Kornimate/medical-research-clean huggingface dataset:
comparison of the efficacy of ultrasound-guided injections of saline, high-concentration dextrose, and ligament repair agents for the treatment of medial collateral ligament pathology in degenerative knee osteoarthritis: a randomized double-blind trial.

Conditions: Medial Collateral Ligament Lesions; Knee Osteoarthritis

Summary: the goal of this clinical trial is to evaluate the effectiveness of stabha, high-concentration glucose water, and saline injections in treating knee osteoarthritis with medial collateral ligament lesions. this prospective, double-blind, randomized trial will recruit 51 patients from the shin kong hospital rehabilitation department. the main questions it aims to answer are: 1. do stabha or high-concentration glucose water injections provide better pain relief and improved knee function compared to saline? 2. what side effects do participants experience with these treatments? participants will be randomly divided into three groups: stabha, high-concentration glucose water, and saline. in addition to routine intra-articular hyaluronic acid injections, each group will receive two ultrasound-guided injections of their assigned treatment into the medial collateral ligament of the knee, with a two-week interval. all participants will also undergo a 4-week physical therapy program. participants will: 1. receive two ultrasound-guided injections over two weeks. 2. undergo 4 weeks of physical therapy. 3. return for follow-up assessments at 1 and 3 months, including the womac osteoarthritis index, pain score, koos knee outcome score, knee range of motion, and knee ultrasound examination.


Eligibility criteria:
inclusion criteria: - the patients should fulfill the following criteria: 1. age between 45 to 80 years old. 2. meet at least three of the six american college of rheumatology (acr) criteria, including age over 50 years, morning stiffness less than 30 minutes, crepitus in passive knee movements, bony tenderness, bony enlargement, and no palpable warmth. 3. radiologic grading of 2 or 3 according to kellgren-lawrence criteria. 4. evidence of medial collateral ligament (mcl) pathology with incomplete injuries (grade i or ii). 5. willing to receive prolotherapy treatment. 6. willing and able to complete all follow-ups and assessments in the randomized double-blind trial. exclusion criteria: * the exclusion criteria are: 1. severe systemic disorders including cancer, uncontrolled diabetes mellitus, sepsis, or cardiopulmonary diseases. 2. history of anticoagulation therapy, knee injection over the past three months. 3. history of knee surgery or candidates for knee arthroplasty. 4. history of intolerance to prolotherapy. 5. pregnancy. 6. infectious arthritis, inflammatory joint diseases, joint dysplasia. 7. body mass index (bmi) greater than 35 kg/m2. 8. complete tear of medial collateral ligament under ultrasound. 9. fracture or other causes of knee pain instead of osteoarthritis.

Keywords: medical collateral ligament (mcl) knee osteoarthritis prolotherapy stabha rehabilitation
effect of tscs on ankle movement training in individuals with sci

Conditions: SCI - Spinal Cord Injury

Summary: this clinical trial explores the effectiveness of transcutaneous spinal cord stimulation (tscs), a non-invasive technique, in facilitating spinal circuitry adaptation in individuals with spinal cord injury (sci). while epidural spinal cord stimulation (escs) has shown functional benefits, its application is limited by the side effects associated with implanted electrodes. tscs, which shares a similar mechanism but does not require surgery, has yet to be extensively studied in large human trials. the study aims to: determine optimal tscs parameters for non-invasive spinal stimulation. investigate the priming effect of tscs on spinal circuitry during machine-assisted ankle movement training. examine the long-term clinical outcomes of combining tscs with ankle movement training in individuals with incomplete sci. the trial will include both healthy participants and individuals with complete and incomplete sci, using the soleus post-activation depression (pad) model to evaluate spinal circuitry adaptation. the results will provide insights into spinal re-adaptation and potentially introduce a novel, non-invasive approach for sci rehabilitation.


