cyrilzakka/clinical-trials huggingface dataset:
Investigation of Wet Cupping Therapy on Heavy Metal Levels of Steel Industry Workers

This interventional study investigates the efficacy of Wet cupping therapy on heavy metal levels.The levels of the selected heavy metals will be measured in the blood samples obtained from the participants before and after the interventions

Wet cupping therapy (WCT) is a traditional therapy which was used for centuries especially for detoxifiying purposes.Current literature also points out its blood clarifiying capacity in order to illuminate the underlying mechanism of this ancient treatment.

Steel industry workers, different from the general population are exposed to heavy metals more often.Conducting a study in this special group where we will evaluate the levels of selected heavy metals in blood before and after the three sessions of WCT might let us know its detoxifiying capacity based on measurable parameters.

Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals
* Iron and Steel industry workers

Exclusion Criteria:

* having any chronic disorder
* being on daily medication
* wet cupping application in the last 6 months
A Phase I Study of Osilodrostat (LCI699) in Healthy Volunteers and Subjects With Impaired Renal Function

To characterize the pharmacokinetics of LCI699 following a single oral dose in adult subjects with various degrees of impaired renal function.


Eligibility Criteria:
Inclusion Criteria:

* Weight must be ≥50 kg and BMI must be between 18-35 kg/m2
* Subjects must have stable renal disease without evidence of progressive decline in renal function (stable renal disease is defined as no significant change, such as, stable eGFR \<90 mL/min, for 12 weeks prior to study entry) Other than renal impairment, subjects must be stable and appropriately managed relative to chronic diseases (such as diabetes and hypertension)

Exclusion Criteria:

* History of any surgical or medical condition other than renal impairment which might significantly alter the absorption, distribution, metabolism or excretion of drugs.
* Subjects with ongoing alcohol or drug abuse within 1 month prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening or baseline evaluations.
* Subjects with screening 12-lead ECG QTcF of \> 450 msec for males or \> 460 msec for female
* History of diabetes mellitus (Type 1 or 2) or blood glucose of \>125 mg/dl at screening
* Subjects with potassium levels greater than the upper limit of normal (\>ULN)

Other protocol defined Inclusion/Exclusion may apply.
Mindreading in Adults With Autism Spectrum Disorder

This study aims to investigate the ability of reading emotions by the Eyes task in adults with ASD, and examine the gazing pattern and frontal activation during the task. We plan to recruit 50 adults with ASD and 50 typically-developing adults. Eye-tracking and frontal activation (measured by functional near-infrared spectroscopy) will be examined during the Eyes task.

Autism spectrum disorder (ASD) is a clinical syndrome characterized by mindreading deficits, or Theory of Mind deficits. The Reading the Mind in the Eyes task (abbreviated as the Eyes task) was developed to assess the mindreading deficits as a hallmark of social deficits of ASD. This study aims to investigate the ability of reading emotions by the Eyes task in adults with ASD, and examine the gazing pattern and frontal activation during the task. We plan to recruit 50 adults with ASD and 50 typically-developing adults. All the participants will complete clinical measures and the Eyes task. Eye-tracking and frontal activation (measured by functional near-infrared spectroscopy) will be examined during the Eyes task.

Eligibility Criteria:
Inclusion Criteria:

* Adult aged between 20 and 50 years who had a diagnosis of ASD based on DSM-5.
* Had a full-scale IQ \> 70 on WAIS-IV.

Exclusion Criteria:

* A history of major mental illness (e.g., bipolar affective disorder, schizophrenia) or neurological diseases.
* Visual impairment and that would preclude participation.
GentleCath™ Air Intermittent Catheter Smartwatch Real Life Pilot Study

As part of the ongoing Clinical Evaluation and Post Market Clinical Follow Up (PMCF) activities it was determined that a pilot study should be conducted to look at how real life data such as various physiological measurements can be collected via a Smart-Watch during intermittent self-catheterisation whilst also collecting real life feedback from users on comfort as measured by levels of possible discomfort and on levels of anxiety which may be associated with intermittent catheterisation over a period of time.

