cyrilzakka/clinical-trials huggingface dataset:
Effects of Compassion Training to Patients Undergoing HSCT on Biological and Psychosocial Parameters

The hematopoietic stem cell transplant (HSCT) experience is emotionally and physically stressful for cancer patients who undergo this procedure. This study aims to evaluate the effects of Cognitively-Based Compassion Training (CBCT) on depression and anxiety symptoms, levels of resilience, hope and self-compassion in patients undergoing HSCT and their caregivers. As well as assessing the effects of CBCT on clinical conditions in patients and cortical activity and heart rate variability in caregivers.

The study hopes to show the positive effects of compassion training in patients and their caregivers.

Overall aim:

This study aims to evaluate the effects of Cognitively-Based Compassion Training (CBCT) on: depression and anxiety symptoms; levels of hope; resilience; mindfulness; self-compassion and quality of life. The study also aims to demonstrate whether CBCT training has any effect on clinical parameters of transplanted patients, as well as whether it has an effect on cortical activity and heart rate variability inpatients and caregivers.

Specific objectives:

1. Develop an adaptation of the CBCT protocol for hospitalized patients;
2. To evaluate the effect of CBCT on depressive and anxious symptoms in patients and their caregivers;
3. To evaluate the effect of CBCT on resilience, quality of life and self-compassion in patients and their caregivers;
4. Investigating the CBCT training results in altering the cortical activity of patients and caregivers while performing a recall task of recent autobiographical experiences;
5. Investigate whether CBCT training results in changes in heart rate variability in patients and caregivers;
6. To investigate whether CBCT training has any effect on patient's levels of symptoms, such as: pain, nausea, insomnia, among others;
7. To evaluate how correlations between psychosocial factors and biological markers: cortical activity and heart rate variability;
8. Evaluate perceptions and impressions of patients and caregivers on the protocol.

Eligibility Criteria:
Inclusion Criteria:

* patients referred for HSCT attended at Albert Einstein Hospital, as well as their respective caregivers.

Exclusion Criteria:

* history of severe psychiatric disorders and neurological diseases.
A Comparison of Activities of Daily Living, Physical Fitness and Quality of Life in Obese and Healthy Adolescents

It is known that activities of daily living, physical fitness, exercise capacity and quality of life are affected by the obesity. It is aimed to determine the effects obesity on daily living activities, physical fitness, exercise capacity and quality of life in obese adolescents compared to healthy subjects in this study. The relationship between these parameters and the activities of daily living which are less studied in obese adolescents will be evaluated.

Obesity among children, adolescents and adults has emerged as one of the most serious public health problems in the 21st century. There has been a significant decrease in the exercise capacity, physical fitness and activities of daily living of children and adolescents with the increase in the prevalence of obesity over the last decade. Obesity can cause not only health problems but also psychological effects. This situation have negative effects on the quality of life. The effect of these parameters on healthy individuals and obese adolescents will be demonstrated by this study and will guide the rehabilitation of obese adolescents.

Eligibility Criteria:
Inclusion Criteria:

Healthy group:

* Being normal weight according to BMI reference system,
* Being between the ages of 10-18 and volunteer to participate in the research,
* Being able to walk and cooperate

Obese Group:

* Obesity diagnosis according to BMI reference system,
* Being between the ages of 10-18 and volunteer to participate in the research,
* Being able to walk and cooperate.

Exclusion Criteria:

Healthy Group:

* Comorbidities that may affect exercise performance and other physical tests,
* Having cardiovascular problems, musculoskeletal and neurological disease,
* Having cognitive or motor limitation or other chronic diseases.

