Kornimate/medical-research-clean huggingface dataset:
clip closure of mucosal defects after endoscopic mucosal resection.

Conditions: Endoscopic Resection; Clip; Haemorrhage; Non-pedunculated Lesions

Summary: an simple-blind, randomized study, to evaluate the efficacy and safety of complete closure with clips of mucosal defects after endoscopic mucosal resection (emr) of large non-pedunculated colorectal lesions (≥ 2 cm) as prophylaxis of delayed bleeding.


Eligibility criteria:
inclusion criteria: * 18 years and older * clinical indication of endoscopic mucosal resection for large-sized (≥ 2cm) non-pedunculated colorectal lesions. * medium-high risk of delayed bleeding (db risk score ≥ 4) * informed consent. exclusion criteria: * patients with colorectal non-pedunculated lesions without endoscopic mucosal resection indication. * lesions resected by endoscopic submucosal resection. * incomplete resections. * resections with suspected deep submucosal invasion. * mucosal defects treated with clips for known or suspected damage to the muscle layer. * lesions with low risk of delayed bleeding (db risk score ≤3). * patients with any other medical, geographic or social condition, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.
paravertebral block for proximal humeral fracture surgery

Conditions: Proximal Humeral Fracture

Summary: this study evaluates the effects of t2 paravertebral block block improving interscalene brachial plexus block and superficial cervical plexus block on the relief of pain intensity during elderly proximal humerus fracture fixation surgery. the brachial plexus and cervical plexus block(ic block) will be performed in half of participants, while the t2 paravertebral block combined with ic block will be performed in the other half.


Eligibility criteria:
inclusion criteria: 1. participant age≥ 65 years 2. body mass index (bmi) \< 30kg/m2 3. american society of anesthesiologists (asa) classification i-ii 4. anterior operative incision approach exclusion criteria: 1. request for general anesthesia 2. nerve block is unable to be performed due to various reasons 3. coagulation dysfunction or anticoagulation therapy 4. history of upper limb nerve injury or phrenic nerve injury 5. multiple trauma 6. uncontrolled respiratory disease (severe chronic obstructive pulmonary disease, asthma, pulmonary infection, pneumothorax, etc.) 7. uncontrolled hypertension (systolic pressure over 180mmhg or diastolic pressure over 110mmhg) 8. uncontrolled heart disease (coronary heart disease, valvular disease or arrhythmia, etc.) 9. stroke or cognitive dysfunction (unable to communicate or cooperate) 10. hypersensitivity or allergy to anesthetics (ropivacaine or remifentanil)

Keywords: thoracic paravertebral block regional anesthesia elderly proximal humeral fracture brachial plexus block cervical plexus block intercostobrachial nerve
a survey to evaluate diabetes management, control, chronic complications, psychosocial aspects of diabetic subjects in thailand

Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: this study is conducted in asia. the aim of this observational study is to evaluate current status of diabetes management, control, complications in diabetic subjects in thailand.


Eligibility criteria:
inclusion criteria: * diabetic patients registered in the particular centre for more than 12 months. * patients should have visited the centre at least once in the last 3-6 months apart from the initial visit. * patients willing to sign informed consent form. exclusion criteria: * repetition of any patient as patients should not be included twice for any reason. * unwilling to participate or unable to comply with protocol requirements.
duet study: a clinical study to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of orally administered tern-501 as monotherapy and in combination with tern-101 in noncirrhotic adults with presumed non-alcoholic steatohepatitis

Conditions: NASH - Nonalcoholic Steatohepatitis

Summary: this is a phase 2a multicenter, randomized, double-blind, placebo-controlled clinical study to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of orally administered tern-501 as monotherapy as well as in combination with tern-101 in noncirrhotic adults with presumed non-alcoholic steatohepatitis (nash)


