Kornimate/medical-research-clean huggingface dataset:
evaluating ileostomy hydration protocol

Conditions: Ileostomy - Stoma; Ileostomy; Complications; Dehydration

Summary: this is a prospective observational study on patients who undergo an ileostomy creation after implementing a hydration algorithm as routine care at robert packer hospital. the department of surgery will be implementing a protocol to prevent dehydration for patients with high output ileostomies. patients with high output ileostomies are at an increased risk for readmission for dehydration. by reviewing the data after applying this standardized hydration protocol, we can assess its efficacy on readmission rates and comorbidities stemming from dehydration.

as of january 1, 2021, robert packer hospital will implement a standardized hydration protocol for patients at high risk for readmission due to dehydration. all postoperative ileostomy patients will be provided the following instructions at the bedside to ensure complete comprehension: 1. stoma maintenance education 2. hydration recommendations 3. intake and output worksheet education and trial the colorectal surgeons standardized the postoperative medical management of ileostomy output. before discharge, the healthcare providers will complete a "discharge assessment checklist". on the day of discharge, patients will be categorized by the "discharge algorithm for patients with ileostomies." the algorithm will assign patients by their ileostomy output and determine their next management steps. after discharge, all patients will record their fluid input and output using the "daily measurement of intake/output worksheet" which will be used to monitor hydration over time. patients who are high risk will receive outpatient intravenous hydration therapy. at each intravenous therapy appointment, the health care provider will review the outpatient intravenous hydration algorithm to determine the volume of fluid to distribute or if re-evaluation is necessary. data collection after starting the standardized hydration protocol, researchers will prospectively collect data from monthly reports of patients who received an ileostomy creation. researchers will not mask the patients, care providers, investigators, and outcomes assessors.

Eligibility criteria:
inclusion criteria: * patients older than 18 years of age will be eligible for this study. * patients who received emergent or elective end or loop ileostomy during the index admission will be eligible for this study. exclusion criteria: - patients who have not received an ileostomy creation at robert packer hospital will be ineligible.

Keywords: ileostomy dehydration
validity of low physical activity questionnaire (lopaq)

Conditions: Chronic Kidney Diseases; End Stage Renal Disease; Hemodialysis Complication

Summary: the goal of this observational study is to assess validity and reliability of persian version of low physical activity questionnaire. the main questions it mains to answer are: what is the level of physical activity in hemodialysis patients? is persian version of low physical activity questionnaire, valid to assess physical activity levels of dialysis patients? is persian version of low physical activity questionnaire, reliable? participants will answer 3 questionnaires and will do some functional tests.

currently, between 8 and 16 percent of the world's population is suffering from chronic kidney disease, and this number is increasing day by day, and it is predicted that by 2040, kidney disease will be the fifth cause of death. end-stage kidney disease patients, especially hemodialysis patients, face various problems, and during the years of dialysis, they suffer from many complications and problems, such as repeated hospitalizations, reduced physical performance, reduced aerobic capacity, low quality of life, and having a sedentary life. suffer, so that the activity level of these patients is between 20 and 50% of healthy people. the physical activity level of patients undergoing hemodialysis treatment is low and significantly lower than the same inactive control groups. research has shown that the level of physical activity of hemodialysis patients gradually decreases by approximately 4.5% per month during the entire period of the disease . in addition, the activities related to the work done at home constitute the largest part of the energy consumption of hemodialysis patients, which means that the types of activities of hemodialysis patients are usually limited to the lower category. valid instruments for measuring physical activity at the low end of the physical activity range and producing quantitative results are required among dialysis patients who are extremely inactive. this study aimed to translate and adapt a persian version of the low physical activity questionnaire (lopaq) and to examine its reliability and validity among hemodialysis patients.

Eligibility criteria:
inclusion criteria: * age ≥18 years * on hemodialysis for ≥3 months * able to walk without assistance * ability to provide informed consent and complete the questionnaires exclusion criteria: * diagnosis of mental or cognitive disorders * unstable conditions * hospitalization in the previous 3 months

Keywords: hemodialysis physical activity validity reliability sedentary behaviour
a dose-finding trial of opc-34712 in patients with schizophrenia

Conditions: Schizophrenia

Summary: to investigate the efficacy and safety of opc-34712 in comparison with placebo in patients with schizophrenia.


