Kornimate/medical-research-clean huggingface dataset:
the effect of traditional chinese medicine on benign prostatic hyperplasia

Conditions: Benign Prostatic Hyperplasia

Summary: this randomized, double-blinded, placebo-controlled, crossover clinical trial aims to investigate the effect of vgh-bph1, a scientific chinese medicine powder prescription, on patients with benign prostatic hyperplasia.

benign prostatic hyperplasia (bph) is an enlargement of the prostate gland due to progressive hyperplasia of the stromal and glandular cells. the aim of this study is to evaluate the efficacy of traditional chinese medicine (vgh-bph1) in treating patients with bph, by using the experimental bph-1 powder, including ji sheng shen qi wan and sangpiaoxiao powder as the main prescription, and adding wuyao, yizhiren, danshen, yinyanghuo, fupenzi, huangbo and zhimu as auxiliary ingredients, to form a 5gm per pack. this study is designed as a double-blinded randomized placebo-controlled cross-over trial to provide experimental evidence and feasibility of traditional chinese medicine vgh-bph1 in the treatment of bph, and to analyze the syndrome pattern of chinese medicinal prescriptions for subgroups of bph.

Eligibility criteria:
inclusion criteria: * patients who have been diagnosed with benign prostatic hyperplasia by a urologist * have been treated with conventional first-line western medicine for more than three months * patients with moderate to severe benign prostatic hyperplasia (ipss score \>12 points) * participate voluntarily in the study exclusion criteria: * at the same time, use other chinese herbal medicines or alternative medicine (including drugs and acupuncture) for more than one month. * syphilis, gonorrhea and other sexually transmitted diseases or urinary tract infections * urinary tract stones, prostate cancer, bladder cancer or acute and chronic renal failure * congenital abnormalities such as bladder neck fibrosis, interstitial cystitis or urethral stricture * a history of genital trauma or surgery affecting the muscle or nervous system * patients with upper urinary tract obstruction, renal edema, etc. affecting renal function * unable to sign a consent form or unable to communicate with researchers

Keywords: benign prostatic hyperplasia traditional chinese medicine
a trial to assess the effect of liraglutide on blood triglyceride (fat) levels after a meal in type 2 diabetics

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in europe. the aim of this trial is to investigate whether a new compound, liraglutide, reduces the level of lipids (fat), including cholesterol, in the blood of type 2 diabetics, following a meal with high fat content.


Eligibility criteria:
inclusion criteria: * subjects with type 2 diabetes mellitus (diet and exercise treated, or treated with specific oral antidiabetics (metformin, sulfonylureas and glinides) mono- or combination therapy) diagnosed at least 3 months previously * bmi between 18.5 and 40 kg/m2 * hba1c between 6.5 and 10.0% both inclusive exclusion criteria: * known or suspected allergy to trial products or related products * previous participation in this trial (randomised). re-screening of screening failures is allowed only once * females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptives are defined as combination oral contraceptives (oc), hormonal intra uterine devices (iuds), implants and injectables; for germany, a condom for the male partner must be used in combination with oc, iud, implant or injectables for the duration of the trial and for 30 days following the last dose of trial medication) if not sterile or post-menopausal * the receipt of any investigational drug within 3 months prior to this trial * previous insulin treatment (short-term insulin treatment of up to 7 days are exempted if this has occurred no later than 3 months prior to screening). * cancer (except basal cell skin cancer or squamous cell skin cancer) or any clinically significant disorder (except type 2 diabetes) * clinically significant active cardiovascular disease including history of myocardial infarction (heart attack) within the past 6 months and/or heart failure at the discretion of the investigator. * history of alcoholism or drug abuse during the last 12 months * blood donation within the last 3 months. plasma donation within the last month. * additional exclusion criteria for germany: male subjects who are sexually active and have partners who are or could be pregnant, not using a barrier method of contraception (e.g. condom) for the duration of the trial and for 30 days following the last dose of trial medication
comparison of overall function between postpartum women with and without diastasis rectus abdominis

Conditions: Diastasis Recti

Summary: the purpose of this research is to examine the effects of diastasis rectus abdominis on the overall function of postpartum women and to determine test-retest reliability and construct validity of a self-assessment palpation of inter-rectus distance for dra using telehealth.

