Kornimate/medical-research-clean huggingface dataset:
a trial of tadalafil and glycemic traits

Conditions: Cardiovascular Disease; Insulin Resistance; Glucose Intolerance; Obesity

Summary: the purpose of this study is to find out if tadalafil can help overweight and obese people metabolize blood sugar more efficiently. the investigators also want to find out if 20 mg/day of tadalafil for 3 months is safe to take without causing too many side effects. the investigators are plan to enroll 100 subjects at massachusetts general hospital (mgh).

this study is examining changes in insulin resistance and glucose tolerance following 3 months of treatment with oral, once daily tadalafil. the investigators primary hypotheses are that measurable decreases in insulin resistance (as measured by homa-ir) and increases in insulin sensitivity (as measured by the matsuda index) will occur following 3 months of treatment with oral tadalafil 20 mg daily compared to placebo. the investigators secondary hypotheses are that improvements in average glycemia (as measured by hemoglobin a1c), pancreatic beta cell function (as measured by the oral disposition index), and body composition (including weight, waist circumference, body mass index, and waist-hip ratio) will occur as a result of tadalafil-mediated changes in the cgmp pathway.

Eligibility criteria:
inclusion criteria: * age \> 18 years and \< 50 years * bmi \> 30 kg/m2 * fasting insulin \> 10 uu/ml exclusion criteria: * systolic blood pressure (sbp) \ 150 mmhg * current anti-hypertensive medication use, including diuretics * current use of organic nitrates * current use of pde-5 inhibitors (sildenafil, tadalafil, vardenafil) * history of reaction to pde-5 inhibitors * known hiv infection * use of medications that strongly alter cyp3a4 activity * history of myocardial infarction, angina, uncontrolled cardiac arrhythmia, stroke, transient ischemic attack, or seizure * known non-arteritic ischemic optic retinopathy (naior) * history of hearing loss * estimated glomerular filtration rate (egfr) \< 60 ml/min/1.73 m2 by the modified diet in renal disease (mdrd) equation * hepatic transaminase (ast and alt) levels greater than three times the upper limit of normal * known pregnancy or those unwilling to avoid pregnancy during the course of the study * history of priapism * use in excess of four alcoholic drinks daily * history of diabetes mellitus or use of anti-diabetic medications * known anemia (men, hct \< 38% and women, hct \< 36%)

Keywords: tadalafil phosphodiesterase 5 inhibitors cyclic guanylyl monophosphate pathway pharmacologic actions vasodilator agents cardiovascular agents obesity glycemic traits insulin resistance glucose metabolism
torsemide for postpartum hypertension

Conditions: Preeclampsia

Summary: currently there is no intervention to prevent persistent postpartum hypertension in preeclamptic women. physiologically, the use of a pharmacokinetically predictable loop-diuretic is a reasonable intervention to increase elimination of extra fluid accumulated secondary to preeclampsia.the purpose of this study is to assess if torsemide reduces the incidence of persistent postpartum hypertension in preeclamptic women.


Eligibility criteria:
inclusion criteria: * postpartum women at ≥ 18 years of age * antepartum/intrapartum or within 24 hours postpartum diagnosis of either: * preeclampsia * preeclampsia with severe features * preeclampsia superimposed to chronic hypertension exclusion criteria: * chronic hypertension without superimposed preeclampsia * gestational hypertension * urine output \< 30 cc/h at time of randomization * heart failure or pulmonary edema * hypersensitivity to torsemide or sulfonylureas * hypokalemia (serum potassium \< 3 meq/l) * preexisting diuretic use within 24 hours prior to randomization

Keywords: preeclampsia, puerperium
atropine weight and risk of postoperative confusion in the elderly

Conditions: Aging

Summary: the identification of a high atropine load of treatment received during hospitalization as a predictor of postoperative confusion could have various benefits: * pharmacoepidemiological: identify factors associated with postoperative confusion * clinics: by favoring treatments with a low atropine load during anesthesia, the management of patients hospitalized in orthopedics. similarly, stopping or re-evaluating treatments with a high atropine weight for scheduled surgery is an easy step to take. * socio-economic: by reducing the costs related to the occurrence of a confusional syndrome (over-treatment, prolonged hospital stay, loss of autonomy, institutionalization of patients...). in total, the present study would improve the daily management of hospitalized patients and the practices of clinicians, by offering a decision-making aid.


