Kornimate/medical-research-clean huggingface dataset:
healthcall:brief intervention to reduce non-injecting drug use in hiv primary care clinics

Conditions: Mental and Behavioral Disorders Due to Harmful Drug Use

Summary: among hiv-infected individuals, non-injection drug use (nidu) is associated with poor hiv medication adherence, greater hiv/aids risk behaviors, and increasing non-aids mortality. thus reducing nidu among hiv infected individuals is critical to their survival and to limiting the spread of hiv. we propose to study the efficacy of a technologically enhanced brief intervention (healthcall) to reduce nidu in hiv primary care patients that demands little from busy medical staff and is well accepted by patients. in a 3-arm randomized clinical trial will test the efficacy of (a) motivational interviewing (mi)+healthcall; (b) mi-only; and (c) a control condition (advice + dvd hiv health education) in reducing nidu.


Eligibility criteria:
inclusion criteria: * all research volunteers will be 18 and older and hiv positive. we will include participants whose primary drug is non-injection use of cocaine, opioids including heroin, or methamphetamines and current use in the past 30 days \> 4 days. participants will need to complete a medically supervised detoxification if such detoxification is required. exclusion criteria: * excluded are research volunteers for whom participation would not be clinically appropriate, who clearly could not participate. psychotic, suicidal or homicidal patients require clinical management that is too intensive for this study, and we have no evidence that mi+healthcall would be effective among injection drug users. leaving new york precludes follow-up. gross psychomotor/cognitive impairments that may hinder patients' healthcall use. hearing and severe vision impairments that preclude telephone use precludes randomization to mi+healthcall.

Keywords: technology based intervention hiv primary care clinic brief behavioral intervention drug abuse
study to evaluate relacorilant (cort125134) in combination with nab-paclitaxel in participants with solid tumors

Conditions: Solid Tumors

Summary: the purpose of this study was to assess the safety of the combination of relacorilant (cort125134), a novel glucocorticoid receptor (gr) antagonist, and nab- paclitaxel in participants with solid tumors and to determine the preliminary efficacy of the combination of relacorilant and nab-paclitaxel. the structure for the study was a single arm, non-randomized, open- label, multicenter trial with no control group.

the study consisted of two segments to evaluate alternative dosing schedules of relacorilant administered at escalating dose levels. segment i was to evaluate a continuous-dosing regimen and segment ii was to evaluate an intermittent-dosing regimen. enrollment in segment i and segment ii were mutually exclusive, and the two segments enrolled participants concurrently. in segment i continuous-dosing cohorts, participants received a single nab-paclitaxel lead-in infusion on day 1 of week -2 before cycle 1, and oral relacorilant lead-in once-daily of week -1 before cycle 1. after the data review committee review of data for 2 dose levels, the nab-paclitaxel lead-in was discontinued. the lead-in period was followed by oral relacorilant administered continuously once daily, in combination with nab-paclitaxel infusions on days 1, 8, and 15 of each 28-day cycle. segment 1 enrolled a total of 64 participants. in segment ii intermittent-dosing cohorts, participants received a single relacorilant lead-in dose on day -1 before cycle 1, followed by oral relacorilant, administered intermittently the day before, the day of, and the day after nab-paclitaxel infusions on days 1, 8, and 15 of each 28-day cycle. segment ii enrolled a total of 21 participants.

Eligibility criteria:
inclusion criteria: * participants with advanced or metastatic solid tumors who have disease progression after treatment with available therapies and for whom nab-paclitaxel treatment is appropriate. * measurable or evaluable disease. * up to 3 prior cytotoxic chemotherapeutics regimens or myelosuppressive therapies in the advanced setting. * eastern cooperative oncology group (ecog) performance status of 0 or 1. * for part 2 only: platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer, or triple negative breast cancer with measurable disease as defined by response evaluation criteria in solid tumors (recist) v1.1 in at least 1 lesion, that in the opinion of the investigator is appropriate to treat with nab-paclitaxel. exclusion criteria: * any major surgery within 4 weeks prior to the first dose of study drug. * some protocol specified treatments prior to the first dose of study drug.

