Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of dorner tablets and aspirin for prevention of arteriosclerosis progress in type 2 diabetes mellitus patients

Conditions: Type 2 Diabetes Mellitus

Summary: the objective was to evaluate the efficacy and safety of combination of beraprost and aspirin for prevention of arteriosclerosis progress in type 2 diabetes mellitus patients.


Eligibility criteria:
inclusion criteria: * patients diagnosed as type 2 diabetes mellitus; * patients who had the intima-media thickness (imt) of carotid artery ≥1.1 mm in at least one side; * patients who had results of aspartate aminotransferase, alanine aminotransferase, and serum creatinine no more than 1.5 times higher than the upper limit of normal; * patients who had not cardio or cerebral vascular events within 3 months, including non-fatal myocardial infarction, stable and unstable angina pectoris, and non-fatal cerebral ischemic and hemorrhagic stroke; * patients who had their systolic blood pressure \<160 mmhg, diastolic blood pressure \<100 mmhg, and glycated hemoglobin (hba1c) \<8.0%; * patients who had not taken any medications with antithrombotic and antiplatelet effect within 3 months; exclusion criteria: * patients who had peptic ulcer or active alimentary tract hemorrhage; * patients who had a known allergy to prostacycline or non-steroid medications; * patients who were pregnant, breast feeding, or had planned to be pregnant; * patients who were attending or had attended any clinical studies within 3 months;

Keywords: type 2 diabetes mellitus arteriosclerosis beraprost aspirin
psychological treatment for children suffering from post traumatic stress symptoms and mild traumatic brain injury

Conditions: PTSD; Traumatic Brain Injury; Post Concussive Syndrome

Summary: the purpose of this study is to determine whether prolonged exposure therapy (pe)is effective in the treatment of post-traumatic stress symptoms in children and adolescents with mild traumatic brain injury (m-tbi) due to motor vehicle accident.

motor vehicle accidents account for a majority of tbi cases and are a leading cause for post traumatic stress disorder (ptsd) among children. the vast majority of these cases involve mild tbi (mtbi) with persistent post concussion syndromes. however, the empirical data on treatment in this field is scarce. few studies demonstrated that cognitive behavioral therapies can be effective for adults with mild tbi suffering from acute stress disorder, but no research, to date, addressed this question in pediatric population. in the current research we intend to examine the effectiveness of pe in reducing post-traumatic stress symptoms in children and adolescents with m-tbi caused by motor vehicle accident, in comparison to children and adolescents without brain injury. sixty children age 6 to 18 attending the anxiety clinic in schneider children's medical center of israel will be included. all subjects will be treated with a manualized 12-18 week prolonged exposure protocol. participants will undergo assessments, which will include interviews, questionnaires and neuropsychological tests concerning symptoms of ptsd, emotional and cognitive functioning. ratings and neuropsychological testing will be made at baseline and following completion of treatment. follow up will include questionnaires ratings at 2 weeks, 4 weeks and 12 weeks after completion of treatment.

Eligibility criteria:
inclusion criteria: for the whole sample: * children age 6 to 18 * language spoken: hebrew, arabic * dsm- iv r diagnosis: ptsd * car accident event within past 3 years for the m-tbi group: * any of the following symptoms or experiences occurring during or shortly after the accident: loss of consciousness, dazed, confused, saw stars, headache, dizziness, irritability, memory gap (not remembering injury or injury period), visual loss, abdominal pain\]. * diagnosis of mtbi within 3 years as confirmed by ct/mri/fmri. * glasgow coma scale; gcs\<15. exclusion criteria: * children presenting with psychotic symptoms * children presenting with mental retardation

Keywords: prolonged exposure cbt ptsd mild traumatic brain injury post concussive syndrome
a study to assess the efficacy and safety of nemolizumab (cd14152) in participants with prurigo nodularis (pn)

