Kornimate/medical-research-clean huggingface dataset:
efficacy of tiotropium in patients of african descent with chronic obstructive pulmonary disease

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the purpose of this study is to look at the benefits of tiotropium, an approved drug for the treatment of bronchospasm associated with copd (chronic obstructive pulmonary disease), in a population of patients with copd who are of african american descent.


Eligibility criteria:
inclusion criteria: * male or female of african descent * 40 years of age or older * diagnosis of copd * history of smoking at least one pack per day for at least 10 years * currently experiencing shortness of breath at least with exertion exclusion criteria: * asthma * recent myocardial infarction or hospitalization for congestive heart failure
ivpca in the management of pain following major intracranial surgery

Conditions: Intracranial Surgery

Summary: this is a prospective, randomized controlled clinical trial to evaluate the efficacy and safety of intravenous patient controlled analgesia (ivpca) in patients following major intracranial surgery (e.g. brain tumors, vascular surgery). we will compare pain, opioid consumption, costs, sedation level, length of hospital stay, patient satisfaction, and complications in patients randomized to receive either pro re nata (prn) or ivpca opioids. we hypothesize that ivpca will be more efficacious than prn opioids in the treatment of postoperative without an increased incidence of adverse effects.


Eligibility criteria:
inclusion criteria: * adults undergoing intracranial surgery exclusion criteria: * patient refusal * pregnancy * aphasia * respiratory failure * allergy/intolerance to fentanyl * opioids use * history of opioid-dependent pain, * patient has been in an investigational drug trial (except chemotherapy) in the month preceding the day of enrollment * mental or physical limitations that would prevent patient assessment or pca use * chronic painful conditions unrelated to the reason for surgery, * clinically significant respiratory disease that required supplemental oxygen or ventilatory support such as use of mechanical ventilation or positive pressure ventilation * patient is unable to initiate a bolus dose of ivpca fentanyl
perinatal handwashing intervention in bangladesh

Conditions: Sepsis; Umbilical Cord; Infection

Summary: the purpose of this study is to determine if an intensive handwashing intervention administered to primiparous women during their pregnancy can increase maternal handwashing with soap at critical times.

in high neonatal mortality settings, about half of neonatal deaths are estimated to occur because of infectious syndromes such as sepsis, acute respiratory infection, neonatal tetanus, and diarrhea. promoting handwashing to mothers in the post-neonatal period has been shown to reduce the risk of pneumonia and diarrhea among infants \> 28 days old but there is little information on the protective effect of handwashing for neonatal health outcomes. the proposed study will assess motivators and barriers to handwashing with soap among new mothers, and develop and test a hand cleansing promotion intervention in rural bangladesh. the handwashing behavior change intervention will include approaches to enhance maternal expectations of being a good nurturer, as well as enhancing maternal self-efficacy to carry out handwashing behavior.

Eligibility criteria:
inclusion criteria: * primiparous women who plan to remain in the study area up to 1 months after birth exclusion criteria: * prior live birth

Keywords: perinatal handwashing neonatal morbidity mortality primiparous health behavior developing countries sepsis omphalitis infectious disease bangladesh
grip test in ventilated icu patients

Conditions: Mechanically Ventilated ICU Patients

Summary: icu patients do experience extubation failure. guidelines rarely include muscle strength criteria. prior work indicates that grip strength is a reliable surrogate for muscle strength. the purpose of the study is to assess the success rate of mechanical ventilation weaning based on the grip test.


