cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Lungs of Normal Individuals by Lung Lavage, Brushing and Bronchial Wall Biopsy

The purpose of this study is to obtain biologic materials from the blood and lungs of normal individuals to establish a set of normal range for various parameters. These will provide important information when applied to individuals with various pulmonary diseases, and will help in understanding of the etiology and pathogenesis of various lung diseases.

Study procedures will be performed at the Weill Cornell Medical College-New York Presbyterian Hospital and/or Weill Greenburg York Avenue Building. Study procedures done elsewhere that are within the protocol timeframe will be accepted if seen fit by the investigators so that they are not repeated unnecessarily. Study individuals who undergo bronchoscopy with intravenous administration of sedatives and analgesia may be required to stay overnight. Bronchoscopy is normally an ambulatory procedure. The subject is observed after the bronchoscopy, including vital signs and level of consciousness, until they are back to baseline. An overnight stay would only be required if the individual was not, in the judgment of the attending physician, safe to be discharged as is standard practice. Follow up of all participants are carried out by telephone within 1 wk following the procedure.

Rockefeller University has been added as a second site.

Individuals undergoing bronchoscopy without intravenous administration of sedatives and analgesia are not required to stay overnight due to the lack of administration of CNS-altering drugs and the limited sampling involved (tracheal brushes only).

Eligibility Criteria:
Inclusion Criteria:

* All study subjects should be able to provide informed consent
* Males or females ages 18 years and older.
* Must provide HIV informed consent.
* Non-smokers, ex-smokers and smokers.

Exclusion Criteria:

* Individuals not deemed in good overall health by the investigator will not be accepted into the study.
* Drug and/or alcohol abuse within the past six months.
* Individuals with history of chronic lung disease, including asthma or with recurrent or recent (within three months) acute pulmonary disease will not be accepted into the study.
* Individuals with allergies to atropine or any local anesthetic will not be accepted into the study.
* Individuals with allergies to pilocarpine, isoproterenol, terbutaline, atropine or aminophylline will not be accepted into the study
* Females who are pregnant or nursing will not be accepted into the study
Efficacy and Safety of a Continent Cutaneous Urinary Diversion in Spinal Cord Injury Patients

Continent Cutaneous Urinary Deviation (CUD), using the Mitrofanoff, Yang-Monti or Casale principle, is offered to patients with neurological diseases who are unable to perform intermittent catheterisation through the native urethra due to upper limb disability.

There is very little data in the literature examining the long-term efficacy and complications of this technique. The main objective of this study is to evaluate the effectiveness of long-term CUDs in spinal cord injury patients. The secondary objectives are to evaluate the surgical complications and the impact on the patient's quality of life.

For each patient, several data will be collected and analyzed: age at operation, sex, Body Mass Index (BMI), ASA score, ASIA score, type of bladder dysfunction assessed by urodynamic evaluation, urinary abnormalities assessed by morphological examination (ultrasound and / or computed tomography) and cystoscopy, creatinine clearance, operative indications, initial mictional mode, surgical assembly and any immediate or late complications. In a second stage, a questionnaire survey will be conducted by telephone.


Eligibility Criteria:
Inclusion Criteria:

Specific inclusion criteria for the study :

* no history of continuous cystostomy in another centre
* a follow-up \> 24 months,
* a continent cutaneous urinary diversion for a spinal cord injury.

General inclusion criteria :

* Patient affiliated to or beneficiary of a health insurance scheme.
* Adult patient (≥18 years of age) and under 85 years of age.

Exclusion Criteria:

* Criteria for non-inclusion specific to the study :
* All urinary incontinence outside of medullary waiting period.
* A history of continuous cystostomy in another centre.
* A follow-up of less than 24 months,
* a continent cutaneous urinary diversion for a neurological pathology other than spinal cord injury.

