cyrilzakka/clinical-trials huggingface dataset:
Hydroxychloroquine Administration for Reduction of Pexophagy

A series of N-of-1, crossover, randomized, placebo-controlled, double-blinded trial. Hydroxychloroquine (HCQ) and a crossover to placebo (order is randomized and blinded) will be administered in liquid suspension for 84 days (12 weeks) each with an 84 day washout in between. We hypothesize that HCQ will reduce peroxisomal turnover, which will arrest ongoing injury in PBDs caused by PEX1, PEX6 or PEX26.

HARP is a phase II/III, double-blind, placebo-controlled, randomized, crossover series N-of-1 study of the effect of hydroxychloroquine (HCQ) in patients with peroxisomal biogenesis disorders (PBD-ZSD). Patients eligible for the study must have a laboratory diagnosis of PEX1, PEX6 or PEX26 dependent PBD-ZSD from a CLIA or SCC-certified clinical laboratory, a history of abnormal VLCFA levels, and must be at least 84 days from their last HCQ dose. Patients will be excluded for known sensitivity to HCQ, known glucose-6-phosphate dehydrogenase deficiency, if they have an expected survival of less than 9 months or if they are participating in another interventional clinical trial.

HCQ will be administered at a dose of 4mg/kg/day divided into two doses, as a liquid suspension that can be given orally or through nasogastric or gastric tube. Within the study, HCQ or placebo will be given for 84 days, followed by a washout period of 84 days followed by an 84 day crossover to the alternative therapy to assess the effect the study measures.

Study measures will be completed at four intervals (initiation, end of period 1, start of period 2, end of trial). Ophthalmological monitoring of patients has three components, electroretinogram (ERG), visual acuity testing and optical coherence tomography (OCT). Plasma levels of very long-chain fatty acids (VLCFA), plasmalogen and phytanic acid will be assessed. Parents will also be administered The Pediatric Inventory for Parents (PIP), a questionnaire that was developed to evaluate the stress associated with parenting a seriously ill child, at the end of period 1 and period 2.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with a peroxisomal defect due to PEX1, PEX6 or PEX26 through a SCC or CLIA-certified clinical genetic testing laboratory.
* Abnormal plasma very-long-chain fatty acid levels.
* All therapies available in Canada have been considered and ruled out, have failed or were justified as being unsuitable for the patient. We note that there are no therapies available.
* At least 84 days from last HCQ dose

Exclusion Criteria:

* Known sensitivity to HCQ.
* Known Glucose-6-phosphate dehydrogenase deficiency.
* Expected survival is less than six months.
* The patient does not provide informed consent.
* The patient is participating in another interventional clinical trial.
Evaluation Of The Efficacy And Safety Of Single Doses Of PF-05089771 In Patients With Primary (Inherited) Erythromelalgia

The purpose of this study is to evaluate the efficacy and safety of single doses of PF-05089771 against placebo in treatment of pain in patients with primary, inherited erythromelalgia.


Eligibility Criteria:
Inclusion Criteria:

* Male and or female subjects between the ages of 18-78 years
* Subject has clinical signs of IEM
* Minimum BMI 17.5kg/m2 and total body weight \>50kg

Exclusion Criteria:

* Other severe pain conditions, e.g. rheumatologic, that may impair subject's self-assessment of pain due to IEM.
* Evidence of clinically significant hypertension, clinically significant hematological, dermatological, renal, endocrine (except diabetes mellitus), pulmonary, gastrointestinal, cardiovascular, hepatic, neurological (other than IEM), or allergic disease (including drug allergies but excluding untreated asymptomatic seasonal allergies).
* Subjects with severe obesity.
Comparison Between Prednisolone and Dexamethasone on Mortality in Patients on Oxygen Therapy, with CoViD-19

The aim of the study is to evaluate two differents regimens of corticosteroids (prednisolone versus dexamethasone) on D28 mortality in patients with CoViD 19 pneumonia requiring oxygen supplementation

Low-dose glucocorticoid treatment is the only medication showing a significant reduction in mortality in cases of COVID-19 pneumonia requiring oxygen supplementation or ventilatory support.

