Kornimate/medical-research-clean huggingface dataset:
evaluation of the efficacy and safety of entelon tab. 150mg in patients with osteoarthritis of knee

Conditions: Knee Osteoarthritis

Summary: this clinical trial is planned to prove entelon tab. arm is not inferior to celebrex cap. arm in terms of the efficacy and safety through the change of k-womac's total score sum in patients with osteoarthritis of knee.


Eligibility criteria:
inclusion criteria: 1. both gender,35 years ≤ age ≤ 75 years 2. patients with a diagnosis of oa(osteoarthritis) of the knee within 3 months prior to study participation, as determined by the american college of rheumatology clinical and radiographic criteria as follows. 1. knee arthralgia 2. more than one case among * 50 years or over * morning stiffness less than 30 min * friction sound 3. osteophyte in radiography 3. kellgren and lawrence scale grade ii\~iii 4. total sum of k-womac scale more than 30 5. negative results in pregnancy test of urine in screening period 6. if women in childbearing age, medically reliable contraception or menopause 7. patients who give written consent of agreement to voluntarily participate in the clinical study 8. patients who can read and understand written instructions exclusion criteria: 1. patients whose total sum of k-womac in visit 2 is less than that in visit 1 2. fibromyalgic, anserine bursitis, infectious arthritis, rheumatoid arthritis, ankylosing spondylitis, gout or pseudogout 3. knee oa with secondary causes including major dysplastic or congenital malformation, ochronosis, acromegaly, hemochromatosis, wilson's disease or primary osteochondromatosis 4. anatomical malformation, disease of vertebra or other lower extremities or other disease of orthopedics which can disturb the evaluation of the target joint 5. wound, inflammation or avascular necrosis of the target joint or arthroscopy within 6 months prior to study participation 6. patients with administration of injectable hyaluronic acid to the target joint within 6 months prior to study participation 7. severe ischaemic heart diseases, peripheral artery disease and/or cerebrovascular disease, congestive heart failure, active bronchial asthma 8. medical history of malignant tumor 9. active peptic ulcer, gastrointestinal tract bleeding or inflammatory bowel disease 10. hypersensitivity with aspirin, celecoxib, corticosteroid, acetaminophen, sulfonamide derivatives or vitis vinifera or intolerance with fructose, glucose or galactose 11. continuously(1 week or more) oral or intraarticular administration of corticosteroids within 12 weeks prior to study participation 12. pregnant or lactating women 13. patients who have experience to participate in other clinical trial within 4 weeks prior to study participation 14. alt, ast and serum creatinine ≥ 2×unl 15. drug administration after diagnosing as alcoholic or psychical disease 16. patients whom the investigators judge as improper to participate in this clinical trial
research of laser ablation for the treatment of lower anogenital tracts' precancerous lesions

Conditions: Squamous Intraepithelial Lesions; Laser Burn

Summary: using multiple targeting co2 laser ablation to treat the precancerous lesion of the female lower anogenital tracts and analyzing the data collected in the study, we aim to form the standard strategy of laser ablation method to increase the effective rate and lower the rate of relapse and progression.

patients diagnosed with cin, vain, vin, ain or pain are recruited with exclusion of suspicion of malignant tumors. we use multiple targeting co2 laser ablation to treat the precancerous lesion of the female lower anogenital tracts and then follow up the patients for at least two years. by analyzing the data collected in the study, we aim to form the standard strategy of laser ablation method to increase the effective rate and lower the rate of relapse and progression.

Eligibility criteria:
inclusion criteria: 1. had the history of sexual life. 2. transferred to colposcopy examination and biopsy for abnormal screening of cervical cancer, contact bleeding of cervix, recurrent discomfort of vulva or abnormal signs of lower genital and anal tract. the pathology of biopsy indicate cin, vain, vin, ain, or pain. 3. if cin, the colposcopy manifests transformation zone-1 which means the lesion can totally be seen. however the consideration of fertility damage of resection overweighs the chance of suffering cancer. 4. the patients can accept multiple laser ablations and colposcopy examinations and follow-up at least 2 years. exclusion criteria: 1. patients who are suffering cancers of other systems and in treatment. 2. patients suffering acute inflammation of lower genital and anal tracts. 3. the colposcopy and pathology examination suspect of cancer of lower genital and anal tract. 4. patients suffering severe diseases such as insufficiency of liver and kidney function, diseases of blood system and other acute infections who will get heath harm from colposcopy and laser vaporization.

