Kornimate/medical-research-clean huggingface dataset:
magnesium sulphate injection in treatment of myofascial trigger points

Conditions: Trigger Point Pain, Myofascial

Summary: this is a prospective, single- center, randomized (1:1) clinical trial comparing the effectiveness of magnesium sulphate injections in treatment of myofascial trigger points in the masseter muscle versus the saline injection.

the proposal presents the magnesium sulphate (mgso4) as a possible injection treatment for trps. the mgso4 prevents the release of pre-synaptic acetylcholine from neuromuscular and sympathetic junctions that could explain the ability of the mgso4 to relax the muscle and reduce pain specific aim: evaluate the effectiveness of magnesium sulphate injections in treatment of myofascial trigger points in the masseter muscle versus the saline injection. hypothesis: the injection of masseter muscle trigger points with magnesium sulphate is more effective than saline injection in pain relief.

Eligibility criteria:
inclusion criteria: * definite diagnosis of myofascial pain with a referral, based on the dc/tmd criteria * the presence of one or more trigger points in the unilateral or bilateral masseter muscle * no history of any invasive procedures in the related masseter muscle. exclusion criteria: * factors that can cause pain in the orofacial region other than mtps (decayed tooth, tmj internal disorder). * any systemic disease that possibly affects the masticatory system such as rheumatoid arthritis and epilepsy * pregnancy and lactation.

Keywords: trigger point masseter muscle myofascial pain magnesium sulphate
study to assess switching to b/f/taf in treatment experienced people with hiv who are at least 65 years of age

Conditions: HIV-1-infection

Summary: to assess patient reported treatment satisfaction and medication tolerability in virologically suppressed hiv-1 infected adults who are at least 65 years of age who switch to a bictegravir/emtricitabine/tenofovir alafenamide (b/f/taf) fixed-dose combination regimen.


Eligibility criteria:
key inclusion criteria: 1. be at least 65 years of age at the time of signing the informed consent form. 2. be currently receiving an antiretroviral regimen for ≥ 3 months prior to the screening visit. 3. have documented plasma hiv-1 rna \< 50 copies/ml for a minimum of 3 months on current art regimen. 4. have a plasma hiv-1 rna \< 50 copies/ml at screening visit. key exclusion criteria: 1. have resistance to tenofovir (k65r/e/n, ≥3 thymidine analogue mutations or t69-insertions), primary insti-resistance, or a history of failure on an insti-based regimen. 2. have been treated with b/f/taf 3. participants with crcl \<30 ml/min 4. known or suspected severe hepatic impairment (child-pugh class c)

Keywords: hiv qol elderly
a mass balance study of [14c]-nanatinostat and relative bioavailability study of nanatinostat in patients with advanced cancers

Conditions: Advanced Cancer

Summary: this study will determine how nanatinostat is absorbed, modified, and removed from the body (part a), the amount of nanatinostat that becomes available to the body (part b), and will evaluate the safety and tolerability of nanatinostat (part c) in patients with advanced cancers.

this is a phase 1, open-label, 3-part study evaluating the mass balance, pharmacokinetics, and metabolism of nanatinostat following a single oral dose of \[14c\]-nanatinostat for part a, evaluating relative bioavailability of nanatinostat mesylate and nanatinostat (free base) tablets after coadministration with valganciclovir in patients with advanced stage cancers for part b, and evaluating the safety and antitumor activity of nanatinostat for part c. the study was terminated prematurely and did not reach its target enrollment.

Eligibility criteria:
key inclusion criteria: * have histologically confirmed advanced stage cancers (excluding gastrointestinal tumors), have received standard therapies appropriate for their tumor type and stage with disease progression on or after the most recent treatment, and have no available treatment with curative intent. * eastern cooperative oncology group performance status of ≤2 at screening. * body mass index ≥18.5 but ≤30.0 kg/m2 at screening. * adequate bone marrow, liver, and kidney function. key exclusion criteria: * presence of active central nervous system and/or leptomeningeal disease. * anticancer therapy including chemotherapy, radiotherapy, endocrine therapy, immunotherapy, or use of other investigational agents within 4 weeks before study entry. * inability to take or tolerate oral medication. * any gastrointestinal, liver, or kidney condition that may affect drug absorption and metabolism. * active infection requiring systemic therapy. * has received radiolabeled material \<12 months (excluding that required for imaging) prior to study entry.
safety and efficacy study for a new antiviral drug to treat genital herpes type 2

