cyrilzakka/clinical-trials huggingface dataset:
Cognitive Behavioral Therapy for Depression Relapse Prevention in Children and Adolescents

This study will determine the effectiveness of cognitive behavioral therapy in preventing a relapse of depressive symptoms in children.

Depression is a chronic and episodic condition that may have devastating effects on social and emotional functioning, particularly in the pediatric population. While approximately 90% of children eventually recover from an episode of depression, up to 40% of those children relapse within 1 to 2 years. Data indicate that cognitive behavioral therapy (CBT) delivered after depressive symptoms subside can significantly reduce depression relapses in adults. However, there are no comparable studies in children or adolescents. This study will determine whether CBT is effective in reducing a relapse of depressive episodes in children and adolescents with major depression.

This study comprises two phases. In Phase 1, all participants will receive drug treatment for 12 weeks. Participants who respond to the treatment will complete the study after 12 weeks. Participants whose depression symptoms return after 12 weeks will be enrolled in Phase 2. In Phase 2, participants will be randomly assigned to either continue drug therapy alone or to receive drug therapy plus CBT for 6 months. The CBT will focus on teaching participants skills to manage depressed moods and to identify situations which might put them at risk for a relapse in depressive symptoms. Self-report scales will be used to assess the depressive symptoms of participants who complete Phases 1 and 2 at study entry and at the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of nonpsychotic major depressive disorder at least 4 weeks prior to study entry
* Clinical Global Impression severity score of 4 or greater
* Children's Depression Rating Scale score of 40 or greater
* Currently attending school
* Willing and able to use acceptable methods of contraception, if applicable
* In good general health
* Parent or guardian willing to provide informed consent, if applicable

Exclusion Criteria:

* History of psychotic disorders
* Alcohol or substance abuse or dependence within 6 months prior to study entry
* History of anorexia nervosa or bulimia
* Chronic medical illness requiring regular medication
* Current use of medication with psychotropic effects
* First-degree relatives (e.g., mother, father, sister, brother) with bipolar I disorder
* At risk for suicide
* Failure of a previous adequate treatment with fluoxetine (defined as at least 40 mg/day for 4 weeks)
* IQ less than 80
* Pregnancy or breastfeeding
Evaluation of the Impact of Embryo Biopsy on the Reproductive Potential of Embryos Undergoing In Vitro Fertilization (IVF)

To assess the impact of embryo biopsy on the reproductive potential of human embryos.

This study will recruit patients from the NY/NJ/CT/eastern PA area only.

All patients will undergo an in vitro fertilization (IVF) cycle with hormonal stimulation and an egg retrieval procedure as deemed appropriate for their diagnosis. Following biopsy, the embryos will be transferred. There will be no delay in the time of transfer as no cells will be analyzed prior to transfer.

On day 3 or day 5 of embryo development, all patients will undergo a two (2) embryo transfer. The embryos selected for transfer will be the 2 morphologically best of the embryo cohort. Once selected for transfer, the embryos will be randomized so that one will be biopsied and the other will be transferred without undergoing biopsy. The embryo randomized to biopsy will have a single cell biopsied.

Following delivery, buccal swabs will be collected from infants.

Eligibility Criteria:
This study will recruit patients from the NY/NJ/CT/eastern PA area only.

Inclusion Criteria:

1. Maximum of one prior failed IVF treatment cycle
2. Female partner less than 35 years of age
3. Normal day 3 FSH level (\<10 miu/mL)
4. Total basal antral follicle count greater than or equal to 12
5. Male partner with greater than 100,000 total motile spermatozoa and at least 1% normal forms
6. Body mass index (BMI) \< or = 32
7. Normal uterine cavity

Exclusion Criteria:

1. Diagnosis of chronic anovulation secondary to polycystic ovarian disease
2. Diagnosis of endometrial insufficiency
3. Clinical indication for pre-implantation genetic diagnosis (PGD) (undergoing IVF with PGD to rule out a known genetic defect)
4. Use of testicular aspiration or biopsy procedures to obtain sperm
Optimizing the Influenza Clinical Decision Support Tool

The proposed study aims to examine several iterations of the Influenza Best Practice Alert at NYU Langone Health. The goal is to increase ordering of the influenza vaccine through the alert.


Eligibility Criteria:
Inclusion Criteria:

* All NYU Langone Health inpatients eligible for the Influenza clinical decision support tool

Exclusion Criteria:

* N/A
Safety of Transcranial Direct Current Stimulation in Pediatric Hemiparesis

The primary objective of this proposal is to investigate the safety of use of transcranial Direct Current Stimulation (tDCS)in children with hemiparesis.

