Kornimate/medical-research-clean huggingface dataset:
piloting home-based movement-to-music among adolescents with cerebral palsy: a randomized controlled trial

Conditions: Cerebral Palsy

Summary: this study pilots the efficacy of a home-based movement-to-music program for increasing physical activity participation among adolescents with cerebral palsy. half of the participants will receive the movement-to-music program immediately, which will include 4 weeks of exercise videos and periodic behavioral coaching calls. the other half of participants will wait 4 weeks before receiving the m2m program.

the movement-to-music program has been tested among adults with physical disabilities and is currently being used in ongoing scale-up clinical trials. current evidence suggests that the program can increase aspects of physical function among adults. the present study aims to test whether the same program can be used among adolescents with cerebral palsy. study findings will be used to examine whether the videos require modifications prior to being implemented in a future scale-up trial for adolescents people with cerebral palsy.

Eligibility criteria:
inclusion criteria: 1. have a diagnosis of cerebral palsy 2. be able to exercise with arms or be assisted through the movements by a parent 3. be between the ages of 10-19 years 4. have access to a wi-fi internet connection at your home 5. have access to a device that is capable of viewing videos from youtube (a television, computer tablet, laptop, or desktop) exclusion criteria: 1. does more than 60 minutes of moderate-to-vigorous physical activity per day in a normal week 2. has complete blindness or deafness

Keywords: exercise physical activity telehealth
a proof-of-concept study to examine quc398 in participants with knee oa

Conditions: Osteoarthritis, Knee

Summary: the purpose of the study is to find out if the investigational treatment named quc398 has beneficial effects on osteoarthritis knee pain and knee cartilage, and if it is safe and well tolerated.

this is a phase iia study to establish the effect of quc398 on pain and cartilage preservation in participants with symptomatic knee oa

Eligibility criteria:
inclusion criteria: * weight ≥ 50 kg and body mass index 18 -35 kg/m2 at screening 1 * kellgren-lawrence grade 2 to 4 in the tibio-femoral compartment in the target knee confirmed by radiography in standing weight-bearing fixed flexion position and posterior-anterior view, at screening 1 * mjsn 1-2 in the medial tibiofemoral compartment of the target knee, confirmed with xray by central reader at screening 1 * symptomatic oa with moderate to severe pain (corresponding to pain nrs ≥ 5 to ≤ 9) in the target knee for the majority of days in the last 3 months prior to screening 1, as per participant's judgement * symptomatic oa with moderate to severe pain (corresponding to pain nrs ≥ 5 to ≤ 9) in the target knee at screening 1 and 2 . moderate to severe oa pain (corresponding to pain nrs ≥5 to ≤9) in the target knee during the last 7 days prior to screening 3, confirmed by: completed pain diary for at least 6 of the last 7 days prior to screening 3, and diary reported pain nrs ≥5 to ≤9 for at least 6 of the last 7 days prior to screening 3 * koos pain subscale ≤ 60 in the target knee at screening 1, screening 2, and screening 3 exclusion criteria: * painful ipsilateral hip oa defined as a pain nrs ≥3 on the majority of days in the last 3 months prior to screening 1, as reported by the patient * symptomatic, patello-femoral pain in the target knee as per investigator's examination at screening 1 * severe malalignment \> 7.5º in the target knee (either varus or valgus), measured using standardized knee x-ray at screening 1 * patient unable or unwilling to undergo mri or presenting absolute contraindications to mri * previous exposure to any adamts-5 drug, including quc398. * history or current diagnosis of ecg abnormalities other protocol-defined inclusion/exclusion criteria may apply

Keywords: quc398 osteoarthritis of knee osteoarthritis of the knee knee joint osteoarthritis
jacardi: a ehealth and health literacy educational training to support older patients with type ii diabetes

Conditions: Type 2 Diabetes

Summary: the jacardi trial is a multicenter study involving an educational training, with the general objective to improve the ehealth of older adults in relation to the management of type 2 diabetes.