Conditions: HSV-2

Summary: the aim of the study is to find out whether aic316 is safe and efficacious for the prevention of reactivation of genital herpes


Eligibility criteria:
inclusion criteria: * adult, immunocompetent men and women in good health of any ethnic group * history of recurrent episodes of genital herpes for at least 12 months * seropositive for herpes simplex virus hsv type 2 * body mass index (bmi) between 18 and 35 kg/m2 exclusion criteria: * present episode of genital herpes * intake of systemic drug against hsv or any topical application against hsv within 7 days before randomization for the trial * intake of systemic corticosteroids, other immunomodulating agents or any investigational agent within 3 months before randomization for the trial * positive results in any of the virology tests for human immunodeficiency virus antibody (hiv-ab), hepatitis c antibody (hcv-ab), hepatitis b surface antigen (hbsag) or hepatitis b core antibody (hbc-ab)
prevalence of vitreomacular adhesion in patients 40 years and older

Conditions: Vitreomacular Adhesion

Summary: the purpose of this study is to evaluate the prevalence of vitreomacular adhesion (vma) in patients 40 years and older using spectral domain optical coherence tomography.

as a function of age, liquefaction of the vitreous body results in separation of the vitreous cavity from the retina. this posterior vitreous separation may be incomplete, leading to areas of residual vma. these adhesions can result in maculopathies such as vitreomacular traction syndrome, macular hole, epiretinal membrane, cystoid macular edema, diabetic macular edema, neovascularization in diabetic retinopathy and retinal vein occlusion, exudative age-related macular degeneration, and myopic traction maculopathy. vma may lead to pathological sequelae due to the static and dynamic anteroposterior tractional forces to the surface of the macula. the resultant complication will depend on the size and strength of the traction, with smaller areas of adhesion leading to greater traction. identifying the prevalence of vitreomacular adhesion and its associated complications will yield valuable, new epidemiologic data, leading to improved diagnosis and management of patients with this condition. the prevalence of vitreomacular adhesion in specific age groups has not been investigated.

Eligibility criteria:
inclusion criteria: 40 years and older * clear media exclusion criteria: less than 40 years of age * prior history of vitreoretinal surgery or pharmacotherapy with intravitreal injection * dense media opacity

Keywords: posterior vitreous detachment vitreomacular traction vitreous
gut microbiota reconstruction in the treatment of irritable bowel syndrome with predominant diarrhea

Conditions: Irritable Bowel Syndrome

Summary: the purpose of this study is to evaluate the efficacy as well as safety of rifaximin combined fecal microbiota transplantation(gut microbiota reconstruction) in the treatment of ibs-d.

in this prospective study, there is only one group with no placebo/blank control. all qualified ibs-d patients could be admitted to hospital for at least one time of combing therapy (taking rifaximin for 3 days and then receiving fecal microbiota transplantation) and follow-up until 6 months after the first treatment.

Eligibility criteria:
inclusion criteria: * age between 18 and 65, no gender limitation; * had received a diagnosis of ibs-d (as assessed according to the rome iii diagnosis criteria of ibs) and had undergone a colonoscopic examination within the previous 2 years with no organic lesions observed; * has current symptoms of ibs-d: ①abdominal pain (at least 2 days in a week with no limitation of severity); ②stool consistency (rated the consistency of their stools of bristol types 6/7 at least once a day and at least 2 days in a week); * can do follow-up at required time points and signed written informed consent before the study. exclusion criteria: * allergic to rifaximin; * taking alosetron, tegaserod, lubiprostone, warfarin, or antipsychotic, antispasmodic, antidiarrheal, probiotic, or narcotic drugs within the previous 1 month; * had infective diarrhea history or had taken antibiotics within the previous 14 days; * patients with a history of inflammatory bowel disease ; * previous abdominal surgery (other than cholecystectomy or appendectomy); * human immunodeficiency virus infection or other immunodeficiency conditions such as congenital immunodeficiency or currently taking immune-suppression drugs; * unstable diabetes, hypertension, thyroid disease, etc; * accompanied malignant tumor or severe heart/lung/renal/hepatic/brain/blood diseases; * accompanied severe neural/psychotic diseases such as epilepsy, depression, mania, schizophrenia, etc; * other conditions that doctor thought not suitable for the study.

