cyrilzakka/clinical-trials huggingface dataset:
iCBT for Children and Adolescents With Obsessive-compulsive Disorder

Internet-based psychotherapy for children and adolescents with obsessive-compulsive symptoms and an age of 7 to 17 years. Sessions are verified with teleconferencing with an psychotherapist, children and their parents. The psychotherapy is supported by an App and a wristband to obtain psychophysiological data.


Eligibility Criteria:
Inclusion Criteria:

* Children and adolescents (ages 7-17) with a primary DSM-5 obsessive-compulsive disorder and at least 1 primary caretaker
* German-speaking (child \& caretakers)
* Family home equipped with broadband connection and appropriate computer, monitor, HD webcam, and speaker and smart phone

Exclusion Criteria:

* IQ below 70
* A psychiatric comorbidity that makes participation clinically inappropriate (for example, primary anorexia nervosa), depression with suicidality that requires acute treatment, and psychosis
Energy Expenditure, Diet and Body Fat in Children

To characterize the pattern of change over a two year period in energy expenditure and energy intake in two cohorts of American Indian (AI) children.

BACKGROUND:

Obesity is highly prevalent in American Indian children, increasing their risk for the development of cardiovascular disease, hypertension and diabetes. Although increasing energy expenditure, through increasing physical activity, and decreasing dietary fat intake should slow the rate of body fat gain, it appears that children actually decrease their physical activity as they mature from pre-to post-pubescence. Several studies have shown that the decline in activity is greater in females than in males, and greater in non-whites than in whites; however, other studies have not supported these findings. Further, there were no data available in American Indian children, which is a population at greatest risk. Additionally, inconsistencies have been reported with respect to the relationship between body weight or body fat and energy intake or dietary fat intake. At the heart of the problem is the difficulty in measuring self-reported physical activity and dietary intake accurately. Accurate self- report measures are necessary for use in the large scale studies that are required to investigate relationships between physical activity and dietary intake and disease. The Healthy People 2000: National Health Promotion and Disease Prevention Objectives include seven objectives emphasizing increasing physical activity in children and adolescents.

DESIGN NARRATIVE:

This study had a combined longitudinal and cross-sectional design in which the investigators modified the best existing methods for the self-report of physical activity and dietary intake in children and adolescents, and evaluated their validity using total energy expenditure (TEE) measured by doubly labeled water (DLW) as the criterion. They then used these methods to measure physical activity and dietary intake in two age cohorts of male and female American Indian children (8-10-years and 11-13-years) at baseline and two years later, with two sets of interim measurements. Change in TEE from baseline to the two-year follow-up was also measured using DLW and the TriTrac accelerometer. Equations for the estimation of percent body fat were cross-validated for this population. The study filled an existing gap by improving existing instruments for the measurement of physical activity and dietary intake in children and adolescents, and provided longitudinal data on change in these variables in the same children over time, plus provided cross-sectional data for each age and gender group to compare to the existing literature.

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
Surfactant Application During Spontaneous Breathing With Continuous Positive Airway Pressure (CPAP) in Premature Infants < 27 Weeks

This study investigates the efficacy of surfactant application during spontaneous breathing with CPAP in avoiding death and chronic lung disease (CLD) in very immature infants with a gestational age of less than 27 weeks.

80 % of extremely preterm infants with a gestational age of less than 27 completed weeks suffer from severe idiopathic respiratory distress syndrome (IRDS). They are still at high risk of mortality and long term morbidity especially of the lung and the brain. At least death and chronic lung disease (CLD) are related to the need and the duration of mechanical ventilation. Continuous positive airway pressure (CPAP) has been shown to be effective to avoid mechanical ventilation in the treatment of IRDS but it often fails in the most immature infants. Early or prophylactic surfactant application is effective in the treatment of IRDS and is the only causal therapy, but it is usually related to intubation and mechanical ventilation that should be avoided.Therefore to overcome the dilemma between need for mechanical ventilation with surfactant administration on the one hand and surfactant withholding with the use of CPAP on the other hand, a strategy was developed to administer surfactant during spontaneous breathing with CPAP (1). In the proposed prospective randomised controlled trial this strategy shall be compared with the recent gold standard in the therapy of extremely preterm infants with IRDS, that is intubation, mechanical ventilation and surfactant administration. Based on the results of a feasibility (1) study and some clinical observations it is hypothesised that the new approach is superior in avoidance of death and chronic lung disease compared to the recent gold standard.