Keywords: cort125134 nab-paclitaxel triple-negative breast cancer ovarian epithelial cancer gr antagonist glucocorticoid receptor antagonist pancreatic cancer solid tumors relacorilant abraxane
muscle energy technique versus maitland mobilization on shoulder pain and disability

Conditions: Neck Cancer; Mobility Limitation; Pain Syndrome; Shoulder Pain; Surgery

Summary: the purpose of this study was to investigate the effect of muscle energy technique versus maitland's mobilization on shoulder pain and disability after neck dissection surgeries.

thirty patients with shoulder pain and limited rom post-neck dissection surgeries participated in this study. patients were subdivided into two groups, fifteen patients in each group. group a received the muscle energy technique and group b received maitland's mobilization. data obtained from both groups regarding the visual analogue scale, it has a 100-mm-long horizontal line labeled ''no pain' (with or without related facial expressions) at one extreme and ''worst pain ever' at the other. pain intensity is determined by the length of the line as measured from the left-hand side to the point marked, the shoulder pain and disability index, it has two subscales; the pain subscale includes five questions about pain intensity. the disability subscale includes eight questions about difficulty in different orders. each question of both pain and disability subscale was scaled in numeric ratings ranging from 0 to 10. each score was summed up and transformed into percentages. finally, the average score between pain and disability subscale comprised the total spadi scores ranging from 0 (the best) to 100 (the worst), and shoulder flexion, abduction, and external rom were statistically analyzed and compared.

Eligibility criteria:
inclusion criteria: * age range between 25-70 years. * male and female patients participated in the study. * all patients had shoulder pain following different nds * all patients had no previous shoulder pain. * all patients enrolled in the study had their informed consent. exclusion criteria: * previous shoulder pain from any other causes. * pregnancy. * epileptics. * radiotherapy. * chemotherapy.

Keywords: muscle energy technique maitland's mobilization shoulder pain and disability neck dissection surgeries
dose response study of dexmedetomidine in orthopaedic spine surgery patients

Conditions: Pain, Postoperative

Summary: to study the multimodal protocol combining adjunct dexmedetomidine with oxycodone in intravenous patient-controlled analgesia bolus dosing and effects in patients scheduled for posterolateral lumbar spine fusion with bilateral transpedicular screw instrumentation.


Eligibility criteria:
inclusion criteria: * scheduled for elective posterolateral lumbar spine fusion with bilateral transpedicular screw instrumentation under general anaesthesia. * written informed consent from the participating subject exclusion criteria: * a previous history of intolerance to the study drug or related compounds and additives * concomitant drug therapy with oxycodone or buprenorphine. * history of ischemic heart disease or conduction disturbance * bmi \> 35 * existing significant haematological, endocrine, metabolic or gastrointestinal disease * history of alcoholism, drug abuse, psychological or other emotional problems that are likely to invalidate informed consent * allergy to dexmedetomidine or oxycodone * blood loss exceeding 1500 ml during operation
cannabidiol and emotional stimuli

Conditions: Drug Addiction

Summary: the purpose of this research is to examine the effect of cannabidiol (cbd), a cannabinoid compound found in marijuana, on responses to emotional stimuli. both preclinical and clinical studies indicate that cbd may act to reduce anxiety without excessive sedative side-effects. thus the investigators hypothesize that cbd may reduce responses specifically to negative emotional and social stimuli, including pictures and emotional faces, without altering responses to positive stimuli. to examine this, the investigators will administer placebo, 300mg, 600mg, and 900mg cbd to healthy normal adults in a double-blind within-subjects study. the investigators will measure subjective and subtle physical responses to positive and negative stimuli using measures that have been characterized with classic anxiety-reducing drugs and drugs of abuse. further, the investigators will examine whether cbd-induced changes in these measures of emotional response relate to changes in actual behavior in a controlled social interaction. these results will allow the investigators to examine the potential usefulness of cbd as an anxiety-reducing drug, and suggest mechanisms by which cbd may reduce anxiety.


