cyrilzakka/clinical-trials huggingface dataset:
A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease

The purpose of this study is to evaluate the clinical and endoscopic efficacy of guselkumab in pediatric participants with Crohn's Disease (CD) at the end of maintenance therapy (Week 52) among participants who were in clinical response to guselkumab at Week 12.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have a diagnosis of Crohn's Disease (CD) or fistulizing CD, with active colitis, ileitis, or ileocolitis, confirmed at any time in the past by clinical, endoscopic, and histologic criteria.
* Participants must have moderately to severely active CD (as defined by a baseline Pediatric Crohn's Disease Activity Index \[PCDAI\] score greater than or equal to \[\>=\] 30)
* Participants must have endoscopy with evidence of active CD defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) score greater than or equal to (\>=) 6 (or \>=4 for participants with isolated ileal disease) within 1 month of receiving study intervention at Week 0
* Participants must have a prior or current CD medication history that includes either inadequate response, loss of response to or failure to tolerate current treatment immunomodulators or with oral or intravenously (IV) corticosteroids or have received biologic therapy/JAK inhibitor for the treatment of CD and have a documented history of inadequate response, loss of response (LOR), or intolerance to the biologic therapy/JAK inhibitor

Exclusion Criteria:

* Participants has complications of CD such as symptomatic strictures or stenosis, short gut syndrome, or any other manifestation that might be anticipated to require surgery.
* Participants must not have an abscess
* Participants must not have any kind of bowel resection within 26 weeks or any other intra-abdominal surgery within 12 weeks of baseline
Study Evaluating GAP-486 in Non-sustained Ventricular Tachycardia

To determine whether the administration of test article will decrease the occurrence of ventricular arrhythmias in patients who have acute coronary syndrome (unstable angina, ST segment elevated myocardial infarction or myocardial infarction without ST elevation).


Eligibility Criteria:
INCLUSION CRITERIA:

* Male and female patients, 18 years of age or older, that have experienced an acute ischemic event within 24 hours prior to study entry.
* Patients with a documented history of coronary artery disease or left ventricular dysfunction
* Patients who have experienced an episode of non-sustained ventricular tachycardia within 24 hours of the index ischemic event

EXCLUSION CRITERIA:

* Patients who have had percutaneous coronary intervention (PCI), thrombolytics, or open-heart surgery within 48 hours prior to study entry, or who require it during test article administration
* Patients who have taken another antiarrhythmic medication (other than a beta blocker) within 5 half-lives of the start of test article
* Patients who have a history of torsades de pointes, long QT syndrome, QTc \> 0.50
Efficacy and Safety of Atomoxetine in Children With Recent Diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD)

Double blinded clinical trial placebo controlled in 153 children (planned enrollment) with recent diagnosis of ADHD. Patients will be randomized to atomoxetine or placebo arm (2:1). The double blinded period will last 12 weeks and the treatment open phase will last up to 1 year, and atomoxetine treatment will be administered.

A gatekeeper strategy will be employed for sequentially testing the secondary objectives.


Eligibility Criteria:
Inclusion Criteria:

1. Child or adolescent patients must be at least 6 years of age, but must not yet have reached their 16th birthday prior to Visit 1, when informed consent is obtained.
2. Patients must meet the Diagnostic and Statistical Manual for Mental Disorders, Fourth Edition Text Revision (DSM-IV-TR) diagnostic criteria for ADHD. For the purposes of this study the diagnosis of ADHD will be confirmed during Visit 1 by administering the K-SADS-PL. Patients must also have an ADHDRS-IV-Parent:Inv score at least 1.5 standard deviations above the age norm for their diagnostic subtype at both Visit 1 and Visit 2. In addition, they must have a CGI-ADHD-S score 4 at both Visit 1 and Visit 2.
3. Patients must have a newly diagnosed case of ADHD. Newly diagnosed case of ADHD means that a specialist (including pediatrician, child psychiatrist, or child neurologist) or child psychologist has diagnosed ADHD (according DSM-IV-TR or International Statistical Classification of Diseases and Related Health Problems \[World Health Organisation; 10th Revision\] \[ICD 10\] criteria) within 3 months prior to Visit 1.

