Kornimate/medical-research-clean huggingface dataset:
intensive multi-couple therapy for ptsd versus relationship education in military couples

Conditions: Posttraumatic Stress Disorder

Summary: the goal of this clinical trial is to test an abbreviated, intensive, multi-couple group version of cognitive-behavioral conjoint therapy for ptsd (aim-cbct for ptsd) in an active military and veteran population. the main questions it aims to answer are: * does aim-cbct for ptsd improve ptsd symptoms? * does aim-cbct for ptsd improve associated symptoms (e.g., depression), romantic partner distress, and couple relationship satisfaction? participants will participate in a two-day retreat in which they are taught and practice skills to decrease ptsd symptoms and enhance their relationships. researchers will compare aim-cbct for ptsd to the prevention and relationship education program (prep) to determine whether it is superior to an evidence-based relationship education curriculum that is also delivered in a two-day multi-couple group format.


Eligibility criteria:
inclusion criteria: * service member or veteran and a romantic partner willing to participate. * couple is married or cohabiting for at least 3 months. couple can be either different or same sex. * service member/veteran diagnosis of ptsd as determined by the caps-5. * each partner is at least 18 years old. * both partners able to speak and read english. exclusion criteria: * either partner reports current suicidal ideation severe enough to warrant immediate attention * current homicide risk meriting crisis intervention for either partner * current and severe alcohol misuse in either partner in the past 12 weeks and/or warranting immediate intervention * recent (past month) manic episode or psychotic disorder symptoms in either partner * evidence of a moderate or severe traumatic brain injury or other cognitive impairment in either partner * couple is separated or have taken steps to dissolve their relationship * either partner is currently participating in evidence-based treatment for ptsd (e.g., prolonged exposure, cognitive processing therapy, present-centered therapy for ptsd, eye movement desensitization and reprocessing, cognitive-behavioral conjoint therapy for ptsd, or structured approach therapy). * evidence or admission of severe intimate aggression as indicated by a "yes" endorsement to the one-question screen for conflict question by either partner occurring within the past 6-months.

Keywords: ptsd
sabril for complex partial seizures in adult tolerability study (ts) patients

Conditions: Complex Partial Seizures

Summary: this is an open-label, phase 4 study to examine the safety and efficacy of vigabatrin (sabril) in tuberous sclerosis patients, a subset of the larger refractory complex partial epilepsy population for which the drug is approved. while enrolled on this trial, subjects will continue to take all of their normally prescribed medications, including their other antiepileptic drugs (aeds). alternatively, there is a prospective observational arm that subjects who are about to take sabril as treatment for seizures associated with tuberous sclerosis may join. subjects who join this arm will not have any study visits and will not be asked to do anything specifically for the study. the study team will collect all study data from subjects' medical records only.


Eligibility criteria:
inclusion criteria: * the patient or patient's legally authorized representative must sign and date the institutional review board approved informed consent and hippa authorization form. * male and female patients 18+ years of age with a clinical diagnosis of tuberous sclerosis who experience an average of at least three partial seizures every two months, of which one must be a complex partial seizure * patient must be on at least one and a maximum of four aeds. patient must be on a stable aed dose regimen for at least 30 days prior to screening. neither a vagal nerve stimulator (vns) nor the ketogenic diet will count as an aed * in the investigator's opinion, the patient or caregiver must be able to keep a seizure diary * an mri in the last 5 years, or willingness to undergo an mri as part of the screening process exclusion criteria: * cause of patient's seizures is a neurologic disease that is not tuberous sclerosis * current, clinical diagnosis of a major depressive episode or suicidal ideation * patient is taking more than four concurrent aeds. note: vns or ketogenic diet is allowed and will not be counted in the four allowed aeds * patient has a progressive cns lesion confirmed by magnetic resonance imaging (mri) or computed tomography (ct) scan * patient is currently abusing drugs or alcohol

Keywords: tuberous sclerosis ts seizures
study of tpi 287 administered every 21 days in patients with advanced malignancies

