Kornimate/medical-research-clean huggingface dataset:
a 4-week study to evaluate the efficacy and safety of hp-5000 in subjects with knee osteoarthritis

Conditions: Osteoarthritis of the Knee

Summary: a 4-week, randomized, double-blind, multicenter, placebo-controlled phase 2 study to evaluate the efficacy and safety of hp-5000 in subjects with osteoarthritis (oa) of the knee

this is a multicenter, randomized, double-blind, and placebo-controlled phase 2 study evaluating 2 formulations of hp-5000 in subjects with oa of the knee. the study will consist of up to 28-day screening phase that will include a washout period of current prescription and over the counter (otc) analgesics, a 4-week double-blind treatment phase, and a 1-week safety follow-up period.

Eligibility criteria:
inclusion criteria: * male or female aged 40 to 85 years with a clinical diagnosis of oa of the target knee according to the american college of rheumatology (acr) criteria, including: * symptoms for at least 6 months prior to screening, and * knee pain in the target knee for 30 days of the preceding month (periarticular knee pain due to oa and not due to other conditions such as bursitis, tendonitis, etc.) and * the pain in the target knee required the use of nonsteroidal anti-inflammatory drugs (nsaids) either over the counter (otc) per recommendation of a physician or prescribed. exclusion criteria: * body mass index (bmi) \> 40 * any subject who disobeyed the restriction of prohibited therapies (i.e., use rescue medication) during screening washout period. * secondary oa of the knee (rheumatoid arthritis, gout, psoriasis, syphilitic neuropathy, ochronosis, metabolic or other primary bone disease or acute trauma).
tga (thrombin generation assay) and prophylaxis in haemophilia

Conditions: Haemophilia A

Summary: haemophilic arthropathy is one of the major complications of severe haemophilia. in order to maintain plasma clotting factor activity levels above 1% and avoid spontaneous joint bleeds and other serious bleeding events, prophylactic factor replacement therapy is used. because of the high cost and limited availability of clotting factor concentrates, dosing is a crucial issue for prophylaxis therapy. several studies reported a better correlation between clinical bleeding tendency of patients with haemophilia and thrombin generation assay results compared to fviii/fix levels. however there is no specific data showing that thrombin generation may be a better indicator of the clinical efficacy of prophylaxis compared to the conventional fviii measurement. the main objective of this open, multicentre, prospective study is to compare trough thrombin generation capacity and fviii levels in severe haemophilia patients and compare these two laboratory results with: * the number of spontaneous haemarthroses and other spontaneous serious bleeds occurred in the last 6 months * the number of additional fviii units used in the last 6 months this project requires no change in term of type of treatment : during the study, each patient will be treated by his usual clotting factor at the usual regimen (frequency and dosage). the clinical outcome with the usual prophylaxis regimen will be correlated to tga results


Eligibility criteria:
inclusion criteria: * severe haemophilia a (fviii \< 1 iu/dl) * currently on prophylactic therapy * the same prophylaxis regimen in the last six months * age: 2 (with a body weight ≥12.5 kg ) - 45 years * adequate venous access * haemophilia patient's diary or equivalent regularly completed * ability of patient or family (for minors) to give informed consent * subject with health insurance exclusion criteria: * age \ 45 years * haemophilia a with documented inhibitor in the last 12 months * clinically symptomatic liver disease (historical evidence documented in patient's medical file) * platelet count \< 100x109/l * poor venous access * presence of a documented target joint * subject under legal protection measure.

Keywords: haemophilia a prophylaxis thrombin generation assay factor viii prophylactic therapy
health education and counseling in smoking cessation behavior, smoking decisional balance, and self-efficacy

Conditions: Coronary Heart Disease; Smoking Cessation; Smoking Behaviors

Summary: most male smokers with coronary heart disease resume smoking after hospital discharge. the main reason for failure to quit smoking is lack of motivation. however, few studies have used individual health education models to explore the effectiveness of smoking cessation according to the stage of change in smoking cessation behavior of patients. the purpose of this study was to examine the effectiveness of health education and counseling on the stages of change, smoking decisional balance, and self-efficacy of smoking cessation in smokers with no intention of quitting.

