Kornimate/medical-research-clean huggingface dataset:
vigabatrin ph 1 cocaine interaction study

Conditions: Cocaine Addiction

Summary: this is a phase 1 safety/tolerably study to determine if there are clinically significant interactions between oral vigabatrin (gamma vinyl-gamma-amino butyric acid; vgb) concurrent with intravenous (iv) cocaine infusions.

study design: this is a randomized, double-blind, placebo-controlled, parallel group study of the effects of vgb compared to placebo control on the physiological and subjective effects of iv infusions of cocaine (cocaine experienced volunteers). subjects will be randomized within each clinical site to one of four groups (placebo control or one of three doses of vgb twice daily).during vgb steady state dosing, subjects will receive double-blind infusions of saline and cocaine. subjects will be asked to return for follow-up approximately 7 and 14 days after the day of clinic discharge. study duration: the maximum duration is 56 days, including 14 inpatient days of assessments and investigational products administration, and two follow-up visits after clinic discharge. sample size: twenty-four subjects will be randomized to one of three doses of vigabatrin or placebo. population: volunteer, cocaine-experienced, non-treatment seeking cocaine users, 18 to 45 years of age.

Eligibility criteria:
inclusion criteria: * be between 18 and 45 years of age, inclusive * currently be a non-treatment seeking cocaine user as confirmed by a positive urine test for cocaine * able to provide written informed consent * a negative pregnancy test within 72 hours prior to receiving the first infusion of cocaine exclusion criteria: please contact site for more information.

Keywords: cocaine addiction vigabatrin ovation pharmaceuticals cocaine cocaine related disorders behavior addictive mental disorders therapeutic uses physiologic effects of drugs disorder of environmental origin central nervous system stimulants central nervous system agents pharmacological actions substance related disorders
a study to test 2 doses of the hrv vaccine given with or without opv in healthy infants in bangladesh

Conditions: Infections, Rotavirus

Summary: the main objective of this study is to provide immunogenicity data for gsk biologicals' hrv vaccine when co-administered with opv or when given alone (hrv vaccine dose given 15 days after the opv dose).

"the study will have four groups: group hrv + opv, group hrv alone, group placebo + opv and group placebo alone. two-dose immunisation will be administered in healthy infants at approximately 12 and 16 weeks of age. immunogenicity, reactogenicity and safety relative to the placebo will also be evaluated. treatment allocation: randomized (2:2:1:1). routine epi vaccines should be administered during the study following the epi recommendation in bangladesh."

Eligibility criteria:
inclusion criteria: * healthy infants aged 6 weeks±1 at first study vaccination. exclusion criteria: * malnutrition, no history of rotavirus gastroenteritis, allergic disease or chronic gastrointestinal disease, not received protocol-prohibited treatment.
effectiveness of the neural mobilization on upper limb functionality in patients with acquired brain injury

Conditions: Hemiplegia and Hemiparesis; Acquired Brain Injury

Summary: the main objective: to determine changes in physiological and structural properties of upper limb muscles with spasticity in patients with acquired brain injury after applying neural mobilization improving their functional performance, their participation in society and quality of life. hypothesis: peripheral nerve mobilizations performed with neurodynamic techniques in upper limb in patients with acquired brain injury, generate changes at structural and physiological level, favoring the performance of daily life activities and improving the quality of life.

randomized clinical trial with blinding of the subject, the evaluator and the person analyzing the data. in the experimental group will be performed neural mobilitazion technique, while in the sham a technique to mimic neurodynamic. the assessment will be made by a single evaluator.

Eligibility criteria:
inclusion criteria: * diagnosis of acquired brain injury (hemiplegia-hemiparesis) * ages between 25 and 50 years exclusion criteria: * unable to understand and respond to verbal instructions * absence of voluntary movement in the upper limb * take medicine for spasticity * botulinum toxin infiltration in the last 6 months

Keywords: acquired brain injury hemiplegia neural mobilization upper limb
suction versus water seal for initial treatment of traumatic pneumothorax trial

Conditions: Pneumothorax; Trauma

Summary: the goal of this clinical trial is to compare the effect of placing chest tubes to water seal versus suction initially, in patients with traumatic pneumothoraces, on overall chest tube duration. the main question it aims to answer is: * does placing chest tubes to water seal initially results in a shorter chest tube duration, without an increase in complications? alternating each month, patients' chest tubes will either be placed to water seal or to suction initially. all other management decisions related to the chest tube will be left to the providers.