Conditions: Neoplasms; Hodgkin's Disease; Non-Hodgkin's Lymphoma

Summary: tapestry pharmaceuticals, inc. has developed a novel taxane analog, tpi 287. tpi 287 is synthetically manufactured from naturally occurring taxanes extracted from yew starting material. the synthesis involves modification to the taxane side chain to overcome multidrug resistance and to achieve mutant tubulin binding. this study will be a multi-center, dose escalation, sequential group, phase 1 study evaluating the intravenous administration of tpi 287 on an every 21 day cycle.

the primary objective of this study is to determine the maximum tolerated dose of tpi 287 administered every 21 days for phase ii clinical trials.

Eligibility criteria:
inclusion criteria: patients must be/have: * histological evidence of malignancy * advanced solid tumors that have recurred or progressed following standard therapy * failed one prior therapy or have no standard therapy available * ambulatory with ecog of 0-1 and estimated life expectancy of \> 3 months * if female, negative pregnancy test * if of childbearing years, agree to use birth control * if patient with prior radiation therapy for brain metastases, on steroids, must have been stable for 1 month exclusion criteria: patients will be excluded if they are or have had: * prior radiation within 4 weeks * active medical condition or organ disease which may compromise safety or interfere with the study * clinically significant cardiac co-morbidities or pulmonary impairment * concomitant therapy needs * treated with any investigational drugs within 30 days * tumors involve major artery or vein * prior or concurrent central nervous system (cns) disease * less than 4 weeks since major surgery * known to be positive for hiv, hepatitis b or c * concurrent use of aspirin * use of thrombolytic agents * uncontrolled hypertension * grade ii-iv peripheral vascular disease * pregnant or lactating * prior allergic history to compounds of similar chemical composition * inpatients * grade ii-iv peripheral neuropathy

Keywords: taxanes multidrug resistance mutant tubulin binding hodgkin's or non-hodgkin's lymphoma
comparison of different bending mode for double-lumen endotracheal tube intubation

Conditions: Anesthesia Intubation Complications

Summary: the purpose of this study is to comparing the effects of different double-lumen endotracheal tube's bending type in tracheal intubation.

intubation with the double-lumen endotracheal tube (dlt) remains a great challenge for anesthesiologists. although new upper airway devices, such as glidescope(r) videolaryngoscope, had been developed for facilitating airway management, the larger size and the complexity of dlt than single-lumen tube (slt) makes the difficulties for dlt intubation. therefore, the investigators designed this study to investigate the effects of different bending type of dlt in tracheal intubation.

Eligibility criteria:
inclusion criteria: 1. american society of anesthesiologists physical status i-iii 2. more than 18 years of age 3. receiving thoracic surgery with double-lumen endobronchial tube exclusion criteria: 1. risk of regurgitation and pulmonary aspiration 2. history of gastroesophageal reflux 3. pregnancy 4. scheduled tracheostomy and postoperative prolonged ventilation in icu 5. limited neck extension (\< 35°) 6. a thyromental distance less than 7 cm 7. a sternomental distance less than 12.5 cm with the head fully extended 8. mouth can not open

Keywords: left-side double lumen bronchial tube bending type glidescope videolaryngoscope
sleep intervention for pediatric epilepsy

Conditions: Epilepsy

Summary: the purpose of the study is to develop and evaluate a sleep intervention program for improving sleep and health in youth with epilepsy and their parents.

sleep problems are more prevalent and serious in children with epilepsy whose sleep can be disrupted by seizures occurring during the night and/or during the day. inadequate sleep has long been recognized as a trigger for seizure and poor sleep habits have been associated with unfavorable outcomes in children with epilepsy. attention to sleep in children with epilepsy as a result is critically important for seizure control and health-related quality of life.