patients diagnosed with coronary heart disease by a medical center and smoked habitually were recruited as participants through convenience sampling. the research period was divided into a control stage (first to fourth week: standard of care) and the experimental stage (fifth to eighth week: health education and counseling). in the control stage, participants only received standard nursing care. in the experimental stage, intervention measures (health education and counseling) were implemented. the baseline data were the pretest data collected in the control stage. four weeks later, a posttest was performed, namely the pretest of the experimental stage. subsequently, 4 weeks of health education and counseling were introduced to smokers according to different stages. after 4 weeks of intervention, participants were asked to fill out the posttest questionnaire again to measure the stages of change for smoking cessation, smoking decisional balance, and self-efficacy of smoking cessation.

Eligibility criteria:
inclusion criteria: * patients diagnosed with coronary heart disease by a medical center and smoked habitually exclusion criteria: -

Keywords: self-efficacy counseling health education smoking cessation behavior
low residue diet during 3 days vs 1 day prior colonoscopy

Conditions: Colonoscopy; Colon Adenoma; Colorectal Neoplasms; Inflammatory Bowel Diseases; Colon Disease

Summary: colonoscopy is the gold-standard for the evaluation of the colorectal mucosa. colonoscopy quality indicators are the adenoma detection rate, the rate of cecal intubation and the bowel preparation. the role of diet in preparing for colonoscopy is not fully established. currently there is not enough evidence available to choice between 3 days of low residue diet versus 1 day. the research hypothesis is that the low residue diet offers a non-inferior bowel preparation and an improved tolerance.


Eligibility criteria:
inclusion criteria: * participants in the colorectal cancer screening program that give consent exclusion criteria: * contraindication for colonoscopy

Keywords: bowel preparation low residue diet colonoscopy
effects of massage with peppermint oil on labor pain

Conditions: Labor Pain

Summary: birth is a very special experience for a woman and her family. labor pain is one of the strongest known and defined pains today. in the literature, it has been stated that labor pain is perceived as more severe than chronic pain such as low back pain, cancer pain, phantom pain and postherpetic neuralgia, and acute pain such as fracture or laceration. when birth pain is not controlled, the vicious cycle of stress, fear and pain can continue and affect the mother and fetus negatively. in this study, our aim is to determine the effect of applying peppermint oil diluted with pure natural olive oil to the abdomen and waist region by massage in labor pain, reducing the labor pain.

the study is a prospective cross-sectional case control study. pregnant women whose mother tongue is turkish, who are term pregnant and who are in active labor, who are hospitalized in the delivery room of our hospital for delivery, that is, who have a gap of at least 70% 5-6 cm in the examination and who have at least 4-5 severe contractions in 10 minutes, who have a single, vertex-presented fetus will be included in our work. pregnant women with co-morbidities, chronic diseases, complications related to childbirth, anemic inactive labor, thyroid disease, skin lesions or infections, allergies, multiple pregnancies, use of any medication, and risky pregnancy will be excluded from the study. for this, 30 pregnant women who were applied peppermint oil and 30 control group pregnant women who were not applied will be included in the study. following the signed consent form obtained from our patients, visual analog scoring (vas) will be provided to the patient during the painful period, and then peppermint oil will be applied to the abdomen and lumbar region where he feels the most pain, with 1/10 diluted peppermint oil by hand massage or with the help of a compress moistened with warm water. after the application, visual pain scoring will be applied to pregnant women again.the study is terminated when sufficient data is obtained. the data will be entered into the computer in the spss program.

Eligibility criteria:
inclusion criteria: * normal pregnant with vertex presentation * at least 70% 5-6 cm gap in the examination at least 4-5 severe contractions in 10 minutes * turkish-speaking exclusion criteria: * pregnant women with co-morbidities, chronic diseases * complications related to childbirth * inactive labor * anemic, thyroid disease, skin lesions or infection, allergies, multiple pregnancies * use of any medication * risky pregnancy

Keywords: labor pain mint oil visuel anolgue scoring
safety and efficacy of an2728 topical ointment, 2% in children, adolescents, and adults (ages 2 years and older) with atopic dermatitis

Conditions: Dermatitis, Atopic

Summary: the purpose of this study is to investigate the safety and efficacy of an2728 topical ointment, 2% in children, adolescents, and adults (ages 2 years and older) with atopic dermatitis.