Keywords: rifaximin fecal microbiota transplantation gut microbiota
blood pressure effects of nebivolol versus lisinopril in new onset or worsening hypertension induced by bevacizumab

Conditions: Hypertension

Summary: the purpose of this study is to directly compare the blood pressure (hypertension) reduction effects of lisinopril and nebivolol in patients who develop new onset or worsening hypertension while treated with bevacizumab.


Eligibility criteria:
inclusion criteria: * patients currently treated at the university of mississippi medical center oncology clinic * patient is being treated with bevacizumab either alone or in combination with other agents for cancer * patient blood pressure is \>140 mmhg (systolic) or \> 90 mmhg (diastolic), either treated or untreated with medications for hypertension * patients may be currently on medications for hypertension (other than beta blocker, acei, or arb); these will be continued at the same dose throughout the study * patients should be \> 18 years of age * patients receiving bevacizumab therapy approximately every 2 weeks exclusion criteria: * history of acei or arb induced angioedema or idiopathic/hereditary angioedema * patient currently treated with a beta blocker, acei, or arb or have a history of intolerance to a medication in any of these classes * hyperkalemia, defined as a potassium value of \>5 meq/l * pregnancy or breastfeeding * severe renal impairment (egfr \<30 ml/min) * moderate hepatic impairment as identified by physician * currently taking cyp2d6 inducers (rifampin, carbamazepine or dexamethasone) or inhibitors (bupropion, fluoxetine, paroxetine, duloxetine, etc.) * history of clinically significant ekg abnormality which would contraindicate beta blocker use * recent stroke (\<6 months) * recent myocardial infarction (\<6 months) * congestive heart failure * severe asthma or copd * diagnosed obstructive sleep apnea

Keywords: hypertension as a result of bevacizumab therapy
sleep after pediatric critical illness

Conditions: Pediatric; Critical Illness; Sleep Disturbance

Summary: this study tests a pilot educational sleep intervention for children after critical care hospitalization.

the investigators are conducting a before-after study evaluating an educational intervention delivered during hospitalization on sleep outcomes 1month after critical care hospitalization for children aged 6 to 18 years.

Eligibility criteria:
inclusion criteria: * age 6 years to 18 years inclusive * inpatient consult to pediatric critical care and neurotrauma recovery program exclusion criteria: * abusive trauma * child protective services custody * prisoners * pregnancy * non-english speaking caregivers
feasibility of a well-being promotion self-management intervention in post-covid-19 patients

Conditions: Post-COVID-19 Syndrome

Summary: a training comprised of positive psychological interventions set out to improve mental well-being was developed for post-covid-19 patients. this study aims to evaluate the feasibility and acceptability of this training.

research has shown that the quality of life and well-being of post-covid-19 patients are often reduced, and that many patients struggle with self-management tasks, such as symptom management and emotion regulation. training in self-management skills related to positive emotions, such as positive affect savouring, might help with these and can be provided prior to or in parallel with usual treatment. this study aims to investigate whether a training to improve the mental well-being is feasible and acceptable for people with post-covid-19 syndrome. the training to be provided is based on previously evaluated sets of positive psychological interventions ('this is your life' and 'training in positivity') and adapted to a post-covid-19 population. as a secondary aim, preliminary effectiveness will be evaluated.

