cyrilzakka/clinical-trials huggingface dataset:
A Study of Efficacy, Safety and Tolerability of Idebenone in the Treatment of Friedreich's Ataxia (FRDA) Patients

The purpose of this trial is to study the efficacy, safety and tolerability of idebenone in 12 months of treatment in children and adults with Friedreich's Ataxia. This is a randomised placebo-controlled double-blind trial conducted in Europe. Efficacy outcomes include measures of neurological impairment and function, and measures of the heart.

Idebenone, a short-chain analogue of Co-enzyme Q10 (CoQ10), has the potential to moderate underlying causes of Friedreich's Ataxia through its antioxidant activity and its role as an electron carrier in the respiratory chain promoting mitochondrial ATP production.

The current 12-month placebo-controlled treatment study in 232 patients aims to confirm the positive effect of idebenone on neurological function, as for instance observed in the recent 48-patient, 6-month NICOSIA study in children, using the International Cooperative Ataxia Rating Scale (ICARS) and the newly developed Friedreich's Ataxia Rating Scale (FARS).

In addition, the study aims to confirm the positive effect on cardiomyopathy associated with FRDA observed in several small studies. Cardiac anatomy and function will be assessed using echocardiography, tissue Doppler imaging and cardiac MRI methods in patients with FRDA cardiomyopathy. In addition exercise capacity, measured as peak workload, will be assessed in patients able to comply with a modified exercise protocol.

Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of FRDA with confirmed FRDA mutations
* Patients 8 years of age or older at baseline
* Patients with body weight ≥ 25kg
* Patients who in the opinion of the investigator are able to comply with the requirements of the study, including swallowing the medication
* Negative urine pregnancy test at screening and at baseline (women of childbearing potential)

Exclusion Criteria:

* Treatment with idebenone or Coenzyme Q10 within the past 1 month
* Pregnancy and/or breast-feeding
* Clinically significant abnormalities of clinical haematology or biochemistry including, but not limited to, elevations greater than 1.5 times the upper limit of normal of SGOT, SGPT, or creatinine
* Past or present history of abuse of drugs or alcohol
Feasibility and Acceptability of an Online ACT Intervention for Disorders of Gut-Brain Interaction

The goal of this clinical trial is to assess the acceptability, feasibility, and usability of the iACTforDGBI intervention among patients with Disorders of Gut-Brain Interaction (DGBI). The main question it aims to answer are:

What are the perceptions of patients with DGBI and healthcare practitioners regarding the acceptability, feasibility, and usability of the iACTforDGBI intervention?

Participants will be asked to:

Complete the iACTforDGBI intervention prototype, consisting of self-guided online sessions.

Participate in online interviews and fill out online questionnaires to evaluate the intervention concerning acceptability, feasibility, usability and preliminary effects.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 75 years
2. Meeting clinical symptom levels for least one DGBI diagnosis (assessed with the Rome IV Diagnostic Questionnaire for Functional Gastrointestinal Disorders in Adults (Palsson et al., 2016))
3. Clinically meaningful levels of depressive symptoms or anxiety: score ≥ 13 on the Montgomery Åsberg Depression Rating Scale (Svanborg \&amp; Åsberg, 1994; (MADRS-S; depressive symptoms), or score ≥ 10 on the Generalized Anxiety Disorder scale-7 (GAD-7; anxiety symptoms; Spitzer et al., 2006)
4. Stable medication for psychiatric symptoms including anxiety, depression and sleep problems for at least two months prior to intervention.
5. Ability to read and write Swedish
6. Have access to a device (like computer, tablet or smartphone with) with access to the internet and that can be used to attend video conferences and preview the intervention platform (i.e., have a microphone and speakers or headphones).

