cyrilzakka/clinical-trials huggingface dataset:
Adverse Drug Reactions in Pediatrics: Experience of a Regional Pharmacovigilance Center

Aim. - To describe the adverse drug reactions (ADR) and the drugs involved in pediatrics.

Methods. - An observational study on all ADR notifications recorded in the French pharmaco-vigilance database by the Regional Pharmacovigilance Center of Champagne-Ardenne between 1 January 1985 and 31 December 2014 involving children from 0 to 17 years inclusive was performed. For all notifications, we studied the patient and the ADR characteristics

Pediatry aged under 18 years accounted for around 22% of the French general population.

Data regarding drug safety from clinical trials are insufficient in this population.

Aim. - To describe the adverse drug reactions (ADR) and the drugs involved in pediatrics.

Methods. - An observational study on all ADR notifications recorded in the French pharmaco-vigilance database by the Regional Pharmacovigilance Center of Champagne-Ardenne between 1 January 1985 and 31 December 2014 involving children from 0 to 17 years inclusive was performed. For all notifications, we studied the patient and the ADR characteristics.

Eligibility Criteria:
inclusion criteria:

* Children from 0 to 17 years inclusive
* Who presented an adverse drug reaction notified to the Regional Pharmacovigilance Center of Champagne-Ardenne

exclusion criteria:

* none
Versius or Laparoscopic TransAbdominal Inguinal Hernia REpair

This trial will compare laparoscopic and robotic-assisted inguinal hernia repairs, using the Versius® system. We will initially aim to recruit 60 patients (20 patients in the laparoscopic arm and 40 in the robotic arm) in order to assess the ergonomic impact of each modality on the operating surgeon. This aims to provide in vivo information on whether robotic surgery provides any advantages to the operating surgeon. This trial will also be used to assess the feasibility of recruitment to a future larger study, and any data collected will be used as pilot data.

This study has been designed to assess the ergonomics of Versius® assisted surgery in comparison with laparoscopic surgery in the management of inguinal hernias. The study will randomise 60 patients who require repair of an inguinal hernia and have been deemed suitable for a minimally invasive approach. Patients will be randomised to receive either laparoscopic or Versius® robotic assisted surgery but will be informed that it will be attempted via a minimally invasive approach that could include either of these two subtypes of minimally invasive surgery. The randomisation will occur on a 2:1 basis, with 2 patients allocated to the robotic arm for every 1 patient allocated to the laparoscopic arm. Laparoscopic surgery is already a well-established technique, and therefore the study team believe more valuable data about the outcomes of robotic surgery will be obtained with this randomisation ratio given that no prior studies have been undertaken using this robotic platform. All surgeons in the study will be required to have been involved in at least 20 cases performed using the relevant modality, whether for the robotic or laparoscopic cohorts.

Data will be collected at four key timepoints; recruitment, intraoperatively, at discharge and again at 14 days following intervention. Feasibility outcomes will include willingness to be recruited to study (acceptability), willingness for patient to undergo desired randomised operative approach (acceptability/concordance), withdrawal of patients (non-concordance), study retention (retention rates), and the usefulness and limitations of outcome measures.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Need for inguinal hernia repair surgery
* Deemed suitable for minimally invasive surgery

Exclusion Criteria:

* Patients who are unable to consent
* Prisoners
* Patients in need of emergency surgery
* Patients with inguinoscrotal or recurrent inguinal hernias
MyFitnessPal Pilot Study

This project is studying whether patients who use MyFitnessPal as an aid to weight loss have more success than patients who are only given traditional medical guidance from the patient's physician.

Patients will be given a survey determining the patient's eligibility to be part of the study. Based on the results patients will be consented and then randomized into two arms. The intervention group will download MyFitnessPal onto the patient's smartphone and given guidance on how to use the application in order to help with weight loss. The control group will receive traditional weight loss counseling from the physician. Both groups will have measurement recorded for weight, blood pressure, and waist circumference at the patient's initial visit. All patients will be asked to return to the clinic at no cost to the patient to have measurements recorded for the patient's weight, blood pressure, and waist circumference at 1 month, 3 months, and 6 months after the patient's initial visit. At the conclusion of the study, patients who were in the intervention group will be asked to take a final survey regarding the patient's use of the MyFitnessPal application.

