Kornimate/medical-research-clean huggingface dataset:
a study of bitopertin (ro4917838) in adults with non-transfusion-dependent (ntd) beta-thalassemia

Conditions: Beta-Thalassemia

Summary: this proof-of-mechanism study is being performed to investigate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of multiple oral doses of bitopertin in adults with ntd beta-thalassemia. this study consists of two parts: part 1 - the main study - 16 weeks in total: participants will undergo a 6-week dose-escalation period followed by 10 weeks of treatment at the attained target dose. part 2 - open label extension (ole) - up to an additional 12 months. participants will be given the option to enroll into the ole once the 16-week treatment of part 1 has been completed. participants who decide not to enroll in the ole, at the end of part 1 will enter a 6-week follow-up period.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of beta-thalassemia * clinically defined non-transfusion-dependent anemia (part 1 only), defined as hb concentrations \>7.5 grams per deciliter (g/dl) and \<9.5 g/dl, less than or equal to 4 transfusions of red blood cell units within 1 year prior to study enrollment, and no transfusion within 12 weeks prior to study enrollment * completion of 16 weeks of treatment with bitopertin in part 1 of this study with more than 80% compliance from expected use of study medication (based on patient diary and study drug accountability; part 2 only) * a favorable benefit-risk ratio from treatment with bitopertin as assessed by the investigator (part 2 only) exclusion criteria: * any history of gene therapy * history of hemolytic anemia except for beta-thalassemia * severe symptomatic splenomegaly and/or hepatomegaly with hypersplenism (part 1 only) * any use of an erythropoiesis-stimulating agent within 24 weeks prior to enrollment. * initiation of iron chelation therapy or hydroxyurea within 24 weeks prior to enrollment (part 1 only) * depression, treatment with anti-depressants, or other psychiatric illnesses and/or drug abuse * clinically significant/uncontrolled comorbid disease * pregnant or breastfeeding females * use of cytochrome p450 (cyp) 3a4 inhibitors within 2 weeks or cyp3a4 inducers within 4 weeks prior to study drug * active hepatitis b or c or known positive human immunodeficiency virus (hiv) test result * diagnosis of cancer within previous 5 years unless treatment has resulted in complete freedom from disease for at least 2 years * any major illness within 1 month or febrile illness within 1 week prior to study drug * pulmonary hypertension requiring oxygen therapy (part 1 only)
a study of treatments for fungal infections of the mouth and throat in hiv-infected patients who have had success with itraconazole but not with fluconazole

Conditions: Candidiasis, Oral; HIV Infections

Summary: to provide maintenance treatment with itraconazole solution for patients who were clinical responders in the itr-usa-94 protocol, even if they subsequently relapsed.

patients who responded to therapy on protocol fda 236b receive maintenance with itraconazole oral solution for up to 6 months.

Eligibility criteria:
inclusion criteria patients must have: * met criteria for clinical response on protocol fda 236b with no residual visible lesion of oropharyngeal candidiasis upon completion of that study or had initial response on protocol fda 236b with subsequent relapse and retreatment with itraconazole solution or other therapies. * life expectancy of at least 3 months. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * underlying clinical condition that would preclude completion of study or place subject at significant risk. * judged unreliable with respect to physician's directives. concurrent medication: excluded: * rifampin. * rifabutin. * phenobarbital. * phenytoin. * carbamazepine. * terfenadine. * astemizole. * systemic antifungals. patients with the following prior conditions are excluded: * previously documented disseminated candidiasis. * previous clinically significant adverse event during treatment with itraconazole oral solution, unless clearly attributable to an intercurrent illness or condition. * history of significant hepatic abnormalities or clinical evidence of significant hepatic disease within 2 months prior to study entry. prior medication: excluded: * any investigational drug (other than itraconazole solution) within 1 month prior to study entry.