Eligibility criteria:
inclusion criteria: * 18-35 years of age. * 38 healthy volunteers (19 male, 19 female; age range 18-35 years) * all participants recruited without regard to race, religion or ethnicity through posters, advertisements and word-of-mouth referrals. * candidates screened in accordance with our general screening protocol, approved by the irb under protocol #13681b, which includes a physical, ekg, psychiatric screening interview and detailed drug use history questionnaire. exclusion criteria: * individuals with a medical condition contraindicating study participation, as determined by the study site physician. * individuals regularly using any medications aside from hormonal contraception in women. * individuals with a current (active in the past year) dsm-iv axis i mood, anxiety, eating, or substance dependence disorder or a lifetime history of a psychotic disorder or mania. * women who are pregnant, nursing, or planning to become pregnant in the next 3 months * participants reporting a known or suspected allergy to cannabinoids. * the self-report questionnaires the investigators use require fluency in english, and have not been translated and validated in other languages, thus individuals with less than a high-school education or those not fluent in english were excluded, as lack of english familiarity at a high school level may compromise our ability to interpret their self-reports. * individuals with a bmi below 19 or above 30, as this would change dosing requirements. * individuals who report using marijuana \>100 times in their lifetime, to reduce variation in possible developed tolerance to cbd.
study to evaluate the effect of bimosiamose on ozone induced sputum neutrophilia

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: the purpose of this study is to evaluate the safety, tolerability and efficacy of repeated inhalative doses of bimosiamose on ozone induced sputum neutrophilia in healthy subjects.


Eligibility criteria:
inclusion criteria: * able to produce sputum with normal sputum neutrophil levels at screening (\< 65% of non-epithelial cells). * ozone responsive, defined as ≥ 20% relative increase in sputum neutrophils cell count after 3 h ozone challenge. * at screening fev1 at least 80% of predicted. exclusion criteria: * smokers (use of tobacco products in the previous 3 months). urine cotinine levels will be measured during screening for all subjects. smokers will be defined as any subject who reports of a recent tobacco use and/or who has a urine cotinine ≥ 500 ng/ml. * significant illness within two weeks prior to dosing (e.g., infection). * recent (within the last three years) and/or recurrent history of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated).
silent progression activity monitoring - spam study

Conditions: Multiple Sclerosis

Summary: real-world data (rwd) exploring the natural history of ms suggested that relapses do not significantly influence the progression of irreversible disability. disability progression independent of relapses activity (pira) has been confirmed as a frequent relapsing-remitting multiple sclerosis (rrms) phenomenon based on randomized clinical trials (rct). recently, rwd demonstrated that the absence of markers of inflammation (no evidence of disease activity (neda) at 2 years did not predict long-term stability. silent progression has been proposed to describe the insidious disability that accrues many patients who satisfy traditional criteria for relapsing-remitting ms. in this study, the investigators would like to evaluate the occurrence of the spms in a population of rrms patient with an highly active treatment (hat).


Eligibility criteria:
inclusion criteria: - patients with rrms (2017 mc donald criteria) treated with highly active treatment in the first 5 years of symptoms onset, at least 1 year, with an edss below 4 * hat start after april 12th 2007 (availability of natalizumab) * naive or failure (or intolerability) to 1 or more first line dmt (injectables, teriflunomide, dmf). * edss \< or equal 4 when starting hat exclusion criteria: * progressive relapsing ms at baseline * clinical or basic mri data unavailable after on-site visit. * ms diagnostic \> 5 years at baseline * immunosuppressive drugs (azathioprine, cyclophosphamide, mycophenolate, methotrexate) prescribed before hat initiation
talocrural joint manipulation in stroke

Conditions: Stroke

Summary: the primary aim of the study is to investigate the effect of talocrural joint manipulation on the static balance of patients with stroke. the secondary aim of this study is to investigate the effect of talocrural joint manipulation on the dorsiflexion range of motion of patients with stroke.

the study, utilizing a randomized crossover design, is planned to be conducted on a minimum of 26 patients with stroke who meet the inclusion and exclusion criteria. patients included in the study will be randomly assigned to receive both placebo talocrural joint manipulation and talocrural joint manipulation treatments.

