Kornimate/medical-research-clean huggingface dataset:
study to investigate the effect of bms-986142 on the pharmacokinetics (pk) of methotrexate and probe substrate cocktail in healthy patients

Conditions: Rheumatoid Arthritis

Summary: to study the pharmacokinetics (pk) parameters of montelukast, flurbiprofen, midazolam, digoxin, pravastatin, and mtx when coadministered with bms-986142.


Eligibility criteria:
inclusion criteria: groups 1 and 2: 1. written informed consent from all subjects. 2. body mass index (bmi) of 18.0 to 32.0 kg/m2, inclusive 3. non-smokers. 4. normal renal function at screening as evidenced by an estimated glomerular filtration rate (gfr) of \> 90 ml/min/1.73 m2 . 5. subject reenrollment. 6. males who are sexually active with women of childbearing potential (wocbp) must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug plus 5 half-lives of bms-986142. 7. male subjects must be willing to refrain from sperm donation during the entire study plus 5 half-lives of bms-986142. group 1 only: 1. healthy male and female (not of childbearing potential) subjects as determined by medical history, and clinical assessments. 2. women must have documented proof that they are not of childbearing potential and must not be breast feeding. group 2 only: 1. healthy male subjects as determined by medical history, and clinical assessments. exclusion criteria: 1. administration of live vaccine including polio vaccine during the course of the study, 12 weeks prior to the first dose of study drug, or 30 days after the last dose of study drug. 2. active tuberculosis (tb) requiring treatment within the previous 3 years. 3. history of herpes zoster. 4. subjects who have experienced recent infection, upper respiratory infection,.
a safety and efficacy study of inhaled r940343 in patients with mild to moderate asthma

Conditions: Asthma

Summary: the purpose of this study is to determine the safety, efficacy and tolerability of r940343 in the treatment of mild to moderate asthma.

the study is a multi-center, randomized, double-blind, placebo-controlled, parallel group study comparing 2 doses of inhaled r343 bid to placebo over 8 weeks in patients with mild to moderate allergic asthma. patients who meet specific inclusion and exclusion criteria after an initial screening evaluation and a single-blind, run-in period will be randomized to receive either r343 or placebo.

Eligibility criteria:
inclusion criteria: * clinical history of asthma * ability to perform spirometry exclusion criteria: * chronic obstructive pulmonary disease or bronchiectasis * upper or lower respiratory infection
electronic health record (ehr) decision support to improve outpatient asthma care

Conditions: Asthma

Summary: to determine whether an innovative clinical decision support system embedded in an existing electronic health record (ehr) will improve provider adherence to the existing national asthma education and prevention program (naepp) guidelines. 12 primary care pediatric practices at the children's hospital of philadelphia(both urban and suburban sites) will be randomized to receive either a passive ehr (control sites) or an interactive decision support system (intervention sites).

after receiving a standardized education module based on naepp guidelines, 12 primary care pediatric practices (both urban and suburban sites) will be randomized to receive either a passive ehr (control sites) or an interactive decision support system (intervention sites). the primary outcome of interest will be the proportion of patients on appropriate asthma controller medication compared over time. secondary outcomes include the proportion of asthma patients with: 1) an updated asthma action plan 2) documentation of spirometry performed (6 to 17 yrs) and 3) an updated problem list reflecting current asthma severity. after hours calls to providers and types of office visits related to asthma will be tracked. 4) in addition, measurement of asthma-related quality of life and missed school and work in a sample of 200 subjects from each group will be performed. contextual factors at the clinic and patient level will be examined to assess their association with outcomes of interest. if shown to be successful, this type of clinical decision support, embedded within the ehr, has the potential to be a powerful tool to improve the implementation of asthma guidelines and clinical practice guidelines for other conditions and illnesses in the primary setting.

Eligibility criteria:
inclusion criteria: * known patients with asthma exclusion criteria: * none

Keywords: clinical decision support tool electronic health record control tool spirometry quality of life survey provider survey
microneedling versus carboxytherapy in stria distensae rubra

Conditions: Striae Distensae

Summary: the aim of this study is to evaluate and compare the efficacy and safety of microneedling and carboxytherapy either with or without platelet-rich plasma in the treatment of striae distensae rubra.