Eligibility criteria:
inclusion criteria: * admitted to the orthopedic department for surgical management of a fracture of the upper end of the femur in emergency or for the installation of a hip or knee prosthesis * patient able to understand and respond to the protocol * no opposition to the collection of data of the patient or his / her designee exclusion criteria: * pre-existing confusion to surgery, detected by the cam scale * serious or moderate head trauma less than three months old * removing / installing prosthesis.

Keywords: atropinic drugs confusion elderly patients
oxytocin and alcohol withdrawal and dependence

Conditions: Alcoholism; Substance-Related Disorders

Summary: this study evaluates the effect of oxytocin nasal spray on alcohol withdrawal and dependence in adults admitted for detoxification of alcohol, and during the following 4 weeks in an outpatient setting. half of the participants will receive oxytocin nasal spray, the other half placebo nasal spray.


Eligibility criteria:
inclusion criteria: 1. at least one prior episode 2 days or longer in duration during which the subject experienced withdrawal symptoms that caused significant incapacitation (e.g., inability to work or do normal activities) or at least one prior inpatient or outpatient medical detoxification during which the subject exhibited withdrawal symptoms of sufficient magnitude that sedative-hypnotic or anticonvulsant medication was required at least once on 2 consecutive days after cessation of or reduction in the use of alcohol following 2 weeks or more of heavy daily consumption 2. average consumption of 8-30 standard drinks per day for at least 2 weeks prior to enrollment in the study; 3. consenting to participate in the study; 4. have residency in trøndelag county after discharge exclusion criteria: 1. chronic treatment with sedative-hypnotic medications such as benzodiazepines or z-hypnotics; 2. dependence on substances other than alcohol, nicotine or caffeine; 3. inadequately treated, unstable and/or compromising medical or psychiatric conditions; 4. low body weight (bmi \< 17) or history of anorexia nervosa or bulimia in the past 2 years; 5. pregnancy; parturition or breast-feeding in the past 6 months; 6. inability to read well enough to complete study questionnaires determined by whether the prospective subject can read the consent form without help and correctly answer basic questions about information in the consent form; 7. no alcohol in the blood and \> 15 h since last intake of alcohol; 8. prior inclusion and participation in the same study.

Keywords: oxytocin administration, intranasal ethanol
comparing centers thrombectomy aspiration stentretriever

Conditions: Acute Stroke

Summary: our aims is to evaluate the equality in efficacy and safety between direct aspiration technique and stent retriever thrombectomy procedure in anterior circulation strokes in a multicenter, prospective study.


Eligibility criteria:
inclusion criteria: * subject experiencing an acute ischemic stroke in which imaging demonstrates a vascular occlusion located in the distal internal carotid artery (ica) through the distal middle cerebral artery (mca). * subjects in which the aspiration technique is used for at least the first two thrombectomy passes per occluded vessel. * subjects older than 18 yo. * subjects with a prestroke modified rankin scale of 0-2 and presenting with an nihss of 2-30. * subjects that the operator feels may be treated with endovascular therapy * subjects in which computed tomography (ct)/magnetic resonance imaging (mri) demonstrates an infarct size of less than 70cc on mri or alberta stroke program early ct (aspects) score overall of 6 or better. * subjects in which groin puncture can be obtained within 6 hours of symptom onset (with or without total plasminogen activator administration). in those patients of more than 8 hours or awake stroke or of unknown onset should be individualized the treatment and must exist area of penumbra in ct perfusion * subjects who have consented in accordance with local institutional review board requirements exclusion criteria: * absence of large vessel occlusion on neuroimaging. * platelet count \< 100 x 10³ cells/mm³ or known platelet dysfunction. * contraindication to ct and/or mri (i.e., due to contrast allergy or prior implant that precludes mri imaging). * previously documented contrast allergy that is not amenable to medical treatment. * women who are pregnant or breastfeeding at time of intervention. * evidence of brain hemorrhage on ct and/or mri at presenting hospital.