Eligibility Criteria:
Inclusion Criteria:

* BMI\>/= 25
* Have a smart phone
* Patient is willing to lose weight

Exclusion Criteria:

* Do not have a smart phone
* pregnant (current, planned, or previous pregnancy within 6 months)
* have already seen a nutritionist
* on weight loss medication
* using outside weight loss programs
* lack interest in weight loss
* hemodialysis patient
* has a life expectancy less than 6 months
Placebo-Controlled Pilot Trial of Mecamylamine for Treatment of Autism Spectrum Disorders

The purpose of this study is to examine the safety and efficacy of mecamylamine for the core symptoms of autism.

This is a placebo-controlled pilot clinical trial of a nicotinic agent based on evidence that a disturbance occurs in nicotinic cholinergic transmission in the brain of autistic children. This pharmacotherapeutic trial will be conducted as a direct result of findings of a nicotinic receptor abnormality in autopsied brain tissue from individuals who suffered from autism. A pharmacological agent, mecamylamine, with specificity for the nicotinic receptors implicated in autism, will be tested in children with autism spectrum disorder. Twenty children who meet inclusion/exclusion criteria will be randomized in a 2:3 ratio to 14 weeks of either matched placebo (n=8) or mecamylamine (n=12). Children randomized to placebo who do not respond will be given the opportunity to enroll in a ten week open label extension.

The trial has been completed and published in J. of Child \& Adolescent Psychopharmacology.

Eligibility Criteria:
Inclusion Criteria:

* Autistic Disorder or Pervasive Developmental Disorder-Not Otherwise Specified
* Age 4-12
* General good health
* IQ of \>=36 or mental age of \>=18 months
* Parent/caregiver willingness to accompany child to clinic and monitor for side effects

Exclusion Criteria:

* Unstable Seizure Disorder
* Psychoactive medication in the process of adjustment
* Antipsychotic medication in previous 3 months before baseline
* Systemic corticoids (inhalers allowed)
* Planned beginning of major behavioral intervention in 3 months of study or the 2 months prior to the study.
Mifepristone Plus Misoprostol Versus Misoprostol Alone for 2nd Trimester Abortion (14 - 21 Weeks Last Menstrual Period (LMP))

The primary goal of this study is to determine the clinical advantage of pre-treatment with mifepristone in second trimester misoprostol induction abortion. This will be a randomized controlled double-blinded trial of 120 women in each country comparing misoprostol alone to mifepristone plus misoprostol for second trimester (14-21 weeks' LMP) medical abortion.


Eligibility Criteria:
Inclusion Criteria:

* 14 to 21 weeks gestation, based on menstrual history and clinical exam (with or without ultrasound)
* Meet legal criteria to obtain abortion
* Present with closed cervical os and no vaginal bleeding
* Live fetus at time of presentation for service
* Have no contraindications to study procedures, according to provider
* Be able to consent to procedure, either by reading consent document or by having consent document read to her
* Be willing to follow study procedures

Exclusion Criteria:

* Known previous transmural uterine incision
* Known allergy to mifepristone or misoprostol/prostaglandin or other contraindications to the use of mifepristone or misoprostol
* Any contraindications to vaginal delivery, including placenta previa
* Presentation in active labor (defined as moderate to severe contractions every 10 minutes or less)
Phase II Study of Weekly Paclitaxel (BMS-181339) in Patient With Non-Small Cell Lung Cancer (NSCLC)

The purpose of this study is to evaluate the efficacy and the safety of paclitaxel given weekly in patients with advanced or recurrent non-small cell lung cancer


Eligibility Criteria:
Inclusion Criteria:

* Patients with no prior chemotherapy who meet either of the listed below:
* Patient with stage IIIB or IV disease
* Patients with recurrent disease following potentially curative surgical resection
* Patients with previous chemotherapy up to one regimen

Exclusion Criteria:

* Patients with serious, uncontrolled medical illness
* Patients with previous therapy with taxanes
Comparing Human and Computer-based Quantification of Airway Stenosis From Bronchoscopic Images

This is a pilot study to assess the utility of the automatic stenosis index quantification using 3D Slicer software (Computer-based Quantification). We will recruit three physicians to perform a similar analysis using video images of the same bronchoscopes images (Human-based Quantification). This study relates to the latter data collection.