Eligibility criteria:
health subjects: exclusion criteria: 1. musculoskeletal injuries on legs. 2. osteoporosis. sci subjects: inclusion criteria 1. participants with chronic spinal cord injury, with injury duration greater than one year. exclusion criteria 1. current musculoskeletal or joint injuries in the lower limbs. 2. history of central or peripheral neuromuscular diseases. 3. presence of a pacemaker. 4. current use of antispastic or antidepressant medications. 5. current venous thromboembolism or osteoporosis. 6. impairment of the soleus h-reflex arc.

Keywords: post activation depression transcutaneous spinal cord electrical stimulation (tscs) machine-assist therapy
impact of explanation given to parents on rate of post-partum influenza vaccination

Conditions: Newborn Morbidity

Summary: the aim of this study is to determine whether an explanation to parents for the need for post-partum influenza vaccination will influence their compliance.


Eligibility criteria:
inclusion criteria: * all parents discharged from well-baby nursery exclusion criteria: -
effect of cvp and ioh on aki and akd

Conditions: Acute Kidney Injury; Acute Kidney Disease

Summary: this study was aimed to explore the effect of intraoperative venous congestion and intraoperative hypotension (ioh) on acute adverse kidney events, defined as acute kidney injury (aki) and acute kidney disease (akd), after cardiac surgery

venous congestion and ioh were primary exposures and quantified as area under the curve (auc) of central venous pressure ≥12, 16 or 20 mmhg or mean arterial pressure ≤55, 65, 75 mmhg. the primary outcome was aki or akd defined as renal dysfunction persisting \> 7 days after surgery. multivariable logistic regression and cox proportional hazard models were used to determine the association between intraoperative venous congestion/hypotension and postoperative acute adverse kidney events, respectively, adjusted for relevant confounding factors and multiple comparisons.

Eligibility criteria:
inclusion criteria: * patients aged 18 years and older, * patients underwent cardiac surgery (coronary artery bypass grafting, heart valve surgery, heart transplant or surgical excision of intracardiac myxoma) * patients receiving invasive intraoperative bp monitoring during surgery * patients underwent cardiopulmonary bypass (cpb) during surgery exclusion criteria: * pre-existing renal insufficiency defined by presence of abnormal preoperative serum creatinine ≥ 133 μmol/l and/or preoperative diagnosis of renal insufficiency within 6 months'preoperative period. * patients with preoperative dialysis dependence within 60 days before the index surgical procedure, * surgical duration less than 30 minutes * surgery on the aorta * insufficient hemodynamic and laboratory data for outcomes and/or exposure ascertainment

Keywords: acute kidney injury intraoperative hypotension central venous pressure acute kidney disease cardiopulmonary bypass
efficacy and safety of aliskiren/amlodipine/hydrochlorothiazide in patients with moderate-severe hypertension

Conditions: Hypertension

Summary: this study evaluated the efficacy (blood pressure lowering effect) and safety of aliskiren/amlodipine/hydrochlorothiazide in patients with moderate to severe hypertension.


Eligibility criteria:
inclusion criteria: * male or female * 18 years of age or older * msdbp and mssbp requirements: * 3a: * diagnosis of moderate to severe hypertension (mssbp ≥ 160 mmhg and \< 200 mmhg, and/or msdbp ≥ 100 mmhg and \< 120 mmhg) at visits 4, 5 or 6 (qualifying bp visit) * in addition, at the visit immediately prior to the above qualifying visit, patients were also to have mssbp ≥ 145 mmhg and \< 200 mmhg and msdbp ≥ 95 mmhg and \< 120 mmhg) at visits 3, 5 or 5. * patients had to meet the above two sets of requirements at subsequent adjacent visits, i.e. either visits 3 and 4, visits 4 and 5, or visits 5 and 6. * or * 3b: * mssbp ≥ 180 mmhg and \< 200 mmhg with msdbp ≥ 95 mmhg and \< 120 mmhg, or msdbp ≥ 110 mmhg and \< 120 mmhg with mssbp ≥ 150 mmhg and \< 200 mmhg after at least one week of treatment with placebo (visit 3 and on). exclusion criteria: * continued use of anti-hypertensive medicines or use of 4 or more hypertensive medicines at study start * patients with an mssbp ≥ 200 mmhg or msdbp ≥ 120 mmhg at any time during the placebo run-in period were to be discontinued from the study. * extremely elevated (defined) blood pressure at any point during the study * pregnant or lactating women * pre-menopausal women not taking accepted form of birth control * history or evidence of secondary form of hypertension * history of cardiovascular conditions other protocol-defined inclusion/exclusion criteria applied to the study.