the jacardi trial is a multicentric study organized as a blended didactic and interactive educational training, with the general objective to improve the ehealth of older adults in relation to the management of type 2 diabetes, thus contributing to independent living, and reduce risks of negative consequences for the health status and quality of life. the trial will be preceded by a pre-study, needed to personalize and finalize the contents of the training, together with the beneficiaries of the study. in particular, during the pre-study, a population with similar characteristics of the target group will be involved in focus groups to refine the contents and practicalities of the training before the recruitment starts. the primary end-point of the jacardi trial is the improvement of the ehealth literacy after the conduction of the training, to be measured through the eheals scale, after 10 weeks of training. the training consisting of 5 modules and will be conducted over 10 weeks (one session every other week), with each session lasting an average of 90 minutes.

Eligibility criteria:
inclusion criteria: * low ehealth literacy (eheals scale ≤ 29) * no acute or untreated medical problems * mini mental state examination (mmse) ≥ 24 * geriatric depression scale (gds) \< 2 exclusion criteria: * a myocardial infarction or stroke within 6 months * painful arthritis, spinal stenosis, amputation, painful foot lesions or neuropathy limiting balance and mobility * uncontrolled hypertension * advanced parkinson's disease or other neuromuscular disorder * metastatic cancer or immunosuppressive therapy * significant visual or hearing impairment

Keywords: type 2 diabetes ehealth literacy elderly subjects wellbeing quality of life
study to assess seroprevalence of hepatitis a, hepatitis b and bordetella pertussis in mexico

Conditions: Hepatitis A; Viral Hepatitis Vaccines

Summary: this study will assess the seroprevalence of hepatitis a virus (hav), hepatitis b virus (hbv) and bordetella pertussis (b. pertussis) in adolescents and young adults in mexico.

a random sample of subjects constituting adolescents and young adults (≥10 - ≤25 years of age) will be selected from the total population that participated in the encuesta nacional de salud y nutrición (ensanut) 2012 in mexico. data (through structured questionnaires and interviews) and stored serum samples of the selected subjects obtained from the ensanut 2012 will be used in this study. a subset database will be designed by the national institute of public health (niph) for the purpose of this study. extracted data and laboratory results of the selected subjects will be captured in this database.

Eligibility criteria:
inclusion criteria: * written informed consent for the ensanut 2012 was obtained according to local regulations from the subject/ from the parent(s)/ legally acceptable representative (lar) of the subject. * a male or female between and including 10 and 25 years of age, who previously participated in the ensanut 2012 in mexico. exclusion criteria: * information required for the study is not available or incomplete. * inadequate or insufficient serum sample to perform the laboratory tests for this study. * serum sample is wrongly identified.

Keywords: mexico adolescents hepatitis seroprevalence pertussis young adults
validation of sms protocol for hcc screening in high-risk patients

Conditions: Hepatocellular Carcinoma

Summary: the investigators will assess implementation of the proposed sms protocol as a surveillance tool in patients at high risk of developing hcc in a prospective multicenter study.

over the past 20 years, the prevalence of hcc has been growing extensively. hcc makes up for 75-85% of primary liver cancers and has a poor prognosis with a 5-year survival rate lower than 20%. the incidence of hcc is higher in patients diagnosed with hepatitis and/or cirrhosis. the current guidelines recommend a bi-annual us screening of this patient group. however, recent meta-analysis showed that the sensitivity of such us surveillance for detecting early stage hcc is merely 47%. in addition, early detection of small hcc lesions (with a diameter less than 2 cm) will provide a higher survival chance. it is therefore of major importance to develop a better surveillance tool. the use of mri should be considered as a surveillance tool for this patient group. in comparison to us, mri come with high cost, long duration of the scan, limited availability and a potential risk related to the use of contrast agents. the investigators have developed and validated a short mri surveillance (sms) protocol for hcc screening in high-risk patients. this protocol has been evaluated among a database of 215 patients. in this prospective, multicenter study, the investigators will evaluate the value of the sms protocol in a high-risk patient group and they will assess the cost-effectiveness of the sms protocol as a surveillance tool with respect to a bi-annual us screening.