Eligibility criteria:
inclusion criteria: * 1. two months or longer elapsed since the stroke, * 2. a mini-mental state examination score of 24 or higher, * 3. the ability to stand independently for 20 seconds or more, * 4. the ability to walk independently for 10 meters with the use of walking aids or orthoses if necessary, * 5. being between 45 and 75 years of age, * 6. having a brunnstrom stage of 4 or above exclusion criteria: * 1. the presence of severe osteoarthritis in the lower extremity, * 2. the presence of cancer or diabetic neuropathy, * 3. the presence of vestibular disorder, * 4. the presence of lower extremity ulceration or amputation, * 5. history of vertigo, * 6. alcohol consumption within the last 24 hours, * 7. hemodynamic instability, * 8. diagnosis of posterior circulation stroke involving the basilar artery and cerebellum, * 9. the presence of other neurological disorders (such as multiple sclerosis, parkinson's disease), * 10. having experienced an acute lower extremity injury in the last six weeks, * 11. history of lower extremity surgery

Keywords: postural balance
efficacy and safety of iv diclofenac (dic075v) for pain after abdominal or pelvic surgery

Conditions: Pain, Postoperative

Summary: this study will compare repeated intermittent iv dosing of diclofenac in patients with moderate to severe post-surgical pain from abdominal or pelvic surgery.

the primary objective is to evaluate the efficacy and safety of two dosage levels of parenteral diclofenac in providing pain relief as compared to placebo or ketorolac tromethamine.

Eligibility criteria:
inclusion criteria: * scheduled within two weeks of the screening visit to undergo abdominal or pelvic surgery * moderate to severe pain within 6 hours following completion of the required surgery. exclusion criteria: * surgical procedure involves a subcostal incision. * chronic disease or recent cardiovascular events. * known allergy or hypersensitivity to the active compounds or any of the excipients used in the study. additional inclusion/exclusion criteria may apply
combination therapy with fecal microbiota transplantation and vedolizumab for induction of ulcerative colitis

Conditions: Ulcerative Colitis

Summary: this is a pilot study of combination therapy using fmt and vedolizumab for induction of uc. the investigators hypothesize that a combination therapy approach which addresses immune trafficking and microbial manipulation simultaneously will lead to superior outcomes than those seen with single agent therapy.

this is a prospective pilot trial involving a single centre (mcmaster university medical centre) recruiting patients from hamilton, ontario canada and the surrounding regions, to evaluate efficacy and safety outcomes when using fecal microbiota transplantation once weekly for six weeks in uc patients who are initiated on vedolizumab. a lead in study will be conducted with the first five patients to ensure engraftment of fmt within the colon. interim analysis will be conducted after these five patients to ensure engraftment within the colon. data safety and monitoring board will also be informed of the results after the first five patients, including any adverse events. decision will be made based on these results whether to proceed with the prospective study using fmt weekly for six weeks, or whether to modify the dose/frequency of fmt treatment. as patients with previous biologic failure tend to have sub-optimal response to vedolizumab monotherapy, this pilot study will focus on recruitment of previous biologic failure patients.

Eligibility criteria:
inclusion criteria: 1. patients aged 18 or over 2. active uc defined as total mayo score of 6 or more points, with endoscopic subscore at \> 2 3. clinician initiating vedolizumab for patients as per standard of care for uc 4. patient previously has been exposed to one or more biologic or advanced therapies (anti-tnf, jak inhibitor, anti-interleukin) and never previously exposed to vedolizumab or other anti-integrin therapy. 5. females of child bearing potential must be willing and able to use acceptable contraception as per appendix iii. ii. b. toxicity section of the health canada guidance exclusion criteria: 1. participating in another clinical trial 2. unable to give informed consent 3. severe comorbid medical illness 4. concomitant clostridium difficile infection 5. increase in medical therapy for uc in the last 4 weeks. continued treatment with 5-asa, azathioprine, or 6-mercaptopurine will be permitted if taken at stable dose for ≥4 weeks prior to study entry. stable dose (same dose for at least 2 weeks) or a tapering dose of steroids will also be permitted provided the dose of steroid is not increased again. stable intake of probiotic therapy also permitted. 6. new antibiotic therapy in the last 28 days. 7. dose of infliximab or golimumab in prior four weeks, adalimumab in prior two weeks, or tofacitinib in prior one week. 8. pregnant women. 9. clinically significant lactose intolerance 10. any condition, in the opinion of the investigator, that the treatment may pose a health risk to the subject, based on lab study results
phase ii study evaluating strategies of lung surveillance of patients operated of high grade soft tissue sarcoma

Conditions: Soft Tissue Sarcoma; Lung Metastasis

Summary: cancer surveillance has a significant cost and generate anxiety for the patient. it is important to avoid exams that will not modify health support or whose results wont allow to decide.

cancer surveillance has a significant cost and generate anxiety for the patient. it is important to avoid exams that will not modify health support or whose results wont allow to decide. our study will help rationalise surveillance of soft tissue sarcoma and standardize medical practices.