Keywords: itraconazole acquired immunodeficiency syndrome aids-related complex candidiasis, oral
epidural steroid following discectomy for herniated disc reduces morbidity

Conditions: Disc Disease

Summary: focus of this study is evaluation of the outcome, neurologic impairment and safety of epidural steroide following lumbar discectomy for herniated disc disease.

methylprednisolone might enhance recovery after discectomy for herniated disc disease without apparent side effect. convalescence after discectomy for herniated disc disease is dependent on pain and the inflammatory response. in arthroscopic and abdominal surgery steroids reduce the inflammatory response and enhance recovery. 200 patients with herniated disc disease are randomly allocated to receive epidural methylprednisolone 40 mg or none.

Eligibility criteria:
inclusion criteria: * patients with primary lumbar herniated disc disease who had received and performed standardized conservative treatment program with intensive exercises * patients more than 18 years old exclusion criteria: * patients with central or lateral spinal stenosis due to spondylosis or disc degeneration who needed bilateral decompression, laminectomy or fusion * patients with cauda equina syndrome who needed acute operative treatment * lack of informed consent and inability to read and understand danish

Keywords: discectomy methylprednisolone randomized control trial
efficacy and safety of nafamostat mesylate for vv-ecmo anticoagulation

Conditions: Critical Illness; Anticoagulation

Summary: the purpose of this study was to compare the efficacy and safety of nafamostat mesylate and unfractionated heparin during ecmo anticoagulation in critically ill patients.

during ecmo treatment, nafamostat mesylate and unfractionated heparin were randomly administered for continuous anticoagulation, respectively, and the incidence of bleeding and thrombotic complications during anticoagulation was compared between the two groups.

Eligibility criteria:
inclusion criteria: * patients aged \>= 18 and \<= 80 years; * successfully established ecmo (va/vv) treatment by percutaneous puncture due to cardiogenic shock or respiratory failure; * anticoagulation required during ecmo treatment; before the establishment of ecmo, the aptt test value was within the normal range, and the platelets were not less than 80g/l; * within 48 hours of ecmo establishment, aptt test results were between 1 and 1.75 times the upper limit of normal, plt\>80 g/l, and no serious bleeding and thrombosis; * sign the informed consent. exclusion criteria: * pregnant; * bleeding risk or active bleeding; * pre-existing diseases requiring long-term anticoagulation before ecmo: pulmonary embolism, deep vein thrombosis, intraventricular thrombosis, atrial fibrillation, etc.; * long-term use of anticoagulants before ecmo; * antiplatelet drugs were used before ecmo; * allergy to heparin, nafamostat mesylate; * repeated puncture at the same site for more than 3 times; * expected ecmo treatment time \< 3 days; * patients with an expected survival period of less than 48 hours; * patients undergoing extracorporeal cardiopulmonary resuscitation; * burn patients; blood purification treatment using polyacrylonitrile membrane filter; * heterozygous ecmo mode or ecmo therapy solely for co2 removal; * other reasons that the investigator considers inappropriate for inclusion;

Keywords: extracorporeal membrane oxygenation nafamostat mesylate unfractionated heparin anticoagulation
ketorolac as an adjuvant agent for postoperative pain control following arthroscopic meniscus surgery

Conditions: Meniscus Tear, Tibial; Pain, Postoperative; Postoperative Complications; Ketorolac Adverse Reaction; Opioid Use

Summary: the utilization of arthroscopic surgery to treat meniscus injuries has continued to increase in recent years, partly due to a younger, more active population, and improved technology and technique. however, pain management in the post-operative period is critical to the ability to perform this procedure as an outpatient surgery. traditionally, oral narcotic agents have been the preferred analgesic postoperatively in orthopaedic surgery. however, these agents are associated with several side effects, including nausea/vomiting, constipation, and somnolence. in addition, opioid agents have a significant potential for abuse in comparison to non-narcotic analgesics. in light of the rising opioid epidemic and nationwide initiatives to limit narcotic usage, surgeons must explore alternate pain modalities in the acute postoperative period. ketorolac is a non-steroidal anti-inflammatory drug (nsaid) with analgesic and anti-inflammatory properties.1 multiple prior studies have examined the beneficial effect of oral and intravenous (iv) ketorolac as an analgesic in the postoperative period,1-3 including arthroscopic meniscus surgery. however, the beneficial effects of this agent following arthroscopic meniscus surgery have not been extensively described.