Intravenous or oral dexamethasone are well evaluated in randomized study but other oral corticosteroids are not. Compared to dexamethasone, prednisolone is more available in France and easily taken by patients, especially in case of home medical care.

The pharmacokinetics/pharmacodynamics of prednisolone and dexamethasone are different. To obtain similar effects, prednisolone should be theoretically taken twice a day and at a superior dose than the strict prednisone equivalence of 6mg dexamethasone.

Eligibility Criteria:
Inclusion Criteria:

* Patient ≥ 18 years old
* Patient with SARS-CoV-2 pneumopathy documented by nasopharyngeal or bronchoalveolar lavage fluid RT-PCR or any documented clinical symptoms support by CT scan
* Patient with SpaO2 ≤ 94 % in room air (90% for patient with respiratory failure) and requiring an oxygen therapy
* Negative pregnancy test for women of childbearing age
* Informed and written informed consent (IC) obtained
* Patients with affiliation to the social security system

Exclusion Criteria:

* Patient with corticosteroids as background treatment (≥ 10 mg equivalent)
* Patient under supplemental oxygen \> 6 L/min
* Immunocompromised patient (AIDS, bone marrow or solid organ transplants, etc.)
* Patient who received a corticosteroid dose within 3 days for Covid-19
* Medical history of hypersensitivity to Prednisolone or Dexamethasone; or lactose / galactose (excipients with known effect)
* Another active virus such hepatitis, herpes, varicella, shingles ....
* Psychotic state not controlled by treatment
Gene Therapy for Blindness Caused by Choroideremia

- Primary objective: To assess the safety and tolerability of the AAV.REP1 vector, administered at two different doses to the retina in 12 patients with a diagnosis of choroideremia.

- Secondary Objective: To identify any therapeutic benefit as evidenced by a slowing down of the retinal degeneration assessed by functional and anatomical methods in the treated eye compared to the control eye 24 months after gene delivery.

Detailed description may be found in the following scientific publication:

Retinal gene therapy in patients with choroideremia: initial findings from a phase 1/2 clinical trial, The Lancet, Volume 383, Issue 9923, Pages 1129 - 1137 (29 March 2014).

Links: www.thelancet.com/journals/lancet/article/PIIS0140-6736(13)62117-0/abstract ; http://dx.doi.org/doi:10.1016/S0140-6736(13)62117-0

Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study,
* Male aged 18 years or above,
* Diagnosed with choroideraemia and in good health,
* Active disease with SLO changes visible within the macula region,
* Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study,
* Vision at least 6/60 or better in the study eye.

Exclusion Criteria:

* Female and child participants (under the age of 18),
* Men unwilling to use barrier contraception methods, if relevant,
* Previous history of retinal surgery or ocular inflammatory disease (uveitis),
* Grossly asymmetrical disease or other ocular morbidity which might confound use of the fellow eye as a long-term control,
* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study,
* Participants who have participated in another research study involving an investigational product in the previous 12 weeks.
Neuroscience of Psychotherapy for Depression

The goal of this study is to learn the extent to which client-therapist brain activity may synchronize during a psychosocial intervention for depression symptoms.

The study will compare behavioral activation, a client-centered type of cognitive-behavioral therapy, to psychoeducation which delivers information on strategies to recover from depression symptoms.

Participants will answer questions about their mental and physical health, attend one psychosocial intervention session receiving either Behavioral Activation or Psychoeducation with simultaneous brain activity measurement and complete follow up surveys two weeks and one month following the intervention.

This is a pilot study to investigate the neuroscience of a single-session psychosocial intervention for depression symptoms. Brain activity is measured with EEG in both research participant and therapist. Participants will fill in questionnaires about their depression symptoms and experience during the psychosocial intervention.

