Kornimate/medical-research-clean huggingface dataset:
food effect of a fixed dose combination of daclatasvir, asunaprevir and bms-791325

Conditions: Hepatitis C

Summary: the purpose of this study is to assess the effect of a high fat meal and light meal on the blood levels of daclatasvir, asunaprevir and bms-791325 after administration of the 3 drugs as a fixed-dose combination in healthy subjects.

ind number: 100,932/79,599/101,943 primary purpose: other: phase 1 clinical pharmacology bioavailability study to assess food effect

Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * healthy male and female subjects ages 18 to 49 years, inclusive. * women of childbearing potential must be using an acceptable method of contraception for at least 4 weeks prior to study drug administration. exclusion criteria: * any significant acute or chronic medical illness * current or recent (within 3 months of study drug administration) gastrointestinal disease * any gastrointestinal surgery that could impact upon the absorption of study drug, including cholecystectomy * history of biliary disorders, including gilbert's syndrome or dubin-johnson disease * use of tobacco-containing or nicotine-containing products * any of the following on 12-lead electrocardiogram (ecg) prior to study drug administration, confirmed by repeat: * pr ≥210 msec * qrs ≥120 msec * qt ≥500 msec * qtcf ≥450 msec * any of the following laboratory results outside of the ranges specified below prior to study drug administration, confirmed by repeat: * alanine aminotransferase (alt) \>upper limit of normal (uln) * aspartate aminotransferase (ast) \>uln * total bilirubin (tbili) \>uln * creatinine \>uln
influence of pronator teres release on treatment of median nerve compression neuropathy

Conditions: Median Nerve Compression

Summary: the investigators are comparing two standard of care procedures which can be performed at the same time, or sequentially. the hypothesis being tested is whether simultaneous release of both the carpal tunnel and the pronator teres results in a better outcome in terms of symptom relief and recurrence than carpal tunnel release alone when signs and symptoms of both carpal tunnel and pronator teres syndromes are present.


Eligibility criteria:
* inclusion criteria: positive tinnels signs over the median nerve at the carpal tunnel and pronator teres * normal two point discrimination * over the age of 18 and under the age of 65 exclusion criteria: * peripheral neuropathy of the median nerve secondary to trauma * presence of thoracic outlet syndrome * presence of cervical disk disease * under the age of 18 and over the age of 65

Keywords: median nerve carpal tunnel syndrome pronator teres release
effect of chlorogenic acid on patients with impaired glucose tolerance

Conditions: Impaired Glucose Tolerance

Summary: chlorogenic acid has demonstrated promising effects in the treatment of glycemic control, obesity, dyslipidemia, insulin secretion, among others. the above mentioned findings show that chlorogenic acid has an excellent potential for the control of glucose as well as insulin secretion and insulin sensitivity.

a randomized, double-blind, placebo-controlled clinical trial was carried out in 30 patients with a diagnosis of impaired glucose tolerance in accordance with the american diabetes association criteria. the patients received 400 mg capsules of chlorogenic acid or placebo, three times daily 1/ 2 hour before meals for 90 days. before and after intervention the investigators evaluated: 2 hours plasma glucose, glycated hemoglobin (a1c), triglycerides, high-density lipoprotein, fasting glucose and blood pressure body weight, body mass index, waist circumference, total cholesterol, low-density lipoprotein, very-low-density lipoprotein, creatinine, aspartate transaminase and alanine transaminase. were calculated: areas under the curve of glucose and insulin were calculated with de trapezoidal formula. total insulin secretion was evaluated with the insulinogenic index and the insulin sensitivity was estimated using the matsuda index.