General criteria for non-inclusion :

* Patient in a period of exclusion determined by another study.
* Patient for whom it is impossible to give enlightened information.
* Patient under legal protection, guardianship or curatorship.
* Patient unable to express consent
Subcutaneous Adaption and Cosmetic Outcome Following Caesarean Delivery

This is a double blinded randomized study investigating if subcutaneous adaption has an impact on cosmetic outcome after Caesarean delivery.


Eligibility Criteria:
Inclusion Criteria:

* women undergoing cesarean section for any indication
* literate in german language

Exclusion Criteria:

* history of keloids
* previous transversal suprapubic scars
* known patient hypersensitivity to any of the suture materials used in the protocol
* a medical disorder that could affect wound healing (eg, diabetes mellitus, chronic corticosteroid use)
The Effect of Tomatis Auditory Stimulation in Children and Adolescents With NDDs

The current study aims to explore the preliminary efficacy of the Tomatis method on auditory processing in children with NDDs.

This will be a two-arm, randomized controlled trial exploring whether the Tomatis training could improve the components of auditory processing in children with Neurodevelopmental Disorders referred to a Romanian Child and Adolescent Psychiatric Unit. Outcomes assessment will be conducted at baseline (T1), immediately after the training (T2).

Eligibility Criteria:
Inclusion Criteria:

- neurodevelopmental disorder

Exclusion Criteria:

* intellectual disability
Comparison of Active vs. Passive Surveillance to Collect Adverse Events

This cluster randomized trial will be the first to specifically evaluate passive versus active surveillance methods collection of adverse events (AEs). The evaluation of these methods will be performed within the chiropractic healthcare profession, specifically among those who treat children. To date there is no mandatory reporting and learning as part of their profession. In Europe, a passive (voluntary) reporting and learning online system (CPiRLS) has been created and will be utilized in this study for the passive reporting and learning arm.

Manual therapy is the most common intervention provided by the chiropractic profession and is the most commonly sought provider-administrated complementary and alternative therapy in the United States pediatric population. This study will randomize participating doctors of chiropractic who often treat children, to of one of two arms (active vs. passive reporting and learning) to evaluate the quantity and quality of AE data collected.


Eligibility Criteria:
Inclusion Criteria:

* Licensed doctors of chiropractic who provide manual therapy in US or Canada
* Willing to collect data per protocol for 60 consecutive pediatric (13 years of age and younger) patients

Exclusion Criteria:

- Doctors of chiropractic and patient participation will be limited to those that speak / read English.
A Single Center Study for the Treatment of Moderate to Severe Allergic Conjunctivitis (EBI-005-AC-1)

This is a Phase II Single Center, Randomized, Double-Masked, Vehicle-Controlled, Parallel, Group Study to Assess the Efficacy of EBI-005 Topical Ophthalmic Solution for the Treatment of Moderate to Severe Allergic Conjunctivitis Using an Environmental Exposure Chamber (EEC) Model and Conjunctival Allergen Provocation Test (CAPT) Model. Approximately 150 subjects will be enrolled and randomized in one study center in Canada for a duration of 0.33 years.


Eligibility Criteria:
Inclusion Criteria:

* Provide written informed consent prior to any study-related procedures.
* Be 18 years of age or older.
* Have at least a 2 year history of moderate to severe allergic conjunctivitis.
* Have a positive skin prick test to ragweed within the past 12 months of Screening (Visit 1A).
* Have a score of ≥ 2 for staff-assessed ocular redness in at least one region (nasal or temporal) in each eye and ≥ 2 for subject-assessed ocular itching within the 3.5-hour period of allergen exposure in the EEC at Visit 1B.
* Have required more than one anti-allergy pharmaceutical treatments in the past 2 years to treat ocular symptoms (including oral, topical, nasal treatments).
* Be able to self-administer topical ophthalmic drops.
* Avoid any topical or systemic ocular medications during the entire study period.
* Are willing and able to follow instructions and can be present for the required study visits for the duration of the study.