Eligibility Criteria:
Inclusion Criteria:

* Physicians who are trained in bronchoscopy.
* Physicians who are willing and able to understand the scope of the study.

Exclusion Criteria:

* Physicians who are not trained in bronchoscopy.
* Physicians who are unwilling and unable to understand the study procedure
* Employees under the direct supervision of the investigators conducting the research
The Influence of Red Grape Cells on Blood Pressure Vascular Function in People With Hypertension

The study hypothesis is that 3 Months Daily Supplementation of RGC will effect blood pressure and vascular function.

This will be a single-center, double-blind, random, parallel controlled Study. Study population will include 60 subjects, who will be divided randomly into three groups. The first group will get RGC 200mg, the second group will get RGC 400mg, and the third group will get 200mg placebo.


Eligibility Criteria:
Inclusion Criteria:

* Age 35-70
* BMI \< 40.0 kg/m2
* Blood pressure: SYS. ≤154 mmHg, DIA. ≤93 mmHg.

Exclusion Criteria:

* Breastfeeding or pregnancy.
* Milk allergy - the substance may contain traces of milk protein (casein).
* Taking anti-hypertensive medications.
* Taking antioxidant food supplements, excluding probiotic agents and fibers (taken for less than two weeks before beginning the study).
* Subjects suffering from any of the following conditions: cardiovascular disorders, renal disorders, intestinal disorders, hepatic disease, malignant or autoimmune diseases or other metabolic diseases.
* A subject whose baseline blood tests indicate abnormalities in hepatic or renal function, thyroid function or blood count.
* Unusual eating habits.
* The subject is in the process of active weight loss / gain.
* Addiction to drugs / alcohol.
* Medically documented psychiatric problems or neurological disorders.
* Smokers. (Subjects who quit smoking more than two years ago may be included in the study).
* Systolic blood pressure above 154 mmHg.
* Diastolic blood pressure above 93 mmHg.
* Taking phosphodiesterase 5 inhibitors for the treatment of erectile dysfunction (Viagra, Cialis, etc.).
Conservative Physiotherapy and Acromion Morphology

In this study, we aimed to evaluate the short-term effects of conservative physiotherapy in the subacromial impingement syndrome (SIS) and its relation to the acromion morphology.

The aim of this study is to investigate the short term effects of physiotherapy in SIS patients on pain, range of motion, muscle strength, joint position sense and functionality and its relation to the acromion shape. Fifty patients (26 female, 24 male) with SIS were evaluated in this study. Patiens were divided into 3 groups according to the their acromion morphology. A conservative physiotherapy method was applied to the patients. All patients were evaluated before and 4 weeks after the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients who were diagnosed (clinically and by MRI) with SIS by the physician, at a stage of II-III levels according to Neer's criteria, who were undergoing physiotherapy for the first time and who had not received any treatment from the shoulder region before were included in this study.

Exclusion Criteria:

* Patients who had a history of fracture in the upper extremity and, surgical operation from any part of the upper extremity, who had acute cervical disc herniation or a neuromuscular disease, receiving a medical therapy for pain relief, less than 80 % participation to sessions were excluded.
The New Intubating Laryngeal Tube Suction-Disposable

The study compares the intubating Laryngeal Tube Suction (iLTS-D) with the Ambu®AuraGain™ in blind and fibreoptic endotracheal intubation.

The current randomized study is designed to assess the success rate of blind and fibreoptic endotracheal intubation using i-LTS-D, in comparison with the Air-Q, i-gel® and Ambu®AuraGain™ in an airway simulator. The investigators hypothesize that the iLTS-D and the Supreme Laryngeal Mask Airway will similarly perform during spontaneous ventilation despite differences in their structural design.

The intubating Laryngeal Tube Suction-Disposable (iLTS-D) (VBM Medizintechnik, Sulz, Germany) is a new updated version of the Laryngeal Tube-Suction Disposable (LTS-D).