Eligibility criteria:
inclusion criteria: * admitted to the trauma surgery service * pneumothorax requiring a chest tube exclusion criteria: * less than 18 years olf * pregnant * prisoner * greater than 300cc of hemothorax on ct * chest tube placed prior to ct scan

Keywords: traumatic trauma pneumothorax chest tube duration
robotic upper-limb neurorehabilitation in chronic stroke patient

Conditions: Stroke

Summary: we have established the feasibility and effectiveness of robot-aided rehabilitation in stroke patients using a robot for neurological rehabilitation designed and built by mit. results of a pilot study of 20 patients were promising and showed that robot therapy is safe, tolerated by patients and produces a significant, measurable benefit. we propose to test that the robotic upper extremity trainer is an acceptable cost effective adjunct to standard occupational therapy for patients with dysfunction of the shoulder and elbow due to hemiparetic stroke in a va rehabilitation program.


Eligibility criteria:
inclusion criteria: * chronic stroke * manual muscle score of grade 3 or lower in at least one muscle of the affected arm exclusion criteria: * acute stroke * contracture or orthopedic problems limiting the movement of the affected arm * visual deficit such that the participant cannot see the test pattern on the robot trainer * serious complicating medical illness * botox treatment to the involved arm within three months of enrollment

Keywords: robot stroke upper extremity
gastroesophageal reflux disease diagnostic trial

Conditions: Gastroesophageal Reflux Disease

Summary: gastroesophageal reflux disease (gerd) is a very common condition in clinical practice. in china, gerd affects nearly 150 million patients, whose quality of life are seriously impacted. currently, the diagnosis of gerd primarily depends on the results of 24h reflux monitoring. however, such examination is under a quite low acceptability. as a result, a large number of patients were not diagnosed timely and accurately, and serious social problems are induced, such as drug abuse of proton pump inhibitor. our team has previously developed a novel device for esophageal cell enrichment and established an internationally pioneering method of cytological screening for esophageal cancer based on cutting-edge deep learning technology. this project aims to develop multiple deep learning algorithms and establish an innovative method for diagnosis of gred, using the novel esophageal cell enrichment technology. the research includes: 1) constructing deep learning algorithms for automatic esophageal inflammatory cells recognition and classification; 2) mining and extracting the key features of esophageal squamous cells and inflammatory cells under physician-ai interaction; 3) establishing a prediction model for gerd by integrating digital features of squamous cells and inflammatory cells and building a cloud-based automatic diagnosis system; 4) investigating the immuno-infiltration atlas of gerd and its diagnostic value based on the enriched inflammatory cells. the ultimate goal is to solve current clinical problems and realize rapid, convenient, and accurate diagnosis of gerd.


Eligibility criteria:
inclusion criteria: 1. ≥18 years and ≤85 years, male or female; 2. a visit was made for symptoms such as persistent reflux, heartburn, bloating, early satiety, and belching; 3. patients volunteered to participate in the clinical trial, signed an informed consent form, and were able to cooperate with clinical follow-up. exclusion criteria: 1. history of esophageal surgery; 2. presence of dysphagia, esophagogastric fundal varices, or esophageal stenosis; 3. presence of coagulation disorders or taking anticoagulant or antiplatelet drugs; 4. those with a life expectancy of less than 5 years; 5. persons with mental anomalies who are incapable of behavioral autonomy; 6. other conditions that, in the judgment of the physician, preclude participation in the trial.
brain imaging after non-traumatic intracranial hemorrhage (savebrainpwi)

Conditions: Aneurysm, Ruptured; Aneurysmal Subarachnoid Hemorrhage; Arteriovenous Malformations; Intracranial Aneurysm; Intracranial Hemorrhages

Summary: the study is an observational prospective evaluation of an approved and unchanged clinical management, evaluating different diagnosis methods to assess brain perfusion in patients with an aneurysmal or avm-related intracranial hemorrhage

the study is a prospective description and evaluation of an approved and unchanged clinical management, evaluating already used different diagnosis methods to assess brain perfusion in patients with atraumatic (aneurysmal, avm-related, unknown cause) intracranial hemorrhage.

Eligibility criteria:
i. inclusion criteria 1. age ≥ 18 years 2. non-traumatic intracranial hemorrhage (subarachnoid hemorrhage secondary to a ruptured aneurysm or avm, unknown cause, per procedural bleed) 3. in case of ruptured aneurysm, avm or other etiology : need to be secured with surgical clipping or endovascular intervention if judged possible 4. no contra-indication to perfusion imaging 5. subject or legal representative is able and willing to give informed consent. ii. exclusion criteria 1. traumatic intracranial hemorrhage 2. contra-indication to imaging or patient's refusal.
a research study looking at how oral semaglutide works in people with type 2 diabetes in spain, as part of local clinical practice

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of the study is to collect information on participant's blood sugar levels, body weight, how satisfied participant is with the treatment, and how participant takes his/her diabetes medicines. participant will get rybelsus® as prescribed by study doctor. the study will last for about 8-10 months. participants will be asked to complete a questionnaire about how they take their rybelsus® tablets. participants will complete this questionnaire during their normally scheduled visit with the study doctor.


