cyrilzakka/clinical-trials huggingface dataset:
Extract of Ginkgo Biloba and Tardive Dyskinesia

The purpose of this study is to determine whether Extract of Ginkgo Biloba is effective in the treatment on Tardive dyskinesia

Tardive dyskinesia(TD) is a common complication of conventional antipsychotic treatment in subjects with schizophrenia. There is no established treatment for TD patients.This disorder remains a significant clinical problem for both patients and physicians for the foreseeable future.

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 to 60yrs
* Meeting Diagnostic and Statistical Manual of Mental Diseases, Fourth Edition(DSM-IV) criteria for schizophrenia or schizo-affective disorder
* Abnormal Involuntary Movement Scale (AIMS) score ≥2.
* Patients from whom informed, written consent is obtained.
* Patients who have been on a fixed dose of antipsychotic medication for at least 4 weeks prior to trial entry.

Exclusion Criteria:

* Significant neurological disorder other than TD
* Substance abuse
* Significant other medical illness
* Psychiatric disorder not stabilised
* Pregnancy or lactation
* Take antioxidants(such as Vitamin C)
Arena Labs - Improving Clinician Well Being

To determine the efficacy of the asynchronous performance coaching platform, Arena Strive at changing measures of physiological resilience, professional fulfillment, burnout, and self-valuation in full time clinicians.

This study is a prospective randomized controlled longitudinal crossover design with a per protocol analysis integrating one sensor (WHOOP, inc Platform) and one educational intervention (Arena Strive Platform). The WHOOP sensor collects data on heart rate (HR), heart rate variability (HRV), and sleep data, and will be worn by all participants in the experimental intervention. Participants will be asked to wear the biometric sensor for 12 weeks but will have optional access to the device for a total of 24 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Employed full time by an Atrium Health affiliated entity
* Age 18+
* Willing and able to give written informed consent for study participation
* Healthcare workers working ≥ 36 hours of clinical duties/week
* Willingness to wear WHOOP and keep it charged for the entire duration of study
* Have a smart phone for pairing with WHOOP and the Arena Strive platform

Exclusion Criteria:

* Current diagnosis of a sleep-related breathing disorder including obstructive sleep apnea not being treated (with or without continuous positive airway pressure (CPAP) treatment)
* Circadian rhythm sleep-wake disorders
* Narcolepsy
* Recurrent isolated sleep paralysis
* Restless legs syndrome
* Periodic Leg Movement Disorder
* Comorbid nocturia or other conditions (benign prostatic hyperplasia) resulting in frequent need to get out of bed to use the bathroom during the night (≥3 times per night average)
* Atrial Fibrillation
* Chronic obstructive pulmonary disease (COPD) other than mild, pulmonary fibrosis or severe chronic lung disease
* Sleep apnea or undergoing treatment for a sleep related illness
* Lack of availability of iPhone or Android device
NeuroAiD II™ (MLC901) in Mild Traumatic Brain Injury

A Randomized Double-blind, Placebo-controlled, Multi-center Trial to determine the efficacy of NeuroAiD II™ (MLC901) in improvement of cognitive functioning of adult patients with long-term cognitive impairment following mild traumatic brain injury (mTBI) and to assess safety of NeuroAiD™ (MLC901) in these patients.


Eligibility Criteria:
Inclusion Criteria:

1. Patient with mild TBI, which occurred 1-12 months prior enrolment to the study. Mild TBI is defined as an external force from an incident causing injury to the brain and resulting in an altered level of consciousness. The mTBI diagnosis should be documented. Mild TBI is evidenced by any of the following:

   * best Glasgow Coma Score 13-15 as assessed on scene, on admission and over next 3 days
   * loss of consciousness for up to 30 minutes
   * dazed and confused at the time of injury or post-TBI amnesia of \< 24 hours duration.
2. Patient experiencing cognitive impairment following injury, determined by the Cognitive Failures Questionnaire score \>30.
3. Adult male or female patients aged 18-65 years.
4. The patient has signed an Informed Consent form (ICF) for participation in this study before initiation of study procedures.
5. The patient can understand all protocol requirements, perform the study procedures, and agree to all limitations specified in the protocol.
6. The patient agrees to use adequate contraception methods.