Obese Group:

* Having a neurological disease or other clinical diagnosis that may affect cognitive status,
* Having musculoskeletal and neurological diseases, symptomatic heart disease, lung disease, diabetes, hypertension and malignant disease that may affect exercise performance,
* Using medication that affects appetite and weight.
Effect of Increasing Motor Cortex Inhibition on Task Specific Dystonia

Dystonia is a disease where muscles in the affected body part are abnormally active. This may result in abnormal postures. The underlying mechanisms are not known. One proposed mechanism is located in the motor area of the brain that controls the coordination of muscles, called the motor cortex. It is well known that the motor area of one hemisphere of the brain (motor cortex) controls the movement of the opposite side of the body. When people perform tasks such as picking up an object or writing there are mechanisms in motor cortex that focus the level of activity so that they can do these tasks with a high level of precision. Focusing activity in motor cortex seems to be disturbed in people with dystonia. Transcranial magnetic stimulation (TMS) is a device that allows the non-invasive stimulation of the brain. When applied to the motor cortex it can upregulate or down regulate its activity. In the present study the investigators will conduct experiments on subjects with task specific focal hand dystonia (such as writers cramp) using TMS to decrease unwanted motor activity. The investigators will assess the effects of this intervention using objective, subjective and kinematic measures. This is a pilot study and will require further research to assess the long-term effects of repetitive TMS on task-specific focal hand dystonia.


Eligibility Criteria:
Inclusion Criteria:

* If you are treated with Botulinum toxin, the testing should be done at least 3 months after your last Botulinum toxin injections.
* Adult patients with task-specific dystonia strictly confined to one hand since the onset of symptoms
* No dystonic movements at rest
* Normal MRI scan of the brain as per clinical record
* No intake of CNS active drugs that may interfere with the study
* No contraindication for TMS
* Ability to perform the selective task
* No other neurological disease that may interfere with the study
* Ability to give informed consent

Exclusion Criteria:

* You have a history of migraines
* You have a diagnosed seizure disorder
* You take any Central Nervous System CNS active drugs, such as benzodiazepines, Lorazepam, Baclofen, SSRI's and other anti-depressants, etc. that may interfere with the response to TMS.
* You have any clips or implants in your head
* You have a pacemaker
The Duchenne Registry

The Duchenne Registry is an online, patient-report registry for individuals with Duchenne and Becker muscular dystrophy and carrier females. The purpose of the Registry is to connect Duchenne and Becker patients with actively recruiting clinical trials and research studies, and to educate patients and families about Duchenne and Becker care and research. At the same time, The Duchenne Registry is a valuable resource for clinicians and researchers in academia and industry, allowing access to de-identified datasets provided by patients and their families-information that is vital to advances in the care and treatment of Duchenne. The Duchenne Registry is a member of the TREAT-NMD Neuromuscular Network.

The Duchenne Registry (previously DuchenneConnect) was created in 2007 by Parent Project Muscular Dystrophy (PPMD), with assistance from the NIH, the CDC, and Emory Genetics. In early 2011, PPMD alone began financing the registry's operation and maintenance, and is the sole guardian of The Duchenne Registry and its material.

Questions may be addressed to the Duchenne Registry Coordinators at telephone 888-520-8675 or coordinator@duchenneregistry.org. The Duchenne Registry Coordinators are certified genetic counselors who are available to answer questions regarding the registration process, genetic testing and counseling, and clinical trials and research studies.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Duchenne or Becker muscular dystrophy; Manifesting female carriers and asymptomatic female carriers also included in registry.

Exclusion Criteria:

* Diagnosis of any other type of muscular dystrophy (including limb-girdle muscular dystrophy).
A Pilot Study to Examine the Feasibility and Effect of Tumor Necrosis Factor (TNF) Inhibition on HIV Disease

This pilot study will investigate the safety and effect of etanercept in HIV infection by studying HIV replication and immune function (as measured by CD4 counts) in individuals with HIV infection.


Eligibility Criteria:
Inclusion Criteria:

* Adults greater than 18 years of age with documented HIV infection
* Highly active antiretroviral therapy (HAART) regimens as defined by the Department of Health and Human Services guidelines; stable regimens for 12 weeks.
* CD4 greater than 200 at time of study enrollment
* Stable monitoring labs (hematology survey with differential, ALT, creatinine)
* Absolute neutrophil count within normal limits

Exclusion Criteria:

* AIDS defining illness within the last 6 months
* Acute bacterial, viral, or fungal infection within the last 1 month, or history of recurring infections
* Women who are pregnant or nursing
* Hypersensitivity to etanercept
* Previous use of etanercept
* Acute malignancy in the last 5 years excluding in situ cervical cancer (CA) and common skin cancers (non melanoma)
* History of active or latent tuberculosis
* History of demyelinating nerve disease
* History of seizure disorder
* Latex allergy
* Subject has any of the following laboratory values within 30 days of baseline:

  * hemoglobin concentration \< 10.0 g/dl for men and \< 9.0 g/dl for women
  * platelet count \< 75,000/mm3
  * AST or ALT \> 5x upper limit of normal (ULN)
  * serum creatinine \> 2.5x ULN
  * serum pancreatic amylase \> 1.5 ULN
* Subject requiring treatment with immunomodulating agents, such as systemic corticosteroids, interleukins, vaccines, or interferon
* Subjects who chronically use any over-the-counter (OTC) or prescription medication (except vitamins) must not change the regimen or switch their medication within 3 days of drug administration and until discharged from the study.
Prevalence of Refractive Errors in Primary School Children

The study aim to determine the prevalence of refractive errors in primary school children aged 6-12 in The New Valley , Egypt .

The refractive state of the eye changes as the eye's axial length increases and the cornea and lens flattens. In general, eyes are hyperopic at birth, and become slightly more hyperopic until the age of 7, at this point we see a myopic shift toward Plano until the eyes reach their adult dimensions, usually by about the age of 16.

Eligibility Criteria:
Inclusion Criteria:

Age: 6 -12-year-old Myopia :- 0.5 D to -10D Hypermetropia: 1 D to 8 D Astigmatism: 0 to 6 D Distance correction: 0.1 logs MAR (20/25 ) or better

Exclusion Criteria:

Retinopathy, Prematurity, history of genetic disease, connective tissue diseases (e.g. Stickler or Marfan syndromes, any ocular diseases, Glaucoma, Cataract, Squint.
Intravitreal Diclofenac Versus Intravitreal Ranibizumab for the Treatment of Diabetic Macular Edema.

The study aims to compare the effect of intravitreal non steroidal anti inflammatory (Diclofenac) versus the standard treatment of diabetic macular edema, intravitreal anti vascular endothelial growth factor (Ranibizumab), measuring central macular thickness changes and best corrected visual acuity.

Thirty eyes of diabetic patients with diabetic retinopathy with macular edema will be randomized using simple randomization method into two groups; A and B.

Group A will undergo intravitreal injection of 500µg Diclofenac, repeated monthly for 3 months. Electroretinogram will be performed before the injections, 4 weeks after first injection and 4 weeks after third injection to assess any risk of toxicity.

Colored photography and fundus fluorescein angiography will be done before the first injection to assess the extent of macular leakage at late phases, and to exclude cases with macular ischemia.

Optical coherence tomography will be done to measure the central macular thickness, before the first injection, and before each injection.

Visual acuity will be assessed before and after each injection.

Group B will undergo intravitreal injection of 0.5 mg Ranibizumab, repeated monthly for 3 months. Colored photography and fundus fluorescein angiography will be done before the first injection to assess the extent of macular leakage at late phases, and to exclude cases with macular ischemia.

Optical coherence tomography will be done to measure the central macular thickness, before the first injection, and before each injection.

Visual acuity will be assessed before and after each injection.

All patients will be examined weekly for one month and then monthly for three months after the injection. At every visit, visual acuity, intraocular pressure, and a dilated fundus examination will be performed.

All patients will be required to instill topical antibiotic Gatifloxacin postoperatively 3 times per day for 5 days.

Patients will be warned about the signs and symptoms of complications (endophthalmitis, retinal detachment, vitreous hemorrhage, lens trauma) and asked to seek medical attention immediately.

Eligibility Criteria:
Inclusion Criteria:

1. Diabetic retinopathy with non tractional maculopathy, where central macular thickness is greater than 400µm, with and without cystic changes.
2. Diabetes Mellitus type one and two
3. Best Corrected Visual Acuity \> 0.1 LogMar

Exclusion Criteria:

1. Patients treated with diclofenac, Ranibizumab or Bevacizumab in the past 3 months
2. Patients with a history of branch or central retinal artery occlusion
3. Patients without clear media and adequate pupillary dilation that allows proper fundoscopy and imaging, and patients who are not complaint with the regular visits.
4. Visual Significant Cataract
5. Evidence of vitreomacular traction or macular ischemia
Evaluation of V.A.C. VERAFLO CLEANSE CHOICE™ Dressing Using Normal Saline to Promote Increased Healthy Wound Bed Tissue

The study goal is to evaluate the ability of the V.A.C. ULTA™ Negative Pressure Wound Therapy System and V.A.C. VERAFLO CLEANSE CHOICE ™ (VFCC) dressing system with saline as an irrigant in increasing viable tissue in full thickness wounds (such as chronic, acute, traumatic, sub-acute, and dehisced wounds and/or ulcers) with difficult to manage bioburden and slough.


