cyrilzakka/clinical-trials huggingface dataset:
The Bioavailability of Polyacetylenes From Carrots Study

Polyacetylenes, compounds found naturally in carrots, have shown promising anti-cancer and anti-inflammatory actions in vitro but have not been tested in vivo. To determine whether the polyacetylenes could have an effect in vivo, this study aims to determine whether they are detectible in human biofluids after the consumption of a portion of carrots and whether a difference is seen between a large and small portion.

Volunteers will collect urine samples 24 hours prior to the 'test' day and a stool sample either the night before or the morning of the test session. They will have fasted blood taken before eating a portion of carrots with bread and butter. Further blood samples will be taken at 0.5, 1, 2, 3, 4, 6, 8 and 24 hours. All urine and all stool samples (after 4 hours) will be collected up to 48 hours after the carrot dose. They volunteers will attend two test sessions and will be randomised to receive high and low doses of carrot. At least a week will separate testing sessions.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults, BMI between 18.5 and 30

Exclusion Criteria:

* Metabolic or gastrointestinal conditions, allergies to carrot or bread, taking any medication that affects metabolism or digestion, smokers
Registry Experience at the Washington Hospital Center, DES - Endeavor for Myocardial Infarction

Single-center registry of patients treated with at least one Endeavor, zotarolimus-eluting, Stent as the primary treatment for acute coronary syndrome at the Washington Hospital Center, with the aim of assessing clinical success and safety at 30 days, 6 months and annually for up to 3 years post Endeavor Stent implantation.

Interventional cardiology was revolutionized by the invention of stents, initially with the bare-metal stents (BMS) and recently with the drug-eluting stents (DES).Zotarolimus-eluting stents have shown promising results in randomized clinical trails, demonstrating a reduction of clinical and angiographic restenosis in comparison to BMS, and comparable clinically-driven target lesion revascularization rates in comparison with Sirolimus-eluting stents. While short-term and 1 year registry data is available from outside of the United States, it will be important to collect "real-world" data regarding the stent usage and outcomes in the United States. In this study we propose to follow patients who received at least one Endeavor® Stent as primary treatment for ACS for up to 3 years post initial stent implantation.

Eligibility Criteria:
Inclusion Criteria:

* Patients, male or female, \>18 years of age
* Patients presenting with acute coronary syndrome (ACS), where ACS is defined as ST segment deviation of \>1mm or an elevation of the isoenzymes greater than 2x upper limit of normal
* Patients who received at least one Endeavor drug-eluting stent at the Washington Hospital Center

Exclusion Criteria:

* N/A
Longitudinal, Prospective, French, Multicenter Cohort Study on Pancreatic Radiofrequency

The purpose of the study is to evaluate the oncological efficacy of pancreatic radiofrequency by the objective response rate (complete and partial responses according to RECIST 1.1.), 5 years after the end of treatment.

This is a prospective, longitudinal, open, non-randomized, non-interventional, multicenter study on ultrasound-guided radiofrequency endoscopy for the treatment of pancreatic tumours. The study will be offered prospectively to all patients in need of treatment. They will be taken care of in accordance with current practice.

The patient will be seen again 7 times after the end of the pancreatic radiofrequency (which will include one or two sessions): the follow-ups will be done according to current practice on D15 ± 7 days, M6 ± 14 days, M12 ± 1 month then annually until M60 ± 1 month.

The study consists to evaluate the oncological efficacy at 5 years of pancreatic radiofrequency delivered by means of a needle guided by ultrasound endoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old;
* Patient to be treated for a pancreatic tumor by ultrasound-guided RF with a fine needle;
* Indication of pancreatic radiofrequency validated in a Multidisciplinary Consultation Meeting;
* Patient able to understand the information related to the study;
* Patient accepting study follow-up visits;
* Patient having been informed and agreeing to participate in the study.