Eligibility criteria:
inclusion criteria: * mechanically ventilated icu patients exclusion criteria: * tracheotomy

Keywords: icu muscle strength mechanical ventilation weaning
immunoglobulin m (igm)-anti-myelin-associated-glycoprotein(mag) peripheral neuropathy study

Conditions: Immunoglobin M Anti-myelin-associated-glycoprotein Peripheral Neuropathy

Summary: there is no international consensus regarding how to assess and treat patients with immunoglobulin m (igm)-anti-myelin-associated-glycoprotein (mag) monoclonal gammopathy associated peripheral neuropathy. the purpose of the imagine study-lyon/bicêtre is to prospectively collect standardized clinical data of 25 patients with igm-anti-mag monoclonal gammopathy associated peripheral neuropathy in order to participate in the international imagine study. the main objective is to describe in detail the various clinical subtypes, clinical course, treatment responses, antibody titers of igm-anti-mag monoclonal gammopathy associated peripheral neuropathy using a variety of outcome measures. the obtained observational data will allow the construction of an igm monoclonal gammopathy associated peripheral neuropathy-specific rasch-built overall disability scale (rods) that should fulfill all modern clinimetric requirements, including cross-cultural validity. the coordinating centers for the igm-rods construction will be the maastricht university medical center and university medical center utrecht, both in the netherlands.


Eligibility criteria:
inclusion criteria: * fulfilling the international criteria for the diagnosis immunogloblin m (igm) monoclonal gammopathy, with anti-myelin-associated-glycoprotein (mag) antibodies, and peripheral neuropathy. * age of 18 years or older followed in neuromuscular department of lyon; * informed consent given by the participant exclusion criteria: * concomitant diseases possibly interfering with peripheral nerve and function, as well as physical functioning, such as diabetes, renal insufficiency, (prior) treatment with chemotherapy for diseases other than their immunogloblin m (igm) monoclonal gammopathy associated peripheral neuropathy, history of hereditary neuropathy, vitamin deficiency, connective tissue disorder, hepatitis b and c and human immunodeficiency virus (hiv) infection, alcohol abuse (more than 5 international units(iu)/day); * an active malignancy with poor prognosis, undergoing treatment aside from monoclonal gammopathy associated peripheral neuropathy; * pregnant; * the use of any medication that may cause peripheral nerve function
motivational intervention for physical activity in psychosis

Conditions: Psychotic Disorders

Summary: the purpose of this study is to determine whether motivational intervention is effective in promoting exercise habit in patients with psychosis.

the current study aims to investigate the beneficial effect of motivational intervention in promoting exercise habit in patients with psychosis. outpatients will be recruited and will be randomized to a 12-week motivational intervention program. they will be assessed for their clinical symptoms, cognitive function, physical fitness, and quality of life. all patients will have cognitive function assessments at baseline, 12 weeks after the completion of the program and 6 months. the primary hypothesis of the current study is that motivational intervention can help patient to develop exercise habit in patients with early psychosis.

Eligibility criteria:
inclusion criteria: * diagnosed to have psychotic disorders * cantonese-speaking chinese (to enable cognitive testing) * ability to understand the nature of the study and to give written informed consent exclusion criteria: * severe physical illness (myocardial infarction, hypertension, fracture, spinal problems in which exercise may be contraindicated), and seizure disorders * comorbid substance dependence * unstable psychotic symptoms * known pregnancy * a history of brain trauma or organic brain disease * known history of intellectual disability or special school attendance

Keywords: motivational interviewing exercise
glatiramer acetate (copaxone®) study to follow participants from the first original study for safety and effectiveness

Conditions: Relapsing-Remitting Multiple Sclerosis

Summary: this open-label extension study will evaluate the long-term safety of glatiramer acetate and its effect on the neurologic course of participants with relapsing-remitting multiple sclerosis (rrms). participants have scheduled visits every 3 months to assess glatiramer acetate safety and their multiple sclerosis (ms) status.


