Kornimate/medical-research-clean huggingface dataset:
dose-finding of lower limb mirror therapy after stroke.

Conditions: Stroke

Summary: this study will investigate the maximum dose per day of using mirror therapy for ankle exercise after stroke. the design is a 3+3 rule based, dose- finding study. each cohort will consist of three participants. the first cohort will be assigned to do a dose of 15 minutes each day for two weeks. the second and subsequent cohorts will exercise at target dose set accordance to the nine preset rules and the modified fibonacci sequence (mfbs).the study will continue until the stopping rule is triggered. the last dose tested will be identified as the maximum tolerable dose per day.

procedure:a 3+3 rule-based, dose-escalation design (colucci et al,2017). recruitment process: the study will begin with a cohort of three participants (n=3). each of the subsequent cohorts will also be of three participants. the start dose will be set at 15 minutes (cohort one). participants will do ankle dorsiflexion exercise at the set dose with the mirror for two weeks. the second and subsequent cohorts will exercise at dose set in accordance to the nine preset rules and the modified fibonacci sequence (mfbs) . sample size: the target sample size is not usually predefined for a dose-finding study. the final sample size will be determined by the response of consecutive cohorts to the set dose. usually, in pharmaceutical dose-finding studies, the sample size lies between 12 and 40. data analysis : the data for each cohort will be analysed using descriptive statistics. no significance testing is involved.

Eligibility criteria:
inclusion criteria: * participants have had a stroke for six weeks or more before recruitment to this study, and are discharged from nhs statutory stroke rehabilitation. * participants will be at least 18 years of age * able to produce some voluntary contraction of paretic ankle ( motricity index between 9 and 19). * ability to understand and follow simple verbal instructions (one-stage commands), i.e. sufficient communication, orientation, and memory to participate in mirror therapy ankle exercise. * participants will have had no lower limb injury in the last six months and were able to walk independently indoors before the index stroke. exclusion criteria: * foot or ankle contracture that prevents 50% of the passive range of motion. * any condition that can be exaggerated by performing the therapy.

Keywords: mirror therapy rehabilitation lower limb motor recovery
an global comparative observational study of roactemra/actemra (tocilizumab) in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this prospective, multi-center, observational study will assess the efficacy and safety of treatment in patients who are treated with a tnf inhibitor or roactemra/actemra (tocilizumab) as the first biologic therapy. data will be collected for 52 weeks.


Eligibility criteria:
inclusion criteria: * adult patients, \>/=18 years of age * diagnosis of rheumatoid arthritis * non-respondent or intolerant to non-biologic disease-modifying anti-rheumatic drug (dmard) therapy * patient has been prescribed a first biologic therapy up to 6 weeks prior to the inclusion visit, irrespective of the treatment prescribed exclusion criteria: * patients whose first biologic therapy is given as part of a clinical trial studying rheumatoid arthritis (ra) treatment * patients who are receiving or have received experimental dmards as part of a clinical trial studying ra treatment in the last 12 months * patients whose first biologic is rituximab, abatacept or anakinra. * patients who have received any biologic therapy for more than 6 weeks prior to the inclusion visit
effect of cannabidiol (cbd) on vision and driving

Conditions: Cannabis Use

Summary: the use of cannabis with ∆9-tetrahydrocannabinol (thc) content has been shown to have negative effects on vision and driving. the use of other cannabinoids, such as cannabidiol (cbd), which is not attributed with a psychoactive effect, is increasing significantly. this project aims to investigate whether consuming cbd can negatively affect visual function by assessing a wide range of visual parameters and whether these changes may pose a risk for everyday activities such as driving.


Eligibility criteria:
inclusion criteria: * being an occasional cannabis and/or cannabidiol user * have a current driving licence * have at least one year's driving experience * drive at least once a week * monocular visual acuity of at least 6/6 (snellen) with habitual correction for driving * absence of binocular disorders exclusion criteria: * certain past or present medical conditions * current cannabis or alcohol use disorder * use of other drugs * pregnancy or lactation * simulator sickness.