Keywords: laser cervical intraepithelial neoplasia vaginal intraepithelial neoplasia vulvar intraepithelial neoplasia anal intraepithelial neoplasia perianal intraepithelial neoplasia
a study of tx000045 in patients with pulmonary hypertension secondary to heart failure with preserved ejection fraction (the apex study)

Conditions: Pulmonary Hypertension; Heart Failure With Preserved Ejection Fraction

Summary: tx000045-003 is a double-blind, randomized, parallel group, placebo-controlled, proof- of-concept (poc) study, evaluating 2 dose regimens of tx000045 over the course of a 24-week treatment period (the apex study).

this study will enroll approximately 180 participants and eligible patients will be randomized to one of 3 treatment arms: * arm 1: treatment group 1: placebo delivered subcutaneously (sc) every 2 weeks (q2w) for 24 weeks * arm 2: treatment group 2: tx000045 sc at dose a q2w for 24 weeks * arm 3: treatment group 3: tx000045 sc at dose b q2w alternating with placebo q2w for 24 weeks

Eligibility criteria:
inclusion criteria: 1. is a male or female of non-childbearing potential between the ages of 18 and 83 years. 2. has a diagnosis of ph-hfpef based on baseline echocardiogram and right heart catheterization (rhc). 3. has nyha functional class ii- iii heart failure. 4. has 6mwt distance from 100 to 450m. 5. chronic medication for heart failure or cardiovascular disease is at a stable dose prior to screening. 6. is able to understand and provide documented consent for participation. exclusion criteria: 1. diagnosis of ph in world health organization (who) group 1, who group 3, who group 4, or who group 5. 2. current or recent hospitalization prior to screening. 3. recently received vasoactive drugs, pulmonary arterial hypertension-specific therapies, or a relaxin receptor agonist. 4. initiated a new exercise program for cardiopulmonary rehabilitation or plans to initiate such a program during the study. 5. has a body mass index \ 45 kg/ meter square. 6. was previously administered tx000045, relaxin, or a relaxin fusion protein. 7. historical or current evidence of a clinically significant disease or disorder such as significant lung disease, cardiovascular comorbitiies, liver disease, infectious disease, or malignancy. 8. has any of the following clinical laboratory values during screening: 1. serum alanine aminotransferase or aspartate aminotransferase levels \> 3 x the upper limit of normal (uln) or total bilirubin \> 3 x uln; 2. egfr \<30 ml/min/1.73 m2; 3. hba1c (glycosylated hemoglobin) \>9%; 4. platelet count \<50,000/millimeter cube; 5. hemoglobin \<10.0g/dl; 9. history of hypersensitivity or reactions to drugs with a similar chemical structure or class to tx000045. 10. is pregnant or breastfeeding. 11. has a history of cancer within 5 years of screening other than basal cell carcinoma, cervical carcinoma, or squamous cell carcinomas of the skin. 12. has a history of drug or alcohol abuse. 13. was recently dosed in any clinical research study.
pilot study testing professional, peer, and mentor health coaches for weight loss

Conditions: Obesity

Summary: participants will be randomly assigned to 1 of 3 types of health coaches, peers, mentors, or professionals. the aim of this study is to examine the feasibility and preliminary efficacy of health coaching for weight loss.