Adherence to catheter regimen and proper emptying of the bladder is of clinical relevance for clean intermittent catheterisation. A Daily Fluid Diary is included in this pilot study together with the use of the microphone of the Apple™ Smart Watch to investigate the feasibility of tracking input and output of fluids. The user acceptance of the Daily Fluid Diary offered via the iPhone app and the feasibility of the microphone to capture bladder emptying or voiding are to be tested within this pilot.


Eligibility Criteria:
Inclusion Criteria:

* • Females aged 18 years old and above who require intermittent bladder drainage

  * Idiopathic and Neurogenic subjects
  * Be willing and able to provide electronic informed consent
  * Be willing and able to wear a Polar H10 chest-strap
  * Must be willing and able to use the smart technology provided e.g. Smart Phone with software application and/or smart watch to answer the required questions
  * Currently use intermittent catheters
  * Have used intermittent catheters for more than 6 months
  * Subjects who perform intermittent catheterisation at least twice per day
  * Speak, read and write in English

Exclusion Criteria:

* • Subjects who require intermittent catheterisation to administer irrigation or instillation.

  * Short term voiding difficulties following Botox injections
  * Currently participating in another clinical trial or has participated in a clinical study in the previous month
  * Current users of the GentleCath™ Air intermittent catheter
  * Exhibiting any other medical condition which, according to the investigator, justifies the subject's exclusion from the study, for example- medical conditions that affect heart rate, anxiety disorders, uncontrolled diabetes, hyperthyroidism, psychological disorders, and other causes of blunted autonomic response.
  * Subjects with a known alcohol dependency and/or recreational drug use
  * Current symptomatic Urinary Tract Infection (UTI) or diagnosed UTI in the previous 2 weeks
  * Known sensitivity to the catheter device components or the Apple™ Watch or Polar™ H10 chest straps
  * Pregnancy or breast feeding
  * Subjects, in the opinion of the Investigator, unable to carry out the study procedures or other factors e.g. Planned surgery which may prevent them from completing the study.
Quality of Life in Children Cured of Retinoblastoma

The aim of the study is to assess the quality of life of children who have been cured of retinoblastoma - a malignant eye tumor. The study is questionnaire-based, and uses standardized quality of life assessment tools.

Retinoblastoma is the most common eye tumor of children. It can present in one eye (unilateral) or in both eyes (bilateral). The bilateral form is always hereditary.

Retinoblastoma is a highly curable tumor. Using a combination of surgery, chemotherapy, radiation and local treatment modalities to the eye, over 98% of patients are cured. This means that most children diagnosed with retinoblastoma will become long-term survivors.

The use of surgery (taking out one eye), chemotherapy, and radiation may be associated with long term side-effects, some of which may have significant impact on the quality of life of the child. In addition, in case where the disease is hereditary, additional psychological issues arise.

The aim of our study is to assess, in a comprehensive and standardized fashion, the long term quality of life in children who were treated for retinoblastoma, and who are currently alive and well.

The assessment will include the use of questionnaires that assess quality of life, as well as participation in age-appropriate activities.

Each child, and his/her parent, will be interviewed and the questionnaires completed. The process will take about one hour for each child. No risk or discomfort to the child is involved.

Eligibility Criteria:
Inclusion Criteria:

* Past treatment for retinoblastoma
Patient-reported Outcomes in the Bergen Early Cardiac Rehabilitation Study

An intervention study with longitudinal follow-up of patients with coronary artery disease undergoing early cardiac rehabilitation is designed.

The main objective of the study is to investigate patient-reported outcomes, their relation to clinical characteristics of the patients and the potential to predict health outcomes and adverse events in coronary artery disease patients participating in an early cardiac rehabilitation programme.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of coronary artery disease
* \>=18 years of age
* Has performed a negative exercise test (bike or treadmill) and thereby able to participate in exercise training.

Exclusion Criteria:

* Cognitive impairment
* Unstable angina pectoris
* Aortic stenosis
* Left ventricular ejection fraction \<30%
* Heart failure NYHA class III-IV
* Serious arrhythmia in need of treatment
* Being on the waiting list for percutaneous coronary intervention or coronary artery bypass grafting.
A Study to Evaluate the Safety and Efficacy of ET-01 Transplantation in Subjects with Transfusion Dependent Β-Thalassaemia.

This is an open label, single site study to evaluate the safety and Efficacy of ET-01 Transplantation in subjects with Transfusion Dependent β-Thalassaemia.