Keywords: cannabis cannabidiol vision driving performance
a study of an automated insulin delivery system in adult participants with type 1 diabetes

Conditions: Type 1 Diabetes Mellitus

Summary: the purpose of this early feasibility study is to assess the predictive low glucose suspend (plgs) feature's safety, functionality and performance.


Eligibility criteria:
inclusion criteria: * participants with t1dm for at least 2 years and who have used an insulin delivery system with any rapid-acting insulin analog for the preceding 6 months * have a body mass index of 18.5 to 37 kilogram per meter squared * have a hemoglobin a1c level ≥6.0% and ≤9.0% exclusion criteria: * have known allergies or history of hypersensitivity to insulin lispro * have had an episode of severe hypoglycemia within the past 6 months * have had more than 1 episode of diabetic ketoacidosis in the past 6 months
empagliflozin and renal oxygenation in healthy volunteers

Conditions: Nephropathy

Summary: sglt-2 inhibitors belong to a new class of hypoglycemic drugs with the unique property of decreasing blood glucose through an increase in glucosuria. these drugs inhibit the sodium glucose transporter 2 (sglt2) expressed at the luminal membrane of the proximal tubule. sglt-2 inhibition in type 2 diabetic subjects and in healthy volunteers shifts the threshold for renal glucose excretion to lower levels. this effect is independent from insulin. the inhibition of sglt2 decreases hba1c, systolic blood pressure and weight in diabetic subjects. recently, the empa-reg trial demonstrated a decrease in cardiovascular mortality and renal endpoints in empagliflozin treated type 2 diabetic patients with established cardio-vascular disease. because this novel hypoglycemic drug has unique and direct effects on renal tissue metabolism, it is important to better examine its effects on the kidney. with this study, we propose to explore the effects of empagliflozin on renal tissue oxygenation. our hypothesis is that sglt-2 inhibition decreases renal cortical energy requirements with consequently an increase in renal tissue oxygenation.

this study is a double-blind, randomized, placebo-controlled study that will examine the acute and chronic renal effects of empagliflozin in healthy volunteers. a total of 45 healthy volunteers will be included in the study: 15 normal weight, 15 overweight (bmi: 25-30kg/m2) and 15 obese (bmi\>30kg/m2) non diabetic subjects (as determined after an oral glucose tolerance test). empagliflozin 10mg vs placebo will be administered in a blinded fashion qd. the acute and chronic renal response to empagliflozin will be assessed.

Eligibility criteria:
inclusion criteria: * normal weight (bmi: 19-24.9kg/m2), overweight (bmi:25-30kg/m2) or obesity (bmi\>30kg/m2) * men and women (with a negative pregnancy test) during the follicular phase of the menstrual cycle. all groups will have a balanced number of men and women. * ogtt/hba1c: normal or pre-diabetes * egfr\>60ml/min, albumin/creatinine ratio \<3.3mg/mmol (\<30 mg/g) * signed consent form * normal renal ultrasound * normal urine dipstick exclusion criteria: * antihypertensive therapy * nsaid treatment * former bariatric surgery * age\ 50y * at risk of dehydration or hypotension * past history of recurrent genital or urinary tract infections * contra-indication for mr imaging (pacemaker or other implanted metallic device, claustrophobia) * pregnancy * sustained systolic blood pressure \>150mmhg or diastolic blood pressure \>95mmhg

Keywords: empagliflozin kidney bold-mri
a registry study on shuxuetong (a chinese medicine injection) used in twenty hospitals

Conditions: Ischemic Stroke

Summary: the purpose of this study is to make a cohort event monitoring to see whether and how shuxuetong injection in hospital results in adverse events or adverse drug reactions.

this is the first academic registry study about adverse events or adverse drug reaction for chinese medicine injection in mainland china. it is well known that chinese medicine injection is just limited in mainland china, which also be accepted by china health care system. however, more and more adverse events or adverse drug reaction have been reported in recent years in the form of case report. in order to improving monitoring adverse events or adverse drug reaction of chinese medicine injection in hospital, registry study will be introduced in this area. to calculate the incidence of adverse events or adverse drug reaction is one of the main aims for this study. according to the 'rule of three', 30,000 cases need to be registered at least.