Eligibility criteria:
inclusion criteria: * age 40-60 exclusion criteria: * participants will be excluded if they: 1. are unwilling to participate in a weight control program that includes weight coaches. 2. report not being able to walk 2 blocks (1/4 mile) without stopping. 3. are participating in a weight loss program, taking a weight loss medication, have a history of bariatric surgery, or lost ≥ 5% of body weight during the past 6-months. 4. are pregnant, lactating, less than 6 months post-partum or plan to become pregnant during the time of the intervention. 5. report a heart condition, chest pain during periods of rest or activity, or loss of consciousness on the physical activity readiness questionnaire (par-q). participants reporting joint problems, medication use, or other medical conditions that may limit their ability to exercise will be required to obtain written permission from their physician to participate in the intervention. 6. report conditions that, in the judgment of the pi, would render the participant unlikely to follow the study protocol (e.g., terminal illness, relocation, substance abuse, bulimia nervosa, dementia, or severe psychiatric condition).
predictors of response to tofacitinib treatment in rheumatoid arthritis patients

Conditions: Rheumatoid Arthritis

Summary: this is a 24-month, prospective, non-interventional, multi-center study with primary aim to identify baseline characteristics of patients that predict response at 6 months of treatment. the study also aims to describe the treatment patterns of ra patients prescribed tofacitinib in a real-world setting and assess the effect of treatment on patient quality of life and physical function. finally the study will assess the use of healthcare resources and costs in patients with ra treated with tofacitinib in greece. the planned recruitment period is 12 months. the planned observation period of each patient is 12 months. in this time period up to 4 visits will be documented. the study will be reviewed and approved by the central regulatory committee for nis and irb board of each participating site


Eligibility criteria:
inclusion criteria: * adult subjects with moderately to severely active rheumatoid arthritis who start treatment with tofacitinib in usual clinical practice conditions in compliance with the label 1. patients aged ≥ 18 years 2. confirmed diagnosis of rheumatoid arthritis by rheumatologist 3. patients with moderate to severe ra diagnosed according to local practice who have already been started on treatment with tofacitinib, for at most seven working days . 4. patients eligible for tofacitinib treatment according to current approved summary of product characteristics (smpc). 5. 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. exclusion criteria: * patients meeting any of the following criteria will not be included in the study: 1. exclusion criteria according to the xeljanz® smpc. 2. contraindications to xeljanz® according to smpc. 3. hypersensitivity to the active substance (tofacitinib) or to any of the excipients. 4. active tuberculosis (tb), serious infections, such as sepsis, or opportunistic infections. 5. receipt of any investigational drug within 3 months before study inclusion as well as currently not participating in an interventional clinical trial. 6. subjects who have received any previous treatment with tofacitinib or other jak inhibitors. 7. subjects who are investigational site staff members or subjects who are pfizer employees directly involved in the conduct of the trial.
post-market clinical follow-up of the srs implant

Conditions: Pelvic Organ Prolapse

Summary: national, multicentre observational study on surgical reconstruction of the anterior and apical compartment of the pelvic floor with an srs implant

national, multicentre, prospective observational study on surgical reconstruction of the anterior and apical compartment in seven clinical centres in germany to obtain post-market information on the srs implant with a follow-up of 24 months. patient reported satisfaction (measured by p qol, prolapse quality of life questionnaire), anatomic outcome (measured by the pop-q, pelvic organ prolapse quantification system) and the rate of complications (measured by adverse events during the study period) are focused.

Eligibility criteria:
inclusion criteria: 1. women with a symptomatic anterior vaginal wall prolapse with/without apex/uterine prolapse ≥ stage ii (according to pop-q system). this applies to primary as well as recurrent intervention. 2. age ≥ 21 years. 3. patient is mentally able to understand the nature, aims, or possible consequences of the pmcf study. 4. patient information has been provided and written consent exists. exclusion criteria: 1. contraindications according to the manufacturer's instructions for use. 2. patient with previous urogynaecological surgeries with alloplastic material. 3. patient with radiological treatment in the pelvic floor. 4. patient is institutionalised by court or official order (mpdg §27). 5. participation in another interventional study concerning pelvic floor reconstruction.