Exclusion Criteria:

* Patient with a contraindication to radiofrequency treatment;
* Pregnant or breastfeeding women
Close Assessment and Testing for Chronic Graft Versus Host Disease, CATCH Study

This trial observes and collects samples from patients before and after stem cell transplantation to learn more about how and why a complication called chronic graft-versus-host disease (GVHD) develops after stem cell transplantation. Performing close observation and various types of testing may enable doctors to notice symptoms or problems sooner than they would normally have been noticed and predict which patients will develop chronic GVHD.

OUTLINE:

Patients undergo collection of tears, saliva, buccal mucosa, and fecal samples before stem cell transplant, at 2-3, 4, 6, 8, 10, and 12 months after stem cell transplant, and at cGVHD onset. Patients also undergo collection of blood samples before stem cell transplant, at 1-2, 2-3, 4, 6, 8, 10, and 12 months after stem cell transplant, and at cGVHD onset. Patients may undergo skin and mouth biopsy over 15-30 minutes before stem cell transplant, at 2-3 and 12 months after stem cell transplant, and at cGVHD onset. Patients undergo digital pictures of the eyes, mouth and skin, and optical coherence tomographybefore stem cell transplant, at 2-3, 4, 6, 8, 10, and 12 months after stem cell transplant, and at cGVHD onset. Patients without standard of care formal pulmonary function test undergo portable spirometry at 2-3, 4, 6, 8, 10, and 12 months after stem cell transplant, and at cGVHD onset. Patients also complete surveys and have their medical records reviewed.

After completion of study, patients are followed up periodically.

Eligibility Criteria:
Inclusion Criteria:

* Adults age 18 or older
* Scheduled for allogeneic HCT from any donor for any indication, with a risk of cGVHD of \> 25% (see below in exclusion criteria for treatment plans with a cGVHD risk \< 25%)
* Ability and willingness to comply with the intensive assessment schedule including evaluation every other month at a participating site
* Ability to communicate in English or Spanish, to allow completion of patient surveys and clear communication with the study team

Exclusion Criteria:

* Receipt of umbilical cord blood, bone marrow with post-transplant cyclophosphamide (peripheral blood with post-transplant cyclophosphamide is allowed), anti-thymocyte globulin, alemtuzumab, or ex-vivo T-cell depletion. These patients are excluded because they have a cGVHD risk of \< 25%
* Hematologic malignancy with active disease at the time of transplant. Minimal residual disease is allowed
* Hematopoietic cell transplant co-morbidity index \> 4 based on parameters known at time of enrollment
* Prior allogeneic transplant
* Prior autoimmune disease with ongoing symptoms
* History of noncompliance
* Inability to comply with study requirements due to geographic, logistic, social or any other factors
An Integrated Treatment for Comorbid PTSD and Substance Abuse in Adolescents

This study plans to develop an integrated treatment for comorbid post-traumatic stress disorder (PTSD) and substance abuse (SA) in adolescents. The investigators aim to develop a treatment approach that is community-friendly, well-tolerated, and deliverable by substance abuse counselors (SAC) in outpatient settings. The proposed Trauma-Focused Substance Abuse Treatment (TFSAT) aims to reduce PTSD symptoms and substance use and build coping skills. The investigators propose to adapt an evidence-based trauma program, Cognitive-Behavioral Intervention for Trauma in Schools (CBITS), for adolescent substance abusers (ASAbusers); to assess the acceptability and feasibility of the integrated approach; and to pilot test the new program against standard care.

The investigators hypothesize that the intervention group, compared to the control group, will reduce substance use and symptoms for traumatic stress.


Eligibility Criteria:
Inclusion Criteria: Youth

* Between ages of 13 \& 19;
* meeting DSM IV criteria for substance abuse/dependence and PTSD;
* previously enrolled at recruitment site for at least 2 weeks;
* parent/guardian provides permission for minors to participate.

Exclusion Criteria: Youth

* Not within the specified age range;
* presence of organic brain damage;
* inability to understand enrollment forms (e.g. Informed Assent/Consent Form)

Inclusion Criteria: Parents/Guardians

* Age 18 or above;
* parents/guardians of youth who meets inclusion criteria.

