Kornimate/medical-research-clean huggingface dataset:
tezosentan in pulmonary arterial hypertension

Conditions: Pulmonary Arterial Hypertension

Summary: multicenter, open-label, non-comparative, proof-of-concept, phase 2a study to evaluate the effect of a single infusion of tezosentan on pulmonary vascular resistance in patients with stable, chronic pulmonary arterial hypertension, currently not treated with endothelin receptor antagonists, phosphodiesterase-5 inhibitors or prostacyclines


Eligibility criteria:
inclusion criteria: 1. signed informed consent 2. male and female patients 18 years of age or older 3. patients with pah according to one of the following subgroups of the venice classification group 1: * idiopathic (ipah), or * familial/heritable (fpah), or * associated (apah) with collagen vascular disease 4. modified nyha functional class ii-iii 5. documented hemodynamic diagnosis of pah by right heart catheterization at baseline: * resting mean pulmonary arterial pressure (mpap) ≥ 25 mmhg and * resting mean pvr ≥ 240 dyn•s•cm-5 and * pulmonary capillary wedge pressure (pcwp) ≤ 15 mmhg exclusion criteria: 1. patients with pah in venice classification groups 2-5, and pah group 1 subgroups not covered by inclusion criterion no. 3 2. hypotensive patients (systemic systolic blood pressure \< 100 mmhg) 3. patients with body weight \< 50 kg (110 lbs) 4. patients with moderate or severe hepatic impairment (child-pugh b and c) 5. patients with clinically significant chronic renal insufficiency (serum creatinine \> 2.5mg/dl / 221µmol/l) 6. patients who have received any endothelin receptor antagonist (era) and/or any phosphodiesterase-5 (pde-5) inhibitor within 28 days of baseline 7. patients who have received prostacyclin (epoprostenol) or prostacyclin analogs (e.g., treprostinil, iloprost) within 28 days of baseline 8. patients who have received any investigational drugs within 28 days of baseline 9. patients who have received cyclosporine a or tacrolimus within 28 days of baseline 10. psychotic, addictive or other disorder limiting the ability to provide informed consent or to comply with the study 11. life expectancy less than 12 months 12. females who are lactating or pregnant or females who are not using a reliable method of birth control (failure rate less than 1% per year) during the study and for at least one month after study drug intake 13. known hypersensitivity to any of the excipients of the drug formulation 14. patients with positive response to vasoreactivity test
bmi effect on the response to ovulation induction in letrozole vs clomid

Conditions: Subfertility

Summary: there is an increased prevalence of high body mass index (bmi) all over the world.high bmi is shown to have an impact on the female reproductive system.it can contribute to both ovulatory and anovulatory subfertility. clomiphene citrate and letrozole have been used for treatment of infertility.both are used for induction of ovulation. clomiphene citrate is an estrogen receptor antagonist .it increases serum fsh and it has its limitation due to his antiestrogenic effect,it has an ovulation rate 70-80% but pregnancy rate is only 22% because of its anti-estrogenic effect on endometrium and poor cervical mucus (legro rs et al.,2007) letrozole is an aromatase inhibitor which inhibits the production of estrogen, which influences the action of the brain's hypothalamus and pituitary on the functioning of the ovaries by increasing fsh.due to the antiestrogenic effect of clomiphene citrate,letrozole can be used as an alternative. the investigators are comparing the effect of both medications on the outcome of the induction of ovulation in women with high bmi.

this is a randomized controlled trial .the researchers include160 women with bmi more than 30 who were suffering from subfertility for more than 2 years. the investigators will randomise them into 2 groups. group a:they were prescribed 100 mg of clomiphene citrate from day 2-5 of the cycle for 5 days. group b : they were prescribed 5 mg of letrozole from day 2-5 of the cycle. vaginal ultrasound was performed on day 11 of the cycle, after at least one follicle reached 15 mm, the patient was encouraged to have sexual intercourse every other day for few days.the patients will have a midluteal progesterone level to confirm ovulation and will have a pregnancy test in 2 weeks if missed period. the researchers will compare the number of mature follicles, endometrial thickness on the day when there are mature follicles, occurrence of pregnancy, multiple pregnancies, and miscarriages .

