an epidemiological investigation conducted in Buffalo in 1960. As part of the investigation, detailed information was gathered from participants with regard to a number of demographic and socioeconomic characteristics (age, body mass index, education, marital status, etc.) and the participants' usual daily activities (both during a weekday and weekend) at work and outside work. This information was used to compute a total physical activity index. The study related the participants' physical activity characteristics to their all-cause and CHD mortality experience throughout the follow-up period and tested whether or not the relationship between physical activity and mortality was similar across gender and race. The detailed baseline demographic and socioeconomic data allowed analysis of the independence of any observed association between physical activity and mortality.

The second study extended to 17 years, the follow-up of the National Exercise and Heart Disease Project (NEHDP), a multi-center, randomized clinical trial designed to study the effects of a regular, medically prescribed and supervised exercise program on the rehabilitation of male survivors (ages 30-64 at baseline) of a myocardial infarction (MI). Three year findings from the trial reported non-significant differences between the treatment and control groups for all-cause mortality, and recurrent MI in favor of the exercise group. Other outcomes favoring the treatment group were reported after one year and included increased physical working capacity, and decreased body fat, diastolic blood pressure, and triglycerides. The study determined vital status for all original study participants, and cause of death in the deceased. The longer follow-up permitted analysis of whether the long-term survival of the treatment group differed from that of the controls. In addition, the investigators were able to assess if the risk factor changes observed in the first year of the trial were present after three years, whether these changes were related to long-term survival, whether differences in mortality observed in sub-groups (i.e. smokers) after three years remained after 17 years, and whether baseline patient characteristics (i.e., anxiety and depression) predicted mortality.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Oxytocin vs. Placebo for the Treatment Hyperphagia in Children and Adolescents With Prader-Willi Syndrome

The investigators propose a randomized double-blind 8 week treatment trial of intranasal oxytocin (IN-OXT) vs. placebo in 24 subjects aged 5 to 18 years with PWS in order to assess IN-OXT's affect on (1) Eating behaviors (2) Repetitive and disruptive behaviors and (3) Salivary OXT levels.

The investigators propose to conduct a treatment study of intranasal oxytocin (IN-OXT) vs. placebo in children and adolescents with Prader-Willi Syndrome (PWS). OXT has already been proven safe and effective in a treatment study of socialization and disruptive behavior in adults with PWS and is being used in infants with PWS in an ongoing clinical trial. The investigators hypothesize that OXT will be superior to placebo and have a positive effect on child and adolescent PWS eating and repetitive behaviors. Additional knowledge of OXT's ability to reduce overeating could lead to improvement of patient's quality of life and physical health and reduction in familial stress.

The investigators propose a randomized double-blind 8 week treatment trial of intranasal OXT vs. placebo in 24 subjects aged 5 to 18 years with PWS in order to assess IN-OXT's affect on (1) Eating behaviors (2) Repetitive and disruptive behaviors and (3) Salivary OXT levels. If superior to placebo, this data will add to the current knowledge that OXT is an effective treatment for hyperphagia as well as other problematic symptomatology of PWS.

Eligibility Criteria:
Inclusion Criteria:

1. Male or Female child outpatients aged 5 to 18 years
2. Diagnosis of PWS confirmed by genetic testing and patient medical records and history
3. Stable pharmacologic, educational, behavioral and/or dietary interventions for 4 weeks prior to the study start, and for the duration of the study.
4. Have a physical exam and laboratory results that are within the norms for PWS
5. Have a parent/caregiver/guardian that is able to consent for their participation and complete assessments regarding the child's development and behavior improvement throughout the study.

Exclusion Criteria:

1. Exposure to any investigational agent in the 30 days prior to randomization
2. Prior chronic treatment with oxytocin.
3. A primary psychiatric diagnosis other than ASD, including bipolar disorder, psychosis, schizophrenia, PTSD or major depressive disorder. These patients will be excluded due to potential confounding results.
4. Pregnant or lactating patients. IN-OXT has not been studied in pregnant or lactating women.
5. A medical condition that might interfere with the conduct of the study, confound interpretation of study results or endanger their own well-being.
6. Plan to initiate or change nonpharmacologic or pharmacologic interventions during the course of the study.
7. Females using an estrogen-based contraceptive. As an alternative to an estrogen based contraceptive, subjects will be counseled to use progesterone-based contraceptives; cervical caps; cervical sponges; or spermicidal foam in combination with a condom. Subjects will need to use a double barrier method to be in the study.
Ultrasound Evaluation of the Vascular Anatomy of the Neck to Minimize the Accidental Risk of Vascular Puncture During Percutaneous Tracheostomy

Tracheostomy is a commonly performed procedure in Intensive Care and its incidence tends to increase over time as a consequence of the increase in chronic diseases and the average age of the population accessing Intensive Care.