Eligibility criteria:
inclusion criteria: * patients between 18 and 89 years of age * patients undergoing primary arthroscopic meniscus surgery exclusion criteria: * patients age less than 18 or greater than 89 years * illiterate or non-english speaking patients * patients with contraindications to ketorolac * history of drug or alcohol abuse * chronic use of analgesic or psychotropic drugs

Keywords: ketorolac meniscus tear analgesics pain
accuracy of non-invasive blood pressure measurement in adults

Conditions: Hypertension; Hypotension

Summary: the purpose of this study is to compare the accuracy of the sotera visi, an investigational device, to auscultation (measurement with a cuff) in determining systolic and diastolic blood pressure (bp) in adult subjects.

this study is a single-center blinded study that will enroll approximately 150 adult subjects. trained auscultators will perform the standard auscultation bp measurements. they will be blinded to each other's measurements and from the visi measurements. the study population will be randomized into two groups based on the side of the blood pressure measurement: the left arm group (lag) and the right arm group (rag). the randomization ratio of the lag and rag will be 1:1. there will be forced stratification in order to ensure that the study subjects meet the required arm circumference and blood pressure distributions as specified in the sp10:2008 and iso 81060-2:2009(e) standards.

Eligibility criteria:
inclusion criteria: * subject is greater than 12 years of age at the time of screening. * subject's upper arm circumference is between 20cm and 55cm. * subject is willing to undergo the informed consent process prior to enrollment in the study. * subject is willing and able to participate for up to 60 minutes. exclusion criteria: * subject is participating in another clinical study that may interfere with the results of this study. * subject is unable to have a blood pressure measurement taken from either arm for any reason. * subject is evaluated by the investigator and found to be medically unsuitable for participation in this study.

Keywords: hypertension hypotension blood pressure
social needs screenings in ed

Conditions: Social Determinants of Health

Summary: this study will determine whether existing health information technology can be leveraged to 1) implement a universal, patient-centered social needs assessment and referral process during routine emergency department care; 2) understand whether linking social needs assessment, community based referral, and health outcomes data may facilitate an understanding of population health; and 3) address the needs and wishes of patients and clinicians. hypothesis: results of this study will provide much needed information to already overburdened hospital systems regarding whether systematically incorporating social needs information and referrals into emergency discharge processes allows for a better understanding of factors placing patients at risk for poor outcomes post-discharge, and whether doing so has potential for enhancing discharge support for a larger patient population seen in emergency departments.


Eligibility criteria:
inclusion criteria: * seen in the uhealth university hospital ed * ability to use touchpad technology * ability to communicate via telephone for 211 follow-up exclusion criteria: * non-english and non-spanish speaking (english nor spanish need not be the 1st language) * unable to communicate verbally * admitted to an inpatient unit or to a skilled nursing facility (vs discharged to a community-based setting where participants are responsible for their own self-care)

Keywords: emergencies social needs
the biopsychosocial burden of prostate biopsy

Conditions: Prostate Cancer

Summary: prostate biopsy was offered to 47 consecutive patients with prostate-specific antigen (psa) over 4 ng/dl or suspicious digital rectal examination (dre) of whom 16 had undergone a biopsy. comprehensive validated questionnaires at time 0 (pre-biopsy), time 1 (before diagnosis, 20 days after biopsy) and time 2 (after diagnosis, 40 days after biopsy) accessed patients' erectile (iief-5) and voiding (ipss) functions, beck scales measured anxiety (bai), hopelessness (bhs) and depression (bdi), added to the emotional thermometers including five visual analog scales for distress, anxiety, depression, anger and need for help. mann-whitney or friedman tests were obtained among times and studied variables.