It has a ventilator channel with a 13.5mm internal diameter, which enables the passage of an Endotracheal Tube (ETT) either blindly or with fibreoptic guidance. Similarly to the LTS-D, the iLTS-D also has a separate channel for gastric tubes placement up to a size of 18 Fr.

The current randomized study was designed to assess the success rate of blind and fibreoptic endotracheal intubation using iLTS-D, in comparison with the Ambu® AuraGain™ in adult patients under general anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* American Society Anesthesiology I and II

Exclusion Criteria:

* Difficult intubation, cervical pathology
A Single Blinded Study on the Effect of Saccharomyces Boulardii CNCM I-745 on Growth and Development in Preterm Infants

Immature gastrointestinal functions increase the risk of poor growth as well as nosocomial infections and necrotizing enterocolitis (NEC) in the preterm infant. The effects of probiotics on growth and development in premature infants have been investigated poorly. Saccharomyces boulardii CNCM I-745 (S. boulardii) is a non-pathogenic probiotic yeast.

Prophylactic supplementation of S. boulardii at a dose of 50 mg/kg twice a day appeared to bring preterm infants weight gain closer to that of intra-uterine growth rate, reduce feeding intolerance, and had no adverse effects.

The objective of this study is to evaluate if feeding supplemented with S. boulardii can improve growth and clinical outcomes in preterm and low birth weight infants.

A prospective, randomized case-controlled trial was conducted in infants with a gestational age of 30 to 37 weeks and a birth weight between 1500 to 2500 g. The study group received S. boulardii supplementation, 50 mg/kg twice daily, compared to no intervention in the control group. The primary outcomes were short term growth parameters including weight gain, linear growth, head and chest circumference, and secondary outcomes were clinical outcomes, feeding intolerance and complications.

A total of 125 infants were enrolled in the study, 63 in the treatment and 62 in the control group. S. boulardii was administered for the first time at 2.63 days after birth (1 day to 6 days, 46 within 3 days, only 5 between 4 and 6 days).

Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria were hospital born infants with a gestational age of 30 to 37 weeks and a birth weight between 1500 to 2500 g.

Exclusion Criteria:

* Exclusion criteria were severe neonatal pathology such as birth complications, GI malformations, chromosomal abnormalities, known immunodeficiency, hydrops foetalis, a central venous catheter and the use of antifungal drugs or probiotics.
Study of the Use of a Contraceptive Vaginal Ring (NuvaRing) in Normal Daily Practice in Indian Women (P07733)

This study will collect information on cycle control, acceptability and tolerability of the vaginal contraceptive ring (NuvaRing) as used in normal daily practice by Indian women.


Eligibility Criteria:
Inclusion Criteria:

* Women at risk of pregnancy and seeking contraception

Exclusion Criteria:

Exclusion criteria based on approved prescribing information in India:

* Presence or history of venous thrombosis, with or without pulmonary embolism.
* Presence or history of arterial thrombosis (e.g. cerebrovascular accident, myocardial infarction) or prodromi of a thrombosis (e.g. angina pectoris or

transient ischemic attack).

* Known predisposition for venous or arterial thrombosis, with or without hereditary involvement such as Activated Protein C (APC) resistance, antithrombin-III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant).
* History of migraine with focal neurological symptoms.
* Diabetes mellitus with vascular involvement.
* The presence of a severe or multiple risk factor(s) for venous or arterial thrombosis (at the discretion of the doctors)
* Pancreatitis or a history thereof if associated with severe hypertriglyceridemia.
* Presence or history of severe hepatic disease as long as liver function values have not returned to normal.
* Presence or history of liver tumors (benign or malignant).
* Known or suspected malignant conditions of the genital organs or the breasts, if sex steroid-influenced.
* Undiagnosed vaginal bleeding.
* Known or suspected pregnancy.
* Hypersensitivity to the active substances or to any of the excipients of NuvaRing.
* Women who are breast feeding
Effect of Web-Based Education on Gestational Diabetes Mellitus and Health Management Self Efficacy

This randomized controlled study aimed to examine the effect of web-based education related to Gestational Diabetes Mellitus on women health management self-efficacy and maternal-fetal-neonatal results.