Eligibility criteria:
inclusion criteria: * age: 18-45 years old. * history of subfertility for 2 years. * no previous ivf * intact tubes as evidenced by hsg or hycosy * normal sperm parameters according to who criteria. * ability to have regular intercourse during the ovulation induction phase of the study. exclusion criteria: * age less than 18 years old or older than 45 years old. * fsh\> 15 miu/ml * tubal factor of infertility * male factor of infertility * current pregnancy,abnormal uterine bleeding. * history of use of hormonal contraception in the last 3 months. * untreated medical problems: thyroid disease,hyperprolactinemia or contraindication to pregnancy as uncontrolled diabetes or severe heart disease. * contraindications to clomiphene citrate: hypersensitivity to clomid. * contraindications to letrozole: hypersensitivity to letrozole .
telenutrition weight loss study for men

Conditions: Obesity; Weight Loss; Men

Summary: this study is a 12-week pilot randomized controlled trial to test the feasibility and effectiveness of a home telenutrition weight loss program in men in west virginia.

this study is a 12-week pilot randomized controlled trial of a home telenutrition weight loss program for men with obesity and at least one additional risk factor for cardiovascular disease. the primary aims are to: 1. to assess the feasibility and acceptability of the male-targeted telenutrition weight loss program in terms of recruitment, retention and satisfaction and 2. to evaluate the effectiveness of the telenutrition program compared to usual care (informational only) with regard to primary and secondary outcome measures at 12 weeks. we hypothesized that men receiving virtual and telephonic support from a registered dietitian nutritionist would have greater weight loss and greater improvements in diet quality than men who were only provided educational materials.

Eligibility criteria:
inclusion criteria: * 40-70 year old man * body mass index ≥ 30 * living with spouse or companion * at least one of the following: hypertension, diabetes, pre-diabetes, hypercholesterolemia or hypertriglyceridemia * a home computer with high-speed internet access * a telephone for health coach phone calls exclusion criteria: * cancer (except skin or prostate), celiac disease, bacterial or viral infections, renal or liver disease (except non-alcoholic fatty liver disease), or condition that prevents fruits and vegetable consumption * major surgery or health event (e.g., stroke, heart attack) in the past six months * taking insulin, anti-obesity medications, steroids (e.g., prednisone), or warfarin (coumadin) * pacemaker or defibrillator * currently on a weight loss diet or lost \> 10 pounds in past six months * consume more than two alcoholic beverages daily

Keywords: telehealth weight loss diet quality behavioral counseling
global postural reeducation exercises versus deep neck flexor activation on non specific neck pain with forward head posture

Conditions: Non Specific Neck Pain; Forward Head Posture

Summary: this study will be conducted to compare between global postural reeducation (gpr) and deep neck flexors (dnf) activation in patients with chronic nonspecific neck pain (nsnp) on pain, disability, forward head posture and deep neck flexors endurance

neck pain (np) is highly prevalent and is the sixth largest cause of disability in the world, causing considerable economic impact. between 50% and 75% of people will not recover from an acute episode and will experience recurrent neck pain within the next 1 to 5 years, approximately 68% of people will develop persistent and chronic neck pain.forward head posture (fhp) is a common posture malalignment which characterized by increased craniocervical angle more than 50 degrees. there is a significant association between neck pain and forward head posture. according to previous studies, it has been proven that an average of 60% of patients with neck pain have a forward head posture.cranio-cervical flexor muscles training focuses on the deep flexor muscles such as longus capitis and longus colli muscles, which flex the neck, not the head. also, these low-load exercises train the deep cervical flexors more specifically, rather than all the neck flexors involved in the head-lifting exercise.global postural reeducation (gpr) is a method of physiotherapy, developed by phillipe souchard in the 1950s.its therapeutic approach depends on causality, and globality and is based on the hypothesis that the muscular system is organized into muscle chains, which can be shortened because of musculoskeletal disorders and constitutional, behavioral and psychological factors. forty four patients will be assigned randomly into two equal groups; fist one will receive global postural reeducation plus active neck exercise and the other will receive deep neck flexor exercises plus active neck exercise

