cyrilzakka/clinical-trials huggingface dataset:
Clinical Trial on the Effectiveness of Herbal Medicinal Mixture in Parkinson Disease

This study was designed to evaluate the symptomatic effects or potential disease progression slowing down effect of a kind of Herbal Medicinal Mixture in Parkinson's disease (PD) patients. The treatment phase includes 12 months period of Herbal Medicinal Mixture per day or placebo and 1 month wash-out period without herbal medicine and placebo.

This study was designed to evaluate the symptomatic effects or potential disease progression slowing down effect of a kind of Herbal Medicinal Mixture in Parkinson's disease (PD) patients. The treatment phase includes 12 months period of Herbal Medicinal Mixture per day or placebo and 1 month wash-out period without herbal medicine and placebo.

The design of the study was a prospective, randomized, multicenter, double-blind placebo-controlled protocol. The intervention includes Herbal Medicinal Mixture Bid or matched placebo for 12 months plus 1 month wash-out period.

Participating study centers include Neurological University Outpatient Clinics and Neurological Departments of Community-based Hospitals experienced with PD patients.

The primary outcome measure was the combined Unified Parkinson's Disease Rating Scale (UPDRS).

The hypothesis of this study was that Herbal Medicinal Mixture improves the overall wellbeing of PD patients and thus may leads to an improvement of parkinsonian symptoms in PD patients.

Eligibility Criteria:
Inclusion Criteria:

* Parkinson's disease according to the UK Brain Bank criteria
* Hoehn \& Yahr stadium Ⅰ～Ⅲ
* Age over 50 years
* Taking only levodopa and/or dopamine agonists when recruiting
* Consistent with the liver kidney deficiency type by Traditional Chinese Medicine (TCM) standard
* Patients voluntarily take part in this study and signed the informed consent

Exclusion Criteria:

* Modified Hoehn-Yahr scale are higher than 4
* Had other serious illness such as liver/kidney failure, serious infection etc
* Allergic to the study drug
* Had been participated in other clinical trials during the last 3 months prior to study inclusion.
* Taking Coenzyme Q10, MAO-B inhibitors, or vitamin E, all of which might improve the symptom or slowdown the progression of PD.
* Taking herbal medicine that can nourish the liver and kidney by TCM standard.
* Had serious mental disorder and could not describe his/her symptom.
A Study of Siriraj Home Exercises Protocol for Primary Osteoarthritis of the Knee

The purpose of this study is to compare the exercise protocol called "Siriraj home base exercise program for OA knee" to usual care and physical modalities for conservative treatment in patients with 1st OA knee.


Eligibility Criteria:
Inclusion Criteria:

* 1st osteoarthritis of the knee Age \>/= 50 yrs

Exclusion Criteria:

* Previous knee surgery for OA knee treatment
* Has plan or schedule for knee surgery
* Severe degree of OA knee.
Genomewide Screening of Pathological Myopia

The purpose of this study is to evaluate the possible candidate gene of pathological myopia

High myopia (pathological myopia) is caused by excessive axial elongation that primarily involves the ora-equatorial area and the posterior pole. Peripheral fundus changes and posterior staphyloma formation are ophthalmoscopic evidences of this process. Pathological myopia often accompanied by glaucoma, cataracts, macular degeneration, and retinal detachment, leading to blindness when the damage to the retina is extremely severe. Population and family studies in Chinese have provided evidence for a genetic component to pathologic myopia. Children of myopic parents are more likely to have myopia than are children of nonmyopic parents. The ocular components (axial length, anterior chamber depth, and corneal curvature) and refractive errors of MZ twins are more closely aligned than are those of DZ twins.

Therefore, it is possible to search a potential candidate gene for myopia through the genomic study of pathological myopia.

Eligibility Criteria:
Inclusion Criteria:

* They are unrelated Chinese subjects with high myopia ≦-6.00D. The diagnosis of myopia is determined by the refractive error. Anisometropic individuals, with a refractive error of ≦-6.00 D for one eye and ≦-6.00 D for the other eye, with at least a 2-D difference between the two eyes, are considered unaffected.