Exclusion Criteria:

1. Patients with history of ADHD diagnosis longer than 3 months prior to Visit 1. Diagnosis of ADHD means that a specialist (including pediatrician, child psychiatrist, or child neurologist) or child psychologist has diagnosed ADHD (according DSM-IV-TR or ICD 10 criteria) and has registered it in medical records or verbally informed parents about this diagnosis.
2. Patients who weigh less than 20 kg at study entry (Visit 1). If a patient's weight changes after Visit 1 to a value outside of the stated range, the patient will still be eligible, and the weight should be rounded to the nearest value within the above range for dosing purposes.
Electromyographic Assessment of the TetraGraph in Normal Volunteers

There is an urgent need for an easy-to-use and accurate quantitative neuromuscular monitor in the clinical setting. The aim of this clinical investigation is to examine a prototype of a quantitative monitoring instrument that will meet most, if not all, of the clinical requirements.


Eligibility Criteria:
Inclusion Criteria

1. Age 18 years or older
2. Volunteer meets the American Society of Anesthesiology (ASA) physical status I-III criteria
3. Volunteer has provided verbal informed consent

Exclusion Criteria

1. Presence of an underlying neuromuscular disease
2. Use of medications known to interfere with neuromuscular transmission
3. Volunteer has open sores/rashes at the locations needed for electrode application
4. Volunteer does not tolerate a trial electrical stimulation comfortably.
Glucagon-like Peptide-1 Receptor Agonist (GLP-1 RA) and Diet in Inflammatory Bowel Disease (IBD) Patients

The purpose of this study is to use diet and an injectable medication called tirzepatide (Zepbound) glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist (GIP-GLP-1 RA) medication as adjunctive therapy (another treatment used together with the primary treatment) for Crohn's disease patients with mild disease who are on stable doses of biologic medication (infliximab or adalimumab) and who have a body mass index (BMI) of at least 27.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥18 years old)
* Confirmed diagnosis of Crohn's disease
* Mildly active disease, defined by clinical symptoms using the Harvey Bradshaw Index (HBI) score between 5 and 7 (the HBI is a continuous score ranging from 0-16 where \<4 is considered remission)
* BMI ≥ 27 kg/m2
* Patients will be on stable doses of medical therapy (anti-tumor necrosis factor (TNF) alpha blockers)

Exclusion Criteria:

* Patients under 18 years of age
* Patients with ulcerative colitis
* Patients with infectious colitis
* BMI\<27 kg/m2
* Patients with type 1 or type 2 diabetes
* Contraindications to a GIP/GLP-1 RA, including patients with a personal or family history of medullary thyroid cancer or in patients with Multiple Endocrine Neoplasia syndrome type 2
* Patients already on GIP/GLP-1 RA therapy
* Patients with the following chronic symptoms: severe constipation, nausea, and/or vomiting
* Patients with the following medical history: small bowel obstruction in the last year, intestinal stricture, known or suspected diagnosis of gastroparesis
* Adults unable to consent
* Pregnant patients (will be confirmed via a pregnancy test)
* Prisoners
The RODEO Micro Mapping Catheter in Cryoablation Procedures

This clinical investigation evaluates the feasibility of the Rodeo Micro Mapping Catheter in combination with cryoablation ssystem (sclerotherapy of muscle tissue of the heart by freezing) in patients with atrial fibrillation (permanent atrial fibrillation excepted).

Further aims of this study are the evaluation of safety of the device and average procedure and fluoroscopy times.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years and legal capacity.
* Atrial fibrillation, diagnosed in accordance with the guidelines of the ESC (version 2016) - permanent AF excluded.
* Patient planned for a pulmonary vein isolation catheter ablation procedure using cryoenergy and suitable for treatment according to the respective instructions for use (IFU).
* Signed and dated informed consent documented by the patient, indicating that the patient has been informed of all the pertinent aspects of the trial prior to study enrolment (patient has received a copy of the ICF).