Eligibility Criteria:
Inclusion Criteria for participants/clients:

* Between ages 18 and 30
* Full-time student status (undergraduate, graduate, and professional)
* Experience mild to moderate depressive symptoms as determined by the Beck Depression Inventory (score: 14-28)
* No current suicidal ideation, score of 0 on Columbia-Suicide Severity Rating Scale (C-SSRS in past month)
* Capacity to understand study procedures (informed consent)
* Ability to speak and understand English
* Willingness to comply with study procedures

Inclusion Criteria for therapists:

* Ages 18 or older
* Qualification to administer therapy (decided by the Principal Investigator)
* Capacity to understand the study procedures (informed consent)
* Speak and understand English
* Willingness to comply with study procedures

Exclusion Criteria for participants/clients:

* Active, Current Suicidal ideation as determined by the Columbia-Suicide Severity Rating Scale (C-SSRS) in the past month
* Past suicidal attempt (lifetime)
* Recently initiated psychotherapy (past month)
* Elevated psychosis risk based on self-report prodromal questionnaire - brief version (PQ-B) or self-reported diagnosis of psychotic disorder by mental health provider
* Positive screen for autism spectrum disorder based on the self-report autism quotient (AQ-10) or self-reported diagnosis of autism spectrum disorder by mental health provider,
* Daily intake of benzodiazepine of \>20 mg diazepam milligram equivalent
* Inability to give informed, voluntary, written consent to participate
* Inability to effectively communicate in English as determined by interaction with study personnel
* Anything else that in the assessment of the study team is not conducive to the successful completion of the study requirements.

There are no exclusion criteria for therapists
The Effects of Video Based Training and Aerobic Exercise Training in Individuals With Internet Gaming Disorder

In this study, video-based training, aerobic training and both training will be applied to individuals with internet gaming disorder. Addiction levels and functional performance will be evaluated before and after treatment.

The aim of this study is to investigate the effect of game-based training and aerobic exercise training on game addiction level, functional performance and exercise capacity in individuals with internet play disorder. In addition, the investigators think that facilitate the transition to exercise by using game-based training in order to gain exercise habit and reduce sedentary behaviours in individuals with internet gaming disorder.

Eligibility Criteria:
Inclusion Criteria:

* DSM V (Diagnostic and Statistical Manual of Mental Disorders, revision 5) Internet Gaming Impairment (IOOB) Diagnostic criteria: approval of five to nine items
* No communication barrier
* Playing game (smart phone,Play Station 4, Xbox, Personal Computer) at least 2 hours a day in the last year

Exclusion Criteria:

* Cigarette use over 10 packsXyear
* be using any medicine
* Be actively involved in any sport.
* Having chronic disease
* Having physical disability
Study of BMS-354825 in Subjects With CML Who Are Resistant to or Intolerant of Imatinib or Ph+All in Japan

This study is composed of Phase I and Phase II part. Phase I part: The objective is to evaluate the safety of BMS-354825 in subject with chronic phase Chronic Myelogenous Leukemia (CML). Dosage of BMS-354825 will be 50 mg BID, 70 mg BID or 90 mg BID. Phase II part: The objective is to evaluate the efficacy of BMS-354825. dosage will be decided according to the results of Phase I part. Treatment period will be 6 months for subjects with chronic phase CML, and 3 months for subjects with accelerated phase or blast phase CML and Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ALL)


Eligibility Criteria:
Inclusion Criteria:

* Philadelphia chromosome positive or bcr-abl gene positive
* Chronic Myelogenous Leukemia (CML)
* Subjects must have primary or acquired resistance to imatinib mesylate or have intolerance of imatinib mesylate
* Philadelphia Chromosome Positive Acute Lymphoblastic leukemia (Ph+ALL)
* Subjects must have primary or acquired resistance to chemotherapy or have intolerance of chemotherapy
* Performance status (general conditions) specified by the Eastern Cooperative Oncology Group: 0-2
* Men and women, ages 20 - 75
* Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 3 months after the study in such a manner that the risk of pregnancy is minimized

Exclusion Criteria:

* Subjects who are eligible and willing to undergo transplantation at pre-study
* Women who are pregnant or breastfeeding
* Uncontrolled or significant cardiovascular disease
* History of significant bleeding disorder unrelated to CML or ALL
* Adequate hepatic function
* Adequate renal function
* Medication that increase bleeding risk
* Medication that change heart rhythms
* Subjects who are compulsorily detained for legal reasons or treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study
The Medacta International GMK Sphere Post-Marketing Surveillance Study

This is a Post-Marketing Surveillance of GMK Sphere knee prosthesis.