Eligibility Criteria:
Key Inclusion Criteria:

* Subject and/or subject's legal personal representative fully understand and voluntarily sign informed consent forms;
* 6\~35 years old, all gender;
* Diagnosis of transfusion dependent β-thalassemia (β-TDT) as defined by protocol;
* Eligible for autologous stem cell transplant;
* Organs in good function.

Other protocol defined Inclusion criteria may apply.

Key Exclusion Criteria:

* Subjects with associated α-thalassemia;
* Active bacterial, virus, fungal or parasitic infection, including HIV infection, HbsAg and HBV DNA positive, HCV DNA positive, or Treponema Pallidum infection;
* HLA identical sibling or unrelated donors are available;
* Prior allo-HSCT or gene therapy.

Other protocol defined Exclusion criteria may apply.
Pioglitazone vs Vitamin E vs Placebo for Treatment of Non-Diabetic Patients With Nonalcoholic Steatohepatitis (PIVENS)

The purpose of this study is to determine if therapy with pioglitazone or vitamin E will lead to an improvement in liver histology in non-diabetic adult patients with non-alcoholic steatohepatitis (NASH).

The purpose of this study is to determine if therapy with pioglitazone or vitamin E will lead to an improvement in liver histology in non-diabetic adult patients with non-alcoholic steatohepatitis (NASH).

Eligibility Criteria:
* Histologic evidence of NASH based on a liver biopsy obtained within 6 months of randomization.
* Age 18 years or older
Evaluation of the Retina of Subjects Without Diabetes Mellitus and Subjects With Diabetes Mellitus Without Diabetic Retinopathy Using Optical Coherence Tomography

The purpose of this study is to evaluate topographic features of the posterior pole of the eye in normal subjects as well as in subjects with diabetes mellitus but without diabetic retinopathy (DR) using optical coherence tomography (OCT). The investigators proposal is a novel study to determine retinal volume of normal and diabetic subjects without DR. Specifically, the investigators will establish a standardized reference range for retinal thickness and volume that will provide standards for OCT analysis of different clinical trials for retinal diseases.


Eligibility Criteria:
Inclusion Criteria:

* Healthy retinas
* Willingness to sign informed consent to have OCT images taken.

Exclusion Criteria:

* No macular pathology
* No Diabetes
Erythropoietin Therapy for Children With Cerebral Palsy: Phase 1

This purpose of this phase 1 study is to investigate the safety and efficacy of erythropoetin for children with cerebral palsy.

Cerebral palsy is a disorder of movement and posture resulted from a nonprogressive lesion or injury of the immature brain. It is a leading cause of childhood onset disability.

Many experimental animal studies have revealed that erythropoietin is useful to repair neurological injury in brain. The main mechanism of erythropoietin is supposed as follows; neuroprotection effect, angiogenesis, and anti-inflammation.

On the basis of many experimental studies, erythropoietin is suggested as a potential therapy for cerebral palsy.

Eligibility Criteria:
Inclusion Criteria:

* Cerebral Palsy
* Abnormal Muscle Tone
* GMFCS (Gross Motor Functional Classification System): II to IV
* Age: 6 months \~ 3 years
* Abnormal Brain MRI compatible to clinical features and non-progressive
* Willing to Comply with All Study Procedure

Exclusion Criteria:

* Known Genetic Disorder
* Baseline Erythropoietin level \> 45 mU/mL
* Presence of Drug Hypersensitivity Related to the Study Remedy
* Previous Erythropoietin Treatment before 3 months
* Coagulopathy:

Family History, Unknown Cerebral Infarction, Thromboembolic Events History

* Intractable Seizure Disorder
* Poor Cooperation of Guardian including Inactive Attitude for Rehabilitation
* Uncontrolled Hypertension
* Liver Dysfunction
* Renal Dysfunction
* Absolute Neutrophil Count \< 500/dL
* Intracerebral or Intraventricular Hemorrhage
* Malignancy
Efficacy of CryoBalloon Focal Ablation System on Human Esophageal Barrett's Epithelium

The purpose of this study is to assess the efficacy and performance of the C2 Focal Cryoablation System in patients with BE.

