Kornimate/medical-research-clean huggingface dataset:
extension study of patidegib topical gel, 2% in subjects with gorlin syndrome (basal cell nevus syndrome)

Conditions: Basal Cell Nevus Syndrome

Summary: this is a multicenter, open label extension study evaluating the safety of patidegib topical gel, 2%, applied topically twice daily to the face of adult subjects with gorlin syndrome.


Eligibility criteria:
inclusion criteria: 1. the subject must have completed pellepharm study pelle-926-201 or pelle-926-301. 2. study pelle-926-301 subjects must have completed the end of treatment visit in study 301, prior to the screening visit in this study. they must also complete all study 301 related procedures prior to the baseline visit of this study. 3. the subject must be willing to abstain from application of a non-study topical medication (prescription or over the counter) to facial skin for the duration of the trial except as prescribed by the investigator. moisturizers and emollients are allowed. subjects will be encouraged to use their preferred sunscreen with a sunscreen protection factor (spf) of at least 30 daily on all exposed skin sites. 4. female subjects must have a negative pregnancy test. for study 301 subjects a negative serum pregnancy test result from study 301 is acceptable if the test was done within 7 days of the screening visit of this study. 5. if the subject is a woman of child bearing potential (wocbp), she must be willing to use birth control methods which may be considered highly effective. hormonal contraception must be supplemented with a barrier method (preferably condom). birth control must start prior to baseline, continue through the duration of the study, and for 30 days after last application of investigational product (ip). 6. if the subject is a male with a female sex partner who is a wocbp, the subject must be willing to use condoms, even after a vasectomy, starting prior to baseline, through the duration of the study, and for at least 3 months after the last application of ip. 7. the subject is willing for all facial bccs to be evaluated and follow treatment recommendations made only by the investigator. 8. the subject is willing to forego treatment of facial bccs with anything other than the study ip except when the investigator believes that delay of treatment of a bcc potentially might compromise the health of the subject. in such instances, the only other allowed form of treatment is surgical. exclusion criteria: 1. the subject has used topical treatment to the face or systemic therapies that might interfere with the evaluation of the study ip. 2. the subject has current, recent (within five half lives of the experimental drug or if half life not known, within the past 6 months prior to the screening visit), or planned (while enrolled in this study) participation in an experimental drug study (excluding study 301). 3. the subject is a wocbp who is unwilling or unable to comply with pregnancy prevention measures. 4. the subject is pregnant or breastfeeding.

Keywords: gorlin syndrome patidegib basal cell nevus syndrome nevoid basal cell carcinoma syndrome basal cell carcinoma hedgehog surgically eligible basal cell carcinomas bcc bcns
the effect of exercise training on cardiac structure and function

Conditions: Myocardial Infarction

Summary: exercise training, as part of cardiac rehabilitation, is effective in improving functional capacity and quality of life in patients with coronary artery disease. other cardiovascular and non-cardiovascular benefits have been reported, namely in glucose metabolism, skeletal muscle function, oxidative stress, vascular function, pulmonary circulation, ischaemia-reperfusion lesion and ventricular remodelling. however, the benefit of exercise training on systolic and diastolic function is controversial especially after acute myocardial infarction where no longitudinal study has evaluated diastolic function using modern echocardiographic parameters. the hypothesis is that a structured program of exercise training can improve systolic and diastolic function in patients after myocardial infarction.


Eligibility criteria:
inclusion criteria: * patients one month after myocardial infarction * older 18 years exclusion criteria: * age above 75 years, * inability to exercise, * hemodinamically significant valvular disease, * moderate to severe chronic lung disease (vital capacity and/or forced expiratory volume in 1 s \<80% of age-dependent predicted value), * atrial fibrillation * exercise induced myocardial ischemia * anaemia (haemoglobin \<12 g/dl).
causal inference research of resistant hypertension treatment with chinese approach in a cohort study

Conditions: Primary Hypertension; Hypertension, Resistant to Conventional Therapy

Summary: the research of clinical effectiveness assessment is to explore the causal relationship between treatment and outcome.accordingly, based on the effectiveness of tan-yu treatment, the research takes the resistant hypertension (rh) as example to study the causal inference methods under real world.

background: syndrome differentiation is one of the substantial characteristics in traditional chinese medicine (tcm) but is still lack of scientific evidence.the inference methods of causal relationship between treatment and clinial effect under real-word study may help. objectives: this study aims to assess the efficacy of phlegm and stasis syndrome differentiation method in treating resistant hypertension and explore causal inference in the real-world study. research design and methods: it is a multi-center,prospective,two-arm,cohort study including 200 patients with resistant hypertension (doctors' diagnosis based on the american heart association criteria 2008).essential hypertension subjects,aged 18-70 years,blood pressure \>140/90mmhg even used to be on 3 or more medications for a month and diagnosed as phlegm and stasis syndrome will be included.thiazide diuretics and/or two more antihypertensive agents for 8 weeks, chinese herbs (for synchronic treating phlegm and blood stasis) and nonpharmacological recommendations were initiated in the observational group and the control group received the same interventions without chinese herbs. outcome measures: the primary outcomes will be systolic (sbp) and diastolic (dbp) blood pressure reductions and changes in symptoms and signs.cardiac event and death incident will be the secondary outcomes.possible side effects and adverse reactions arising from the treatment like diarrhea will be recorded. discussion: this is a rigorous methodology pilot study and 200 patients are enough to calculate sample size in later formal trial.