Conditions: Prurigo Nodularis

Summary: the primary objective was to assess the efficacy of nemolizumab (cd14152) compared to placebo in participants greater than or equal to (\>=) 18 years of age with prurigo nodularis (pn) after a 16-week treatment period.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of pn for at least 6 months with: pruriginous nodular lesions on upper limbs, trunk, and/or lower limbs, at least 20 nodules on the entire body with a bilateral distribution and investigator global assessment (iga) score more than equal to (\>=) 3 (based on the iga scale ranging from 0 to 4, in which 3 was moderate and 4 is severe) at both the screening and baseline visits * severe pruritus was defined as follows on the pp nrs: 1. at the screening visit (visit 1): pp nrs score was \>= 7.0 for the 24-hour period immediately preceding the screening visit. 2. at the baseline visit (visit 2): mean of the daily intensity of the pp nrs score was \>= 7.0 over the previous week * female participants of childbearing potential (that is \[i.e,\], fertile, following menarche and until becoming post-menopausal unless permanently sterile) must agree to use at least 1 adequate and approved method of contraception throughout the study and for 12 weeks after the last study drug injection exclusion criteria: * body weight less than \< 30 kg * chronic pruritus resulting from another active condition other than pn, such as but not limited to scabies, lichen simplex chronicus, psoriasis, atopic dermatitis, contact dermatitis, acne, folliculitis, lichen planus, habitual picking/excoriation disorder, sporotrichosis, bullous autoimmune disease, end-stage renal disease, or cholestatic liver disease (example \[eg\] primary biliary cirrhosis) or diabetes mellitus or thyroid disease that is not adequately treated, as per standard of care * unilateral lesions of prurigo (eg, only one arm affected) * history of or current confounding skin condition (eg, netherton syndrome, cutaneous t-cell lymphoma \[mycosis fungoides or sezary syndrome\], chronic actinic dermatitis, dermatitis herpetiformis) * participants with a current medical history of chronic obstructive pulmonary disease and/or chronic bronchitis * neuropathic and psychogenic pruritus such as but not limited to notalgia paresthetica, brachioradial pruritus, small fiber neuropathy, skin picking syndrome, or delusional parasitosis * requiring rescue therapy for pn during the screening period or expected to require rescue therapy within 4 weeks following the baseline visit * positive serology results (hepatitis b surface antigen \[hbsag\] or hepatitis b core antibody \[hbcab\], hepatitis c (hcv) antibody with positive confirmatory test for hcv (eg, polymerase chain reaction \[pcr\]), or human immunodeficiency virus antibody) at the screening visit

Keywords: prurigo neurodermatitis pruritus skin diseases
comparison of two liraglutide formulations in healthy subjects

Conditions: Diabetes; Healthy

Summary: this trial is conducted in europe. the aim of this trial is to test for bioequivalence of the phase 3a formulation of liraglutide at ph 8.15 (formulation 4) and liraglutide at ph 7.7 (formulation 3).


Eligibility criteria:
inclusion criteria: * good general health as judged by the investigator, based on medical history, physical examination including 12-lead ecg (electrocardiogram), vital signs and blood and urinary laboratory assessments * bmi (body mass index) of 18.0-27.0 kg/m\^2, both inclusive exclusion criteria: * history of any clinically significant renal, hepatic, cardiovascular, pulmonary, gastrointestinal, metabolic, endocrine, haematological, neurological, psychiatric disease or other major disorders that may interfere with the objectives of the trial, as judged by the investigator * impaired renal function * any clinically significant abnormal ecg, as judged by the investigator * active hepatitis b and/or active hepatitis c * positive human immunodeficiency virus (hiv) antibodies * known or suspected allergy to trial product(s) or related products * pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures * use of any prescription or non-prescription medication, except for paracetamol and vitamins, as judged by the investigator
nutritional supplements and foot surgery

Conditions: Foot Injuries and Disorders

Summary: this is a prospective randomized trial wherein participants will be assigned to nutraheal™, nutraheal plus™, or standard of care for 1 week prior to foot surgery and 3 weeks after surgery. the central hypothesis is that among patients undergoing surgery, nutritional supplements that maintain energy production, muscle structure, immune function, and response to pain will support recovery from surgery.