Eligibility criteria:
inclusion criteria: * bmi: 30.0-34.99 kg / m2. * diagnosis of igt (ogtt values between 140mg / dl and 199mg / dl. * written informed consent. * body weight stable over the last 3 months. * women in follicular phase of the menstrual cycle (days 3 to 8 of the cycle) at the time of laboratory tests. * women who are not contemplated get pregnant within the next 6 months. exclusion criteria: * women pregnant or breastfeeding. * physical or mental disability that makes it impossible to perform the intervention. * diagnosis of hypertension or heart failure. * smokers. * untreated thyroid disease. * consumption of oral agents or other medications or supplements with proven properties that modify the behavior of glucose and lipids (oral hypoglycemic agents, insulin, lipid-lowering). * diagnosis of liver disease or elevation twice of the upper normal value of liver enzymes. * diagnosis of renal disease or creatinine \> 1.5 mg / dl. * diagnosis of type 2 diabetes mellitus (t2dm) fasting glucose ≥ 126 mg / dl and/or ogtt ≥ 200 mg / dl and/or a1c ≥ 6.5%. * total cholesterol ≥ 280 mg/dl. * triglycerids ≥ 300 mg/dl. * known allergy to calcined magnesia or chorogenic acid.

Keywords: chlorogenic acid control glucose insulin secretion insulin sensitivity
mindfulness-based intervention prior to external cephalic version

Conditions: Breech Presentation in Pregnancy; External Cephalic Version

Summary: the study is a randomized controlled trial examining the effectiveness of a short mindfulness-based intervention on the success rate of external cephalic version in pregnant women with breech presentation. it is hypothesized that this intervention will increase the ecv success rate and decrease the pain experienced after the ecv.


Eligibility criteria:
inclusion criteria: * pregnant women (18+y). * with a breech presenting fetus undergoing external cephalic version. * dutch/english-speaking or understanding dutch/english.

Keywords: breech presentation pregnancy external cephalic version mindfulness intervention
study to assess the efficacy and safety of ntra-2112 on intestinal malabsorption in preterm infants

Conditions: Premature Birth of Newborn; Intestinal Malabsorption

Summary: the study will evaluate the effect of ntra-2112 on intestinal malabsorption in preterm infants.

the study will assess the efficacy and safety of ntra-2112 on intestinal malabsorption in preterm infants as compared to placebo

Eligibility criteria:
inclusion criteria 1. male or female pre-term infant 26 and up to 32 weeks gestation. gestational age matching (±2 weeks) between maternal dates and/or early antenatal ultrasound 2. birth weight ≥ 500g 3. singleton or twin birth exclusion criteria 1. complete enteral feeding
s-1 plus nedaplatin with concurrent radiotherapy for advanced esophageal cancer

Conditions: Esophageal Cancer

Summary: patients with advanced esophageal cancer will receive thoracic radiation therapy 60gy over 30 fractions,and concurrent with s-1 and nedaplatin.

purpose: to determine the maximum tolerated dose (mtd) and recommended dose (rd) of s-1 in combination with nedaplatin and thoracic radiotherapy in patients with advanced esophageal cancer. methods: thoracic radiation therapy was administered in 2gy fractions five times weekly to a total dose of 60 gy.concurrently, nedaplatin was given at a fixed dose of 75 mg/m2 on days 1, and s-1 was given on days 1-14,repeated every 4 weeks for four cycles. the dose of s-1 was initially 60 mg/m2/day and gradually increased to determine the mtd and rd of this regimen.

Eligibility criteria:
inclusion criteria: * histologic proof of primary squamous cell or adenocarcinoma of the esophagus * locoregionally advanced carcinoma of esophagus without systemic metastases * zubrod performance status 0-1; * patients ≥ 18 years of age; * no hypersensitivity to e. coli -derived products; * agc ≥ 1500/mm3, platelets ≥ 150,000/mm3, hgb ≥ 10 gm%, serum creatinine ≤ 1.5 mg/dl and/or calculated creatinine clearance ≥ 65 cc/min; serum calcium ≤ 11gm/dl; * patients with prior malignancy are eligible if curable non-melanoma skin cancer or cervical cancer in situ or disease free ≥ 5 years; * no prior chest or upper abdomen radiotherapy; no prior systemic chemotherapy within the past 5 years; no prior esophageal or gastric surgery; * written informed consent. exclusion criteria: * evidence of tracheoesophageal fistula, or invasion into the trachea or major bronchi. * prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible). * prior systemic chemotherapy or radiation therapy for esophageal cancer

Keywords: esophageal cancer radiation s-1 nedaplatin
acne detection software (acnedect)

Conditions: Acne Lesions; Acne Vulgaris

Summary: this study is to create a self-learning software that can detect acne lesions. patients take a picture of their face every single day for 3 months with a secure mobile phone and fill out a pre-designed questionnaire. after 3 months, the mobile will be collected back and the pictures will be evaluated by 3 dermatologists. the software is able to learn from the dermatologists' evaluation and -using machine learning- a mechanism that should be able to automatically detect acne to some extent will be established.