Eligibility criteria:
inclusion criteria: * essential hypertension subjects, aged 18-70 years, blood pressure \> 140/90 mm hg even used to be on 3 or more medications for a month and diagnosed as phlegm and stasis syndrome will be included. exclusion criteria: * patients will be excluded for the following conditions: with secondary resistant hypertension because of other disease like renal disease or pheochromocytoma; included in other clinical trial in one month; pregnant or breast-feed or preparing for pregnancy female; combined with disease like stroke, coronary atherosclerotic heart disease, diabetes, chronic renal failure or mental disease.

Keywords: resistant hypertension causal inference a chorot study recipe of removing both phlegm and blood stasis
the effect of ophiocephalus striatus extract on levels of igf-1, albumin, and mna score in elderly with malnutrition

Conditions: Malnutrition

Summary: this study is a double-blind randomized controlled trial comparing the effect of ophiocephalus striatus extract in elderly patients with malnutrition. the measured outcomes are the level of igf-1, albumin, and mna score.

this research was conducted in cipto mangunkusumo general hospital and m. djamil general hospital, in collaboration with biomedical laboratory faculty of medicine university of andalas and prodia laboratory, indonesia. the inclusion criteria were elderly patients (≥ 60 y.o.) with malnutrition (mna score ≤ 23,5) and hypoalbuminaemia (\< 3,5 g/dl), had been treated, and permitted to leave from the hospital. all participants had been interviewed and physically examined to measure the anthropometric profile. investigators also measured participant's activity of daily living adl barthel, geriatric depression scale (gds), and abbreviated mental test (amt) to assess participant's compliance for consuming ophiocephalus striatus extract. blood samples were obtained to measure participant's level of igf-1 and albumin before intervention. recruited-randomized participants were classified into two groups (control and intervention) with double-blind scheme. intervention group was given the extract 5 grams two times/day for two weeks. after two weeks, all participants were invited back to out-patient clinic in hospital. mna score was measured after the intervention. blood sample were obtained again to know if there were any changes in igf-1 level and albumin level. finally, investigators analyzed results to generate the conclusion.

Eligibility criteria:
inclusion criteria: * elderly patient (≥ 60 y.o.) * malnutrition or high risk for malnutrition (mna score ≤ 23,5) * hypoalbunemia (albumin level \< 3,5 g/dl) exclusion criteria: * chronic liver disease (liver cirrhosis) or severe liver dysfunction or increasing alt \> 3x normal * renal dysfunction with glomerulus filtration rate (\< 30ml/minute) * nephrotic syndrome * acute infection / stroke / trauma * neoplasma * depression with geriatric depression scale \> 10 * hypersensitivity to ophiocephalus striatus * receive parenteral albumin * refuse to accept the treatment

Keywords: ophiocephalus striatus igf-1 hypoalbuminemia mna score elderly
stellate ganglion block in patients with cerebral small vessel disease

Conditions: Cerebral Small Vessel Diseases

Summary: this is a prospective study conducted on patients with cerebral small vessel disease, dysphagia and cognitive impairment. they were divided into the comparison group and observation group evenly. all the patients were provided with routine therapy, while the patients in the observation group were given stellate ganglion block. the swallowing function, cognitive function and activities of daily living of the two groups of patients before and after treatment were evaluated by penetration-aspiration scale, mini-mental state examination and modified barthel index.

this study is conducted for exploration of stellate ganglion block in patients with cerebral small vessel disease. this is a prospective study conducted on patients with cerebral small vessel disease, dysphagia and cognitive impairment. they were divided into the comparison group and observation group evenly. all the patients were provided with routine therapy, while the patients in the observation group were given stellate ganglion block. the swallowing function, cognitive function and activities of daily living of the two groups of patients before and after treatment were evaluated by penetration-aspiration scale, mini-mental state examination and modified barthel index.