Keywords: srs implant quality of life pelvic organ prolapse surgical reconstruction
effectiveness web-based training on perinatal loss

Conditions: Pregnancy Loss; Psychological Distress; Depression

Summary: the study was conducted in a randomized controlled parallel group experimental design to determine the effect of web-based supportive care provided to women who experienced perinatal loss on perinatal grief, depression, hopelessness and coping with stress.

loss, which includes many complex emotions, is the loss of a person or object that is valuable to the individual after having it. perinatal loss is the most painful situation that pregnancy can potentially result in. with perinatal loss, parents may show behavioral (shock, anger and loneliness) and physical (crying, loss of appetite or overeating, insomnia, irritability, inability to concentrate, forgetfulness, pain, etc.) reactions. however, emotional problems such as grief and depression after loss are more common than physical and behavioral problems. while the prevalence of major depression in society is 3-10%, this rate varies between 10-51% in those who experience perinatal loss. loss can become a life crisis with biopsychosocial and spiritual dimensions for parents and especially for women.

Eligibility criteria:
inclusion criteria: * spoke turkish, had at least primary school level education * did not have a psychiatric disease diagnosis * could use and access the internet and information technologies * did not have vision and hearing problems * experienced pregnancy loss of 12 weeks or more * were hospitalized in the perinatology clinic exclusion criteria: * women who did not accept to participate in the study * did not use the internet and information technologies and could not access them * applied to psychological support units during the training process * started using psychiatric medication during the training process were not included in the study
evaluation of safety, tolerability, pharmacokinetics and pharmacodynamics of ta-8995 with single, escalating doses in healthy subjects

Conditions: Dyslipidemia

Summary: the purpose of this study is to assess the safety and tolerability of single doses of ta-8995 in healthy caucasian and japanese volunteers.


Eligibility criteria:
inclusion criteria: * caucasian men aged 18-55 years and ≥65 years * women of non-childbearing potential * japanese men aged 18-55 years * subjects were deemed healthy on the basis of medical history, physical examination, electrocardiogram (ecg), vital signs and safety tests of blood and urine * subjects were able to give fully informed written consent exclusion criteria: * hdl-c level ≥2.59 mmol/l * abnormal holter ecg * family history of long qt syndrome, hypokalaemia or torsade de pointes * vital signs or 12-lead ecg values outside the acceptable range * positive tests for hepatitis b and c, hiv 1 and 2 * positive urine pregnancy test (women only) * severe adverse reaction or allergy to any drug * drug or alcohol abuse * smoking within the 6 months before dosing with ta-8995 (caucasian subjects), or smoking more than 10 cigarettes daily (japanese subjects) * over-the-counter or prescribed medication up to 7 days or 5 half-lives (whichever was longer) before dosing with ta-8995 * consuming food or drinks containing grapefruit or cranberry within the 7 days before dosing * participation in other clinical trials, or loss of more than 450 ml blood within the previous 3 months * clinically relevant abnormal findings at the screening assessment * clinically relevant abnormal medical history or concurrent medical condition * possibility that volunteer would not cooperate

Keywords: mt-8995 dyslipidemia cholesteryl ester transfer proteins
relative bioavailability of pimasertib in cancer patients

Conditions: Neoplasms

Summary: this is a phase 1, multi-center, open-label, single-dose, 2 period, 2 sequence cross-over trial to investigate the relative bioavailability of 2 solid oral pimasertib formulations in cancer subjects (part a), followed by open-label pimasertib administration (part b and trial extension phase).


Eligibility criteria:
inclusion criteria: * pathologically confirmed solid tumors, either refractory to standard therapy or for which no effective standard therapy is available, with a measurable disease as defined by response evaluation criteria in solid tumors (recist) v1.1 * an eastern cooperative oncology group performance status (ecog ps) of less than or equal to (\<=) 1 * other protocol defined inclusion criteria could apply exclusion criteria: * disease conditions or concomitant medication that may significantly influence the conduct of the trial or an abnormal electrocardiogram (ecg) or blood pressure at screening as defined in the protocol * treatment with strong inhibitors or inducers of cytochrome p450 2c19 (cyp2c19) and cyp3a4 including fruit juices or beverages containing these substances * history of prior mitogen-activated protein kinase/extracellular signal-regulated kinase (mapk/erk) kinase (mek) inhibitor exposure (including, pimasertib) or progression of disease on mek inhibitors * evidence of a retinal vein occlusion (rvo) on fluorescein angiogram or a history of rvo * life expectancy of less than 12 weeks * other protocol defined exclusion criteria could apply