Eligibility criteria:
inclusion criteria: * strongly suspected or clinically confirmed post-covid-19 syndrome, i.e. confirmed symptoms persisting for at least 3 months after strongly suspected or confirmed sars-cov-2 infection * ages ≥18 years * dutch proficiency * provided informed consent exclusion criteria: * recent (\<5 years) diagnosis of a mood disorder, anxiety disorder or other psychiatric condition

Keywords: mental well-being positive psychological intervention self-management long covid
a safety & efficacy study of bgs649 in women with refractory endometriosis

Conditions: Pelvic Pain Associated With Refractory Endometriosis

Summary: the purpose of this study is to determine efficacy, safety, tolerability and pharmacokinetics of multiple doses of bgs649 with concurrent daily administration of combined oral contraception in patients with refractory endometriosis


Eligibility criteria:
inclusion criteria: * must have surgical diagnosis of endometriosis est. w/in 5 years before screening. subjects must have self reported moderate to severe pelvic pain at screening to be confirmed during the run-in-phase * subjects with moderate to severe pelvic pain who were refractory to surgery (persistent or recurrent pelvic pain within 24 months after any therapeutic surgery) and at least two hormonal therapies from two different classes, including one approved hormonal therapy exclusion criteria: * subjects who have undergone hysterectomy or bilateral oophorectomy. * surgical treatment of endometriosis within 3 months before screening. * subjects who are pregnant or who were pregnant within 3 months of visit one. * subjects who are nursing or lactating * subjects who are tobacco smokers. other protocol-defined inclusion/exclusion criteria may apply

Keywords: menstrual pain refractory endometriosis pelvic pain
polyprenols (ropren) in acute coronary syndrome

Conditions: Acute Coronary Syndrome

Summary: the aim of this study is to determine efficacy and safety of polyprenols (ropren) using in patients with acute coronary syndrome

this study is randomized double blind placebo controlled. patients with acute coronary syndrome taking standard therapy including atorvastatin 40 mg/day were randomized into 2 groups: group 1 takes ropren 8 drops 3 times per day for 3 week, then 5 drops 3 times per day for 5 weeks; group 2 take placebo in the same dose regimen. the hepatoprotective, hypolipidemic, antiinflammatory, cognitive, antidepression functions evaluates after one and two - month therapy

Eligibility criteria:
inclusion criteria: * acute coronary syndrome * informed consent received exclusion criteria: * patient's incapacity to take accurately drops by oneself * cardiogenic shock

Keywords: acute coronary syndrome polyprenols cholesterol
btt-1023 in rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: patients with adult-onset rheumatoid arthritis will be enrolled. they will be dosed with repeated intravenous doses of btt-1023 or placebo. during the trial, the safety of the treatments and the pharmacokinetics of btt-1023 will be assessed. the patient allocation to treatment groups will occur at random, and the actual treatment will not be revealed to the investigator or to the patient during the trial.


Eligibility criteria:
inclusion criteria: * adult-onset rheumatoid arthritis exclusion criteria: -

Keywords: rheumatoid arthritis safety
abuse liability of controlled-release oxycodone formulations

Conditions: Substance-Related Disorders

Summary: the objective of this study is to examine the abuse liability of a single 40mg dose of 2 controlled release oxycodone formulations (apo-oxycodone cr® and oxyneo®) in non-dependent recreational opioid users by assessing the self-reported acute effects of the drugs and taking blood samples to measure drug concentrations. the investigators think there may be differences in how well these drugs are liked when swallowed whole due to differences in how the products are formulated.

this is a single-center, single-dose, double-blind, placebo-controlled, randomized, crossover, abuse liability study conducted in healthy subjects who are non-dependent recreational opioid users. the study consists of 3 study days during which each subject will take one tablet of either 40mg oxyneo®, 40mg apo-oxycodone cr®, or placebo. the participants will be assessed for both pharmacokinetic and pharmacodynamic outcomes.