Eligibility criteria:
inclusion criteria: * adult physiotherapists with mechanical neck pain and base line score of at least 3 out of 10 pain intensity on vas . * adult physiotherapists with fhp and cva less than 50 as a reference angle * adult physiotherapists aged from 18 to 24. exclusion criteria: * specific cause of neck pain as (rheumatic ,sytemic ,neuromuscular diseases ). * cognitive impairment . * cervical radiculopathy . * cervical spondylolisthesis

Keywords: global postural reeducation deep neck flexor activation chronic non specific neck pain forward head posture
relationship between coronary angiography findings and fractional flow reserve after balloon angioplasty

Conditions: Coronary Artery Disease

Summary: the goal of this prospective observational study is to learn about in patients who need percutaneous coronary intervention for coronary artery disease. the main questions it aims to answer are: * fractional flow reserve according to coronary angiography findings after coronary artery balloon angioplasty * differences in fractional blood flow reserve before and after lesions between coronary balloon angioplasty using a scoring balloon and a regular balloon participants will voluntarily consent to the study after being fully informed about the study and given ample opportunity to ask questions.


Eligibility criteria:
inclusion criteria: * patients with clinically stable coronary artery disease * patients undergoing balloon angioplasty as an interventional procedure (ffr-guided pci) using coronary artery fractional blood flow reserve for de novo lesions with a standard vessel diameter of 2.25 mm or more under percutaneous coronary angiography (hereafter referred to as coronary angiography) (note) if there are other lesions in the proximal area and the ffr of the distal lesion is collected, it is included in the selection target regardless of whether or not the proximal lesion was operated on. exclusion criteria: * target lesion with stenosis of less than 50% or greater than 90% of the internal diameter * procedure for restenosis within the stent * pre-dilation performed on the target lesion before the coronary artery fractional blood flow reserve test * prior coronary artery bypass surgery * clinically unstable or st-segment elevation myocardial infarction * myocardial infarction in the region supplied by the target vessel * target vessel is a blood vessel that supplies collateral circulation for occlusion of other blood vessels (not applicable when the need for collateral circulation has been resolved due to the opening of another vessel occlusion) * left ventricular ejection fraction (ef) less than 30% * most recently measured egfr is less than 30 right before the procedure * accompanying primary valve disease requiring treatment * accompanying primary heart disease such as dilated cardiomyopathy, hypertrophic cardiomyopathy, or restrictive cardiomyopathy * congenital heart disease

Keywords: coronary artery disease fractional flow reserve balloon angioplasty coronary artery dissection coronary artery elastic recoil
the predictive value of peak cough flow for endotracheal extubation of patients after craniotomy

Conditions: Extubation Success; Craniofacial Pain Syndrome; Cough Peak Flow; Endotracheal Tube

Summary: in severe cases after craniotomy, tracheal intubation is often required, and the removal of tracheal intubation presents certain risks and challenges. premature removal of the tracheal intubation can lead to failure of extubation and increased proportion of re-intubation, resulting in increased risk of airway injury and hospital-acquired pneumonia, resulting in prolonged hospital stay and even adverse effects on neurological outcomes and mortality. however, delayed extubation can also lead to an increased risk of hospital acquired pneumonia, affecting early recovery and neurological recovery. it can be seen that the accurate evaluation of the possibility of tracheal intubation and the appropriate timing can have a greater impact on the prognosis of patients after craniotomy. however, there are currently no relevant standards or guidelines to guide clinical work. previous studies have shown that for general critically ill patients, peak cough flow (pcf) can play a certain role in predicting tracheal intubation, but the results of each study are not consistent. the predictive value of pcf for tracheal intubation and extubation in patients after craniotomy is less relevant. this study intends to use pneumotachograph to measure the active and passive pcf of patients with extubation, to explore the predictive value of pcf for tracheal intubation after craniotomy, and to provide guidance for the development of clinical extubation decisions.