Eligibility criteria:
inclusion criteria: * acne vulgaris exclusion criteria: * refusal to participate

Keywords: machine learning self-learning software image-detecting software
an innovative method fluid-jet to to remove residual lens fibers

Conditions: Posterior Capsule Opacification

Summary: residual lens fibers (rlfs) on the posterior lens capsule during cataract surgery can cause after cataract, affecting visual quality and increasing the medical cost for further laser posterior capsulotomy. however, conventional polish is inconvenient and time-consuming. we use an innovative fluid-jet method to remove rlfs, and compare the efficacy of fluid-jet and polish to prevent posterior capsular opacity after phacoemulsification.

purpose: residual lens fibers (rlfs) on the posterior lens capsule during cataract surgery can cause after cataract, affecting visual quality and increasing the medical cost for further laser posterior capsulotomy. however, conventional polish is inconvenient and time-consuming. we use an innovative fluid-jet method to remove rlfs, and compare the efficacy of fluid-jet and polish to prevent posterior capsular opacity after phacoemulsification. design: single-center, prospective, randomized controlled clinical study subjects of study: age-related cataract patients receiving phacoemulsification from zhongshan ophthalmic center, guangzhou, china. methods: patients are 1: 1 randomized to two groups. polish group: after irrigation and aspiration (i/a), the rlfs on the posterior capsule are removed by polishing before intraocular lens (iol) implantation; fluid-jet group: polish is not performed. rlfs on posterior capsule are removed by jetting fluid with an irrigating syringe after iol implantation. the posterior capsular images of all the patients are obtained immediately before and after iol implantation, and at the end of surgery, then the amount of rlfs is quantitatively analyzed by using lyz-pco, a software we developed. best corrected visual acuity and parameters of visual quality, such as objective scattering index(osi), strehl ratio (sr) and modulation transfer function (mtf)-cut off are evaluated by objective visual quality analyser (oqas) at 1 day, 1 week and 1 year after surgery. the patients receives telephone follow-up every month. the severity of posterior capsular opacification (pco) and incidence of laser posterior capsulotomy is recorded. main indicators for the study: the incidence of laser posterior capsulotomy a year after surgery.

Eligibility criteria:
iinclusion criteria: 1) cataract patients aged between 50 and 80 years; 2) graded 5 or less for lens opalescence by the lens opacities classification system, version iii (locs iii); 3) listed for phacoemulsification combined with intraocular lens implantation in topical anesthesia; 4) signed informed consent. exclusion criteria: 1) a history ophthalmic trauma or surgery; 2) other ophthalmic diseases such as glaucoma, uveitis, high myopia; 3) diabetes requiring medical control; 4) disagree with follow-up monitoring; 5) other factors inappropriate to participate in this project, including but not limited to severe cataracts, very shallow anterior chambers, etc.

Keywords: cataract surgery polish residual lens fibers fluid-jet
pembro+chemo in brain mets

Conditions: Lung Cancer; Lung Cancer Metastatic; Brain Cancer; Cancer

Summary: the goal of this study is to evaluate whether providing pembrolizumab prolongs survival and preserves quality of life while minimizing side effects for patients with nsclc with untreated asymptomatic brain metastasis.


