Kornimate/medical-research-clean huggingface dataset:
reproductive health of couples of childbearing age: a community based prospective cohort study

Conditions: Reproductive Health; Time to Pregnancy; Infertility; Risk Factor; Medical Care

Summary: this community based prospective cohort study was established to investigate the fecundability of couples of childbearing age. data are collected regarding age, body mass index, education, menstrual regularity as well as childbearing history. results of routine examination of leucorrhea, blood glucose, liver function of the female spouse, and semen analysis of the male spouse are obtained from the national free pre-conception check-up projects (nfpcp) in china. couples recruited will be followed every 6 months for at least 1 year, and their time to pregnancy as well as behavior of seeking medical care would be recorded. blood sample and/or information of antral follicle count would be collected from participants who fail to conceive after 12 months of attempts.

infertility is a heavy burden on families, with important implications for individuals and public health. in the last decades, the trend of delaying marriage and childbearing has further exacerbated the burden of infertility. from february 2010 to november 2011, a large-scale population-based cross-sectional study was conducted in northern and eastern china. it was reported that the overall prevalence of infertility was 15.5% among women 'at risk' of pregnancy, and 25.0% among women attempting to become pregnant in china. the prevalence of infertility was surprisingly high and aroused our great attention. to further explore the fecundability and associated risk factors in current china, this community based prospective cohort study was established. recruitment will be performed at cites of national free pre-conception check-up projects (nfpcp). besides of the information of sociodemographic characteristics and childbearing history of couples, their results of check-ups will also be obtained. by regular follow-ups, valid data of time to pregnancy will be collected. a prospective cohort would provide an opportunity to reveal the incidence of infertility, and explore the underlying risk factors of infertility, as well as the demand of assisted reproductive technology.

Eligibility criteria:
inclusion criteria: * couples who finish the national free pre-conception check-up * couples who agree to receive follow-ups every half year for at least 1 year exclusion criteria: * none

Keywords: reproductive health time to pregnancy infertility risk factor assisted reproductive technology prospective cohort
effect of physical activity on weight loss and cardiovascular risk factors after gastric bypass

Conditions: Morbid Obesity; Inactivity

Summary: the aim of this study is to increase our knowledge about the effect of physical activity in patients who have undergone gastric bypass surgery. the study will provide novel information in two areas. the main objective is to study the effect of physical activity on the weight loss and cardiovascular risk factors. this will be accomplished in a randomized clinical trial in patients, who are eligible for gastric bypass (gb). patients will be randomized to six month of structured physical activity or standard postoperative counseling. the study will include an exhaustive panel of blood tests related to cardiovascular risk and the most extensive evaluation of structural and functional vascular test done in this patient group so far. in addition the study will provide information of the effect of bariatric surgery per se since both pre- and postoperative investigations are conducted. the study will learn us to what degree it is possible to motivate this group of patients to increased physical activity. all together this will enable us to improve the counseling of the patients undergoing gb.

the study will be conducted as a prospective, randomized, controlled, two-group, intervention study. patients will be recruited among individuals referred to the tertiary center for bariatric surgery. the patients will be asked to participate in the study when they attend the preoperative education for bariatric surgery. randomization will be performed in blocks ensuring an equal distribution of type 2 diabetes patients in the two study groups. participants will be investigated before gastric bypass surgery, six, 12 and 24 month post-operative. intervention, consisting of structured physical activity will take place from six to 12 month after operation. the intervention program will continue for six month. the supervised exercise program will take place at the training center consisting of 40 min. sessions two times pr. week for 26 consecutive weeks.