Eligibility criteria:
inclusion criteria: * male and female patients above 18 years of age * high-risk patients with cirrhosis and/or hepatitis exclusion criteria: * patients below the age of 18 years * patients who will not sign the informed consent form * patients with general contra-indications for undergoing mri examination

Keywords: cirrhosis hepatitis hepatocellular carcinoma mri surveillance
evaluation of the efficacy and safety of methylprednisolone combined with the jak inhibitors in the treatment of toxic epidermal necrolysis

Conditions: Toxic Epidermal Necrolysis

Summary: to evaluate the efficacy and safety of methylprednisolone combined with the jak inhibitor abxitinib and tofacitinib in the treatment of toxic epidermal necrolysis


Eligibility criteria:
inclusion criteria: 1. age 18 and above. 2. diagnosed with sjs/ten according to the registry of severe cutaneous adverse reactions (regiscar) criteria. 3. liver and kidney function is within acceptable ranges. 4. blood parameters, including complete blood count, coagulation function, and platelet count, are within acceptable ranges. 5. patients must sign an informed consent form, understanding the risks and potential benefits of the treatment. 6. patients need to be capable of participating in follow-up visits and treatment plans. exclusion criteria: 1. history of allergy to jak inhibitors. 2. pregnant or breastfeeding women. 3. severe infectious conditions. 4. history of central nervous system demyelinating diseases. 5. history of lymphoproliferative diseases. 6. active and latent tuberculosis. 7. hiv carriers with a cd4+ t cell count lower than (\<200/ml). 8. active hbv/hcv infection. 9. coagulation disorders or a tendency for thrombosis. 10. significant abnormalities in blood routine indicators. 11. liver or kidney dysfunction.
the effects of anesthesia type on the prognosis of hip fracture surgery on elderly patients

Conditions: Postoperative Complications; Postoperative Mortality

Summary: the aim of this study is to figure out whether anesthesia type have an influence on the prognosis of hip fracture surgery.30-day mortality and morbidity after the surgery are our main observational index,and according to literature and our experience,regional anesthesia may have a better prognosis after hip fracture surgery compared with general anesthesia.

hip fracture is a common disease among elderly people,and has a high mortality and morbidity.but,seldom practice can be done to improve this condition.for a long time,whether anesthesia type could influence the prognosis after surgery is controversial.several studies have confirmed regional anesthesia may be better for patients for its fewer complications.but most studies are retrospective,and information may be less convincing .besides,as a matter of fact,patients of different anesthesia type may have different status,so,a scoring system may be need for comparing the status of patients of different groups. our study is a prospective observational trial.patients needing hip fracture surgery are divided into two groups according to the anesthesia type during surgery:regional anesthesia group(ra),general anesthesia group(ga).to evaluate the status of patients before surgery,we use orthopedic possum scoring system.it consists of 12 physiological factors and 6 operative severity factors.then,we will observe outcome of the two groups and record every complication after surgery.finally,the initial and adjusted morbidity and mortality according to orthopedic possum scoring system of the two groups are compared.

Eligibility criteria:
inclusion criteria: * patients with hip fracture; * need surgery; * anesthesia type is regional anesthesia or general anesthesia; * age≥60 years. exclusion criteria: * choosing conservative treatment; * other types of anesthesia or without anesthesia.

Keywords: morbidity mortality hip fracture anesthesia type possum
insomnia and drug relapse risk

Conditions: Poor Quality Sleep; Opiate Addiction

Summary: the purposes of this study are: 1. to evaluate the relationship between subjective complaints of sleep and objective measures of sleep quality, as measured through polysomnography, and 2. to evaluate the efficacy of trazodone, as compared to placebo, in individuals early in methadone maintenance.

individuals new to methadone maintenance will be asked to participate in this 6-month, double-blind, randomized control trial. all participants will complete a baseline interview, a medical screening and follow-up interviews at 1, 3 and 6-months post-baseline. these interviews take approximately 60 minutes, and survey various areas of the participants' experiences, including basic demographic information, mood, sleep and substance use areas. all participants will also be asked to complete a 2-night sleep monitoring at the time of the baseline interview and again at the 1-month follow-up interview. participants will also receive study medication; half of the participants will receive a placebo medication, and the other half will receive trazodone, a widely-prescribed, well-tolerated, low side-effect medication. neither the participant nor the study staff will know which medication the participant is taking while the participant is actively enrolled in the study. this information can be available to the participant at the end of his/her study participation.