Eligibility criteria:
inclusion criteria: * patients age 18 years or older to less than 65 years (at time of informed consent) diagnosed with schizophrenia based on dsm-iv-tr diagnostic criteria * patients who are hospitalized, or judged to required hospitalization, for acute relapse of schizophrenia at time of informed consent * patients who are experiencing acute exacerbation of psychotic symptoms exclusion criteria: * female patients who are breastfeeding or who have a positive pregnancy test (urine) result prior to receiving investigational medicinal product * patients presenting a first episode of schizophrenia based on the clinical judgment of the investigator * patients who are diagnosed with a disease other than schizophrenia (schizoaffective disorder, major depressive disorder, bipolar disorder, posttraumatic stress disorder, anxiety disorder, delirium, dementia, amnesia, or other cognitive disorder) based on current dsm-iv-tr axis ι criteria, or who are diagnosed with a personality disorder (borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial)
validity and reliability study of the muscle excitability scale in spinal cord injury patients

Conditions: Spasticity, Muscle; Spinal Cord Injuries

Summary: the aim of the study is to verify validity and reliability of the muscle excitability scale (mes), which has been developed to access muscle susceptibility to spasms and/or clones as part of spastic motor behavior in spinal cord injured patients.

the muscle excitability scale (mes) is intended for patients after spinal cord injury. the objective is to evaluate a motor response (muscle spasms or clones) to a sensory or motor stimulus. a sensory stimulus is created by thumb and pointfinger compression of cutaneous tissue on the inside part of the middle thigh and calf. a motor stimulus is created by passive movement of the lower limb to flexion and extension. the mes grades from 0 to 4 reflect the muscle spastic or clonic tendency and the extent of this motor response (from isolated to generalized). two investigators will examine a spastic motor behavior in 50 chronic sci subjects using mes, modificated ashworth scale (mas) and penn spasms frequency scale (psfs) to verify the validity and reliability of the mes.

Eligibility criteria:
inclusion criteria: * spasticity in spinal cord injury exclusion criteria: * parallel brain injury * cognitive deficit affecting cooperation * acute infection or other sudden complication * recent change of antispastic medication

Keywords: spasticity spinal cord injury validity reliability
sexual absorption of vaginal progesterone

Conditions: Infertility; Pregnancy

Summary: the purpose of this study is to determine if sexual intercourse lowers serum progesterone in women using vaginal progesterone gel (crinone®), and increases serum progesterone in their male sexual partners. we hypothesize, based on previous estrogen studies done by our group, that intercourse will interfere with absorption of vaginal progesterone.

the effects of intercourse on the absorption of vaginal progesterone for the female user and her sexual partner have not been studied. however, a previous study performed by our group found that intercourse lowered the absorption of vaginal estrogen cream in women, and men absorbed a small but statistically significant amount of estradiol during intercourse. vaginal progesterone gel may be used by women for several clinical indications, and if intercourse alters the absorption and distribution of vaginal progesterone, clinical outcomes may be compromised. if intercourse lowers absorption, the efficacy of the treatment could be reduced. if intercourse enhances absorption, side effects may be increased. also, if the male sexual partner absorbs vaginal progesterone, undesirable side effects may occur.

Eligibility criteria:
inclusion criteria: * sexually active 18-40 year old heterosexual couple * subject willing to take mircette birth control pills for at least one cycle (one pack) * willing to have intercourse at the defined times (at least weekly within a 3 week interval, and draw blood within 10 hours of intercourse) * irb signed informed consent exclusion criteria: * undiagnosed vaginal bleeding * contraindication to oral contraceptives * liver dysfunction or disease * known sensitivity to crinone * known or suspected malignancy of the breast or genital organs * history of or active thrombophlebitis or thromboembolic disorders * use of condoms during intercourse * male erectile or ejaculatory dysfunction

Keywords: assisted reproductive technology infertility progesterone vaginal gel luteal-phase support
role of folinic acid in improving the adaptive skills and language impairment in children with autism spectrum disorder

Conditions: Autism Spectrum Disorder

Summary: no such study has been conducted in pakistan so the primary objective of this study was to determine the role of folinic acid in improving the speech and adaptive skills while secondary objective was improvement of stereotype movements and hyperactivity in asd among children aged 3 to 14 years.


Eligibility criteria:
inclusion criteria: * children of both genders aged 3 to 14 years with diagnosis of autism spectrum disorder established by dsm-5 criteria, childhood autism rating scale (cars) scoring and clinical examination along with documentation of language impairment exclusion criteria: * all children having autism with seizure disorder, autism with serious medical illness within last 6 months or those with autism with well-defined genetic syndrome.
a trial of shr7280 in healthy subjects

Conditions: Endometriosis; Uterine Fibroids; Assisted Reproduction

Summary: the study is being conducted to evaluate the effect of high-fat meal on pharmacokinetics of shr7280 after oral administration and the effect of shr7280 on qt interval at low and high doses in healthy chinese volunteers.