Eligibility Criteria:
Inclusion Criteria:

* IRDS with Silverman-Score ≥ 5 and / or FiO2 ≥ 0,3
* Postnatal age of more than 10 min. and less than 2 hours
* Gestational age ≥ 23+0 and \< 27+0

Exclusion Criteria:

* Primary cardio- pulmonary resuscitation
* Prenatally diagnosed severe malformation
* No parental consent
* Participation in another interventional trial
Outpatient Use of Analgesics in Children and Adolescents in France

outpatient use of analgesics in children and adolescents in France from 2012 to 2015

To describe the outpatient use of analgesics in children and adolescents in France from 2012 to 2015

Eligibility Criteria:
Inclusion Criteria:

* all children and adolescents (0-17 years)
* registered in the French Health Insurance Database from 2012-2015
A TQT Study to Investigate the Effect of Enpatoran on Cardiac Repolarization in Healthy Participants

The purpose of this study is to assess potential effects of enpatoran on cardiac repolarization (i.e. prolongation of QT interval).


Eligibility Criteria:
Inclusion criteria:

* Participants are overtly healthy, as determined by medical evaluation, including no clinically significant abnormality identified on medical history, physical examination, vital signs, 12-lead ECG, or laboratory evaluation and no active clinically significant disorder, condition, infection, or disease that would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion
* Participants have a body weight within the range 50.0 to 100.0 kilograms (kg) (inclusive) and body mass index (BMI) within the range 19.0 to 30.0 kilograms per square meter (kg/m\^2) (inclusive)
* Other protocol defined inclusion criteria could apply

Exclusion criteria:

* History or presence of clinically relevant respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, musculoskeletal, genitourinary, immunological, dermatological, connective tissue, psychiatric (due to rare risk of hallucinations, agitation, and activation of psychosis), and other diseases or disorders, and epilepsy, as determined by medical evaluation
* Individuals with diagnosis of hemochromatosis, Wilson´s disease, alpha 1 antitrypsin deficiency, or any other chronic liver disease including Gilbert's disease
* Prior history of cholecystectomy or splenectomy, and any clinically relevant surgery within 6 months prior to the first administration of study intervention
* History of malignancy (e.g. hematologic, skin, solid tumor) less than or equal to (\<=) 10 years prior to Screening
* History of chronic or recurrent acute infection or any bacterial, viral, parasitic, or fungal infections within 30 days prior to Screening and at any time between Screening and admission to CRU, or hospitalization due to infection within 6 months prior to the first administration of study intervention
* History of shingles within 12 months prior to Screening
* Other protocol defined exclusion criteria could apply
Nicotine Vaccination and Nicotinic Receptor Occupancy

This is a molecular imaging research study designed to examine how much nicotine gets into the brain before and after vaccination with NicVAX, a nicotine vaccine developed by Nabi Biopharmaceuticals. NicVAX (Nicotine Conjugate Vaccine) is an investigational vaccine designed as an aid to smoking cessation and long-term abstinence, as well as an aid to prevent relapses of a treated smoker.

In this project we want to understand the degree to which NicVAX administration changes how much nicotine enters the brain in smokers.