Eligibility criteria:
inclusion criteria: * female patients. * age ranging from 18-45 years old. * fitzpatrick skin type iii-iv. * striae distensae rubra on the abdomen (bilateral and more or less symmetrical). exclusion criteria: * patients taking immunosuppressants or having any disease affecting wound healing including diabetes. * patients receiving systemic glucocorticoids for chronic health conditions. * patients with chronic dermatologic diseases such as psoriasis and vitiligo. * pregnant and lactating females. * patients with a tendency for keloid formation. * patients with endocrine disturbance. * patients with autoimmune diseases, systemic diseases such as severe anemia, respiratory, cardiac, renal or liver disorder. * patients with bleeding and coagulation disorders. * patients who received any form of treatment for their sd in the past 6 months.

Keywords: striae distensae striae rubra microneedling carboxytherapy
proximal medial gastriocnemius recession for chronic plantar fasciitis

Conditions: Chronic Plantar Fasciitis

Summary: this prospective kohort study will follow 150 patients treated with proximal medial gastrocnemius recession for plantar fasciitts. follow up time is two years and the main outcome is the manchester oxford foot questionnaire. a regression analasys will be performed to identify possible patient baseline factors that may affect the effect of surgery,

recent studies indicate that chronic plantar fasciitis can be treated effectively with proximal medial gastrocnemius recession (pmgr). in our hospital this treatment has been inocorporated into routine care. this prospective kohort study will follow 150 patients with chronic planatar fasciitis operated with pmgr study. the follow up time is 2 years and the study aims at documenting the effect of the surgery with proms (patient related outcome measures), mri (magnetic resonnance imaging) and ankle movement measurements. 26 patient-related baseline factors will also be registered. a regression analysis will be performed to identify factors that may be predictive to the effect of pmgr surgery.

Eligibility criteria:
inclusion criteria: 1. age 18-75 years. 2. diagnosis plantar fasciitis verified clinically by orthopaedic surgeon. 3. diagnosis verified by mri. mri criteria: thickening of the plantar fascia, oedema in the calcaneus, pathological singal changes in the plantar fascia (37) 4. duration of symptoms must be at least 12 months. 5. an isolated gastrocnemius contracture must be verified with the silverskiölds test before inclusion. 6. conventional physical therapy must have been tried at least three months without positive effects on symptoms from affected foot. exclusion criteria: 1. previously undergone surgery for plantar fasciitis. 2. patients with severe talocrural pathology or serious malalignment of foot and ankle 3. severely reduced peripheral circulation or chronic ulcerations of the foot 4. history of alcoholism, drug abuse, psychological or other emotional problems likely to jeopardize informed consent. 5. patients with a contraindication/non-compliance for mri examination. 6. unable to walk without aid. 7. not able to read and/or speak a scandinavian language or english adequately.

Keywords: proximal medial gastrocnemius recession moxfq vas eq5d mri regression analysis ankle movement adverse events
camostat mesilate treating patients with hospitalized patients with covid-19

Conditions: Severe Acute Respiratory Syndrome

Summary: to determine if the reduction in tmprss2 activity via direct inhibition with camostat mesilate combined with standard of care (soc) treatment will increase the proportion of patients alive and free from respiratory failure at day 28 in sars-cov-2 as compared to soc treatment with placebo.