Eligibility criteria:
inclusion criteria: * participants must have participated (been randomized) in the copaxone double-blind placebo-controlled study 01-9001 and/or the double-placebo-controlled extension study 01-9001e. * participants could be male or female. women of childbearing potential must have practiced an acceptable method of birth control. * participants must have completed the scheduled termination visit for amendment 12 (month 264). * participants must have signed an approved informed consent form (icf) prior to continuing in the study extension or at the first visit in the extension (month 264 which corresponds to the termination visit of amendment 12). * participants must have been psychologically and physically stable to participate in the trial as judged by the investigator. * all participants enrolled in this extension study were required to have the following study-specific baseline characteristics prior to entry to study 01-9001: a diagnosis of rrms as defined by poser et al 1983, at least 2 clearly identified relapses and remissions in the 2-year period prior to study entry, ambulatory with a kurtzke edss score of 0 to 5.0 inclusive, and a stable neurologic state for at least 30 days prior to study entry. exclusion criteria: * pregnancy or lactation. * medical or psychiatric conditions that affect the participant's ability to give informed consent or complete the study. * inability to self-administer subcutaneous medication or lack of another responsible individual to administer the study preparation daily. * use of approved ms therapies including interferons, experimental ms therapies, or previous immunosuppressive therapy with cytotoxic chemotherapy (azathioprine, cyclophosphamide, or cyclosporine).
persistence of biological treatment and inhibitors of jak kinases in patients with rheumatoid arthritis.

Conditions: Arthritis, Rheumatoid

Summary: one-center observational study aimed at determining the survival of patients with rheumatoid arthritis treated with targeted synthetic disease-modifying drugs (famesd) and biologic disease-modifying drugs (fameb). these patients will be administered a series of medications and a follow-up will be carried out to analyze their evolution.

one-center observational study aimed at determining the survival of patients with rheumatoid arthritis treated with targeted synthetic disease-modifying drugs (famesd) and biologic disease-modifying drugs (fameb). the drugs to be administered to patients are: * jak-type kinase inhibitors. * monoclonal antibodies against tnf. * soluble receptor against tnf. * biosimilar fameb. * rituximab. * abatacept. * drugs that block il6. a follow-up will be carried out at 12, 24, 48, 60, 72 and 84 months from the start of treatment, to analyze how the patient's health improves.

Eligibility criteria:
inclusion criteria: * patients aged ≥18 years. * with a diagnosis of adult rheumatoid arthritis according to the 2010 acr / eular criteria. * who have received at least one of the doses of the study drugs. * in follow-up in the consultations of the ugc of rheumatology of the huvm. * with at least two complete evaluations (baseline and final) of clinical variables. exclusion criteria: * patients where the medical records lack sufficient baseline and final variables to perform the analysis. * patients in whom more than 50% of the variables to be collected are missing in the data collection.
increasing uptake of behavioral weight loss programs among primary care patients

Conditions: Obesity

Summary: this pilot trial will test feasibility and acceptability of a primary care-based intervention that aims to increase the portion of patients who enter evidence-based behavioral weight loss treatment.

this trial is a pilot, pragmatic cluster randomized trial conducted in primary care clinics to determine intervention acceptability and the feasibility of proposed study protocol.

Eligibility criteria:
primary care provider inclusion criteria: * employed by duke pcrc clinic as primary care provider at least ½ fte. * has a primary adult panel * has worked at duke pcrc clinic for at least one year patient inclusion criteria * bmi ≥ 30 kg/m2 as measured at any clinic in previous 12 months. * english speaking * self-report bmi ≥ 29 kg/m2 (to allow for under-reporting) * regular email usage, defined as accessing email 3 or more times per week (on home or work computer or cell phone) * age 18-75 * clinical appointment (well visit or chronic care visit) with enrolled duke provider in 2-6 weeks of record review. * at least one prior appointment with the provider they are scheduled to see at target clinical appt. * has a valid email address in electronic health records. patient exclusion criteria: * in weight loss treatment program in past year * unable to read content on websites without any assistance
pain during injection with botulinum toxin in post-stroke spasticity treatment

Conditions: Post-stroke Spasticity

Summary: the aim of the study was to analyze which step of the procedure of toxin botulinum injection is the most painful between skin break-in, electric stimulation, injection and needle withdrawal.

post-stroke spasticity management by botulinum toxin injections may be limited by pain or discomfort at the injection side. particularly tracking by electrostimulation, but also skin puncture, toxin injection or needle withdrawal may be painful. the objective of this study is to define an individual injection strategy in order to limit pain.