Keywords: thrombectomy stentriever adapt
development of a clinical and biological database in rectum cancer

Conditions: Rectal Neoplasms

Summary: a clinical and biological database will provide to the scientific community a collection of blood and tissues with clinical data to improve knowledge about cancer and help to develope new cancer treatments. this database is specific to rectum cancer.

in france, colorectal cancer is the second major cause of cancer-related death with 17 000 cases per year. rectal carcinoma represents 40% of colorectal cancers. locally advanced rectal carcinoma raises the issue of both the oncological control, local and general, and the therapeutic morbidity. currently, pre-operative radiochemotherapy associated with radical proctectomy (tme) is the standard treatment. radiochemotherapy improves the local control but with enhanced postoperative morbidity and poor functional results. moreover, some patients have no downstaging (around 1/3) and the metastatic risk remains about 30%. then, compliance to adjuvant chemotherapy is generally poor after radical proctectomy. tumor response to preoperative treatment is the major prognostic factor which reveals tumor aggressiveness. nevertheless, at present, there are no predictive markers of tumor response. progresses in rectal cancer management are related to sharing biological and clinical resources with scientific community. a clinical and biological collection will allow to : * develop research programs on predictive markers to pre-operative radiochemotherapy or prognostics factors to disease recurrence * optimize diagnostic and follow-up tests * develop new biomarkers to improve patient's therapeutic management in this context, the montpellier cancer institute (icm) decided to initiate a biological collection biomedical research dedicated to the tissular and blood samples of patients with colorectal cancer.

Eligibility criteria:
inclusion criteria: * patient treated at the montpellier cancer institute, whatever the treatment received (systemic cancer treatment or radiotherapy or surgery) * age \> 18 years * signed informed consent exclusion criteria: * patient not affiliated to social protection system * patient unable to understand or comply with study instructions or requirements for psychological, family, social or geographical reasons * patient under guardianship

Keywords: cancer colorectal cancer biological specimen banks
study of dupilumab auto-injector device when used by patients with atopic dermatitis

Conditions: Atopic Disorders; Eczema, Atopic

Summary: to collect data on actual-use to assess technical performance and user injections of dupilumab auto-injection device by patients with atopic dermatitis (ad).

study is conducted in 2 parts: part a and part b. part a - patients with moderate-to-severe ad will be randomized to receive dupilumab (dose 1) by auto-injector (ai) device or prefilled syringe. once part a is completely enrolled, part b will randomize patients with moderate-to-severe ad to receive dupilumab (dose 2) by auto-injector (ai) device or prefilled syringe.

Eligibility criteria:
key inclusion criteria: 1. diagnosis of chronic atopic dermatitis for at least 3 years with inadequate response to topical medications within 6 months before screening 2. willing and able to comply with all clinic visits and study-related procedures 3. provide signed informed consent key exclusion criteria: 1. patient \< 30.0 kilograms (kg) in weight 2. patient who has previously participated in a dupilumab clinical study 3. patient who has been treated with the following: * an investigational drug within 8 weeks or within 5 half-lives (if known),whichever is longer, before the baseline visit * immunosuppressive/ immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate-mufti, ifn-γ, janus kinase inhibitors, azathioprine, methotrexate, etc.) or phototherapy for ad within 4 weeks before the baseline visit * an experimental monoclonal antibody within 5 half-lives or within 6◦months prior to visit 1 if the half-life is unknown * biologic agents within 5 half-lives (if known) or 16 weeks prior to baseline visit, whichever is longer * anti-immunoglobulin e therapy (omalizumab) within 130 days prior to visit 1 * a live (attenuated) vaccine within 4 weeks before the baseline visit 4. patient who has initiated treatment with prescription moisturizers or moisturizers containing additives such as ceramide, hyaluronic acid, urea, or filaggrin degradation products during the screening period (patients may continue using stable doses of such moisturizers if initiated before the screening visit) 5. patient who has skin comorbidities that may interfere with study assessments 6. patient with a planned or anticipated major surgical procedure during the patient's participation in this study 7. women of childbearing potential unwilling to use adequate birth control measures during the study 8. pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study note: other protocol defined inclusion/exclusion criteria may apply
a study to evaluate both the efficacy and safety profile of cp-690,550 in patients with moderately to severely active ulcerative colitis

Conditions: Ulcerative Colitis

Summary: this study is designed to evaluate the efficacy and safety of tofacitinib (cp-690,550) in patients with moderate to severe ulcerative colitis who have failed or be intolerant to one of following treatments for ulcerative colitis: oral steroids, azathiopurine/6-mercaptopurine, or anti-tnf-alpha therapy.