Keywords: aliskiren antihypertensive hypertension renin inhibitor moderate-severe hypertension
first in human study to test the safety and preliminary efficacy of ppsgg in patients with anti-mag neuropathy

Conditions: Anti-MAG Neuropathy

Summary: in this study, the new drug called ppsgg (pn-1007) will be tested. preliminary studies conducted in animals suggest ppsgg (pn-1007) might be a good treatment for reducing levels of anti-mag antibodies in patients with anti-mag neuropathy. this is the first research of ppsgg (pn-1007) in people and its main purpose is to test its safety and acceptability in patients. in this study it will be examined how the drug is changed by and removed from the body and checked for signs that the drug may be truly effective against anti-mag neuropathy. ppsgg (pn-1007) will be tested at several different doses.

ppsgg (pn-1007) is intended to bind anti-mag igm autoantibodies, the underlying cause of anti-mag neuropathy, in a highly selective manner, resulting in their neutralization and removal from the circulation. this allows specific targeting of anti-mag igm in the circulation and circumvents unspecific immunosuppression associated with current treatment strategies. this is a phase i/iia, first in human (fih), multicenter, single and multiple ascending dose escalation trial of ppsgg (pn-1007), an antibody scavenger of pathogenic anti-mag immunoglobulin m (igm) autoantibodies for treatment of anti-mag neuropathy. the aim of the study is to assess the safety and tolerability, pharmacokinetics (pk), pharmacodynamics (pd), and preliminary efficacy of ppsgg (pn-1007) in a sad and a mad phase in an adaptive trial in anti-mag neuropathy patients.

Eligibility criteria:
inclusion criteria: * patients with a confirmed diagnosis of monoclonal igm associated with mgus with anti-mag activity (titer of \> 10'000 btu) and demyelinating neuropathy defined by electrophysiological criteria according to efns/pns pdn guideline, 2010. * clear clinical signs of disability * adequate hepatic and renal function exclusion criteria: * patients with total serum igm levels \>30 g. * hematological malignancy, prior malignancy of any organ system (except bcc) * prior immunosuppression: no ivig in previous 3 months, no previous cyclophosphamide or biologicals in prior 6 months. * other neurological, neuromuscular, rheumatologic or orthopedic condition with significant impact on the capabilities of walk preventing evaluation of neurological scores

Keywords: peripheral neuropathy
phase 3 study of oto-104 in subjects with unilateral meniere's disease

Conditions: Meniere Disease

Summary: the purpose of this study is to evaluate the effectiveness of oto-104 for the treatment of meniere's disease.


Eligibility criteria:
inclusion criteria: * subject has a diagnosis of unilateral meniere's disease by 1995 american academy of otolaryngology - head and neck surgery (aaohns) criteria and reports active vertigo for the 2 months prior to the study lead-in period. * subject has experienced active vertigo during the lead-in period. * subject has documented asymmetric sensorineural hearing loss. * subject agrees to maintain their current treatments for meniere's disease while on-study. exclusion criteria: * subject is pregnant or lactating. * subject has a history of immunodeficiency disease. * subject has a history of significant middle ear or inner ear surgery, or endolymphatic sac surgery in the affected ear. * subject has a history of tympanostomy tubes with evidence of perforation or lack of closure. * subject has a history of vestibular migraine. * subject has used an investigational drug or device in the 3 months prior to screening. * subject has previously been randomized to a clinical study of oto-104.