Eligibility criteria:
inclusion criteria: * stroke * severe upper or lower limb spasticity (ashworth score ≥ 2 for at least one muscle) * patients requiring a treatment by botulinum toxin * patients refusing analgesia for injections. exclusion criteria: * severe aphasia (severity subscore of the bdae \<3) * cognitive impairment or psychiatric disease altering the reliability of pain evaluation * patient medically unstable.

Keywords: pain spasticity stroke injection botulinum toxin a
saddle block with it morphine for penile inversion vaginoplasty

Conditions: Pain, Postoperative

Summary: penile inversion vaginoplasty (piv) is a transition-related surgery (trs) that is associated with severe postoperative pain. the optimal pain management strategies for this surgery remain unknown. we hypothesized that the addition of a saddle block with intrathecal morphine would yield clinically important analgesic benefits.

piv is a trs offered for male-to-female transition associated with severe postoperative pain despite contemporary analgesic strategies, including opioid-based multimodal systemic analgesia and local anesthetic-based pudendal nerve block. intrathecal opioids directly target the nociceptors in the spinal cord and can provide potent analgesia for abdominopelvic procedures, including piv, but are associated with important dose-related adverse effects with rostral spread within the cerebrospinal fluid. motor-sparing saddle block using ultra-low dose hyperbaric spinal anesthesia has been successfully implemented as the standard of care for anesthesia in patients undergoing ambulatory perianal procedures at wch. saddle block produces reliable sensory anesthesia and long-lasting analgesia of the perineum ("saddle") as the hyperbaric local anesthetic preferentially blocks the small pain fibers of the sacral nerve roots with gravity when the patient is placed in the seated position. with the aim to directly target the opioid nociceptors in the sacral roots and limit rostral opioid spread (and associated opioid-related adverse effects), we recently began to offer a presurgical saddle block with a low dose of intrathecal morphine (100mcg) to patients undergoing piv at wch with excellent anecdotal results. therefore, we are undertaking the present randomized placebo-controlled study to determine whether or not the addition of a saddle block with it morphine to multimodal systemic analgesia and surgeon-administered pudendal nerve block provides superior analgesia to multimodal systemic analgesia and surgeon-administered pudendal nerve block alone.

Eligibility criteria:
inclusion criteria: * asa i-iii patients * ages 18-70 years * penile inversion vaginoplasty exclusion criteria: * local infection * history of use of over 30mg oxycodone or equivalent per day. * contraindication to a component of multi-modal analgesia * complications or adverse events unrelated to the local anesthetic that precludes evaluation of the primary and secondary outcome measures. * unable to speak or read english. * revision and vulvaplasty surgeries

Keywords: saddle block transition pudendal nerve block gender confirmation surgery penile inversion vaginoplasty
canadian medical assessment of jinarc™ outcomes registry

Conditions: Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Summary: this study is part of the health canada approval requirement for jinarc™ (tolvaptan) and is an observational, non-interventional study (nis) describing the impact of tolvaptan on adpkd-related burden of illness as measured with a set of patient reported outcome (pro) questionnaires. the study is also describing the time to renal replacement therapy (rrt), such as dialysis and transplantation, and the long-term mortality rate and causes (i.e. renal and hepatic), in adpkd patients treated with jinarc™ (tolvaptan)


Eligibility criteria:
inclusion criteria: * adpkd patients ≥18 years old at the time of tolvaptan initiation * the treating physician must have reached the decision to treat the patient with jinarc™ (tolvaptan) as per the canadian product monograph prior to and independently of soliciting the patient to participate in the study * the patient or legal guardian must have signed an informed consent indicating the understanding of the study and allowing the use of their anonymous data for the purposes of the study exclusion criteria: * the patient does not comprehend or refuses to sign the informed consent * the patient has any contraindications to the use of jinarc™ (tolvaptan) as specified in the canadian product monograph * the patient has any condition which, as per the judgment of the treating physician, prohibits them from participating in the study