Eligibility criteria:
key inclusion criteria: * male or female, 18 to 75 years of age * overweight or obese with a body mass index (bmi) ≥ 25 kg/m2 * presumed nash diagnosed by prior biopsy and/or imaging criteria * written informed consent key exclusion criteria: * history or clinical evidence of chronic liver diseases other than nafld * history or known clinical evidence of cirrhosis, esophageal varices, hepatic decompensation or other severe liver impairment, * history of liver transplant, or current placement on a liver transplant list * current diagnosis or history of pituitary or thyroid disorders - except for patients with primary hypothyroidism on a stable dose of thyroid hormone replacement therapy. * abnormal tsh or free t4 levels * weight loss of \> 5% total body weight within 3 months prior to screening * uncontrolled diabetes * uncontrolled hyperlipidemia * unstable cardiovascular disease * excessive alcohol consumption other protocol-defined i/e criteria that apply.

Keywords: nonalcoholic steatohepatitis (nash) fxr agonist nonalcoholic fatty liver disease (nafld) thr-β agonist
pipeline flex with shield technology embolization - an international multicenter observational post market study

Conditions: Intracranial Aneurysm

Summary: this is a prospective, single-arm, multi-center post-market observational study assessing the performance of the pipeline™ flex embolization device with shield technology™ in subjects undergoing treatment for intracranial aneurysms in a large real-world, post-market setting.

eligible subjects will be treated with the pipeline™ flex embolization device with shield technology™. subjects will undergo standard of care follow-up visits. data generated per standard of care will be collected for 1 year beyond the index procedure. this clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (that is, clinical trial information for this applicable clinical trial was submitted under section 402 (j)(4)(a) of the public health service act and 42 cfr 11.60 and is not subject to the deadlines established by sections 402 (j)(2) and (3) of the public health service act or 42 cfr 11.24 and 11.44.)

Eligibility criteria:
inclusion criteria: * subject has provided written data release form (drf) or informed consent using the institutional review board (irb)/ ethic committee (ec)-approved consent form and agrees to comply with protocol requirements. * at least 18 years of age. * subject has already been selected for flow diversion therapy as the appropriate treatment. * subject has a target ia that has a parent vessel with diameter 1.5-5.0 mm distal/proximal to the target ia. exclusion criteria: * major surgery including endovascular procedures within the past 30 days. * subject with target ia located in the basilar artery * subject with anatomy not appropriate for endovascular treatment due to severe intracranial vessel tortuosity or stenosis determined from baseline or pre-procedure imaging, or a history of intracranial vasospasm not responsive to medical therapy. * stent is in place in the parent artery at the target ia location. * subject with an acutely (within 30 days) ruptured aneurysm with a hunt and hess grade of 4 or higher. * any known contraindication to treatment with the pipeline™ flex embolization device with shield technology™ per instructions for use. * the investigator determines that the health of the subject or the validity of the study outcomes (e.g., high risk of neurologic events, conditions that may increase the chance of stroke, worsening of clinical condition in the last 30 days) may be compromised by the subject's enrollment. * pregnant or breast-feeding women or women who wish to become pregnant during the length of study participation. * subject is currently enrolled or planning to participate in a potentially confounding drug or device trial during the course of this study. co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from medtronic. * legal incapacity or evidence that a subject cannot understand the purpose and risks of the study or inability to comply fully with study procedures.
recurrent hypoglycemia in type 1 diabetes (aim 2)

Conditions: Diabetes Mellitus, Type 1

Summary: this study will explore the cerebral mechanisms of impaired awareness of hypoglycemia (iah) in type 1 diabetics following exposure to experimental recurrent hypoglycemia (hg). to induce iah, patients with t1d identified to have normal awareness of hypoglycemia (nah) will undergo three 2-hour long hypoglycemic clamps. neurochemical profiles will be measured by high field mrs before and after induction of iah. subject glycemic variability and activity/sleep for 1 week before each study will be monitored as all factors have been shown to alter responses to hg.