Eligibility criteria:
inclusion criteria: * males or females 2 years and older * has a clinical diagnosis of ad according to the criteria of hanifin and rajka * has ad involvement ≥ 5% treatable %bsa (excluding the scalp) * has an isga score of mild (2) or moderate (3) at baseline/day 1 * all female subjects of childbearing potential must use acceptable methods of contraception from the screening visit continuously until 30 days after stopping study drug exclusion criteria: * as determined by the study doctor, a medical history that may interfere with study objectives * unstable ad or any consistent requirement for high potency topical corticosteroids * history of use of biologic therapy (including intravenous immunoglobulin) * recent or anticipated concomitant use of systemic or topical therapies that might alter the course of ad * recent or current participation in another research study * females who are breastfeeding, pregnant, or with plans to get pregnant during the participation in the study * participation in a previous an2728 clinical trial

Keywords: atopic dermatitis
the effect of non-invasive respiratory support on outcome and its risks in sars-cov-2-related hypoxemic respiratory failure

Conditions: Target Trial Emulation, Invasive Mechanical Ventilation

Summary: to determine whether early endotracheal intubation compared to late endotracheal intubation affects clinical outcome (duration of invasive mechanical ventilation, mortality).

non-invasive respiratory support, especially hfno is usually well-tolerated, especially in covid-19 patients and can be applied for a prolonged period of time. however, there is a heated debate whether later/delayed endotracheal intubation (due to hfno / niv) increases the risk of lung injury, so-called patient self-inflicted lung-injury (p-sili). the concept of p-sili assumes that high forces applied to the lung resulting from strenuous breathing effort generated by the patient exacerbates lung-injury and is associated with adverse clinical outcome. it is therefore important to investigate if a longer period of non-invasive respiratory support before invasive mechanical ventilation is associated with adverse clinical outcome. thus, it is unknown if delaying invasive ventilation worsens clinical outcome. in this study, the research question is whether early compared to late endotracheal intubation improves clinical outcome (duration of invasive mechanical ventilation, mortality)? the aim is to identify the optimal s/f ratio and respiratory rate thresholds for initiating intubation to either improve survival or reduce the duration of invasive ventilation without compromising survival. this is achieved by comparing 25 dynamic treatment regimes defined by combinations of s/f thresholds (\ any, 16, 20, 25, 30). thresholds indicating less severe illness (e.g., s/f \ 16) are considered 'early intubation,' while thresholds indicating more severe illness (e.g., s/f \ 30) are considered 'late intubation'. two sensitivity analyses will be conducted: 1. restricting to patients without hypercapnia (pco2 \ 45. 2. including only patients with non-missing glasgow coma scale (gcs) values and adjusting for gcs as a confounder. additionally, seven subgroup analyses will be conducted: 1. patients diagnosed with covid-19 2. patients with a history of copd 3. patients with a history of chf 4. patients with bmi ≤ 30 5. patients with bmi \> 30 6. patients on high-flow nasal oxygen (hfno) at time zero 7. patients on non-invasive ventilation (niv) at time zero

Eligibility criteria:
inclusion criteria: * hospitalized (inpatient or icu) * 18 years or older * hypoxemic respiratory failure: s/f\<250 * not yet intubated exclusion criteria: * do not intubate order * presence of tracheostomy
liver transplantation and uveal malignant melanoma

Conditions: Uveal Malignant Melanoma

Summary: patients with uveal malignant melanoma with liver metastases have median survival of less than 12 months. there is no established treatment showing increased overall survival. the study will determine if liver transplantation will result in long term survival in patients with liver metastases from uveal malignant melanoma.


