Kornimate/medical-research-clean huggingface dataset:
effect of blood flow restriction technique on delayed onset muscle soreness

Conditions: Pain Intensity

Summary: the aim of our study is to determine and evaluate the effects of blood flow restriction technique on pain, biomechanical properties and strength of the muscle in delayed onset muscle pain in healthy individuals. a double blind, randomized controlled, prospective study was planned.

all participants will be taken into the doms creation protocol. participants will then be divided into 80% intensity bfr and 20% intensity blood flow restriction technique (bfr) groups and will be included in an exercise protocol accompanied by bfr application.

Eligibility criteria:
inclusion criteria: * healthy individuals between the ages of 18-35 (who have not participated in any resistance training program for at least 6 months) exclusion criteria: * having a previous musculoskeletal system injury * having a condition that prevents resistance exercise * having cardiovascular disease * using medication for blood pressure control

Keywords: pain muscle strength muscle tonus
herbal-based medication vs. placebo in preventing acute otitis media in children at high risk of recurrence

Conditions: Acute Otitis Media

Summary: the purpose of this study is to study whether a herbal-based medication is superior to placebo for prevention of acute otitis media in pre-school children with upper respiratory tract infection.

this is a prospective, controlled parallel-group comparison for superiority of otovowen®. patient will be identified by screening of patient cards. patients with recurrent aom aged 12 to 59 months will be randomly assigned either to otovowen® or placebo. randomization will be stratified by age at enrolment (12-35 versus 36-59 months). the observation period per subject will be 6 months. data collection and documentation will be performed weekly via online diary by the parents/legal representative(s) and by the investigator via ecrf. patients will be seen by the doctor at baseline and at end of study. unscheduled visits in case of aom or severe uri or any other disease are initiated by the parents/legal representative(s). study medication will be sent to the patient/parents/legal representative(s) after randomization. and will be administered at first signs or symptoms of uri (e. g. elevated temperature, common cold, influenza, coughing, sore throat, hoarse voice, frequent sneezing, running or stuffy nose, sinusitis, fever, headache, etc.) until resolved (maximally 8 weeks of continuous application). aom will be diagnosed during unscheduled visits according to the criteria detailed in the study protocol. an aom will be considered as resolved through confirmation by the investigator only. compliance will be assessed by weighing contents of bottles of imps.

Eligibility criteria:
inclusion criteria: * children with at least 3 episodes of acute otitis media (aom) within 12 months prior to study inclusion as documented in their medical records. diagnosis criteria for aom see study protocol * parental written consent exclusion criteria: * ongoing acute otitis media or uri * current prophylaxis/treatment for uri or aom * current use of phytotherapeutic and homeopathic agents with secretolytic, anti-inflammatory or immune enhancing properties * use of tympanostomy tubes * chronic tympanic membrane perforation (tmp) * palatine cleft * parents/legal representative(s) of children unable to follow study procedures, who have no internet access and are not willing to use an online diary on a weekly basis * history of hypersensitivity to the investigational drug or to its ingredients. * systemic, severe as well as history of uncontrolled chronic disease or a concurrent clinically significant illness, or medical condition, which in the investigator's opinion, would contraindicate study participation or compliance with protocol mandated procedures. * simultaneous participation in another clinical trial or participation in any clinical trial involving an investigational medicinal product within 30 days prior to written informed consent for this trial.
mapping the moa behind gi protection from bif195

Conditions: Reduction of Small Intestinal Ulceration Risk

Summary: the trial will investigate effects of daily intake of the bacterial strain bif195 or placebo when co-administered to once-daily oral intake of 300 mg of acetylsalicylic acid (asa). the trial includes a run-in period of two weeks duration followed by a 4-week intervention period in which bif195/placebo and asa are co-administered. this period is followed by a 6-week wash-out period before a new 4-week period is performed with a cross-over bif195/placebo intervention as well as asa co-administration. bif195 and placebo interventions are performed double-blinded in randomised order in a cross-over fashion for each subject.

subjects will participate in the trial for a total duration of approximately 17 weeks including the run-in phase. besides the screening visit, the trial will consist of 4 visits. after having given their written informed consent, subjects will complete the screening procedures to evaluate their eligibility for participation in the trial and complete a run-in period of two weeks duration to washout possible pre-trial probiotics and/or use of medication. on the morning of day 4 after baseline assessments at visit 2, all subjects will start daily intake of 300 mg asa in combination with bif195 or placebo in a ratio of 1:1 according to the randomisation performed at visit 2. at visit 2 - 5, all subjects will be biopsied from the upper small intestine and the ventricle during a gastroscopy procedure. at each of these 4 visits, 6 biopsies will be taken from pre-specified locations in the duodenum and 2 biopsies will be taken from the ventricle (approximately 5 mg each). luminal fluids will also be collected during the gastroscopy (approximately 2 ml per visit). one venous blood sample (of 20 ml per visit) will also be collected at each of these visits. the analysis on biopsies and luminal fluid samples will include a combination of transcriptomic, microbiome, proteomics and metabolomics analysis.