Exclusion Criteria:

1. Moderate or Severe TBI, determined by best Glasgow Coma Score of \<13 (as assessed on scene, on admission and over next 3 days), or injury requiring neurosurgery (even if surgery was not done)
2. Co-existing severe co-morbidity, including end stage renal failure, spinal cord injury, significant substance abuse, severe liver disease, significant mental illnesses, diabetes requiring insulin injections, severe agitation, advanced cancer or other severe conditions with life expectancy of less than 5 years. The decision on significance of the comorbidity for inclusion/exclusion from current study is made by the Investigator.
3. Current participation in another clinical trial within 30 days.
4. Women who are pregnant or who have a positive urine pregnancy test or breast-feeding.
5. Not fluent in Russian language or have aphasia/dysphasia.
6. No documented evidence of mTBI.
7. Known allergy to MLC901/NeuroAiD II™ or any of its component ingredients.
8. Other medical condition which in the opinion of the Principal Investigator would place undue risk on the patient if included in the trial or likely to interfere with NeuroAiD II™.
9. History of psychic (including depressive) disorders, physical and other factors that do not allow for adequate self-assessment of one's behaviour and for compliance with the protocol requirements, including history of psychiatric disorders.
10. Use of hormonal contraceptives, either oral or implant\*.
Humalog® Mix50/50(tm) as a Treatment for Gestational Diabetes

Evaluation of the Safety and Efficacy of Humalog® Mix50/50TM administered as 3 injections daily to Humalog® plus Humulin N® insulin administered as 6 separate injections daily in terms of glucose control for women with Gestational Diabetes.

Controlling hyperglycemia during pregnancy decreases the risk of adverse neonatal and maternal outcomes. Not only must fasting glucose be normalized, but clinical evidence also indicates that controlling postprandial hyperglycemia will significantly reduce the risk of adverse neonatal and maternal outcomes.

Standard therapy to achieve near-normal glycemia in gestational diabetes involves combining intermediate-acting basal (NPH) insulin with rapid-acting insulin (insulin lispro), thereby requiring 6 daily injections. Premixed Humalog® Mix50/50TM has the potential advantage over combination rapid-acting plus NPH insulin because it involves fewer injections, and those injections are associated with mealtime. The potential downside to the premixed formulation is nocturnal hypoglycemia associated with the time lag between the dinner and breakfast dose. This study will evaluate the efficacy and safety of Humalog® Mix50/50TM compared to that of Humalog® plus Humulin N® insulin for the treatment of insulin-requiring patients with gestational diabetes mellitus, while monitoring glucose control, intrauterine growth and assessing pregnancy outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant and at least 13 weeks gestation
* Diagnosed with gestational diabetes mellitus
* Failed diet therapy

Exclusion Criteria:

* \<18 years old or over 45 years old
* urine dipstick \>2+ protein
* blood pressure \>140/80 mmHg
* hematocrit \<30%
* refusal to take insulin
* inability to understand instructions or to consent to participate.
Endothelial Function and IMT in Survivors of Hodgkin's Lymphoma

The aim of the proposed study is to assess endothelial function and IMT, as correlates of cardiovascular disease (CVD), in young adult Hodgkin's disease (HD) survivors, and to relate endothelial function to other risk factors including obesity, dyslipidemia, hyperinsulinemia and fasting glucose.

Disease free survival of Hodgkin's disease (HD) patients has improved dramatically over the past few decades. With the dramatic advance in patient's survival, the prevention and treatment of long-term adverse effects of chemotherapy and radiotherapy has become a major focus of interest. HD survivors have excess mortality compared with the age-matched general population, even after excluding disease relapse. A considerable proportion of the excess mortality is due to cardiovascular disease (CVD), principally ischemic heart disease and stroke.

The proposed study will assess endothelial function in HD survivors, using the non-invasive technique of brachial artery flow-mediated dilation (FMD), by high-resolution ultrasonography. We will also assess IMT. The results of these tests are independent predictors of atherosclerosis disease progression and cardiovascular event rates. This is a prospective study comprising 40 young-adult (aged 18-30 years) . The study will comprise 40 survivors of HD: 20 patients treated with chemotherapy and radiotherapy to the chest and 20 patients treated with chemotherapy alone. The patients will be compared to age and sex-matched patients from the data base of the endothelial function laboratory at the heart institute of the Sheba Medical Center. In addition to brachial artery endothelial function assessment, the patients will also undergo a physical examination including anthropometric measurements (height, weight, waist and hip circumference), and blood pressure. The evaluation will also include blood tests for glucose, lipid profile, CRP, AST, ALT and insulin. A medical history including smoking history and family history of CVD and dyslipidemia will be obtained.