Eligibility criteria:
inclusion criteria: * uveal malignant melanoma * liver metastases * ecog 0-1 exclusion criteria: * extra hepatic disease * previous other malignancy * previous organ transplantation

Keywords: liver transplantation overall survival
effects of empagliflozin an sglt2-inhibitor on healthy volunteers with induced hypotonic hyponatremia - the dive study

Conditions: Inappropriate ADH Syndrome

Summary: empagliflozin (jardiance)® is a sodium glucose co-transporter 2 (sglt2)-inhibitor, which is a new treatment option developed for patients with diabetes mellitus type 2. the sglt2 is expressed in the proximal tubule and reabsorbs approximately 90 percent of the filtered glucose. the inhibition of sglt2 results in renal excretion of glucose with subsequent osmotic diuresis. this mechanism could result in a therapeutic effect in patients with hypotonic hyponatremia as in the syndrome of inappropriate antidiuretic hormone (adh) secretion (siad). because patients with siad usually have several comorbidities and different medications, studies investigating the physiological effects are difficult to interpret. therefore a model to study the possible physiological effect of sglt2-inhibitors in hypotonic hyponatremia as in siad is needed. the aim of this study is to evaluate whether empagliflozin (jardiance)® has an effect on serum sodium levels of healthy volunteers with induced hypotonic hyponatremia.


Eligibility criteria:
inclusion criteria: * informed consent as documented by signature * age 18 to 65 years * serum sodium level 135-145mmol/l * clinically euvolemic status exclusion criteria: * known or suspected allergy to trial product or related products * pregnancy or breast feeding * inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant * participation in another study with investigational drug within the 30 days preceding and during the present study * enrolment of the investigator, his/her family members, employees and other dependent persons * untreated hypothyroidism * cortisol deficiency * history of heart failure * liver cirrhosis at any stage * kidney disease (gfr \<60ml/min) * epileptic seizures within the last year * uncontrolled hypertension (systolic blood pressure \>160mmhg) * diabetes mellitus type 1 or 2 * bmi \ 29kg/m2 * other severe disease

Keywords: hyponatremia sglt2 inhibitor
effect of using nanochitosan versus calcium hydroxide as disinfectant on pain and apical bone healing

Conditions: Postoperative Pain; Healing

Summary: effect of using nanochitosan versus calcium hydroxide as intracanal medications on the postoperative pain and apical bone healing

pico approach p (population): maxillary anterior teeth having necrotic pulp with symptomatic apical periodontitis with evidence of apical radiolucency (minimum size 2 mm x 2 mm). i (intervention):0.2% nanochitosan as intracanal medication. c (control): calcium hydroxide paste intracanal medication. o (outcome): primary outcome: postoperative pain at time interval 4, 12, 24, 48, 72 hours secondary outcome: 1. postoperative pain, swelling, palpation, percussion and mobility at one week, 3, 6, 12 months 2. number of analgesic tablets used at 4, 12, 24, 48, 72 hours and one week. 3. healing of apical periodontitis using cbct at 3, 6, 12 months

Eligibility criteria:
inclusion criteria: * patients in good general health. * patient's age ranging between 20-40 years with no sex predilection. * maxillary anterior teeth with non-vital pulp and symptomatic apical periodontitis. * evidence of apical radiolucency (minimum size 2 mm x 2 mm). * patients' acceptance to participate in the study. exclusion criteria: * medically compromised patients with a severe systemic condition. * pregnant female patients. * patients who had taken any antibiotic or analgesics during the past 24 hours. * presence of a swelling because emergency management may include incision and drainage. * retreatment cases. * generalized periodontitis (calculus, deep pockets). * out of normal variations (open apex- severely curved canal- obstructed canal).
administration of high-dose intravenous proton pump inhibitor for upper gastrointestinal bleeding prior to endoscopy

Conditions: Peptic Ulcer

Summary: to evaluate if intravenous ppi infusion, when administered prior to endoscopy, hastens resolution of bleeding stigmata and thereby facilitates endoscopic examinations and reduces the need for endoscopic treatment. clot stabilization may itself sustain control of bleeding before endoscopy. these may translate into improved patients'outcome and survival. to determine the therapeutic effect of high-dose ppi infusion in upper gastrointestinal bleeding from causes other than peptic ulcers.