Eligibility criteria:
inclusion criteria: 1. voluntarily sign the informed consent form prior to any activities in the trail, demonstrate comprehension of the trial procedures and methodology, and agree to strictly adhere to the protocol throughout the study period. 2. be aged between 18 and 45 years inclusive (determined at the time of signing the informed consent form). 3. have a body weight of ≥50 kg for males and ≥45 kg for females, with a body mass index (bmi) between 18 and 26 kg/m² inclusive. 4. have no plans for pregnancy or sperm/egg donation from the time of signing the inform consent form until 1 week after the last administration of the investigational product, and agree to use highly effective contraceptive measures. exclusion criteria: 1. individuals with a history of chronic or serious diseases, or current conditions affecting the respiratory, circulatory, digestive, urinary, hematological, endocrine, immune, nervous, or psychiatric systems, and deemed ineligible to participate in this trial by the investigator. 2. females who are pregnant, breastfeeding, or with a positive serum pregnancy test during the screening or baseline period. 3. history of smoking (average daily cigarette consumption \>5 cigarettes) within 3 months prior to randomization, or any use of tobacco products during the study period. 4. history of drug abuse, positive urine drug abuse screen at the screening period. 5. receipt of live (attenuated) vaccines within 1 month prior to screening or planned administration during the trial (excluding influenza vaccines). 6. undergoing any surgical procedure within 3 months prior to randomization, incomplete recovery from surgery, or anticipated need for surgery or hospitalization during the trial period. 7. inability to comply with standardized dietary requirements, intolerance to high-fat meals, or presence of dysphagia. 8. any condition judged by the investigator to potentially affect drug absorption, distribution, metabolism, or excretion, reduce compliance, or pose other risks that make participation in the study inappropriate.
a study to investigate the pharmacokinetics and safety of risdiplam in infants with spinal muscular atrophy

Conditions: Muscular Atrophy, Spinal

Summary: this study will evaluate the pharmacokinetics (pk) and safety of risdiplam in participants with spinal muscular atrophy (sma) under 20 days of age at first dose.


Eligibility criteria:
inclusion criteria: * male or female newborn infant aged \<20 days at first dose * newborn infants with genetic diagnosis of 5q-autosomal recessive sma or newborn infants identified as positive for sma via newborn screening or via prenatal testing. * gestational age equal to or greater than 37 weeks * receiving adequate nutrition and hydration at the time of screening * adequately recovered from any acute illness at baseline and considered well enough to participate in the study * parent/caregiver is willing to consider nasogastric, nasojejunal, or gastrostomy tube placement during the study to maintain safe hydration, nutrition, and treatment delivery, if recommended by the investigator. exclusion criteria: * presence of clinical symptoms or signs consistent with sma type 0 * in the opinion of the investigator, inadequate venous or capillary blood access for the study procedures * systolic blood pressure or diastolic blood pressure or heart rate abnormalities * presence of clinically relevant electrocardiogram (ecg) abnormalities * the infant (or the person breastfeeding the infant) taking any of the following: any inhibitor of cyp3a4 taken within 2 weeks (or within 5 times the elimination half-life, whichever is longer) prior to dosing, any inducer of cyp3a4 taken within 4 weeks (or within 5 times the elimination half-life, whichever is longer prior to dosing, and/or use of any multidrug and toxin extrusion (mate) substrates taken within 2 weeks (or within 5 times the elimination half-life, whichever is longer) prior to dosing * concurrent or previous administration of nusinersen or onasemnogene abeparvovec * clinically significant abnormalities in laboratory test
study of lurbinectedin (pm01183) in combination with capecitabine in patients with metastatic breast cancer (mbc), pancreatic cancer (pc) or metastatic colorectal cancer (crc).

Conditions: Metastatic Breast Cancer; Pancreatic Cancer; Metastatic Colorectal Cancer

Summary: phase i multicenter, open-label, clinical and pharmacokinetic study of lurbinectedin (pm01183) in combination with capecitabine in patients with unresectable metastatic breast cancer (mbc), pancreatic cancer (pc) or metastatic colorectal cancer (crc) to determine the recommended dose (rd) of pm01183 in combination with capecitabine, to characterize the safety profile, to explore the feasibility of pm01183 dose optimization, to characterize the pharmacokinetics (pk), to obtain preliminary information on the clinical antitumor activity of this combination and to conduct an exploratory pharmacogenomic (pgx) analysis.


