Kornimate/medical-research-clean huggingface dataset:
efficacy of bushen huatan decoction in the treatment of polycystic ovary syndrome

Conditions: Polycystic Ovary Syndrome

Summary: polycystic ovary syndrome (pcos) is a common reproductive disease associated with endocrine and metabolic disorders. some studies have shown that chinese herbal medicine is beneficial for pcos, but the efficacy of chinese herbal medicine in the treatment of pcos is not clear, because the quantity of pre-clinical data was limited and the quality of clinical evidence was variable. therefore, this randomized double-blind placebo-controlled trial aim to evaluate the efficacy of chinese herbal medicine (bushen huatan decoction) in women with pcos.


Eligibility criteria:
inclusion criteria: 1. the diagnosis of pcos is based on the rotterdam criteria. 2. meet the syndrome differentiation standard of kidney-yang deficiency with phlegm-dampness and blood stasis in tcm theory. 3. women aged 18-40 years without fertility requirements. 4. a willingness to undergo this treatment plan. exclusion criteria: 1. hyperprolactinemia (2 times serum prolactin levels of more than 25 ng/ml at least one week apart). 2. diminished ovarian reserve, fsh (follicle-stimulating hormone) level more than 10 iu/l. 3. abnormal thyroid function, tsh (thyroid stimulating hormone) level less than 0.2 miu/ml or more than 5.5 miu/ml. 4. suspected cushing's syndrome. 5. adrenal or ovarian tumors secreting androgen. 6. poorly controlled type ii diabetes. 7. pregnancy or lactation. 8. hypertensive patients with poorly controlled blood pressure (a systolic blood pressure more than 160 mmhg or a diastolic blood pressure more than 100 mmhg). 9. those who had taken hormones or other drugs during the previous 3 months. 10. acute heart, liver, kidney or blood diseases.
the influence of estradiol supplementation during the luteal in patients undergoing ivf treatment

Conditions: Infertility

Summary: to evaluate whether treatment with estradiol supplementation during the luteal phase improves ivf outcomes patients undergoing ivf treatment with controlled ovarian hyperstimulation using a gnrh analog will receive 4 mg estradiol valerate in the luteal phase.patient's followup will include e2 progesterone and bhcg 14 days after embryo transfer and vaginal ultrasound on day 21 and 28 after embryo transfer

the study will include patients undergoing ivf treatment with controlled ovarian hyperstimulation using a daily gnrh analog in a long protocol,older then 18, .the women will be randomised to two groups.both groups will be given vaginal tabs of natural micronized progesterone(uterogestan) the study group will be given oral estradiol valerate 4 mg.prior to treatment, each patient will be signed on informed concent. patients will be excluded if they are older than 40, have any systemic illnesses or a personal or family history of a thromboembolic event. follow up: verification of pregnancy status and hormonal profile will be carried out on day fourteen after embryo transfer by means of serum hcg,p and e2. clinical pregnancy will be defined as the presence of a gestational sac on ultrasonography on day 21 after embryo transfer and fetal heart will be evaluated on day 28

Eligibility criteria:
inclusion criteria: * women treated for infertility with controlled ovarian hyperstimulation using daily gnrh agonist exclusion criteria: * women younger then 18 or older then 40 * women with systemic disease * women with a family or personal history of thromboembolic event

Keywords: luteal phase estradiol pregnancy rate
a study of gefapixant (mk-7264) in japanese adult participants with refractory or unexplained chronic cough (mk-7264-038)

Conditions: Chronic Cough

Summary: the primary objective of this study is to evaluate the safety of two doses of gefapixant (mk-7264) in japanese adult participants with refractory or unexplained chronic cough.


