cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Angong Niuhuang Wan for Stroke

To evaluate the efficacy and safety of using Chinese Medicine Angong Niuhuang Wan in stroke patients, the modified Rankin Scale (mRS) score will be used as primary outcome, the National Institutes of Health Stroke Scale (NIHSS) score, The Modified Barthel Index (MBI) score and the Montreal Cognitive Assessment (MoCA) scores will be used as secondary outcome measures.

This study is a randomized, double-blind, placebo-controlled trial which is used to further determine the effectiveness of Angong Niuhuang Wan in treating stroke patients on top of the standard conventional treatment, also to evaluate the improvement level on quality of life of post-stroke after using Angong Niuhuang Wan. The effect of Angong Niuhuang Wan on liver and kidney function will be focused and using NMR techniques to analysis metabolomics to further study the safety and effectiveness of Angong Niuhuang Wan on the prevention and treatment of stroke.

It is a 24-week trial, Double-blind treatment for 1 week, follow up visit for 23 weeks. All participant will have study blood taking for renal and liver function test and questionnaires assessment during study visits. Informed consent will be obtained before study enrollment.

Eligibility Criteria:
Inclusion Criteria:

1. Chinese adults aged 40 or above;
2. diagnosed as a stroke by a neurologist, with imaging of CT or MRI support;
3. Neurologist confirms the symptoms of stroke occur within 28 days and are clinically stable. In the past 48 hours, the condition of the nervous system has not deteriorated significantly;
4. TCM diagnosis is a stroke and belongs to a heat syndrome;
5. There is a movement defect caused by stroke;
6. The severity of stroke was scored 5-25 by the National Institutes of Health Brain Stroke Scale (NIHSS);
7. Informed consent will be given by participant or its representatives

Exclusion Criteria:

1. The movement defects are not associated with stroke. Before commencement of study treatment, patient has physical activity dysfunction caused by lameness , osteoarthritis, rheumatoid arthritis, gouty arthritis, etc. that may affect neurological function examination;
2. Subjects are unlikely to come back for follow-up visits during the 24-week study period;
3. The subject has a brain tumor on a computed tomography scan (CT);
4. The subject has thrombocytopenia (known platelet count \<100,000 / mm3) or coagulopathy disease;
5. Taking warfarin or other anticoagulant;
6. Concomitant diseases such as severe hypertension or diabetes;
7. Comorbidities or complications associated with drug evaluation;
8. Pregnant or breast-feeding female.
9. The alanine aminotransferase (ALT) value is 1.5 times higher than the normal maximum value in liver function test and the estimated glomerular filtration rate (eGFR) \<30 ml/min/1.73 m2 in the renal function test.
10. Present the sign of pure yin syndrome or yin / yang defecation in TCM diagnosis;
11. Subject has G6PD
12. Known swallowing problem
13. Dependent in all daily life activities
Effect of UGIR in Adults With Compromised Gut Function and Malabsorption

This study assessed the effect of a nutrition support product on quality of life in adults with compromised gut function and malabsorption.

This prospective, non-randomized, open-label study assessed the effect of a nutrition support product on quality of life in adults with compromised gut function and malabsorption. Adults with irritable bowel syndrome (IBS), inflammatory bowel disease (IBD) or celiac disease were enrolled in the study and asked to take the study product for 6 weeks. The primary measure of the study was a validated quality of life questionnaire, the Gastrointestinal Quality of Life Index (GIQLI). Secondary measures included the Inflammatory Bowel Disease Questionnaire (IBDQ), the Celiac Disease Questionnaire (CDQ), and the Digestive Symptom Frequency Questionnaire (DSFQ).