Keywords: neoplasms pimasertib cancer
a study of ly3502970 in participants with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the main purpose of this study is to learn more about the safety of ly3502970 and any side effects that might be associated with it. blood tests will be done to measure how much ly3502970 is in the bloodstream, how long it takes the body to eliminate it, and how it affects blood sugar. participation could last up to 18 weeks and may include up to 14 visits (including three overnight stays) in the study center.


Eligibility criteria:
inclusion criteria: * have type 2 diabetes mellitus (t2dm) for at least 6 months * have a glycated hemoglobin (hba1c) value at screening of greater than or equal to (≥)7.0 percent (%) and less than or equal to (≤)10.5% and are treated with diet and exercise alone or a stable dose of metformin for at least 3 months prior to screening * have a body weight of ≥45 kilograms (kg) and have a body mass index of 18.5 to 45 kilograms per square meter (kg/m²), inclusive * have had a stable body weight for the 3 months prior to screening (less than \[\<\]5% body weight change) * males and females (not considered woman of childbearing potential) exclusion criteria: * have type 1 diabetes mellitus, latent autoimmune diabetes in adults or have had an episode of ketoacidosis or hyperosmolar state requiring hospitalization in the 6 months prior to screening * have had any of the following within the past 6 months prior to screening: myocardial infarction, unstable angina, coronary artery bypass graft, percutaneous coronary intervention (diagnostic angiograms are permitted), transient ischemic attack, cerebrovascular accident or decompensated congestive heart failure, or currently have new york health association class iii or iv heart failure * show evidence of hepatitis b, and/or positive hepatitis b surface antigen * show evidence of human immunodeficiency virus (hiv) infection and/or positive human hiv antibodies * any glucose-lowering medications other than metformin within 3 months prior to screening
measuring environmental tobacco and cannabis: pollutants and exposures

Conditions: Healthy

Summary: this is an unblinded pilot study of an environmental exposure to secondhand cannabis smoke in one group of healthy nonsmokers.

the goal is to gather accurate information on uptake of smoke toxicants from cannabis exposures in the real world. the investigators will be taking healthy nonsmokers to public places where people are consuming cannabis and measuring their uptake of cannabinoids.

Eligibility criteria:
inclusion criteria: - adult nonsmokers, aged 21-50, who: * are healthy on the basis of medical history * have systolic blood pressure \<150 * have diastolic blood pressure \<100 * have bmi between 18.1 and 34.9 * able to perform moderate exercise, * are not exposed to tobacco or cannabis shs in their daily lives. (nonsmoking status and low shs exposure are determined by self-report on the screening questionnaire, salivary cotinine \< 10 ng/ml and thc \< 50 ng/m and exhaled co2 below 4 ppm) exclusion criteria: * current use of cannabis products, including cbd and edible thc products * regular exposure to secondhand tobacco or cannabis smoke * positive sars-cov-2 antibody test * age 18 \ 50 * physician diagnosis of asthma, heart disease, hypertension, thyroid disease, diabetes, renal or liver impairment or glaucoma. * unstable psychiatric condition (such as current major depression, history of schizophrenia or bipolar disorder) or current use of more than two psychiatric medications * systolic blood pressure \> 150 * diastolic blood pressure \> 100 * pregnancy or breastfeeding (by urine hcg and/or history) * alcohol or illicit drug dependence within the past 5 years * bmi \> 35 and \< 18 * current illicit drug use (by history or urine test) * more than 1 pack year smoking history * ever a daily marijuana smoker * smoked anything within the last 2 months * occupational exposure to smoke, dusts or fumes * concurrent participation in another clinical trial * unable to communicate in english * no social security number

Keywords: nonsmokers secondhand cannabis smoke environmental cannabis exposure