Kornimate/medical-research-clean huggingface dataset:
effects of hippotherapy on physical fitness and attention in cerebral palsy

Conditions: Cerebral Palsy; Physical Activity; Attention Disorder

Summary: this research analyzes whether hippotherapy improves the physical activity, cardiopulmonary fitness, and attention in children with cerebral palsy and whether this enhances their general health and quality of life.

this research aims to promote hippotherapy by scientifically proving its therapeutic effects and mechanism to contribute to improving the health and quality of life of the patients as well as reducing their global burden of disease by shifting the current passive "therapy-oriented" paradigm to a more proactive "participation-oriented" paradigm. ever since physical activity and physical fitness have been reported to have an inverse relationship with the mortality rate, especially deaths due to cardiovascular disease, various efforts have been made to optimize physical activity and physical fitness among children with cerebral palsy. adhd is one of the most common coexisting conditions of cerebral palsy. more participation in engaging sports activities like therapeutic riding is anticipated to improve patient health and their quality of life. hippotherapy is expected to improve clinical symptom of adhd in children with cerebral palsy while preventing possible ensuing psychiatric disorders, thereby bringing significant improvement in their health and quality of life.

Eligibility criteria:
inclusion criteria: * diagnosis of spastic cp * gmfcs level i-iii * weight \< 35kg * ability to walk independently with or without an assistive device * ability to comply with the study protocol and follow verbal directions exclusion criteria: * botulinum toxin injection within 3 months * orthopedic surgery within 1 year (difficulty performing one step instructions) * moderate to severe intellectual disability * uncontrolled seizure * poor visual or hearing acuity * patients who weigh more than 35 kg * hip dislocation * scoliosis more than 30 degrees * musculoskeletal surgery within 1 year

Keywords: cerebral palsy hippotherapy cardiopulmonary fitness physical activity attention
fragility fracture integrated rehabilitation management (firm)

Conditions: Hip Fractures

Summary: a number of studies for clinical pathway (cp) after hip fracture have been suggested to improve post-fracture outcome. however, cp is not carried out properly in most countries due to inadequate system and awareness, and lack of interdisciplinary approach among orthopaedists, geriatricians and rehabilitation specialists. thus, we developed fragility fracture integrated rehabilitation management (firm), a new standardized guideline and the multidisciplinary fragility fracture care based on the clinical rehabilitation pathway and conducted a prospective study to evaluate the effects of firm compared to conventional rehabilitation.

the purpose of this prospective study to develop a standardized fragility fracture integrated rehabilitation management (firm) based on the critical rehabilitation pathway for fragility fractures. 1. standardization of initial evaluation for fall and re-fracture risks before rehabilitation 2. standardization in initial screening for prevention for common complication after fracture and early diagnosis 3. evidence based standardization in rehabilitation after fragility fracture 4. development for safe return to normal daily life

Eligibility criteria:
inclusion criteria: 1. type of fracture : femoral neck, intertrochanteric, subtrochanteric fracture 2. type of surgery : bipolar hemiarthroplasty, tha, orif exclusion criteria: 1. surgery not for hip fracture, but for infection, arthritis, implant loosening, avn 2. femur shaft fracture, acetabular fracture, periprosthetic fracture, pathologic fracture for tumor 3. combined multiple fracture (ex. upper extremity) 4. revision operation 5. disagree to participation for clinical trial 6. severe cognitive dysfunction (obey command ≤1)

Keywords: rehabilitation multi-disciplinary rehabilitation clinical pathway fragility
a randomised trial of sertraline, cognitive behaviour therapy & combined therapy for postnatal depression

Conditions: Depression; Anxiety

Summary: th purpose of this study is to determine whether dual psychological and pharmacological treatment is superior to either mono-therapy alone in the treatment of postnatal depression.