The clinical performance of the GMK® Sphere, manufactured by Medacta International, will be evaluated by a multicentre, prospective clinical surveillance study.

The Elective Orthopaedic Centre (EOC), in Epsom, Surrey, will be the study coordinating centre. Four further centres will participate in the clinical study, for five total centres. Each participating centre will recruit approximately 100 patients. Patient recruitment will cease when a cohort of 500 GMK® Sphere knee replacements have been implanted.

Eligibility Criteria:
Inclusion Criteria:

* A disabled or severely disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis, poly-arthritis or avascular necrosis
* Patients must be between the age of 18 and 80 at the time of consent
* Listed for total knee replacement surgery.
* Patients who are willing to give informed written consent

Exclusion Criteria:

* Progressive local or systemic infection
* Muscular loss, neuromuscular disease or vascular deficiency of the affected limb, making the operation unjustifiable
* Severe instability secondary to advance destruction of condylar structures or loss of integrity of the medial or lateral ligament
* Any patient who cannot or will not provide informed consent for participation in the study
* Those whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems
* Patient whose BMI exceeds 40
* Any case not described in the inclusion criteria
Lemon Verbena Extract Oxidative Stress and Muscle Damage

In the present study, investigators investigated whether supplementation with lemon verbena extract (LVE) could improve muscle damage and biochemical indicators after exhaustive exercise challenge. Based on maximum jump heights, 60 subjects (30 males and 30 females) were equally divided into a placebo group (0 mg/human/day) and an LVE supplement group (400 mg/human/day), with gender-equal distribution. All subjects started supplementation 10 days before exhaustive exercise and continued it until all tests were completed. Before the intervention, after the exhaustive exercise, and on the following 3 days, the participants underwent 12-minute Cooper running/walking; blood collection; assessments of pain, muscle stiffness, maximum jump heights, and isometric maximum muscle strength; and anaerobic strength tests.


Eligibility Criteria:
Inclusion Criteria:

* health
* Must be able to swallow tablets

Exclusion Criteria:

* non-smokers
* no musculoskeletal
* medical
* metabolic disease
* women not on the reproductive cycle
* high blood pressure, asthma
* skeletal neuromuscular injuries in the upper or lower extremities
The Effect of Plant-based Diets (Vegetarian and Vegan) on Endothelial Function and Atherogenic Parameters

The investigators' hypothesis is that a plant-based diet may be beneficial if nutritional deficiencies will be corrected. The aims of the present proposal are to 1) study endothelial functions of subjects on well-defined vegetarian/vegan diets compared to age and sex matched omnivores (controls), and 2) study the differences in energy expenditure, body composition, overnight substrate utilization, blood work results, and levels of intracellular reactive oxygen species (ROS) and of adhesion molecules on the different diets.

The serious doubts about the nutritional adequacy of vegetarian diets in the past were essentially put to rest by recent studies that suggested that plant-based diets are healthy and associated with lower risk of several chronic diseases. Nevertheless, various nutritional deficiencies have been identified, and it has been shown that individuals who follow different types of vegetarian/vegan diets may not experience the same effects on their health.

Working Hypothesis

1. Vegetarian/vegan diets will promote protection against cardiovascular risk factors if supplemented with possibly deficient nutrients.
2. There will a further protective effect and a greater number of differences between subjects following a vegetarian diet compared to those following a vegan diet.
3. Higher energy expenditure and lower and different caloric intake will promote a favorable difference in body composition (lower body fat) via a different substrate utilization expressed in the measured respiratory quotient (RQ).
4. Extra- and intracellular free radicals will be higher in subjects who adhere to vegetarian/vegan diets compared to omnivores.

Aims of the study

1. To study the effect of vegetarian/vegan diets on endothelial functions after correcting for modifying factors.
2. To study the effect of the above-mentioned plant-based diets on carotid intima-media thickness.
3. To study the differences in body composition, resting energy expenditure and over-night substrate utilization between the different diets.
4. To study the intracellular ROS of subjects following different diets.