Eligibility criteria:
inclusion criteria: * signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol) * diagnosed with type 2 diabetes mellitus * the decision to initiate treatment with commercially available oral semaglutide has been made by the patient/legally acceptable representative (lar) and the treating physician based on local label before and independently from the decision to include the patient in this study * male or female, age above or equal to 18 years at the time of signing informed consent * available hba1c value less than or equal to 90 days prior to the 'informed consent and treatment initiation visit' (v1) or hba1c measurement taken in relation with the 'informed consent and treatment initiation visit' (v1) if in line with local clinical practice * treatment naive to injectable glucose-lowering drug(s). an exception is short-term insulin treatment for acute illness for a total of less than 14 days exclusion criteria: * previous participation in this study. participation is defined as having given informed consent in this study * treatment with any investigational drug within 30 days prior to enrolment into the study * mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
a randomized, sham device controlled, single blinded trial of portable transcutaneous electrical nerve stimulation and heat therapy machine in women with dysmenorrhea

Conditions: Dysmenorrhea

Summary: the hypothesis is that a transcutaneous electrical nerve stimulation and heat therapy machine could reduce dysmenorrhea in women with primary or secondary dysmenorrhea.

inclusion/exclusion: described in eligibility section. outcome measures: change of vas score before and after use of tens and heat therapy machine.

Eligibility criteria:
inclusion * age\>19 * premenopausal * moderate or severe dysmenorrhea, mainly in low abdomen area exclusion * pregnant * surgery history on lower abdomen * recent history of cancer * tens device use is contraindicated * ibuprofen use is contraindicated

Keywords: dysmenorrhea transcutaneous electrical nerve stimulation heat therapy
schlaganfallkonsortium rhein-neckar (stroke consortium rhine-neckar)

Conditions: Ischemic Stroke; Vascular Diseases; Cardiovascular Diseases

Summary: fast is an investigator-initiated multicenter study embedded in a german multistate acute stroke network. the main objectives of the fast study are to improve outcomes and quality of care for stroke patients, to quantify the number of patients in need of thrombectomy within an integrated stroke network, to study the best way of delivering and performing thrombectomy and to investigate the best model of pre-hospital selection and referral for stroke patients.

since 2015, mechanical thrombectomy in patients with large vessel occlusion has become an evidence based highly efficient treatment. in contrast to thrombolysis, thrombectomy can only be delivered by qualified interventionalists at comprehensive stroke centers. thus, the implementation of thrombectomy into clinical practice remains a challenge. the investigators aim to establish a population based approach within a patient registry in a federal state overarching regional stroke network covering over 4 million inhabitants and integrating approximately 30 hospitals with different levels of expertise. the registry will include data from all acute ischemic stroke patients - approx. 12.000 patients p.a - within the network. the investigators plan to establish a central multi-interface platform integrating clinical data from the prehospital, intrahospital and rehabilitation phase including mandatory quality assurance, neurological and neuroradiological treatment and outcome data. the registry will allow addressing important questions, such as how many patients are candidates for thrombectomy, how many resources are needed to meet that demand and how treatment procedures and times can be improved. the overarching aim is to deliver high quality stroke care to every patient in the region.

Eligibility criteria:
inclusion criteria: * 18 years or older * patients with ischemic stroke who are admitted to one of the hospitals of the stroke consortium rhein-neckar (fast) * informed consent exclusion criteria: * no informed consent

Keywords: stroke network acute stroke care emergency medical services integrated care
residual sars-cov-2 presence in the respiratory tract and lung parenchyma (after sars-cov-2 infection or covid-19)

Conditions: Covid19

Summary: the aim of this study is to confirm or rule out the residual presence and viability of sars- cov-2 in the respiratory tract and lung parenchyma of patients previously infected with sars-cov-2. presence and viability of sars-cov-2 in lung tissue will be assessed with reverse transcriptase-polymerase chain reaction (pcr) and viral culture. the histological location of residual sars-cov-2 will be determined with fluorescence immunohistochemistry and single molecule fluorescence in situ hybridization, targeting viral proteins and rna respectively.

the investigators will collect residuary lung tissue after medically indicated pulmonary resections at the thoracic surgery department of university hospitals leuven. more specifically the investigators will collect lung tissue from patients that had earlier pcr proven covid-19 and/or serum anti-sars-cov-2 antibodies. furthermore, for negative control of the methodology the investigators will also collect lung tissue from patients that have no signs for earlier sars-cov-2 infection.

