Kornimate/medical-research-clean huggingface dataset:
evaluate the effect of osteo introducer system in total hip arthroplasty

Conditions: Joint Disease

Summary: osteo introducer system is the instruments used in minimal invasive tha. this study will compare the minimal invasive tha using the osteo introducer system and tha using common instruments, to show the non-inferiority of osteo introducer system in safety and efficacy of tha surgery.


Eligibility criteria:
inclusion criteria: * with indications of total hip arthroplasty (e.g. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis; rheumatoid arthritis; correction of functional deformity, etc.) * bmi\<30 * subject is a candidate for primary total hip arthroplasty * no obvious congenital abnormality in hip joint * subject has no mental illness, is willing to join the study voluntarily and sign the approved informed consent document; is willing and able to complete required study visits or assessments exclusion criteria: * subjects with inadequate neuromuscular status (e.g., prior paralysis, fusion and/or inadequate abductor strength), poor bone stock, poor skin coverage around the joint which would make the procedure unjustifiable * overt infection * distant foci of infections * allergy to metals * rapid disease progression as manifested by joint destruction or bone absorption apparent on x-ray * skeletally immature * neuropathic joints * hepatitis or hiv infection * neurological or musculoskeletal disease that may adversely affect gait or weight-bearing * pregnant or lactating women * subjects enrolled in another drug or device clinical investigation within 3 month * investigator has judged the subject is not suitable for the study

Keywords: total hip arthroplasty minimal invasive
a weight loss study evaluating subcutaneous treatment with azd9550 and azd6234 in combination against placebo or each of the drugs alone

Conditions: Obesity or Overweight

Summary: the purpose of this study is to determine whether treatment with azd9550 when given in combination with azd6234 as once weekly subcutaneous (sc) injections is superior to placebo or either agent administered as monotherapy for weight loss in participants living with obesity or overweight with at least one weight-related co-morbidity.

this is a phase iib, global, randomised, parallel-group, double-blind, placebo-controlled, multi-centre, reduced factorial study designed to evaluate the efficacy, safety and tolerability of treatment with azd9550 and azd6234 in combination or as monotherapy in adults who are living with obesity or overweight with at least one of the following weight-related co-morbidities: hypertension, dyslipidemia or obstructive sleep apnoea. the study is composed of a screening period, a treatment period and a follow up period with participants expected to be in the study for approximately 47 weeks. the study will be conducted at around 60 sites and in approximately 7 countries with about, 360 participants will be randomly assigned to study intervention or placebo.

Eligibility criteria:
inclusion criteria: * participant must be 18 to 75 years of age inclusive. * bmi: ≥ 30 kg/m2, or ≥ 27 kg/m2 with at least one weight related comorbidity. * a stable, self-reported body weight for 3 months prior to screening. * male and female participants: contraceptive use by males or females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. * female participants must have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline. * capable of giving signed informed consent. exclusion criteria: * history of any clinically important disease or disorder, which, in the opinion of the investigator, may put the participant at risk. * history or presence of gi, renal, hepatic disease. * previous or planned bariatric surgery or fitting of a weight loss device. * obesity induced by endocrine disorders such as cushing's syndrome, insulinoma or prader-willi syndrome. * history of t1dm or t2dm or symptoms indicative of insulinopenia or poor glucose control. * hba1c ≥ 6.5% (48 mmol/mol), fasting serum glucose ≥ 126 mg/dl (7.0 mmol/l) or random glucose ≥ 200 mg/dl (11.1 mmol/l). * significant gastric and hepatobiliary disease. * history of acute or chronic pancreatitis or pancreatic amylase or lipase \> 2 × uln at screening. * history of psychosis or bipolar disorder. * history of major depressive disorder within the 2 years prior to screening or depression. * treatment with a glp1 containing preparation, either as part of treatment or while participating in another clinical study within the 3 months or 5 half-lives of the drug prior to screening. * vulnerable populations

Keywords: obesity overweight azd9550 azd6234
efficacy evaluation of triple up® collagen drink on skin condition

Conditions: Skin Condition

Summary: to assess triple up® collagen drink on skin condition improvement


Eligibility criteria:
inclusion criteria: * healthy adults aged above 20 years old exclusion criteria: * subject who is not willing to participate in this study. * patients with diseases of the skin, heart, liver, kidney, endocrine and other organs and patients with mental illness (according to medical history). * subjects who have known cosmetic, drug or food allergies, difficulty in digestive tract absorption or disorder. * female who is pregnant or nursing or planning to become pregnant during the course of the study. * received facial laser therapy, chemical peeling or uv overexposure in the past 4 weeks. * vegetarian * subjects who have large spots (area \>3 square centimeter) or abnormal acne.
vitamin b6 supplementation and mood states in college women taking oral contraceptives