Eligibility criteria:
inclusion criteria: * • written informed consent * healthy and without any gastrointestinal discomfort/pain or other significant symptoms * age ≥ 18 and ≤ 40 years * willing to abstain from any other probiotic products and/or medication known to alter gastrointestinal function throughout the participation of the trial exclusion criteria: -
prevention of weight gain in adult patients with type 2 diabetes treated with pioglitazone

Conditions: Type 2 Diabetes; Obesity

Summary: the purpose of the study is to investigate the effectiveness of three lifestyle treatment programs varying in level of intensiveness on prevention of pioglitazone-induced weight gain and to measure the composition of the change in body weight.

the three lifestyle interventions were usual care (1 visit), standard care (4 total visits) and intensive care (10 total visits)

Eligibility criteria:
inclusion criteria: * type 2 diabetes with bmi 27 or greater, glycated hemoglobin 7% or greater exclusion criteria: * insulin treated

Keywords: type 2 diabetes obesity weight gain thiazolidinediones
hcv positive heart donors

Conditions: Heart Failure

Summary: study subjects active on the waiting list for a heart transplant at the nyu langone transplant institute who are hepatitis c (hcv) negative will receive a heart transplant from a donor who tests positive for hcv. the study will entail surveillance for the development of hcv viremia post-transplant. patients who develop hcv viremia post-transplant will be treated with an fda-approved, pan-genotypic direct acting antiviral drug, mavyret. patients who are treated with mavyret will be monitored for clearance of viremia and for sustained virologic response.


Eligibility criteria:
inclusion criteria: * listed for an isolated heart transplant at nyu langone health * able to travel to the nyu langone health for routine post-transplant visits and study visits for a minimum of 6 months after transplantation * no active illicit substance abuse * weight at least 50kg * women of childbearing potential must agree to use birth control in accordance with mycophenolate risk evaluation and mitigation strategy (rems) after transplant due to the increased risk of birth defects and/or miscarriage * both men and women must agree to use at least one barrier method after transplant to prevent any secretion exchange * able and willing to provide informed consent exclusion criteria: * hiv positive * hcv rna positive or history of previously treated hcv * hepatitis b surface antigen positive or on active antiviral treatment for hbv * pregnant or nursing (lactating) women * use of strong cyp3a inducers
safety and pharmacokinetics of escalating doses of dnib0600a in participants with non-small cell lung cancer (nsclc) and platinum resistant ovarian cancer

Conditions: Non-Small Cell Lung Cancer, Ovarian Cancer

Summary: study dnb4987g is a phase i, multicenter, open label, dose-escalation study of dnib0600a administered as a single agent by intravenous (iv) infusion every three weeks (q3w) to participants with non-squamous nsclc or non-mucinous, platinum-resistant ovarian cancer. the study will be conducted in two cohorts: dose-escalation cohort and expansion cohort.


Eligibility criteria:
inclusion criteria: * eastern cooperative oncology group (ecog) performance status of 0 or 1 * histologic documentation of incurable, locally advanced or metastatic disease that has failed prior chemotherapy and for which no standard therapy exists, including the following: non-squamous nsclc or non-mucinous and platinum-resistant ovarian cancer * availability and willingness to provide an adequate archival sample of tumor * measurable disease * for fertile men or women of childbearing potential, documented willingness to use a highly effective means of contraception exclusion criteria: * anti-tumor therapy, including chemotherapy, biologic, experimental, or hormonal therapy within 4 weeks prior to study treatment * major surgical procedure within 4 weeks prior to study treatment * known active bacterial, viral, fungal, mycobacterial, or other infection (including human immunodeficiency virus \[hiv\] and atypical mycobacterial disease, but excluding fungal infections of the nail beds) * clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis * untreated or active central nervous system (cns) metastases * requirement for supplemental oxygen to carry out activities of daily living * any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the participant at high risk from treatment complications * evidence of significant uncontrolled concomitant diseases, such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders; or a serious non-healing wound or fracture * for participants in the second nsclc cohort expansion, not more than two prior regimens in the metastatic setting * pregnancy or breast-feeding
a pilot trial of triheptanoin for the preventive treatment of migraine

Conditions: Migraine

Summary: a pilot trial of triheptanoin, a natural compound able to promote anaplerotic mitochondrial metabolism, for the preventative treatment of migraine.

to test the ability of a daily 3-month treatment with triheptanoin to prevent migraine attacks in 10 migraine patients. this is an open, non-randomized pilot trial that might justify a placebo-controlled trial, if there are at least 50% of patients with ≥50% reduction in attack frequency.