Patients treated with radiotherapy to the chest will be compared to patients treated with chemotherapy alone and both patients will be compared to healthy controls. The patients will be characterized by age, risk factors for coronary heart disease and endothelial function as assessed by brachial artery FMD. We will establish the rate of endothelial function abnormalities in survivors of HD and its correlation with the other risk factors.

Eligibility Criteria:
Inclusion Criteria:

* Hodgkin's disease survivors over 18 years old
Comparability of Fingerprick vs Venous Blood for Tacrolimus Monitoring

Organ transplant rejection occurs when the immune system attacks the transplanted organ. To prevent rejection, transplant-patients are given immunosuppressant drugs which can suppress the immune system from attacking the transplanted organ. Patients who have had a kidney-transplant take immunosuppressant drugs such as tacrolimus, but the dosage must be closely monitored through regular blood tests to avoid complications like organ failure and kidney damage. The current practice at Nottingham University Hospitals NHS Trust is that kidney-transplant patients being monitored for tacrolimus have regular blood samples taken by venepuncture (vein), and the samples are sent to the laboratory to be measured using liquid chromatography-tandem mass spectrometry (LC-MS/MS), a technique used in chemistry to identify and quantify substances in a sample. Patients will also often have their blood-creatinine measured to get an idea of kidney health. Visits to the GP/hospital for this type of blood collection can be disruptive to a patient's daily life and stretches resources of the NHS. An alternative blood sample collection process involves the use of a hand-held blood collecting device called a Mitra device, designed to allow patients to collect samples at home through a finger-prick and send them by post for analysis. This method is especially beneficial for those who find hospital visits challenging or venepuncture painful.

This study aims to develop an LC-MS/MS method for measurement of tacrolimus and creatinine, using finger-prick samples collected on the Mitra device. To do this, kidney-transplant patients who are having routine venepuncture to measure tacrolimus and creatinine will simultaneously have a finger-prick sample collected using the Mitra device. Both the venepuncture sample and finger-prick samples will be analysed using existing LC-MS/MS technology to determine tacrolimus and creatinine values. The LC-MS/MS analysis method for the finger-prick samples collected using the Mitra device will be optimised and then results obtained using this method will be compared to the results obtained from venepuncture-collected samples to ensure consistency of results. Agreement of results between the two analysis methods will confirm the suitability of LC-MS/MS method for the measurement of tacrolimus and creatinine using samples collected using the Mitra device.


Eligibility Criteria:
Inclusion Criteria:

* Patients attending renal clinic who are receiving immunosuppressant treatment (tacrolimus) and require regular monitoring.

Exclusion Criteria:

* No exclusion criteria
Exploratory Non Comparative Study to Evaluate the Efficacy of Highly Bioavailable Curcumin (Flexofytol) in Patients With Knee Osteoarthritis

The purpose of this study is to evaluate the efficacy of bio-optimized curcumin(Flexofytol) during a 90-days period in knee ostearthritis patients on the serum levels of specific biomarkers of osteoarthritis and on the evaluation of pain.


Eligibility Criteria:
Inclusion Criteria:

* 45 to 80 years of age
* Internal femorotibial gonarthrosis responding to the clinical and radiological criteria of ACR
* Symptomatic knee for more than 6 months
* Mean knee pain on the last 24 hours of at least 40 mm on VAS
* Kellgren \& Laurence grade II to III
* Patients able to avoid NSAIDs and analgesics during the study
* Patients having signed informed consent
* Patients able to follow the study instructions

Exclusion Criteria:

* Related to the osteoarthritis pathology:

  * Osteoarthritis linked to a metabolic arthropathy
  * Predominant associated symptomatic femoropatellar osteoarthritis
  * Chondromatosis or villonodular synovitis of the knee
  * Recent trauma (\< 1 month) of the knee responsible for the pain
  * Inflammatory flare
  * Pathology potentially interfering with the evaluation (metabolic inflammatory arthropathy, rheumatoid arthritis, lower limb radiculalgia, arthritis...
  * Paget disease
  * Homolateral coxarthrosis
  * Articular Prosthesis
  * Knee joint effusion
* Related to previous and associated treatments:

  * Corticosteroids injection in the previous month, whatever the joint concerned,
  * Hyaluronan injection in the evaluated knee during the previous 6 months,
  * NSAID or analgesics in the 72 hours prior to inclusion
  * No modification of Slow-acting drugs for OA and/or dietary supplements taken within less than 6 months prior to the study(ex: chondroitin sulfate, diacerein, soy and avocado unsaponifiables, oxaceprol, granions de cuivre, glucosamine, phytotherapy for OA, homeopathy for OA...),
  * Anticoagulant (coumarinic) treatment and heparin
  * General corticotherapy,
  * Contraindication to paracetamol.
* Related to associated pathologies:

  * Patient suffering from serious associated illness (liver failure, kidney failure, non-controlled cardiovascular diseases...)
* Related to patients:

  * Pregnant or breastfeeding women
  * Pre-menopausal women with no contraception
  * Patients unable to write
  * Patients enrolled in a clinical trial in the previous 3 months
  * Patients under juristic protection or under guardianship.
VR Training for Pilots With Neck Pain

The aim of the proposed study is to investigate the effectiveness of an interactive, virtual reality (VR) training program for pilots compared with standard care. The study will be a randomized controlled trial (RCT) consisting of 60 pilots randomized into one of two groups: standard physiotherapy and medical care vs standard care and VR training. Outcome measures will include subjective scores of pain intensity and global perceived effect; objective measures of range of motion (ROM), neck motion velocity, and motion accuracy; and functional measure of days grounded due to neck pain. Data will be analyzed using ANOVA for within and between groups analyses.

The aim of the proposed study is to investigate the effectiveness of an interactive, virtual reality (VR) training program for pilots compared with standard care. The proposed intervention program includes training in neck range of motion, control, accuracy and coordination and is expected to reduce the prevalence and operational impact of neck pain in the intervention group more effectively than does standard care alone.

The proposed study will be designed as a randomized, controlled trial (RCT). Sixty fighter and helicopter pilots will be randomized into two groups, to receive either standard physiotherapy and medical care or standard care with the addition of interactive, dynamic, controlled training (a self-exercise program) in VR to address the fast, accurate head control required in flying tasks.

Subjective outcome measures will include pain intensity and global perceived effect. Objective measures will include range of motion, motion velocity and accuracy. The functional measure will include days grounded due to neck pain.

Statistical analysis will use independent, repeated measures ANOVA on each parameter, within and between groups. Post hoc comparisons, including several preplanned contrasts, will be performed to assess differences before and after treatment, and the stability of changes over time, in each group. The relationship of risk factors to performance failures will be assessed using multivariate logistic regression analyses.

This study is the first in the Israeli Air Force to evaluate this type of comprehensive, functional intervention program. Such research will dramatically advance the military's health care approach to neck pain, and may be further applied to other populations in and outside the Israeli Defence Force (IDF). This study may serve as a stepping stone to further research related to diagnosis, treatment, and prevention methods during a pilot's active service.

Eligibility Criteria:
Inclusion Criteria:

* fighter and helicopter pilots from the Israeli Air Force
* acute, sub-acute, and chronic neck pain, with or without referral to the upper limbs

Exclusion Criteria:

* neurological disorders (e.g. evidence for positive neurological signs), systemic disease, history of spinal surgery, or any disorders that may limit the ability to exercise
Assessment of Thrombotic Status in Patients With Acute Coronary Syndrome

Impaired thrombotic status is associated with adverse cardiovascular events. Patients with acute coronary syndrome (ACS) are at increased cardiovascular risk. The aim of the study is to determine the usefulness of thrombotic status assessment in a large cohort of ACS patients, managed with contemporary treatments, to identify patients at risk of thrombosis and those at risk of bleeding complications.