The purpose of this study is to assess the efficacy and performance of the C2 Focal Cryoablation System in patients with BE. The study will involve up to 50 subjects with each subject receiving cryoablation therapy of all visible BE using the C2 System Focal Ablation System. Length of ablation will be 10 seconds. The ablations will be performed on Barrett's epithelium with a maximal length of 6 cm.

At the time of endoscopic follow up, biopsies of the treated area will be taken and submitted for analysis according to Histopathology Protocol.

This study is:

* Prospective
* Multi-center
* Non-randomized

Eligibility Criteria:
Criteria Inclusion Criteria

* Patients with known Barrett's esophagus, with an indication for ablation therapy during which the cryoablation may be performed.
* Patient is 18 to 80 years of age at the time of consent (inclusive).
* Patient has provided written Informed Consent (IC) using an Informed Consent Form (ICF) that has been approved by the Institution's reviewing IRB/EC.
* Patient is willing and able to comply with all Clinical Investigation Plan (CIP) requirements.
* Patient is deemed operable per standard institutional criteria.
* BE lesion length \<6cm excluding visible BE islands, and Prague Classification C ≥ 0 / M ≥ 0.
* One of the following: Flat LGD, Flat HGD, Residual BE after EMR for visible lesions (containing any degree of dysplasia or low-risk early adenocarcinoma (i.e.: not poorly differentiated, negative vertical (deep) resection margins, absence of (lympho)vascular invasion), Residual BE after a single circumferential RFA (performed for indications listed above: i-iii)
* BE lesion within the treatment zone should be flat

Exclusion Criteria

* Esophageal stenosis preventing advancement of a therapeutic endoscope within 4 cm of treatment zone.
* Patient has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post treatment instructions or follow-up guidelines.
* Patient refuses or is unable to provide written informed consent.
* Patients that are pregnant.
* Patient with endoscopically active inflammation in the treatment zone.
* Endoscopically visible abnormalities such as masses or nodules requiring endoscopic resection.
Injection Site Pain Botulinum Toxin Reconstituted in NS With and Without Sodium Bicarbonate

This study was designed to investigate the effects of botulinum toxin type A injections diluted with the mixture of sodium bicarbonate (SB) and normal saline (NS) on pain reduction, onset of action and duration of action.

This is a prospective, randomized, double-blind clinical study, which included 30 female patients (age\>25). The patients were randomized to receive botulinum toxin (BT) injections diluted with NS and SB on one side of the face and saline control injections on the other side. Pain severity was assessed using visual analogue scale. The onset and duration of action were recorded according to the patients' subjective opinions after 1 week and 3 months, respectively. The study was approved with an IRB (Institutional Review Board) number of RC19/371.


Eligibility Criteria:
Inclusion Criteria:

* Any female patient who is in good health and has moderate dynamic forehead and glabellar wrinkles.

Exclusion Criteria:

* • Patients \<25 years old

  * Presence of neuromuscular disease or intake of drugs affecting muscle tone.
  * Any active infection in the treatment area.
  * Patients receiving anticoagulation or had a diagnosis of bleeding disorders.
  * Any patient who had undergone the following treatments to the forehead area in the past 6 months: botulinum toxin injections, ablative laser procedures, radiofrequency device treatments, ultrasound device treatments, or medium to deep chemical peels.
  * Any patient who had temporary soft-tissue augmentation material to the forehead area in the past 12 months, semi permanent soft-tissue augmentation material in the past 2 years, or permanent soft-tissue augmentation material at any point in the past.
  * Any patient with prior facial cosmetic surgical procedures such as eyebrow-lifts, blepharoplasties, and rhytidectomies.
Effects of Exer Gaming on Balance and Gait in Parkinson's Patients

To compare the effects of exer-gaming with conventional physiotherapy on balance and gait in Parkinson's patients

Parkinsons Disease is a progressive neuro degenerative disorder manifested by a broad spectrum of motor and non-motor features. Approximately 500 000 people suffer from Parkinson's Disease in the United States and there are approximately 50,000 new cases reported annually . Postural instability, impaired gait, and freezing episodes are all common occurrences in Parkinson's. Agility activities, including supine-to-stand, ambulation, turning, and reaching activities, have been used to reduce freezing episodes, particularly in the early stages of disease.