Exclusion Criteria:

* Individuals are excluded if there is known ocular disease or insult that could predispose to myopia, such as retinopathy of prematurity or early-age media opacification, or if they had a known genetic disease associated with myopia, such as Stickler or Marfan syndrome.
Molecular Mechanisms of Malignant Cerebral Edema After LHI

The study is to explore the molecular mechanisms underlying the occurrence of malignant cerebral edema (cerebral hernia) after large hemispheric infarction. Acute LHI (\<=48h) patients that develop cerebral hernia or not within 5 days post-stroke onset, as well as the healthy controls will be studied. The participants will be followed for up to 6 months post stroke-onset, and their modified Rankin Scale (mRS) will be recorded. A mRS score of 0-4 is considered as a favorable outcome while a score of 5-6 as an unfavorable one.

A total of 80 patients with acute large hemispheric infarction (LHI) within 48h after occurrence admitted into NICU of Xuanwu Hospital as well as 40 healthy volunteers will be recruited. The patients' baseline characteristics, treatment and changes of clinical conditions will be recorded, and ICP monitoring (D2-D7 post-stroke), chest X-ray (D2, D7, D14 post-stroke), ECG (D2, D7, D14 post-stroke), cerebral vascular ultrasound, TCD and head MRI (T1WI, T2WI, FLAIR, DWI) on D2 and D14 post-stroke will be performed. Blood samples from both the LHI patients (D2, D4, D7, and D14 post-stroke) and the controls will be analyzed for NEU, TNF-alpha, IL-1b, IL-6, IL-8, IL-17, ICAM-1, VCAM-1, MPO, NE, MMP-9,miRNA, free dsDNA, H3CIT and NETosis levels. All patients were treated for brain edema with osmotic medications-either intravenous 20% mannitol or 10% hypertonic saline. In addition, some patients were treated with decompressive surgery.The patients will be followed up to 6 months and their modified Rankin Scale (mRS) will be recorded. A mRS score of 0-4 is considered as a favorable outcome while a score of 5-6 as an unfavorable one. Statistical differences in the different parameters between different groups at different time points will be analyzed by SPSS 22.0 software.

Eligibility Criteria:
Inclusion Criteria:

* 1. 18-80 years old;
* 2. Clinical diagnosis of large hemispheric infarction
* 3. Within 48h after stroke onset.

Exclusion Criteria:

* 1. Clinical diagnosis of severe infection;
* 2. Clinical diagnosis of severe heart, liver or kidney diseases;
* 3. Clinical diagnosis of bleeding tendency, active bleeding or hematological diseases;
* 4. Malignant tumor;
* 5. Modified Rankin Scale (mRS)\<2 before stroke onset.
Combating Physical Inactivity Pandemic in Kindergartens

The aim of this study is to examine the effects of a kindergarten-based, parent-involved intervention during the upper kindergarten year (K3) on physical activity and physical fitness in preschool children.

This study is a two-arm cluster randomized controlled trial. Kindergartens will be randomly allocated to two groups: the usual care group and the intervention group. The usual care group will continue with their usual curriculum, which includes 30 minutes of daily physical activity stipulated by the Hong Kong SAR Government's Education Bureau. The intervention group will receive an additional 2.5 hours of physical activity per week in addition to the stipulated 30 minutes of daily physical activity. Outcome measures will be examined at baseline, 10 months (post-intervention), and 16 months (follow-up).