Eligibility criteria:
inclusion criteria: * age 25 - 60 years * able to understand and cooperate with the interventions in the study * eligible for gastric bypass surgery exclusion criteria: * inability to perform physical activity at the intensity and quantity required in the study, such as physical disabled patients including severe osteoarthritis * use of vitamin k antagonists, oral contraceptives, or hormone replacement therapy

Keywords: obesity gastric bypass
comparison efficacy between two different frequency of maintenance dose oral immunotherapy

Conditions: Wheat Hypersensitivity; Immunotherapy

Summary: oral immunotherapy(oit) is effective in desensitized food allergy. oit protocols are not standardized, and a wide heterogeneity exists in the literature . so the purpose of our study is to compare short term unresponsiveness rate between once daily dose and four times/week dose during one year maintenance phase of wheat oit

all subject in this study were patients with history of ige mediated wheat allergy and positive ofc test. all of them received wheat oit and reached target maintenance dose of wheat oit. the primary outcome was to compare short term unresponsiveness rate between once daily dose and four times/week dose during one year maintenance phase of wheat oit. other outcomes were collected during the projected such as blood and skin examination for immunologic parameter, changing in body weight, wa, wh and bmi, compliance, adverse reactions, rates of medication used during oit and quality of life

Eligibility criteria:
inclusion criteria: * age 5-18 years old * children aged 5-18 years with history of ige mediated wheat allergy and positive ofc test * reach target maintenance dose of wheat oit and ongoing to maintenance phase of wheat oit exclusion criteria: * patient with low dose oit protocol * patients with uncontrolled atopic dermatitis, uncontrolled asthma, or any chronic disease; * patients who had been treated with some other immunotherapy (eg, slit, another oit) or biologic therapy (eg, omalizumab) * patients with a developmental problem or mental disorder * active eosinophilic gastrointestinal disease in the past 2 years * use of b-blockers (oral), angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, or calcium-channel blockers * pregnancy or lactation * patient who could not visit clinic as protocol

Keywords: wheat hypersensitivity immunotherapy short term unresponsiveness
treatment of knee osteoarthritis with autologous adipose-derived mesenchymal stem cells

Conditions: Knee Osteoarthritis

Summary: the purpose of this study is to explore the efficacy and safety of autologous adipose-derived mesenchymal stem cells (amscs) plus autologous platelet rich plasma (prp) in the treatment of severe knee osteoarthritis.

this is a single centered, randomized, single blind phase ii clinical study. patients will be divided into two groups of case and control. patients of case group will receive intra-articular injection of autologous amscs suspended in 3 ml autologous prp for 3 times, patients of control group will receive intra-articular injection of 3 ml of autologous prp for 3 times. the investigators designed this clinical study to evaluate therapeutic effects of amscs in patients with severe knee osteoarthritis.

Eligibility criteria:
inclusion criteria: 1. subject has kellgren and lawrence grade ii-iv primary osteoarthritis as determined by x-ray. 2. subject's pain score is 8-13 points (lequesne's index). 3. ages between 40-70 years. 4. signed informed consent from the subject. exclusion criteria: 1. subject infected with hepatitis b, hepatitis c, hiv, syphilis or htlv 2. subject not suitable for liposuction surgery. 3. subject with hypersensitivity/allergy to anesthetic. 4. subject's creatinine values higher than 1.6mg/dl. 5. subject with body mass index, bmi over 30. 6. subject's studied knee treated with intra-articular injection therapy within 6 months prior to screen. 7. subject has undergone surgery on studied knee, including fracture surgery, arthroscopic surgery, meniscus repair surgery, or cruciate ligament reconstruction surgery. 8. subject enrolled in any other cell therapy studies within the past 30 days. 9. subject who the investigator considers inappropriate for the clinical trial due to any other reasons than those listed above. 10. subject has a history of gouty arthritis, septic arthritis, rheumatoid arthritis and any other autoimmune arthritis of the knee joint. 11. subject has had major medical problems in vital organs, such as; heart, liver, kidney, or lung.
multimodal recurrence scoring system for stratifying stage iii clear cell renal cell carcinoma of receiving adjuvant treatment

Conditions: Renal Cell Carcinoma

Summary: whether patients with stage iii clear cell renal cell carcinoma (ccrcc) should receive adjuvant targeted therapy or not is still on debate. the investigators invented a multimodal recurrence scoring system that was successfully categorise patients with stage iii clear cell renal cell carcinoma into high-risk and low-risk groups with hazard ratio (hr) of 6.21. here the investigators randomly assign assay-defined high risk patients of locally advanced ccrcc into adjuvant targeted therapy group and observation group. disease free survival and overall survival are the end points of observation.


