Kornimate/medical-research-clean huggingface dataset:
multi-centre clinical trial on hormone replacement treatment in china

Conditions: Menopausal Syndrome; Cardiovascular Disease; Osteoporosis; Breast Cancer

Summary: this study is to evaluate the benefit/risk of hormone replacement treatment among early menopausal women in china. this is a multi-centre, random, prospective study.


Eligibility criteria:
inclusion criteria: * going through amenorrhea above 6 months and within 5 years, * aged 40 to 60 years, * going though postmenopausal symptoms, * serum e2 concentration \<30pg/ml, * serum fsh concentration \>40iu/l. exclusion criteria: * uterine fibroid diameter≥5cm, * history of diabetes or hypertension, * history of thromboembolism, severe endometriosis, epilepsy, asthma, hyperprolactinemia, * first degree relative had a history of breast cancer, * being in severe or unstable condition of somatic diseases, * receiving hrt in the past 3 month, * drug or alcohol abuse in the past 3 month, * endometrial thickness ≥0.5cm after withdrawal bleeding, * being allergic to the medicine, * participating in other clinical trials within 1 month ago.

Keywords: lipid profiles coronary heart disease menopausal syndrome mmse menqol had
effects of lovaza on high density lipoprotein (hdl) composition and function in hypertriglyceridemia

Conditions: Hypertriglyceridemia

Summary: study hypothesis: lovaza (purified prescription fish oil) is likely to help hdl (the "good cholesterol") work better. study summary: we are testing effects of lovaza versus placebo, on various aspects of hdl and other lipoproteins, in patients with high triglyceride levels. study funding: this study is being funded by an investigator-initiated research grant from glaxo smith kline.


Eligibility criteria:
inclusion criteria: * fasting tg 500-2000 mg/dl (off of tg-lowering medications-see below) * age 35-75 years exclusion criteria: * use of lovaza (2g/d or more) or high-dose dietary supplement omega-3 oil (4g/d or more) in the past 2 months * use of lipid therapy (statin, ezetimibe, fibrate, bas, or niacin at therapeutic dose, 1g/d or higher) in the past 3 weeks (washout of prior therapy permitted) * anticipated need to change type or dose of bp medicine (all types allowed), of lipid-active diabetes medication (thiazolidinedione), of oral estrogen (bcp or hrt), or glucocorticoid during the study (16 + 2 weeks = 18 weeks total) * excess ethanol consumption (regular intake \>4 drinks/d, or binges of \>8 drinks at once for men, half these levels for women) * poorly controlled diabetes mellitus (a1c \>9%) * history of acute or chronic pancreatitis * use of exenatide (byetta) or sitagliptin (januvia), medications believed to increase the risk of acute pancreatitis * history of significant unexplained or uncontrolled bleeding or bruising * poorly controlled blood pressure (\>140/90mmhg, with or without treatment) * poorly controlled thyroid disease (tsh outside of normal range) * hepatic disease (alt \> 2.5x uln, dx of hepatitis or cirrhosis) * any contraindication or prior adverse reaction to lovaza * active cancer (except basal cell or squamous cell skin cancer) * pregnancy, plan/desire to become pregnant, breast feeding * inability or unwillingness to provide informed consent

Keywords: hypertriglyceridemia omega-3 acid ethyl esters high-density lipoproteins fish oil
an app that can provide early warning of temperature health risks and give protective suggestions or personalized suggestions based on patients' own secondary prevention risk factors was applied to intervene, and the intervention effect of app on stroke recurrence risk was analyzed

Conditions: Acute Ischemic Stroke

Summary: this study employs individualized temperature health risk early warning and risk factor management interventions for stroke, and explores their actual intervention effects. this enables patients to promptly understand their own risk levels and take corresponding protective measures, thereby enhancing the management outcomes and quality of life. the study also promotes the interdisciplinary integration of environmental epidemiology and clinical intervention management, providing new ideas and methodological support for future relevant research.


