Kornimate/medical-research-clean huggingface dataset:
long-term analgesic efficacy and safety of tanezumab alone or in combination with non-steroidal anti-inflammatory drugs (nsaids) versus nsaids alone in patients with osteoarthritis of the knee or hip

Conditions: Osteoarthritis; Arthritis

Summary: the purpose of this study is to investigate the long-term analgesic efficacy and safety of tanezumab for patients with osteoarthritis (oa) of the knee or hip currently experiencing partial benefit from, and are tolerating, non-steroidal anti-inflammatory drug (nsaid) therapy.

this study was terminated on 28 october 2010 following a us fda clinical hold for tanezumab osteoarthritis clinical studies which halted dosing and enrollment of patients on 23 june 2010 for potential safety issues.

Eligibility criteria:
inclusion criteria: * osteoarthritis of the knee or hip according to acr criteria with kellgren-lawrence x-ray grade equal to, or greater than, 2. * patients must be experiencing some benefit from their current stable dose regimen of oral nsaid therapy of either naproxen 500-1000 mg/day or celecoxib 200 mg/day (either 100 mg bid or 200 mg qd) and be tolerating their nsaid regimen. * pain level and function levels as required by the protocol at screening and baseline. * willing to discontinue all non-study pain medications for osteoarthritis except rescue medication (acetaminophen) and not use prohibited pain medications throughout the duration of the study except as permitted per protocol. * willing and able to comply with lifestyle guidelines, scheduled visits, treatment plan, laboratory tests and other study procedures. exclusion criteria: * pregnant women. * bmi greater than 39. * fibromyalgia, regional pain caused by lumbar or cervical compression with radiculopathy or other moderate to sever pain that may confound assessments or self-evaluation of the pain associated with oa. * signs and symptoms of clinically significant cardiac disease with 6 months prior to screening. * diagnosis of tia within 6 months prior to screening or diagnosis of stroke with residual deficits that would preclude completion of required study activities. * history, diagnosis, signs or symptoms of clinically significant neurological and/or psychiatric disease/disorder. * at screening: uncontrolled hypertension, hemoglobin a1c greater than or equal to 10%, alt or ast greater than or equal to 3x upper limit of normal, creatinine exceeding 1.7 mg/dl (men) or 1.5 mg/dl (women). * patients on warfarin or other coumadin anticoagulant therapy and/or lithium therapy within 30 days prior to screening. * known hypersensitivity to nsaids or cyclooxygenase inhibitors.

Keywords: monoclonal antibody nerve growth factor (ngf) anti-ngf tanezumab pf-04383119 rn624 osteoarthritis (oa)
tdcs-enhanced working memory training in subjective cognitive decline

Conditions: Subjective Cognitive Decline

Summary: this 2-armed randomized, sham-controlled, single-blind study aims at providing evidence for the efficacy of a transcranial direct current stimulation (tdcs)-enhanced cognitive control training (pasat) in participants with subjective cognitive decline (scd). overall, the study will include 30 participants. each participant will take part in a four weeks training (12 sessions); 50% of the participants will receive 2ma anodal tdcs for 20 minutes applied to the left dorsolateral prefrontal cortex (dlpfc), the other half will receive sham stimulation. event-related potentials (erps) evoked by the feedback on the correctness of the response at baseline and after training will be measured with eeg as neurophysiological signatures of cognitive control. near and far transfer will be assessed by a verbal 2-back task and the trail making test a and b. the amount of worrying regarding the memory impairment will be quantified by means of a 10 point likert-scale. together with changes of pasat performance these measures will be obtained before and after the tdcs-enhanced training. follow-up assessments 3, 12 and 24 months after training will investigate the stability of training effects.


Eligibility criteria:
inclusion criteria: men and women, aged 60 years and above native german speaker subjective feeling of worsening cognitive abilities, including memory present concerns regarding the subjective memory decline right handedness exclusion criteria: * present objective cognitive impairment (mini-mental state examination \< 24) * current depression or depressive episode (geriatric depression scale \> 5) * current substance abuse * presence of other psychiatric disorders (mini international neuropsychiatric interview) * history of epilepsy * presence of other neurological disorders * absence of independent living skills (instrumental activities of daily living, iadl) scale) * metallic implants near the electrodes (i.e. pacemakers)

Keywords: brain stimulation cognitive training cognition treatment
body versus machine: deep breathing versus vagus stimulation for the treatment of fibromyalgia

Conditions: Chronic Widespread Pain; Fibromyalgia

Summary: this randomized controlled trial aims to compare the efficacy of two vagal nerve innervation treatments, motivational nondirective resonance breathing and transcutaneous vagus nerve stimulation, on heart rate variability and pain intensity in patients suffering from cwp. this project tests new and potentially effective means of treating a major global and public health concern where prevalence is high, disability is severe, and treatment options are limited.

the primary objective of this randomized controlled trial is to investigate the effects of motivational nondirective resonance breathing (mnrb) and transcutaneous vagus nerve stimulation (tvns) on autonomic health and pain intensity in participants diagnosed with chronic widespread pain (cwp). two versions of mnrb and two versions of tvns will be delivered and practiced by participants at home for two weeks. the primary outcome is photoplethysmography (ppg) measured heart rate variability (hrv). secondary outcomes are self report numeric rating scale (nrs) pain intensity, fm pain severity and associated parameters, computerized cuff pressure algometry, blood pressure, psychological distress and health related quality of life.