a placebo-controlled randomised study is being proposed. we hypothesize that early administration of intravenous omeprazole infusion stabilizes clots overlying arteries and hastens resolution of bleeding stigmata in peptic ulcer, and facilitates subsequent endoscopic examinations and reduces the need for endoscopic treatment. this may translates into clinical benefits in those who receive early intravenous omeprazole. consecutive patients with overt signs of upper gastrointestinal bleeding will be randomised to receive omeprazole or its equivalent placebo (80mg i.v. bolus followed by 8mg/hr) until next scheduled endoscopy. patients with circulatory instability or fresh hematemesis will undergo endoscopic examinations urgently after initial stabilisation. the infusion will continue until endoscopic examination with or without therapy. next scheduled endoscopy is performed within 24 hours from admission by experienced endoscopists with expertise in therapeutic endoscopy. at endoscopy, actively bleeding ulcers or ulcers with non-bleeding visible vessels are to be treated by endoscopic therapy. omeprazole infusion 8mg/hr is to be continued for 72 hours after endoscopic hemostasis. patients will be followed-up for 30 days from the time of admission or if patients stay longer than 30 days, the time to hospital discharge or death.

Eligibility criteria:
inclusion criteria: * patients with overt signs of upper gib; fresh hematemesis and/or melena with or with circulatory compromise exclusion criteria: * chronic aspirin user, * pregnancy, * age\<16, * allergy to ppi, * no consent

Keywords: peptic ulcer ivppi prior endoscopy
presentations of hyperandrogenic phenotypes in taiwanese women

Conditions: Hyperandrogenism,; Polycystic Ovary Syndrome,; Metabolic Syndrome,; Insulin Resistance,; Cardiovascular Disease.

Summary: study question: which of the four abnormally elevated androgen groups (total testosterone \[tt\], androstenedione \[a4\], free androgen index \[fai\], or dehydroepiandrosterone-sulfate \[dhea-s\]) present with an unfavorable metabolic and hormonal profile, appear to be more insulin-resistant and pose additional cardiovascular risk? summary answer: subjects with excess free androgen index tend to be obese and face the highest metabolic syndrome risk, adipocytokine alterations, insulin resistance (ir) and cardiovascular risk. the excess tt group presents with a marginal ir risk, while the excess a4 group has the highest antimüllerian hormone (amh), and may counterbalance obesity; this group and the excess dhea-s group have a favorable association with ir.

study design, size, duration:a retrospective study in 160 taiwanese women with ha and 165 women without ha, with medical records reviewed from 2009 up to 2012. the hyperandrogenic women were classified into four groups (tt, a4, fai, and dhea-s) according to independent abnormally elevated androgen measures each above its cut-off value, and the groups were compared with each other and with controls. participants/materials, setting, methods: this study was performed in the reproductive endocrinology clinic at wan fang medical center in taipei, taiwan. anthropometric, metabolic, endocrine, and ir components as well as lipid accumulation product (lap) index were compared between the groups. ir was assessed with the following markers: fasting glucose and insulin levels, oral glucose tolerance test, glucose-to-insulin ratio and homeostasis model assessment of ir index (homa-ir).

Eligibility criteria:
inclusion criteria: * hyperandrogenic women who were classified into four groups: * total testosterone (tt), * androstenedione (a4), * free androgen index (fai), * and dehydroepiandrosterone sulphate(dhea-s). * according to abnormally elevated androgen measures each above its cut-off value, and non hyperandrogenic women (who had all androgens below their cut-off values) exclusion criteria: * none of the women studied had * hypogonadotropic hypogondism, * hyperprolactinemia, * congenital adrenal hyperplasia, * premature ovarian failure, * androgen-secreting tumors, * cushing's syndrome, * or any other endocrine or systemic disease that may affect the reproductive function, * or any disorders of the uterus (e.g. asherman's syndrome and mullerian genesis) and chromosomal anomalies (e.g. turner's syndrome). * in addition, we excluded females who had * experienced menarche less than three years preceding the study start, * or who had day 3 fsh \> 15 miu/ml, as well as women with insufficient clinical/biochemical records, * and women with ovarian cysts or tumors in an ultrasonographic examination.

Keywords: hyperandrogenism/ fai/ metabolic syndrome/ adipocytokines/ insulin resistance.