the objection of this study is to evaluate the preditive value of pcf for endotracheal extubation in patients undergoing craniotomy. for patients who met the inclusion criteria, the pcf value will be measured before the removal of entracheal tubes, and the predictive value of pcf will be evaluated by roc curves, as will as the cut-off value of pcf. according to state of consciousness, patients will be grouped as consciousness and unconsciousness group, and the predictive value of pcf for endotracheal extubation will be evaluated seprately in both groups. for patients with disturbance of consciousness, only passive pcf value will be measured. for lucid patients, inaddition to passive pcf value, the voluntary pcf value will also be measured.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * post- craniotomy * icu los ≥ 24h exclusion criteria: * no extubation attempt during the icu stay; * underwent tracheostomy without extubation attempt; * pregnant or lactating women; * enrolled in other clinical trials; * declined to participate in the study.

Keywords: endotracheal tube extubation success cough peak flow predictive value post-craniotomy critically ill
to investigate the correlation of stroke patients and demoralized

Conditions: Post-stroke Depression

Summary: this study aim to clarify the participants's mental state with demoralization scale- mandarin version(ds-mv). based on clinical observations and literature review, investigators assume participants's ds-mv score high correlation with phq-9 score.

the chinese version of demoralization scale-mandarin version (ds-mv) was used to assess the mental state of patients with stroke after debridement. the statistical analysis test of correlation is carried out, and the reliability and validity test and the norm establishment of the chinese version are further tested. convenient sampling will be performed at a single medical facility. the planned implementation period is 2019/01/01 \~ 2019/12/31, and the location of the case is the rehabilitation ward and outpatient clinic of taoyuan hospital. the diagnosis must be: intensive stroke or hemorrhagic brain within three years. in the case of a 20- to 100-year-old clinical patient with stroke, the subject should explain the content of the case, and the subject will complete the test consent form after informed consent, and then begin the evaluation process of the self-assessment questionnaire. the assessment procedure is preceded by a clinical psychologist conducting with mmse test to determine the cognitive function. when the patient's consciousness is blurred, the simple intelligent state test (mmse) score less than 24 points, aphasia can not be effectively communicated, the diagnosis of mental illness or mental disorder has been recorded on the medical record, or the patient or family member is unwilling to sign the informed consent form. if the above situation is met, subjects will be excluded. the self-assessment questionnaire will obtain the scores of the subjects in the chinese version of the demoralization scale-mandarin version (ds-mv) and the patient health questionnaire (phq-9). statistical analysis, as well as the chinese version of the loss of the scale of the reliability and validity of the test and the establishment of clinical norm scores.

Eligibility criteria:
inclusion criteria: * inpatient and outpatient of rehabilitation department in taoyuan general hospital, patients diagnosis : who have an infarct stroke or hemorrhagic stroke within three years. exclusion criteria: * conscious state confusion, the mmse score less than 24. * unable to understand information, speech disorders, dementia, aphasia. * the diagnosis of mental illness or mental disorder has been recorded on the medical history. * the patient or family unwilling to sign an informed consent.