Eligibility criteria:
inclusion criteria: * confirmatory diagnosis of chronic widespread pain, including fibromyalgia * widespread pain index (wpi) ≥ 7 and symptom severity scale (sss) score ≥ 5 or wpi of 4-6 and sss score ≥ 9 * generalized pain in at least 4 of 5 body regions must be present * pain symptoms have been generally present for at least 3 months * average pain intensity ≥ 6 on a 0-10 numerical rating scale, where 0 represents "no pain" and 10 represents the "worst pain imaginable" exclusion criteria: * history and/or presence of comorbid severe neurological or psychiatric disorders (e.g., mania, psychosis, suicidality, bipolar/schizophrenia/autism spectrum disorders) * neurodegenerative disorders (e.g., parkinson´s, alzheimer´s, huntington´s disease) * pregnancy or planned pregnancy * planned surgery * eating disorder (e.g., obesity, anorexia nervosa, etc.) * head trauma * migraine * active heart implants (e.g., pacemaker) * active ear implants (e.g., cochlear implant) * individuals who have practiced meditation consistently (for more than 20 min/day) within the last 6 months

Keywords: chronic widespread pain heart rate variability pain intensity diaphragmatic breathing vagus nerve stimulation fibromyalgia
evaluation of the impact of rotating posterior and transverse presentations at 2 hours of full dilation

Conditions: Fetus in Posterior or Transverse Position; Manual Rotation ; Obstetrics ; Delivery Room Practice

Summary: during labor, 20% of fetuses present in a posterior or transverse position. among them, 90% rotate spontaneously during labor. for the remaining 10%, maintaining a posterior or transverse position leads to longer labor, increased instrumental deliveries, more cesarean sections, and more severe perineal tears. obstetricians can intervene by manually rotating the fetus to an anterior position. several studies have shown the benefits of this technique, but they were all conducted at full dilation or one hour after full dilation. this timing does not allow enough time for the fetus to rotate spontaneously. additionally, manual rotation can be poorly tolerated by the patient, especially if pain management is insufficient. our study aims to demonstrate the benefits of manual rotation two hours after full dilation. this delay allows 90% of fetuses to rotate spontaneously, and it could help harmonize obstetrical practices.


Eligibility criteria:
inclusion criteria: * - patient delivering at hospices civils de lyon (xr, hfme, ls?) * low-pitched voice agreement * mobile fetal cephalic presentation * transverse or posterior presentation confirmed by ultrasound * 2 hours of complete dilation * agreement for 3 hours by ob-gyn * normal fetal heart rate * epidural anesthesia in place * bladder catheterized exclusion criteria: * - multiparous uterus with scars * breech presentation * fetus \> 5000 g * patient refusal * inadequate analgesia * fetal hypoxia
use of text messaging reminders to increase fit completion among patients at the nyu fhcs

Conditions: Colon Cancer

Summary: the research team will compare the efficacy of targeted text message reminders against currently used phone call reminders at increasing patient completion of fecal immunochemical test (fit) for colon cancer screening.


Eligibility criteria:
inclusion criteria: * adult patients (ages 45-75) eligible for fit at a family health center clinic (excluding flatbush locations). exclusion criteria: * see inclusion criteria.
effect on pao2 of adding an aerosol mask above the nasal canulas

Conditions: Hypoxemic Respiratory Failure; Emergencies; Covid19

Summary: this study will compare the impact of a classical aerosol mask above low-flow nasal cannula on the arterial oxygen tension in patients with covid-19.

hospitalized patients with covid-19 typically present with hypoxemia. in some patients, hypoxemia can be corrected with low flow nasal cannula. when placed above nasal cannula, some systems have demonstrated their interest in improving the performance of the patient's oxygen delivery. for example, two recent studies have shown that adding a double-trunk mask (dtm) or surgical mask (sm) above nasal cannula has the potential to improve the pao2 despite no change in oxygen output (1, 2) . however, no study has compared the effect on pao2, of the addition of a classical aerosol mask above nasal canula.