Eligibility criteria:
inclusion criteria: * women with an infant \> 2 months and \< 8 months of age * infant born after a full-term pregnancy * infant born with no congenital abnormalities * diagnosis of depression with postnatal onset according to the diagnostic and statistical manual of mental disorders 4th edition (dsm-iv). exclusion criteria: * positive serum pregnancy test; * concurrent psychiatric disorder (excepting co-morbid anxiety); * recent history of antidepressant usage (within the last month); * history of major allergy or drug allergy; * history of substance abuse; * prior non-response to sertraline, or prior non-response to adequate trials of two selective serotonin reuptake inhibitors (ssris); * predisposition to headache, migraine or nausea; * tobacco habit in excess of 10 cigarettes per day; * caffeine consumption in excess of 6 cups of coffee/tea or cola-flavoured drinks per day; * ongoing dental work; * extreme levels of depression (psychotic); * suicidal intent; * participation in any medical trial within the previous three months;
syndesmotic injury and fixation in supination-external (se) ankle fractures

Conditions: Trauma

Summary: the aim of our study was to determine whether transfixation of unstable syndesmosis is necessary in supination-external rotation type ankle fractures. our hypothesis was that syndesmotic ligaments heal at the proper length after malleolar reduction and that syndesmotic transfixation is not needed in supination-external rotation fracture types.

a prospective randomized study comparing syndesmotic transfixation to no fixation in ao/ota weber b-type ankle fractures was designed. to show a clinically significant difference (olerud-molander ankle score 20%, standard deviation (sd) 24 points, from our previous study) between the groups, the sample size was estimated (α=0.05, β=0.2, 20% drop out) to be 30 patients per group. all skeletally mature patients (≥16 years old) with a unilateral lauge-hansen supination-external rotation type 4 ankle fractures treated within one week after injury at our hospital were considered eligible for the present study. exclusion criteria were bilateral ankle fractures, pathologic fractures, concomitant tibial shaft fractures, previous significant injury or a fracture of either ankle, significant peripheral neuropathy, soft tissue infection in the region on either injured ankle, or inability to complete the study protocol. after bony fixation, the 7.5-nm standardized external rotation (er) stress test for both ankles was performed under fluoroscopy. a positive stress examination was defined as a difference of more than 2 mm side-to-side in the tibiotalar or tibiofibular clear spaces on mortise radiographs. if the stress test was positive, the patient was randomized to either syndesmotic transfixation with 3.5-mm tricortical screws or no syndesmotic fixation. clinical outcome was assessed using the olerud-molander scoring system, rand 36-item health survey, and visual analogue scale (vas) to measure pain and function after a minimum 1-year of follow-up.

Eligibility criteria:
inclusion criteria: * all skeletally mature patients (≥16 years old) with a unilateral lauge-hansen supination-external rotation type 4 ankle fractures treated within one week after injury at our hospital exclusion criteria: * bilateral ankle fractures, pathologic fractures, concomitant tibial shaft fractures, previous significant injury or a fracture of either ankle, significant peripheral neuropathy, soft tissue infection in the region on either injured ankle, or inability to complete the study protocol.

Keywords: ankle; fracture; syndesmosis;
part 2 on the study prevalence of sars -cov2 carriage in asymptomatic and mildly-symptomatic children (coville2) (who)

Conditions: COVID19

Summary: france and in particular the paris area was one of the countries most affected by the pandemic covid19. school closures and a generalized lockdown of the population were instituted in france from 17 march 2020 to 10 may 2020. schools and nurseries have reopened partially since 11 may 2020. from 2 june, this reopening is more widespread. by combining the search for sars-cov2 viruses by pcr and micro-method serology we will be able to evaluate both the infection at a given time and also older contact with sars-cov2. the temporal knowledge of the prevalence of sars-cov2 carriage and the serological status (igm and igg) after return to the community are crucial information to evaluate the speed of spread of the virus in children. this is the objective of coville2, phase 2 of the coville study.


Eligibility criteria:
inclusion criteria: * birth to 15 years old * taking over the community (kindergarten, school, college, holiday centre, etc.) for at least 1 week exclusion criteria: * refusal to participate

Keywords: rt-pcr sars-cov-2 serology sars-cov-2 children
in-office and at-home tooth bleaching using low concentration peroxides.