Eligibility criteria:
inclusion criteria: * subject must be at least 18 years of age. * males and females with a documented diagnosis of uc at least 4 months prior to entry into the study. * subjects with moderately to severely active uc based on mayo score criteria. * subjects must have failed or be intolerant of at least one of the following treatments for uc: * corticosteroids (oral or intravenous). * azathioprine or 6 mercaptopurine (6 mp). * anti tnf therapy. exclusion criteria: * presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of crohn's disease. * subjects with disease limited to distal 15 cm. * subjects without previous treatment for uc (ie, treatment naïve). * subjects displaying clinical signs of fulminant colitis or toxic megacolon.

Keywords: tofacitinib cp-690 550 moderate to severe ulcerative colitis phase 3 clinical trial mayo score
nasal provocation testing in occupational rhinitis

Conditions: Allergic Rhinitis (Disorder)

Summary: in a previous study the investigators found that many bakery workers were sensitized to storage mites, and many had rhinitis symptoms. the role of storage mites as an occupational allergen with clinical relevance has been questioned, and the investigators wanted to investigate whether a nasal provocation with a storage mite extract would trigger symptoms and objective signs of rhinitis in bakery workers and a control group.

the investigations include allergy testing with skin prick testing, and measuring of specific immunoglobulin e (ige) in sera, answering a questionnaire, and symptom scoring before and after provocations. the participants will be investigated one day with a placebo, and another day with the allergen extract of either acarus siro or lepidoglyphus destructor. as a measurement of nasal patency we use the nasal peak inspiratory flow meter, but also clinical scoring of nasal secretion and blockage. indices of inflammation (ecp and alfa-macroglobulin) will be monitored in nasal lavage.

Eligibility criteria:
inclusion criteria: * bakery workers * \> 18 years * sensitized to a storage mite (a.siro or l. destructor) exclusion criteria: * pregnant or breast-feeding * infection in upper or lower airways the last month * nasal polyposis

Keywords: rhinitis allergy occupational storage mites nasal lavage challenge test ecp alfa2macroglobuline
efficiency and safety of prophylactic use of antibiotics in endoscopic injection of tissue adhesive in gastric varices

Conditions: Gastric Varices; Cirrhosis

Summary: the purpose of the study is to assess the efficiency and safety of prophylactic use of antibiotics in endoscopic injection of tissue adhesive in gastric varices.

at present, there is still a controversy about the application of antibiotics in the treatment of patients with non acute hemorrhage of esophageal varices. this study is a randomized controlled trial. patients randomly enter two treatment groups: 1. the prophylactic use of antibiotics group and 2. the non-prophylactic use of antibiotics group treatment allocation is by block randomization with an equal number for both groups. the incidence of infection after endoscopic treatment will be analyzed.

Eligibility criteria:
inclusion criteria: * capable of understanding the purpose and risks of the study and informed consent to participate in the study; * age between 18-75 years old; * diagnosis of esophageal gastric varices by gastroscopy * preparation of endoscopic injection of tissue adhesive exclusion criteria: * no esophageal gastric varices bleeding history; * esophageal varices or gastric varices which temporarily won't be treated by endoscopic therapy; * the cefotiam contraindications: such as allergies, pregnancy etc; * patients with the other malignant tumor except liver cancer; * the preoperative diagnosis of infection; * the large amount of ascites; * the acute bleeding period (\< 5 days); * patients refused to participate in the study.