the long-term goal of this project is to identify how recurrent hypoglycemia (hg) leads to the clinical syndrome of impaired awareness of hypoglycemia (iah) in type 1 diabetes (t1d). this study will test the hypothesis that recurrent hg in t1d leads to an upregulation in brain glucose transport and alterations in glutamatergic and gabaergic tone. the investigators will use mrs methodology that permits evaluation of cerebral cortex and hypothalamus in the same session to simultaneously evaluate the cerebral correlates/mediators of impaired awareness and impaired counterregulatory hormone responses (crr). high mr data quality and reproducibility will be ensured by using high field mr scanners and technical advances (automated voxel placement, real-time voxel position, frequency, shim updates). continuous glucose monitoring and actigraphy will be used to chronicle glucose variability and activity/exercise/sleep in the weeks before each experiment to assess the impact of these variables on iah.

Eligibility criteria:
inclusion criteria: * type 1 diabetes diagnosed on clinical or laboratory grounds * diabetes duration 2 - 30 years * hemoglobin a1c \<8.5% exclusion criteria: * impaired awareness of hypoglycemia as determined by the cox and gold questionnaires * pregnant or plan to become pregnant during the study period * uncontrolled hypertension (blood pressure \> 145/95 mmhg at screening) * evidence of autonomic neuropathy (presence of orthostatic hypotension or history of gastroparesis) * proliferative retinopathy * impaired kidney function (gfr \< 45) * history of myocardial infarction, stroke, seizures, neurosurgical procedures, major depression requiring hospitalization within the last 5 years, arrhythmias * current substance abuse * use of drugs that can alter glucose metabolism including but not limited to glucocorticoids and niacin, and excluding insulin and glucose lowering drugs used to treat diabetes, as determined by a clinician * inability to undergo mri scanning, including but not limited to unable to remain still in an mri scanner for more than 30 minutes, claustrophobia, presence of paramagnetic substances or pacemakers in body, weight over 300 lbs * unable to complete all study visits or procedures, as determined by the investigator
a study to evaluate the safety and antiviral effect of abt-450/ritonavir and abt-530 coadministered with and without ribavirin in adults with genotype 3 hepatitis c (hcv) infection

Conditions: Chronic Hepatitis C; Hepatitis C Virus

Summary: the purpose of this study is to evaluate the safety and antiviral effect of abt-450/r and abt-530 coadministered with and without ribavirin in adults with genotype 3 hcv infection.

once the efficacy and safety data were obtained from participants administered abt-450/r + abt-530 + rbv weight-based (arm 1) in study m14-213, the decision was made to end this study before subjects were enrolled into arm 2.

Eligibility criteria:
inclusion criteria: * male or female (of non-child bearing potential) between 18 and 70 years of age with body mass index ≥18 to \<38 kg/m2. * chronic hcv genotype 3 infection prior to study enrollment and has never received antiviral treatment for hcv. * subject has plasma hcv rna level \> 10,000 iu/ml at screening. * sexually active males must be sterile, have male partners only, or agree to use two effective forms of birth control for 7 months after stopping study drug. exclusion criteria: * history of severe, life-threatening or other significant sensitivity to any drug. * positive test result for hepatitis b surface antigen (hbsag) or anti-human immunodeficiency virus antibody (hiv ab). * prior therapy for the treatment of hcv. * any current or past clinical evidence of cirrhosis. * any cause of liver disease other than chronic hcv-infection. * hcv genotype co-infection with any other hcv genotype. * use of contraindicated medications within 2 weeks or 10 half-lives of dosing.

Keywords: hepatitis c hcv interferon free chronic hepatitis c hepatitis c virus hepatitis c genotype 3
opt-80 in clostridium difficile-associated diarrhea (cdad)

Conditions: Diarrhea

Summary: the purpose of this study is to investigate the safety and perform preliminary clinical evaluation in patients with mild to moderate cdad.

this is a dose-finding study to select a safe and efficacious dose of opt-80. patients will be evaluated for safety and efficacy and pharmacokinetic parameters will be investigated.

