Kornimate/medical-research-clean huggingface dataset:
glucokinase activator in monogenic diabetes

Conditions: Diabetes Mellitus; Monogenic Diabetes

Summary: evaluating a novel, allosteric glucokinase activator in monogenic diabetes secondary to inactivating glucokinase mutations: a randomised, cross-over trial

evaluating a novel, allosteric glucokinase activator in monogenic diabetes secondary to inactivating glucokinase mutations: a randomised, cross-over trial

Eligibility criteria:
inclusion criteria: 1. age ≥18 and \<75 years 2. body mass index (bmi) \>18 and \<30 kg/m2 3. fasting plasma glucose \>5.6 mmol/l at screening 4. participants with gck-mody had and are heterozygous carriers of a pathogenic or likely pathogenic gck mutation at screening based on guidelines published by the american college of medical genetics and genomics (acmg), association for clinical genomic science (acgs) and the clingen monogenic diabetes expert panel (mdep) . exclusion criteria: 1. body weight \<45kg at screening 2. current or planning pregnancy or lactating 3. troke or cardiovascular disease within 6 months of recruitment 4. severe renal dysfunction (estimated glomerular filtration rate \<30ml/min/1.73m2 or renal replacement therapy) 5. severe hepatic dysfunction (aspartate transaminase and/or alanine transaminase \> 3 times upper limit of normal) 6. history of drug abuse or excessive alcohol intake 7. severe hypoglycemia within 6 months prior to screening 8. anaemia with hb \<10 g/dl at screening 9. excessive blood loss \>300ml within 1 month of screening 10. use of strong or moderate cyp3a4 inhibitors or inducers 11. use of sulfonylureas, dipeptidyl peptidase-4 inhibitors, glucagon-like peptide-1 agonists, sodium glucose transporter 2 inhibitors, insulin, thiazolidinediones, acarbose in the 6 weeks prior to randomisation 12. use of long-term high-dose corticosteroids at randomisation 13. serious concurrent infections at time of screening

Keywords: gck-mody glucokinase activator
evaluation of effectiveness and safety of xience sierra in routine clinical practice

Conditions: Coronary Artery Disease; Coronary Disease

Summary: the objective of this study is to evaluate effectiveness and safety of xience sierra stent in the "real world" daily practice as compared with other drug-eluting stents.


Eligibility criteria:
inclusion criteria: * age 19 and more * patient with xience sierra everolimus eluting coronary stent * written consent exclusion criteria: * intervention with xience sierra everolimus eluting coronary stent and other drug eluting stent at the same time * life-expectancy less than 1 year * cardiac shock

Keywords: xience sierra drug eluting stent percutaneous coronary intervention
a study to evaluate the change in weight after 24 weeks treatment with lik066 in obese or overweight adults

Conditions: Obesity; Overweight

Summary: this was a dose-finding study that evaluated the change in weight after 24 weeks treatment with 8 different doses of lik066 compared to placebo in obese or overweight adults, followed by 24 weeks treatment with 2 doses of lik066 and placebo.


Eligibility criteria:
inclusion criteria: 1. informed consent 2. (bmi\>=30) or (bmi\>=27 with history of cv disease, hypertension, dyslipidemia, pre-diabetes or type 2 diabetes mellitus, sleep-apnea syndrome) 3. willing to comply with life-style intervention and treatment during the full duration of the study (approximately 54 weeks) exclusion criteria: * hypersensitivity to any of the study medications * pregnancy or lactating women * history of malignancies * use of pharmacologically active weight loss products * bariatric surgery * ketoacidosis, lactic acidosis, hyperosmolar coma in the 6 months before the screening visit. * hba1c \>10% at the screening visit.