step 1: recruitment * the investigators will place recruitment fliers in local obstetrician offices, labor and delivery units in local hospitals, retail and daycare establishments, and on social media outlets such as facebook, instagram and twitter. * the recruitment fliers will ask interested women to email a student investigator to enroll in the research project. step 2: collection of functional outcome data using a qualtrics version of the inventory of functional status after childbirth (ifsac), a demographic survey, a numeric pain reporting scale, oswestry low back pain disability questionnaire, and the pelvic floor distress index. step 3: a meeting time will be set up with every participant to conduct a telehealth visit with a research assistant. during this virtual visit on a private, password protected zoom call the participant will be instructed on self-assessment palpation of the abdominal wall in order to determine the presence or absence of diastasis rectus abdominis (dra) along the inter-rectus distance (ird). step 4: the first 18 participants with self-assessed dra and the first 18 participants without self-assessed dra, who live in wichita or surrounding areas, will be scheduled for a one-time in-person confirmation appointment. the appointment will last a maximum of 15 minutes and occur at the wsu old town campus room a106. during this confirmation appointment research assistants will screen the participant with the covid pre-screening questions tool, obtain written informed consent, check the participant in, collect height and weight, and the principal investigator will measure the participants abdominal wall using real-time ultrasound, measure the ird using the pi's palpation method, and ask the participant to demonstrate and measure ird using the same palpation method used on the telehealth visit. see the virus protection plan for details of which all participants and investigators will follow in order to minimize risks related to covid-19). step 5: the data will be entered into spss and analyzed with appropriate statistical analyses.

Eligibility criteria:
inclusion criteria: * women ages 18-40 years * postpartum (within 6-10 weeks of vaginal delivery) exclusion criteria: * women who are currently being treated by a physical therapist for their diastasis rectus abdominis * women who had high-risk pregnancies (bedrest, gestational diabetes, pregnancy-induced hypertension) * women with a history of abdominal or back surgery * women with history of connective tissue disease such as ehlers-danlos syndrome

Keywords: overall function
comparison of duration of treatment interruption with or without curcumin during the off treatment periods in patients with prostate cancer undergoing intermittent androgen deprivation therapy

Conditions: Prostate Cancer

Summary: this was a placebo-controlled, double-blind, randomized trial designed with the aim of establishing whether curcumin influenced the duration of treatment interruption and rate of prostatic specific antigen(psa) progression, compared with placebo among men with prostate cancer receiving intermittent androgen deprivation therapy.


Eligibility criteria:
inclusion criteria: * patients diagnosed with prostate cancer in biopsy * among patients with biochemical recurrence after treatment(radical prostatectomy, radiation therapy, focal therapy, etc.) for localized prostate cancer or metastatic prostate cancer at the time of diagnosis, who received intermittent androgen deprivation therapy(iad) * patients who off-treatment for the first time by receiving androgen deprivation therapy(adt) for more than 6 months and psa nadir remained stable for more than 3 months exclusion criteria: * previous history of iad * patient with other serious or ongoing medical or psychiatric disease other than prostate cancer * hypersensitivity or suspicious of curcumin * history of taking health supplements containing curcumin for prostate cancer treatment before 6 months of clinical trial participation

Keywords: intermittent androgen deprivation therapy curcumin
the effect of providing free samples of generic cardiovascular medications to physicians

Conditions: Hypertension; Hyperlipidemia

Summary: in this randomized controlled trial, we will provide primary care physicians with free samples of highly effective generic cardiovascular medications. we will test whether this intervention will stimulate cost-effective prescribing, reducing drug costs and improving adherence to essential cardiovascular medications.

highly-effective generic cardiovascular medications are frequently underused, leading to greater overall drug costs and cost-related non-adherence. interventions are needed to stimulate appropriate generic drug use without creating administrative or financial barriers to branded medications that may impede essential medication use. the samples trial is a clustered, randomized controlled trial of the effect of providing physicians with free generic samples of hydrochlorothiazide for hypertensive patients and simvastatin for patients with hyperlipidemia. we will randomize 660 primary care physicians in pennsylvania, clustered by physician practice, to receive free samples for both conditions or to receive no samples. we will use pharmacy claims of their patient population enrolled in a state-sponsored prescription drug assistance program to evaluate outcomes of interest. the primary outcomes are physician prescribing behavior (proportion of prescriptions that are generic), and patient adherence to chronic therapy. secondary outcomes will include physician adherence to established guidelines (for anti-hypertensive regimens) and overall prescription drug costs. primary analyses will be based on intention-to-treat principles. this trial highlights a new and innovative approach to stimulate cost-effective prescribing. free generic samples can reduce overall drug costs as well as out-of-pocket costs to the patient without sacrificing efficacy, and may result in improved adherence to essential cardiovascular medications. this intervention may also improve adherence to practice guidelines and improve the quality of care received. if found to be effective, this strategy could be utilized broadly by private insurers or government payers aiming to stimulate more cost-effective and higher-quality care.