Eligibility Criteria:
Inclusion Criteria:

* Body mass index 19 - 40 kg/m2
* Previous diagnosis of ulcerative colitis (UC), Crohn's disease, irritable bowel syndrome (IBS), or celiac disease

Exclusion Criteria:

* Gastroenterologic surgery within 3 months before the study period
* Have a colostomy or ileostomy bag
* Malignancy within the last 5 years
* Women who are lactating, pregnant or planning pregnancy during the study period
* Taking antibiotic, antiparasitic, or antifungal medications
* Initiation of or changes to supplements or medications within 28 days prior to screening
Remotely Observed Methadone Evaluation

Opioid addiction, which affects 16 million individuals worldwide, can be treated using methadone, a proven and effective opioid medication for treating OUD that extends retention in care, reduces mortality, and inhibits illicit drug use. However, methadone treatment is limited to federally certified Opioid Treatment Programs (OTPs), which must meet complex regulatory requirements, and require new patients to take their dose in person six days per week, presenting significant barriers to treatment. To address these barriers, Sonara Heath has developed the Sonara software platform, which will enable OTPs to offer accelerated take-home methadone regimens while maintaining safety and diversion prevention.


Eligibility Criteria:
Inclusion Criteria:

* Receiving methadone for the treatment of opioid use disorder

Exclusion Criteria:

* Patients with \>13 take-homes
* Patients with positive toxicology results in last 30-60 days
* Patients involved with drug court ineligible for take-homes
* Patients without adequate access to technology
* Patients with \<30 days in treatment
* Patients with mental health instability
* Patients with recent diversion attempts
* Patients using buprenorphine for agonist therapy
* Patients guest dosing at another clinic during trial period
Determination of Changes in Total Body Stores of Vitamin A in Response to Orange Maize Consumption by Zambian Children

Determination of liver stores of vitamin A will be determined before and after consumption of high pro-vitamin A orange maize, compared to low provitamin A white maize.

This study will determine the change in total body stores of vitamin A in response to feeding orange maize for 90 days. This will be compared to two other groups of children that are fed white maize, one of which will get a vitamin A supplement at the estimated average requirement.

Eligibility Criteria:
Inclusion Criteria:

1. Children aged 57-88 months at the time of initiation of the study
2. Children living in the locality defined by the study and not enrolled in school.
3. Consent from parent/guardian.

Exclusion Criteria:

1. Severely malnourished children (weight for age or height z-scores \<-3 standard deviations below the WHO growth reference standards)
2. Children found to be below 57 months and still holding an under five card or above 88 months at the time of initiation of the study or enrolled in school, based on verification of birth dates at screening
3. Children whose families plan to leave the study area before completion of the study
4. Consent not obtained from parent/guardian
5. Children suffering from diarrhea at the time of initiation of the study or with high fever, based on the report of symptoms by the parent/guardian
6. Children with severe anemia (Hb \<7.0 g/dL) as determined at the baseline blood draw.
A Safety and Efficacy Study of Travoprost 0.004% Compared to Latanoprost 0.005% in Patients With Chronic Angle-Closure Glaucoma

To demonstrate that the intraocular pressure(IOP)-lowering efficacy of Travoprost (0.004%) is equal or better than that of Latanoprost 0.005% in patients with chronic angle-closure glaucoma.


Eligibility Criteria:
Adult patients of any race and either sex with chronic angle-closure glaucoma.
Neuropeptides in Human Reproduction

The investigators are seeking healthy volunteers and volunteers with reproductive disorders for the study of the role of dynorphin in the reproductive system. Dynorphin is a naturally occurring opioid hormone that is blocked by naloxone.

We hypothesize that naloxone, by blocking dynorphin, will stimulate production of gonadotropin-releasing hormone (GnRH) and kisspeptin, two other naturally occurring reproductive hormones.