Eligibility criteria:
inclusion criteria: * laboratory confirmed sars-cov-2 infection * admitted to hospital for management of sars-cov-2 * age ≥18 * subject or legal representative able to give informed consent * ability to take all study drugs * respiratory status of 3 or greater on the who ordinal scale * alt or ast ≤5 x uln * creatinine clearance ≥50 ml/min using the cockroft-gault formula * willingness to provide mandatory specimens for correlative research and banking exclusion criteria: * women who are pregnant or breastfeeding * known hypersensitivity to the study drug, the metabolites or formulation excipient
a study to evaluate the safety, tolerability & efficacy of msdc-0602k in patients with nash

Conditions: Non-alcoholic Fatty Liver Disease; Non-alcoholic Steatohepatitis; NASH - Nonalcoholic Steatohepatitis

Summary: this is a randomized, double-blinded study of three doses of msdc-0602k or placebo given orally once daily to subjects with biopsy proven nash with fibrosis and no cirrhosis.

this is a randomized, double-blinded study of three doses of msdc-0602k or placebo given orally once daily to subjects with biopsy proven nash with fibrosis and no cirrhosis. visits to the clinic will be at baseline, 1, 2, 3, 6, 9, and 12 months, with one 2- week follow-up visit. safety will be assessed by monitoring of vital signs, 12 lead electrocardiogram (ecg), physical examinations, safety labs, and adverse events (aes).

Eligibility criteria:
selected inclusion criteria: * adult subjects 18 years of age or greater * histological evidence of nash, based on biopsy, with a nas (nash crn scoring) ≥ 4 with a score of at least 1 in each component of nas. * histological evidence of liver fibrosis defined as nash crn system fibrosis score f1 to f3. * subjects with type 2 diabetes mellitus (dm) must be under stable and reasonable control. * male and female subjects who are taking vitamin e should be on a stable dose of vitamin e (if ≥ 400 iu) for a period of at least 3 months prior to randomization. * females should be either postmenopausal (at least 12 months since last menses) or surgically sterilized (bilateral tubal ligation or hysterectomy). males with female partners of child-bearing potential must agree to use adequate contraceptive methods (including a condom, plus one other form of contraception) if engaging in sexual intercourse. * willing and able to sign an informed consent document indicating understanding the purpose of and procedures required for the study and willingness to participate in the study. selected exclusion criteria: * known history of hiv. * prior liver transplantation. * other well-documented causes of active chronic liver disease. * history of cirrhosis and/or hepatic decompensation including ascites, hepatic encephalopathy or variceal bleeding. * history of alcohol abuse or drug abuse within 6 months of screening. * type 1 diabetes mellitus. * current or history of recent (≤ 6 months) use of ursodeoxycholic acid. * use of concomitant medications with a known significant metabolism by cyp2c8 or cpy2c9. * history of diabetic ketoacidosis or hyperosmolar non-ketotic coma within 6 months prior to randomization. * history of heart failure (including chf) or previous cardiovascular event (myocardial infarct, by-pass surgery, or ptca) within the past 6 months prior to randomization. * blood pressure greater than 160/100 mmhg. * participation in an investigational study or received an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to study drug administration. * malignancy, including leukemia and lymphoma (excluding basal cell and squamous skin cell cancers and localized prostrate cancer) treated within the last 2 years.

Keywords: nash
short-term oral prednisone for acute subjective tinnitus

Conditions: Tinnitus, Subjective

Summary: the goal of this clinical trial is to investigate the efficacy of oral steroids in the acute tinnitus population. participants will receive appropriate dosages of short-term prednisone and/or oral ginkgo biloba tablets.

researchers will compare the intervention group and placebo-control group to see whether short-term systemic steroid therapy is effective for acute tinnitus.

Eligibility criteria:
inclusion criteria: 1. 18-65 years old; 2. a primary complaint of frequent occurrences of subjective tinnitus lasting at least 5 minutes within the past 3 months ; 3. a definition of normal hearing in line with the world report on hearing (2021), of which the average value of hearing threshold at 500, 1000, 2000, 4000 hz in better ear was less than 20 decibels; 4. a score of more than 16 points on the tinnitus handicap inventory (thi), which indicates that the level of tinnitus exceeds mild severity; 5. a state of good general condition. exclusion criteria: 1. had previous history of middle ear pathology, apparent history of noise exposure, noise trauma or head injury; 2. had received treatment for their current condition before the study; 3. taken oral steroids within 3 months before randomization; 4. had hearing implants; 5. had participated in other clinical trials and have not terminated the trials; 6. had a history of known corticosteroid contraindications (including osteoporosis, peptic ulcers, poorly controlled hypertension, diabetes, chronic liver or renal insufficiency, tumorous condition, alcohol abuse, pregnancy, or taking estrogen-containing oral contraceptive steroids); 7. auditory hallucinations or other conditions deemed inappropriate for inclusion by the investigator.
efficacy and safety of additive manufacturing personalized titanium mesh in guided bone regeneration