over a 6 month period the investigators will enroll 45 male and female patients undergoing foot surgery. this is a prospective randomized trial and participants will be assigned to nutraheal™ (n=15), nutraheal plus™ (n=15), or standard of care (n=15) for 1 week prior to surgery and 3 weeks after surgery. nutraheal™ is a nutritional supplement that contains 7.5 micrograms (300 iu) of vitamin d3, 80 mg of calcium as calcium hydroxymethylbutyrate monohydrate, 7.5 mg of zinc, 600 mg of calcium hydroxymethylbutyrate monohydrate, and 45 mg of bromelain. nutraheal plus™ is a nutritional supplement that contains 80 mg of calcium as calcium hydroxymethylbutyrate monohydrate, 7.5 mg of zinc, 600 mg of calcium hydroxymethylbutyrate monohydrate, 45 mg of bromelain, and 7.5 mg of reduced nicotinamide adenine dinucleotide (nadh). patients randomized to standard of care will not receive any of the ingredients in nutraheal™ or nutraheal plus™. the foot surgeon will evaluate the patient for wound healing time, healing quality, erythema and new tissue quality, using a likert rating scale against expected results from -4 (much worse) to +4 (much better) including the expected reference grade of zero (0). wound healing will be assessed at 1 and 3 weeks after surgery. patients will document medication compliance (day of surgery, 1 and 3 weeks after surgery), pain medication use (baseline, on the day of surgery and at 1 and 3 weeks after surgery) and rate overall satisfaction (5-point scale (1 = excellent; 2 = good; 3 = moderate; 4 = sufficient; 5 = unsatisfactory) at 3 weeks after surgery). patients will also complete the promis-29 instrument at baseline, the day of surgery, and at 1 and 3 weeks after surgery).

Eligibility criteria:
inclusion criteria: * ≥ 20 years of age * undergoing foot surgery (matrixectomy (ingrown toenail removal) and wart removal) exclusion criteria: * \> 80 years of age * pregnant patients or those anticipating pregnancy in the 1 month study period * allergic to pineapple * treated with oral anticoagulation * currently receiving bromelain, hydroxymethylbutyrate monohydrate (hmb), reduced nicotinamide adenine dinucleotide (nadh), vitamin d3, or zinc. * alcoholism (\>2 drinks/day) * insulin dependent diabetes * hepatic insufficiency (prior known liver function tests \> 1.5 times the upper limit of normal) * renal failure (prior known creatinine \> 2.0 mg/dl) * severe pulmonary disease (requiring home oxygen therapy) * psychiatric illness requiring therapy (dsm-v thought disorders, recurrent major depressive disorder)

Keywords: nutritional supplements
reducing hiv in adolescents

Conditions: HIV Infections

Summary: the purpose of this study is to assess the impact of a cash-incentivised prevention intervention on reducing hiv incidence rates in high-school learners in rural kwazulu-natal.

the impact of the cash incentivised intervention will be assessed using a matched pair, cluster randomised controlled trial design. the 14 selected high schools in the vulindlela school circuit will be matched in pairs. the matched pairs of schools will be the unit of randomisation. baseline measurements, using a standardised tool (structured questionnaire and biological specimens) will be undertaken simultaneously in each matched pair and will include all eligibly enrolled and consenting learners in the respective schools. on completion of baseline measurements in each matched pair of schools, the randomisation code for the pair will be revealed and the intervention will be implemented in the intervention school. all schools will receive the same prevention intervention but only the intervention school will receive the cash incentives. follow-up measurements will be undertaken approximately 12 and 24 months after implementation of the intervention using a similar standardised assessment tool to that used at baseline. at baseline and during follow-up assessments in intervention and control schools, linked hiv and substance use testing will be undertaken in all learners and pregnancy testing in female learners. other secondary endpoints will be assessed using a structured questionnaire.