Conditions: Discolored Teeth

Summary: to evaluate the efficacy, safety and impact on quality of life related to oral health of home and office tooth whitening techniques in young individuals.

the aim of this study is to evaluate the efficacy, safety and impact on quality of life related to oral health of tooth whitening techniques in young individuals. it will be a randomized, parallel and single blind. participants are divided into three groups (n = 30) according to bleaching technique to be performed (g1 = office / hydrogen peroxide 6%; g2 = office / hydrogen peroxide 15%; g3 = home / carbamide peroxide 10%). the color of the teeth will be evaluated in seven different times, using the color scale vita master classic 3d and spectrophotometer vita easy shade advance. igm (1986) - the presence of tooth sensitivity by visual analogue scale and gingival security through modified gingival index will be evaluated. the impact of bleaching quality of life will be assessed using the brazilian version of the oral impact on daily performance (oidp). the instrument will be applied in interview form at two different times at baseline (t0) and thirty days after the first evaluation (t4). statistical analysis include descriptive analysis and testing to compare the two bleaching techniques as the color change, sensitivity, gum irritation and impact on quality of life.

Eligibility criteria:
inclusion criteria: * tooth color ranging from a3 or darker, teeth with no stains and restorations without whitening experience exclusion criteria: * participants with gingivitis and periodontal disease, the total biofilm accumulation greater than 30%, severe crowding dental, smoking with tooth sensitivity and pregnant women.

Keywords: carbamide peroxide hydrogen peroxide quality of life
clinical study on post evaluation after listing of qizhi weitong granules

Conditions: Functional Dyspepsia; Traditional Chinese Medicine

Summary: this study is a randomized, double blind, double dummy, multicenter, parallel controlled clinical trial, the investigators objective is to evaluate the efficacy and safety of qizhi weitong granules in the treatment of functional dyspepsia.

this study is a randomized, double blind, double dummy, multicenter, parallel controlled clinical trial, the investigators objective is to evaluate the efficacy and safety of qizhi weitong granules in the treatment of functional dyspepsia. the experiment will be carried out in 8 sub centers at the same time, and the investigators estimated that there will be 384 cases of income, including the experimental group and the control group (n = 192), and the investigators choose mosapride citrate tablets for drug control.

Eligibility criteria:
inclusion criteria: 1. metting the diagnostic criteria of functional dyspepsia in rome iv. 2. the subjects were informed, and the subjects voluntarily signed informed consent. 3. the subjects have reading ability. exclusion criteria: 1. patients suffering from gastric ulcer, gastroscopy see bleeding and mucosal erosion, pathological examination showed atrophy of gastric mucosa, intestinal metaplasia or dysplasia. 2. patients with hp infection positive. 3. patients with gastroesophageal reflux disease. 4. patients with digestive system organic lesions. 5. the patient had a history of stomach or abdominal surgery. 6. patients had taken the relevant drugs in the past 2 weeks. 7. patients suffering from severe illness affecting survival. 8. pregnant or lactating women. 9. participating in clinical trials of other drugs. 10. long term using of sedative hypnotics. 11. suspected or true alcohol, drug abuse history.

Keywords: functional dyspepsia qizhi weitong granules traditional chinese medicine
pilot study of strength and balance training program for persons with oxaliplatin induced neuropathy

Conditions: Neuropathy; Gastrointestinal Cancer

Summary: the purpose of this study is to evaluate the effects on strength, balance, and neuropathic symptoms (numbness, tingling, pain, weakness) of a 12 week, bi-weekly, 60 minute, group exercise program designed to improve lower extremity strength and balance with persons with oxaliplatin induced peripheral neuropathy.