Keywords: obesity overweight
a multi-national study in bladder cancer patients to detect recurrences after turb (trans-urethral resection of the bladder) earlier with the xpert bladder cancer monitor assay (anticipate x)

Conditions: Non-muscle-invasive Bladder Cancer

Summary: bladder cancer is the 5th most common cancer in europe, with more than 151,000 new cases diagnosed in 2012 (4% of the total). bladder cancer has the highest recurrence rate of any malignancy, often as high as 70% within 5 years of successful treatment. this high recurrence rate requires diligent and accurate monitoring as a means for early diagnosis and treatment. considering the burden associated to repeated invasive cystoscopies, there is a need for robust but accurate tests for surveillance. in that prospect, urinary molecular tests have been developed although none were deemed adequate in the european clinical guidelines to replace cystoscopies. the xpert bladder cancer monitor assay is a qualitative in vitro diagnostic test designed to monitor for the recurrence of bladder cancer in patients previously diagnosed with this cancer. the test provides a fast and accurate result, is non-invasive and easy to perform. the aim of this study is to assess the non-inferiority of the xpert bladder cancer monitor assay in detecting recurrences in comparison to cystoscopy in the follow-up of patients with low or intermediate risk non-muscle-invasive bladder cancer (nmibc).

patient recruitment and follow-up are closed. the study is in analysis phase.

Eligibility criteria:
inclusion criteria: * patient undergoing a follow-up cystoscopy at the time of enrolment for low or intermediate risk nmibc patients in the follow-up phase (according to the 2017 eau guidelines), * patient must accept to be followed for 1 year after enrolment cystoscopy, * patient who can provide urine samples naturally (e.g. no catheterization), * 18 years or older at the time of enrolment, * signed informed consent. exclusion criteria: * patient with history of nmibc stratified at the time of enrolment as high risk according to 2017 eau guidelines, * patient with history of muscle-invasive bladder cancer (mibc), * patient having undergone a turb less than 3 months before enrolment, * patient having received mitomycin c (mmc) or bacillus calmette-guerin (bcg) intravesical instillations less than 3 months before enrolment (a single mmc post-operative instillation is acceptable for inclusion).
efficacy and safety of baricitinib in patients with moderate and severe covid-19

Conditions: Covid19

Summary: this is multicenter clinical trial to evaluate efficacy and safety of baricitinib in treatment for covid-19. this trial will compare baricitinib, a drug recommended for rheumatoid arthritis, against standard of care, to assess its relative effectiveness against covid-19. by enrolling patients in multiple centers, this trial aims to recruit more patients to evaluate whether this drug slow disease progression or improve survival. currently no effective therapeutics treatment or vaccine is available in the world for this highly transmissible respiratory borne infection, covid-19. a number of drug trials are ongoing to measure the efficacy of the drug against the virus. bangladesh as a resource limited country with limitation to provided health care services to the huge number of covid-19 patients who will need hospitalization will be benefited from this study. there is no physical, psychological, social, legal risk in this study. the trial therapeutic will be approved form the directorate of drug administration (dgda), bangladesh.


Eligibility criteria:
inclusion criteria: * sars-co-v2 positivity to the nasal-swab by reverse-transcriptase-polymerase chain- reaction (rt-pcr) assay tested by the local diagnostic laboratory * age \>18 years * presence of any symptoms suggestive of covid-19, such as such as fever, fatigue, cough (with or without sputum production), shortness of breath, sore throat, nasal congestion, anorexia, malaise, or headache. rarely, patients may also present with diarrhea, nausea, and vomiting * presence of radiological findings of pneumonia assessed by chest radiograph, computed tomography * moderate and severe covid-19 as per previous definition national guideline/who * give informed written consent exclusion criteria: * absolute lymphocyte count \<500/mm3 and absolute neutrophil count of \<1000/mm3 and hemoglobin 8gm/dl or less * severe hepatic or renal impairment * live vaccine within 3 months prior to first dose of the drug * pregnancy * lactation * current malignancy or history of malignancies over the previous 5 years and/or history of malignancies in first degree relatives * transaminases values 5-fold higher than the upper normal limit * proven evidence of concomitant bacterial infections * clinical evidences suggestive of pulmonary tuberculosis, or past history and/or history of contact with tb patient * known hypersensitivity to baricitinib * those who have received tocilizumab previously
blood flow and vascular function in cystic fibrosis