Eligibility criteria:
inclusion criteria: * healthy male and female subjects 18 to 50 years of age * willing and capable to give written informed consent * subjects must have used opioids recreationally to achieve a "high" on at least five occasions in the 12 months before screening and at least once in the 90 days before screening according to self-report * females of childbearing potential have to use a medically acceptable form of birth control and have a negative pregnancy test * pass medical assessment, which includes physical examination, assessment of medical history, vital signs, blood work, and urine toxicology screen * willing to abstain from alcohol 12 hours before and during the study days exclusion criteria: * current or past axis i psychiatric illness (including current drug dependence or past opioid dependence, except nicotine dependence) * current hepatic disease or renal failure * pregnancy or lactation in women * current medication that is known to interact with opioids * known contraindications or hypersensitivity to opioids * current opioid therapy * chronic pain disorder requiring regular medication

Keywords: substance-related disorders prescription drug misuse analgesics, opioid oxycodone randomized controlled trial cross-over studies placebo healthy volunteers
efficacy of intra-articular nsaid versus corticosteroid in the treatment of shoulder and knee conditions: a randomized, double-blind, prospective study

Conditions: Knee Arthritis; Shoulder Arthritis; Shoulder Impingement; Meniscus Lesion; Rotator Cuff Tear; Rotator Cuff Tear Arthropathy

Summary: the proposed study will compare the efficacy of triamcinolone versus ketorolac for intra-articular injection of the knee and shoulder

this study will be a randomized prospective study comparing triamcinolone to ketorolac for injections in the knee and shoulder for a variety of orthopedic conditions. the investigators will monitor pain relief, length of pain relief, cost, and patient satisfaction after the injections

Eligibility criteria:
inclusion criteria: * knee and shoulder arthritis * shoulder impingement * rotator cuff tear exclusion criteria: * chronic pain management * allergy to nsaids or steroids * prior surgery * kidney disease that would preclude nsaid administration
feasibility and clinically application of magnetic resonance fingerprinting

Conditions: Neurofibromatosis Type 1; Brain Tumor; Glioma

Summary: this study will look at the feasibility of using magnetic resonance fingerprinting (mrf) in children, adolescents and young adults (aya) with and without brain tumors. this study will also look at subjects with and without neurofibromatosis type 1(nf1), a genetic disorder that affects the growth of nervous system cells. further, it will explore potential ways of using of mrf signal measurements in children, adolescents, and young adults with brain tumors, including tissue characterization, looking at whether the treatment was effective, and finding metastasized tumors of unknown origin (occult tumors). to explore the feasibility and potential applications of mrf, this study will recruit up to 80 subjects but will stop once 10 subjects have usable data in each of six groups.

specific aim 1: demonstrate the feasibility of magnetic resonance fingerprinting (mrf) in children, adolescents and young adults (aya) with and without brain tumors. specific aim 2: characterize the mrf signature of low-grade gliomas specific aim 3: determine whether mrf can identify occult tumor in subjects with low-grade glioma. specific aim 4: determine whether mrf can identify treatment effects in low-grade gliomas. specific aim 5: explore whether common brain tumors can be differentiated by comparing pre-operative mrf signature with pathologic diagnosis. outline: this study will examine the feasibility of mrf in children and aya and determine whether quantitative measures of t1 and t2 relaxation times can be derived in subjects \<35 years of age. approximately 80 subjects will be evaluated and include subgroups where mrf may be of particular utility, including children and aya subjects with brain tumors and subjects with neurofibromatosis type 1 (nf1). additional aims will investigate the utility of mrf in these groups.

Eligibility criteria:
inclusion criteria: * subjects undergoing mri evaluation of the brain * nf1 status will be determined by clinical exam or genetic testing * nf1-associated optic pathway glioma (opg) will be defined as radiographic evidence of glioma along the optic nerve, chiasm, tract or radiation in a child with nf1 * untreated low grade gliomas will be imaging-defined gliomas that have not yet been exposed to radiation or systemic chemotherapy. those exposed to therapy will have had radiation and/or systemic chemotherapy more than 1 month prior to scans exclusion criteria: * history of mental retardation unrelated to brain tumor * presence of a genetic disorder other than nf1 that effects cognition or is associated with mr imaging abnormalities (e.g. tuberous sclerosis) * history of cerebrovascular accident (stroke) * birth weight below five pounds, premature birth prior to 36 weeks of gestation, or ischemic episode at birth * major psychiatric diagnosis prior to neuro-oncological diagnosis

Keywords: brain cancer neurofibromatosis type 1 nf1 magnetic resonance fingerprinting mrf