Eligibility criteria:
inclusion criteria: * prior history of colon cancer * completed oxaliplatin based chemotherapy at least 6 months prior to enrollment * report numbness, tingling, or pain of the lower extremities ≥ 4 by chemotherapy induced peripheral neuropathy (cipn) visual analog rating * karnofsky performance status of at least 60% * able to read, write, and understand english exclusion criteria: * patients will be excluded from the study if they live outside of a 30 mile radius of the university of south florida, if they are currently undergoing chemotherapy or radiation therapy, or if they regularly (at least once a week) participate in strength or balance training exercises. the investigators will not exclude participants if they are participating in aerobic exercise, but we will collect that information so that the investigators may control for aerobic exercise in our data analysis.

Keywords: oxaliplatin induced peripheral neuropathy strength balance training program colon rectal
study of patients with itp estimating the proportion administering romiplostim correctly after receiving home administration training

Conditions: Immune Thrombocytopenic Purpura

Summary: cross-sectional study, observation made by healthcare professionals of subjects or caregivers, administering romiplostim at their first standard-of-care visit 4 weeks after training with the home administration training pack. further observations can also be recorded in the study if made within 16 weeks of enrolment. data will be collected from the subjects' dose diary at their first standard of care visit to ensure there were no problems with administration while not at the clinic.

this cross-sectional study involves direct observation by a healthcare professional of a series of subjects and caregivers in the act of administering romiplostim at their first standard-of-care visit occurring 4 weeks after training with the hat pack. further observations, if they occur, will also be recorded in the study if made within 16 weeks of enrolment. (additional observations are voluntary and are not required for study participation; they occur only if the healthcare professional requests them.) additionally, data will be collected from the subjects' dose diary at the first standard of care visit to ensure there were no problems with administration while not at the clinic.

Eligibility criteria:
inclusion criteria: * (1) adult itp patient, treated per eu summary of product characteristics (smpc), or caregiver new (or at least a 3 month gap) to administering romiplostim, * (2) has received hat pack training, * (3) available at standard-of-care medical visit 4 weeks (range 2 to 8 weeks) after hat pack training, * (4) patient provides informed consent. exclusion criteria: -no exclusion criteria for this observational study

Keywords: romiplostim, nplate, immune thrombocytopenic purpura
digital assessment of well-being in new parents

Conditions: Postnatal Depression

Summary: the mental health of new parents around the time of the birth of their baby has been identified as a key priority in the nhs (national health service) long term plan. at present, there is no nationally implemented method for monitoring parents' mental health, although the use of the edinburgh postnatal depression scale (epds) has been recommended. this is a paper based questionnaire administered by health visitors in the postnatal period. for the purposes of this project, the investigators contacted health visitors in manchester to find out how they use epds in practice. currently, health visitors only use the questionnaire if they feel there is a need during visits, and the questionnaire is not kept (only the overall score). since almost 20% of mums develop postnatal depression, more systematic and thorough screening is needed. the investigators developed an app version of the epds which takes less than 2 minutes to complete on a smartphone. it is anticpated that this will be a more accessible and practical method of conducting this important assessment. this project is a feasibility study to find out whether an app would be a feasible, acceptable, valid and safe way to monitor perinatal mental health in women and their partners. the investigators aim to recruit 20 women and their partners in late pregnancy (after 36 weeks gestation) and ask them to use the app. the app will prompt completion of the epds once per day until 6 weeks postnatally. participants' responses on the app will be transferred to a secure server at the university of manchester. participants will be invited to complete a paper version of the epds at the beginning and end of the study to check validity. they will also be asked to complete a questionnaire measuring the acceptability of the app and to take part in a brief qualitative interview at the end of the study.


Eligibility criteria:
the investigators aim to recruit 20 women in late pregnancy from the antenatal assessment unit and the antenatal clinic at st mary's hospital, manchester. their partners will be invited to participate where applicable. inclusion criteria for pregnant women: * after 36 weeks gestation * aged over 18 years * fluent in english * under the care of manchester university nhs foundation trust exclusion criteria for pregnant women: * current stillbirth (women experiencing a stillbirth during the study will be withdrawn from the study) * fetal abnormality * multiple pregnancy inclusion criteria for partners: * male or female partners of a mum participating in the study * aged over 18 * fluent in english.