Eligibility criteria:
inclusion criteria: * all inpatients use shuxuetong injection in 20 selected hospitals during their hospital stay
impedance pneumography measurement during acute airway obstruction and recovery phase in young children

Conditions: Obstruction; Airway, With Asthma

Summary: the purpose of this study is to evaluate the association of signals recorded and analysed with ventica® lfts in infants and preschoolers during acute airway obstruction/asthma exacerbation and recovery thereof for changes in the ip-derived tbfv curves within and between nights.


Eligibility criteria:
inclusion criteria: * age 1-7 * diagnosis of acute airway obstruction or asthma exacerbation requiring inpatient treatment exclusion criteria: * need for an icu treatment * bronchiolitis * pneumonia (not including viral infections) * other cardiorespiratory or neurological chronic diseases or states that may significantly alter the overnight breathing pattern * implanted or external active medical devices
a study to evaluate the efficacy and safety of js002 in patients with heterozygous familial hypercholesterolemia (hefh).

Conditions: Heterozygous Familial Hypercholesterolemia

Summary: js002 is a recombinant human anti-pcsk9 monoclonal antibody.the study is a multicenter, randomized, double-blind, placebo-controlled phase iii clinical study in chinese patients with heterozygous familial hypercholesterolemia (hefh). objective to evaluate the efficacy and safety of js002 150 mg (q2w) and 450 mg (q4w) subcutaneous injection (sc).

a randomized, double-blind, placebo-controlled phase iii clinical study evaluating the efficacy and safety of js002 in patients with heterozygous familial hypercholesterolemia. 120 subjects are planned to be enrolled. each subject is required a maximum of 6 weeks of screening, 24 weeks of treatment, and 8 weeks of follow-up. to evaluate the lipid-lowering efficacy of subcutaneous injection of js002 at 24 weeks compared with placebo in heterozygous familial hypercholesterolemia patients under optimized lipid lowing therapy . subjects meeting the study inclusion criteria will be randomly assigned in a 2:1:2:1 ratio to js002 150 mg q2w or js002 450 mg q4w or matched placebo to receive the study drug (js002) or placebo subcutaneously for 24 weeks. treatment cohorts: js002 150mg cohort:js002 150mg or placebo treatment(js002 :placebo=2:1) q2w js002 450mg cohort:js002 450mg or placebo treatment(js002 :placebo=2:1)q4w

Eligibility criteria:
inclusion criteria: 1. signed informed consent. 2. males and females ≥ 18 to ≤ 80 years of age 3. dlcn\>8 in hefh 4. stable lipid-lowering therapies for at least 4 weeks 5. patients with ascvd ldl cholesterol≥1.4mmol/l at screening patients without ascvd ldl cholesterol≥2.6mmol/l at screening 6. triglyceride≤4.5 mmol/l（400 mg/dl）; exclusion criteria: 1. hofh or meet the diagnostic criteria of hofh 2. new york heart association (nyha) class iii or iv or last known left ventricular ejection fraction \< 30% 3. history of uncontrolled arrhythmia within 90 days 4. myocardial infarction, unstable angina, percutaneous coronary intervention (pci), coronary artery bypass graft (cabg) or stroke within 90 days of randomization 5. planned cardiac surgery or revascularization. 6. uncontrolled diabetes mellitius (hba1c\>8.0%）. 7. uncontrolled hypertension. 8. other conditions that the researchers considered inappropriate to participate in the study.
sta-9090 in castration-resistant prostate cancer with assessment of androgen receptor pathway signaling

Conditions: Adenocarcinoma of the Prostate

Summary: in this research study, the investigators are looking to determine the safety and efficacy of an investigational drug, sta9090 alone and in combination with dutasteride for the treatment of castrate resistant prostate cancer. sta9090 may cause the growth of cancer to slow down or shrink by targeting proteins required for the cancer to grow. the investigators are also looking to determine whether the use of dutasteride to lower male hormone levels will enhance the effect of sta9090 in the treatment of castrate resistant prostate cancer.

subjects will have a tumor biopsy before treatment begins. subjects who are randomized to arm a will receive infusions of sta9090 on days 1, 8, and 15 of a 28 day cycle. subjects randomized on arm b will receive daily oral dutasteride for 2 weeks prior to beginning sta9090 treatment. they will continue to receive dutasteride while on study.