Conditions: Cystic Fibrosis

Summary: cystic fibrosis (cf) has many health consequences. a reduction in the ability to perform exercise in patients with cf is related to greater death rates, steeper decline in lung function, and more frequent lung infections. however, the physiological mechanisms for this reduced exercise capacity are unknown. the investigators laboratory recently published the first evidence of systemic vascular dysfunction in patients with cf. therefore, it is reasonable to suspect that the blood vessels are involved with exercise intolerance in cf. this study will look at how 1) blood flow and 2) artery function contribute to exercise capacity in cf.

the most disturbing aspect of cystic fibrosis (cf) is the associated premature death. low exercise capacity predicts death in patients with cf and is also associated with a steeper decline in lung function and more lung infections. a critical barrier to improving exercise tolerance in patients with cf is the investigators lack of knowledge regarding the different physiological mechanisms which contribute to their lower exercise capacity. we have compelling data to indicate that the blood vessels may contribute to the low exercise capacity in cf. the impact of this proof of concept investigation will test phosphodiesterase type 5 inhibitors (pde5) inhibitors as a potential therapy in cf and will explore blood flow and endothelial function as potential mechanisms which contribute to exercise intolerance in cf. improvements in exercise capacity will not only contribute to a better quality of live for patients with cf, it will also increase longevity in these patients.

Eligibility criteria:
inclusion criteria. * diagnosis of cf and healthy controls * men and women (greater than 18 yrs. old) * resting oxygen saturation (room air) greater than 90% * forced expiratory volume (fev1) percent predicted greater than 30% * patients with or without cf related diabetes * traditional cf-treatment medications * ability to perform reliable/reproducible pulmonary function tests (pft) * clinically stable for 2 weeks (no exacerbations or need for antibiotic treatment within 2 weeks of testing or major change in medical status) exclusion criteria. * children less than 17 years old * body mass less than 20 kg * a diagnosis of pulmonary arterial hypertension (pah) * fev1 less than 30% of predicted * resting oxygen saturation (spo2) less than 90% * self-reported to be a smoker * current use of any vaso-active medications * history of migraine headaches * pregnant or nursing at the time of the investigation * a clinical diagnosis of cardiovascular disease, hypertension, or cf related diabetes

Keywords: arterial stiffness flow-mediated dilation endothelial function pulse wave velocity inflammation oxidative stress pulmonary function test cystic fibrosis lung disease nitric oxide exercise capacity cf muscle function sildenafil viagra revatio
postoperative ccrt with docetaxel vs cisplatin in high risk oral cavity cancer

Conditions: Oral Cavity Squamous Cell Carcinoma

Summary: this is a randomized,controled, phase ii, open label study of postoperative concurrent chemoradiotherapy with docetaxel versus cisplatin for high-risk squamous cell carcinoma of the oral cavity cancer.the primary purpose of this study is to evaluate the efficacy of concurrent chemoradiotherapy with docetaxel in occ patients.


Eligibility criteria:
inclusion criteria: * 1.histologically confirmed squamous cell carcinoma of the oral cavity 2. gross total resection, with pathology demonstrating one or more of the following risk factors: 1. histologic extracapsular nodal extension 2. histologic involvement of ≥ 2 regional lymph nodes 3. invasive cancer is seen on microscopic evaluation of the resection margin, with no evidence of gross tumor residual 3. no evidence of distant metastases 4. no synchronous or concurrent head and neck primary tumors 5. ecog 0-1 6. adequate organ function including the following: 1. absolute neutrophil count (anc) \>= 1.5 \* 10\^9/l 2. platelets count \>= 100 \* 10\^9/l 3. hemoglobin \>= 10 g/dl 4. ast and alt \<= 2.5 times institutional upper limit of normal (uln) 5. total bilirubin \<= 1.5 times institutional uln 6. creatinine clearance \>= 50 ml/min 7. serum creatine \<= 1 times uln 7.signed written informed consent exclusion criteria: * 1. evidence of distant metastasis 2. prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region 3. other previous cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma 4. pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures 5.presence of an uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia

Keywords: oral cavity squamous cell carcinoma concurrent chemotherapy high-risk
randomizing two gestational diabetes screening methods in a diverse hmo

Conditions: Gestational Diabetes; Obesity; Pregnancy

Summary: this project randomizes two different screening strategies for diabetes in pregnancy, among a study population of over 17,500 pregnant women and their babies (over 35,000 total) in a large diverse health maintenance organization (hmo), to determine how diagnosis and treatment based on these two strategies in routine clinical care affects complications for the baby and the mother.