Eligibility Criteria:
Inclusion Criteria

1. Children aged 5-6 years (limited number of children may be between 4-5 and 6-7 years)
2. Able to communicate in Chinese
3. Able to participate in physical activity in a standard kindergarten setting

Exclusion Criteria:

1. Inherent or serious disease limiting participation in physical activity (e.g., congenital heart disease, pediatric cancer, Down syndrome).
2. Diagnosed mental illness impairing daily behavior and performance (e.g., anxiety disorder, depression, attention deficit hyperactivity disorder, psychotic disorders, autism spectrum disorder).
3. Physical disability (e.g., physical handicap, assistive device to walk).
4. Visual or hearing impairment.
5. Cognitive deficit or intellectual disability that requires special care and educational needs (e.g., handicapped children with learning difficulties).
Quantitative and Qualitative Research for "mHealth Program to Support People Living With HIV Across the HIV Care Continuum"

The goal of this randomized control trial (RCT) is to assess the effectiveness of Amp, a mobile health (mHealth) app designed to improve outcomes along the HIV care continuum for young Black men who have sex with men (YBMSM) living with HIV. HIV care continuum (linkage to care, retention, viral suppression), quality of life and self efficacy outcomes will be compared after a 4-month period between the intervention group (use Amp and standard of care) and the control group (standard of care only).

A maximum of 400 YBMSM participants will be recruited into a randomized control trial from multiple sites across the US to assess the effectiveness of Amp, an mHealth app designed to improve outcomes along the HIV care continuum for YBMSM living with HIV. HIV care continuum (linkage to care, retention, viral suppression), quality of life and self efficacy outcomes will be compared after a 4-month period between the intervention group (use Amp and standard of care) and the control group (standard of care only).

Eligibility Criteria:
Inclusion Criteria:

* MSM AND;
* Black or African-American AND;
* 18-29 years old AND;
* Diagnosed with HIV during the study period (From April 1, 2024-August 31 2024) OR;
* Diagnosed with HIV in the year prior to the study period (April 1, 2023-March 31, 2024) OR;
* HIV positive but not linked into care OR;
* Fallen out of care (no HIV care visits within last 6 months) OR;
* Currently in care but NOT virally suppressed (viral load ≥200 copies/mL)
* AND, Online access through a mobile device AND;
* Ability to read and write English.

Exclusion Criteria:

* Currently participating in another HIV care continuum or mobile health intervention
* Plan to leave the study site within the study period
* Cognitively impaired at recruitment or baseline testing
* Has a self-reported health issue that prohibits them from participating
Simvastatin in Patients With Isolated Arterial Hypertension

The purpose of this study is to determine whether combined therapy with simvastatin and hypotensive drugs (ACEI or ARB) may decrease the blood pressure. Moreover, we would like to assess the influence of isolated hypertension on endothelial injury, and on the development of atherosclerosis.

Hypertension is one of the most important predictors of cardiovascular diseases (CVD). Due to the fact that hypertension frequently coexists with hypercholesterolemia and diabetes which increase the risk of CVDs development, it is advisable to use the optimal combined therapy (hypotensive + hypolipidemic + hypoglycemic)in this group of patients. Statins are the most effective and widely used drugs for the treatment of hypercholesterolemia. According to the available experimental and clinical data they may decrease the blood pressure (BP) in normotensive and hypertensive patients. However, it is still difficult to determine to what degree the reduction of both blood pressure and cardiovascular risk is due to hypotensive or hypolipidemic/pleiotropic effects of statins.

Eligibility Criteria:
Inclusion Criteria:

* isolated hypertension (I or II class according to ESH guidelines 2009)

Exclusion Criteria:

* ischemic heart disease, prior percutaneous coronary intervention (PCI), prior coronary artery bypass grafting (CABG), heart failure, diabetes, hyperlipidemia, active smokers
Intraosseous Basivertebral Nerve Ablation for Treatment of Chronic Low Back Pain

Objective of study is to evaluate the procedural success rate, clinical effectiveness, and heath-economic profile using the Intercept Intraosseous Nerve Ablation System in adult subjects with chronic low back pain in the post-market setting

This is a prospective, open-label, single-arm, single-center study. There is no randomization or blinding. Subjects will receive the Intercept System procedure to treat one or two motion segments at L3/L4, L4/L5, or L5/S1 as identified by Modic Type 1 or 2 changes.