Exclusion Criteria:

* Are female and of childbearing potential and unwilling to remain abstinent through 30 days following the last dose of study drug or not willing to use acceptable birth control methods.
* Have previously used an IL-1 blocker (e.g., Anakinra, Rilonacept, or Ilaris).
* Have a known contraindication or hypersensitivities to Anakinra (Kineret®) or any therapeutic agent targeted to IL-1 or any component of study drug formulation.
* Current participation in another clinical study involving an experimental treatment or participation in such a study within 30 days prior to study entry.
* Require concomitant use of TNF-blocking agents (e.g., Etanercept, Adalimumab, Infliximab).
* Have a history of glaucoma or intraocular pressure (IOP) \> 25 mmHg at the Visit 1A (Medical Screening) or a history of elevated IOP within the past year.
* Have had ocular surgery including laser procedures within the past 12 months of Visit 1A (Medical Screening).
* Have had contact lens wear within 4 weeks prior to Visit 1A (Medical Screening) or unwilling to discontinue wear during the study period
Development and Evaluation of the Impact of a Safety Checklist Adapted to Interventional Cardiology

The hypothesis is that patients undergoing cardiac catheterization, in which the New Safety Checklist has been used, have fewer perioperative complications compared to patients in which the habitual practice has been used.

The aim of this study is to develop a New Safety Checklist in perioperative patients undergoing cardiac catheterization in interventional cardiology units and assess it impact on the incidence of perioperative complications compared to habitual practice.

The study will consist in two phases; the first phase: development of the New Safety Checklist, and the second phase will be a multicenter randomized clinical trial, a parallel two-arm corresponding to the use of the New Safety Checklist compared to the habitual practice in all patients undergoing cardiac catheterization in interventional cardiology units, according to the inclusion criteria..

The expected number of patients in this trial will be 6000. The principal outcome of this study will be: the incidence of perioperative complications. The secondary outcomes will be: socio-demographic data, clinical patient data and procedure type data. Data collection will be done through reviewing clinical history.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\>18 years) undergoing cardiological intervention in hemodynamic units and interventionist cardiology.
* Patients who accept to participate in the study.

Exclusion Criteria:

* Patients undergoing urgent procedure.
* Patients requiring ventilatory support or in a situation of hemodynamic instability.
* Patients with cognitive impairment, mental disability or other serious difficulty in communication.
* Patients with insufficient fluidity of the main languages.
A Study for the Treatment of Unresectable Stage III or Metastatic Stage IV Melanoma

A study with YM155 for the treatment of unresectable stage III or metastatic stage IV melanoma.

A phase II, multicenter, open-label study in subjects with unresectable Stage III or metastatic (Stage IV) Melanoma to evaluate the efficacy and safety of YM155

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed unresectable stage III or IV malignant melanoma
* Life expectancy \>12 weeks

Exclusion Criteria:

* History of other malignancy in the last 5 years
* Major surgery within the past 21 days
Molecular Genetic Epidemiology of Three Cardiac Defects -SCOR in Pediatric Cardiovascular Disease

To identify genes involved in the pathogenesis of three types of congenital heart disease, atrial septal defects, paramembranous ventricular septal defects, and atrioventricular canal defects.

BACKGROUND:

Congenital heart defects (CHDs) are thought to result from genetic and environmental factors that disturb cardiac embryogenesis. Because families with multiple members affected with atrial septal defects (ASDs) and atrioventricular canal defects (AVCDs) have been described in previous studies, and the paramembranous ventricular septum is in part completed by the formation of the atrioventricular cushions, this project describes a genetic-epidemiologic study of ASDs, paramembranous ventricular septal defects (VSDs), and AVCDs

DESIGN NARRATIVE:

The study is one of several subprojects within a Specialized Center of Research (SCOR) in Pediatric Cardiovascular Disease. Three groups of subjects, each with surgically- or echocardiographically-confirmed diagnoses of ASDs, VSDs or AVCDs have been identified for study at the University of Iowa Hospitals and Clinics, and at Wolfson Children's Hospital in Jacksonville, Florida. A fourth group of older subjects with ASDs and their progeny will be studied at Iowa because of the reported high recurrence of heart disease in the offspring of subjects with ASDs. The strategy calls upon the molecular genetic capacities available at the University of Iowa to carry out genome-wide searches for genetic loci involved in these defects. Several candidate regions have been identified for ASDs, VSDs and AVCDs. In addition, three well-recognized syndromes provide additional candidate regions - Down syndrome, Holt-Oram syndrome and 8p-syndrome. Parent-affected child trios will be genotyped for closely-spaced markers within these regions and linkage disequilibrium analysis will be used to narrow or exclude these candidate intervals. A genome-wide association study of the trios will employ a parsimonious technique in which DNA from cases with the same CHD phenotype will be pooled, and compared to the pooled DNA from their parents. Loci will be identified where the allele frequency distributions in the affected children and their parents are significantly different. When such loci are identified, a finer localization of the chromosomal area will be undertaken using a high-density set of short tandem repeat polymorphic markers that spans each of the candidate intervals.

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
Computerized Single-Session Interventions for Indian Adolescents

The overall aim of this project is to understand if single-session interventions are acceptable, culturally appropriate, and effective for Indian adolescents. The investigators will be examining the effects of three interventions on the well-being and mental health of adolescents. The investigators hypothesize that at least one of the three interventions will yield statistically significant improvements in wellbeing and mental health relative to a study skills control condition.


Eligibility Criteria:
Inclusion Criteria:

* Attending a participating secondary school
* Age 12 to 18
* Literate in English

Exclusion Criteria:

* Unable to provide informed consent
Interpersonal Psychotherapy in Youth With Severe Mood Dysregulation-Pilot

The purpose of this study is to determine the feasibility and acceptability of an utilizing an adapted form (IPT-SMD)of a psychosocial intervention, Interpersonal Psychotherapy for Depressed Adolescents, for youth with severe mood dysregulation (SMD).

The investigators hypothesize that retention rates will be \>80%,satisfaction scores will average 6 (high) on a 7 point satisfaction scale, and that youth who receive the IPT-SMD intervention will have overall improvement in SMD symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects, ages 13 to 17 years, who meet criteria for severe mood dysregulation as defined by NIMH criteria.
* Subject has an estimated IQ \>70 on the Kaufman Brief Intelligence Test (KBIT-2)
* Subjects will have continuously resided with a legal guardian who has known the adolescent well for at least one year before study entry and is legally able to sign the consent form.
* Participants must be on the same dose of any prescribed medication for 4 weeks prior to randomization.
* Children's Global Assessment Scale (CGAS) ≤ 60

Exclusion Criteria:

* Subject poses a significant risk for dangerousness to self or others. Risk will be determined by clinical history, clinical diagnostic interview and KSADS-PL interview of parent and patient by clinician.
* Subject suffers from a concomitant medical or psychiatric co-morbidity that makes this study protocol inadvisable (either the treatment is contraindicated or the disorder is not the primary focus of treatment).
* Subject meets DSM-IV criteria for current alcohol or substance dependence or current use (defined as the past 4 weeks).
* Pregnant females.
* Primary caretaker does not speak English
Lacto-fermented Sauerkraut in the Treatment of Irritable Bowel Syndrome

The aim of the present study is to assess the efficacy of traditionally fermented sauerkraut in the treatment of irritable bowel syndrome.

Irritable bowel syndrome (IBS) is a chronic gastrointestinal (GI) disorder that affects around 11% of the population globally. Several factors have been implicated in the pathogenesis of IBS, including psychological stress, gastrointestinal motility, and diet . More recently, it has become clear that the gastrointestinal microbiota may play a critical role in the pathophysiology of this functional GI condition.

Several studies have shown that an altered gut microbiota profile is present in at least some subgroups of IBS patients. This may, in part, explain why a proportion of IBS patients have elevated levels of inflammatory mediators in systemic circulation.