Eligibility criteria:
inclusion criteria: * non-small cell lunch cancer (nslc) with untreated asymptomatic brain metastases * nslc lacks oncogenic driver mutations * absence of new onset neurological symptoms * presence of fewer than ten intracranial lesions * each lesion measures three centimeters or less * life expectancy of greater than three months * adequate organ and marrow function * ability to understand and willingness to sign a written informed consent document exclusion criteria: * presence of oncogenic driver mutations * measurable lesion located within 10mm of the optic chiasm or optic nerve, or within the brainstem * known leptomeningeal involvement. * midline shift * serious non-healing wound, ulcer or bone fracture * baseline inability to participate or complete neurocognitive testing * major surgical procedure (including craniotomy and open brain biopsy) or significant traumatic injury within 14 days prior to registration * receipt of a non-cns minor surgical procedure (e.g. core biopsy or fine needle aspiration) within three days prior to registration * history of allergic reactions attributed to monoclonal antibodies (mab), compounds of similar chemical or biologic composition to pembrolizumab * clinically significant cardiovascular disease * patients with uncontrolled intercurrent illness * patients with psychiatric illness/social situations that would limit compliance with study requirements
resting metabolic rate reliability

Conditions: Resting Metabolic Rate Reliability

Summary: this research is being conducted to study the reliability of a method used to measure resting metabolic rate, or how much energy a person expends while at rest.


Eligibility criteria:
inclusion criteria: * age 18 - 65 years old * bmi of 19 - 40 kg/m2 * women must not be pregnant or planning to become pregnant exclusion criteria: * age less than 18 or greater than 65 * bmi less than 19 or greater than 40 * tobacco use * taking medications that affect metabolic rate (unless weight stable for past 3 months) * any disease that affects the metabolic rate

Keywords: rmr reliability obese energy expenditure resting energy expenditure resting metabolic rate
guideline-directed management for chronic kidney disease: evaluation of an education progamme in a national cluster randomized controlled trial

Conditions: Renal Insufficiency, Chronic; Cardiovascular Diseases (CVD)

Summary: study objective: to evaluate the impact of guideline-based ckd comprehensive management medical re-education for community healthcare providers on improving cardio-renal outcomes in ckd patients. study design: a nationwide, multicenter, prospective, cluster-randomized controlled trial. inclusion and exclusion criteria: inclusion criteria: chronic kidney disease (ckd) patients meeting the following criteria: egfr \ 30 mg/g on two separate occasions at least 3 months apart. exclusion criteria: age \<18 years. end-stage renal disease (esrd) with egfr \<15 ml/min/1.73 m², or patients already on regular dialysis or having received a kidney transplant. pregnant or breastfeeding women. patients participating in any other clinical trials. patients who exhibit characteristics at the screening stage that suggest they are unable to complete the study. intervention: control group: routine community training and management. intervention group: training for community healthcare providers on guideline-based ckd management, including lifestyle management, risk assessment and referral recommendations, risk factor control, pharmacological treatment, and the application of a ckd management checklist incorporating these components. efficacy evaluation indicators: primary outcome: a renal composite endpoint, defined as at least a 25% decline in egfr, progression to esrd (dialysis, kidney transplantation, or sustained egfr \<15 ml/min/1.73 m²), or death due to renal or cardiovascular causes. secondary outcomes: cardiovascular composite endpoint: cardiovascular death, non-fatal stroke, non-fatal myocardial infarction, and hospitalization for heart failure. delayed ckd progression, defined as a reduction in the annual egfr decline rate by 0.5-1 ml/min/1.73 m² or a 30% reduction in uacr per year. proportion of patients receiving guideline-recommended pharmacological treatment. safety evaluation indicators: acute deterioration of renal function (serum creatinine increase \>30% within 4 weeks). new-onset hyperkalemia. symptomatic hypotension. recurrent hypoglycemia.