Conditions: Alveolar Bone Atrophy; Guided Bone Regeneration

Summary: this goal of this single-blind, simple randomized, positive-controlled prospective study is to evaluate the effects of additive-manufactured personalized titanium mesh and traditional titanium mesh in guided bone regeneration for large alveolar bone defects. the study will assess the short-term and long-term efficacy, safety, and incidence of complications of the additive-manufactured personalized titanium mesh, along with an analysis of risk factors. participants will be followed up for two years after surgery with free-of-charge clinical and radiographic examinations.


Eligibility criteria:
inclusion criteria: 1. patients missing single or multiple teeth with moderate to severe bone defects in the edentulous area requiring complex guided bone regeneration. （moderate bone defects: bone loss with residual alveolar ridge width between 1 mm and 3 mm; severe bone defects: bone loss with residual alveolar ridge width ≤ 1 mm.） 2. the edge of the edentulous area within 1 mm is alveolar bone, with no adjacent tooth roots or nerve canals, ensuring complete retention of the personalized titanium mesh edge. the apical edge of the edentulous area within 2 mm is alveolar bone, with no nerve canals, ensuring that retention screws for the personalized titanium mesh can be designed in this area. 3. the patient and/or his/her guardian agrees to participate in this trial and signs the informed consent form. exclusion criteria: 1. patients with edentulism. 2. patients with mild bone defects (residual alveolar ridge width greater than 3 mm). 3. presence of acute or chronic infection in the surgical area. 4. presence of acute or chronic infection in the teeth adjacent to the edentulous area. 5. participation in similar trials or other interventional clinical trials within 30 days prior to signing the informed consent form. 6. history of metal allergies, severe allergy history, or severe immune deficiency. 7. uncontrolled metabolic diseases, such as type 1 diabetes or type 2 diabetes (hba1c ≥ 7% or fasting blood glucose ≥ 7 mmol/l despite medication control), severe liver or kidney dysfunction (alt, ast \> 2 times the upper limit of normal, serum creatinine above the upper limit of normal). 8. long-term use of steroid medications. 9. history of drug abuse or alcoholism. 10. pregnant or breastfeeding women. 11. poor compliance. 12. other conditions deemed unsuitable for participation by the investigator.
the resistance exercise training for worry trial

Conditions: Analogue Generalized Anxiety Disorder

Summary: this protocol details the full methods of two parallel, randomized controlled trials of an eight-week resistance exercise training intervention compared to a wait-list control condition among young adults with and without analogue-generalized anxiety disorder.

recent meta-analyses support the chronic anxiolytic effects of resistance exercise training among women with diagnosed generalized anxiety disorder. however, the effects of resistance exercise training among those with subclinical, or analogue-generalized anxiety disorder is unknown. this protocol details the full methods of two parallel, randomized controlled trials of an eight-week resistance exercise training intervention compared to a wait-list control condition among young adults with and without analogue-generalized anxiety disorder. analogue-generalized anxiety disorder status was determined using validated cut-scores for both the psychiatric diagnostic screening questionnaire generalized anxiety disorder sub-scale score of 6 or greater, and the penn state worry questionnaire score of 45 or greater. the ecologically-valid resistance exercise training was designed according to world health organization and american college of sports medicine guidelines.