Conventional physical therapy(balance training, stretching and strengthening exercises) being used for the balance and gait training in Parkinson. In recent time, there has been development in such treatment plan. Virtual reality based games have been used for such purposes. This study will look at the effects of virtual reality gaming in patients suffering from Parkinson's disease and its outcomes in term of gait and balance training. A randomized clinical trial will be performed. total 16 patients will be included in the study and will be divided into two groups. VR Group will be receiving virtual reality based exercise plan while the CONVENTIONAL group will receive conventional physical therapy . Division will be done through lottery method. Unified parkinson's disease rating scale and dynamic gait index will be used to collect the data. Treatment frequency will be three days per week for three months .

Eligibility Criteria:
Inclusion criteria:

* Diagnosed Parkinson's disease patients in stage I, II,III according to Hoeh n-Yahr classification.
* Patients with balance and gait disorders

Exclusion criteria:

* Other neurological conditions (stroke, Alzheimer)
* Red flag signs (tumors, fractures, infections etc)
* Uncontrolled hypertension.
* Patients with visual disturbances
* Patients with cognitive disorders
Dietary Impact on Intestinal Sulfate Metabolism

This is a 5-week crossover pilot study of 15 highly motivated healthy volunteers who will consume two 7-day intervention diets: 1) a diet low in sulfur-containing amino acids (Low-S diet), emphasizing plant-based foods and fat sources; and 2) a diet high in sulfur-containing amino acids (High-S diet), emphasizing animal protein and fat sources. A 14-day washout period will follow each intervention, in which participants will eat their typical diets.


Eligibility Criteria:
Inclusion Criteria:

* Provide informed consent
* Ambulatory and community dwelling
* Able and willing to comply with the study schedule and procedures
* 18 - 80 years of age
* BMI between 18.5 - 40.0 kg/m2
* Omnivorous or willing to consume animal products through duration of study

Exclusion Criteria:

* Antibiotic use within 3 months
* Planned antibiotic therapy within the period of the study, e.g., perioperative antibiotics.
* Use of sulfonamides or sulfasalazine, as these sulfur-containing medications may confound results
* Use of 5-aminosalicylates (5-ASA), as they are known to inhibit sulfidogenesis
* History of anaphylactic food allergies, e.g., peanuts, seafood.
* Food intolerances and allergies, including gluten sensitivity, lactose intolerance, and intolerance of high fiber dietary content.
* Strict vegan eating practices, with refusal to consume animal products.
* Planned use of oral probiotics while on study.
* Serious, concomitant illness that, in the opinion of the Investigator, would interfere with evaluation of safety or efficacy, or put the participant at risk of harm from study participation.
* Significant alcohol use, defined as \> 20 g/day in females and \> 30 g/day in males for a period of 3 months within one year prior to screening.
* Underlying chronic gastrointestinal disease that can cause diarrhea, including short bowel syndrome, irritable bowel syndrome, malabsorption, and celiac disease.
* History of partial or complete colectomy.
* History of malabsorptive bariatric surgery.
* Currently participating in another clinical study.
* Legally incompetent and unable to understand the study's purpose, significance and consequences, and to make decisions accordingly.
Long Term Follow up of Spinal Stenosis Inpatients Treated With Korean Integrative Medicine Treatment.

The purpose of this study is to reveal the effectiveness and safety of integrative Korean medicine for spinal stenosis by observation inpatients treated with integrative Korean medicine.

This study is a prospective observational study. The subjects for study are patients diagnosed with spinal stenosis and who have been admitted to four Jaseng Hospital of Korean medicine (Gangnam, Bucheon, Daejeon, and Haeundae) for 2015.01-2018.12.

Medical records of selected patients will be analyzed, and telephone surveys will be conducted for each patient. The survey questions are Numeric rating scale (NRS), Oswestry disability index (ODI), quality of life, and Patient Global Impression of Change (PGIC), etc.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with spinal stenosis by an Korean medicine doctor and was admitted to Jaseng hospital of Korean medicien.
* Patients undergone MRI readings of central spinal stenosis
* Patients have no communication problems
* Patients have agreed to participate the study.

Exclusion Criteria:

* Patients who have been diagnosed with certain serious diseases that may cause back pain or neck pain (tumor metastases to the spine, acute fractures, spinal dislocations, and so on)
* Patient hospitalized for pain caused by a traffic accident
* Patients with serious mental illness
* Patients deemed unable to participate in the clinical research by other researchers