Eligibility criteria:
inclusion criteria: * chest radiograph or computed tomography scan of the thorax not demonstrating any abnormality considered to be significantly contributing to the chronic cough or any other clinically significant lung disease in the opinion of the principal investigator or the sub-investigator. * chronic cough for ≥ 4 months and a diagnosis of refractory or unexplained chronic cough. * persistent cough, despite treatment in accordance with the latest guideline of cough from the japanese respiratory society, cough is a burden to the participant, and needs further treatment. * if female, is not pregnant, not breast-feeding, and either is not a woman of childbearing potential or agrees to follow the contraceptive guidance. exclusion criteria: * current smoker, or has given up smoking within 12 months of screening. * history of upper or lower respiratory tract infection or recent clinically significant change in pulmonary status. * has a history of chronic bronchitis. * current use of an angiotensin converting enzyme inhibitor (acei) or has taken an acei within 3 months of screening. * estimated glomerular filtration rate (egfr) \<30 ml/min/1.73 m\^2 or ≥30 ml/min/1.73 m\^2 and \<50 ml/min/1.73 m\^2 at visit 1 with unstable renal function (defined as a ≥50% increase of serum creatinine compared to a value obtained at least 6 months prior to visit 1). * history of malignancy ≤ 5 years. * user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence. * systolic blood pressure \>160 mm hg or a diastolic blood pressure \>90 mm hg at screening. * history of cutaneous adverse drug reaction to sulfonamide antibiotics or other sulfonamide-containing drugs. * known allergy/sensitivity or contraindication to gefapixant. * donated or lost ≥1 unit of blood within 8 weeks prior to the first dose of gefapixant. * previously received gefapixant or is currently participating in or has participated in an interventional clinical study.
bioprothetic valve versus mechanical valve of bioprothetic valve versus mechanical valve

Conditions: Valve Heart Disease

Summary: in this study, the investigators aim to use data identified through the hospital's integrated medical database and national health insurance database to explore the long-term performance and benefits of biological and mechanical valves. this research aims to provide more recommendations and references for valve replacement in different patient populations.

long-term follow-up of valve surgery is essential in all cardiac surgeries and is the most commonly discussed indicator. the choice of valves has evolved over the past 30 years, offering two options: biological valves and mechanical valves. biological valves have seen advancements in the last 15 years, including new processes and improved valve preservation methods. the question of whether these new process valves offer better long-term effectiveness has become a hot research topic in recent years. mechanical valves have a longer lifespan, but the need for long-term anticoagulant use to prevent mechanical valve thrombosis has raised concerns about anticoagulant side effects, abnormal clotting function, and bleeding. biological valves, on the other hand, do not require long-term anticoagulation and only necessitate 2-3 months of anticoagulant treatment. however, the risk of biological valve degeneration results in an average lifespan of 10 to 20 years, which cannot match the durability of mechanical valves. this is the drawback of using biological valves. therefore, the investigators hope to utilize the hospital's integrated medical database and the long-term national health insurance database for tracking. the investigators aim to observe valve performance in different patient groups, such as young people, the elderly, patients on dialysis, those with rheumatic autoimmune diseases, and those taking specific medications, among others.

Eligibility criteria:
inclusion criteria:this is a retrospective study, and we plan to utilize data from the hospital's integrated medical database and the national health insurance database from january 2007 to december 2019. we will identify all patients within the data who were diagnosed with valve diseases and underwent valve replacement surgery. - exclusion criteria:individuals under 20 years of age. -
monitoring biomarker for detecting change in physical activity and limb function in inclusion body myositis over time

Conditions: Inclusion Body Myositis

Summary: inclusion-body myositis (ibm) results in weakness and the deterioration of distal arm muscles, the symptoms of which are currently assessed through expert examination at clinical visits. such in-clinic assessments are time-consuming, subjective, of limited sensitivity, and only provide a snapshot of a patient's disease. in this project, the investigators will conduct clinical validation of monitoring digital biomarkers of upper limb function during activities of daily living using a wearable sensor platform that enables frequent, at-home monitoring of upper limb function health in ibm and could be incorporated into ibm trials.


Eligibility criteria:
inclusion criteria: 1. meet any of the european neuromuscular centre inclusion body myositis research diagnostic criteria 2011 categories for ibm. 2. able to provide informed consent. exclusion criteria: 1. unwillingness to follow study procedures. 2. participation in an investigational drug research study within the past 30 days.