Patients presenting with acute coronary syndrome (ACS) are at increased risk of future cardiovascular events, despite optimal medical treatment and coronary intervention. Such events are usually caused by increased stickiness of the blood causing a blood clot (thrombus) to block arterial blood vessels in the heart. Much of the medication to prevent recurrent thrombotic events increases the risk of bleeding complications. Identification of patients at recurrent thrombotic risk could allow targeted treatment with potent antithrombotic medications, with less potent agents in others to reduce bleeding. The investigators will assess the stickiness of the blood (i.e. thrombotic status) in patients who are admitted to hospital with ACS; at baseline, at discharge from hospital and at 30 days post hospitalisation. Blood stickiness will be tested using a number of tests of thrombotic status including thrombin generation assays, Thromboelastography (TEG) and the near-patient, point-of-care Global Thrombosis Test (GTT). The results will be evaluated to assess the effect of disease process and clinical state on blood stickiness to gain further understanding of the condition and form the basis for future studies aimed at identifying patients who are at high risk of future cardiovascular events.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients aged 18 years or over.
2. Patients diagnosed with ACS and free of exclusion criteria below.
3. The patient is willing and able to understand the Patient Information Sheet and provide written informed consent.
4. The patient must agree to comply with the drawing of blood samples for the assessments.

Exclusion Criteria:

1. The patient has, in the opinion of the investigator, significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, haemorrhagic, metabolic or other disease likely to confound the study requirements or analyses.
2. The patient has a history of substance abuse or demonstrates signs or clinical features of active substance abuse or psychiatric disease.
3. Alcohol consumption above recommended safe levels (i.e. more than 21 units per week for males, or more than 14 units per week for females) due to the potential effects of high alcohol levels on platelet reactivity.
4. Any illness deemed significant by the investigator during the four (4) weeks preceding the screening period of the study.
5. Any major bleeding diathesis or blood dyscrasia (platelets \< 70 x 109/l, Hb \< 8 g/dl, INR \> 1.4, APTT \> x 2 UNL, leucocyte count \< 3.5 x 109/l, neutrophil count \< 1 x 109/l).
6. Currently enrolled in an investigational device or drug trial.
Study on Optimization and Evaluation of Integrated Chinese and Western Medicine for pSS Glandular Damage

ChatGPT In a randomized controlled trial, 136 patients with primary Sjögren's syndrome (pSS) meeting the inclusion criteria were enrolled and randomly divided into two groups of 68 each. The treatment group received an optimized program combining Chinese and Western medicine for pSS glandular injury, while the control group received a conventional program for pSS glandular damage. The primary efficacy endpoint was the 12-week non-stimulated salivary flow rate (UWS) score. Secondary efficacy endpoints included the glandular damage Visual Analog Scale (VAS) scores, the European Sjögren's Syndrome Patient Reported Index (ESSPRI), among others. The treatment course lasted 12 weeks. The efficacy and safety of the optimized program for pSS glandular injury were evaluated by comparing within and between groups before and after treatment.


Eligibility Criteria:
Inclusion Criteria:

* 1. clinical diagnosis of pSS and qi and yin deficiency ; 2.Sign the informed consent form.

Exclusion Criteria:

* 1. pSS activity system damage (ESSDAI score ≥5); 2. Combined connective tissue diseases other than pSS; 3. Pregnant or lactating women; 4. severe cardiovascular and cerebrovascular diseases, liver and kidney failure, and severe malignant tumors; 5. taking psychotropic drugs; 6. assessed by the investigator to be ineligible for enrollment.
EMR Chemotoxicity Risk Calculator To Decrease Chemotherapy Toxicity

This study will formally test the quality improvement intervention of an EMR based tool that informs medical oncologists visiting a patient for the first time of potential risk of chemotherapy toxicity.


Eligibility Criteria:
Inclusion Criteria:

* New outpatient visits with a medical oncologist following a new diagnosis of cancer and no prior history of chemotherapy treatment.
* aged \> 65 will be included.

Exclusion Criteria:

* Patients who opt out of clinical research will be excluded from analysis, but not the intervention (which will be applied to all patients). Specifically, as sometimes opt-in/opt out status is coded ambiguously in the data we will only analyze results of patients with clear opt in and no history of opt out.
* Patients with no EHR data after initial oncologist appointment.