Eligibility criteria:
inclusion criteria: hypoxemia exclusion criteria: hypercapnia confusion

Keywords: mask, oxygen
randomized controlled trial of integrated early palliative care

Conditions: Advanced Cancer; Solid Tumor

Summary: this study verifies whether integrated early palliative care for advanced cancer patients diagnosed due to a solid tumor improve quality of life and enhances the ability to overcome the current crisis.

previous reports suggest that starting palliative care early in cancer patients appears to improve patient's quality of life, symptom management, depression, and anxiety. this study aims to evaluate the effect of the introduction of early palliative care services to advanced cancer patients. eligible patients are 20 years or older, and has an advanced cancer diagnosis (histologically or cytologically confirmed) due to a solid tumor, a european cooperative oncology group performance status of 0-2, an estimated life expectancy of 12 months or less. the primary goal of an integrated early palliative care program is to improve the overall quality of life of patients and their families. secondarily, it is to help understand the disease, resolving conflicts in the decision-making process, improving the crisis coping capacity, and further determining the patient's and family's advanced care planning. at last, it is desired to evaluate the effect of the program on overall medical cost savings and 1 year survival. participants of the study will be allocated in the intervention group and the control group equally. within three weeks from the time of randomization, the first meeting with a palliative care team will be held. in the time of baseline questionnaire, patients will be provided with self-study education materials and videos on the early palliative care and advance care planning. once in every three weeks for six months, which is the duration for one treatment course, palliative care for advance care planning, symptom control, and other mental, social and spiritual problems will be provided. after the first meeting with the palliative care team, telephone coaching will be performed once a week for the first 12 weeks and then every two weeks until the end of the study.

Eligibility criteria:
inclusion criteria: * subject 20 years and older. * subject who has an advanced cancer diagnosis (histologically or cytologically confirmed) due to a solid tumor * subject whose ecog performance status is between 0 to 2. * subject with an estimated life expectancy of 12 months and less (assessed by the treating oncologist) * subject who volunteers exclusion criteria: * inability to speak, understand or write korean. * medical conditions that would limit adherence to participation of the clinical trial(as confirmed by their referring physician; e.g. dyspnea) * suspension of all cancer treatment * palliative care consultation at any time or in palliative care

Keywords: integrated early palliative care
a study to investigate the safety, tolerability, pharmacokinetics (pk) and pharmacodynamics (pd) of ro7497372 in participants with diabetic macular edema (dme)

Conditions: Diabetic Macular Edema

Summary: this study will assess the safety and tolerability of ro7497372 in participants with dme. the study consists of 2 parts. part 1 will test multiple-ascending doses of ro7497372 after unilateral intravitreal (ivt) administration in participants with dme. the main purpose of part 1 is to provide data for ro7497372 safety and tolerability, as well as to characterize the ocular and systemic pharmacokinetics (pk), systemic anti-drug antibodies (ada), and duration of target engagement, i.e., the pharmacodynamics (pd) in aqueous humor (ah) and blood. part 2 will evaluate the safety, tolerability, pk, and pd of two dose strengths of ro7497372 (low dose and high dose), identified as safe and tolerated in part 1.


Eligibility criteria:
inclusion criteria: * diagnosis of diabetes mellitus (type 1 or type 2), as defined by the world health organization (who) and/or american diabetes association * participant consents to ah collection * collection of \> 90 microlitres (µl) ah (at each visit required per schedule of activities \[soa\]) if deemed feasible and safe by the investigator. * macular thickening secondary to dme involving the center of the fovea with cst \>= 325 µm at screening * decreased bcva primarily due to dme with etdrs score of 78 to 19 letters (both inclusive) at screening * adequately clear ocular media and adequate pupillary dilation to allow acquisition of good quality retinal images * diagnosis of non-proliferative dr * treatment-naive and pre-treated participants after washout exclusion criteria: * any major illness or major surgical procedure ≤ 4 weeks before day 1 * any febrile illness and associated sequelae ≤ 1 week prior to day 1 * active cancer ≤ 1 year prior to day 1 * cerebral vascular accident (including stroke and transient ischemic attack) or myocardial infarction ≤ 24 weeks prior to day 1 * hba1c ≥ 12% at screening * any panretinal photocoagulation or macular laser photocoagulation treatment prior to day 1 * history of vitreoretinal surgery/pars plana vitrectomy * any cataract surgery within 12 weeks prior to day 1 or any planned surgery during the study * history of any glaucoma surgery including laser glaucoma procedures * uncontrolled glaucoma * any active intra- or periocular infection on day 1 * any active or history of intraocular inflammation * intravitreal treatment with an anti-il-6 (e.g., vamikibart) or anti-il-6 receptor treatment at any time * any proliferative dr
impact of integrated hiv/ncd screening on hiv testing uptake and engagement in hiv care in kisarawe, tanzania