two recent randomized placebo-controlled trials show that gestational diabetes (gdm) treatment (vs. none) improves maternal and perinatal outcomes, based on diagnosis with a 2- step screening strategy. also, a large multi-center prospective cohort study showed a linear relationship with glucose and maternal and perinatal outcomes, based on screening with a single 75g oral glucose tolerance test (ogtt). based on this large cohort's findings, the american diabetes association recommended that clinical practice adopt the 1-step 75g screening approach for diagnosing gdm. the american college of obstetrics \& gynecology took the opposite stance, recommending the traditional 2-step screening: because it alone has rct outcome evidence. what is urgently needed to best inform clinical practice and health policy is not an additional gdm treatment vs. control trial, but a pragmatic randomized controlled trial (rct) testing the 2 recommended clinical strategies. to pragmatically address this critical research gap, we propose to randomize an estimated 17,626 diverse women to gdm screening (2-step vs. 75g ogtt) as part of their clinical care in the kaiser permanente northwest (kpnw) and hawaii (kph) regional health plans. the investigators will use the plans' electronic medical record (emr) system at the time of gdm screening to randomize the women. both kpnw and kph regions universally screen for gdm at 24-28 weeks gestation, as part of clinical care. by randomizing gdm screening in the context of clinical care, the investigators will: compare gdm prevalences (aim 1) and differences in maternal and perinatal outcomes between screening strategies (aim 2). determine the concordance of the 75g ogtt with gdm diagnosed by 2-step, among a recruited sub-sample of 1,000 pregnant women at kpnw and kph (aim 3). the results of this pragmatic rct are expected to help resolve the current public policy debate on the potential benefits and risks of each strategy in clinical obstetric practice.

Eligibility criteria:
inclusion criteria: * pregnant adult women in kpnw and kph exclusion criteria: * pre-existing diabetes

Keywords: gestational diabetes obesity pregnancy
double-blind naltrexone in compulsive sexual behavior

Conditions: Compulsive Sexual Behavior

Summary: the goal of the proposed study is to evaluate the efficacy and safety of naltrexone in compulsive sexual behavior. twenty subjects with dsm-iv compulsive sexual behavior will receive 8 weeks of naltrexone or placebo. the hypothesis to be tested is that naltrexone will be effective in reducing the urges to act out sexually in patients with compulsive sexual behavior. the proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.

the proposed study will consist of 8 weeks of treatment with either naltrexone or placebo in 20 subjects with compulsive sexual behavior.

Eligibility criteria:
inclusion criteria: 1. men and women age 21-75; 2. current diagnosis of compulsive sexual behavior exclusion criteria: 1. unstable medical illness or clinically significant abnormalities on prestudy laboratory tests or physical examination; 2. history of seizures; 3. myocardial infarction within 6 months; 4. current pregnancy or lactation, or inadequate contraception in women of childbearing potential; 5. clinically significant suicidality; 6. current or recent (past 1 month) dsm-iv substance abuse or dependence; 7. illegal substance within 2 weeks of study initiation; 8. initiation of psychotherapy or behavior therapy from a mental health professional within 3 months prior to study baseline; 9. initiation of a psychotropic medication within 2 months prior to study inclusion; 10. previous treatment with naltrexone; and 11. treatment with investigational medication or depot neuroleptics within 3 months, with fluoxetine within 6 weeks, or with other psychotropics within 2 weeks prior to study baseline

Keywords: impulse control disorder compulsive sexual behavior
a study to evaluate aprepitant for the prevention of post-operative nausea and vomiting in children (mk-0869-219)

Conditions: Post-operative Nausea; Post-operative Vomiting

Summary: the purpose of this study is to evaluate the pharmacokinetics (pk), safety, and tolerability of aprepitant for the prevention of post-operative nausea and vomiting (ponv) in pediatric participants. post-operative aprepitant plasma concentrations will be evaluated with a non-compartmental analysis (nca) at each dose and for each age cohort. full pk profiles analyzed using population pk modeling and simulation will be described in a separate report.

because the opportunity to collect specimens for pk analyses in children will be limited, a flexible sparse sampling scheme using ranges of collection times will be utilized which will limit the burden to participants.