Eligibility criteria:
inclusion criteria: learners must meet all of the following criteria at enrolment in order to be eligible for inclusion in the study: * male or female learner in grade 9 or 10 in one of the 14 selected schools * willing and able to provide informed consent and/or assent to participate in the study * willing to provide locator data for home visits if necessary * not planning to move to another school or relocate in the next 36 months * willing to be finger-printed to verify identity for study procedure purposes * willing to participate in this study * willing to complete all study procedures exclusion criteria: * refusal by the learner and/or parent or legal guardian to participate in the study. * unable to provide necessary informed consents * cognitively challenged learners

Keywords: cash incentive hiv prevention adolescents south africa hiv
nutraceutical supplement in the management of hypertension

Conditions: Hypertension

Summary: the purpose of this study is to evaluate the efficacy and safety of a proprietary nutraceutical supplement in capsule form over 4 months in treating blood pressure in a group of chronic hypertensive subjects that are not receiving any pharmaceutical anti-hypertensive agents or other nutraceutical supplements.


Eligibility criteria:
inclusion criteria * diagnosed with chronic hypertension: blood pressure at study entry must be greater than or equal to systolic blood pressure of 140 mm hg but less than 180 mm hg or diastolic blood pressure greater than or equal to 90 mm hg but less than 105 mm hg * subjects are not taking any prescription anti-hypertensive drugs. * subjects must be off all nutraceutical supplements for at least 30 days prior to entry into the study. exclusion criteria * myocardial infarction, ptca , stent, cabg within 5 years, known clinical chd or clinical angina. * history of cerebrovascular accident (cva). * creatinine over 2.5 mg/dl. * known allergy or sensitivity to any components of the study blood pressure supplement. * chronic liver disease with ast, alt, alkaline phosphatase over 1.5 x normal lab values. * known cancer within 2 years. * clinical congestive heart failure ( systolic or diastolic chf) * pregnant and nursing women and women. * women of child bearing age not on approved contraception control. * type 1 and type 2 diabetes mellitus on medications. * if the study subjects develop bp over 180 mm hg systolic or 110 mm hg diastolic during the study, they will be discontinued from the study and the investigator will immediately start rescue drug therapy for bp control.
parents as friendship coaches for children with adhd

Conditions: ADHD

Summary: many children with attention-deficit/hyperactivity disorder (adhd) have problems with making and keeping friends. the current study compared the efficacy of two 10-week behavioral interventions for improving the friendships of children with this disorder. participants were children ages 6-11 with adhd and their families, who were experiencing friendship problems. outcome measures assessed friendship quality and friendship behaviors at baseline (pre-treatment), post-treatment, and 8-month follow-up.


Eligibility criteria:
inclusion criteria: * children who meet diagnostic criteria for adhd * children who are have peer relationship problems exclusion criteria: * children with autism spectrum disorder, psychosis, or active suicidality (requires other interventions * children with intellectual disability (may not benefit from the interventions offered) * children who are not on a stable dose of medication (this treatment may affect outcome measures) * children who are receiving other behavioral treatment or treatment for social problems (these other treatments may affect outcome measures).

Keywords: friendship
profile of hiv seropositive patients

Conditions: HIV Infection; HIV Infections

Summary: the aim of this study was to delineate the epidemiological profile of hiv seropositive patients on antiretroviral therapy at the clinical hospital of the federal university of goiás.

objective: to delineate the epidemiological profile of hiv seropositive patients on antiretroviral therapy at the clinical hospital of the federal university of goiás. methods: the present study is documental and analitical descriptive and it was conducted at the clinical hospital of the federal university of goiás, trough data collection of 222 records of individuals in drug therapy. data were collected regarding the personal aspects, aspects related to the infection and information about the most used therapeutic.

Eligibility criteria:
inclusion criteria: * all of the patients that had data in the hospital * all with the diagnose of hiv * using antiretroviral drugs exclusion criteria: * incompleted records * patients who didn't take their medicines regularly.