Keywords: meniere's disease vertigo endolymphatic hydrops labyrinth diseases ear diseases otorhinolaryngologic diseases
a novel prosocial online support group for distressed breast cancer survivors

Conditions: Breast Neoplasms

Summary: the investigators hypothesize that breast cancer survivors participating in a prosocial online support group will have a significantly lower mean level of psychological symptoms (anxiety/depression) and higher mean level of sense of purpose post-intervention than participants in a standard online support group.

psychological distress is a significant problem among breast cancer survivors. many survivors turn to the internet for information and support, yet few controlled studies have examined the effectiveness and safety of online support groups. the investigators are testing the potential efficacy, acceptability, and feasibility of an innovative theory-based online support group (osg) for breast cancer survivors. members of the control group will participate in a standard osg that encourages self-expression. members of the experimental condition will participate in a prosocial osg that provides structured helping opportunities and coaching on how best to give support to others. participants will complete two telephone interviews and six weekly online support group meetings.

Eligibility criteria:
inclusion criteria: * diagnosed with stage i or ii breast cancer in preceding 36 months * 21-64 years of age * access to and ability to use a computer and the internet to communicate with others * fluent in spoken english * meet the screening criteria for psychological distress (score \>7 on either the depression or anxiety subscale of the hospital anxiety and depression scales exclusion criteria: * currently taking medication for depression

Keywords: breast cancer breast tumor
effectiveness of an oral health literacy intervention on oral health behaviors and plaque index in orthodontic patients

Conditions: Dental Plaque; Periodontal Diseases; Oral Health Behavior Change

Summary: this study aims to evaluate the effectiveness of a novel psychologic-based oral health instruction program (ohl program) by comparing oral health behaviors (ohb) and plaque index (pi) scores between intervention and control groups at three key time points-pre-intervention, post-intervention, and follow-up-enabling a comprehensive assessment of the intervention's impact and and persistence over time. the study hypothesizes that (1) the ohl program will lead to greater improvements in ohl compared to a traditional control group and (2) these effects will be sustained through the follow-up period. participants in the intervention group received the ohl program, while those in the control group received traditional oral hygiene instruction. both groups had data collected at baseline, post-intervention, and at a 3-week follow-up.

the outcomes were oral health behavior (ohb) and plaque index (pi), compared at three time points: baseline (initial), post-intervention (final), and at a 3-week follow-up. additionally, as a manipulation check, oral health literacy (ohl) levels were assessed at all three intervals. demographic information, ohl, and ohb were measured using standardized questionnaires from previous research. the 31-item ohl scale assessed five elements: 1) access, 2) understanding, 3) evaluation, 4) application, and 5) communication of oral health information and services. a 14-item scale evaluated ohb across three domains: 1) oral hygiene practices, 2) dietary choices, and 3) utilization of dental services. in addition, clinical assessments of plaque were conducted using the silness and löe plaque index (pi, 1964). plaque was evaluated on four surfaces of each tooth (mesial, distal, buccal, and lingual) using a who probe. scores ranged from 0 to 3, reflecting the absence to a large amount of plaque accumulation, based on their established criteria. a single oral examiner recorded the plaque scores for each surface, and the average score for each tooth was calculated. the total score was then summed and divided by the total number of teeth examined, providing an overall plaque index for each individual. there were no outcome changes after trial commencement.

Eligibility criteria:
inclusion criteria: * participants undergoing fixed orthodontic treatment, free from non-communicable chronic diseases (such as diabetes mellitus, hypertension, and heart disease), capable of reading, writing, and providing informed consent, and willing to participate in the oral health program. exclusion criteria: * reluctance to provide health information, inability to complete assessments, or withdrawal from the program at any stage.