Exclusion Criteria:

* Indication that the vascular system is not accessible through the left or right groin.
* Indication that a transseptal puncture cannot be performed.
* Any previous ablation or surgery due to AF.
* Important comorbidities such as cardiovascular events within six months of enrolment or high-risk surgical patients.
* Left atrial diameter \> 50 mm in the short axis.
* Advanced structural heart disease including

  * moderate-to-severe valvular stenosis or regurgitation,
  * previous valve replacement or valve repair,
  * congenital heart disease,
  * left ventricular ejection fraction \< 45% during sinus rhythm,
  * congestive heart failure NYHA III or IV,
  * coronary artery bypass graft surgery within the last 3 months.
* Permanent pacemaker.
* Pregnant women at the time of the cryoablation procedure.
* Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the Informed Consent Form.
* Participation in interventional trials for cardiovascular devices or drugs.
Pivotal Response Treatment Package for Young Children With Autism

This is a research study examining the effectiveness of a pivotal response treatment package (PRT-P) in targeting language skills in young children with autism.

Researchers at the Stanford University School of Medicine are seeking participants for a research study examining the effectiveness of a pivotal response treatment package (PRT-P) in targeting language skills in young children with autism. Research has demonstrated that behavioral interventions, such as Pivotal Response Training (PRT), lead to improvements in the core symptoms of autism. Researchers have begun to develop strategies to investigate the effectiveness of combining a parent training program teaching parents how to implement PRT with in-home, therapist-implemented treatment. To determine the effectiveness of a PRT-P, it will be compared to a delayed treatment group (DTG) by conducting a randomized controlled 24-week trial. This research will allow us to help in the development of therapeutic approaches that can meet the increasing service demands for families. We hope that investigating interventions that aim to improve core deficits will aid clinicians in providing better care for children with autism.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Autism Spectrum Disorder (ASD) based on Autism Diagnostic Interview- Revised (ADI-R), Autism Diagnostic Observation Schedule (ADOS-2), and expert clinical opinion
* Males and females in good medical health between 2.0 and 5.11 years
* Ability to participate in the testing procedures to the extent that valid standard scores can be obtained
* Language delay as measured by the Preschool Language Scale: Standard score at least 1 Standard Deviation below average for expressive language ability
* Stable treatment, speech therapy, school placement, psychotropic medication(s) or biomedical intervention(s) for at least 1 month prior to baseline measurements with no anticipated changes during study participation
* No more than 60 minutes of individual 1:1 speech therapy per week
* Availability of at least one parent who can consistently participate in parent training and research measures
* Parents intend on continuing Pivotal Response Treatment Package (PRT-P) for a minimum of 12 weeks
* Parents must be 18 years of age or older

Exclusion Criteria:

* Current or lifetime diagnosis of severe psychiatric disorder, such as bipolar disorder
* Receiving in-home Applied Behavior Analysis (ABA) of 10 hours or more
* A genetic abnormality, such as Fragile X
* Presence of active medical problem, such as unstable seizure disorder or heart disease
* Previous adequate PRT trial
* Participants living more than 50 miles from Stanford University
* At least one room of the house must be available to be dedicated to treatment during session times
* There must be no serious health and safety risks present in the home environment
* The research team has the right to refuse to perform sessions in-home even if the criteria above are met
Ursodiol for Treating Parenteral Nutrition Associated Cholestasis in Neonates

The purpose of this study is to determine whether ursodiol is effective in the treatment of parenteral nutrition associated cholestasis in neonates.

This is the first randomised controlled study that address the question of the role of ursodiol as treatment of cases of PNAC.

It includes all neonates with stratification of less than and equal to 32 weeks or more than 32 weeks of gestation.

Eligibility Criteria:
Inclusion Criteria:

* Preterm or in-term newborns hospitalized in neonatal care units at CHU Sainte-Justine between October 1st 2008 and October 1st 2011.
* Must be receiving parenteral nutrition (either partial or total) at the diagnosis of cholestasis.
* Parental Consent must be obtained.