Eligibility criteria:
inclusion criteria: * primary care physicians receiving an existing academic detailing program in pennsylvania exclusion criteria: * those with administrative policies stating they do not accept free samples

Keywords: hypertension hyperlipidemia free generic samples
inspiratory muscle training in children with beta thalasemia

Conditions: Beta Thalassemia Major

Summary: respiratory complications are very prevalent in children with beta thalasemia major (btm), so choosing inspiratory muscle trianing to decrease of prevent it and to improve pulmoanry funntions is important

children patients with btm accounted 40 children will assigned to a group of inspiratory muscle training or waiting list group. the group will contain twenty children. the group of training will receive two session per day of training by threshold inspiratory muscle trainer ( for six day per week for 12 weeks)

Eligibility criteria:
inclusion criteria: * 40 beta thalassemia major children * boys and girls exclusion criteria: * respiratory diseases * cardiac diseases renal diseases liver diseases muscle and joint disease
study of sitagliptin in older type 2 diabetics (0431-047)(completed)

Conditions: Type 2 Diabetes

Summary: to evaluate the effect of treatment with sitagliptin compared to placebo in elderly patients with type 2 diabetes mellitus who have poor glycemic control with diet and exercise.


Eligibility criteria:
inclusion criteria: * community dwelling patients 65 years of age or older diagnosed with type 2 diabetes not controlled with diet and exercise * patients must have a hba1c of 7-10% off medication, or as a result of a protocol wash-out from oral anti-hyperglycemic agents by the qualifying visit exclusion criteria: * patients with type 1 diabetes * history of ketoacidosis or requires insulin use * alanine aminotransferase / aspartate aminotransferase \> 2.5 x uln, triglycerides \> 600 mg/dl, creatinine clearance \< 35 ml/min * fasting plasma glucose consistently \> 260 mg/dl * poorly controlled hypertension
study evaluating how patients with acute coronary syndrome are managed during 2 years after discharge

Conditions: ACS; Acute Coronary Syndrome; Myocardial Infarction; Unstable Angina; Coronary Artery Disease

Summary: the aim of this international study is to describe the short- and long-term (i.e. up to 2 years following the index event) antithrombotic management patterns (amps) in patients hospitalized for acute coronary syndromes (st segment elevation myocardial infarction (stemi), non-st-segment elevation acute coronary syndrome (nste-acs)), and to document the impact of amps in clinical outcomes, economic variables and quality of life in a 'real-life' setting and to compare these between sites, countries and regions.


Eligibility criteria:
inclusion criteria: * diagnosis of myocardial infarction or unstable angina * hospitalized for the first time within 24 hours of onset of symptoms exclusion criteria: * presence of any condition/circumstance which in the opinion of the investigator could significantly limit the complete follow up of the patient (e.g. tourist, non-native speaker or does not understand the local language, psychiatric disturbances) * current participation in a clinical trial.

Keywords: acute coronary syndrome heart attack myocardial infarction acs long-tem follow up antithrombotic management quality of life antithrombotic
evaluation of il-6 in synovial fluid in obese and normal weight patients suffering from gonarthrosis during pta

Conditions: IL-6 Concentration in the Synovial Fluid of Obese Patients is 100% Higher Than the IL-6 Concentration of the Synovial Fluid in Normal Weight Patients

Summary: evaluate the concentration of il-6 in the synovial fluid of obese patients suffering from gonarthrosis during knee arthroplasty surgery


Eligibility criteria:
inclusion criteria: * age between 55 and 85 years inclusive, * normal weight patients with bmi 18-24.9 included * obese patients with bmi ≥ 30 * patients suffering from gonarthrosis awaiting knee arthroplasty surgery * patients awaiting knee replacement surgery * patients who agree to sign informed consent exclusion criteria: * patients under 55 years of age. * patients over 85 years of age * patients suffering from diabetes mellitus * patients who are unable to understand * patients with severe neurological disorders or severe disability * rheumatoid arthritis patients * cancer patients * patients on immunosuppressive therapy
use of cheetah® cardiac monitoring system to guide discontinuation of magnesium sulfate in women with severe preeclampsia

Conditions: Preeclampsia With Severe Features

Summary: this is a single site pilot randomized, controlled, trial randomizing patients with pe with severe features to one of 2 groups: * 24 hours of postpartum magnesium sulfate (current arbitrary standard of care) * using the cheetah® device to aid in an individualized duration of magnesium sulfate.