Eligibility criteria:
inclusion criteria: * recent methadone maintenance enrollment * sleep complaints as measured by the pittsburgh sleep quality index (psqi) * no medical contraindications to trazodone exclusion criteria: * methadone maintenance enrollment not recent * no sleep complaints as measured by the psqi * medical contraindications to trazodone

Keywords: sleep quality methadone substance use
r-tpa thrombolytic therapy in combination with remote ischemic conditioning for acute ischemic stroke recovery

Conditions: Stroke, Acute

Summary: to detect the efficiency and safety of intravenous rtpa combined with ripc in acute ischemic stroke patients

remote ischemic post-conditioning, which consists of several brief cycles of intermittent ischemia-reperfusion of the arm or leg, may potentially confer a powerful systemic protection against prolonged ischemia in a distant organ. numerous reports have confirmed it strongest endogenous neuroprotection against brain injury after stroke. ren et al demonstrated that remote ischemic post-conditioning (ripc) performed in the hind limbs can not only significantly reduce the stroke volume within 3 hours in rat model, but also ameliorate the outcome of the behavioral test. a long-term repeated ripc therapy can also help improving neurological functions. a combination of ripc and tpa can help with neuroprotection which improves the neurological functions. thus, it is meaningful to transform these basic experimental results to the clinical treatment. in the recast-1 trial, ric has shown it safety and efficiency in ais patients without tpa. however, there is no further explanation for the patients with ivt. thus, in this study, we aim to demonstrate the efficiency and safety of ripc in ais patients performed rt-pa within 4.5 hours.

Eligibility criteria:
inclusion criteria: * male or female, age≥18; * clinical sign and symptoms consistent with the diagnosis of an acute ischemic stroke, onset of stroke symptoms within 4.5 h before initiation of intravenous rt-pa thrombolytic therapy; * baseline national institutes of health stroke scale (nihss) score of 4-15 (assessed before intravenous alteplase), mrs ≤1 before onset of stroke symptom; * no contraindication for mri. * informed consent obtained exclusion criteria: * cardioembolism； * contraindication for remote ischemic conditioning: severe soft tissue injury, fracture, or peripheral vascular disease in the upper limbs; * life expectancy \< 1 year; * pregnant or breast-feeding women; * unwilling to be followed up or poor compliance for treatment; (5) patients being enrolled or having been enrolled in other clinical trial within 3 months prior to this clinical trial.

Keywords: remote ischemic conditioning r-tpa thrombolytic therapy
trf-1101 assessment in sickle cell disease

Conditions: Sickle Cell Disease

Summary: this study is designed to assess the safety, tolerability, and activity of trf-1101 on microvascular blood flow, vascular endothelial injury, and vasoocclusive pain associated with sickle cell disease.


Eligibility criteria:
inclusion criteria: * be 18 years of age or older at the time of informed consent; * have a diagnosis of homozygous sickle cell anemia or sickle cell-beta° thalassemia; * have had 2 - 10 documented pain crises in the past year (pain crises are defined as visits to a medical clinic, emergency department or hospital, being bedridden and requiring constant analgesia at home for at least three days, or having a three-day interruption of life's activities \[i.e., school, work, planned leisure activity\] because of pain); * if female and of child bearing potential, have a negative serum or urine pregnancy test and be using an effective birth-control method with a history of reliability for the individual patient (use of mifepristone is not allowed); * be properly informed of the nature and risks of the clinical investigation, be willing and able to comply with all clinical investigation-related procedures and assessments, and sign an institutional review board (irb) approved informed consent form prior to entering the clinical investigation. exclusion criteria: * have a history of abnormal bleeding, stroke, moya moya vascular malformations, or any other contraindication to anticoagulation; * be currently taking anticoagulant or thrombolytic medication; * be currently taking an endothelin receptor antagonist, e.g., bosentan (tracleer®); * have a known sensitivity or allergy to heparin or related drugs; * have a history of thrombocytopenia (platelet count \< 100 x 103/mm3) induced by heparin or related drugs; * have had fewer than 2 documented pain crises in the past year; * have had a pain crisis within one month of screening or randomization; * if currently on or recently discontinued hydroxyurea treatment, have initiated or discontinued treatment or changed regimen within the past 6 months; * have had a transfusion within last 120 days or have hba% \> 15% from prior transfusion; * creatinine levels \> 1.53 mg/dl (135 umol/l); * alt levels ≥ 3 times normal; * platelet count \< 100 x 103/mm3; * inr \> 2.0; * be unable to tolerate oral medications; * have unreliable venous access; * be noncompliant with regular care; * have a positive pregnancy test, be currently lactating, or be trying to become pregnant; * have participation in an investigational drug or medical device study within previous 30 days; * have any other condition or circumstance that in the opinion of the investigator makes the patient a poor candidate for participation in the study.
importance of the current density in tens