Objective: To examine the effect of web-based education related to Gestational Diabetes Mellitus on women health management self-efficacy and maternal-fetal-neonatal results.

Design: Randomized controlled study. Patients: Thirty one pregnant women were included in the intervention group and thirty four pregnant women in the control group.

Interventions: For 8 weeks, web-based education for Gestational Diabetes Mellitus was offered to pregnant women who diagnosed with Gestational Diabetes Mellitus for the first time. The data were collected before web-based education, after web-based education and postpartum between 4-12 weeks at three different times. Control group was offered routine clinical procedure.

Main Outcome Measures: health management self efficacy (primary outcomes), maternal-fetal-neonatal results (secondary outcome).

Eligibility Criteria:
Inclusion Criteria:

* Being 18 years or older
* Being primigravida or multigravida
* Getting a diagnosis of Gestational Diabetes Mellitus
* Having a gestational week between 24-28
* Having a single fetus
* Ability to use the Internet (Computer, tablet, smart phone, etc.)
* Voluntary participation in the research

Exclusion Criteria:

* Having a diagnosis of Type 1 and Type 2 Diabetes Mellitus
* Having another chronic disease
* Having a visual or hearing impairment
* Having a psychiatric medical diagnosis
* Having a diagnosis of risky pregnancy not related to GDM
Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer

The primary objective of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) and pembrolizumab versus treatment of physician's choice (TPC) and pembrolizumab in participants with previously untreated, locally advanced inoperable or metastatic triple-negative breast cancer, whose tumors express programmed cell death ligand 1 (PD-L1).


Eligibility Criteria:
Key Inclusion Criteria:

* Individuals with locally advanced, inoperable, or metastatic triple-negative breast cancer (TNBC) who have not received previous systemic therapy for advanced disease and whose tumors are programmed cell death ligand 1 (PD-L1) positive at screening.

  * Individuals must have completed treatment for Stage I to III breast cancer, if indicated, and ≥ 6 months must have elapsed between completion of treatment with curative intent and first documented local or distant disease recurrence.
  * Individuals presenting with de novo metastatic TNBC are eligible for this study.
  * TNBC status and tumor PD-L1 combined positive score (CPS) will be confirmed centrally on a recent or archival tumor specimen.
  * Individuals must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria as evaluated locally.
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
* Demonstrates adequate organ function
* Male and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.
* Individuals with HIV must be on antiretroviral therapy (ART) and have a well-controlled HIV infection/disease.

Key Exclusion Criteria:

* Positive serum pregnancy test or women who are lactating.
* Received prior therapy with an agent directed to another stimulatory or coinhibitory T-cell receptor.
* Individuals may not have received systemic anticancer treatment (with the exception of endocrine therapy) within the previous 6 months or radiation therapy within 2 weeks prior to enrollment.
* Individuals may not be participating in a study with an investigational agent or investigational device within 4 weeks prior to randomization. Individuals participating in observational studies are eligible.
* Have previously received topoisomerase 1 inhibitors or antibody drug conjugates containing a topoisomerase inhibitor.
* Have an active second malignancy.
* Have active serious infection requiring antibiotics.
* Individuals positive for HIV-1 or 2 with a history of Kaposi sarcoma and/or Multicentric Castleman Disease.
* Have active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
* Has an active autoimmune disease that has required systemic treatment in the past 2 years.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
ASS-Nonresponse Following Cardiac Surgery as Assessed With Multiple Electrode Aggregometry

It is the aim of the present study to assess the prevalence of ASS-Nonresponse following cardiac surgery using the Multiple Electrode Aggregometry (MEA).

Up to now there are no data concerning the prevalence of ASS-Nonresponse following surgical coronary revascularization procedures as assessed with the Multiple Electrode Aggregometry. Results of the present observational study are needed to assess the prevalence of ASS-Nonresponse in order to perform a sample size analysis for a prospective interventional study in a second step.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years after cardiac surgery
* Antiaggregatory therapy with aspirin postoperatively

Exclusion Criteria:

* known allergy to aspirin
* need for an antiaggregatory therapy other than aspirin
* pregnancy