Eligibility criteria:
inclusion criteria: * females aged 18-65 years old having an effective contraception or being menopaused * diagnosis of migraine without aura (ichd3beta 1.1) since at least 2 years * 4-10 migraine days per month during the last 3 months * no preventive anti-migraine therapy during the last month exclusion criteria: * \> 4 tension-type headache episodes per month * medication overuse headache or other headache types * resistance to \>3 previous preventive anti-migraine drug treatments * any serious medical or psychiatric condition * on-going or previous bowel disorder
chicago parent program for foster and kinship caregivers

Conditions: Behavior Problem; Parenting

Summary: the primary objective of this study is to test the effects of an evidence-based prevention intervention (cpp) adapted for foster and kinship caregivers of young children (fc; foster care) on caregiver competence and child behavior problems for children in foster care compared with an active comparator group that receives standard supports through the child welfare and healthcare systems (i.e., usual care).

the purpose of the study is to evaluate the impact of an evidence-based parenting program, the chicago parent program (cpp) adapted for foster and kinship caregivers of young children (cpp-fc). a parallel, two-arm, randomized controlled trial of 300 caregiver-youth dyads will be conducted, comparing the impact of cpp-fc versus a usual care control on caregivers and foster youth. quantitative and qualitative data about cpp-fc will be collected from foster and kinship caregivers and through observations of caregivers and youth. the findings from this study will demonstrate whether cpp-fc is effective in reducing behavior problems in young foster children and whether that contributes to reduced caregiver stress, increased caregiver confidence, increased positive parenting behavior, and longer lengths of time that children remain with foster and kinship caregivers, preventing unnecessary moves from one caregiver to another and improving child wellbeing.

Eligibility criteria:
inclusion criteria: * must be a licensed foster caregiver or kinship caregiver to a foster child between the ages of 2 and less than 9 years of age * must be a licensed foster caregiver or kinship caregiver to a foster child in ohio and in the custody of hamilton county job and family services, butler county children services, or montgomery county children services * must be in good standing with the foster care agency * must be english-speaking exclusion criteria: * not having a foster child between the ages of 2 and less than 9 years * the foster child not being in the custody of ohio counties: hamilton county job and family services, butler county children services, or montgomery county children services * the foster child was placed in the home more than 45 days prior to enrollment * the foster child being moved out of the placement prior to the start of the intervention * the foster child having been previously enrolled with another caregiver * the caregiver having been previously enrolled with another child * the caregiver unable to commit to completing all study activities * the foster child is not enrolled in the study

Keywords: foster care child behavior parenting skills behavioral health prevention parenting confidence parenting stress
relationship between serum n/ofq and acute myeloid cell leukemia

Conditions: AML

Summary: patients diagnosed with acute myeloid leukemia in the second hospital of shanxi medical university were selected and divided into the newly diagnosed group, the relapsed group, the complete remission group as the experimental group, and the healthy physical examination subjects as the control group. the relationship between il-1β, catecholamine and norkephalin in peripheral blood of the experimental group and the control group was observed. according to the literature, the experimental group was significantly higher than the control group. in the experimental group, the newly diagnosed group was higher than the relapse group, and the relapse group was higher than the complete remission group, and the correlation was positive, and the difference was statistically significant.


Eligibility criteria:
inclusion criteria: * in accordance with adult acute myeloid leukemia (non-acute promyelocytic leukemia)the diagnostic criteria for aml in the chinese diagnosis and treatment guidelines (2017 edition); ②leukocyte count ≤ 25×109/l; * no treatment has been received in the past 6 months. * none of the candidates are related and known this study, and sign the informed consent. exclusion criteria: * patients who are allergic to the drugs used in this study; * people with mental illness or cognitive impairment; * patients with infectious diseases; ④patients with severe heart, liver, kidney and other organ function lesions; ⑤ combined with other malignant swelling. the tumor.
comparison of nn1250 with insulin glargine in subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial was conducted in europe and north america. the aim of this clinical trial was to compare nn1250 (insulin degludec (ideg)), a soluble insulin basal analogue (siba), with insulin glargine (iglar), as add-on to subject's ongoing treatment with metformin and/or dpp-4 (dipeptyl peptidase 4) inhibitors, in patients with type 2 diabetes being treated with oral anti-diabetic drugs (oads).