Eligibility Criteria:
Inclusion Criteria:

* Ages 21-40 (healthy men and regularly cycling women) OR ages 18-75 (men and women with hypogonadotropic hypogonadism (HH))
* Normal blood pressure (systolic BP \<140 mm Hg, diastolic BP \<90 mm Hg)
* White blood cell, platelets, prolactin, and thyroid stimulating hormone (TSH)within 90%-110% of laboratory reference range
* Negative urine drug screen panel
* Hemoglobin:

  1. For healthy men and healthy regularly cycling women: normal
  2. For men and women with HH: No less than 0.5 gm/dL below the lower limit of the reference range for normal women
* Blood urea nitrogen (BUN), creatinine, liver function tests not elevated
* For healthy subjects: Normal reproductive function and history
* For healthy subjects: Body Mass Index (BMI) 18.5-30kg/m2
* For subjects with HH: All medical conditions stable and well controlled

Exclusion Criteria:

* History of medication reaction requiring emergency medical attention
* Illicit drug use
* Consumption of more than 10 alcoholic drinks per week
* Difficulty with blood draws
* Currently seeking fertility, breastfeeding, or pregnant
* For healthy subjects: history of chronic disease and prescription medication use (with the exception of seasonal allergy medication)
* For subjects with HH: prescription medications known to affect reproductive endocrine function except for those used to treat the subject's reproductive condition
Study of Efficacy and Safety of Investigational Treatments in Patients With Moderate to Severe Hidradenitis Suppurativa

The main purpose of this study is to assess preliminary efficacy and safety of CFZ533, LYS006, MAS825 , LOU064 and VAY736 in patients with moderate to severe hidradenitis suppurativa and to determine if CFZ533, LYS006, MAS825, LOU064 and VAY736 have an adequate clinical profile for further clinical development.


Eligibility Criteria:
Inclusion Criteria:

* Patients with moderate to severe HS based on the number of lesions, fistulae and anatomical areas involved
* Minimal body weight of 50 kg
* Able to communicate well with the investigator and understand and comply with the requirements of the study, and the ability and willingness to conduct study visits as per the study schedule

Exclusion Criteria:

* Use of other investigational drugs at the time of screening or before
* Women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception
* Pregnant or lactating women

Other protocol-defined inclusion/exclusion criteria may apply
A Study of Subcutaneous Mircera, Versus no Erythropoiesis-Stimulating Agent (ESA) Therapy, in the Treatment of Anemia in Patients With Chronic Kidney Disease After Kidney Transplant

This 2 arm study will assess the efficacy, safety and tolerability of subcutaneous Mircera, versus no ESA therapy, in chronic kidney disease patients with anemia after kidney transplant, not currently treated with ESA. Patients will be randomized to receive a)subcutaneous Mircera at a recommended starting dose of 0.6 micrograms/kg every 2 weeks, switching to monthly treatment at week 16 or b)supportive treatment (eg. iron supplementation) for management of low hemoglobin concentrations. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* kidney transplant \>=6 months and \<5 years prior to randomization;
* anemia;
* no ESA therapy during 3 months prior to randomization.

Exclusion Criteria:

* requirement for hemodialysis or peritoneal dialysis within 3 months prior to randomization;
* change in Hb concentration \>=1.5g/dL during screening period;
* transfusion of red blood cells during 3 months prior to randomization;
* poorly controlled hypertension;
* significant acute or chronic bleeding within 3 months prior to randomization.
Severe Male Factor Infertility Management

This study is the first to evaluate the effect of oral supplementation with antioxidants combined with lifestyle modification for severe male factor partner of couples undergoing ICSI.

Patients underwent a therapy of a three-month period of treatment with either oral L-carnitine only (2g daily) or oral carnitine (2g daily) combined with modifiable lifestyle factors.

Eligibility Criteria:
Inclusion Criteria:

* Long protocol for ovulation
* Oligoasthenoteratozoospermic male partner ( (count \< 0.5 million/ml, Motility=\< 40% Progressive motility =\<10 %, Abnormal forms \>99%).
* Fresh semen samples.