The purpose of the present study is to examine the occupancy of brain β2-containing nicotinic acetylcholine receptors (β2-nAChR) by nicotine both at baseline and following administration of a nicotine vaccine. The number of brain β2-nAChR and the amount of nicotine occupancy both before and after vaccination will be measured using the nicotinic agonist \[123I\]5-IA-85380 (\[123I\]5-IA) and single photon emission computed tomography (SPECT). \[123I\]5-IA will be administered using the bolus plus constant infusion paradigm to smokers abstinent for 4-9 days (time period necessary for nicotine and pharmacological active metabolites to clear from brain). Three baseline SPECT images will be obtained after equilibrium has been reached (\~6 hours into the \[123I\]5-IA infusion). Then, IV nicotine will be administered (0.5-1.5 mg/70 kg will be infused over 10 minutes). Following a series of 4 nicotine vaccine shots, the same procedure will be repeated for a second \[123I\]5-IA scan day. We hypothesize that occupancy of β2-nAChR will be significantly lower, and take longer to plateau, following nicotine vaccine administration.

Eligibility Criteria:
Inclusion Criteria:

* Current smoker who smokes at least 10-25 cigarettes a day
* Good general health

Exclusion Criteria:

* Subjects with a pacemaker or other ferromagnetic material in body.
* Prior exposure to NicVAX or any other nicotine vaccine.
* Use of systemic steroids or other immunosuppressive agent
* History of significant neurological, cardiovascular, hepatic, endocrine, renal, liver, psychiatric or thyroid illness
* Cancer or cancer treatment in last 5 years
* HIV infection
* Use of varenicline (Chantix), bupropion (Wellbutrin, Zyban), mecamylamine (Inversin), within 30 days prior to administration of NicVAX and for the duration of the study.
* Inability to fulfill all visits and examination procedures for approximately 20 weeks.
Caffeinated Gum to Prevent Post-Operative Ileus: A Prospective, Randomized, Placebo-controlled Trial

This is a randomized, three-arm, double-blind, placebo-controlled, Phase III clinical trial of caffeinated gum and sugar-less gum in adult patients after an abdominal procedure. Patients will be randomized to receive placebo, sugar-less gum or caffeinated gum three times daily for 30 minutes starting the day following surgery until discharge or 24 hours after attainment of the primary endpoint.


Eligibility Criteria:
Inclusion Criteria:

* Abdominal procedure (Laparoscopic or open, occurring electively), American Society of Anesthesiologists (ASA) physical status score ≤ 3, Glasgow Coma Score (GCS) ≥ 15.

Exclusion Criteria:

* ASA physical status score of \>3, GCS \< 15, complete bowel obstruction, history of cardiac arrhythmia, history of phenylketonuria, alcohol abuse. substance abuse dentures
Evaluate Quality of Life in Type 2 Diabetes, Before and After Change to Insuline Glargine

Primary objective:

To assess quality of Life (QoL) changes and treatment satisfaction in a real life situation in patients with Type 2 diabetes inadequately controlled on a combination of oral antidiabetic drugs (OAD) plus Neutral Protamine Hagedrone (NHP) insulin treatment that are switched to insulin glargine.

Secondary objective:

To determine:

change in HbA1c, comparision of the incidence of symptomatic hypoglycemia and severe hypoglycemia before and after introduction of insulin glargine, change in weight, change in insulin dose.


Eligibility Criteria:
lists of inclusion and exclusion criteria:

Inclusion Criteria:

* Patients with type 2diabetes inadequately controlled on a combination of OAD + NPH insulin for more than three months
* Stable OAD therapy for at least three months, according to the following specified daily dose: glibenclamide\> 3, 5 mg, glipizid \>5 mg, glimeperid \>2mg, metformin\>1000 mg, acarbose \>150 mg
* HbA1c \> 7,0%
* Ability to perform QoL assessment
* Body Mass Indes: women \<30 and men \<32

Exlusion criteria:

* Autoimmune diabetes, as defined by WHO
* Ongoing treatment with tiasolidindion drug
* Retinopathy with surgical treatment during preceding three months of study entry or requiring treatment within three months after study entry
* Drug abuse
* Hypersensitivity to insulin glagine excipients

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Effect of Oral Vitamin D Supplement on Atopic Dermatitis; A Clinical Trial With Staphylococcus Aureus Colonization Determination

Background: Increase in skin colonization of Staphylococcus aureus (S. aureus) in atopic dermatitis patients (AD) resulted from the reduction of cathelicidin production in these patients plays the important role in pathogenesis of this disease. Recently in vivo study has showed that vitamin D can stimulate cathelicidin production. Oral supplement of vitamin D might be beneficial in atopic dermatitis.