Keywords: gastric varices endoscopic injection of tissue adhesive
apprehension-based training compared with standard physical therapy for military personnel following anterior shoulder dislocation - a randomized clinical trial

Conditions: Anterior Shoulder Dislocation

Summary: the goal of this clinical trial is to determine if a new rehabilitation protocol (apprehension-based training), leads to better recovery after shoulder dislocation among military personnel. participants will be randomly allocated to apprehension-based training or standard physical therapy. in apprehension-based training participants will train to control their shoulder under progressively more unstable conditions. standard physical therapy will be provided based on the clinical judgment of the treating physical therapist the primary hypothesis is that participants undergoing apprehension-based training will experience a more complete recovery of function, better shoulder-related quality of life, and incur less recurrent dislocations.


Eligibility criteria:
inclusion criteria: * age 18-39 years * shoulder dislocation (primary or recurrent) documented by a medical practitioner (physician, military medic) * positive anterior apprehension test * gross shoulder muscle strength 3/5 or greater exclusion criteria: * previous shoulder fracture, tendon tear, or shoulder surgery * voluntary shoulder dislocation * functional (stanmore polar iii) shoulder instability * dislocation associated with a motor vehicle accident. * diagnosis of rheumatoid arthritis, cancer (current), fibromyalgia, psychiatric disease) * current pregnancy * inability to attend at least one physical therapy session every 2 weeks.

Keywords: randomized clinical trial anterior shoulder dislocation shoulder instability physical therapy
effect of paracervical block volume on pain control for dilation and curettage.o

Conditions: Abortion, Spontaneous; Abortion in First Trimester; Pain Uterus; Abortion Early; Abortion, Missed

Summary: the investigators are conducting a study on pain control for dilation and curettage (d\&c). participants are eligible to enroll if they are a planning to have a d\&c in a participating clinic. the investigators are studying how different ratios of medication to liquid affect pain when injected around the cervix. both potential methods use the same dose of medication, though researchers would like to know which one works better. to be in this study, participants must be over the age of 18 with an early pregnancy loss or undesired pregnancy measuring less than 12 weeks gestation undergoing d\&c while awake in clinic.

dilation and curettage (d\&c) is often performed in the first trimester for surgical abortion and management of miscarriage and can be painful for patients before and after the procedure. most procedures are performed while the patient is awake or with minimal sedation in the clinic setting, and a key component of pain control is the paracervical block, or injecting lidocaine into the tissue around the cervix. a paracervical block with 20cc of 1% buffered lidocaine has been proven to provide superior pain control than a sham paracervical block. however, many providers often use similar doses of lidocaine in a higher volume to improve pain control. at university of california, san diego (ucsd) and university of california, los angeles (ucla), some providers routinely use a 20cc of 1% buffered lidocaine block and some routinely use a 40cc of 0.5% buffered lidocaine block. this practice has not been studied in a randomized controlled trial. the purpose of this study is to compare pain control during d\&c with a 20cc 1% buffered lidocaine with vasopressin paracervical block compared to a 40cc 0.5% buffered lidocaine with vasopressin paracervical block. an inclusion criterion for this study is that patients must specifically be referred to family planning clinics at ucsd and ucla for an in-clinic d\&c. therefore, the d\&c is a required procedure for both study groups. the only difference in care between the study groups will be which paracervical block they receive.

Eligibility criteria:
inclusion criteria: 1. women over the age of 18 presenting to uc san diego and uc los angeles 2. undesired pregnancy or missed abortion \< 11 weeks 6 days gestation 3. must speak english or spanish 4. desire surgical termination of pregnancy or management of miscarriage in clinic exclusion criteria: 1. women with a diagnosis of inevitable or incomplete abortion 2. desire for general anesthesia or iv sedation 3. chronic pain conditions 4. any medical comorbidities that are a contraindication to performing the procedure in the clinic setting 5. allergy to or refusal of ketorolac, oral versed, or a paracervical block 6. if they have taken any pain medications the day of presentation to clinic 7. if they have taken misoprostol the day of presentation to clinic

Keywords: dilation & curettage paracervical block
gestational diabetes in central asia: prevalence and management

Conditions: Gestational Diabetes Mellitus

Summary: evaluate prevalence and management of gestational diabetes in tajikistan in two different settings (one rural and one urban).


Eligibility criteria:
inclusion criteria: * pregnancy exclusion criteria: * known diabetes mellitus