a prospective, longitudinal and observational study in which the sexually active patients were evaluated in the urology department of the city of paulínia, submitted to biopsy guided by transrectal ultrasound after ethics committee approval (355.357). consecutive patients who were attended by urologist and present prostate cancer suspicions (psa\> 4 ng / dl and/or rectal examination (tr) were submitted a bxp. they were evaluated at three different moments of the biopsy: * seven days before the biopsy procedure (t0); * 20 days after the biopsy, upon receiving the histopathological result, before becoming aware of it (t1); * 40 days after the biopsy, 20 days after being aware of the test result (t2). sixty-one consecutive patients were invited to participate in the study, 10 of them had no active sexual life and 9 answered the questionnaires only at the first moment, were excluded; 47 responded at three times (t0, t1, and t2). validated instruments were applied - iief-5 (erectile function); - ipss (voiding function); - beck scales - bai (anxiety), bhs (hopelessness), bdi (depression); and - emotional thermometers. the comparison among the moments (t0, t1, and t2) was performed through friedman (analysis of variance) for repeated measures with the variables transformed in stations. the comparison between patients and variables was performed using the mann-whitney test. the sample power was calculated and the level of significance considered was 5%.

Eligibility criteria:
inclusion criteria: * prostate cancer suspicion (psa \> 4 ng / dl, digital rectal examination) exclusion criteria: * not agree to participate

Keywords: prostate cancer biopsy
a three-part study of gsk580416 in healthy subjects

Conditions: Respiratory Tract Infection; Infections, Bacterial

Summary: studies for gsk580416 have been completed in rats and dogs. the main toxic effects seen in animals affected the digestive system and blood cells. study ops106400 will be the first administration of gsk580416 in humans. parts a and b of this study will examine the safety, tolerability, and pharmacokinetics of increasing single doses of gsk580416 with reference to placebo. part c of the study will assess the effect of food on the safety, tolerability, and pharmacokinetics of a single dose of gsk580416 in healthy subjects.


Eligibility criteria:
inclusion criteria: * healthy as determined by a physician * healthy male or female of non-child bearing potential between 18 and 55 years of age (inclusive) * body weight \> = 50 kg and bmi between 19 and 30 kg/m2 (inclusive) exclusion criteria: * positive hiv antibody, hepatitis b surface antigen or hepatitis c antibody with 3 months of screening * male and female subjects not willing to follow study specified contraceptive methods * subjects taking any recreational drugs * regular use of tobacco- or nicotine-containing products within 6 months prior to screening * has participated in a clinical trial and have not received a drug within 30 days before the dose of study drug * has exposed to more than 4 new chemical entities within 12 months before the first dosing day * use of prescription or over-the-counter medications within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study drug * use of st. john's wort within 28 days before the first dose of study drug * subjects not willing to follow study specified life style restrictions * blood donation in excess of 500 ml within a 56 days period

Keywords: tolerability, pharmacokinetics, first time in human, food effect safety,
the peer support intervention - supporting hiv positive adolescents in zimbabwe to improve hiv care continuum outcomes

Conditions: HIV

Summary: youth with evidence of virologic failure defined as an hiv vl\>400 copies/ml on two consecutive occasions at least 1 month apart will be eligible for enrollment. youth will be randomized to a community based peer counseling support group or clinic based standard of care, with viral load, and drug monitoring evaluations at 3 month intervals to determine the efficacy of the intervention in improving adherence and virologic suppression.