Eligibility criteria:
inclusion criteria: patients with chronic kidney disease (ckd) (defined as egfr \ 30 mg/g on two occasions at least 3 months apart). exclusion criteria: 1. age \<18 years 2. patients with end-stage renal disease (egfr \<15 ml/min/1.73 m²) or those already receiving regular dialysis or kidney transplantation 3. pregnant or breastfeeding women 4. patients currently participating in any other clinical trial 5. patients who exhibit characteristics during the screening phase that indicate an inability to complete the study
validation of 5-point investigator global assessments for pemphigus

Conditions: Pemphigus

Summary: this study aims to explore the reliability and validity of newly developed investigator global assessments (igas) in scoring the severity of pemphigus. igas are simple 5-point scales ranging from clear - severe and are preferred by the fda as endpoints in clinical trials.

this study aims to obtain statistical data regarding the inter-rater and intra-rater reliability of the igas, pemphigus disease activity index (pdai) and autoimmune bullous skin disease intensity score (absis) as well as the convergent validity of the igas with the pdai and objective component of the absis. photograph sets of pemphigus lesions will be gathered from the lead site and participant sites. they will be de-identified and printed in a two hardcopy booklets; the first containing 20 photo sets and the second containing 17 new photo sets and 3 repeat photo sets. in the first part of the study, 8 dermatologists will score 20 sets of photographs of pemphigus lesions (a mixture of skin and mucosal lesions), using the igas for pemphigus as well as the pdai and absis. the first booklet will be mailed to dermatologists and they will use the booklet to score each photo set and will submit their scores in a confidential online survey. in the second part of the study, the second booklet will be sent to dermatologists in the same manner 4 weeks later, and each dermatologist will score the photo sets using the same scoring tools. it is estimated that each scoring session will take two hours to complete. data gathered here will allow for calculation of inter-rater reliability and intra-rater reliability of the igas and convergent validity of the igas with pdai and absis. later, a sub-study will occur to calculate minimal clinically important differences (mcid) for the igas and pdai. this will involve scoring pemphigus severity of patients at premier specialists using pdai and iga scores and a likert score to classify patients as improved, stable or deteriorated compared to previous visits.

Eligibility criteria:
inclusion criteria: * having pemphigus diagnosed by a qualified dermatologist * aged 18 or older at the time of photography exclusion criteria: * those whose photographs are unable to be adequately de-identified
development of compensation-based problem solving therapy

Conditions: Stroke

Summary: the aim of the study was to develop a compensation-based problem-solving therapy and to examine its effects on activities of daily living, participation, self-efficacy, and quality of life in individuals with stroke.

the study was designed as a randomized controlled trial. a simple randomization method was employed to randomly assign individuals to two groups (intervention and control groups). a simple randomization method was employed, whereby the intervention and control group papers were selected from a closed envelope. following the initial evaluation of each participant, one of the papers bearing the designation "intervention" or "control" was selected at random. this decision determined whether the individual would be included in the intervention or control group. the study was conducted in the occupational therapy department of the physical therapy and rehabilitation clinic of etlik city hospital. the study was approved by the ethics committee of etlik city hospital on may 17, 2023, and was assigned the code aeşh-ek1-2023-176. following approval from the ethics committee, the compensation-based problem solving training (cbpst) was developed. the training program was developed in accordance with the tenets of the occupational adaptation model. all subsequent steps were conducted in accordance with the aforementioned model. the adaptive response, as outlined in the model, encompasses the occupational adaptation that is anticipated to occur at the conclusion of the training program. the therapy was then trialled with a pilot group of five individuals, with the aim of refining the content. subsequently, the final iteration of the training program was established. all individuals included in the study signed a consent form indicating their willingness to participate. this was completed at the outset of the study. all individuals were provided with a standard rehabilitation program comprising five days a week (40 minutes) of routine therapy. in addition to this, the intervention group received cbpst in the form of five days a week (20 minutes) sessions. the evaluations completed at the beginning of the training were repeated one month later.

Eligibility criteria:
inclusion criteria: * individuals with ischemic stroke due to middle cerebral artery lesion 18-64 years of age stroke time between 3-12 months scoring 24 and above on the standardized mini mental test scoring 16 and below on the nih stroke scale receiving service in the inpatient service at etlik city hospital exclusion criteria: * having any psychiatric or neurological disease that may affect the study individuals whose affected hand is not their dominant hand individuals who tend to neglect their affected hand

Keywords: stroke activities of daily living compensation self-efficacy problem solving participation