Eligibility criteria:
inclusion criteria: * patient requires medically indicated pulmonary resection * informed consent exclusion criteria: * active sars-cov-2 infection/covid-19 * no informed consent
co-existent obstructive sleep apnea (osa) and obesity: finding non-exercise activity thermogenesis (neat) targets for intervention

Conditions: Childhood Obesity; Childhood Obstructive Sleep Apnea

Summary: rationale: obesity is an increasing childhood epidemic in canada. obstructive sleep apnea (osa) is a complication of obesity which causes cardiovascular disease, reduced quality of life, and premature death. while the complex interactions between obesity and osa are not entirely clear, we hypothesize that these conditions may compound each other by: 1. decreasing physical activity and total energy expenditure by reducing both non-exercise physical pursuits (neat- non-exercise activity thermogenesis) and purposeful physical activity. 2. alterations in the secretion of appetite-controlling hormones, which may lead to increases in energy intake. objective: to determine whether the presence of both obesity and osa in children is associated with a decrease in physical activity and alterations in appetite-regulating hormones greater than those seen in either condition alone or compared to controls. methods: comparison of children 10-17 years with obesity and osa, obesity alone, osa alone and neither condition, for the following outcomes: (1) neat (kcal/day) (2) physical activity behavior, appetite regulating hormone profile and self-report appetite assessment. unique aspects: this study combines expertise in sleep medicine, exercise physiology and obesity. conclusions from this study will better characterize this high-risk clinical population so that innovative strategies targeting improvements in lifestyle behaviors can be developed.


Eligibility criteria:
inclusion criteria: * age 10-17 years * coming for polysomnography at the children's hospital of eastern ontario exclusion criteria: * children receiving treatment for osa with cpap (continuous positive airway pressure) or bi-level therapy * craniofacial abnormalities * genetic syndromes * neuromuscular disease * tracheostomy * medications that may affect appetite or energy balance (systemic corticosteroids)

Keywords: sleep overweight physical activity appetite neat
tissue collection for understanding intervertebral disc degeneration and back pain

Conditions: Intervertebral Disc Degeneration; Back Pain

Summary: the purpose of the research is to collect and examine spinal disc and ligament tissues to see if there are any biological markers that can be correlated with mri images to help us learn more about causes of back pain. spinal discs are the pillow-like cushions between the bones of the spine. they act as shock-absorbers for the spine. spinal ligaments support the disc structure during movement.

degenerative disc disease is the most prevalent indication for spine surgery and the major source of back pain in afflicted patients. age related degeneration of the intervertebral discs is not the exception, but the rule. degenerative changes are associated with weakening of the disc and hypertrophy of the ligamentum flavum in the spine. the aim of this study is to determine if there are any local or systemic biomarkers that correlate with the severity of degeneration as indicated by radiological examination. to date, imaging (xray, mri, ct scans) are the most widely used diagnostic tools for identifying degenerated discs. physical changes in the disc are also associated with increased secretion and expression of inflammatory mediators in the tissue. the investigators are interested in measuring both gene and protein level changes of inflammatory mediators in degenerated discs in order to correlate these levels with imaging based indicators of degeneration. protein level changes in the disc and ligamentum flavum have yet to be correlated with mri-derived disc modic changes classification system. the investigators hypothesize that as the image characteristics of advancing degenerative disease increase, a corresponding change will be present in the secretion (or expression) of specific markers related to inflammatory processes in the disc. cytokines found to be upregulated in disc tissue or ligamentum flavum will also be measured in patient's serum levels to begin developing a systemic diagnostic method for detecting disc degeneration.

Eligibility criteria:
inclusion criteria: 1. 18 years of age or older 2. patients requiring surgery in lumbar spine region (l1-l2 to l5-s1) 3. potential procedures: spinal stenosis, discectomy, laminectomy, lumbar fusion, disc herniation. exclusion criteria: 1. patients requiring revision surgery in lumbar spine 2. patients who have had a discography procedure performed at the same disc level as the one being operated on. 3. known inflammatory conditions- rheumatoid arthritis, osteomyelitis, discitis, gout, ankylosing spondylitis, and other infections. 4. oncologic conditions- any history of cancer of any type.

Keywords: intervertebral disc degeneration back pain spine surgery