Eligibility Criteria:
Inclusion Criteria:

* Skeletally mature subjects age 25-70 years, inclusive
* Chronic lower back pain for at least six months
* Failure to respond to at least six months of non-operative conservative management
* Oswestry Disability Index (ODI) at time of evaluation of at least 30 points
* Modic changes (Type 1 or 2) in at least one vertebral endplate, at one or more levels from L3 to S1

Exclusion Criteria:

* Radicular pain by history or evidence of pain neurological deficit within the past one year.
* Previous surgery performed on the lumbar spine
* Current or history of symptomatic spinal stenosis
* Current or history of osteoporotic or tumor-related vertebral body compression fracture
* Current or history of vertebral cancer or spinal metastasis
* Current or history of spinal infection
* Metabolic bone disease
* BMI greater or equal to 40
* Any radiographic evidence of other important back pathology
* MRI evidence of Modic changes, Type 1 or 2 at greater than 3 vertebral bodies or at non-consecutive levels, or at vertebral bodies other than L3 to S1
* Any back pathology related to trauma, evidence of vertebral compression fracture or other spinal pathology that could affect assessment of response to back pain
* Subjects who are bed bound
* Demonstrates 3 or more Waddell's signs of Inorganic Behavior
* Any evidence of current systemic infection
Intercostal Nerves Block in the Midaxillary Line Versus Paravertebral Block for no Reconstructive Breast Surgery

The main objectives of the trial are the efficacy and safety of intercostal nerve block in the midaxillary line versus paravertebral block, both guided by ultrasound in patients scheduled for not reconstructive breast surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Patients scheduled for not reconstructive unilateral breast surgery.
2. Physical status American Society Anesthesiologists (ASA) I-III.
3. Signed informed consent.
4. Aged between 18 and 75 years.
5. Ability to assess pain using a verbal and numerical scales.
6. Assessment of pain at the time of inclusion in the study is lower than 3 verbal simple scale

Exclusion Criteria:

1. Personal history of disorders of hemostasis or previous history of abnormal bleeding evidence.
2. Local infection at the site of the puncture or to puncture prior systemic.
3. Contraindications to study medication.
4. Muscle or neurological disease, peripheral or central.
5. Patients with prior history of opioid.
6. Pregnancy or lactation.
7. Difficulties in assessing pain or inability to understand or assist in the development of the study (psychiatric illness, cognitive impairments)
8. Active Chronic alcoholism or drug addiction.
9. BMI under 20 or mayor 30.
10. Chronic treatment with non-steroidal anti-inflammatory drugs, antidepressants, anticonvulsants or opioids.
11. Rejection of the patient
Intervention to Change Attributions That Are Negative (ICAN)

ICAN is the first treatment to target hostile attributions after TBI, making it a novel anger/ aggression management approach in this population. This is a randomized waitlist control trial. The length of time in the trial is approximately 15 weeks and the intervention is 6 weeks long.

ICAN is the first treatment to target hostile attributions after TBI, making it a novel anger/ aggression management approach in this population. Since the investigator's prior research shows that stronger hostile attributions are associated with poorer perspective taking,39 ICAN employs a unique perspective-positioning technique to train perspective taking and reduce hostile attributions. After recalling a personal situation in which others' ambiguous actions led to an unpleasant outcome, participants will explore different perspectives: sitting or standing in one position, s/he will explore his or her own thoughts and feelings (self-perspective), then move to a different position to experience the other person's perspective, eliciting their thoughts and feelings.

In 40 participants with TBI, we will conduct a Phase I, randomized waitlist controlled trial with 4 data collection points: Baseline; Week 1; Week 8 (post-treatment for ICAN; post-wait period for WLC); Week 15 (WLC post-treatment).