Exclusion Criteria: Parents/Guardians

* presence of organic brain damage.
Prospective Intervention Study to Improve HRQoL and Exercise Tolerance After Heart Transplantation

A prospective, interventional rehabilitation program was initiated to improve exercise tolerance and psychosocial functioning in patients after heart transplantation (HTx) and to evaluate long-term effects on health-related quality of life (HRQoL).Study subjects were randomized to either intervention or to control group and were followed with regular cardiopulmonary exercise testings and HRQoL measurements (SF-36) for 36±3 months after HTx. Patient characteristics did not differ concerning age, gender, and diagnosis at study entry. IG patients received regular psychosocial support and performed a home-based supervised ergometer training program. CG patients were recommended to perform regular exercising.


Eligibility Criteria:
Inclusion Criteria:

Heart transplant (6-9 mts post Tx) stabile health condition at study entry (pt stays within home environment)

* Age ≥ 18 yrs
* Sufficient language skills to answer questionnaire
* Follow-up at our center
* Willingness to participate by written informed consent

Exclusion Criteria:

* TVP diagnosis before study inclusion
* Episodes of recurrent acute rejections
* Medical contra-indication for regular exercise ergometer training
* Malignancy
Efficacy, Safety, and Tolerability of Eslicarbazepine Acetate in the Recurrence Prevention of Bipolar I Disorder

This was an extension study consisting of 2 parts. In Part I, all participants received open-label treatment with BIA 2-093 900 mg once daily for 2 weeks. Part II followed a double-blind, parallel-group design in which participants were randomly assigned to treatment with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily. Patients stable in remission continued double-blind therapy until approximately 6 months after the last patient entered Part II.

The occurrence of a new manic/depressive episode was considered a treatment failure, and the patient was discontinued from the study. At the end of Part II, 6 months after last patient enrolled and after no longer than approximately 15 months, if patients were still in remission and the investigational product was well-tolerated, patients had the option to enter long-term open-label treatment at the same dosage as used in Part II until a new episode occurred, until marketing was authorized, or until clinical development of BIA 2-093 in the recurrence prevention indication was discontinued. If patients did not enter long-term treatment, an established recurrence prevention medication was prescribed, and BIA 2-093 was tapered off (patients assigned to 1800 mg had the daily dose decreased to 900 mg for 6 days; those assigned to 900 mg or 300 mg received placebo for 6 days).

Eligibility Criteria:
Inclusion Criteria:

* signed the Informed consent form (ICF)
* completed the 3-week treatment period in Protocol with identification number SCO/BIA-2093-203 or Protocol with identification number PRA/BIA-2093-204 and shown response to treatment, defined as ≥ 50% improvement in the Young Mania Rating Scale (YMRS) total score or a YMRS total score \< 12
* presented a serum pregnancy test (in cases of women of childbearing potential) consistent with a non-gravid state and used double-barrier contraception throughout the study

Exclusion Criteria:

* relevant electrocardiogram (ECG) or laboratory abnormalities
* any uncontrolled clinically relevant disorder
* uninsured capability to comply with the study protocol
Innovative Robotic Gait Trainer Use to Enable Walking in Children With Cerebral Palsy GMFCS III and IV

Exploration to optimize mixed quantitative and qualitative methodology using multiple outcome measures in a randomized, cross-over trial structure comparing the effect of robotic gait training (RGT) group, and functional clinical therapy (FCT) using each subject as their own control.

Exploration to optimize mixed quantitative and qualitative methodology using multiple outcome measures in a randomized, cross-over trial structure comparing the effect of robotic gait training (RGT) group, and functional clinical therapy (FCT) using each subject as their own control.

The primary objective is to assess feasibility of the study design and device tolerability. Specifically:

* Recruitment success (number screened, number eligible, number enrolled) where 80% of the recruitment target is reached.
* Attrition rates of less than 10% (i.e. ≥90% of participant's successfully complete assessments).
* Adherence for each participant: 80% of participants who complete assessments achieve the minimum target dose (i.e. approx. ≥30 hours of therapy in both study groups).
* Qualitative feedback from clinicians and patients/caregivers on device tolerability and study participation.