Conditions: Human Immunodeficiency Virus; Diabetes Mellitus, Type 2; Hypertension

Summary: this study focuses on the integration of hiv and ncd screening and care. the investigators will conduct a randomized controlled trial examining the efficacy and cost-effectiveness of the intervention strategy in kisarawe district, tanzania, a rural area 40 km southwest of dar es salaam. the study will match two similar hiv care and treatment centers (ctc) in the district, one of which will be randomized to receive the enhanced intervention which will integrate diabetes (dm) and hypertension (htn) screening with the existing hiv testing program, and integrate care for dm and htn into the hiv care program. comparisons of the community hiv testing rates in the two communities, engagement in hiv care among those testing positive, and 24-month retention in hiv care will be assessed among a cohort of 107 newly enrolled patients per community. specifically, the aims are to determine: 1. whether integrating dm and htn screening with hiv testing will increase the uptake of community-level hiv testing. 2. if integrating dm/htn care with hiv care enhances engagement in hiv care. 3. whether integration of dm/htn care with hiv care enhances retention in hiv care for those newly enrolled in hiv care. 4. the cost-effectiveness of integrating ncd screening and care with hiv screening and care with regard to the incremental cost per hiv infected client engaged in hiv care, and cost per newly enrolled hiv client retained in hiv care over 24-months.


Eligibility criteria:
eligibility criteria for screening: • be aged 18 years or above. inclusion criteria for intervention and control cohorts: * be aged 18 years or above. * recently enrolled in hiv care and treatment exclusion criteria: * potentially vulnerable populations (incarcerated, under age of consent, unable to understand the procedures planned, etc.). * individuals under the influence of drugs or alcohol and anyone presenting with mental disability that would preclude ability to understand study procedure, risks, and benefits. * inability or unwillingness of subject to provide informed consent.

Keywords: human immunodeficiency virus community health services chronic disease integrated delivery of health care tanzania
study of daxdilimab (hzn-7734) for the treatment of systemic lupus erythematosus in an open-label extension study

Conditions: Systemic Lupus Erythematosus

Summary: a phase 2, open-label extension study to evaluate the long-term safety and tolerability of daxdilimab in participants with systemic lupus erythematosus completing the treatment period of the recast sle clinical study.

approximately 156 participants will be enrolled to receive daxdilimab administered subcutaneously over 48 weeks. the maximum trial duration per participant is approximately 56 weeks, including the 48 weeks for the open-label treatment period where participants will receive daxdilimab and approximately 8 weeks for the follow-up period. safety evaluations will be performed regularly throughout the course of the study. acquired from horizon in 2024.

Eligibility criteria:
inclusion criteria: * willing and able to understand and provide written informed consent. * must have completed the treatment period in the recast sle study. * women of childbearing potential must have a negative urine pregnancy test on day 1. * nonsterilized male subjects who are sexually active with a woman partner of childbearing potential must agree to use a condom with spermicide from day 1 and until 3 months (approximately 5 half-lives) after receipt of the last dose. exclusion criteria: * any condition or change during the recast sle study that in the opinion of the investigator or the sponsor would interfere with evaluation and interpretation of subject safety or alter the risk-benefit associated with ip administration. * participation in another clinical study with an ip during the recast sle study period. * planned elective surgeries that in the opinion of the investigator or the sponsor would interfere with evaluation and interpretation of subject safety. * any herpes zoster, cytomegalovirus, or epstein-barr virus infection that was not completely resolved prior to visit 1. * clinically significant active infection at visit 1, in the opinion of the investigator. * pregnant or lactating females.
glassy trial for effects of wearing glasses

Conditions: COVID-19

Summary: randomized trial testing 6 forms of a communication summarizing the results of a recent study (about the effects of wearing glasses on reducing covid infection risk). the goal of the trial is to test the effect of different language options to describe uncertainty, and of including the margin of error around the main result.

the study is designed as a proof-of-concept exercise to develop and test a communication meant to summarize the results of a recent randomized trial examining the effects of wearing glasses on the chance of developing covid-19. the objectives of the randomized trial are: * to compare the effects of three ways of communicating the overall uncertainty of the effects of wearing glasses to reduce the chance of getting covid and * to compare the effects of including the margin of error (confidence interval) compared to not including it. researchers will conduct an online, parallel group, individually randomized, pragmatic trial using a 3x2 factorial design, ie, 3 uncertainly language options (grade language, colloquial language or none 2 options for the statistical margin of error for the main results (margin of error language or none).

Eligibility criteria:
inclusion criteria: * \>= 18 years old * literate in english or norwegian * currently residing in norway or the united states exclusion criteria: * individuals who regularly wear any kind of glasses (i.e., prescription or sunglasses) all or most of the time

Keywords: colloquial language uncertainty bias