Eligibility Criteria:
Inclusion Criteria:

* History of complicated mild to severe TBI (injury due to an external physical force), with injury severity being defined either by Glasgow Coma Score at time of injury (≤12), or post-traumatic amnesia (≥1 day), or loss of consciousness (≥30 minutes), or positive head CT scan consistent with TBI.
* At least 18 years of age or older;
* ≥1 year post-injury;
* Have adequate vision, hearing, and speech/ language skills to participate in assessments and group therapy (determined based on interaction with the participant at screening)
* Have adequate reading comprehension (due to the primary assessment involving written scenarios)
* Have abnormal scores of negative attributions or perspective taking (determined at T0 screening)
* Have above average aggression (prescreened on telephone, and confirmed T0 screening).
* No anticipated medication changes for emotions/ behavior during length of study participation; medications for emotions/ behavior must be stable within last 30 days prior to consent at T0 (Screening)
* Have reliable mode of transportation

Exclusion criteria:

* Pre-morbid neurological disorders that could affect mood and cognition (e.g. stroke); does not include controlled seizures
* Progressive central nervous system disorders (e.g. dementia, Parkinson's)
* Developmental disability (e.g., autism, developmental delay);
* Major psychiatric disorders (e.g. schizophrenia, Borderline Personality Disorder);
* Severe Depression and/or perceived risk to self or others (mental health resources will be provided and if suicide risk, approved suicide protocol will be utilized);
* Currently receiving active behavioral therapy for anger.
* On drug research study for irritability, anger, aggression
Acute Subcutaneous Defibrillation

To assess the defibrillation efficacy of a subcutaneous defibrillation system.


Eligibility Criteria:
Inclusion Criteria:

* Subject must be undergoing implant of a commercially approved ICD system
* Subject must be willing to provide Informed Consent
* Subject must be \> 18 years old

Exclusion Criteria:

* Subject with impaired kidney function as measured by a glomerular filtration rate (eGFR) estimate \< 29 mls/min/1.73m2 (recorded in the last six months)
* Subject has high risk of infection
* Subject has EF \< 15%
* Subject at high risk of stroke
* having a device replacement
* Subject with an implanted active non-ICD device, cardiac or non-cardiac (e.g., Neuro stimulator, Pacemaker)
* Subject is indicated for CRT
* Subject is pacemaker dependent
* Subject enrolled in a concurrent study that may confound the results of this study
* Subject has medical conditions that would limit study participation
* Subject is pregnant
* Subject meets exclusion criteria required by local law (e.g. age, breast feeding, etc.)
A Study of Hydrogen Peroxide-Generating E-bandage Safety

A novel hydrogen peroxide-generating electrochemical bandage for wound infection treatment and prevention, and wound healing has been developed. The purpose of this research is to gather information on the safety and to confirm lack of toxicity of small hydrogen peroxide-generating e-bandages on normal human skin.


Eligibility Criteria:
Inclusion Criteria:

* Healthy.
* Intact skin on arms.
* Able to provide appropriate consent.

Exclusion Criteria:

* Vulnerable study population.
* Pregnancy.
* Children.
* Skin disease.
* Non-intact skin on arms.
Evaluation of Anti-mullerian Hormone Levels as Predictive of IVF Outcomes in Women Over 38 Years Old

The present study is designed to evaluate the basal serum levels of anti-mullerian hormone (AMH) and inhibin B as early predictors of ovarian response, implantation rate, and pregnancy rate in women 38 years old or older that are undergoing an IVF cycle.

Specifics aims are: a) to describe AMH and inhibin levels on day 3 previous to ART cycle; b) to analyze the association between these hormone levels and the retrieved metaphase II oocytes quantity; c) to analyze the association between these hormone levels and quality embryo score d) to analyze the association between these hormone levels and the number of gestational sacs per transferred-embryo (implantation rate); e) to analyze the association between these hormone levels and the pregnancy rate; f) to make a prediction model for pregnancy rate by using a multivariable regression analysis.

Patient participation includes signing the consent and having additional tubes of blood drawn at a regularly scheduled blood draw. This blood is used to run the study tests (AMH and inhibin levels).

Eligibility Criteria:
Inclusion Criteria:

1. Women 38 years old or older at the time of initiating treatment

Exclusion Criteria:

1. Uterine disease: malformation, septum, submucosal myomas, endometrial polyps Advanced endometriosis with endometrioma (s)
2. No uterus
3. Single ovary