Conditions: Depression

Summary: purpose of study the purpose of this crossover study was to determine how vitamin b6 supplementation impacts mood states in college age (18-25 y) women that use oral contraceptives, in comparison to a placebo treatment. hypothesis daily supplementation of vitamin b6 (100 mg) over a 4-week period will improve mood states in college age women (18-25 y) with marginal vitamin b6 status that use oral contraceptives, compared to the placebo treatment.

this study is a 12-week, randomized, double-blinded crossover trial. after eligibility is confirmed through prescreening and onsite screening assessments (screening visit; \~30 minutes), participants will sign the consent form and enter the trial. participants are stratified by age, bmi, and length of oral contraceptive use and randomized by a coin flip into the experimental group (b6 supplement) or control group (low does vinegar pill). participants will visit the test site in the fasted state (no food or drink with the exception of water for 10 hours) on 4 occasions (pre and post weeks 1-4 and pre and post weeks 9-12) these visits are approximately 30 minutes long. at the start of the trial, participants are instructed to take the provided pills once daily for four weeks. for weeks 5-8, participants will not take any pills (the washout period). daily pill consumption will resume during weeks 9-12 (the crossover treatment). participants are their own control in this crossover trial. all participants are instructed to maintain their normal exercise and eating patterns consistently throughout the duration of the 12-week study. additionally, participants are instructed not to start any new medications or nutritional/herbal supplements. to promote compliance, participants will have a calendar to check off each day that the pills are consumed during the study. anthropometric data are collected and fasting blood draws are performed at weeks 0, 4, 9 and 12. fasting blood samples will be tested for b6 and associated metabolites. additionally, mood assessments, including the profile of mood states and the beck depression inventory will be administered at weeks 0, 4, 9 and 12.

Eligibility criteria:
inclusion criteria: * female who has taken a combined oral contraceptive (estrogen with progestin) consistently for at least one year * healthy by self-report; no active disease state, depressive state, or prescription medication use (exception: oc) * 18-25 years of age * nonsmoking * not pregnant or lactating if female * not a regular user of supplements aside from multivitamin/mineral supplement * dietary b6 at or below the rda (1.3 mg/day) * not vegetarian/vegan * not a competitive athlete exclusion criteria: * unwilling to take a vitamin supplement or placebo daily as prescribed during the 12 week study * unable to meet with investigators and provide a fasting blood sample on 4 occasions over a 12 week period

Keywords: vitamin b6 contraception depression
effect of repeated tdcs sessions on cognitive improvement in patients with disorders of consciousness

Conditions: Disorders of Consciousness; Severe Brain Injury; Post-comatose Non-communicative Patients

Summary: in this study, researchers will show to caregivers of patients how to use a tdcs device (this device was designed to be easy to use, with fixed parameters and only one button to press to run the stimulation). they will be asked to apply a stimulation every day, 5 days per week during for 4 weeks, in chronic patients in minimally conscious state (mcs). 2 sessions of 4 weeks of stimulations will be realized, one anodal and one sham in a randomized order. before and after each session, behavioral improvement will be assessed with the coma recovery scale revised (crs-r). a final assessment will be done 8 weeks after the end of the sessions to assess the long term effect of tdcs.

a single session of tdcs showed positive effects on patients in mcs (study published in neurology, 2014). nevertheless, the effects went down after 1 or 2 hours. in a second study (protocol id: 2009/201/b) we have found that 5 days of tdcs increase the lasting of the effects up to one week. to know if tdcs could be use in clinical daily practice, a new study will evaluate the effects of 20 minutes of tdcs over the left prefrontal dorsolateral cortex for 4 weeks, 5 days per week, in chronic patients in mcs. 2 sessions of 4 weeks of stimulation (total=20 stimulations per session) will be performed, one session will be real (anodal stimulation) and one placebo (sham stimulation). firstly, the patient will be seen at the hospital for a behavioral assessment (crs-r) with one of his/her caregiver. the investigator will explain to the caregiver how to perform the stimulation. in addition, he/she will receive a folder and a video. the caregiver will take an exam to be sure he/she performs the tdcs properly. before and after each stimulation session, behavioral improvement will be assessed with the crs-r by a trained neuropsychologist, at the hospital. a final assessment will be done 8 weeks after the end of the session to assess the long term effect of tdcs. the compliance will be recorded by the deice to be sure that the caregiver performs the stimulation every day as expected. researchers expect to see (a) an improvement of the crs-r total score at the end of the anodal session and (b) this improvement persists for 8 weeks.