Keywords: biomarker
simbrinza® suspension bid as an adjunctive to prostaglandin analogue (pga)

Conditions: Open-Angle Glaucoma; Ocular Hypertension

Summary: the purpose of this study is to evaluate the additive intraocular pressure (iop) lowering effect of brinzolamide 1%/brimonidine 0.2% (dosed twice per day (bid)) when added to a prostaglandin analogue (pga) in subjects with open-angle glaucoma or ocular hypertension.

this study consisted of 2 sequential phases: screening/eligibility phase, followed by a masked treatment phase (phase ii). subjects were assigned into one of 3 pga therapy groups for the duration of the study, based upon commercial availability.

Eligibility criteria:
inclusion criteria: * diagnosis of either open-angle glaucoma or ocular hypertension; * must sign an informed consent form; * mean iop measurements at both the eligibility 1 and 2 visits, in at least 1 eye (the same eye\[s\]) ≥ 19 and \< 32 mmhg at 09:00. * willing and able to attend all study visits; * other protocol-specified inclusion criteria may apply. exclusion criteria: * women of childbearing potential who are pregnant, breast-feeding, intend to become pregnant during the study, or not using adequate birth control methods to prevent pregnancy throughout the study; * any form of glaucoma other than open-angle glaucoma or ocular hypertension; * ocular disease, trauma, infection, inflammation, pathology, or surgery as specified in the protocol; * any other conditions including severe illness which would make the subject, in the opinion of the investigator, unsuitable for the study; * other protocol-specified exclusion criteria may apply.
correlation between types of lateral pterygoid muscle attachment and internal derangement of the temporomandibular joint

Conditions: TMJ Disorder

Summary: the study aimed to evaluate the clinical and mri finding of tmj and lpm with predication of the risk factors. study design: this retrospective study included 1365 joints in 800 patients diagnosed as tmj internal derangement and all the patients examined by mri from 2008 to 2019. cases with loss of continuity of articular disk or the posterior attachment of the disk were considered as positive cases.

the study aimed to evaluate the clinical and mri finding of tmj with lpm with predication of the risk factors. study design: this retrospective study included patients diagnosed as tmj internal derangement and all the patients examined by mri from 2008 to 2019. cases with loss of continuity of articular disk or the posterior attachment of the disk were considered as positive cases.

Eligibility criteria:
inclusion criteria: - study included patients seeking treatment for tmd at al-azhar university hospital and the outpatient clinic at the faculty of dental medicine of al-azahr university. exclusion criteria: * exclusion inclusion criteria: patients were included if they were older than 18 years and diagnosed with tmjd. criteria for this study included systemic diseases (the presence of polyarthritis or other rheumatic diseases), contraindications for mri (e.g., implanted metal or medical devices, claustrophobia), the presence of neurologic disorders, head and neck cancer, oral submucous ﬁbrosis, a history of tmj surgery, a history of previous nonsurgical treatment such as occlusal splints, and a history of joint injection with ha/prp. trauma patients with subcondylar fracture and patients with congenital and developmental disorders of the tmj were also excluded from the study.
evaluation of the performance of maf-1217 on cataract surgery

Conditions: Dry Eye

Summary: maf-1217 is meant as the medical device which is to be effective in most forms of ded; therefore, it is expected that study patients benefit from study participation, and can reduce the signs and symptoms of surgery induced ded in patients undergoing cataract surgery, in a tid application pre-surgery.

this is a multicentre, pre-market, open label, randomized, prospective study exploring the performance of maf-1217 when administered pre-surgery, in reducing the sign and symptoms of post-surgery ded in patients undergoing cataract surgery. patients will be enrolled 2 weeks before surgery (screening visit), will undergo cataract surgery (day 0 - baseline/surgery), and then will be seen at week 1 and 2 after surgery.

Eligibility criteria:
inclusion criteria: 1. at least 18 years old patients, male and female 2. patients without diagnosed ded (including subclinical ded) or with mild ded, with but \>7 3. normal to mild ded according to osdi chart 4. diagnosis of cataract requiring surgery 5. wishing to participate in the study and able to sign the icf 6. shirmer test \> 15 mm /5' 7. no topic ophthalmic medication, including lubricating eyedrops administration for at least 4 days before screening visit. exclusion criteria: 1. neuropathic causes of dry eye (diabetes, long-standing contact lens wearing, previous ocular herpes infections) 2. patients with diagnosis of glaucoma 3. functional and anatomic eyelid abnormalities, 4. complicated cataract, 5. suture affixing during surgery, 6. use of artificial tears in the month preceding the study visit 7. coexisting corneal diseases 8. autoimmune diseases 9. past or active cicatricial conjunctivitis 10. past ocular surface burns 11. keratinization of the eyelid margin 12. sjogren syndrome 13. history of corneal trauma 14. pregnant and lactating women 15. younger than 18 years old patients 16. inability to self-administer study medications 17. known allergic sensitivity to any of the devices ingredients, or any other type of allergy 18. participation in a clinical trial during the 3 months prior to the beginning of the study
reliability of a endurance and a strength test for shoulder rotation