Eligibility criteria:
inclusion criteria: * the informed consent has been obtained from the patient. * with confirmed diagnosis of stage iii clear cell renal cell carcinoma * with moderate/good eastern cooperative oncology group (ecog) health rating (ps): 0-1 score. * the patient receive no anti-cancer treatment before primary surgery. * the patient receive radical operation for renal cancer with negative margin. exclusion criteria: * patients who have previously received neoadjuvant therapy * with severe comorbidities, such as cardiovascular disease, chronic obstructive pulmonary disease, diabetes mellitus, and chronic renal dysfunction. * with bad compliance or contraindication to enrollment. * pregnant woman or lactating woman. * with contraindication to receive adjuvant targeted therapy.

Keywords: target therapy tyrosine kinase inhibitors (tkis)
safety, tolerability and efficacy of a6 in patients with chronic lymphocytic leukemia (cll)

Conditions: Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma; CLL; SLL

Summary: this study will assess the efficacy, safety and pharmacodynamic markers of the study drug, a6, in patients with cll and small lymphocytic lymphoma (sll).

in patients diagnosed with cll or sll, study medication will be injected subcutaneously two times a day in an outpatient setting for up to 6 cycles (28 days = 1 cycle) prior to the primary endpoint assessment.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of cll or sll based on iwcll criteria * measurable or evaluable disease based on iwcll criteria * previously untreated patients who have been counseled on approved alternative therapeutic options. not a candidate for fludarabine/cyclophosphamide/rituximab (fcr) or has preference to not receive chemotherapy. * eastern cooperative oncology group (ecog) status of 0-2. * adequate bone marrow, renal, liver, cardiac and pulmonary function. * life expectancy of greater than or equal to 6 months. exclusion criteria: * receipt of other cancer therapy, immunomodulatory drug therapy or immunosuppressive therapy within 4 weeks prior to 1st dose. * receipt of corticosteroids \> 20 mg/day within 4 weeks prior to1st dose * major surgery or radiation within 4 weeks prior to 1st dose * presence of uncontrolled infection requiring systemic therapy * active second malignancy other than non-melanoma skin cancer * uncontrolled autoimmune anemia or thrombocytopenia * receipt of any investigational agent within 4 weeks prior to 1st dose * pregnant or lactating female * any severe, acute or chronic medical or psychiatric condition, or lab abnormality that may increase the risk associated with trial participation, study drug administration or interfere with informed consent process or compliance with requirements of the trial.

Keywords: leukemia lymphoma
the effect and safety of pulsed field ablation (pfa) in patients with paroxysmal atrial fibrillation (paf)

Conditions: Paroxysmal Atrial Fibrillation

Summary: this study is aimed to evaluate the efficacy and safety of pulsed field ablation (pfa) in patients with paroxysmal atrial fibrillation (paf)

this clinical trial is a prospective, multi-center and single-arm study. it will be carried out in 3 or more clinical trial institutions, and eligible patients with paroxysmal atrial fibrillation are enrolled. for those patients recruited, pulmonary vein isolation will be performed using pulsed field ablation device (sichuan jinjiang electronic technology co., ltd. chengdu, china). the safety and efficacy of pulsed field ablation(pfa) in patients with paroxysmal atrial fibrillation (paf) will be studied using ring-shaped pulsed field ablation catheter