Surgical open tracheostomy (ST) is the standard procedure but has a relatively high incidence of peristomal infections and perioperative bleeding. Percutaneous dilatational tracheostomy (PDT) was introduced in 1985 and has since become a common bedside procedure. Compared to open ST, PDT has the advantages of a lower risk of wound infection, lower bleeding-related mortality, shorter procedure times, and improved cost-effectiveness.

Fiberoptic bronchoscopy is commonly used during PDT to verify the safety of direct tracheal access \[5\]. However, bronchoscopy-guided PDT has several limitations regarding the precise identification of cervical anatomical structures and the prevention of complications such as vascular injury.

Preliminary ultrasound examination of neck anatomy has numerous potential benefits, including increased safety during the procedure, identification of cervical vascularization, and localization of the tracheal puncture site with lower risk of complications \[6-8\]. Several studies have shown that the use of ultrasound in a preliminary and real-time manner can improve first-pass success rate and puncture accuracy, reduce procedure time, and complications.

The objective of this study is to map the arterial and venous vascular anatomy of the neck in order to identify points with a lower risk of vascular injury during PDT. This helps prevent bleeding during tracheostomy, which is one of the major complications associated with the procedure.


Eligibility Criteria:
Inclusion Criteria:

* Patients of eighteen years or older
* Informed consent

Exclusion Criteria:

* Tracheostomized patients
Vildagliptin Compared to Pioglitazone in Combination With Metformin in Patients With Type 2 Diabetes

Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. The purpose of this study is to assess the long-term safety and effectiveness of vildagliptin, an unapproved drug, compared to that of pioglitazone in lowering overall blood glucose levels when added to metformin in people with type 2 diabetes not at target blood glucose levels on metformin alone.


Eligibility Criteria:
Inclusion Criteria:

* On a stable dose of metformin as defined by the protocol
* Blood glucose criteria must be met
* Body mass index (BMI) in the range 22-45

Exclusion Criteria:

* History of type 1 diabetes
* Pregnancy or lactation
* Evidence of significant diabetic complications
* Serious cardiovascular events within the past 6 months
* Laboratory value abnormalities as defined by the protocol
* Known sensitivity to pioglitazone
* Other protocol-defined exclusion criteria may apply
The Effects of Hesperidin and Flaxseed on Biochemical Factors and Hepatic Fibrosis in Nonalcoholic Fatty Liver Disease

To study the effects of Hesperidin and flaxseed supplement on lipid profile, liver enzymes, inflammatory factors and hepatic fibrosis in patients with Nonalcoholic Steatohepatitis (NASH), 50 patients who referred to Gastrointestinal (GI) clinic with steatosis grade 2 and 3 will be randomly allocated to contol group or 2 capsules Hesperidin and 30 gram flaxseed for 12 weeks; both groups will be advised to adherence the investigators' diet and exercise program too. At the first and the end of the intervention, lipid profiles, liver enzymes, some inflammatory markers, and liver fibrosis will be assessed and compared between groups.


Eligibility Criteria:
Inclusion Criteria:

- Age of 18 to 70 years

* Body Mass Index (BMI) between 25-40
* Sonographic findings compatible with hepatic steatosis (degree 2 or more)

Exclusion Criteria:

* Diabetes
* Taking any kind of antibiotics two weeks before recruitment
* History of alcohol consumption
* pregnancy or lactation
* Professional athletes
* Other liver disease (viral/etc)
* Use of drugs such as calcium channel blockers, high dose synthetic estrogens, methotrexate , amiodarone, steroids, chloroquine, immunosuppressive drugs, lipid-lowering agents, metformin and vitamin E
* A history of Hypertension, Cardiovascular disease, Pulmonary disease, Renal disease \& Celiac disease; Cirrhosis
* History of Upper GI surgery / Prior surgical procedures such as jejunoileal or jejunocolic bypass, gastroplasty
* Following program to lose weight in recent 3 mo
* A history of hypothyroidism or Cushing's syndrome