Keywords: demoralization scale-mandarin version demoralization syndrome
clinical performance evaluation of sars-cov-2 (covid-19) antigen assay in point of care settings

Conditions: Covid-19

Summary: the purpose of this study is to evaluate the performance of freedom for all diagnostics, inc.'s colloidal gold immune technology sars-cov-2 antigen investigational assay when compared to a high-sensitivity emergency use authorization (eua) sars-cov-2 rt-pcr assay. the study will evaluate the accuracy in the intended use environment of the sars-cov-2 antigen assay when testing is conducted in a clia-waived setting (e.g., a physician's office or clinic) by non-laboratory personnel serving in a healthcare facility or setting.

the objective of this study is to demonstrate that non-laboratory personnel can accurately perform the sars-cov-2 antigen assay in the intended use environment using nasopharyngeal samples by demonstrating that the assay can achieve a ≥ 80% sensitivity when it is compared to the results of a high sensitivity eua sarscov-2 rt-pcr assay using nasopharyngeal samples. this study is designed as a prospective, blinded study to evaluate the sensitivity and specificity of the sars-cov-2 antigen assay when non-laboratory personnel conduct testing on subjects presenting with symptoms of covid-19. a minimum of 30 positive and 30 negative samples are required in order to meet eua submission guidelines. enrollment will continue until both minimum requirements have been achieved.

Eligibility criteria:
inclusion criteria: * subject suspected of having covid-19 infection and within 7 days of symptom onset. this will include at least one of the following: * fever or chills * cough * shortness of breath or difficulty breathing * fatigue * muscle or body aches * headache * new loss of taste or smell * sore throat * congestion or runny nose * in addition to the above primary symptoms, the subject might also report nausea, vomiting and/or diarrhea, but these symptoms alone are not sufficient to include the subject in the study. * subject is willing to provide consent/assent. * subject is willing to have two (2) nasopharyngeal swabs collected for the study and in the event of inconclusive results, be willing to return to the site to have two (2) more nasopharyngeal swabs exclusion criteria: to be enrolled in the study, each subject must not meet: * subject unable or unwilling to provide informed consent/assent. * subject tested positive for sars-cov-2 within the past 3 months. * subject has already participated in this study. * subject is a vulnerable population and deemed inappropriate for study by site principal investigator and/or irb.
a study to evaluate the safety, pharmacokinetics, and pharmacodynamics of subcutaneous cinryze administration

Conditions: Hereditary Angioedema

Summary: the objectives of the study are to: 1. evaluate the safety and tolerability of cinryze administered by subcutaneous injection in subjects with hereditary angioedema 2. characterize the pharmacokinetics and pharmacodynamics of cinryze administered by subcutaneous injection 3. assess the immunogenicity of cinryze following subcutaneous administration


Eligibility criteria:
inclusion criteria: to be eligible for this protocol, a subject must: 1. have a confirmed diagnosis of hae. 2. during the 3 consecutive months prior to screening, have a history of less than 1 hae attack per month (average) treated with c1inh therapy or any other blood products, ecallantide (kalbitor), icatibant (firazyr), antifibrinolytics (e.g., tranexamic acid), iv fluids, or narcotic analgesics. 3. agree to strictly adhere to the protocol-defined schedule of assessments and procedures. exclusion criteria: to be eligible for this protocol, a subject must not: 1. have received c1inh therapy or any blood products for treatment or prevention of an hae attack within 14 days prior to the first dose. 2. have received any ecallantide (kalbitor), icatibant (firazyr), or antifibrinolytics (e.g., tranexamic acid) within 14 days prior to the first dose. 3. have any change (start, stop, or change in dose) in androgen therapy (e.g., danazol, oxandrolone, stanozolol, testosterone) within 14 days prior to the first dose. 4. if female, have started taking or changed the dose of any hormonal contraceptive regimen or hormone replacement therapy (i.e., estrogen/progestin containing products) within 3 months prior to the first dose. 5. have a history of abnormal blood clotting or other coagulopathy. 6. have a history of allergic reaction to cinryze or other blood products. 7. be pregnant or breastfeeding. 8. have received an immunization within 30 days prior to the first dose. 9. have participated in any other investigational drug study within 30 days prior to the first dose.

Keywords: hae c1 inhibitor (c1inh) subcutaneous