Eligibility Criteria:
Inclusion Criteria:

* over 5 years' adherence to any type of diet
* age range 35-50 years
* BMI ≤32

Exclusion Criteria:

* smoking
* type I and II diabetes
* liver and kidney impairments
* cardiovascular diseases
* patients with tumors
* patients on medications which may affect cardiovascular parameters (including 5 phosphodiesterase inhibitors, beta blockers, ACE inhibitors and others)
* BMI \>32 kg/m2.
Use of Ultrasound Guidance to Facilitate Obtaining Peripheral Intravenous Access

The purpose of this study is to determine if the use of ultrasound guidance to insert peripheral intravenous catheters will decrease the number of punctures required to successful insertion. The hypothesis is that fewer attempts will be required with the use of ultrasound potentially leading to preservation of vessels, decreased patient pain scores and increased patient/parent satisfaction.

Patients with known or current difficult venous access will be referred to the Vascular Access Team for peripheral intravenous catheter insertion. The Vascular Access Team will randomize patients to ultrasound guidance or non-ultrasound guidance for placement of the peripheral intravenous catheter.

Eligibility Criteria:
Inclusion Criteria:

* patients 0-17 years of age requiring peripheral intravenous access
* have not had PIV attempt in preceding 24 hours

Exclusion Criteria:

* patients who are medically unstable
* patients who require emergent intravenous access
Effect of Low Level Laser Versus Interferential Current on Postmenopausal Low Back Pain

This study will be conducted to compare the effect of low-level laser and interferential current on postmenopausal low back pain.

Low back pain (LBP) is a major health problem affecting majority of the people at some point of their life.The prevalence of postmenopausal LBP is 32.4%. It has major implication for quality of life, such as limitation of daily activities and physiological stress, being one of the main causes of work absenteeism.

The prolonged use of NSAIDs is associated with cardiovascular, hepatic, and renal problems. Therefore, there is a need for emphasis on alternative methods of conservative treatment as non-pharmacological and non-invasive therapy to relieve postmenopausal LBP.

Low level laser has been proven to have an impact on postmenopausal LBP, through several mechanisms as (a) increased endogenous opioid neurotransmitter production ;(b)raised threshold to thermal pain and enhanced local blood circulation ; (c)increased oxygen consumption by accelerating the redox reaction rate of the electron respiratory chain of mitochondria ; (d) increased adenosine triphosphate (ATP) production at the cellular level ;(e) increased production of the anti-inflammatory cytokines.

Also, another non- invasive technique is the interferential current which is one of the existing electrotherapy treatments used to reduce pain and has been studied for its effectiveness in relieving LBP through its deeper penetration into the tissues.

So, this study will be conducted to provide new evidence and information about the efficacy of low-level laser versus interferential current on LBP in postmenopausal women

Eligibility Criteria:
Inclusion Criteria:

• Sixty postmenopausal women (at least one year after stoppage menses).

* Their age will be ranged from 50 to 60 years.
* Their body mass index (BMI) will be less than 30 kg/m2.
* All of them suffer from chronic low back pain (at least 3 months).
* The score of pain will be 2 or more according to visual analogue scale (VAS).

Exclusion Criteria:

* Spinal fracture or any other neurological disorder.
* Lumbar disc herniation, degenerative joint diseases, or spondylolisthesis.
* BMI\>30 kg/m2
* Gynecological Diseases as Chronic pelvic pain or genital prolapse.
Study of HIV Patients With Undetectable Viral Load and Abnormal Lipids Switching to Atazanavir/Ritonavir

Patients with HIV who are virologically suppressed on a lopinavir/ritonavir combination highly active antiretroviral therapy (HAART) regimen but with elevated non-HDL cholesterol are randomized to remain on lopinavir/ritonavir or change to atazanavir/ritonavir in combination with current nucleoside reverse transcriptase inhibitors (NRTIs).


Eligibility Criteria:
Inclusion Criteria:

* HIV positive
* LPV/RTV-based HAART for at least 6 months
* HIV-1 RNA less than 50c/mL (confirmed)
* Non-HDL higher than 160 mg/dL
* CD4 of at least 50 cells/mL

Exclusion Criteria:

* Use of lipid-lowering agents