The research question, "Is transcranial Direct Current Stimulation safe for use in children with congenital hemiparesis?" relates to two hypotheses:

1. tDCS will not produce a major adverse event, including seizure activity.
2. No change in paretic or nonparetic hand function or cognitive status will occur.

Completing a pilot safety study is paramount to the future goal of incorporating the tDCS pediatric safety data and combining tDCS and rehabilitation with constraint-induced movement therapy in order to improve motor outcomes beyond what rehabilitation therapies alone can provide and enhance quality of life for these children with hemiparesis.

Eligibility Criteria:
Inclusion Criteria:

1. Congenital Hemiparesis confirmed by most recent MRI or CT radiologic report.
2. Hemispheric Stroke or Periventricular Leukomalacia
3. Ages 8-17 years old
4. ≥ 10 degrees of active motion at the metacarpophalangeal joint
5. Adequate receptive language function to follow two-step commands as evidenced by performance on TOKEN test of intelligence
6. No evidence of seizure activity within the last 2 years.
7. Subject is able to give informed assent and providing a signature, along with the informed consent signature of the legal guardian as evidenced by signature.

Exclusion Criteria:

1. Metabolic Disorders
2. Neoplasm
3. Epilepsy
4. Disorders of Cellular Migration and Proliferation
5. Acquired Traumatic Brain Injury
6. Expressive Aphasia
7. Pregnancy
8. Indwelling metal or incompatible medical devices
9. Evidence of skin disease or skin abnormalities
10. Botulinum toxin or phenol intramuscular block within the one-month preceding tDCS
Pilot Study of Virtual Reality for Providing Exposure Therapy to Children

Drs. from the Mayo Clinic Rochester will plan and execute a feasibility study of the phase I prototype version of the Virtual Reality exposure therapy system. Dr. X, who has significant experience in evaluating patient experiences and opinions of technologies intended to change behavior, will oversee a qualitative study to examine the prototype system. Twenty children with generalized anxiety disorder with perfectionism who have received less than 3 treatment sessions and a parent will be recruited to pilot the Virtual Reality system.

Twenty children with generalized anxiety disorder (perfectionism) who have received less than 3 treatment sessions and a parent will be recruited to pilot the Virtual Reality system. Participants will be identified through the Mayo Clinic Pediatric Anxiety Disorders Clinic (PADC) using purposive sampling methods. Each patient will participate in a single (up to) 2-hour visit, allowing for breaks as needed. Staff from Mayo Clinic HealthCare Policy \& Research experienced in qualitative data analysis and not involved with the patients' medical care or development of the prototype system will conduct the study visits. During the first 30 minutes the patient and parent will be introduced to the Virtual Reality system and the rationale for this feasibility study. Next, a therapist from the PADC, all of whom are experienced exposure therapists, will lead the patient through exposure exercises using the Virtual Reality system for up to 30 minutes. During the next period, up to 30 minutes, the therapist will go to a different room and the patient, with support from their parent, will complete exposure exercises using the Virtual Reality system that the therapist directed them to complete. During the exposures the interviewer will observe, code and record the patient's interaction with the Virtual Reality system. The data from the Virtual Reality system will be automatically transmitted to a cloud service running on a local laptop to study the effectiveness of the system's automatic logging capabilities. For the remaining time (up to 30 minutes) the interviewer will interview the patient about his or her experience with the Virtual Reality system and then will ask for observations and opinions from the parent.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of Generalized Anxiety Disorder with perfectionism and have received less than three treatment sessions

Exclusion Criteria:

* too young to safely and effectively participate with the study materials
Evaluation of Two Methods of Administration of Photobiomodulation in the Context of the Prevention and Treatment of Mucositis Induced by Radiotherapy, During the Treatment of Head and Neck Cancers

The aim of this feasibility, prospective, single-center trial is to compare an intra-oral Photobiomodulation (PBM) via the Caremin650TM device (NeoMedLight) and a transcutaneous PBM via the ATP 38® device (Swiss Bio Innov) in patients treated with radiotherapy or chemoradiotherapy for cancer of the oropharynx or oral cavity. PBM session will be carried out first at the rate of two sessions per week for preventive purposes, and then, in case of occurence of grade 1 mucositis, three sessions per week with curative purpose.

Oral mucositis (OM) is defined as damage to the mucosa of the oral cavity; it can be due to chemotherapy or radiotherapy. The incidence of OM is 59 to 100% according to studies in patients with oral cavity or oropharyngeal cancer receiving radiotherapy.

Clinically, OM is characterized by erythematous changes in the mucosa, which can progress to oral ulcerations. It can significantly alter the quality of life, the ability to eat, cause weight loss in patients and interfere with the proper realization of anti-tumoral treatment. Additionally, OM may increase the risk of bacteremia and sepsis in immunocompromised patients.