Secondary objectives will evaluate the distance a child can walk in two minutes using the Two Minute Walk Test (2MWT, 18) and will examine a more global impact of the use of this technology. Data collected will include quality of gait, child or proxy chosen individualized goals, hypertonicity, contractures, and bone health.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of cerebral palsy
* GMFCS Levels III and IV
* Ages ≥2 to ≤12 years
* Ability to take steps with and/or without assistance
* Meet the Trexo Plus device size requirements
* Ability to follow instructions and signal pain, fear, or discomfort
* Ability to safely use the device at home as determined by the study team

Exclusion Criteria:

* Lower limb or orthopedic surgery within 9 months prior to enrollment
* Botulinum toxin injections within 4 months prior to enrollment
* Serial casting within 3 months prior to enrollment
* Knee flexion contracture \> 20°
* Knee valgus \> 40°
* Hip subluxation \> 40 % migration percentage
* Uncontrolled movements that prevent transfer in and/or out of device
* Weight bearing restrictions
* Uncontrolled seizures
* Skin lesions in areas where the device straps would be attached
* Significant language barrier with parents and/or caregivers Note: children with severe contractures will be unable to fit in the device and are therefore excluded from the study
Determine The Percentage Of Depressed Outpatients Who Do Not Effectively Metabolize Extended-release Venlafaxine HCl

This is a study to determine the percentage of patients with depression who are treated with extended-release venlafaxine HCl (U.S. marketed brand Effexor XR®) who are Poor Metabolizers (based on the levels of the drug in the blood) at 2D6 (a system in the liver that breaks down some medications and other chemicals).


Eligibility Criteria:
Inclusion Criteria:

* Men and women subjects aged 18 years or older.
* Current outpatient treatment with extended-release venlafaxine HCl (U.S. marketed brand Effexor XR®), within the US Food and Drug Administration (FDA)-approved dosage range for depression (37.5 mg/day to 225 mg/day), for 8 weeks or less.
* Ability to have a blood draw within 4 to 12 hours of the most recent dose of Effexor XR®.

Exclusion Criteria:

* Determination by the investigator that a blood draw is contraindicated.
* Participation in an investigational study within the past 30 days where the study medication is not known.
* Previous treatment with Effexor XR® or extended-release venlafaxine HCl (generic) in the 6 months prior to current treatment regimen.
* Treatment with DVS SR within the last 30 days.
Project Attention Deficit Hyperactivity Disorder (ADHD) and Electroencephalography (EEG)-Neurofeedback THERapy

Background:

Electroencephalography (EEG)-neurofeedback has been shown to offer therapeutic benefits to patients with ADHD in several mostly uncontrolled studies with relatively small sample sizes. It is unknown how EEG-neurofeedback affects brain functioning and exerts therapeutic effects in ADHD. This study is designed to examine the efficacy and safety of EEG-neurofeedback in a scientific rigorously way and to study the underlying neurobiological mechanisms of EEG-neurofeedback.

Objectives:

1. To investigate the efficacy of EEG-neurofeedback in reducing behavioral symptoms of ADHD.
2. To investigate whether EEG-neurofeedback is able to improve neurocognitive functioning.
3. To investigate whether EEG-neurofeedback is able to improve neural functioning.

Study design:

Double-blind randomized placebo-controlled treatment study.Study population: 120 subjects with ADHD (age 8-15, IQ of 80 or more). Intervention: 60 subjects with ADHD receive 30 sessions EEG-neurofeedback, and 60 subjects with ADHD receive placebo EEG-neurofeedback.

Main study parameter: ADHD-DSM-IV rating scale, rated by the investigator.