Exclusion Criteria:

1. Currently undergoing any form of psychological intervention.
2. Increased risk of suicide (≥4 points on MADRS item 9)
3. Severe depression (\&amp;amp;gt;34 points on MADRS)
Clinical and Economic Impact of Interventions by a Clinical Pharmacist on Antibiotic Use on Surgical Wards

The purpose of this study is to establish the impact of a pharmacist's recommendations regarding choice, dosing and duration of antibiotic therapy on quality and cost of antibiotic treatment on surgical wards.

Inappropriate or incorrect use of antibacterials exerts selection pressure on pathogens potentiating emergence of resistance, puts patients at risk for unnecessary adverse drug reactions and potentially prolongs the length of stay in hospital thus increasing healthcare costs.

In an effort to improve the quality of antibiotic drug therapy on surgical wards of a large university hospital, specific consulting by a clinical pharmacist was established.

The objective of this study is to assess the impact of pharmaceutical consulting on the quality and costs of antibiotic use in surgical wards.

Comparison:

Within a control period the current pattern of antibiotic use is monitored. During the intervention period, the impact of the interventions made by the clinical pharmacist on antibiotic use is examined. One ward serves as a parallel control group; no intervention is being made on this ward throughout this study.

Eligibility Criteria:
Inclusion Criteria:

* female and male patients receiving antibiotics for a proven or suspected infection on designated surgical wards

Exclusion Criteria:

* patients under 18
* patients unable or unwilling to consent to their data being evaluated
* patients receiving antibiotics perioperatively as prophylaxis
* patients receiving antibiotics for less than 48hrs
Effect of B-GOS on GI Discomfort in Healthy Adults

The aim of the study is to evaluate the effects of a new food supplement which is currently available in the market, called Bimuno® (B-GOS), on gastrointestinal discomfort (e.g. bloating, abdominal pain/cramp and flatulence) in adults who often experience these symptoms but are otherwise healthy.

About 400 volunteers will take part in this study, which will last 6 weeks (to include 4 weeks treatment and 2 weeks follow up period).

Episodes of abdominal pain or discomfort (e.g. bloating, abdominal pain/cramp and flatulence), in the absence of diseases, are commonly associated with food or drug intake or with alterations of bowel habit and vary between individuals in frequency and severity.

Some dietary ingredients are known to reduce these symptoms. We have used B-GOS previously in trials with healthy younger and older adults and we have observed a trend towards reducing abdominal bloating. However, the investigators have not tested B-GOS in healthy adults who often experience these symptoms and this is what we will investigate now.


Eligibility Criteria:
Inclusion Criteria:

1. Aged between 18 and 65 years old.
2. Presence of bloated feeling or experiencing abdominal fullness, with or without visible distention, often in the last 12 months.
3. Ability to communicate well with the investigator and to comply with the requirements of the entire study.
4. Volunteer has given written informed consent to participate and is willing to participate in the entire study.

Exclusion Criteria:

1. History or evidence of organic disease of the gastrointestinal tract; such as tumour, irritable bowel syndrome, etc., within the previous 5 years.
2. Undergone surgical resection of any part of the bowel.
3. History of malignancy within the previous 5 years (with exception of well-treated basal cell carcinoma or in situ cervical carcinoma).
4. Received antibiotics in the previous four weeks.
5. Consumed probiotic or prebiotic preparations on a regular basis (at least 3 times per week) in the last 2 weeks.
6. Former participation in another study involving prebiotic or probiotic preparations or investigational drugs within the previous one month, or intention to use such drugs during the course of the study.
7. Severe allergy or any history of severe abnormal drug reaction, drug or alcohol abuse.
8. Regular use of any medication with exception of hormonal replacement therapy and contraception.
9. Women who are pregnant or breast-feeding.
10. Fertile women not practicing a medically-approved method of contraception.
Pre-Salpingo-Oophorectomy Pilot Study of MAKO 7 Device Performance