Conditions: Spasticity

Summary: the purpose of this study is demonstrate the importance of density current of tens in the effect about h-reflex in healthy volunteers.

tens have been used to treatment against pain and reflex modulation. however, the most part of evidence do not show the current density. this parameter has been demonstrated like a important factor in the effect of the current about the outcome measures. this study show the difference between the same subjective sensation "strong but comfortable" in current density and the relation with the effect about h-reflex.

Eligibility criteria:
inclusion criteria: * participants will be volunteer healthy students of physiotherapy, university of castilla - la mancha, older than 18 years. exclusion criteria: * neuromuscular disease. * epilepsy. * trauma, surgery or pain affecting the upper limb, shoulder girdle or cervical area. * osteosynthesis material in the upper limb. * diabetes. * cancer. * cardiovascular disease. * pacemaker or other implanted electrical device. * take any drug (nsaids, corticosteroids, antidepressants, analgesics, antiepileptics, ...) during the study and in the previous 7 days. * presence of tattoos or other external agent introduced into the treatment or assessment area. * pregnancy. * sensitivity disturbance in lower limb.

Keywords: h-reflex current density tens
performance of tension free vaginal mesh (prolift) versus conventional vaginal prolapse surgery in recurrent prolapse.

Conditions: Pelvic Organ Prolapse

Summary: pelvic organ prolapse is a common problem. a lot of women have surgery for prolapse. the recurrence rate op pelvic organ prolapse after surgical treatment is high. placement of a mesh aims at reducing the recurrence rate, but mesh implants can cause complications. this study is designed to determine the effectiveness of one type of mesh (tensionfree vaginal mesh; prolift), compared with the standard prolapse surgery. a secondary objective is to track the complications of both procedures.

patients with recurrent prolapse after surgery can participate in this study. a total of 194 women will be included. at random 97 patients undergo a standard prolapse operation and 97 patients undergo an operation with the mesh. evaluation will take place during surgery, at the postoperative visit after six weeks, and after six months and twelve months. quality of life, degree of vaginal prolapse, subjective effectiveness, safety and incidence of complications will be evaluated. an amendment to the original study has been approved by the ethical committee to examine long term outcome of this rct at 7 years. this study was completed in december 2015.

Eligibility criteria:
inclusion criteria: * recurrent anterior and/or posterior prolapse pop-q stage 2 or more * patient has agreed to undergo implantation of tvm (prolift) or fascial plication * patient is willing to return for follow-up evaluation at 6 weeks, 6 months and 12 months * patient is willing to complete quality of life questionnaires at 6 and 12 months exclusion criteria: * patient is or wants to become pregnant * patient has had previous synthetic mesh procedure (a previous mid-urethral sling procedure is not an exclusion criterion) * patient has current urinary tract or vaginal infections * patient has a blood coagulation disorder * patient has a compromised immune system or any other condition that would compromise healing * patient has renal insufficiency and/or upper urinary tract obstruction * patient is unwilling or unable to return for evaluation * patient has had previous irradiation * patient has any malignancy * patient has large ovarian cysts of large myoma

Keywords: pelvic organ prolapse recurrence mesh complications treatment