Eligibility criteria:
inclusion criteria: * be in an minimally conscious state * be chronic (more then 3 months post insult) * stable condition exclusion criteria: * nmda receptor inhibitor drugs * modification of the treatment during the protocol * illness or infection during the protocol * pacemaker * metallic cerebral implant * prior neurological disorder * tdcs or other non-invasive brain stimulation treatment less than 3months before the inclusion in the present study
registry on the effectiveness and safety of the 9-month mdr-end treatment regimen in korean patients with fq-sensitive mdr-tb (mdr-end registry)

Conditions: Tuberculosis, Multidrug-Resistant

Summary: this study is to evaluate the effectiveness and safety of a 9-month mdr-end regimen as a treatment for fluoroquinolone-sensitive multidrug resistant pulmonary tuberculosis in the real-world clinical setting. it will be conducted as a non-interventional, prospective, single group, multicenter design. subjects who are considered to meet the inclusion /exclusion criteria will receive mdr-end regimen for 9 months (or 12 months) during the treatment period according to the 5th edition of the korean guidelines for tuberculosis, and will be followed-up for 12 months after the end of treatment.


Eligibility criteria:
inclusion criteria: 1. adults aged 19 years or older who have been diagnosed with multidrug resistant pulmonary tuberculosis 2. adults prescribed mdr-end regimen according to the korean guidelines for tuberculosis after being informed of this study from the investigator and signing an informed consent form exclusion criteria: 1. patients with confirmed quinolone resistance 2. patients with hypersensitivity to one or more of the following drugs: delamanid, linezolid, levofloxacin, and pyrazinamide 3. patients who are found to have contraindications according to the approved labels of delamanid, linezolid, levofloxacin, or pyrazinamide 4. patients with or with a history of optic neuritis or peripheral neuritis 5. patients with genetic problems such as galactose intolerance, lapp lactase deficiency, or glucose-galactose malabsorption 6. pregnant or lactating women 7. women of childbearing potential who are unwilling to use appropriate contraception during the study treatment
long-term evaluation of primary trapeziectomy and placement of a regjoint implant in the treatment of rhizarthrosis

Conditions: Rhizarthrosis

Summary: in a society based on the use of everyday tools and objects, the loss of function of one or both thumbs due to rhizarthrosis can drastically reduce the quality of life. many patients are refractory to preservative treatments.therefore, multiple arthroplasty techniques were developed. trapeziectomy, with or without tendon interposition, gives very good results in terms of pain, function or force. however, it can result in a reduction of the size of the column of the thumb, therefore leading to a loss of force. replacement of the trapezo-metacarpal joint with prosthetic material is also proposed and has the advantage to avoid the reduction of the thumb column. several models are available, mono or bipolar, with a conical or hemispherical cup. another option is the placement of implants. they were first used when a partial trapeziectomy was possible to counter the collapse of the column and are made of different materials such as metal, silicone, ceramic, pyrocarbon , and gelfoam. the bioabsorbable poly-ld-lactide implant (pldla) is a relatively new possibility for the reconstruction of small joints. studies have previously revealed that the pldla implant is biocompatible and represents a good alternative to arthroplasty by tendon interposition in the reconstruction of the trapezo-metacarpal articulation with osteoarthritis. in this study, the investigators will investigate the long term effects (1 year after placement) of the regjoint, a poly-ld-lactide implant (pldla).


Eligibility criteria:
inclusion criteria: * adults\> 18 years * patients having had a trapeziectomy for more than one year, because of chronic rhizarthrosis defined by pain and radiographic signs, aka articular pinching, bone erosion and potential subluxation of the trapezo-metacarpal joint. exclusion criteria: * surgery less than 1 year ago. * concomitant pathology of the thumb or wrist (recent injury or trauma, quervain tenosynovitis, carpal tunnel syndrome, dupuytren, jumping finger). * trapeziectomy secondary to distal prosthesis and scaphoidectomy.

Keywords: rhizarthrosis regjoint trapeziectomy
the effects of covid-19 infection on respiratory muscle strength and core stabilization

Conditions: COVID-19; Pandemic, COVID-19; Corona Virus Infection

Summary: world health organization (who) novel-19 corrosion disease (covid) in 2019 without being used by a pathway caused by the sars-cov-2 virus. after the acute period in covid-19 patients, muscle weakness may continue in breathing, weakness, and training. the effects on core stabilization, pulmonary functions, respiratory muscle strength, physical activity scores and quality of life in healthy adults who do not have covid-19 who do regular exercise may be higher than in healthy adults who do regular exercise with covid-19.

the type of our study was planned as case-control. 50 exercises will be included in our study. the first covid-19 (n= 25) is healthy, and the second group will come from the successful group without covid-19 (n=25). between february and april, a student will accept participating in the clinic at bezmialem foundation university. after being informed about it, the attached form will be signed. in addition, participants will be asked to fill in our attached document, including demographic and clinical studies, in a face-to-face interview. all body exercises, breathing muscle test, six-minute walking test, mcgill core endurance test, short-form test, and quality of life test were planned in our two groups. the results of these tests will be evaluated by testing and checking.