This study evaluates the ability of the MAKO 7 device to collect various cells

Prospective, multi-center observational study to evaluate the ability of the MAKO 7 device to collect cells from the fallopian tubes for cytological evaluation for determination and/or differentiation of normal versus atypical versus malignant cells.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is medically cleared for surgery
2. Subject is scheduled to undergo a salpingo-oophorectomy for a pelvic mass suspicious for malignancy or for BRCA1 or BRCA2 mutations
3. Subject must be 18 years of age
4. Subject must be able to provide informed consent

Exclusion Criteria:

1. Contraindication to hysteroscopy
2. Acute pelvic inflammatory disease
3. Active or recent lower pelvic infection
4. Pregnancy
5. Delivery or termination of a pregnancy in the past 6 weeks
6. Known tubal obstruction including tubal ligation
7. Invasive carcinoma of the cervix or endometrium
8. Intolerance of anesthesia
Effect of Treatment for Vitamin D Deficiency on Thyroid Function and Autoimmunity in Hashimoto's Thyroiditis.

The objective of this study is to evaluate the effect of vitamin D supplementation on thyroid autoimmunity, thyroid function, and other metabolic and clinical variables associated with the thyroid axis in patients with Hashimoto's thyroiditis and vitamin D deficiency.


Eligibility Criteria:
Inclusion Criteria:

* women between 18-45 years old (pre-menopausal stage)
* men between 18-60 years old
* BMI between 18.5-34.9 kg/ m2
* medical diagnosis of Hashimoto's thyroiditis
* treatment with levothyroxine (LT4) with stable dose (from four months from the start of the intervention)
* positive antithyroid antibody (peroxidase and/or thyroglobulin)
* serum 25 (OH) D levels \<20 ng / ml.

Exclusion Criteria:

* radioiodine, thyroidectomy, antithyroid treatment
* disease, condition or drug treatment that alters the immune system or hypothalamic-pituitary-thyroid axis or vitamin D metabolism.
* disorder of kidney, liver, or bone-metabolic function
* Graves disease, toxic nodular goiter, postpartum thyroiditis, coronary heart disease, epilepsy, cancer, Turner or Down syndrome, primary hyperparathyroidism
* vitamin D, calcium, complex B, omega-3 supplements
* pregnant or breastfeeding
* type 2 diabetes or dyslipidemia with drug treatment at unstable doses
* intense physical activity
The Effect of Repetitive Transcranial Magnetic Stimulation on Cognitive Impairment in Parkinson's Disease (PD)

This study aims to assess the therapeutic role of rTMS on parkinson's patients with cognitive impairment. Patients diagnosed with Parkinson's Disease and cognitive impairment will be recruited. All patients will be admitted and will be allocated randomly into two groups one of which will receive real sessions of high frequency rTMS for each hemisphere for 10 consecutive sessions totally over period of 10 days with repeated booster sessions every month during the period of follow up. The other will receive sham sessions.

This study aims to assess the therapeutic role of rTMS on parkinson's patients with cognitive impairment. Thirty PD patients with cognitive impairment using United Kingdom (UK ) bank criteria for PD will be recruited from outpatient clinic in Assiut University. All patients will be admitted at Neuropsychiatric Department, Assiut University Hospital/ Assiut, Egypt.Each patient fulfilled the inclusion criteria as having score less than 24 on Mini-Mental Status Examination will be recruited. The patients will be allocated randomly into two groups one of which will receive real sessions of high frequency rTMS (25 HZ), with intensity of 80% of resting motor threshold detected from the hand motor area, with total 2000 pulses for each hemisphere for 10 consecutive sessions totally over period of 10 days with repeated booster session every month during the period of follow up among three months. The other will receive sham sessions. All subjects will be followed up by selected clinical rating scales at different intervals pre session, post 10 sessions, and after one, two and three months.

Eligibility Criteria:
Inclusion Criteria:

* All patients with Parkinson's Disease who were diagnosed according to UK bank criteria for PD, Aged 45-75 years, with criteria for cognitive impairment (Mini-Mental Status Examination\< 24), and consent obtained from the patient or his caregiver.