Eligibility criteria:
inclusion criteria: * age\>18 years. * meeting the diagnostic criteria for cerebral small vessel disease. * dysphagia confirmed by videofluoroscopic swallowing study * mini-mental state examination (mmse)\<27, indicating the existence of cognitive impairment. * no history of prior stroke. * stable vital signs. exclusion criteria: * dysphagia that might be caused by other diseases that might cause dysphagia, such as head and neck tumors, traumatic brain injury, myasthenia gravis, etc. * cognitive impairment that might be caused by other diseases, such as alzheimer's disease. * neurological blockade contraindications such as bleeding tendency, blocked site infection. * unable to successfully finish the assessment of this study. * complicated with severe liver and kidney failure, tumors, or hematological disorders. * simultaneously in need to undergo other therapy that might affect the outcomes of this study. * pregnant or nursing females
efficacy of peanut ball usage on labor pain, support and control, anxiety, and labor duration

Conditions: Labor Pain

Summary: \*primary: to compare the control group, women in the experimental group will have lower level of labor pain after the intervention of peanut ball usage. \*secondary: to compare the control group, women in the experimental group will have higher level of support and control after the intervention of peanut ball usage; to compare the control group, women in the experimental group will have lower level of anxiety after intervention of peanut ball usage; to compare the control group, women in the experimental group will have shorter duration of labor after intervention of peanut ball usage.

we will ask the participants to join this research on the department of obstetric outpatient department, and give the consent form to sign. then we will allocate the participant into the experiment group or the control group, furthermore, we will give the sheet which includes the information about peanut ball usage, like the destination, method, position, duration, and quick response code of the video. when they finish the admission process in the delivery room, we will give the peanut ball to the participants who is in the experimental group, and the participants of the control group will receive the routine care of delivery room.

Eligibility criteria:
inclusion criteria: 1. vaginal birth; 2. pregnant women at ≥3 6 weeks of gestation; 3. greater than 20 years old of age; 4. no major obstetric or medical complications; 5. singleton pregnancy; 6. the partner will be accompanied during the labor; 7. cervical dilation is less than 5 cm; 8. able to listen, speak, read and write in chinese; 9. complete the informed consent form. exclusion criteria: 1. emergency cesarean section; 2. diagnosed with metal disease or drug abuser; 3. complicated with abnormality during labor.

Keywords: peanut ball labor pain support and control anxiety labor duration
gender-based differences in the outcome of treatment with aldosterone antagonists in patients with heart failure

Conditions: Heart Failure; Heart Failure With Reduced Ejection Fraction; Heart Failure NYHA Class II; Heart Failure NYHA Class III; Heart Failure NYHA Class IV

Summary: heart failure (hf) is a major healthcare problem. in patients with heart failure with reduced ejection fraction (hfref), aldosterone antagonists reduce mortality and hospitalization rate. gender-related differences have been described in the regulation of renin angiotensin aldosterone system (raas), which is at the core of the pathophysiology of hf. regarding gender-related differences in the use of mras, less is known about the effects of androgens on raas. in this single-center prospective cohort, a total of 100 adult (≥ 18 years) ambulatory patients of both sexes with the diagnosis of hf with hfref (lvef≤ 40%) and nyha class ii-iv under optimized medical therapy started an aldosterone antagonist are enrolled and followed-up for 6 months. patients are categorized according to their apparent sexual gender into two groups: the male group and the female group.


Eligibility criteria:
inclusion criteria: * the diagnosis of heart failure with reduced ejection fraction hfref (lvef≤ 40%) and new york heart association (nyha) class ii-iv under optimized medical therapy who are presented to the outpatient clinic and started an aldosterone antagonist at the time of enrollment. exclusion criteria: * pregnancy or breast-feeding. * serum creatinine \> 2.5 mg/dl (221 μmol/l) in males and \> 2 mg/dl (177 μmol/l) in women (or estimated glomerular filtration rate egfr ≤ 30 ml/minute/1.73 m2). * hyperkalemia (serum potassium level \> 5 meq/l). * renal transplant. * concomitant administration of strong cyp3a inhibitors. * concomitant administration of potassium supplements or potassium-sparing diuretics. * disorders of adrenal glands (addison disease). * patients who used mineralocorticoid receptor antagonists in the last 2 weeks before enrollment. * patients with a history of mineralocorticoid receptor antagonists allergy or intolerance.

Keywords: heart failure heart failure with reduced ejection fraction gender eplerenone spironolactone hospitalization
a study of long-acting antibodies alone and in combinations for moderate to severe ulcerative colitis

Conditions: Ulcerative Colitis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative

Summary: this is a phase 2, multicenter, proof-of-concept platform study in adult participants with moderately to severely active ulcerative colitis (uc). the primary goal of the study is to assess the efficacy and safety of multiple interventions following intravenous (iv) induction and subcutaneous (sc) maintenance treatment.

this platform study will evaluate the efficacy and safety of investigational treatments, including 3 monotherapies and 3 combination therapies, for moderately to severely active uc in adults. the study will progress in two parts. part a is the open-label portion of the study assessing safety and preliminary efficacy of monotherapies. part b, which will be open for enrollment after part a, is the randomized, placebo-controlled portion of the study assessing the safety and efficacy of the 6 interventions (3 monotherapies and 3 combinations) compared to placebo. intervention arms will be added to the study over time and may complete at different times.