Eligibility criteria:
inclusion criteria: * patients with cdad exclusion criteria: * patients with severe cdad

Keywords: cdad, diarrhea clostridium difficile-associated diarrhea
telephone intervention after traumatic brain injury

Conditions: Brain Injuries

Summary: this study seeks to determine if telephone counseling improves the outcome for persons with moderate to severe traumatic brain injury (tbi).

subjects are recruited from the three participating tbi model systems of care at seattle, philadelphia, and jackson. after informed consent is obtained, some information is gathered about the injury and information about how the subject is doing cognitively, socially, and emotionally. after this information is obtained and after the subject is discharged from the acute rehabilitation unit, the subject is randomly selected to receive either standard care after discharge or standard care plus the telephone counseling. the telephone follow-up group receives a telephone call from a research coordinator in 3-4 days, 2, 4, 8 weeks, and 5, 7, 9, 12, 15, 18, and 21 months after the date of injury. the research coordinator will work with the subject on problem-solving and self-management skills. in addition, the research coordinator will check in with a family member or friend for whom the subject has given permission to speak. an outcome assessment is done by telephone at 12 months and 24 months after injury.

Eligibility criteria:
inclusion criteria: * a primary diagnosis of traumatic brain injury upon admission to inpatient rehabilitation * age 16 years or older * arrival to an emergency department within 24 hours of acute injury * receipt of both acute hospital care and inpatient rehabilitation within our facilities * a permanent home address exclusion criteria: * previous hospitalization for tbi * acute psychiatric disorder (e.g., schizophrenia or bipolar affective disorder) * progressive neurological disease * lack of a permanent home address * discharge to a skilled nursing facility

Keywords: rehabilitation directive counseling brain injuries
haescs prevent acute graft-versus-host disease after hematopoietic stem cell transplantation

Conditions: Acute Graft Versus Host Disease

Summary: this is a parallel controlled clinical study evaluating the safety and efficacy of haecs in preventing agvhd after hsct.

this study is a controlled trial, with 18 subjects enrolled in the experimental group or the control group. the study will consist of four phases, including screening phase, preparation phase, haescs treatment phase and observational follow-up period. the cell dose of the experimental group was 1x10\^6 cells/kg and the control group is infused placebo (the composition was the same as haescs injection excipients, but did not contain haescs). the infusion of haescs/placebo at the day before hsct and 7th days after hsct.

Eligibility criteria:
inclusion criteria: * standard risk gvhd patients with hematological malignancies older than 18 years; * high risk gvhd patients with hematological malignancies: haplotype hematopoietic stem cell transplantation patients, donor is female or more than 30 years old; * well informed about this study and signed a consent form before the trial; * left ventricular ejection fraction (lvef) ≧ 50%, no evidence of pericardial effusion; * no evidence of lung infection by x-rays examination; * eastern cooperative oncology group (ecog) performance status of 0 or 1, hematopoietic cell transplantation - specific comorbidity index (hct-ci) of 0, 1, 2; * normal liver and kidney function: serum bilirubin≤35µmol/l, ast/alt was less than 2 times the upper limit of normal value, and serum creatinine ≤130µmol/l exclusion criteria: * reduce pretreatment dose or secondary transplantation; * participate other clinical trials within 2 months before this study; * female, 1) pregnant/nursing period, or 2) have a pregnancy plan during the study period, or 3) have fertility and cannot take effective contraception; * history of severe allergic disease or is allergic to one or more drugs; * patients who are considered unsuitable for the study by the investigator.