Exclusion Criteria:

* History of repeated head injury
* History of repeated cerebrovascular strokes
* History of defined encephalitis
* Oculogyric crisis, supranuclear gaze palsy
* Family history of more than one relative
* History of drug intake as antipsychotics or 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine (MPTP) exposure
* Moderate and Severe depression (Hamilton Depression Rating Scale score \>16)
* severe dysautonomia
* Cerebellar signs
* Babinski sign
* Strictly unilateral features after 3 years
* Hydrocephalus or intracranial lesion on neuroimaging
* We also excludes patients with intracranial metallic devices or with pacemakers or any other device.
A Patient Registry Study for Patients Treated With Voretigene Neparvovec in US

The objective of this study is to collect long-term safety information (i.e., for 5 years after treatment) associated with voretigene neparvovec-rzyl (vector and/or transgene), its subretinal injection procedure, the concomitant use of corticosteroids, or a combination of these procedures and products.

The enrollment period will last for two years from the first treatment following product approval (through 31March2020) and include a minimum of 40 patients.

Voretigene neparvovec-rzyl is a gene therapy intended for use in individuals with confirmed biallelic RPE65 mutation-associated retinal dystrophy and viable retinal cells. Mutations in the RPE65 gene are associated with several clinical manifestations including nyctalopia, decreased visual field and decreased visual acuity. Voretigene neparvovec-rzyl uses a non-pathogenic recombinant adeno-associated virus vector serotype 2 (AAV2) to deliver cDNA encoding RPE65 protein to target cells in the retina. Voretigene neparvovec-rzyl is administered to each eye via subretinal injection. The administration of voretigene neparvovec-rzyl is recommended to be performed to each eye on separate days within a close interval. Prescribing information recommends an immunomodulatory regimen concomitant with administration, with the actual regimen dependent upon the dosing center.

This post authorization safety study will focus on further characterizing the long-term safety profile of voretigene neparvovec-rzyl in patients with RPE65 mutation-associated retinal dystrophy using an observational, longitudinal design.

Eligibility Criteria:
Inclusion Criteria:

1. Received voretigene neparvovec-rzyl in at least one eye.
2. Signed informed consent/assent (when applicable). These are obtained as required under institutional policies and applicable laws and regulations unless a consent waiver is obtained from the Institutional Review Board (IRB)/Independent Ethics Committee (IEC).

Exclusion Criteria:

1. Previously participated in, or are currently participating in, a Spark Therapeutics clinical trial and received voretigene neparvovec-rzyl in both eyes.
Postapproval Trial On Carotid Stenting in Patients With High Risk Vs Standard Risk for Open Carotid Endarterectomy(REAL)

Until the irruption of the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST), carotid stenting (CAS) has been mainly offered to those patients considered at "high risk" for open carotid endarterectomy (CEA) based on the available data from large randomized clinical trials. "High risk" has been defined as (1) patients with severe comorbidity (class III/IV congestive heart failure, class III/IV angina, coronary disease involving ≥ 2 major vessels, left ventricular ejection fraction ≤ 30%, myocardial infarction, severe pulmonary disease, severe renal failure) and (2) Technical/challenging anatomical criteria (previous neck surgery, cervical irradiation, contralateral carotid occlusion, post-endarterectomy restenosis, inaccessible lesions or tracheotomy). Several recent studies have called medical "high-risk" into question for CAS indication.

The purpose of this study is to evaluate the safety and perioperative and long-term effectiveness in patients with significant carotid artery stenosis with "high-risk" criteria (for CEA) treated with carotid stenting and proximal protection device (MOMA®) compared to patients with standard-surgical-risk features.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic patients who have a transient ischemic attack, amaurosis fugax, or minor nondisabling stroke in the distribution of the study artery within 180 days of inclusion and have been shown carotid artery stenosis ≥50% by angiography, ≥70% by ultrasound, or ≥70% by CT angiography or MR angiography if ultrasound is 50% to 69%
* Asymptomatic patients who have carotid artery stenosis of ≥60% by angiography, ≥70% by ultrasound, or ≥80% by CT angiography or MR angiography if ultrasound is 50% to 69%