Eligibility criteria:
inclusion criteria: paroxysmal atrial fibrillation (paf) exclusion criteria: 1. a history of atrial fibrillation ablation; 2. left ventricular ejectfraction(lvef)\<35% 3. left atrium(la)（echocardiography）\>55mm 4. thrombus in the left atrial or heart before surgery 5. new york heart association(nyha) grade ⅲ-ⅳ 6. second or third degree atrioventricular block 7. significant congenital heart defects (e.g. atrial septal defect or severe pulmonary vein stenosis, but except foramen ovale) 8. prosthetic valves 9. pacemakers or defibrillators (icd) 10. hypertrophic cardiomyopathy, chronic obstructive pulmonary disease or myxoma 11. symptomatic carotid stenosis 12. untreated or uncontrolled hyperthyroidism or hypothyroidism 13. systemic active infection 14. renal failure with obvious bleeding tendency or undergoing hemodialysis 15. myocardial infarction or any cardiac intervention/open surgery within 3 months 16. stroke or transient ischemic attack within 6 months 17. obvious contraindication for interventional surgery who were determined by the investigator to be unable to undergo ablation 18. pregnant or lactating women or those who planned to have a family during the study period 19. have participated in clinical trials of other drugs or medical devices within 3 months 20. unsuitable to participate in this clinical trial by the investigator

Keywords: pulsed field ablation paroxysmal ablation atrial fibrillation ring-shaped ablation catheter
co-creation of tools for children and adolescents with suicidal thoughts and/or behaviour

Conditions: Suicide Prevention; Suicidal Ideation; Suicidal Behaviors

Summary: evidence shows that there are very few evidence-based tools or interventions specifically targeting suicidality in children and adolescents. it is crucial to address suicidal thoughts in these populations, as research indicates that discussing suicidality does not increase suicidal behavior but may instead reduce the associated risk. furthermore, the field of suicide prevention increasingly incorporates digital technologies. studies suggest that digital interventions targeting suicidality in young people show promise in enhancing knowledge, regulating emotions, developing coping skills, and managing suicidal thoughts and behaviors. as part of this project, we will develop the following practical tools: * a creative methodology for professionals to engage children and adolescents in talking about their suicidal thoughts. * a self-help app for suicidal young people and their support networks. the development process will involve co-creation, with input from children and adolescents playing a central role. a total of 30 children and adolescents aged 10 to 18 years, who have experienced suicidal thoughts in the past, will participate in this project. the co-creation sessions will be conducted in groups of up to 10 participants. participants can attend a minimum of 1 and a maximum of 10 sessions, each lasting up to 1.5 hours. the sessions will be facilitated by researchers from vlesp and will take place at a location convenient for participants or in ghent (the primary location of the research team). if preferred by participants, one or more sessions may also be held online. for participants who do not wish to join a group, individual sessions can be arranged. each session will be attended by two researchers, with the potential involvement of professionals specializing in tool development. several potential developers will be invited to submit proposals for creating the tools, and the selection of the developer will be based on these submissions. during the sessions, participants will review and evaluate various prototypes of the app. however, the prototypes will not be tested for effectiveness by the young participants.


Eligibility criteria:
inclusion criteria: * aged 10-18 years * proficient in dutch * has experienced suicidal thoughts in the past exclusion criteria (as assessed by the care provider): * limited cognitive ability * currently experiencing an acute suicidal crisis

Keywords: co-creation participatory research children adolescents suicide prevention suicidal ideation suicidal behaviour suicide
venous thrombo-embolic complication prévention in pelvic surgery

Conditions: Venous Thromboembolism; Pelvic Surgery

Summary: pelvic fracture surgery are very high thrombotic risk surgery with about 10% to 50% venous thrombo embolic complications and 0.5% to 10% of pulmonary embolism. the st joseph's hospital have almost 60 cases per year . following a fatal pulmonary embolism per operatory the team has set up a venous exploratory protocol before surgery. this protocol includes a venous doppler ultrasound of lower limbs associated to a abdo pelvic scanner in the 48hours before surgery. the aim is to evaluate this new protocol efficacy on prevention of thrombo embolic complications in pelvic fracture surgery.