title the peer support intervention - supporting hiv positive adolescents in zimbabwe to improve hiv care continuum outcomes short title the peer support intervention study design prospective randomized study study duration 2 years study population 250 youth (ages 10-24 years) with virologic failure study outcomes primary outcomes 1. virologic suppression rate in the the peer support intervention group compared with the standard of care group following 48 weeks in the peer support intervention. secondary outcomes 1. frequency of acquired drug resistance mutations among youth failing art. 2. baseline prevalence of psychological distress among adolescents and young adults failing first line therapy 3. prevalence of psychological distress (measured using phq-a and ssq) after 48 weeks of enrolment in the peer support intervention compared with the standard of care 4. association between self-reported adherence, pill counts and objective surrogate markers of adherence obtained from plasma (viral load), dbs and hair (tenofovir concentrations). 5. effectiveness of point mutation assays for the detection of drug resistance as compared with standard sequencing techniques. description of intervention youth with evidence of virologic failure defined as an hiv vl\>400 copies/ml on two consecutive occasions at least 1 month apart will be eligible for enrollment. youth will be randomized to a community based peer counseling support group or clinic based standard of care, with viral load, and drug monitoring evaluations at 3 month intervals to determine the efficacy of the intervention in improving adherence and virologic suppression. study sites parirenyatwa hospital family care centre

Eligibility criteria:
inclusion criteria: * documented hiv positive * age \> 10 years and ≤ 24 years * two consecutive hiv vl\>400 copies/ml, at least one month apart * residence within 50 km of harare * able to provide written informed consent (age 18 or older) or assent (age \<18 years) exclusion criteria: * inability to provide informed consent or assent * past or current involvement in the zvandiri intervention program
gait parameters in a cohort of patients fitted with a canadian prosthesis: contribution of quantified gait analysis

Conditions: Amputation; Gait, Unsteady

Summary: the goal of this clinical trial is to learn about the biomechanics characterics of amputee with a canadian prothesis during gait. the main question to answer is : what are the main biomechanical characteristics and their statistical description. participant had pass through a quantitative movement analysis during their classic reeducaiton and we are going to use these data.


Eligibility criteria:
inclusion criteria: * with canadian prothesis * presence of the gait analysis exclusion criteria: * major gait disorder due to another pathologie * major gait disorder due to a wrong adapration of the prothesis

Keywords: canadian prothesis
hfnc and prone positioning in awake patients with severe covid-19

Conditions: Hypoxemic Respiratory Failure

Summary: the investigators evaluate the effects of high-flow nasal cannula (hfnc) in association with prone in patients with covid-19 severe arf.

the investigators evaluate the effects of high-flow nasal cannula (hfnc) in association with prone in patients with covid-19 severe arf. all patients with arf related to covid-19 and admitted to the icu are turned in prone position whenever tolerated, while receiving oxygenation with hfnc. outcomes of interest are the rate of success or failure (defined as the need for intubation and mechanical ventilation)

Eligibility criteria:
inclusion criteria: * aged ≥18 years, admitted to the medical icu for confirmed covid-19 and acute hypoxemic respiratory failure exclusion criteria: * patients already intubated at admission or those requiring immediate intubation
short term weight loss with liraglutide and metformin in infertile obese pcos patients

Conditions: Obesity; PCOS

Summary: the aim of this study was to evaluate the impact of short-term weight reduction achieved with 12-week intervention with metformin alone or in combination with liraglutide on oocyte maturity and embryo quality in infertile obese pcos population.

polycystic ovary syndrome (pcos) is the most common cause of anovulatory infertility, in particular when pcos is linked to obesity. obese pcos has poor ivf outcomes associated with impaired oocyte and embryo parameters and morphology. the purpose of this pilot prospective study was to investigate the effect of the antiobesity medical therapy (combination of metformin and liraglutide (combi)) on short time weight loss in the specific infertile obese pcos population. additionally, we analyzed eventual impact of the short term weight loss 5% or more before ivf on oocyte maturity and embryo quality in infertile obese pcos population.

Eligibility criteria:
inclusion criteria: * polycystic ovary syndrome (rotterdam criteria) * bmi of 30 kg/m² or higher * infertility for ivf with normal male sperm exclusion criteria: * type 1 or type 2 diabetes mellitus * history of carcinoma * cushing's syndrome or congenital (non-classic) adrenal hyperplasia * personal or family history of multiple endocrine neoplasia 2 * significant cardiovascular, kidney or hepatic disease * the use of medications known or suspected to affect reproductive or metabolic functions * the use of statins, within 90 days prior to study entry

Keywords: obesity pcos infertility liraglutide metformin ivf