Hypothesis:

The hypothesis is EEG-Neurofeedback can reduce symptoms of ADHD.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis ADHD, classified by the (Diagnostic and Statistical Manual of Mental Disorders, 2000)
* Age between 8 and 15
* A full scale IQ of more than 80
* Psychopharmaca- naïve or -free, or using a stable dosage of psychostimulants or atomoxetine but still with room for improvement (defined by an average score of more than 1 on ADHD-DSM-IV rating scale).
* Deviant EEG of more than 1.5 standard deviation compared to the database

Exclusion criteria:

* Currently intensive (i.e. weekly) individual or group psychotherapy
* Regular use of medication other than psychostimulants or atomoxetine
* Diagnosis of one or more of the following comorbid psychiatric disorders:
* Major depression
* Bipolar disorder
* Psychotic disorder
* Chronically motor tic disorder or Gilles de la Tourette
* Conduct disorder
* Autism spectrum disorders
* Eating disorders
* Neurological disorders (e.g. epilepsy) currently or in the past
* Cardiovascular disease currently or in the past
* Participation in another clinical trial simultaneously
* EEG-neurofeedback training in the past
* Use of alcohol or drugs
Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula

The main aim is to follow-up on long term side effect and symptom improvement of Darvadstrocel in the treatment of complex perianal fistula in adults. Participants will not receive any drug in this study.

The drug being tested in this study is called darvadstrocel (Cx601). Darvadstrocel is being tested to treat people who have complex perianal fistula in CD. This study will look at the long-term safety and efficacy of darvadstrocel in the treatment of complex perianal fistula in CD.

The study will enroll approximately 150 patients. Participants who received darvadstrocel or placebo in study ADMIRE-CD II (Cx601-0303, NCT03279081) and who have completed the 52 weeks of the study will be enrolled in this long-term extension study.

This multi-center study will be conducted worldwide. The overall time to participate in this study is 104 weeks (in addition to the 52 weeks on ADMIRE-CD II study). Participants will make multiple visits to the clinic and will be contacted by telephone every 3 months for a follow-up assessment. After unblinding of the ADMIRE-CD II study, the LTE study will be conducted as an open-label study. Participants will remain in the treatment group assigned in the ADMIRE-CD II study.

Eligibility Criteria:
Inclusion Criteria:

1. Has participated in and completed the ADMIRE-CD II (NCT03279081) study (i.e., did not discontinue).

Exclusion Criteria:

1. Has been more than 3 months since the participant completed the ADMIRE-CD II study.
Interest of Learning Self-hypnosis for Patients Awaiting Lung Transplantation

Patients benefitting from a lung transplantation are subject to long-lasting and often severe post-operative pain. Self-hypnosis has been proven effective in the management of acute pain.

The study hypothesis is that pre-operative training in self-hypnosis given to patients awaiting lung transplantation, will result in a reduction of post-operative pain one month after surgery.


Eligibility Criteria:
Inclusion Criteria:

* patients over 15 years of age
* indication of lung transplantation

Exclusion Criteria:

* patient unable to receive training in self-hypnosis (for cognitive, linguistic or cultural reasons)
Patient Education Program for Osteoarthritis With Exercise Included

The purpose of this study is to investigate if inclusion of exercise in an education program for patients with osteoarthritis can improve self efficacy, self-perceived health and function.

Osteoarthritis (OA) is a degenerative disease, considered to be one of the major national diseases that cause suffering for affected patients and costs for society.The predominant symptoms are pain, stiffness and impaired quality of life, often together with psychological distress. Treatment often consists of medication. Later in the disease, when the joint is destroyed, joint replacement surgery commonly occurs. Physical exercises aimed to increase muscle strength, endurance, proprioception and stability have proved to influence cartilage as well as function, symptoms and quality of life positively. Physical exercise may also reduce the need for hospital care after knee joint replacement.Research suggests that patient education is feasible and valuable in terms of improvements in quality of life, in function, in well-being and improved coping . Accordingly, guidelines recommend education and exercise as a core treatment for osteoarthritis.

Since 1994, Primary Health Care in Malmö has used a patient education programme directed towards OA.The program does not include exercise. In 2007-09 a study was made to investigate this education program.The study showed improvements in self-perceived health and in a few functional tests but not in self-efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of osteoarthritis

Exclusion Criteria:

* Must be able to speak and understand swedish