Keywords: digital screening mental health smartphone app postnatal depression maternal mental health paternal mental health
a phase 2 study to evaluate the efficacy and safety of hs-20004 in type 2 diabetes subjects.

Conditions: Diabetes Mellitus, Type 2

Summary: the study is being conducted to evaluate the efficacy and safety of noiiglutide injection as mono-therapy with different doses in subjects with type 2 diabetes compared to placebo for 16 weeks.


Eligibility criteria:
inclusion criteria: * type 2 diabetes diagnosed for more than 3 months * hba1c between 7.5 and 11.0 % (inclusive), and fpg ≥9.0mmol/l * body mass index (bmi) between 23 and 35 kg/m2(inclusive) exclusion criteria： * history or family history of drug allergy * subjects treated with any other anti-diabetes drug within 8 weeks before screening * participation in any other clinical trial of an investigational medicinal product within 3 months before screening * smoker or alcohol abuse * currently use or plan to use systemic corticosteroid * history of recurrent severe hypoglycemia * type 1 diabetes or secondary diabetes mellitus * uncontrolled active or untreated hypertension * history of pancreatitis (acute or chronic) * family or personal history of multiple endocrine neoplasia type 2 (men2) or medullary thyroid carcinoma (mtc) * serious unconscious hypoglycemia history * within the past 6 months before screening any of the following: coronary artery revascularization, patients presently classified as being in new york heart association (nyha) class iii or iv, myocardial infarction, stroke or unstable angina and/or persistent and clinically significant arrhythmias * female subject of childbearing potential who does not use an acceptable method of birth control, is pregnant or planning a pregnancy, or breastfeeding, or male subject who does not use an acceptable method of birth control * subject was not used for the study as determined by the investigator
study of kn026 monotherapy or combination therapy in patients with metastatic breast cancer

Conditions: Metastatic Breast Cancer

Summary: this is an open-label, three-cohort phase 2 study of kn026 in subjects with advanced breast cancer.

kn026 is an anti-her2 bispecific antibody that can simultaneously bind two non-overlapping epitopes of her2, leading to a dual her2 signal blockade.the her2- positive mbc subjects without systemic treatment will be enrolled in cohort 1 and received 30 mg/kg kn026 and docetaxol. the her2 low expression and hormone-receptor positive mbc subjects failed standard chemotherapy and hormone therapy will be enrolled in cohort 2 and received 30 mg/kg kn026 monotherapy. the her2 low expression and hormone-receptor negative/weak positive mbc subjects failed standard chemotherapy will be enrolled in cohort 3 and received 30 mg/kg kn026 and 5 mg/kg kn046

Eligibility criteria:
inclusion criteria: * male or female subject \>= 18 years * histologically/cytologically confirmed, locally advanced unresectable or metastatic breast cancer * ecog score 0 or 1 * life expectancy \>3 months * according to the definition of recist1.1, the patient has at least one measurable lesion * adequate organ function prior to start treatment with kn026 * able to understand, voluntarily participate and willing to sign the icf exclusion criteria: * accepted any other anti-tumor drug therapies within 4 weeks before fist dose * accepted radiotherapy within 4 weeks before enrollment * subjects are eligible with clinically controlled and stable neurologic function \>= 4 weeks, which is no evidence of cns disease progression; subjects with spinal cord compression and cancerous meningitis are not eligible * pregnant or nursing females；or intend pregnancy within this study period or within 6 monthes after the end of this study * history of immunodeficiency, including hiv positive or other acquired, congenital immunodeficiency disease, or a history of organ transplantation * history of immunodeficiency, including hiv positive or other acquired, congenital immunodeficiency disease, or a history of organ transplantation * cavity effusion (pleural effusion, ascites, pericardial effusion, etc.) are not well controlled, and need locally treatment or repeated drainage