Eligibility criteria:
inclusion criteria: * children aged between 1.5 and 6 years with a confirmed diagnosis of epilepsy based on clinical and electro-encephalogram examinations. exclusion criteria: * children born before 37 weeks gestation, children with evidence of structural brain damage, or with cerebral palsy or those who are bedridden.
the exercise and colorectal cancer treatment trial

Conditions: Colon Cancer; Rectal Cancer

Summary: this study will examine the biologic processes through which exercise may prevent disease recurrence in patients who have completed treatment for colorectal cancer.

this randomized trial will examine the biological effects of 12-weeks of moderate-intensity aerobic exercise versus wait-list control in 60 subjects who have completed standard medical therapy for colorectal cancer. the primary objective is to determine if aerobic exercise can reduce systemic inflammation, quantified using plasma concentrations of high-sensitivity c-reactive protein and interleukin-6. the secondary objectives are to determine if exercise can reduce: 1) insulin resistance quantified using an oral glucose tolerance test, and; 2) circulating tumor cells quantified using a microfluidic antibody-mediated capture platform. the exploratory objective is to determine if exercise can improve mitochondrial respiration rates and fatty acid oxidation in peripheral blood mononuclear cells and tumor fraction.

Eligibility criteria:
inclusion criteria: * age ≥18 years * histologically-confirmed stage i-iii colorectal cancer * completed surgical resection * completed chemotherapy (if applicable) * completed radiotherapy (if applicable) * provide written approval by physician or other qualified healthcare provider * no planned major surgery during the study period (including colostomy reversal; chemotherapy infusion port removal is permitted) * readiness to exercise \[as determined by a modified version the physical activity readiness questionnaire (par-q) * allow the collection and storage of specimens and data for future use * willing to be randomized exclusion criteria: * evidence of metastatic colon cancer * concurrently actively treated other cancer (except non-melanoma skin cancer or in situ cancers) * currently enrolled in another clinical trial of weight loss, physical activity, or dietary intervention * current body mass greater than or equal to 181 kg * unable to provide a baseline fasting blood sample * unable or unwilling to give informed consent * unable or unwilling to be randomized * or any other condition that may impede testing of the study hypothesis or make it unsafe to engage in the exercise program (as determined by the investigative team)
attention bias modification for transdiagnostic anxiety

Conditions: Anxiety; Anxiety Disorders

Summary: this project seeks to identify neural mechanisms underlying the tendency for anxious individuals to pay more attention to threatening information than to other types of information. a computerized treatment designed to train individuals to reduce their attention towards threat will be tested, with a focus on understanding the aspects of brain function that predict response to the treatment. this work could ultimately lead to the ability to treat anxiety more effectively by directly targeting the aspects of brain function that are altered in a given patient.


Eligibility criteria:
inclusion criteria: * participants will: 1. be between the ages of 18 and 55 years, 2. score \>45 on the spielberger state-trait anxiety inventory-trait form. 3. score \>=75th percentile on the world health organization disability assessment schedule 2.0 exclusion criteria: 1. current medication or cognitive-behavioral therapy for anxiety or depression; 2. failure to meet standard magnetic resonance imaging (mri) inclusion criteria: those who have cardiac pacemakers, neural pacemakers, surgical clips in the brain or blood vessels, surgically implanted metal plates, screws or pins, cochlear implants, intrauterine devices, metal braces, or other metal objects in their body, especially in the eye. if the subject has any metal or implants in the body they must be deemed safe by the mri research center's safety screening procedure prior to enrollment. dental fillings do not present a problem. plastic or removable dental appliances do not require exclusion. pregnancy, determined by pregnancy tests on females. 3. currently suicidal or at risk for harm to self or others, 4. visual disturbance (\<20/40 as per the snellen test, corrective lenses allowed) 5. \<6th grade reading level as per the wide range achievement test 6. presence of bipolar, psychotic, autism spectrum, substance dependence, or primary depressive disorder 7. positive urine drug test

Keywords: anxiety attention bias modification computer
study of vi-0521 compared to placebo in the glycemic management of obese diabetics

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to evaluate the efficacy and safety of vi-0521 compared to placebo in the glycemic management of obese diabetic adults.