Eligibility criteria:
inclusion criteria: * pelvic fracture with surgery indication * age above 18 years exclusion criteria: * pelvic fracture without surgery indication
noninvasive estimation of work of breathing

Conditions: Acute Respiratory Distress Syndrome

Summary: this study will evaluate the correlation between invasively measured parameters (work of breathing/power of breathing, resistance and elastance), derived using esophageal pressure measurements, and their corresponding non-invasive estimated values (noninvasive work of breathing/power of breathing, resistance and elastance), computed using airway pressure and flow measurements only.

this study will evaluate the correlation between invasively measured parameters (work of breathing/power of breathing, resistance and elastance), derived using esophageal pressure measurements, and their corresponding non-invasive estimated values (noninvasive work of breathing/power of breathing, resistance and elastance), computed using airway pressure and flow measurements only. vent settings will be adjusted to test accuracy over a range of respiratory support conditions.

Eligibility criteria:
inclusion criteria: * adult medical/surgical icu patients (age≥18) on mechanical ventilation for respiratory failure, spontaneously breathing and receiving eligible for pressure support ventilation (psv). exclusion criteria: * prisoners and patients with closed-head injury (e.g., trauma), hemodynamic instability, multiple organ system failure or late term pregnancy will not be studied.
adam17 and vascular function in diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the objective of this project is to determine the extent to which administration of the dietary supplement phosphatidylserine (ps), a competitive inhibitor of adam17 sheddase activity, effects vascular function and insulin-stimulated leg blood flow in subjects with t2d.

as part of a randomized (1:1, experimental/placebo), double-blinded parallel design, each of the 34 subjects will complete 4 weeks (+/-4 days) of supplementation with either 900mg of a ps supplement or placebo. assessment visits (2) will occur pre-intervention and post-intervention and include: 24-hour ambulatory blood pressure measurement (abpm), vitals, dexa scan for body composition, fasting blood work, carotid-femoral pulse wave velocity (cfpwv), brachial and femoral artery fmds, femoral blood flow imaging during passive leg movement (plm), glycocalyx integrity assessment via glycocheck, and an oral glucose tolerance test (ogtt) with blood flow measurements and beat-to-beat sphygmomanometry via finometer.

Eligibility criteria:
inclusion criteria: 1. men and women with a bmi of 25-39 kg/m2, who are 45-64 years of age at randomization. 2. t2d patients classified based on physician diagnosis. 3. no vulnerable populations (e.g., prisoners, pregnant, children) will be enrolled. exclusion criteria: 1. cardiovascular disease including myocardial infraction, heart failure, coronary artery disease, stroke 2. history of chronic renal or hepatic disease 3. active cancer 4. autoimmune diseases 5. immunosuppressant therapy 6. hormone replacement therapy 7. excessive alcohol consumption (\>14 drinks/week for men, \>7 drinks/week for women) 8. current tobacco use 9. pregnancy 10. bodyweight change ≥5% within the last 6 months

Keywords: endothelial dysfunction vascular function
a study to evaluate the impact of acid-reducing agents on the pharmacokinetics (pk) of amg 510 in healthy participants

Conditions: Healthy Participants

Summary: the primary objective of this study is to evaluate the pk of amg 510 alone and in combination with either famotidine or omeprazole in healthy participants under fed conditions.


Eligibility criteria:
inclusion criteria: * healthy male subjects or female subjects, between 18 and 60 years of age (inclusive), at the time of screening. * body mass index, between 18 and 30 kg/m2 (inclusive), at the time of screening. * females of nonchildbearing potential exclusion criteria: * inability to swallow oral medication or history of malabsorption syndrome. * history of hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee) and in consultation with the sponsor. * poor peripheral venous access. * history or evidence, at screening or check in, of clinically significant disorder, condition, or disease not otherwise excluded that, in the opinion of the investigator (or designee), would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.

Keywords: healthy participants amg 510 famotidine omeprazole