Eligibility criteria:
inclusion criteria: * voluntarily signed and dated written informed consent (ic) * age between 18 and 75 years * women of childbearing potential must have pregnancy excluded by appropriate testing before study entry. * life expectancy ≥ 3 months. * patients with a histologically/cytologically confirmed diagnosis of unresectable metastatic breast cancer, pancreatic cancer or metastatic colorectal cancer. exclusion criteria: * three or more prior chemotherapy-containing lines for advanced disease. * prior treatment with pm01183 or with capecitabine containing therapy for advanced disease. * history within the last year or presence of unstable angina, myocardial infarction, congestive heart failure, or clinically relevant valvular heart disease or symptomatic arrhythmia or any asymptomatic ventricular arrhythmia requiring ongoing treatment. * ongoing chronic hepatopathy of any origin. * active uncontrolled infection. * patients with dyspnea who are requiring any ongoing oxygen support. * known human immunodeficiency virus (hiv) infection. * any other major illness that, in the investigator's judgment, will substantially increase the risk associated with the patient's participation in this study. * men or women of childbearing potential who are not using an effective method of contraception
a safety and efficacy study of hpp404 on weight loss in overweight or obese subjects

Conditions: Obesity; Overweight

Summary: the purpose of this study is to compare the safety and effect of hpp404 versus placebo on body weight in overweight or obese subjects.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) from 30.0 to 39.9 kg/m2, for subjects with no additional co morbidities; * bmi from 27 to 39.9 kg/m2, for subjects with co morbidities (i.e. dyslipidemia defined as high ldl (≥ 160 mg/dl) or high total cholesterol (≥ 240 mg/dl), or subjects with hypertension) exclusion criteria: * systolic blood pressure \> 160 mmhg and/or diastolic pressure \> 90 mmhg at the screening visit without treatment * history of use of tobacco or nicotine-containing products 180 days prior to screening visit * subjects with type 2 diabetes or fasting blood glucose concentration ≥ 126 mg/dl * history of appetite or weight modifying surgeries/procedures

Keywords: obesity overweight body mass index
a study of baricitinib in participants with systemic lupus erythematosus (sle-brave ii)

Conditions: Systemic Lupus Erythematosus

Summary: the reason for this study is to see how effective and safe the study drug known as baricitinib is in participants with systemic lupus erythematosus (sle).


Eligibility criteria:
inclusion criteria: * have a clinical diagnosis of sle at least 24 weeks prior to screening. * have documentation of having met at least 4 of 11 revised criteria for classification of systemic lupus erythematosus according to the 1997 update of the 1982 american college of rheumatology (acr) criteria for classification of sle prior to randomization. * have a positive antinuclear antibody (ana) (titer ≥1:80) and/or a positive anti-double-stranded deoxyribonucleic acid (dsdna), and/or a positive anti-smith (anti-sm) as assessed by a central laboratory during screening. * have a total systemic lupus erythematosus disease activity index 2000 (sledai-2k) score ≥6 during screening. * have a clinical sledai-2k score ≥4 at randomization. * have at least 1 british isles lupus assessment group (bilag) a score or 2 bilag b scores during screening. * are receiving at least one of the following standard of care medications for sle: * a single antimalarial at a stable dose for at least 8 weeks prior to screening * a single immunosuppressant at a stable dose for at least 8 weeks prior to screening * an oral corticosteroid, initiated at least 4 weeks prior to screening, at a stable dose ≤40 milligrams/day prednisone (or equivalent) for at least 2 weeks prior to screening. if the participant is not receiving an antimalarial or immunosuppressant, the dose of corticosteroid must be ≥7.5 milligrams/day prednisone (or equivalent) exclusion criteria: * have severe active lupus nephritis. * have active central nervous system (cns) lupus. * have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute an unacceptable risk when taking investigational product or interfere with the interpretation of data. * have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection. * have received cyclophosphamide (or any other cytotoxic agent) within 12 weeks prior to screening.

Keywords: sle
facebase biorepository

Conditions: Craniofacial Abnormalities; Cleft Lip; Cleft Palate

Summary: the purpose of this study is to find out if there are any genetic differences between people with and without disorders of the head, face, and eye. we will create a biorepository of samples from people with and without these types of birth defects. a biorepository is a collection or "bank" of human tissue materials (such as blood or saliva) for research purposes. these samples will then be available to investigators studying these disorders.

samples from the facebase biorepository and data collected from these samples will be available to investigators who are studying birth defects of the head, face, and eye. data and samples will be deidentified prior to use by other investigators. researchers will be allowed to use samples and medical information only after approval by the facebase biorepository data access committee. once the facebase biorepository data access committee has established that the proposed use of the samples and clinical data meet the criteria for sound, ethical research, then the investigator will be granted permission to use a small portion of the sample and have access to clinical data stored in the computer database. investigators who are not part of the facebase biorepository research team will not know participant's names or other personally identifiable information.

Eligibility criteria:
inclusion criteria: * english speaking * individual with a craniofacial anomaly or family member of an individual with a craniofacial anomaly exclusion criteria: * non-english speaking * prisoners * minors in foster care or wards of the court

Keywords: biorepository genetics craniofacial cleft lip cleft palate