Eligibility criteria:
inclusion criteria: * preeclampsia with severe features, diagnosed using the american congress of obstetricians and gynecologists (acog) standard criteria 4 requiring magnesium sulfate * females older than 18 years of age * singleton pregnancy * gestational age greater than 24 0/7 weeks * the patient is physically and mentally able to understand the informed consent and is willing to participate in this study * able to speak english or spanish exclusion criteria: * multiple gestation * prisoners * patients with chronic renal insufficiency or epilepsy * known cardiovascular disease * patients with contraindications to magnesium sulfate use (e.g. myasthenia gravis) * patients with eclampsia or hellp syndrome * contraindications for magnesium sulfate

Keywords: preeclampsia with severe features magnesium sulfate systemic vascular resistance non-invasive cardiac monitoring
observational study to assess the effectiveness and treatment adherence of tofacitinib of ulcerative colitis in clinical practice in sweden

Conditions: Ulcerative Colitis

Summary: this is a prospective observational study using data from an existing, ongoing national swedish registry (swibreg). this study is designed to assess the effectiveness and treatment adherence of tofacitinib on clinical disease activity parameters in patients with ulcerative colitis in swedish clinical practice. the study will also assess treatment adherence of tofacitinib using the swedish prescribed drug register.


Eligibility criteria:
inclusion criteria: * the assignment of the patient to tofacitinib is not decided in advance by the protocol but falls within clinical practice and the prescription of the medicine is done according to the smpc and is clearly separated from the decision to include the patient in the study. * the patient must sign the informed consent before enrollment in the study. the informed consent permits extraction of data from swibreg at baseline and during the duration of the study. for patients not registered in swibreg, they must complete all swibreg consents and registration at the time of treatment initiation. evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study. * patients, male or female, must be 18 years old or above. * the patient must have active disease as confirmed by fecal calprotectin \>250 mg/kg or endoscopic assessment corresponding to a mayo endoscopic subscore ≥2 not more than 4 weeks prior onset to the initiation of tofacitinib treatment. this inclusion criteria applies also to patients that have already been enrolled in the study. exclusion criteria: * the patient is enrolled in a clinical trial in which the treatment of ulcerative colitis is dictated by a study protocol. if the patient is participating in another ongoing observational study (non-interventional), the patient may be included in this observational study. * patients that fulfill any of the contraindications according to the latest version of the smpc. any smpc label updates will be communicated to all study sites. * for whatever reason the physician feels the patient unsuitable to participate in the study.
a study to evaluate the safety, pharmacokinetics and pharmacodynamics of abbv-181 (budigalimab) in adult participants with human immunodeficiency virus (hiv)-1

Conditions: Human Immunodeficiency Virus (HIV); HIV Infection; HIV-1

Summary: this study will be conducted in two stages and will test the safety/tolerability, pharmacokinetics (how the body handles study drug) and pharmacodynamics (effects on the immune system and the virus) of the study drug abbv-181 in human immunodeficiency virus (hiv)-1 infected participants undergoing antiretroviral therapy (art) interruption.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) between 18.0 and 35 kg/m2. * hiv-1 infected on antiretroviral therapy (art) for at least 12 months prior to screening and on current art regimen for at least 8 weeks prior to screening. * meets hiv-specific laboratory parameters as below: * plasma hiv-1 rna below lower limit of quantification (lloq) at screening and at least 6 months prior to screening. * cd4+ t cell count \>= 500 cells/ul at screening and at least once during the 12 months prior to screening. * cd4+ t cell nadir of \>= 200 cells/ul during chronic infection. * willing to undergo art interruption. * agrees to use an effective barrier method of protection (male and/or female condoms) during sexual activity for protection against hiv-1 transmission throughout the entire study. exclusion criteria: * known resistance to at least 2 classes of art. * history of aids-defining illness. * active or suspected malignancy or history of malignancy (other than basal cell skin cancer or cervical carcinoma in situ) in the past 5 years. * history of or active immunodeficiency (other than hiv). * active autoimmune disease or history of autoimmune disease that has required systemic treatment. * prior receipt of immunomodulatory or immunosuppressive (including intravenous infusion or oral steroids at any dose, but excluding steroids that are inhaled, topical or by local injection) therapy within 24 weeks prior to the first dose of study drug. * prior therapy/exposure to abbv-181 or any other immune checkpoint inhibitor. * current hepatitis b virus or hepatitis c virus infection. * clinically significant medical disorders that might expose the participants to undue risk of harm, confound study outcomes, or prevent the participant from completing the study (including but not limited to significant or unstable cardiac, neurologic or pulmonary disease, chronic active infectious disease except for hiv, chronic liver disease, poorly controlled diabetes mellitus and history of stevens johnson syndrome toxic epidermal necrolysis (ten), or drug reaction with eosinophilia and systemic symptoms (dress)). * known psychiatric or substance abuse disorders that would interfere with adherence to study requirements. * female participants must not be pregnant, breastfeeding, or considering becoming pregnant during the study.

Keywords: human immunodeficiency virus (hiv) hiv infection hiv-1 abbv-181 analytical treatment interruption budigalimab programmed cell death protein-1 (pd-1) anti-pd-1 antibody