Exclusion Criteria:

* Active urinary tract infection
* Presence of clinical signs(acholic stool) of or ultrasound evidence of biliary tract anomalies.
* Positive TORCH infections(Toxoplasmosis, Other infections, Rubella, Cytomegalovirus, Herpes simplex virus)
* Known short bowel syndrome
* Known congenital hypothyroidism
* Known genetic disorders associated with cholestasis like galactosemia, phenylcytonuria, antitrypsin 1 deficiency... etc
Evaluation of an Aerobic Exercise Program in Migraine Management

This trial assesses the impact of a supervised aerobic exercise program by a kinesiologist in patients with migraine. Patients can be assigned to one of two groups 1)The exercise group or 2)non-exercise group. This is a important area to study because there is currently limited information regarding exercise and its impact on migraine frequency and severity. In many cases, migraine patients are disabled by their headaches and sometimes will not have a significant response to medications. As a result, it is important to study other non-pharmacological interventions. In this study, the investigators hope to show the benefits of exercise by a reduction in number of headache days per month as well as by improvement in quality of life, disability,depression,anxiety,and aerobic fitness.This study will not interfere with the usual treatment patients receive at our headache clinic and patients can remain on medications deemed necessary.


Eligibility Criteria:
Inclusion Criteria:

1. Patients must meet diagnostic criteria for migraine without aura, migraine with aura or chronic migraine.
2. Patients must be 18-50 years of age.
3. Individuals motivated to exercise and complete the study.

   -

Exclusion Criteria:

1. Patient has a headache on more than 25 days a month
2. Patient is a medication over-user by International Headache Society (IHS) criteria
3. Patient currently has a fitness program with regular aerobic exercise for 30 minutes three times a week or more.
4. Known cardiovascular disease which contraindicates the exercise program
5. Inability to complete the outcome measure questionnaires. -
Safety and Efficacy of Oral Fampridine-Sustained Release (SR) for the Treatment of Spasticity Resulting From Spinal Cord Injury

Normally, nerve fibers carry electrical impulses through the spinal cord, providing communication between the brain and the arms and legs. In people with spinal cord injury, some fibers may be destroyed at the site of injury, while others remain connected but do not work correctly to carry electrical impulses. As a result, subjects with an incomplete spinal cord injury may have spasticity which is muscle spasms or muscle stiffness that makes movement difficult. Fampridine-SR is an experimental drug that increases the ability of the nerve to conduct electrical impulses. This study will examine the effects of Fampridine-SR on moderate to severe lower-limb spasticity, as well as the effects on bodily functions such as bladder control, bowel function and sexual function. The study will also examine the possible risks of taking Fampridine-SR.


Eligibility Criteria:
Inclusion Criteria:

* Incomplete traumatic Spinal Cord Injury (at least 18 months prior and stable for 6 months)
* Moderate to severe lower-limb spasticity
* Able to give informed consent and willing to comply with protocol

Exclusion Criteria:

* Pregnancy
* History of seizures
* Existing or history of frequent Urinary Tract Infections
* History of drug or alcohol abuse
* Allergy to pyridine-containing substances
* Received a botox injection 4 months prior to study
* Received an investigational drug within 30 days
* Previously treated with 4-aminopyridine (4-AP)
* Not on stable medication dosing in 3 weeks prior to study
* Abnormal ECG or laboratory value at screening
Randomized Trial of IN.PACT Admiral® Drug Coated Balloon vs Standard PTA for the Treatment of SFA and Proximal Popliteal Arterial Disease

The objective of this Study is to evaluate the safety and efficacy of the IN.PACT Admiral® drug coated PTA balloon, utilized for the dilatation of the narrowed sections of the artery, as compared to other standard (non drug coated) PTA balloons. The IN.PACT Admiral, besides the mechanical dilatation effect typical of all PTA balloons, releases a drug (paclitaxel) from the balloon surface into the vessel walls. This drug absorption is intended to limit the chances and the entity of artery re-narrowing over time.

The efficacy of the IN.PACT Admiral balloon will be evaluated by assessing the primary patency rate of the treated arteries in the thighs of all patients included in the Study. Primary patency is a measure of the durability up to 1 year of the free lumen in the artery as restored during the procedure and is based on:

* the need for re-dilatation of the previously treated vessel segment
* an ultrasound examination The safety of the IN.PACT Admiral will be assessed by evaluating the incidence of deaths, amputations and re-dilatation of the pre-treated arteries in all patients included in the Study.

The IN.PACT SFA Trial enrolled in 2 phases: IN.PACT SFA I and IN.PACT SFA II. The 150-patient IN.PACT SFA I phase is intended to support the second phase IN.PACT SFA II IDE trial with congruent design and protocol. Aggregate data from the two phases is intended to provide statistical power for the 12-month primary safety and effectiveness endpoints.