Eligibility criteria:
inclusion criteria: * adenocarcinoma of the prostate * progressive castration resistant disease * metastatic disease * normal organ and marrow function exclusion criteria: * history of current coronary artery disease, myocardial infarction, angina pectoris, angioplasty or coronary bypass * current treatment with the following antiarrhythmic drugs: flecainide, moricizine or propafenone * new york heart association class ii/iii/iv congestive heart failure * current or prior radiation therapy to the left hemithorax * treatment with chronic immunosuppressants * uncontrolled intercurrent illness * poor venous access for study drug administration * venous thromboembolism in the past 6 months

Keywords: castration resistant prostate cancer
a phase 2b trial of epb-348 for the treatment of herpes zoster

Conditions: Herpes Zoster

Summary: the purpose of this study is to determine the pharmacokinetics and dosage of epb-348 that best balances safety and efficacy among adult immunocompetent patients with an acute episode of herpes zoster.

in cells infected with varicella-zoster virus, there is evidence to suggest that epb-348 could offer clinically important advantages in the treatment of acute herpes zoster over currently available therapies due to rapid absorption and conversion to the active moiety as well as a longer intra-cellular half-life in infected cells. clinically, these characteristics could translate into once-daily dosing versus thrice-daily dosing as seen with current therapy, leading to a higher rate of compliance and quality-of-life, especially among elderly patients. the objective of epb348-0201 is to determine the pharmacokinetics and dosage of epb-348 that best balances safety and efficacy among adult immunocompetent patients with an acute episode of herpes zoster. this multi-center study will randomly assign patients to either epb-348 1000 mg once daily or epb-348 2000 mg once daily or valacyclovir 1000 mg three times daily.

Eligibility criteria:
inclusion criteria: * male and female adults at least 18 years of age * patients with signs and symptoms consistent with acute herpes zoster disease, namely, a dermatomal vesicular rash which may be preceded by pain and parasthesias in the days before vesicular eruption * herpes zoster associated rash present for ≤ 72 hours * patients who are deemed to be immunocompetent based on history and physical exam exclusion criteria: * females who are pregnant or nursing * history or clinical manifestations of significant metabolic, hematological, pulmonary, ischemic, or unstable heart disease, gastrointestinal, neurological, psychiatric, renal, urological, endocrine, opthalmologic, or immune mediated disease including hiv or hbsag positivity * chronic genital herpes * patients who received cytotoxic or immunosuppressive drug therapy within 3 months prior to study participation * previous vaccinations against herpes zoster * patients with \> 50% of vesicles crusted at screen * patients who received topical or systemic antiviral medications or immunomodulatory agents for herpes zoster viral infections or capsaicin within 4 weeks of study participation * patients with a history of congenital, acquired, or corticosteroid induced immunodeficiency, including malignancy, significantly impaired renal function (creatinine clearance \ 3 times the upper limit of normal) * qtc \> 500msec * patients with a history of intolerance or hypersensitivity to acyclovir, penciclovir, valacyclovir, or famciclovir * patients with gastrointestinal dysfunction that might interfere with drug absorption * patients, considered by the investigator, for any reason, to be an unsuitable candidate for receiving the study drug

Keywords: epb348 valomaciclovir stearate valacyclovir herpes zoster shingles
efficacy of sterol-fortified low fat soy beverage on cholesterol metabolism, inflammation and oxidative status in humans - study ii