Objective: To determine the effect of oral vitamin D supplement on clinical impact including skin colonization of S. aureus in atopic dermatitis patients.


Eligibility Criteria:
Inclusion Criteria:

* Eligible criteria included patients with mild to moderate atopic dermatitis by SCORAD (Scoring for Atopic Dermatitis) score criteria1,17,18, age between 1-18 years old. All patients had been advised to take normal, dietary product and their activities. They had been advised to discontinue at least 4 weeks of oral corticosteroid, at least 2 weeks of topical corticosteroid or topical calcineurin inhibitor application and at least 6 months of vitamin supplement prior to starting the protocol

Exclusion Criteria:

* The exclusion criteria were to coexisting skin infection on top with AD lesions, known case of primary or secondary immune-compromised host, hepatic or renal disease, those taking vitamin D or nutraceutical supplementation, those continues taking with antibiotics, corticosteroid, immunosuppressive agents, anti-epileptic drugs, thiazide diuretics, proton-pump inhibitors, histamine 2-receptor antagonists at the time of enrollment. Patients who used topical antiseptic or antibiotic products during study period were also excluded. Patients who developed worsening of AD with flare-up of clinical manifestation or SCORAD greater than 40, secondary infection on-top tested lesions were excluded from data analysis.
Safety and Efficacy of the UNILEXA Exoskeleton for Regular Verticalization and Assisted Walking

The primary objective of this clinical follow-up is to analyze data regarding the safety of the UNILEXA passive exoskeleton post-market. The secondary objective is to assess the effectiveness of the device in improving activities of daily living (ADL) through improved mobility, endurance and health-related quality of life (QoL). The aim of this study is to provide real-world evidence to support wider clinical and home use of the exoskeleton. This observational study is designed for 6 participants from a population of individuals with lower limb paralysis. The study will have a duration of 14 weeks. During this period, participants will visit Janske Lazne three times for routine measurements in a biomechanical laboratory, which will be integrated into their usual physiotherapy sessions.


Eligibility Criteria:
Inclusion Criteria:

* Individuals with lower limb paralysis due to spinal cord injury (T5-T12 lesion) in chronic phase (\> 6 months)
* Age 18 years and older.
* ASIA score: AIS A or AIS B.
* Ability to provide informed consent and follow study procedures.
* Weight below 100 kg.
* Height between 165 - 195 cm. (PI can decide to include participants outside of this range. The IFU specifies an EXTENDED range of 160 - 200 cm with certain conditions.)

Exclusion Criteria:

* Severe contractures in the lower limbs.
* Spasticity greater than 2 according to the Modified Ashworth Scale (MAS).
* Autonomic dysreflexia.
* Spinal instability.
* Untreated deep vein thrombosis.
* Untreated fractures of the pelvis or limbs.
* Advanced osteoporosis.
* Complete tetraplegia.
* Lack of upper limb control grade 3 or less, according to the ASIA test.
* History of fracture due to osteoporosis.
* Medication that increases the chance of fracture.
Colonisation of Scalp by Topical Probiotic Micrococcus Luteus Q24

The purpose of this study is to evaluate the skin quality improvement and colonization efficacy following the application of probiotic Micrococcus luteus Q24 (BLIS Q24) to the scalp from a serum format in healthy adults.

This is a randomized double-blind baseline controlled pilot study with no crossover for the assessment of any changes to the microbial make-up of the skin (The local skin microbiome), detection of colonization by the probiotic bacterium (BLIS Q24) on the skin on the scalp and to evaluate the changes in skin quality parameters following topical application of probiotic in a serum format.