Keywords: kidney disease adpkd-related outcome quality of life
clinical efficacy of acupuncture in the treatment of temporomandibular disorders (tmd)

Conditions: Temporomandibular Disorders

Summary: this is a single-blinded, randomized controlled trial to explore the effectiveness of acupuncture in the treatment of the pain due to tmd using the latest diagnostic criteria combined with subjective and objective indexes.

this is a single-blinded, randomized controlled clinical trial. a total of 60 participants will be randomly assigned to two different groups. the treatment group will receive acupuncture with real penetration of the needle, while participants in the control group will be treated with the park sham needle. all participants will be given for 4 weeks of treatment and 4 weeks of follow-up.the primary end-point is the reducing in intensity of pain due to tmd, which will be evaluated before treatment, 4 weeks after treatment and follow-up (4 weeks after treatment) by using 0-10 visual analogue score. secondary end points include graded chronic pain scale version 2.0(gcps 2.0),jaw functional limitations scale - 20-item (jfls-20),depression, anxiety and stress scales (dass-21),pittsburgh sleep quality index (psqi),pressure pain threshold (ppt),surface electromyogram(semg).

Eligibility criteria:
inclusion criteria: 1. pain disorders in accordance with diagnostic criteria for temporomandibular disorders (dc/tmd) 2. pain in the jaw, temple, in the ear, in front of ear or headache in the temple at any sides, and pain or headache modified (remission or aggravation) with movement at least 3 months. 3. cooperated in completing the clinical trial successfully without language and mental disorders. exclusion criteria: 1. conditions that result in regional pain in temporomandibular joint. 2. autoimmune diseases that result in regional pain in the temporomandibular joint. 3. mental illness or substance abuse. 4. pregnant women.
phase iiib subcutaneous abatacept monotherapy study

Conditions: Rheumatoid Arthritis (RA)

Summary: to evaluate safety and immunogenicity of abatacept when used with or without methotrexate in the absence of an iv loading dose of abatacept


Eligibility criteria:
inclusion criteria: * clinical diagnosis of rheumatoid arthritis * subjects global disease assessment of greater than equal to 20 mm on a visual analog scale * discontinue all biologics and disease-modifying antirheumatic drugs (dmards) except for methotrexate exclusion criteria: * received treatment with rituximab * subjects who have received treatment with immunoadsorbtion columns (such as prosorba columns), mycophenolate mofetil (cellcept®), cyclosporine a or other calcineurin inhibitors, or d-penicillamine
prognosis factors for the treatment of pectus carinatum with a dynamic compression system

Conditions: Pectus Carinatum

Summary: pectus carinatum is a deformation of the thoracic wall causing an aesthetic prejudice. since 2011, our team uses a dynamic compression system to treat this deformation. it is a harness that the patient wears all day long for an average duration of 1 year, and that remodels the chest by exerting a moderate pressure on it. the local cohort is one of the largest in the world. the few previous publications have shown the validity of this method, but the prognosis factors for success of this innovative treatment are not yet identified.

the principal insvestigator hypothesizes that the success or failure of the treatment depends on several parameters assessable before treatment, such as the patient's age, gender, initial correction pressure, symmetry or not of the deformation.

Eligibility criteria:
inclusion criteria: * patient who received proper information about the study. * patient with clinically diagnosed pectus carinatum. * treated at saint-etienne university hospital using a dynamic compression system. * between october 2011 and january 2020 for the retrospective part, then between january 2020 and january 2022 for the validation cohort. * with more than 6 months of follow-up since the beginning of the treatment. exclusion criteria: -

Keywords: pectus carinatum dynamic compression system