Eligibility Criteria:
General Inclusion Criteria:

* Age ≥18 years and ≤85 years
* Patient or patient's legal representative is informed of the nature of the study, agrees to participate and has signed an EC approved consent form

Angiographic Inclusion Criteria:

- Target vessel is the superficial femoral artery and/or proximal popliteal artery (above the knee)

General Exclusion Criteria:

* Patient unwilling or unlikely to comply with follow-up schedule
* Stroke or STEMI within 3 months prior enrolment

Angiographic Exclusion Criteria:

- Acute or sub-acute thrombus in the target vessel
Determine the Bioequivalence of Two Formulations of Tamsulosin HCl Capsules in Fasted Male.

A bio-equivalence of 2 different capsule formulations in fasted subjects


Eligibility Criteria:
Inclusion criteria:

Healthy male volunteers 18 years and older

Exclusion criteria:

History of hypersensitivity or allergy to the IPM or its excipients or any related medication
A Trial to Assess the Efficacy and Safety of 400mg/Day Lacosamide in Subjects With Painful Diabetic Neuropathy

The purpose of this trial is to assess whether 400mg/day of lacosamide is effective in reducing pain caused by distal diabetic neuropathy. Two dose-escalation schemes for lacosamide will be used to further determine the efficacy of the "standard" scheme and to evaluate the efficacy and safety of a more rapid titration scheme. Subjects will be randomly assigned to one of three treatment groups. Subjects in two of the groups will receive lacosamide at a dose of 400mg/day, but different dose-escalation schemes will be used to reach this final dose. The third group of subjects will receive a placebo. Subjects will have a 2 in 3 (66 %) chance of getting lacosamide.

The maximum lacosamide dose in this trial will be 400mg/day. The maximum treatment duration will be 18 weeks, including a two-week Pre-Treatment Phase and a 12 weeks period on a stable dose of lacosamide or placebo.


Eligibility Criteria:
Inclusion Criteria:

* Subject has had symptoms of painful diabetic neuropathy for at least 6 months and has a diagnosis of diabetes mellitus (Type I or Type II).

Exclusion Criteria:

* Subject has previously participated in this trial or subject has previously been assigned to treatment in a trial of the drug under investigation in this trial
Cognition Intervention Study Dortmund- Continued (Coco)

The Cognition Intervention Study Dortmund (CogniDo) and the Cognition Intervention Study Dortmund PLUS (CogniDo PLUS) investigated the short-term effects of having school lunch versus skipping it on children's basal (CogniDo) and executive (CogniDo PLUS) cognitive functions in the afternoon. The present Coco study connect this two previous studies and investigates the effect of having school lunch versus skipping it on children's basal and executive cognitive functions later in the afternoon.

Because of cerebral particularities, children may react highly sensitive to variations of nutrient supply. Therefore, an optimised composition of meals at favourable mealtime should be considered for optimal cognitive performance. The increasing implementation of all-day schools in Germany requires the children's catering for lunch at school. However, the number of 'meal skippers' is increasing among children and adolescents. Thus, the effect of skipping lunch at school on cognitive functioning is examined in this experimental cross-over trial. As prior intake of food can have an influence on the physiological effect of test meal, the children's dietary intake in the mid-morning is standardized. The intervention is integrated in everyday school life:

9.15 a.m. standardized snack within the frame of the regular break, 9.45 a.m. to 12.25 p.m. everyday school life, 12.25 p.m. either lunch (control) or water as a beverage (intervention of 'skipping meal'), 12.45 p.m. to 1.15 p.m. regular lunch break, 1.15 p.m. to 14.10 p.m. regular school lesson. 14.15 p.m. computerized tests of executive cognitive and basal (alertness) functioning, 3 p.m. lunch for the 'skipping meal'-group. Parameters of cognition with relevance to everyday school life are measured by a computerized test program developed by the Institute of Working Learning and Aging (ALA). Usual eating behaviour, sleep behaviour, physical activity and parental education were determined as control variables by questionnaires for children, parents.

Eligibility Criteria:
Inclusion Criteria:

* All fifth and sixth grade students of Gesamtschule Berger Feld with the consent of parents and child

Exclusion Criteria:

* Metabolic diseases or special diet