Eligibility criteria:
inclusion criteria: * inclusion criteria were age 18-40y; no medical contraindication to safe participation in resistance exercise training; and no current pregnancy or lactation. exclusion criteria: -

Keywords: anxiety
health information technology system ("roadmap 2.0") in the context of hematopoietic cell transplantation

Conditions: Hematologic Diseases

Summary: the purpose of this research study is to measure the effects of using a mobile phone app (roadmap 2.0) on the health-related quality of life of caregivers and patients undergoing allogeneic/autologous hematopoietic cell transplantation (hct).

health information technology tools may enable caregivers and patients to become more active participants in their healthcare.this study is not to provide any treatment, but rather to investigate the use of this mobile health technology-mediated intervention (roadmap 2.0). roadmap 2.0 is a web-based application that integrates patient-specific information and includes several domains: laboratory results, medications, clinical trial details, photos of the healthcare team, trajectory of transplant process, and discharge checklist. this trial is anticipated to enroll 664 participants, but only caregivers (332 total) will be evaluated for the primary and secondary outcome measures. thus, the sample size is 332. the total enrollment includes 166 caregiver-patient dyads of adult patients (age \>/=18 years) undergoing hct ("adult dyads" = 332 total) and 166 caregiver-patient dyads of pediatric patients (age 5-17 years) undergoing hct ("pediatric dyads" = 332 total).

Eligibility criteria:
inclusion criteria * the caregiver must have an eligible patient (see below) * the caregiver must be of age ≥18 years. * the caregiver should be comfortable in reading and speaking english and signing informed consents. * the caregiver should provide at least 50% of care needs. * an eligible patient is one who identifies the eligible caregiver as their primary caregiver (i.e., provides at least 50% of care needs). * an eligible patient is age ≥5 years. * an eligible patient is scheduled to undergo hct. * an eligible patient is able to sign informed consent/assent forms. * patients and caregivers agree to provide informed consent that is in regulatory compliance and irbmed-approved and also in accordance to institutional guidelines. a patient is able to undergo hct at the u-m only if a designated family caregiver (e.g., parents, adult children, spouses, family members, neighbors, friends) accepts the roles, in accordance to the clinical practice guidelines of the u-m bmt program. * the caregiver and patient must have his/her own smartphone to participate. exclusion criteria - patient does not meet eligibility criteria to undergo hct at the u-m bmt program or oregon health \& sciences university.

Keywords: hematopoietic cell transplantation mobile health technology
suv max as predictor of outcome in cervical cancer

Conditions: Cervical Cancer

Summary: cervical cancer is staged clinically, not surgically. patients in whom an extensive disease is identified are not usually eligible for surgery. pet-ct is used to support staging. however, some patients received surgery after staging and subsequently require radio/chemotherapy due to findings on operation. this study will attempt to find a correlation between suv-max on pet-ct and subsequent outcomes i.e. need for adjuvant therapy.


Eligibility criteria:
inclusion criteria: * having stating pet-ct stored on site * treated with surgery exclusion criteria: * not eligible for surgery based on pet-ct, clinical stage

Keywords: cervical cancer pet ct suv max
neurostimulation device for treatment of migraine headache

Conditions: Migraine Headache

Summary: this is a single-site, prospective, non-randomized and open label study to investigate the feasibility of home-use cvs for the prevention of episodic migraine headache and specifically to better understand what type of waveform to apply.


Eligibility criteria:
inclusion criteria: * a history of at least four, and not more than fourteen total monthly headache days of which between four and nine were migraine headache days. (note: patients were permitted continued access to migraine abortive medications and were being treated at the duke university headache clinic.) * a history of some responsiveness (incomplete) to at least one and a maximum of two prophylactic pharmaceutical therapies (utilized concurrently); * the investigator must have confidence in the patient's ability to reliably complete and return the daily headache diary. * subject must be at least 18 years of age. exclusion criteria: * individuals who were pregnant, who had a history of cardiovascular disease, who worked night shifts or who had vestibular migraine, menstrual migraine, post-traumatic migraine, a history of unstable mood disorder or unstable anxiety, moderate or greater hearing loss or a history of traumatic brain injury. * a history within the last six months of tobacco use, narcotic or barbiturates use or experiencing one or more analgesic rebound headaches.

Keywords: caloric vestibular stimulation