Keywords: health profile aids health promotion hiv treatment experienced
chronic sildenafil for severe diaphragmatic hernia

Conditions: Hernia, Diaphragmatic; Hypertension, Pulmonary; Hypoplasia, Pulmonary

Summary: the purpose of this study is to test if sildenafil is effective in the treatment of infants with severe congenital diaphragmatic hernia (determined by the presence of prolonged pulmonary hypertension or prolonged oxygen supplementation on mechanical ventilation), as measured by the estimated pulmonary artery systolic pressure following treatment.

congenital diaphragmatic hernia (cdh) is a condition characterized by pulmonary parenchymal and vascular hypoplasia. severe cdh carries a high rate of mortality, and significant morbidity among survivors. this proposal is a randomized, blinded, placebo-controlled study designed to evaluate the efficacy and potential mechanisms of activity of sildenafil, a phosphodiesterase-5 inhibitor, for treatment of severe cdh. infants who meet criteria at ≥10d of age predicting a poor outcome \[death or chronic lung disease (cld) severe enough to require hospital discharge on supplemental oxygen (o2)\] will be eligible for the study. infants whose parents consent for the study will undergo an initial echocardiogram to assess the degree of pulmonary hypertension. they will then begin either sildenafil or placebo therapy for a 45d course. a final echocardiogram will be performed after the experimental drug course is completed. the pulmonary arterial systolic pressure estimate during hyperoxic conditions will be compared between the sildenafil and placebo groups. infants from either group who have severely elevated pulmonary arterial pressure (despite supplemental o2) will be considered for open-label sildenafil, which will continue after hospital discharge, depending on the results of a cardiac catheterization performed for clinical care.

Eligibility criteria:
inclusion criteria: * congenital diaphragmatic hernia * 10-42 days (d) of age * significant illness severity as demonstrated by: * receiving assisted ventilation and * fio2 \>= 0.40 at 10-14d of age, or * fio2 \>= 0.40 for \>=48hours at 15-27d of age, or * fio2 \>= 0.35 at 28-42d of age * or, need for extracorporeal support at \>=10d of age * or, estimated pulmonary arterial or right ventricular systolic pressure of \>= 2/3 systemic pressure at 14-42d of age exclusion criteria: * structural congenital heart disease (other than patent ductus arteriosus or patent foramen ovale/atrial septal defect \[asd\] or non-hemodynamically significant ventricular septal defect \[vsd\]) * sildenafil contraindicated (until condition resolves): * unable to absorb oral medication, or * unstable systemic blood pressure, or * receiving a drug that may interfere with sildenafil metabolism, or * renal insufficiency * hepatic insufficiency previous use of sildenafil

Keywords: chronic lung disease nitric oxide cyclic guanosine monophosphate phosphodiesterase inhibitor
intestinal microbiota of breast cancer patients undergoing chemotherapy

Conditions: Microbiota

Summary: to date, few studies have addressed the link between gut microbiota and breast cancer chemotherapy, and previous studies have only provided a link between the gut and breast cancer.

to date, few studies have addressed the link between gut microbiota and breast cancer chemotherapy, and previous studies have only provided a link between the gut and breast cancer.at present, studies on the interaction mechanism between intestinal flora and breast cancer mainly focus on two aspects: first, intestinal flora affects the occurrence and progress of breast cancer by affecting estrogen metabolism;second, intestinal flora can influence the occurrence and treatment of breast cancer by affecting the regulation of the immune system.however, the specific types (or groups) of bacteria that promote the occurrence, development and mechanism of breast cancer still need to be further studied.in addition, since most of the current clinical studies on microorganisms and breast cancer are small sample studies, the accuracy of their conclusions remains to be studied.

Eligibility criteria:
inclusion criteria: * aged 18 to 65 years * first use of chemotherapy after breast cancer exclusion criteria: * pregnancy * lactation * cigarette smoking * alcohol addiction * hypertension * diabetes mellitus * lipid dysregulation * bmi \> 27 * recent (\< 3 months prior) use of antibiotics, probiotics, prebiotics, symbiotics, hormonal medication, laxatives, proton pump inhibitors, insulin sensitizers or chinese herbal medicine * history of disease with an autoimmune component, such as ms, rheumatoid arthritis, ibs, or ibd * history of malignancy or any gastrointestinal tract surgery

Keywords: gut microbiota 16s rrna gene breast cancer chemotherapy