Exclusion Criteria:

* Day 3 embryo transfer
* Incomplete ICSI cycles
* Endometrial thickness\> 7mm
Cardiovascular Effects of Aerobic and Strength Training in Hypertensive Middle-aged Individuals

Systemic arterial hypertension (SAH) is characterized by elevated and sustained blood pressure levels, related to several risk factors. Modifying lifestyle to combat risk factors associated with cardiovascular disease is critical, as such factors are related alteration of endothelial vasodilator response leading to progressive loss of its protective function. However, endothelial dysfunction related to hypertension is not only related to the decrease in the bioavailability of endothelium relaxants, but also to the time of presence of hypertension, increased production of vessel contraction factors and oxidative stress related to the disease. In this way, physical training presents as a non-drug strategy capable of directly and indirectly influencing the pathophysiology of hypertension. In this way the objective of the present work will be to evaluate the acute and chronic effect of aerobic exercise and strength on blood pressure, blood markers of vasodilation and vascular endothelial vasoconstriction, as well as the repercussion on flow-mediated dilatation and oxidative stress markers, In middle-aged hypertensive individuals before and after 12 weeks of training. Study hypothesis: The expected results of the research are that the endothelial response of biochemical markers of vasodilation and vasoconstriction will change positively after aerobic and strength training and the responses will be similar when compared between groups. There will be an improvement in the antioxidant capacity in both groups and the magnitude of the hypotensive effect will be greater in the aerobic group when compared to control and strength.


Eligibility Criteria:
Inclusion Criteria:

Study inclusion criteria consisted of the following: 1) Individuals should use antihypertensive medication; 2) 30-59 years of age.

Exclusion Criteria:

The following aspects were regarded as exclusion criteria: 1) body mass index (BMI) up to 40 kg/m2; 2) regular engagement in any type of physical exercise training in the past 6 months prior to inclusion in the study; 3) symptomatic peripheral arterial occlusive disease; 4) aortic insufficiency or stenosis more than stage I; 5) hypertrophic obstructive cardiomyopathy; 6) congestive heart failure (\>NYHA II); 7) uncontrolled cardiac arrhythmia with hemodynamic relevance; 7) change of antihypertensive medication in the past 4 weeks prior to inclusion in the study; 8) indication of unstable coronary artery disease. 9) use of tobacco products.
A Study to Evaluate the Pharmacokinetics of PEP005 (Ingenol Mebutate) Gel, 0.05%, When Applied in a Maximal Use Setting to the Dorsal Aspect of the Forearm in Patients With Actinic Keratosis

This Phase II study is designed to evaluate the pharmacokinetics of PEP005 (ingenol mebutate) Gel, 0.05% when applied in a maximal use setting to the dorsal aspect of the forearm in patients with actinic keratoses


Eligibility Criteria:
Inclusion Criteria:

* Male or female;
* Multiple actinic keratosis (AK) lesions over a 100 cm\^2 area of skin located on the dorsal aspect of one forearm.

Exclusion Criteria:

* Cosmetic or therapeutic procedures: within 2 weeks and within 2 cm of the selected treatment area(s);
* Treatment with immunomodulators, or interferon/interferon inducers or systemic medications that suppress the immune system: within 4 weeks;
* Treatment with 5-FU, imiquimod, diclofenac, or photodynamic therapy: within 8 weeks and within 2 cm of the selected treatment area(s).
Increasing Cessation Motivation and Treatment Engagement Among Smokers in Pain

The goal of this study is to develop and pilot test a brief intervention to increase motivation to quit and smoking cessation treatment engagement among smokers with chronic pain.

Pain and tobacco smoking are both critical national health problems, and there is mounting evidence that smokers in pain may represent an important and large subgroup who experience unique barriers and greater difficulty quitting. Smoking has been identified as a risk factor in the onset and exacerbation of chronic pain, and smokers experience greater levels of pain intensity and disability, relative to non-smokers. Initial evidence indicates that quitting smoking may improve pain outcomes (e.g., lower pain intensity) and supports the notion that smoking cessation may be an essential behavior change for smokers in pain. However, the vast majority of smokers are not yet ready to engage a serious quit attempt, and evidence-based treatments for smoking cessation remain dramatically underutilized. Therefore, the goal of this study is to develop and pilot test a brief intervention that will address smoking in the context of pain in order to increase motivation to quit smoking and engagement of available smoking cessation treatment. Participants will be randomized to either the adapted brief motivational intervention or an intervention consistent with standard clinical practice