Conditions: Fatigue

Summary: introduction: verification of the progression of individuals submitted to training programs is performed by diagnostic tests with a focus on strength and muscular endurance. among the tools used are the elastic bands, the halter, the pulley, the digital dynamometer and, additionally, the isokinetic dynamometer, considered the gold standard of evaluation. however, there is a lack of standardization in assessments and scarcity in the exploration of some tools and some muscle groups. observation is often restricted to a particular study design and makes comparisons difficult even with the use of the same tool. thus, to include different clinical possibilities in the same scenario can enrich the discussion about the topic. objective: to develop and analyze the validity and reliability of a maximal muscle strength test for the external rotator muscles of the shoulder in five tools; to develop and analyze the validity and reliability of a localized resistance test for the external rotator muscles of shoulder in three different percentages of maximum strength (60%, 70%, 80%) in four tools; to characterize by means of the physiological response the localized muscular endurance test with the load that presents with the highest reliability values in each tool. method: the study will consist of a sample of 50 participants of both genders, and will be performed in 3 steps: (1) validation and reliability of the maximum muscle strength test; (2) reliability of the muscular endurance test (met); (3) physiological characterization of the muscular endurance test (met). stage 1 will be held in 3 sessions (familiarization, test and retest) in which participants will perform 5 tests of maximum strength with different tools (elastic bands, pulley, halter, digital dynamometer and isokinetic dynamometer). stage 2, consisting of 6 sessions, will be tested and retest of a muscular endurance test with different loads (70%, 80% and 90% of maximum force) with the same devices of step 1, except the digital dynamometer. in step 3 participants will be selected with the lowest variations between the test and retest in the variable "time" to perform the physiological characterization of the test with the different tools. in order to observe the physiological response, we will analyze the lactic anaerobic (lactate concentration), allelic anaerobic (post-exercise oxygen uptake (epoc) and aerobic (vo 2 values) parameters). the statistical package spss statistics 22.0 will be used to conduct the analyzes. key words: fatigue, physical resistance, muscle strength, lactate.


Eligibility criteria:
inclusion criteria: should report the absence of: * anemia, * diabetes, * cardiovascular disease, * and upper limb and spinal muscular injuries in the last six months exclusion criteria: * absence at any study session and * episode of muscle-tendon or osteoarticular injury in the upper limbs during the study.
circadian disturbances after breast cancer surgery

Conditions: Circadian Rhythm Disorders; Anxiety; Breast Cancer

Summary: the purpose of this study is to investigate circadian disturbances after breast cancer surgery by means of monitoring sleep and heart-rate variability, by measuring a metabolite of melatonin in urine and by questionnaires and a sleep-diary.

an increasing number of studies have shown that circadian variation in the excretion of hormones, the sleep-wake cycle, the core body temperature, the tone of the autonomic nervous system and the activity rhythm are important both in health and disease processes. more attention is being paid towards the circadian variation in endogenous rhythms in relation to surgery and whether this can affect postoperative recovery, morbidity and mortality. studies have been done on circadian disturbances after major and minor surgery but never in relation to breast cancer surgery. this study will investigate circadian disturbances in this specific group of patients by using actigraphy, polysomnography (psg), holter-monitoring (hrv), the primary metabolite of melatonin in urine 6-sulfatoxymelatonin (amt6s), questionnaires and a sleep-diary.