Eligibility criteria:
inclusion criteria: * soft tissue sarcoma, histologically proven * tumor size \> 5 cm (sbr grade 2) or whatever size (sbr grade 3) * complete excision (r0 or r1) * no metastasis (checked by spiral chest ct) * social security covered * informed signed consent exclusion criteria: * bone, visceral, uterine, retroperitoneal sarcoma * gist * other malignant tumor * patients over 70, or for whom thoracic surgery is excluded * pneumoconiosis or known system disease * breast feeding or pregnant woman * patient unable to undergo trail medical follow up for geographic, social or psychological reasons

Keywords: soft tissue sarcoma lung metastasis surveillance
a study to assess the pharmacokinetics, pharmacodynamics of asp1941 in diabetes mellitus patients with renal impairment

Conditions: Type 2 Diabetes Mellitus

Summary: the primary objective of this study is to compare the pharmacokinetics of asp1941 in type 2 diabetes mellitus patients with normal renal function and those with mild or moderate renal impairment.


Eligibility criteria:
inclusion criteria: * type 2 diabetic patients for at least 12 weeks * fasting plasma glucose level of \< 240 mg/dl * body mass index ( bmi )20.0 - 35.0kg/m2 * gfr value based on the japanese gfr estimation equation at screening, of ≥ 30 ml/min/1.73m2 exclusion criteria: * type 1 diabetes mellitus patients * receiving insulin within 12 weeks before screening * diabetic ketoacidosis * dysuria and/or urinary tract infection, genital infection * significant renal, hepatic or cardiovascular diseases * severe gastrointestinal diseases

Keywords: urinary glucose excretion diabetes mellitus asp1941
inhaled nitric oxide and neuroprotection in premature infants

Conditions: Prematurity; Bronchopulmonary Dysplasia; Intraventricular Hemorrhage; Periventricular Leukomalacia

Summary: the purpose of this study is to determine whether inhaled nitric oxide improves the neurological outcome for premature infants.

with the advances in modern neonatal intensive care medicine in the last 20 years, survival of extremely preterm infants weighing less than 1500g (\< 3 lbs, 5 oz) has risen markedly. however, with this increased survival has come a marked increase in the number of infants with serious neurodevelopmental disabilities: premature infants with birth weights less than 1500g who survive to go home are at significant risk for serious neurodevelopmental problems: cognitive and motor delays, blindness, deafness, and cerebral palsy. in a recent randomized, placebo-controlled clinical trial, we assessed whether giving mechanically ventilated preterm infants inhaled nitric oxide gas (ino) for 1 week after birth decreased the incidence of death and chronic lung disease. an unanticipated outcome of that study (schreiber et. al. 2003) and a subsequent study of those infants at 2 years of age (mestan et. al. 2005) was that premature infants treated with inhaled nitric oxide (ino) have improved neurodevelopmental outcomes and physical growth at 2 years corrected age, compared with placebo-treated infants (mestan et. al. 2005). ino therapy, therefore, appears to be a new treatment to protect the premature brain during development outside the womb. the overall goal of this application is understand the efficacy of ino treatment in improving neurodevelopmental outcomes in at-risk premature infants.

Eligibility criteria:
inclusion criteria: * prematurity (birthweight ≤ 1500g, \< 31 weeks gestation) * requiring respiratory support * admitted to the nicu at the university of chicago exclusion criteria: * severe congenital anomalies * genetic syndromes * extremely sick preterm infants requiring very high ventilatory pressures (oi ≥ 20) * premature infants judged by the physician as nonviable

Keywords: prematurity nitric oxide bronchopulmonary dysplasia intraventricular hemorrhage periventricular leukomalacia neurodevelopment