Eligibility criteria:
inclusion criteria: * participant enrolled at birth should be at least 37 weeks gestation and ≥3 kg of weight * scheduled to receive general anesthesia and must have at least one of the following risk factors for post-operative nausea and vomiting (ponv) in addition to receiving general anesthesia: 1. scheduled to have a surgery with an associated risk of ponv: tonsillectomy, adenoidectomy, strabismus surgery, dental surgery, hydrocelectomy, orchidopexy or herniorraphy; or 2. scheduled to have an operative procedure associated with ponv: intraoperative opioid use or anticipated opioid administration within the first 24 hours following surgery. exclusion criteria: * emergency surgery for a life-threatening condition * scheduled to receive propofol for maintenance of anesthesia (note: propofol is permitted for induction of anesthesia). * expected to receive opioid antagonists (e.g., naloxone, naltrexone) or benzodiazepine antagonists (e.g., flumazenil) * scheduled to undergo cardiac or neurosurgery * vomiting caused by any organic etiology (such as gastric outlet obstruction or small bowel obstruction) * vomiting within 24 hours prior to surgery * participant had a nasogastric or oral gastric tube intra- or post-operatively for suctioning gastric contents (note: nasogastric or oral gastric tube intra- or post-operatively could only be used for feeding. participants were to be excluded if a nasogastric or oral gastric tube for suctioning was routinely used for the type of surgery being performed) * active infection (e.g., pneumonia), congestive heart failure, bradyarrythmia, any uncontrolled disease (e.g., diabetic ketoacidosis, gastrointestinal obstruction) except for malignancy, or a history of any illness which in the opinion of the investigator, might confound the results of the study or pose unwarranted risk to the participant * use of any illicit drugs, including marijuana or has current evidence of alcohol abuse
reduce trial: perineural dexamethasone on scalp nerve blocks

Conditions: Postoperative Pain; Craniotomy; Dexamethasone; Scalp Nerve Blocks

Summary: pain is common in the first 2 days after major craniotomy. inadequate analgesia may lead to an increased risk of postoperative complications. most pain following craniotomy arises from the pericranial muscles and soft tissues of the scalp. scalp nerve blocks with local anesthesia seem to provide effective, safe, however transient postoperative analgesia which does not seem to meet the requirements of craniotomy. currently, peripheral dexamethasone has been observed to significantly prolong the duration of analgesia of nerve blocks (e.g., saphenous nerve block, adductor canal block, thoracic paravertebral block, brachial plexus nerve block). on the contrary, a study reported that perineural dexamethasone did not appear to prolong the analgesic time after supratentorial craniotomy. however, all patients in this study were given 24 mg of oral or intravenous dexamethasone regularly at least 7 days during the perioperative period, which possibly masked the role of single local low doses of perineural dexamethasone. therefore, the analgesic effect of single dexamethasone for scalp nerve blocks without the backdrop of perioperative glucocorticoid deserves further clarification.


Eligibility criteria:
inclusion criteria: * scheduled for elective supratentorial craniotomy under general anesthesia; * age 18 to 64 years; * an american society of anesthesiologists (asa) physical status of i, ii or iii; * preoperative glasgow coma scale (gcs) score of 15/15. exclusion criteria: * history of chronic headache or chronic pain syndrome of any cause, psychiatric disorders, or uncontrolled epilepsy; * inability to understand or use the pain scales before surgery; * excessive alcohol or drug abuse, chronic opioid use (more than 2 weeks or 3 days per week for more than 1 month), use of drugs with confirmed or suspected sedative or analgesic effects, or use of any painkiller within 24 hours before surgery; * request of oral/intravenous glucocorticoid to decrease cerebral edema within 1 week before surgery; * pregnancy or breastfeeding; * extreme body mass index (bmi) (\ 35); * participation in another interventional trial that interferes with the intervention or outcome of this trial; * refusal or inability of the patient and/or legal guardian to provide informed consent; * coagulopathy; * infection around the puncture point; * history of allergies to any of the study drugs.