Exclusion Criteria:

* Patient is unable to respond to external questions and stimuli and to exert a pressure with the contralateral hand
* Patient has an myocardial infarction within 72 hours prior to carotid stenting
* Patient has a major residual neurological deficit (stroke scales: Barthel ≤ 60, NIH ≥ 15 or Rankin \>3) at pre-procedure neurological exam
* Patient had a transient ischemic attack (TIA) or amaurosis fugax within 48 hours prior to index procedure
* Patient had a stroke or retinal artery occlusion within 1 month prior to index procedure
* Patient has severe chronic renal failure (creatinine \> 2.5mg/dL)
* The target carotid artery is completely occluded
* The common carotid artery ostium has stenosis that required treatment
* The presence of ipsilateral intracranial stenosis that requires treatment
* The inability to position a stiff 0.035" guidewire in the external carotid artery
* Contralateral occlusion of internal carotid artery and vertebral arteries
68Ga-PSMA PET in the Renal Cell Carcinoma

The primary research purpose is to evaluate the diagnostic efficacy of 68Ga-PSMA PET in metastatic lesions of locally advanced and advanced renal cell carcinoma, and to compare with that of enhanced CT. The second purpose is to evaluate whether 68Ga-PSMA PET can change the treatment decision of patients with locally advanced and advanced renal cell carcinoma


Eligibility Criteria:
Inclusion Criteria:

* 2017 AJCC renal cell carcinoma TNM stage III, IV lesions;
* In contrast-enhanced CT staging, suspicious metastases were found;
* There were no known peripheral or central venous problems;
* 68Ga PSMA PET / CT imaging can be performed within 6 weeks after the diagnosis of renal cell carcinoma;
* Signed the informed consent form of voluntary participation in clinical trials.

Exclusion Criteria:

* Age ≤ 18 years old;
* Can't stand lying flat in PET / CT examination;
* There are contraindications for 68Ga PSMA ligands;
* In the past two years, there was a history of other malignant tumors, or according to the doctor's research judgment, complications may occur and affect the normal operation of the test;
* Renal function is impaired or hemodialysis is in progress.
Identification of Anxiety and Depression in Adolescents/Young Adults (AYA) With Cancer

This is a prospective, multisite (but all within the UTSW IRB), observational study assessing the relationship of hope to anxiety and depression, QoL, and social support over time in the first year after cancer diagnosis or relapse in AYA (ages 15-29 years of age).

The principal investigators' ongoing work suggests hope is a target for intervention to improve quality of life (QoL) and reduce anxiety and depression (A/D) among adolescents/young adults (AYA). No study to the investigators' knowledge has evaluated the promising impact of hope interventions in AYA cancer patients. To address this gap, the investigators will expand the investigators' prior research on hope, A/D, and QoL to AYA receiving care across three diverse healthcare systems.

Patients will be approached for participation within 3 months of their initial/relapse cancer diagnosis. Eligible patients (and the parent/caregiver for minor patients) will be approached in a private area of the clinic or hospital room to explain the research aims and informed consent process. After obtaining informed consent/assent (from parents if patients are under 18, from AYA if patient is 18 or older), participants (patients) will utilize an iPad to complete measures via Redcap.

Eligibility Criteria:
Inclusion Criteria:

* Adolescents and young adults (15-17, 18-29 years of age, respectively) with a new or relapse diagnosis of a malignancy
* Patients will include those being followed (treatment or observational) for any malignant disorder at Children's Medical Center, UT Southwestern Medical Center, or Parkland Health and Hospital Systems
* Patients whose native language is Spanish or English are eligible to participate
* Patients may have any life expectancy
* Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

* Patients with clinically apparent cognitive disabilities which would preclude understanding and completion of measures.
* Patients with significant medical issues such as delirium which preclude their ability to consent and complete initial measures