Eligibility criteria:
inclusion criteria: * type 2 diabetes (diagnosed clinically) for at least 6 months * insulin naïve subjects (allowed are: previous short term insulin treatment up to 14 days; treatment during hospitalisation or during gestational diabetes is allowed for periods longer than 14 days) * current treatment: metformin monotherapy or metformin in any combination with insulin secretagogues (sulphonylurea (su) or glinide), dpp-4 inhibitor, alpha-glucosidase-inhibitor (acarbose) with unchanged dosing for at least 3 months prior to visit 1 with the minimum doses stated: -metformin: alone or in combination (including fixed combination) 1500 mg daily or maximum tolerated dose (at least 1000 mg daily)-insulin secretagogue (sulfonylurea (su) or glinide): minimum half of the daily maximal dose according to local labelling -dpp-4 inhibitor: minimum half of the daily maximal dose according to local labelling -alpha-glucosidase-inhibitor (acarbose): minimum half of the daily maximal dose or maximum tolerated dose * hba1c 7.0-10.0 % (both inclusive) by central laboratory analysis * bmi (body mass index) below or equal to 45.0 kg/m\^2 exclusion criteria: * use within the last 3 months prior to visit 1 of: thiazoledinediones (tzds), exenatide or liraglutide * cardiovascular disease, within the last 6 months prior to visit 1, defined as: stroke; decompensated heart failure new york heart association (nyha) class iii or iv; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty * uncontrolled treated/untreated severe hypertension (systolic blood pressure at least 180 millimetre (mm) mercury (hg) and/or diastolic blood pressure at least 100 mmhg) * pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements * cancer and medical history of cancer hereof (except basal cell skin cancer or squamous cell skin cancer)
evaluation of 611 in combination with topical corticosteroid in participants with moderate to severe atopic dermatitis

Conditions: Dermatitis, Atopic; Eczema, Atopic

Summary: this is a randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of 611 when used in combination with topical corticosteroid (tcs) treatment compared with placebo in combination with tcs treatment for moderate-to-severe atopic dermatitis.


Eligibility criteria:
inclusion criteria: * male or female adults ages 18 to 75 years old when signing the informed consent. * ad (according to hanifin-rajka criteria) that had been present for at least 1 years before the screening visit. * moderate to severe atopic dermatitis. * recent history of inadequate response to treatment with topical medications. exclusion criteria: * participation in a prior 611 clinical study. * treatment with the following prior to the baseline visit: 1) systemic corticosteroid or immunosuppressants / immunomodulators within 4 weeks or within 5 half-lives (if known), whichever is longer. 2) monoclonal antibody within 5 half-lives (if known) or 4 months, whichever is longer. 3) cell-depleting within 6 months. * treatment with a live (attenuated) vaccine within 2 months of the baseline visit or planned during the study. * serious or uncontrolled diseases that may affect the safety of participants during the study period or hinder their completion of the study. * evidence of active acute or chronic hepatitis. * history of malignancy within 5 years before the screening visit or currently. * pregnant or breastfeeding women, or women planning to become pregnant. * any history of vernal keratoconjunctivitis (vkc) and atopic keratoconjunctivitis (akc).
humanized anti-il-2 receptor monoclonal antibody in moderate-to-severe ulcerative colitis

Conditions: Ulcerative Colitis; Gastrointestinal Disease; Inflammatory Bowel Disease

Summary: the purpose of the prospect study is to evaluate an investigational medication for the treatment of moderate to severe ulcerative colitis. this study is being conducted at up to 38 clinical research centers in the us, canada, and belgium, and is open to male and female patients 12 years and older. participants in the study will have a number of visits to a research center over a five-month period. all study related care and medication is provided to qualified participants at no cost: this includes all visits, examinations, and laboratory work.


Eligibility criteria:
* moderate to severe active ulcerative colitis diagnosed for at least 4 months. * mayo score of 5-10 (inclusive) * not used any investigational therapy for 30 days prior to screening * no treatment with monoclonal antibody therapy within 12 weeks of screening * no prior treatment with daclizumab

Keywords: ulcerative colitis inflammatory bowel disease gastrointestinal humanized monoclonal antibody