Eligibility criteria:
inclusion criteria: * aged 40 to 80, with no gender restrictions; * acute ischemic stroke inpatients within 2 weeks of onset, where the onset time is the time when stroke symptoms appear or the last known normal time of the patient (when it is an onset during sleep or the symptom onset time cannot be accurately obtained due to aphasia, impaired consciousness, etc.); ③ confirmed diagnosis of ischemic stroke by ct or mri of the brain within 2 weeks after symptom onset; * local residents (residing for ≥6 months); ⑤ patients who voluntarily participate in the study, have high compliance, and can sign the informed consent form; * patients who own a smartphone or other smart devices. exclusion criteria: * patients diagnosed with other cerebrovascular diseases (hemorrhagic stroke, transient ischemic attack, cerebral venous sinus thrombosis, etc.) or non-cerebrovascular diseases; * known pregnant or lactating women, or those who tested positive on a pregnancy test before cluster randomization; * patients with other conditions that may affect participation in the trial (e.g., refractory hypertension, severe aphasia, etc.); * patients undergoing psychiatric/psychological treatment that may contaminate the results; ⑤ patients with a life expectancy of less than one year (e.g., coexisting malignant tumors, severe cardiopulmonary diseases, etc.); ⑥ patients already participating in other interventional clinical studies that may influence the outcome assessment; ⑦ patients for whom the investigator deems unsuitable for participation in this study or who may pose significant risks to the patients (e.g., cognitive impairment preventing understanding and/or compliance with the study procedures and/or follow-up).
a multicenter trial assessing the impact of lipoprotein(a) lowering with pelacarsen (tqj230) on the rate of weekly lipoprotein apheresis sessions in patients with hyperlipoproteinemia(a) and established cardiovascular disease in germany

Conditions: Hyperlipoproteinemia(a)

Summary: phase iii study to test the hypothesis that treatment with pelacarsen (tqj230) 80 mg q4w compared to placebo significantly reduces the rate of lipoprotein apheresis in patients with hyperlipoproteinemia (a) and established cardiovascular disease currently undergoing lipoprotein apheresis in germany on a weekly schedule.

lipoprotein apheresis to date is the only approved therapeutic option for cardiovascular (cv) risk reduction in patients with severely elevated lp(a) levels in germany. lipoprotein apheresis is an expensive, burdensome, and time-consuming procedure. the current study (ctqj230a12302) will investigate if treatment with pelacarsen (tqj230) 80 mg q4w vs placebo reduces the rate of lipoprotein apheresis in patients with hyperlipoproteinemia(a) and established cv disease

Eligibility criteria:
inclusion criteria: * patients currently undergoing lipoprotein apheresis for isolated lp(a) on a weekly schedule in germany for ≥ 12 months prior to screening with at least 40 sessions within the past 52 weeks prior to randomization * lipoprotein(a) (lp(a))\> 60 mg/dl at screening * spontaneous prior myocardial infarction (mi): ≥ 3 months from screening visit to ≤ 10 years prior to the screening visit, and/or * ischemic stroke: ≥ 3 months from screening visit to ≤ 10 years prior to the screening visit, and/or * clinically significant symptomatic peripheral artery disease (pad) exclusion criteria: * uncontrolled hypertension * heart failure new york heart association (nyha) class iv * history of malignancy of any organ system * history of hemorrhagic stroke or other major bleeding * platelet count \<140,000 per mm3 at screening * active liver disease or hepatic dysfunction * significant kidney disease * pregnant or nursing women

Keywords: lipoprotein (a) cardiovascular disease apheresis tqj230 pelacarsen
determining the age of first acute coronary syndrome

Conditions: Acute Coronary Syndrome; Age Problem; Risk Factor, Cardiovascular

Summary: the study aimed to evaluate the association between the obesity grade and the age of the first acute coronary syndrome (acs). the effect of cardiovascular (cv) risk factors and the age of first acs in patients with severe obesity was also examined. consecutive patients with diagnosis of first episode of acs were prospectively enrolled in 2014 to 2024.cardiovascular risks of patients will be determined according to clinical and laboratory evaluation and patients were categorized by their body mass indices (bmi). independent variables that effected the age of first acs were examined by linear regression analysis

in the first stage, the first acs diagnosis of the patients will be tried to be clarified. it will be tried to clarify whether the patients have had acs before, according to their history, ecg echo and coronary angiography findings. patients with previous acs or uncertain acs diagnosis will not be included in the study. in the second stage, cardiovascular risk burdens of patients for whom the initial acs diagnosis is clear will be revealed. smoking, diabetes mellitus (dm), hypertension (ht), psychological stress, socio-economic status, migration history, cholesterol parameters will be determined. the duration and severity of these risk factors will be determined. in the final model, each risk factor will be examined in detail with its sub-tabs and the effect of each risk factor will be examined separately. eventually, a model will be developed that allows predicting the first acs age. the shortcomings of this model and the narrow scope of the definition of the population will be determined and the direction will be determined for the studies that improve these points.