Eligibility criteria:
inclusion criteria: * women, age 30-70, with breast cancer who are admitted for a lumpectomy at herlev hospital * asa score i-iii exclusion criteria: * known sleep apnea * pre-operative treatment with beta-blockers * diabetes mellitus * known pre-operative depressive illness or dementia * previous or current cancer * known medically treated sleep-disorder (insomnia, restless legs etc) * shift-work * daily alcohol intake of more than 5 units * pre-operative treatment with psychopharmacological drugs, opioids or anxiolytics (including all sleeping pills) * predicted bad compliance * pregnant or breast-feeding * pre- or post-operative complications or events which are expected to increase morbidity or pain the first post-operative days. * missing written consent * pre-operative mmse score less than 24 * urine or fecal incontinence

Keywords: circadian rhythm disorders breast neoplasms surgery sleep heart rate
treating chronic pain and depression in hiv+ patients in primary care settings

Conditions: Pain Interference; Depression; Antiretroviral Adherence

Summary: the purpose of this study is to determine whether participation in the study intervention, which involves collaboration between the study interventionist and the participant's primary care physician, will reduce symptoms of pain and depression in hiv+ patients.


Eligibility criteria:
inclusion criteria: * chronic pain (pain duration for at least six months with a mean score of 5 or higher on the bpi pain interference scale) * pain severity of 40 or higher on a visual analog scale (0-100) indicating "worst pain in the last week" * at least one trial of pcp-recommended medication (i.e. acetominophen, nsaids, skeletal muscle relaxants) judged through interviews with patients and pcps * qids score of ≥ 9 (depression severity) * stable dose of an antidepressant, if using, for the previous 2 months * age 18 or older * hiv+ exclusion criteria: * lifetime dsm-iv diagnosis of bipolar disorder, schizophrenia, or other chronic psychotic condition * current dsm-iv diagnosis of substance dependence for alcohol, sedative/ hypnotic drugs, stimulants, or cocaine * suicidal ideation or behavior requiring immediate attention * in psychotherapy or in a multidisciplinary pain management program * expected surgery in the next 6 months * pain thought to be due to cancer, infection, or inflammatory arthritis * pregnancy

Keywords: pain depression hiv adherence
study to assess the potential for adrenal suppression following treatment with dsxs in patients with atopic dermatitis

Conditions: Dermatitis, Atopic

Summary: this study is to evaluate the potential of dsxs to suppress hpa axis function in patients with moderate to severe atopic dermatitis.

the objective of this study is to evaluate the potential of dsxs to suppress hpa axis function in patients with moderate to severe atopic dermatitis. the secondary objectives are to evaluate to evaluate adverse event (ae) profiles of dsxs administered to patients with moderate to severe atopic dermatitis.

Eligibility criteria:
inclusion criteria: * patients with a definite clinical diagnosis of stable atopic dermatitis exclusion criteria: * patient is under the age of 2
entyvio (vedolizumab) long term safety study

Conditions: Ulcerative Colitis and Crohn's Disease

Summary: the purpose of this study is to assess the long-term safety of vedolizumab versus other biologic agents in participants with ulcerative colitis (uc) or crohn's disease (cd).

the drug being tested in this prospective, observational study is called vedolizumab. vedolizumab is being used to treat people who have uc or cd. this study will look at the long-term safety of vedolizumab versus other biologic agents in participants with uc or cd. the study will enroll approximately 5000 participants. all participants enrolled in this will belong to one of the two treatment group: * vedolizumab * other biologic agents -adalimumab, certolizumab pegol. golimumab and infliximab. study drugs will be prescribed by the physician according to local prescribing information in the participating countries. this multi-centre trial will be conducted worldwide. the overall time to participate in this study is 7 years. participants will make visits at every 6 months to their treating physician.

Eligibility criteria:
inclusion criteria: 1. signed informed consent, by the participant or a legally acceptable representative. 2. aged at least 18 years. 3. initiating vedolizumab or another biologic agent for uc or cd. 4. signed release form, by the participant or a legally acceptable representative, permitting abstraction of the participant's medical records at baseline and during participation in the study. exclusion criteria: 1. the participant is enrolled in a clinical trial in which treatment for cd or uc is managed through a protocol. 2. prior treatment with vedolizumab. 3. any other reason that, in the investigator's opinion, makes the participant unsuitable to participate in this study.

Keywords: drug therapy