Eligibility criteria:
inclusion criteria: * diagnosis of uc for ≥3 months before day 1, confirmed by endoscopy and histology either previously or during screening * active uc with disease extent of ≥15 cm from the anal verge, as confirmed by screening endoscopy (up to approximately 15% allowed to have only proctitis) * moderately to severely active disease as defined by a modified mayo score of 5-9, rectal bleeding subscore of ≥1, and mayo endoscopic subscore ≥2 exclusion criteria: * current diagnosis of crohn's disease or inflammatory bowel disease (ibd)-undefined * confirmed or suspected fulminant colitis, toxic megacolon, bowel perforation and/or other conditions that will likely require surgery during induction * failed 4 or more approved or investigational advanced therapy classes
the evaluation of orange peel fermentation on body fat lowering efficacy in adults

Conditions: Overweight; Fatty Liver Disease

Summary: to assess whether orange peel fermentation has the effect of reducing body fat in adults

this is a double-blind and randomized study. subjects are informed to consume the samples every day for 2 months. the clinical diagnosis item of overweight or fatty liver is evaluated by the doctor. the questionnaires are collected at every visit of the trial.

Eligibility criteria:
inclusion criteria: 1. adults between the ages of 20 and 65 who are willing to sign the consent form of the subject. 2. for those with bmi ≥ 24 or fatty liver, male body fat ≥ 25%, female body fat ≥ 30%. 3. those who are not pregnant and are willing to cooperate with contraception during the trial period. 4. no history of cardiovascular disease, history of organ transplantation, history of epilepsy or convulsions, liver and kidney disease, malignant tumor, endocrine disease, mental disease, alcohol or drug abuse, or other major organic diseases (according to medical history). exclusion criteria: 1. pregnant women, people with a history of cardiovascular disease, organ transplantation, epilepsy or convulsions, liver and kidney disease, malignant tumors, endocrine diseases, mental illness, alcohol or drug abuse, and other major organic diseases (according to medical history). 2. no person who has received major surgery or bariatric surgery (according to medical history). 3. i have used drugs that affect body fat, waist circumference or significantly increase weight, such as systemic corticosteroids, tricyclic antidepressants, atypical psychiatric drugs, and mood stability in the current or 3 months before participating in the screening drugs (according to medical history).
glucose regulation during risperidone and olanzapine treatment

Conditions: Schizophrenia

Summary: the overall purpose of this research is to look at how two of the most commonly prescribed newer antipsychotic medications, risperidone and olanzapine, affect substances in the body such as glucose and insulin. undesirable changes in blood sugar control, or glucose regulation, and type 2 diabetes can occur more commonly in individuals with schizophrenia compared to healthy subjects and subjects with other psychiatric conditions. while abnormalities in glucose regulation were first reported in schizophrenia before the introduction of antipsychotic medications, antipsychotic treatment may contribute significantly to abnormalities in glucose regulation. attention to the way that antipsychotic medications may affect glucose regulation has increased as doctors have become more concerned in general about disease- and drug-related medical complications, including weight gain during antipsychotic treatment.

this study will include 70 patients diagnosed with schizophrenia, taking either risperidone, olanzapine or haloperidol, and 20 healthy control subjects. each subject will undergo a 4 hour glucose tolerance test. in addition, there will be a small project within the overall study to measure the effects of risperidone and olanzapine on glucose regulation as the individuals switch from their prior treatment with a conventional antipsychotic medication to either risperidone or olanzapine. ten subjects will be studied on a typical neuroleptic at baseline then switched over a one week period to risperidone or olanzapine. the participants will be evaluated at 1 week, 4 weeks, and 12 weeks, prospectively. each evaluation will consist of a 4 hour glucose tolerance test.

Eligibility criteria:
inclusion criteria: * meet dsm-iv criteria for schizophrenia, any type, or schizoaffective disorder; * able to give informed consent; * no medication changes for 2 weeks prior to and during the period of study; * currently taking olanzapine, risperidone, haloperidol or another typical antipsychotic
a bioequivalence study of tobradex af

Conditions: Cataract

Summary: the purpose of the study is to determine the amount of study medication that moves from the front of the eye into the fluid at the front of the inside of the eye.


Eligibility criteria:
inclusion criteria: * 18 or older * other protocol-defined inclusion criteria may apply exclusion criteria: * under 18 * other protocol-defined exclusion criteria may apply