Eligibility Criteria:
Inclusion Criteria:

* Current daily cigarette smoking (at least 10/day)
* Current moderate-very sever chronic pain with a numerical pain rating of at least 4/10
* At least 18 years of age

Exclusion Criteria:

* Current active attempt to quit smoking
* Enrollment in smoking cessation treatment or use of a smoking cessation medication
* Less than 18 years of age
Use of Fiber-optic Probe for Non-invasive Diagnosis of Melanoma and Assessment of Impact of Ultraviolet (UV) Exposure on Skin

This study is designed to collect information about melanoma using a research probe, a device placed only on the skin. This study will investigate whether using the probe to examine skin lesions could improve the accuracy of identification pre-cancerous melanoma lesions or to predict the risk melanoma in the skin of subjects. Ultimately, we would see this technique used routinely as a non-invasive device during subjects' skin examination to aid dermatologists to identify pre-cancerous (melanoma) lesions without taking tissue samples of the skin. Alternatively, this technique would, in the future, also be used to screen patients at risk for melanoma.


Eligibility Criteria:
Inclusion Criteria:

* Male and female above 18 years of age;
* Subjects who are planned to undergo skin examinations with and without atypical nevi, with and without personal or family history of melanoma and potentially with pigmented lesions to be removed for medical care or cosmetic purposes.

Exclusion Criteria:

* Individuals whose pathology cannot be obtained or retrieved.
* Inability to provide informed consent.
To Demonstrate the Relative Bioavailability of Alprazolam Tablets, 1 mg

To demonstrate the relative bioavailability of Alprazolam tablets, 1 mg.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.
The Effects of Inorganic Nitrate on Cardiac Muscle in Angina

Previous studies have shown that interventions which modestly increase blood nitrite_ improve skeletal muscle function on exercise while sparing oxygen, and have been also shown to open up the blood flow during periods of oxygen deprivation. Inorganic nitrate in the diet is absorbed into the bloodstream, concentrated and reduced by bacteria in the mouth to nitrite, which is then absorbed into the bloodstream. .

The purpose of this study is to look at the effects of oral inorganic nitrate supplementation on clinical markers of heart ischaemia and the frequency of angina.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 and over with chronic stable angina (≥2 months duration).

Inclusion Criteria Following screening visit:

* A positive exercise ECG (1mmSTD at J+0.08 seconds) on a modified Bruce protocol treadmill exercise test.
* A positive dobutamine stress echocardiogram,
* and/or a positive myocardial perfusion scan (MPI),
* and/or a positive coronary angiogram.

Exclusion Criteria:

* Unable to do exercise test
* Women of child bearing potential
* If of a racial origin at risk of glucose-6-phosphate dehydrogenase (G6PD) deficiency, G6PD will be excluded prior to inclusion in the study
* Resting STD\>=1mm
* NYHA 3 or 4 HF or LVEF\<45%
* Myocardial infarction or revascularisation within the last two months
* Left bundle branch block (LBBB)
Olaratumab (LY3012207) Patient Access for Soft Tissue Sarcoma

The purpose of this study is to continue to provide olaratumab to eligible patients who are currently receiving olaratumab commercially for the treatment of soft tissue sarcoma (STS).


Eligibility Criteria:
Inclusion Criteria:

* Are currently receiving olaratumab and who, in consultation with their treating physician, want to continue their course of therapy.
* Have metastatic or locally advanced unresectable soft tissue sarcoma not amenable to curative treatment with surgery or radiotherapy.
* Have given written informed consent.
* Have an absolute neutrophil count (ANC) ≥1,000/microliter.
* Females of childbearing potential and males must agree to use highly effective contraceptive precautions during treatment with olaratumab and up to 3 months following the last dose of olaratumab. A highly effective method of birth control is defined as one that results in a low failure rate (that is, \<1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomized partner.

Exclusion Criteria:

* Breastfeeding (patients who discontinue breastfeeding would be considered eligible).