Gut microbiome manipulation, for example through the use of probiotic and prebiotic supplements, has shown some promise in the treatment of IBS. However, the research in this area is still in its infancy, and it remains unclear what type of intervention that is the preferred choice in cases of IBS.

Several studies have investigated how the use of probiotic supplements containing Bifidobacteria and Lactobacilli affect the clinical outcome of patients with IBS. However, to date, no studies have assessed whether fermented vegetables, a "natural" source of probiotic bacteria such as Lactobacillus plantarum, are useful in the treatment of IBS.

Eligibility Criteria:
Inclusion Criteria:

Rome III criteria (Criteria fulfilled for the last 6 months with symptom onset at least 3 months prior to diagnosis):

Recurrent abdominal pain or discomfort at least 3 days/month in the last 3 months associated with two or more of the following:

1. Improvement with defecation
2. Onset associated with a change in frequency of stool
3. Onset associated with a change in form (appearance) of stool

Exclusion Criteria:

* Psychiatric disorder
* Metabolic disease
* Chronic infection
* Organic gastrointestinal disorder
* Pregnancy
* Breastfeeding
Enantyum® IV Versus Piroxen® IM in Emergency Pain Management

For pain of traumatic origin, the RICE protocol (Rest, Ice, Compression, Elevation) is the main therapeutic measure during the first 4 to 5 days post-trauma. However, there is currently insufficient evidence that this protocol is effective \[4\].

In the emergency department, paracetamol, NSAIDs or a combination of several molecules are generally prescribed. Patients even use these drugs without a prescription.

The aim of this study is to Compare the effect of dexketoprofen® IV versus piroxen® IM in the treatment of pain in emergency departments.

This was a prospective, randomized, double-blind, controlled study conducted at the Sahloul emergency department, Sousse.

Study duration: 3 months.

Inclusion criteria:

Patients over 18 years of age requiring analgesia for acute pain of traumatic origin and who signed a written consent form were included in this study.

Exclusion criteria:

Patients who meet the following conditions:

* refusal, incapacity, difficulties with consent or communication
* Patients with chronic pain.
* Any known allergy or secondary reaction to piroxen or dexketoprofen trometamol.
* Pregnant women.
* Cirrhosis of the liver.

Methodology:

1. Dexketoprofen group Patient receives an intravenous injection of Dexketoprofen + IM placebo + follow-up sheet + appointment card.
2. Piroxican group. Patients receive one intramuscular Piroxen injection + IV SSI infusion + follow-up sheet + appointment card.

For each patient included, VAS, blood pressure, heart rate, respiratory rate and Sa02 are taken on admission and discharge from the emergency department, and at the second telephone visit after 07 days.

At the 7th day visit (by telephone), patients were asked to answer satisfaction questions and complete the EQ50 quality of life questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age who required analgesia for acute pain of traumatic origin and who signed a written consent form were included in the study.

Exclusion Criteria:

* Patients who meet the following conditions:
* refusal, incapacity, difficulties with consent or communication
* Patients with chronic pain.
* Any known allergy or secondary reaction to piroxen or dexketoprofen trometamol.
* Pregnant women.
* Cirrhosis of the liver.
Safety and Pharmacokinetics of Antipsychotics in Children 2: Studying TDM in an RCT

The aim of this study is to test whether therapeutic drug monitoring of risperidone in children with autism spectrum disorder and comorbid behavioral problems is able to reduce metabolic side effect burden, while retaining clinical effectiveness.


Eligibility Criteria:
Inclusion Criteria:

* Age 6 to 18 years
* Documented clinical diagnosis of autism spectrum disorder according to DSM IV or DSM V and comorbid behavioural problems
* To start treatment with risperidone

Exclusion Criteria:

* Diabetes type I or II
* Congenital or acquired syndrome associated with changes in appetite, body weight or lipid profile (e.g. Prader Willi)
* Treatment with antipsychotic medication within the last 6 months
* Known Long QT syndrome (LQTS)
* Pregnancy