So far, effective management strategies for OM and associated pain are still insufficient. A wide variety of topical and oral agents are available, but effectiveness is still lacking.

Photobiomodulation (PBM) therapy involves the application of visible or infrared light produced by laser diodes or light-emitting diodes (LEDs) to stimulate wound healing, reduce inflammation, and decrease pain.

PBM can be performed in two main ways: intraoral and transcutaneous. Intraoral PBM involves applying red or near-infrared light directly in contact with the oral mucosa, while transcutaneous PBM involves the application of infrared radiation to the skin. Both techniques have shown their effectiveness. Numerous trials have evaluated the impact of PBM in radiomucositis but its use in clinical practice is to date not widespread and heterogeneous.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient (18 years old and older);
* Patients with oral cavity or oropharynx cancer treated with radiotherapy or chemo-radiotherapy;
* Karnofsky Performance Status \> 60%;
* Able to understand French;
* With signed informed consent;
* Affiliated to French Health Security Insurance

Exclusion Criteria:

* Allergy to polyurethanes;
* Head and Neck tumors that are localized to other sites than oral cavity or oropharynx
* Previous irradiation of Head and Neck (whatever the time lapse between the two irradiations)
* Pregnant and breastfeeding woman;
* Patients with pacemaker device
* Epileptic patients;
* Concomitant treatment or treatment within the 7 days before inclusion with one of several drugs from the following list: fluoroquinolones, cycline, methotrexate, auranofin
* Patients with ophthalmic diseases (such as maculopathy, retinopathy, glaucoma and cataract, retinal damage)
* Patients under judicial protection
A Study of Computed Tomography (CT) for Evaluation of Coronary Artery Blockages in Typical or Atypical Chest Pain

To compare computed tomography (CT) images (pictures) of the coronary arteries using the General Electric (GE) LightSpeed VCT scanner with x-ray coronary angiography in patients with typical or atypical chest pain suspected of coronary artery disease (CAD).


Eligibility Criteria:
Inclusion Criteria:

* The subject has typical or atypical chest pain suspected of CAD and is referred for an elective coronary angiography.
* The subject must be scheduled to undergo a CATH procedure between 48 hours and 3 weeks post CCTA procedure.
* The subject must not undergo any cardiac interventional treatment between the 2 procedures.
* The subject must have sinus rhythm with stable heart rate of ≤65 beats per minute (bpm) or if heart rate was \>65 bpm, the subject must agree to the use of beta-blocker(s) prior to the CT scan procedure to achieve stable heart rate of ≤65 bpm.

Exclusion Criteria:

* The subject had an established diagnosis of CAD by a) previous CATH, b) prior myocardial infarction confirmed by ECG, or c) prior revascularization (balloon angioplasty, stent placement, or CABG).
* The subject had a known allergy to iodinated contrast agent, including but not limited to hives, anaphylactoid or cardiovascular reactions, laryngeal edema and bronchospasm.
* The subject had impaired renal function with a serum creatinine level of 1.7 mg/dL (150 μmol/L) or above.
* The subject had atrial fibrillation/flutter or any irregular heart rhythm considered by the investigator to interfere with temporal acquisition of cardiac CT images.
* The subject had a resting heart rate of \>100 bpm and/or a resting systolic blood pressure of \<100mm Hg.
* The subject had an artificial heart valve(s).
* The subject has had prior pacemaker or internal defibrillator lead implantation.
* The subject's resting heart rate was \>65 bpm and beta-blocker therapy was contraindicated.
* The subject had a contraindication to verapamil when beta-blocker therapy could not be administered. The subject had a contraindication to nitroglycerin.
* The subject had evidence of ongoing or active clinical instability.
Advice vs Advice + Exercise vs Advice + Exercise + Injection for Individuals With Plantar Fasciopathy

The purpose of this trial is to investigate the efficacy of fundamental patient advice and a heel cup versus fundamental patient advice and a heel cup plus heavy-slow resistance training versus fundamental patient advice and a heel cup plus heavy-slow resistance training and an ultrasound-guided corticosteroid injection in improving the Foot Health Status Questionnaire pain domain score in individuals with plantar fasciopathy after 12 weeks.

This trial will be designed as a randomised, data analyst-blinded, superiority trial, with a 3-group parallel design to be conducted in Aalborg, Denmark. Reporting of the trial will follow CONSORT guidelines and TIDieR for intervention description. Reporting of the protocol will follow the SPIRIT statement. The planning of the trial is done in accordance with the PREPARE Trial guide.

Participants will be stratified by sex and block randomised in block sizes of 3 to 12 (1:1:1) into 3 parallel groups of 60 participants using a random number generator on www.sealedenvelope.com. The block sizes will be random and concealed to the research assistants responsible of including participants. Group allocation will be coded, and the data analyst will be blinded to this code until after the analyses have been performed.