Keywords: haescs
diastolic dysfunction during conservative lifestyle treatment

Conditions: Obesity

Summary: the purpose of this study is to 1) investigate prevalence of diastolic dysfunction in patients with morbid obesity attending a conservative lifestyle change program, 2) investigate effects on cardiac function, cardiorespiratory fitness, body composition, quality of life and cardiovascular risk through the program, 3) investigate feasibility of introducing two different activity monitors throughout the program, and 4) comparing compliance to activity sensor market leader fitbit application versus mio pai application


Eligibility criteria:
inclusion criteria: * bmi \> 40 kg/m2 (or bmi \> 35 kg/m2 with comorbidity) * stable weight last three months (≤ 2 kg variation) * norwegian speaking * smartphone exclusion criteria: * other weight reduction treatment, including medication affecting appetite * known chronic cardiac condition * previous bariatric surgery * alcohol or other substitute abuse * psychiatric disorder needing treatment, including eating disorders * pregnancy or planned pregnancy during project period
pilot study on the effects of intravenous ketamine on acute pain crisis in patients with sickle cell disease

Conditions: Sickle Cell Disease

Summary: the purpose of this pilot study is to provide a preliminary assessment of the feasibility and efficacy of intravenous ketamine in controlling pain in patients with sickle cell disease (who are admitted to the hospital with severe, acute pain crisis, and who have been resistant to intravenous narcotics).

it is often difficult to manage acute painful crisis in patients with sickle cell disease. the usual management of these crises relies on hydration, administration of oxygen and narcotics, like morphine. a select group of patients, for unknown reasons, does not respond to this management and these patients often require prolonged use (several days) of intravenous narcotics. narcotics have proven to be ineffective in controlling this type of pain and can cause multiple side effects (sedation, vomiting, respiratory depression). we propose to administer intravenous ketamine in this group of patients who are resistant to intravenous narcotics. ketamine has been proven to be effective in controlling pain in multiple clinical situations. however, there are no data in the literature describing its use in patients with sickle cell disease.

Eligibility criteria:
inclusion criteria: * children ages 7 to \<19 * acute vaso-occlusive crisis * persistent pain despite initial pain management with intravenous (iv) opioids exclusion criteria: * contraindications to the use of ketamine * mental retardation or psychological conditions that may affect the proper evaluation of pain and side effects * known allergy to ketamine
dextrose gel does not prevent neonatal hypoglycemia

Conditions: Hypoglycemia; Infant, Small for Gestational Age; Premature Birth of Newborn; Fetal Macrosomia; Intrauterine Growth Restriction; Complication of Prematurity; Neonatal Hypoglycemia

Summary: this was a quasi-experimental pilot study comparing blood glucose values 30 minutes after feeding alone or feeding + dextrose gel in newborns at risk for transient neonatal hypoglycemia.

objective: to test the hypothesis that prophylactic dextrose gel administered to newborns at risk for hypoglycemia will increase the initial blood glucose (bg) concentration after the first feeding and subsequently decrease nicu admissions for treatment of asymptomatic transient neonatal hypoglycemia (tnh) vs those given feedings alone. study design: this quasi-experimental pilot study allocated asymptomatic at-risk newborns (late preterm, birth weight \ 4000 g, and infants of diabetic mothers) to receive prophylactic dextrose gel (insta-glucose®); other at-risk newborns served as controls. after the initial feeding, the prophylactic group received dextrose gel (0.5 ml/kg) rubbed into the buccal mucosa, and bg was checked 30 min later. initial bg concentrations and rate of nicu admissions (for treatment of hypoglycemia) were compared between the prophylactic group and controls using the wilcoxon rank-sum test and fisher's exact test, where appropriate. a multivariable linear regression compared first bg between groups after adjusting for at-risk categories and age at first bg concentration.

Eligibility criteria:
inclusion criteria: * gestational age above 35 weeks * infants less than 1 hour of age * infants with informed parental consent * infants who are born at the harris health ben taub hospital in houston, tx exclusion criteria: * infants with known metabolic, genetic, or congenital anomalies * infants not expected to survive the neonatal period * infants determined later to have a metabolic, genetic, or congenital anomaly that was not immediately obvious in the newborn period * hypoglycemic infants with symptoms * infants transferred to the level 3 nicu for other reasons

Keywords: dextrose gel newborn hypoglycemia late preterm infant large for gestational age small for gestational age prophylactic neonatal hypoglycemia