Eligibility criteria:
inclusion criteria: * informed consent * type 2 diabetes * bmi 27-42 * specified diet/exercise and/or diabetes medications exclusion criteria: * bp \> 150/95 * stroke/mi/unstable cardiovascular disease within 6 months * clinically significant renal, hepatic, or psychiatric disease * unstable thyroid disease or replacement therapy * nephrolithiasis * obesity of known genetic or endocrine origin * participation in a formal weight loss program or lifestyle intervention * history of glaucoma * pregnancy or breastfeeding * alcohol abuse * eating disorder * excluded medications

Keywords: diabetes, obese diabetics
injection of subcutaneous glucose 10% in small shots is effective in the treatment of diabetic neuropathic pain

Conditions: Painful Diabetic Neuropathy

Summary: observational cohort prospective study with the following of 100 patients of type 1 and type 2 diabetes mellitus in 2 groups each group 50 patients, each group 30 males, and 20 females,35 patients with type 2 diabetes and 15 patients type 1 diabetes all have diabetic peripheral neuropathy, the second group is considered as control.

observational cohort prospective study with the following of 100 patients of type 1 and type 2 diabetes mellitus in 2 groups each group 50 patients, each group 30 males, and 20 females,35 patients with type 2 diabetes and 15 patients type 1 diabetes all have diabetic peripheral neuropathy, the second group is considered as control. the ages of all patients are between 20 and 50 years. the first group was on subcutaneous glucose 0.5 ml per site around subcutaneous nerves in the foot region both on palm and sole.which is repeated every 2 weeks for 2 months. pain severity was evaluated by using the visual analogue scale (vas) which is a numerical rating scales, with a straight horizontal line of 100 mm. which is directed from the left with severe pain to the right with no pain. 1-3 = mild pain,4-6 = moderate pain,7-10 = severe pain. the evaluation of neuropathy was done by using the michigan neuropathy screening instrument (mnsi) after translation to the arabic language.which consists a 15 self-administered questionnaires and examination lower extremities which comprise inspection and examination of vibratory senses and ankle reflexes. a score which is more than 7 was suggested to be abnormal.

Eligibility criteria:
inclusion criteria: 1. patients 20 years to 50 years with type 1 or type 2 diabetes who have symptoms of symmetrical peripheral neuropathic pain. 2. female patients are not pregnant. 3. patient has a pain score of at least 5 on the visual analogue scale (vas). 4. patients are on their antidiabetes medication. 5. patents are not on any medication for peripheral neuropathy. 6. patient must be able to complete questions on the michigan neuropathy screening instrument (mnsi). exclusion criteria: 1. patient has conditions that could affect the evaluation of painful dpn, or non-diabetic neurologic disorders. 2. patient has skin conditions in the area affected by the neuropathy that could alter sensation. 3. patient with history of drug abuse. 4. patients on any drug for diabetic neuropathy like pregabalin or gabapentin. no side effects were monitored during the period of treatment.

Keywords: diabetes mellitus diabetic neuropathy pain glucose 10%
to demonstrate the relative bioequivalency of generic haloperidol tablets versus haldol in normal volunteers

Conditions: Psychosis

Summary: to demonstrate the relative bioequivalency of generic haloperidol tablets versus haldol in normal volunteers.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. exclusion criteria: * positive test results for hiv or hepatitis b or c. * treatment for drug or alcohol dependence.

Keywords: typical antipsychotic
a structural hiv prevention intervention targeting high-risk women

Conditions: Sex Work

Summary: the purpose of this study is to assess the effectiveness of a community based combination hiv prevention package, including biomedical, behavioral, and structural services for female sex workers (fsw) in baltimore, maryland. this study is a prospective two-group trial comparing the efficacy of a community-based comprehensive hiv/sti prevention package compared to standard of care (hiv testing, counseling, and referrals) among fsws. outcomes will be assessed through self-reported illicit drug use and sexual risk behaviors (behavioral) as well as hiv/sti testing (biological).