Eligibility criteria:
inclusion criteria: * adult patients with the diagnosis of the first acute coronary syndrome exclusion criteria: * previous cardiovascular disease * chronic renal disease, * chronic obstructive pulmonary disease, * malignancy, * regularly use of statins, antiplatelets or anticoagulants, * situations where oral communication cannot be established with the patient * situations when coronary angiography (cag) could not be performed . * patients with findings that might be related to previous mi on electrocardiography (ecg) or echocardiography and total occlusion other than 'culprit' lesion and no critical stenosis on cag

Keywords: acute coronary syndrome age obesity risk factor, cardiovascular smoking gender hyperlipidemia diabetes mellitus psychosocial stress
a randomized clinical trial for women with vulvodynia

Conditions: Vulvodynia

Summary: this study will evaluate the relative effectiveness of cognitive-behavioral therapy and supportive psychotherapy for the treatment of women with vulvodynia.

many treatments used for women with vulvodynia are based solely upon expert opinion. this randomized trial aimed to test the relative efficacy of cognitive-behavioral therapy (cbt) and supportive psychotherapy (spt) in women with vulvodynia. of the 50 participants, 42 (84%) completed 10-week treatments and 47 (94%) completed one-year follow-up. mixed effects modeling was used to make use of all available data. participants had statistically significant decreases in pain severity (p's\<.001) with 42% of the overall sample achieving clinical improvement. cbt, relative to spt, resulted in significantly greater improvement in pain severity during physician examination (p=.014), and greater improvement in sexual function (p=.034), from pre- to post-treatment. treatment effects were well maintained at one-year follow-up in both groups. participants in the cbt condition reported significantly greater treatment improvement, satisfaction and credibility than participants in the spt condition (p's\<.05). findings from the present study suggest that psychosocial treatments for vulvodynia are effective. cbt, a directed treatment approach that involves learning and practice of specific pain-relevant coping and self-management skills, yielded better outcomes and greater patient satisfaction than a less directive approach.

Eligibility criteria:
inclusion criteria: * independently diagnosed with vulvodynia by two study physicians exclusion criteria: * any conditions known to better account for the vulvar pain * psychotic illness * actively suicidal * substance dependent * life-threatening illness * initiated psychotherapy, psychopharmacologic treatment or pain medication within one month prior to beginning the assessment phase of the study.

Keywords: vulvodynia vulvar pain dyspareunia sexual dysfunction vestibulitis
study of shr-1210 in combination with chemotherapy in advanced esophageal cancer

Conditions: Advanced Esophageal Cancer

Summary: this is a randomised, double-blinded, placebo-controlled, multi-center phase iii trial, comparing the efficacy and safety of shr-1210 + paclitaxel + cisplatin vs placebo+paclitaxel +cisplatin as 1l therapy for advanced esophageal cancer patients in china. shr-1210 is a humanized anti-pd1 igg4 monoclonal antibody.

in this study, eligible subjects will be randomized into study arm or control arm. treatment cycles of chemotherapy will be at most 6 cycles which would be decided by the investigators. progression-free survival (pfs) assessed by the independent review committee (irc) and overall survival (os) will be the primary outcomes.

Eligibility criteria:
inclusion criteria: 1. histologically or cytologically confirmed unresectable local advanced/recurrent or metastasis esophageal squamous cell carcinoma; 2. no previous systemic anti-tumor treatment; 3. subjects must have at least one measurable tumor lesion per recist 1.1; 4. tissue samples should be provided for biomarkers (such as pd-l1) analysis; 5. ecog: 0-1; 6. adequate organ and bone marrow function; exclusion criteria: 1. allergic to monoclonal antibodies, any shr-1210 components, paclitaxel, cisplatin and other platinum drugs; 2. prior therapy as follow: 1. anti-pd-1 or anti-pd-l1; 2. any experimental drugs within 4 weeks of the first dose of study medication; 3. received major operations or serious injuries within 4 weeks of the first dose of study medication; 4. received last dose of anticancer therapy (including chemotherapy, radiotherapy, targeted therapy, etc.) within 4 weeks of the first dose of study medication; 3. not recovered to ≤ctcae 1 from adverse events (except for hair loss) due to a previously anti-tumor treatment; 4. subjects with any active autoimmune disease or history of autoimmune disease; 5. pregnancy or breast feeding;

Keywords: pd-1antibody advanced esophageal cancer paclitaxel cisplatin
triiodothyronine (t3) supplementation in the treatment of bipolar and unipolar depression.