Eligibility Criteria:
Inclusion Criteria:

1. is anticipated to be hospitalized for the duration of treatment.
2. is ≥22 years of age or their legally authorized representative is able to provide informed consent.
3. has a full thickness wound (such as chronic, acute, traumatic, sub-acute, and dehisced wounds and/or ulcers) measuring ≥4cm in length and ≥4cm in width (before removal of eschar at the bedside) excluding undermining/tunneling.
4. has, in the opinion of the investigator, no more than 2/3 of the visible wound bed surface area considered to be clean, healthy, and viable. If eschar is present at baseline, it must be removed by bedside debridement prior to assessing the percentage of clean, healthy, and viable wound bed.
5. has a negative urine or serum pregnancy test at screening (if female and has potential for pregnancy) and is willing to take precautionary measures to prevent pregnancy during the duration of the study (up to 9 days).

Exclusion Criteria:

1. has been diagnosed with malignancy in the wound.
2. has untreated osteomyelitis.
3. has an untreated systemic infection.
4. has active cellulitis in the peri wound area.
5. has a known allergy or hypersensitivity to study materials: dressing and/or dressing components such as acrylic adhesives or polyurethane.
6. has, in the opinion of the investigator, a clinically significant condition that would impair the Subject's ability to comply with the study procedures.
7. has had radiation directly to the wound.
8. has been diagnosed with a major vascular deficit limiting arterial inflow to the wound region, as determined by the Investigator's interpretation of the Subject's medical history.
9. has eschar in the wound that cannot be removed by beside or sharp and/or mechanical debridement.
10. is participating in another interventional clinical trial for the duration of the study.
11. has unexplored fistulas in the wound or fistulas in the wound that connect to other body cavities.
12. has inadequate hemostasis at the wound site, as determined by the investigator.
Expectations and Beliefs of Transgender People Regarding Hormonal Treatment

Hormonal treatment of gender dysphoria can have repercussions on metabolism, cardiovascular system and fertility and represents à potential oncological risk. According to the recommendations of the Endocrine society. Therefore, initial assessment and follow-up visits are necessary and must be carried out to avoid the apparition of potentially undesirable effects.


Eligibility Criteria:
Inclusion Criteria:

* being a parent of adolescent/child presenting Gender dysphoria
* adult subject (age \> 18 years) presenting Gender dysphoria

non-inclusion criteria

* Severe, uncontrolled psychiatric or somatic illness
* Chronic alcoholism
* Substance abuse
* Refusal or linguistic, physical or psychological incapacity to participate in the study
* Ongoing pregnancy
Flow Arrest Safety and Technical Success With Balloon Guide Catheters

The objective of this post-market registry is to assess technical efficacy and safety associated with the use of the BOSS Balloon Guide Catheter during neuro-vascular procedures while providing temporary arrest of blood flow.

This is a prospective, multi-center, non-randomized observational registry evaluating use of BOSS balloon guide catheters in patients diagnosed with an acute ischemic stroke due to large intracranial vessel occlusion.

Eligibility Criteria:
Inclusion Criteria:

* Acute ischemic stroke vessel occlusion (ICA, M1 or M2) of the anterior circulation with associated symptoms
* Adult patient willing to provide Informed Consent
* Pre-treatment National Institutes of Health Stroke Scale (NIHSS) ≥ 6

Exclusion Criteria:

* Posterior circulation stroke
* Tandem occlusions
* Cervical carotid stenosis
* Participating in another clinical trial
Nasal Obstruction With Oxymetazoline and Corticosteroids

This study aims to examine the efficacy and safety of commination oxymetazoline/intranasal steroids for long-term management of chronic nasal obstruction that is recalcitrant to the current standard of care. The investigators hypothesize that combination treatment with oxymetazoline and intranasal corticosteroid spray will provide a larger reduction in nasal obstruction than intranasal corticosteroid alone for patients suffering from chronic nasal obstruction, and there will not be occurrences of rhinitis medicamentosa.