this study aims: 1. to examine the effect of exposure to community intervention components on hiv/sti risk behaviors (e.g., drug use/unprotected sex), and hiv/sti cumulative incidence over time in fsws in the intervention (n=275) compared to those in the comparison group (n=175); a. to explore the intervention's effects on the risk environment of exotic dance clubs (n=15) over time 2. to examine how socio-structural (e.g., social cohesion, stigma) and structural vulnerability (e.g., financial and housing stability) indicators change and are associated with the biological and behavioral outcomes over time in fsws in the intervention (n=275) compared to those in the comparison (n=175) group a. examine the role of these indicators as mediators of the intervention effect on study outcomes; 3. to examine the intervention's implementation through qualitative (e.g., in-depth interviews) and quantitative (e.g., assessment of program fit, reach, facilitators, barriers, program costs) measures. 3.1 to examine participant knowledge of the covid-19 crisis as well as the impact of the crisis on their mental, and physical well-being.

Eligibility criteria:
inclusion criteria: * age 18 or older; * assigned female at birth and identify with female gender * have exchanged sex in baltimore city at least 3 times in the past 3 months; * willing to undergo testing for hiv, gonorrhea, and chlamydia * willing to provide locator information. exclusion criteria: * inability to provide informed consent in english; * women who are determined as too high or drunk; * women who are cognitively impaired. * currently enrolled in the sapphire study

Keywords: sex work hiv sti
interaction of sleep, diurnal eating pattern, gut microbiota, and obesity

Conditions: Obesity

Summary: the goals of the proposed study are 1) to provide scientific basis for the relationship between subjective sleep quality, diurnal eating pattern, gut microbiome, and obesity, 2) to develop and test a pragmatic, cost-effective new tool to advance lifestyle changes using e-health approach, and 3) to compare differences in subjective sleep quality, diurnal eating pattern and gut microbiome at baseline 4) to compare changes induced by the e-health intervention among the three study groups and participants with different work schedules.

the data are fragmented and studies are focusing on interactions of sleep and obesity, eating pattern and obesity, or gut microbiota and obesity, but not the cross-talk of all these factors in the same individual or population. therefore, we need a multifactorial approach to get a more deep insight on the obesity and weight regulation. further, novel cost-effective tools to advance lifestyle changes are needed. emerging evidence suggests that novel countermeasures, such as modulation of the timing of food intake, may be effective strategies in weight control and prevention of obesity. the goals of the proposed study are 1) to provide scientific basis for the relationship between subjective sleep quality, diurnal eating pattern, gut microbiome, and obesity, 2) to develop and test a pragmatic, cost-effective new tool to advance lifestyle changes using e-health approach, and 3) to compare differences in subjective sleep quality, diurnal eating pattern and gut microbiome at baseline 4) to compare changes induced by the e-health intervention among the three study groups and participants with different work schedules.

Eligibility criteria:
inclusion criteria: * community dwelling 18 - 65 year old adults * bmi 18.5 - 30 kg/m2 (n = 40, m:f = 1:1) * bmi \> 30 kg/m2 (n = 40, m:f = 1:1) * osas patients with bmi \> 30 kg/m2 using nasal continuous positive airway pressure (cpap) treatment on an average \> 4 h/d (n = 40, m:f = 1:1). exclusion criteria: * antimicrobial treatment within 3 months prior the baseline visit * inflammatory bowel diseases
effectiveness of intratympanic dexamethasone with ligmocaine for alleviation of tinnitus

Conditions: Tinnitus

Summary: objective: to determine the effectiveness of intratympanic dexamethasone with lignocaine in control of idiopathic tinnitus. methodology: 264 consenting patients with idiopathic unilateral tinnitus presenting at ent department were assessed for tinnitus severity using modified tinnitus handicap inventory and the scores recorded and subsequently administered intratympanically 2.0 ml (milliliter's) of dexamethasone and lignocaine (1.5 ml dexamethasone + 0.5 ml 1% lignocaine). the dose was repeated twice at weekly intervals. all patients were re assessed on modified tinnitus handicap inventory two weeks after third intratympanic administration.


Eligibility criteria:
inclusion criteria: * score 20 or above on modified tinnitus handicap inventory exclusion criteria: * head trauma, tympanic membrane perforation, depression, ear surgery