Eligibility criteria:
inclusion criteria: 1. to be between the ages of 18-50, 2. volunteering to participate in the research, 3. those who have done aerobic exercise at least three days a week in the last three months exclusion criteria: 1. neurological deficits in the upper or lower extremities, 2. fractures or orthopedic problems in the upper or lower extremities, 3. cardiovascular diseases that prevent rehabilitation, 4. systematic rheumatic disease (rheumatoid arthritis, ankylosing spondylitis), 5. history of surgery in the last three months, 6. patients with spine problems, 7. smokers, 8. patients with chronic respiratory problems.

Keywords: covid-19 coronavirus respiratory physiotherapy core stabilization
adapting a secondary prevention program for nonstudent emerging adult drinkers

Conditions: Alcohol Drinking

Summary: emerging adulthood is a period of heightened vulnerability for problematic alcohol use. considerable research has been devoted to reducing alcohol risks in college student populations, though far less effort has focused on their noncollege-attending peers. research targeting nonstudent emerging adults is critical as this group is at risk for experiencing alcohol-related harms. consequently, the main objective of the present study was to examine the preliminary efficacy of a brief personalized feedback intervention (pfi) tailored for nonstudent at-risk drinkers.


Eligibility criteria:
inclusion criteria: * study eligibility included being 18 to 25 years old, having no prior or current college attendance (e.g., technical/vocational programs, associate's degree programs, or four year college programs), and not being currently enrolled in high school. high school completion was not a required eligibility criteria. they also had to report engaging in a minimum of two heavy drinking episodes (i.e., 4/5+ standard drinks for women/men on one occasion) in the past month exclusion criteria: * exclusion criteria included consumption above 40 drinks weekly and/or a history of substance use treatment
clinical study on the safety and efficacy of cd7 car-t cell sequential allo-hsct and kidney transplantation in the treatment of siod

Conditions: Schimke Immuno-osseous Dysplasia

Summary: a clinical study on the safety and effectiveness of cd7 car-t cell sequential allo-hsct and kidney transplantation in the treatment of schimke immuno-osseous dysplasia

this is a single-arm, open-label, dose-escalation clinical trial to evaluate the safety and efficacy of cd7 car-t cell sequential allo-hsct and kidney transplantation in patients with schimke immuno-osseous dysplasia. it is planned to enroll 20 participants in this trial.

Eligibility criteria:
inclusion criteria: * 1. diagnosed as siod and was in stage 5 of chronic kidney disease * 2. having allogeneic hsct indications, at least suitable donors (relatives) for haploidentical allogeneic transplantation and kidneys from stem cell transplantation donors; * 3. serum total bilirubin ≤ 1.5 times the upper limit of normal, and serum alanine aminotransferase (alt) and aspartate aminotransferase (ast) were both ≤ 3 times the upper limit of the normal range. * 4. echocardiogram shows left ventricular ejection fraction (lvef) ≥ 50%; * 5. there is no active pulmonary infection, and the oxygen saturation during air inhalation is more than 92%； * 6. estimated survival time ≥ 3 months; * 7. ecog performance status 0 to 1; * 8. pregnant/lactating women, or male or female patients who have fertility and are willing to take effective contraceptive measures at least 6 months after the last cell infusion during the study period; * 9. those who voluntarily participated in this trial and provided informed consent; exclusion criteria: * 1. allergic to pretreatment measures * 2. received any containing atg/alg such ist、alemtuzumab、high-dose cyclophosphamide (≥ 45mg/kg/day) , received csa treatment within 6 months, or used thrombopoietin receptor (tpo-r) agonists in the past; * 3. patients with the history of epilepsy or other cns disease; * 4. patients with prolonged qt interval time or severe heart disease; * 5. previous recipients of allogeneic hematopoietic stem cell transplantation or organ transplantation * 6. people infected with hiv, active hepatitis b or hepatitis c virus, and patients with active infection who are not cured; * 7. the proiferation rate is less than 5 times response to cd3/cd28 co-stimulation signal; * 8. patients with malignant tumor; * 9. people with other genetic diseases； * 10. after receiving cd7 car-t treatment, patients who were unable to accept subsequent kidney transplantation due to severe infection or poor amplification of car-t in vivo. * 11. any situation that researchers believe may increase the risk to the subjects or interfere with the trial results.

Keywords: car-t allo-hsct kidney transplantation