Participants will be directed to apply the intranasal spray, at a dosage of two sprays in each nostril, twice daily. The total treatment time for participants in both trial arms is 7 weeks. Participants will be randomized to either 1) oxymetazoline + budesonide intranasal spray or 2) budesonide intranasal spray. Participants will be mailed the intranasal spray directly from the pharmacy. Participants will complete questionnaires via REDCap survey link at baseline, Week 2, Week 4, Week 5, Week 6, and Week 7. A group of 10 participants will be asked to have nasal mucosal biopsies done at baseline and between weeks 4 and 6.

Eligibility Criteria:
Inclusion Criteria:

1. males and females ages 18 years or older
2. have a history of nasal obstruction
3. have failed a trial of topical steroids (that included at least 1 month of daily use)
4. ability to read, write, and understand English
5. either do not desire surgery or are poor surgical candidates due to medical comorbidities.
6. Patients who have had prior use of oxymetazoline or other nasal decongestants are eligible for the study but must have stopped usage 4 weeks prior to randomization.

   1. Must be willing to stop using any other nasal sprays, besides saline, and oral decongestants.

Exclusion Criteria:

1. Any history of sinonasal mass/tumor
2. Any history of nasal polyps
3. a known history of chronic sinusitis
4. an allergy to oxymetazoline
5. or who have any medical contraindication to oxymetazoline use, such as pulmonary hypertension.
A Comparison Study of Apadenoson and Adenosine to Treadmill Exercise Stress.

The purpose of this clinical research study is to compare Apadenoson and adenosine to treadmill exercise stress SPECT MPI


Eligibility Criteria:
Inclusion Criteria:

* Clinically appropriate for exercise stress testing

Exclusion Criteria:

* Contraindication to adenosine stress or inability to perform treadmill exercise test
Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis

This is a double-blind, parallel group, vehicle-controlled study to assess the safety and efficacy of roflumilast (ARQ-151) 0.3% cream vs vehicle (placebo) cream for treatment of chronic plaque psoriasis (CPP) in adult participants with 2 to 20% body surface area (BSA) of CPP.


Eligibility Criteria:
Inclusion Criteria:

* Participants legally competent to sign and give informed consent and if appropriate assent as required by local laws
* Males and females ages 2 years and older (inclusive)
* Clinical diagnosis of psoriasis vulgaris of at least 6 months duration (3 months for children) as determined by the Investigator
* Females of childbearing potential (FOCBP) must have a negative pregnancy test at Screening (Visit 1) and Baseline (Visit 2). In addition, sexually active FOCBP must agree to use at least one form of highly effective contraception throughout the trial.
* In good health as judged by the Investigator, based on medical history, physical examination, serum chemistry labs, hematology values, and urinalysis.
* Subjects considered reliable and capable of adhering to the Protocol and visit schedule, according to the judgment of the Investigator.

Exclusion Criteria:

* Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED.
* Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
* Previous treatment with ARQ-151 or its active ingredient
* Subjects with any serious medical condition or laboratory abnormality that would prevent study participation or place the subject at significant risk, as determined by the Investigator.
* Subjects with a history of chronic alcohol or drug abuse within 6 months of initiation of investigational product
* Subjects who are unable to communicate, read or understand the local language, or who display another condition, which in the Investigator's opinion, makes them unsuitable for clinical study participation
Oral Aripiprazole Open-Label Rollover Study

The purpose of this study is to test the long-term safety and tolerability of oral aripiprazole in adolescent patients with schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with a confirmed Axis I Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis of schizophrenia who must have completed Otsuka study 31-03-241 (NCT00102518) treatment of adolescent subjects with schizophrenia

Exclusion Criteria:

* Patients with a co-morbid serious, uncontrolled systemic illness
* Patients with a significant risk of committing suicide