The investigators will only conclude superiority of one intervention over the other if the intention-to-treat analysis leads to mean between-group differences of the Foot Health Status Questionnaire pain domain ≥14 points (minimally important difference) and P-values \<0.05 at the primary endpoint (12 weeks) after adjustment for the baseline value.

Eligibility Criteria:
Inclusion Criteria:

* history of inferior heel pain for at least three months before enrolment
* pain on palpation of the medial calcaneal tubercle or the proximal plantar fascia
* thickness of the plantar fascia of 4.0 mm or greater as measured by ultrasonography
* mean heel pain of ≥30 mm on a 100 mm VAS during the previous week

Exclusion Criteria:

* below 18 years of age
* diabetes
* history of inflammatory systemic diseases
* pregnancy or breastfeeding
* corticosteroid injection for plantar fasciopathy within the previous six months
* pain or stiffness in the 1st metatarsophalangeal joint to an extent where the exercises cannot be performed
* known hypersensitivity to corticosteroids or local anaesthetics
* skin or soft tissue infection near the injection site
* received treatment by a healthcare professional for plantar fasciopathy within the previous 12 weeks
* made any substantial changes to usual self-care of the condition in the last 4 weeks (e.g. started using insoles, started performing stretching, made a substantial decrease in physical activity level)
A Study of Ribavirin in Combination With PEGASYS (Peginterferon Alfa-2a (40KD))in Patients With Chronic Hepatitis C

This single arm study will evaluate the safety and tolerability of ribavirin in combination with PEGASYS in patients with chronic hepatitis C. Patients will receive ribavirin 800mg, or 1000-1200mg po daily, according to HCV genotype and body weight (\< and \>75kg)in combination with PEGASYS 180micrograms sc weekly. The anticipated time on study treatment is 3-12 months, and the target sample size is \>500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* serological evidence of chronic hepatitis C;
* detectable serum HCV-RNA;
* liver biopsy findings consistent with a diagnosis of chronic hepatitis C.

Exclusion Criteria:

* history or other evidence of a medical condition associated with chronic liver disease other than HCV;
* co-infection with active hepatitis A or B;
* hepatocellular carcinoma;
* patients with severe cardiovascular disease whose condition may worsen due to acute anemia.
Transitional Care Model for Patients With Stroke

Patients with stroke benefitted from superior improvements in physical function, particularly when performing activities of daily living, fewer visits to the emergency room, less depression symptoms, and improved health-related quality of life thanks to transitional model care. Despite widespread implementation of transitional care for stroke patients, intervention effectiveness remains inconclusive, and another concern with transitional care for patients is the scarcity of effects on specific findings.

A stroke may be a profound and life-changing occurrence for both the survivors and those who care for them, mandating participation in the adaptation and reinvention of a new post-stroke lifestyle that is sometimes unpredictable and temperamental. The sudden onset of a stroke and its accompanying treatment in an acute hospital setting can be distressing for both patients and caregivers. Admission after stroke may have a profound impact as patients and their caregiver start to understand the effects of the occurrence, which is scary, puzzling, and stressful. Nonetheless, adjusting to situations or life after a stroke might be made easier by implementing relevant and timely strategies throughout hospitalization, discharge, and the post-discharge period. Both populations, stroke patients and caregivers, may have unmet needs once the patients are discharged at home, such as communication, recovery plan and process, medicine, emotional needs, and stroke information, as well as social involvement. To address unmet needs after discharge from the hospital to a variety of settings, such transitional care is recommended to tackle the adverse outcomes.One of the widely used transitional care models is TCM, which was developed at the University of Pennsylvania under the direction of a nurse and was then made available to patients who were elderly at risk of poor outcomes and suffering from chronic illnesses including stroke patients. Incorporated into the model, TCM were developed to meet the needs that arose during hospitalization and to provide continuity of care for patients, including those with stroke, who were unable to receive it after their acute illness treatment

Eligibility Criteria:
Inclusion Criteria:

* Being at least 18 years old, being admitted in neurology department for at least 24 to 48 hours,
* Not having cognitive impairment as measured by the Montreal cognitive assessment (score ≥ 23),
* Being able to communicate in Indonesia, having the ability to provide informed consent,
* Being willing to participate in this study during hospitalization and 8 weeks after hospital discharge

Exclusion Criteria:

* Have potentially biased information, such as being unable to provide informed consent due to cognitive impairment,
* Having major speech and language problems or aphasia that prevent them from participating in the study,
* Having serious psychiatric disorders or other with terminal disease requiring active treatment, and
* Being discharged to a nursing home or welfare institution.