Conditions: Hypercholesterolemia

Summary: hypercholesterolemia is a well-established risk factor for the development of atherosclerosis, a component of cardiovascular disease (cvd). the national cholesterol education program advises the public to consume 2 g/day of plant sterols or stanols in addition to the therapeutic lifestyle change diet to lower elevated low-density lipoprotein (ldl) cholesterol levels. for foods to carry the fda health claim label they must contain 0.65 g of phytosterol ester or 1.7 g of phytostanol ester per serving. the study was a controlled diet, cross-over clinical investigation using a latin square sequence. it consisted of two 29 d phases separated by a four week wash out interval. subjects were randomized to one of two treatment arms: 1 % dairy milk or low-fat soy beverage providing 1.95 g plant sterols/day.


Eligibility criteria:
inclusion criteria: 1. healthy males and females, age 19-60 years old, will be screened for determination of fasting circulating ldl-cholesterol and triglyceride (tg) levels. 2. subjects accepted into the study will have plasma ldl-c levels between 120 and 200 mg/dl, tg levels below 250 mg/dl, and a body mass index (bmi) between 22 to 32 kg/m2. 3. subjects must also demonstrate an ability to understand dietary and exercise procedures and be judged as compliant and motivated by the investigators. 4. subjects will be permitted to take stable doses of thyroid hormone and anti-hypertensive agents, as long as these are continued equivalently throughout the duration of study. exclusion criteria: 1. history of recent (i.e. less than 3 mo) or chronic use of oral hypolipidemic therapy, including fish oils, or probucol within the last 6 months. 2. history of chronic use of alcohol (\>2 drinks/d), systemic antibodies, corticosteroids, androgens, or phenytoin. 3. myocardial infarction, coronary artery bypass, or other major surgical procedures within the last six months. 4. recent onset of angina, congestive heart failure, inflammatory bowel disease, pancreatitis, diabetes, or significant current (ie. onset within past three months) gastrointestinal, renal, pulmonary, hepatic or biliary disease, or cancer (evidence of active lesions, chemotherapy or surgery in the past year). 5. exercise greater than walking or running 15 miles/wk or 4,000 kcal/week.

Keywords: plant sterols diet soymilk cholesterol
a study to evaluate the safety and efficacy of ublituximab in combination with umbralisib for participants previously enrolled in protocol utx-tgr-304

Conditions: Chronic Lymphocytic Leukemia

Summary: the purpose of this study was to provide the opportunity to the participants who progressed on treatment arm previously in the study utx-tgr-304 (nct02612311) to receive ublituximab (tg-1101) treatment in combination with umbralisib (tgr-1202).


Eligibility criteria:
inclusion criteria: * prior treatment in clinical trial utx-tgr-304 * eastern cooperative oncology group (ecog) score of 0 to 2 exclusion criteria: * participants refractory to ublituximab + tgr-1202 * transformation of chronic lymphocytic leukemia (cll) to aggressive non-hodgkin's lymphoma (nhl) (richter's transformation)
a safety study to investigate the skin sensitization potential of mfc51123

Conditions: Pain

Summary: this research study is being carried out to determine the possibility that a new medication causes allergic reactions. this new medication contains two active ingredients (diclofenac and menthol) together in a gel and is being developed to treat mild to moderate pain and inflammation, such as acute sport injuries, and sprains and strains. approximately 240 participants will have the medication (gel) applied to the skin on a small area of the upper back for approximately 48-hour or 72-hour periods over the course of six weeks. participation in this research study is voluntary, requiring participants to visit the study clinic on 17 occasions for about 45 minutes each visit. during the visits, doctors or trained staff members will examine the amount of redness, swelling, and other signs of irritation (if any) of the skin where the medication (gel) was applied.


Eligibility criteria:
inclusion criteria: * healthy men or women participants with 18 years of age or older. exclusion criteria: * participants with a history of hypersensitivity, allergy with the use of nsaids or menthol or currently receiving systemic or topical nsaids within 3 days of visit 1. * participants having psoriasis and/or active atopic dermatitis/eczema, and skin infected. * lesions, burn or wound in the application site.