Conditions: Major Depression; Bipolar Disorder; Unipolar Depression

Summary: the purpose of this project is to determine whether concurrent treatment of patients with major depression (unipolar or bipolar) with triiodothyronine (t3) and sertraline, will lead to a stronger and/or more rapid antidepressant effect than treatment with sertraline alone.

aim: to determine the therapeutic efficacy and adverse effects of triiodothyronine (t3) as a supplement to the treatment of bipolar depression (bpd) with a mood stabilizer (ms) (lithium - li, valproic acid - vpa or carbamazepine - cbz) and the specific serotonin reuptake inhibitor (ssri), sertraline; and as a supplement to the treatment of unipolar depression (upd) with sertraline. method: a random assignment, double blind, placebo-controlled trial separately evaluating patients with a) bpd who are treated with ms + sertraline + t3 or ms + sertraline + placebo and b) upd who are treated with sertraline + t3 or sertraline + placebo, for up to 8 weeks in both cases. the design of the trial will permit both the outcome of treatment and the speed of response to be evaluated.

Eligibility criteria:
inclusion criteria: 1. diagnosis of major depressive episode (mde) in the context of bipolar disorder i or ii (bpd-i or bpd-ii) or major depressive disorder (upd), according to dsm-iv criteria, without psychotic features. 2. hamilton depression scale (ham-d) total \>16 with item 1 (depressed mood) \>2. 3. age 18-70 years, male or female. 4. competent and willing to give written informed consent. exclusion criteria: 1. no clinical hyper- or hypothyroidism nor other thyroid illness. 2. no neurological or other physical illness that may impact upon the study or limit prescription of the study medications. 3. no lifetime history of substance or alcohol dependence or of abuse in the preceding 12 months. 4. no significant suicidal risk (ham-d item 3 (suicide) \<3).

Keywords: major depression bipolar disorder unipolar depression sertraline triiodothyronine
the effect of a coloring prompt on health engagement

Conditions: In Need of a Pap Smear (Cervical Cancer Screening); In Need of a Blood Pressure Check (Hypertension Screening); In Need of a Cholesterol Test (Lipid Disorder Screening); In Need of a Fasting Plasma Glucose Test (Diabetes)

Summary: the goal of this project is to determine whether prompting the recipient of a health reminder mailing to ask his or her 4-9 year-old child to color on the reminder could increase engagement with the targeted health behavior

the investigators will randomly assign some individuals with 4-9 year old children to receive colorful reminders to engage in a given health behavior. others will receive identical reminders along with a prompt to share the reminder sheet with their child so it can be turned into a piece of art. the investigators are interested in whether the coloring prompt will lead the reminder to stay in the home for longer, be placed on the refrigerator, etc. and thus result in an increase in compliance with the recommended health behavior.

Eligibility criteria:
inclusion criteria: * indications according to spring 2011 cdc criteria for a pap smear * indications according to spring 2011 cdc criteria for a blood pressure check * indications according to spring 2011 cdc criteria for a cholesterol test * indications according to spring 2011 cdc criteria for a fasting plasma glucose test * employee at partner corporation that implemented the study

Keywords: behavioral economics nudge artwork pap smear blood pressure check cholesterol test fasting plasma glucose test
maximal plantar pressure and comfort evaluation of orthopedic stilettos

Conditions: Metatarsalgia

Summary: 22 women testing "orthopedic" stilettos compared to standard stilettos and a comfy trainer. testing involves pedobar pressures and a validated comfort questionnaire.