Keywords: oral health literacy self-efficacy experiential learning oral health intervention oral health behavior plaque index
safety study to evaluate the cumulative irritation potential of topically applied zuraprep™ and zuraprep™ without ipa

Conditions: Surgical Site Infection

Summary: this is a safety study to determine the cumulative skin irritation potential of zuraprep™ and zuraprep™ without isopropyl alcohol after repetitive patch applications to skin of human subjects.

this cumulative irritation evaluation is designed to determine the skin irritation potential of zuraprep™ and zuraprep™ without isopropyl alcohol (ipa) after repetitive patch application to skin of healthy human subjects.

Eligibility criteria:
inclusion criteria: * subjects may be of either sex, at least 18 years of age and of any race * subjects must be free of tattoos, sunburn, dermatoses, cuts, lesions or other disorders of the skin of the back. * subjects must be in good general health exclusion criteria: * known allergies to latex, metals, tape and/or adhesives, soap, citric acid, methylene blue, methylparaben, propylparaben, chlorhexidine gluconate, isopropyl alcohol, and sodium lauryl sulfate. * exposure of the back region to antimicrobial agents, medicated soaps, medicated shampoos, medicated lotions, strong detergents, sun-tanning, use of tanning beds, or swimming or soaking in pools or hot tubs, in the 7 days prior to, or during the 3-week test period. * use of topical or systemic corticosteroid, antihistamine, or anti-inflammatory medications in the 7 days prior to, or during the 3-week test period. * current or recent severe illness such as asthma, diabetes, hepatitis, organ transplant, mitral valve prolapse, congenital heart disease, internal prostheses, or any immunocompromised condition such as aids or hiv positive. * pregnancy, plans to become pregnant, breast-feeding * any active skin rash or breaks in the skin of the back * any sunburn or tattoos on the skin of the back * current active skin disease or inflammatory skin condition including contact dermatitis * participation in a clinical study in the past 7 days or current participation in another clinical study * any medical condition or use of any medications that, in the opinion of the principal investigator, would preclude participation * unwillingness to fulfill the performance requirements of the study
suture fixation system versus tendonous reconstruction in carpometacarpal (cmc) arthroplasty

Conditions: Thumb Carpometacarpal Arthritis

Summary: thumb carpometacarpal (cmc) arthritis affect 1 in 4 females and 1 in 12 males. patients who fail to respond to conservative treatment may benefit from surgery; however, controversy exists over the most effective surgical technique. a popular technique, ligament reconstruction with tendon interposition (lrti) involves a trapeziectomy, followed by reconstruction of the palmar oblique ligament using a harvested flexor tendon from the wrist. we believe that use of a suture fixation system to reconstruct the palmar oblique ligament, instead of harvesting a wrist tendon, may provide a superior repair. the objective of this study is to compare functional outcome measurements among patients who receive cmc arthroplasty using a suture fixation system (investigational group) to those who receive lrti surgery (control group). we hypothesize that patients in the investigational group will demonstrate superior functionality, compared to patients in the control group.


Eligibility criteria:
inclusion criteria: * male or female patients aged \>18. * eaton stage iii or iv cmc arthritis * failure to respond to conservative treatment exclusion criteria: * previous surgical interventions on that thumb * upper extremity neurological dysfunction * inability to effectively communicate with the research staff, due to hearing impairment, cognitive impairment, or a language barrier * unwilling or unable to provide written informed consent

Keywords: cmc arthritis thumb carpometacarpal arthritis basal joint arthritis thumb cmc arthritis
single embryo transfer vs. double embryo transfer in an oocyte donation programme

Conditions: Infertility; Oocyte Recipient; Single Embryo Transfer/Double Embryo Transfer; Cumulative Pregnancy Rate; Multiple Pregnancy

Summary: experimental study to assess the efficacy of single embryo transfer (set) with respect to double embryo transfer (det) in an oocyte donation programme, 160 recipients will be randomized in two groups


Eligibility criteria:
inclusion criteria: * patients under their first or second cycle of a synchronous donation * to have a minimum of 5 available embryos to transfer * patients who accept transfers of frozen-thawed embryos exclusion criteria: * medical indications to transfer only one embryo (turner syndrome, uterine surgical history, uterine myomas,...)