Eligibility Criteria:
Inclusion Criteria:

1. In general, good health, is 18 - 80 years of age.
2. Practice good general body and hair hygiene.

Exclusion Criteria:

1. Have a history of autoimmune disease or are immunocompromised (have a weakened immune system).
2. Free from any scalp disease, active cut, or open wound
3. On hair loss treatment at least 2 months prior to sampling.
4. Have used anti-dandruff shampoos on the scalp and hair for at least 1 week prior to the trial.
5. On concurrent antibiotic or antifungal therapy or regular antibiotic or antifungal. use within the last 1 week.
6. People with allergies or sensitivity to dairy.
Neurofeedback Training for Older Adults With Mild Cognitive Impairment: a Protocol Study

This is a non-pharmacological study evaluating the effects of SMR/delta ratio and beta1/theta ratio neurofeedback trainings on cognitive performance and electrical brain activity in elderly with mild cognitive impairment.

Older adults with Mild Cognitive Impairment (MCI) are at high risk to progress to Alzheimer's disease (AD). Slowing down effect of dementia by enhancing brain plasticity represents one of the most prominent challenges. Neurofeedback is one of the promising techniques that showed therapeutic efficacy and cognitive improvement in attention-deficit hyperactivity disorder, epilepsy, stroke. We aim to study the effects of two neurofeedback training protocols, SMR/delta ratio and beta1/theta ratio, on cognitive performances in older adults with Mild Cognitive Impairment and to assess whether MCI patients change in brain electrical activity in a resting state after training.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Mild Cognitive Impairment
* MMSE score \>24
* Subjective memory complaint confirmed by an informant.
* Perform at/or below 1.5 standard deviations from the mean for age and education-matched norms on more than one of the neuropsychological tests.
* Preserve activity of daily living
* Absence of dementia.

Exclusion Criteria:

* Psychiatric and neurological disorders
* History of alcohol or other substance consumption
Clinical and CPET Parameters That Predict Improvement in Functional Capacity After TAVI

Determining Clinical and Cardiopulmonary exercise testing Parameters that may predict Improvement in Capacity After Transcatheter Aortic Valve Implantation

Transcatheter Aortic Valve Implantation (TAVI) has emerged as a less invasive alternative to surgical aortic valve replacement, especially for high-risk patients. However, existing research on functional outcomes after TAVI has yielded mixed results. To our knowledge, the potential functional benefit of TAVI has not been well explored using cardiopulmonary exercise testing (CPET). The present study aims to 1) characterize the mid-term exercise tolerance response to TAVI, and 2) determine the clinical (symptoms, frailty, quality of life, etc.) and functional factors (parameters derived from CPET) that determine the magnitude of this response. A positive functional response to TAVI will be considered as an increase in VO2 max \> 2.5ml/kg/min or \>10% of its baseline value one month post-TAVI. The exercise test will be conducted by a physiotherapist and supervised by a physician using a standard incremental cardiopulmonary exercise testing on cycle ergometer (Ergoline 900, Ergoline, Bitz, Germany (CE-0123) and Ergocard Professional, Medisoft, Sorinnes, Belgium (CE-1434)). To this end, 161 patients with severe aortic stenosis scheduled for TAVI will be included in 3 expert centres. They will be evaluated clinically and functionally (incremental CPET) in the 2 weeks prior to the procedure and 4-6 weeks after.

Eligibility Criteria:
Inclusion Criteria:

* All those patients ≥ 18 years of age with severe aortic stenosis approved for transfemoral TAVI.

Both sexes, male and female will be included in the study.

Exclusion Criteria:

Very severe aortic stenosis, defined as a valve area of ≤0.6 cm2

, mean gradient ≥60 mmHg or Vmax \>5 m/s

* Previous syncope
* Proven exercise-induced arrhythmias
* Previously known dynamic left ventricular outflow tract (LVOT) obstruction, defined as LVOT gradient of ≥ 30 mmHg by echocardiography
* Concomitant coronary artery disease pending percutaneous coronary intervention
* Inability to consent
* Physical limitation to perform an exercise test
* Non-elective procedure
* Valve-in-valve procedure