22 women testing "orthopedic" stilettos compared to standard stilettos and a comfy trainer testing involved pedobar pressures and a validated comfort questionnaire. x rays with arthrosis 1. metatarsophalangeal joint (mtpj), hallux valgus and intermetatarsal (im) angles will be recorded. clinically, weight, height, foot length, heel valgus, 1. mtpj range of motion, pain, callus, hammertoes will be recorded. sole pressure in heel, arch and forefoot grids measured by in-sole pressure pedar-x (novel) and possible emed system (novel). 3 working days in each type of shoe with steps measured by pedometer comfort assed as vas according to: mundermann,a., nigg,b.m., stefanyshyn,d.j., and humble,r.n.: development of a reliable method to asses footwear comfort during running. gait posture, 16:38-45, 2002. primary outcome is the foot sole pressures. both vas comfort and foot pressures will be regressed to see if age, bmi, shoe size, steps, shoe type, callus, index minus, hallux valgus etc has an effect. 16 needed for the pressure and 21 for the comfort score. 22 will be included to make sure the investigators have enough power.

Eligibility criteria:
inclusion criteria: * foot healthy females used to wearing stilettos. exclusion criteria: * shoe sized outside european 37-42. * sought doctor for foot or balance related issues

Keywords: metatarsalgia pedobar foot stiletto insoles
gluteus medius dry needling and ankle instability

Conditions: Chronic Instability of Joint; Trigger Point Pain, Myofascial

Summary: randomized clinical trial in individuals with chronic ankle instability. main outcomes were as follows: pain intensity, pressure pain threshold, lower limb balance and range of motion. the sample will be divided in two groups: 1) dry needling at the gluteus medius trigger point (intervention). 2) dry needling 1,5 cm from the gluteus medius trigger point (control).

inclusion criteria will be: individuals with chronic ankle instability, 20 to 50 years old. exclusion criteria: any lower limb disease, fractures, infections, pregnancy, received any treatment in the previous 3 months. initially, the base measurements were as follows: paint intensity, pressure pain threshold at the gluteus medius trigger point, ankle range of motion and balance of the lower limb. once baseline measurements will be taken, the same evaluations will be performed at 4 weeks from the start.

Eligibility criteria:
inclusion criteria: * individuals with chronic ankle instability, 20 to 50 years old. exclusion criteria: * any lower limb disease, fractures, infections, pregnancy, received any treatment in the previous 3 months.

Keywords: ankle dry needling trigger point
surgical correction of pelvic organ prolapse

Conditions: Pelvic Organ Prolapse

Summary: objective: this prospective randomized trial evaluated outcomes of colposacropexy performed either by open or by conventional laparoscopic approach as therapy for uterovaginal prolapse. surgical techniques, efficacy and overall results are compared. methods: in this prospective study 40 consecutive patients with uro-genital prolapse are randomized to sacropexy: 20 by an open approach, 20 by a conventional laparoscopy approach. anchorage is achieved in both groups by two polypropylene meshes. check-ups were scheduled at 3, 6, 12 months and then yearly. pre-operative patient characteristics, operative and post-operative events and follow-up results are recorded.

surgical technique in both open or laparoscopic approach the anterior vaginal wall is dissected from the bladder to expose a vaginal wall area of at least 3 x 5 cms where the mesh will be attached with four-five polyglycolic 0 sutures. the procedure is repeated for the posterior vaginal wall, where the mesh will be attached with three-four polyglycolic 0 sutures. the sacral promontory surface is prepared and 1 or 2 non-reabsorbable 0.0 sutures are placed into the sacral periosteum about 2 cm below the promontory. a sub-peritoneal tunnel is created through which meshes are passed avoiding traction to the sacrum. the peritoneum is closed over the meshes.

Eligibility criteria:
inclusion criteria: * study inclusion criteria were pop \> 2, age ≥ 18 and ≤ 75 yrs. exclusion criteria: * malignant uterus lesion (leiomyoma, fibromyoma, cervical or endometrial carcinoma) * active pelvic inflammatory disease, * known hypersensitivity to synthetic materials (polypropylene or polyglycolic acid) * pregnancy or lactation * evidence of clinically significant cardiovascular, renal, hepatic or respiratory diseases; and * any condition that in the judgment of the investigators would interfere with the subject's ability to provide informed consent, comply with study instructions, place the subject at increased risk, or which might confound interpretation of study results.

Keywords: pelvic organ prolapse colposacropexy surgery