Kornimate/medical-research-clean huggingface dataset:
jiangzhuo prescription ，fenofibrate and placebo in the treatment of hyperlipidemia (syndrome of phlegm obstruction)clinical study (jzf)

Conditions: Metabolic Syndromes; Hyperlipidemia

Summary: jiangzhuo prescription ,fenofibrate and placebo in the treatment of hyperlipidemia(syndrome of phlegm obstruction), randomized, parallel-controlled, multi-center clinical study

charged by the five research centers in line with traditional chinese medicine syndrome of phlegm obstruction 240 cases have hyperlipidemia, and overweight, as well as hypertension or diabetes were randomly divided into chinese herbal compound jiangzhuo prescription group and western medicine fenofibrate group and placebo group.the treatment groups were compared 12-week regulation of blood lipids and step-down, blood sugar effect.

Eligibility criteria:
inclusion criteria: * 1. consistent with diagnosed hyperlipidemia, tg≥2.26mmol/l and ≤7.0mmol/l. 2. aged 18-65 years old. 3.bmi ≥ 24kg/m2, but \<35 kg/m2. 4. waist circumference ≥ 90cm (male) or waist circumference ≥ 80cm (women). 5. comply with any of the following 3 :bloode pressure elevated levels of:sbp ≥130mmhg or dbp ≥85mmhg; fasting plasma glucose (fpg) increased: fpg ≥ 100mg/dl (5.6mmol / l ), or previously diagnosed type 2 diabetes or have received appropriate treatment. exclusion criteria: * 1. has been used to control lipidsdrugs, but use the time for those below the 3 month. 2.secondary dyslipidemia, such as nephrotic syndrome, hyperthyroidism, etc. 3.taking thyroid medications and other drugs that affect lipid metabolism, such as high-dose thiazide diuretics, β-receptor blockers, corticosteroids. 4.severe diseases of heart, lung, liver, kidney, brain, blood ,etc. 5.with the treatment of insulin, sulfonylureas, rosiglitazone or metformin. 6.3 months prior to the study of myocardial infarction or unstable angina confirmed. 7.uncontrolled blood sugar or after controlling fpg\>7.0mmol/l or 2hpg\>11.1mmol/l 8.uncontrolled blood pressure or after contraolling blood pressure\>140/90mmhg 9.alt≥80mmol/l 10.pregnancy, for pregnancy or breast-feeding women 11.allergis of fibrates or chinese medicine 12.mental illness 13.cancer patients 14.history of gallbladder disease or cholelithiasis 15.with the treatment of cyclosporine or coumarin anticoagulants 16.the patient with other clinical studies in the past 3 months 17.history of alcoholism and drug dependence
konjac-mannan improves glycemia and other risk factors for chd in t2dm

Conditions: Type2 Diabetes; Coronary Heart Disease

Summary: to examine whether konjac-mannan fiber improves metabolic control measured by glycemia, lipidemia, and blood pressure in individuals with type-2 diabetes.


Eligibility criteria:
inclusion criteria: * hyperlipidemia controlled by medication * hypertension controlled by medication * type 2 diabetes controlled by medication * minimum 3 years since onset of all three conditions * sedentary lifestyle exclusion criteria: * regular smoking * regular alcohol consumption * family history of premature coronary heart disease * hypothyroidism * renal, hepatic or gastrointestinal disease

Keywords: konjac type2 diabetes fiber coronary heart disease
idecide.decido: diabetes medication decision support study

Conditions: Diabetes, Type 2

Summary: two of ahrq 's consumer-focused guides, "pills for type 2 diabetes" and "premixed insulin for type 2 diabetes" could be of great use to underserved ethnic and racial minority adults. the presentation of content and delivery mechanisms of these guides, however, needs to be modified to increase their use and impact among these difficult-to-reach populations. to achieve this goal, a long-standing collaboration among african american and latino community organizations, health care centers and systems, public health organizations, and academics (the reach detroit partnership) is joining with leading experts in the development of personally and culturally tailored health decision aids (university of michigan's center for health communications research \[chcr\] and center for behavioral and decision sciences in medicine \[cbdsm\]). the investigators will develop and evaluate a computer tailored online diabetes medication decision aid that will enable community health workers (chws) to provide personalized patient education materials to underserved diabetic african american and latino adults in detroit, michigan.

the specific aims of this study are: aim 1: to use the information in the two diabetes medications consumer cersgs to build an interactive, computer tailored diabetes medication guide that will enable patients to assess their treatment goals, personal preferences, and side-effect concerns and generate a personally tailored assessment of their current diabetes treatments with, as appropriate, options for improving their diabetes care; aim 2: to determine the extent to which this personally tailored diabetes medication guide compared with the print consumer guides reduces latino and african american diabetes patients' decisional conflict, through improved knowledge of anti-hyperglycemic medications and satisfaction with information received. aim 3: to examine the computer tailored program's effects on participants' changes in medications (medication intensification), self-reported medication adherence and beliefs and a1c levels between baseline and follow-up compared to participants receiving the print consumer guides.

Eligibility criteria:
inclusion criteria: * type 2 diabetes * stated concern about diabetes and diabetes treatment * poor glycemic control * over 21 years of age exclusion criteria: * blind, deaf, otherwise unable to use the telephone or visual resources * pregnant * currently enrolled in other reach detroit research study * in hospice care * current radiation or chemotherapy

Keywords: diabetes decision aid antihyperglycemic medication tailored health information medication information
helical ct, pet/ct, mri, and cbct alone or in combination in predicting jaw invasion in patients with oral cancer

Conditions: Oral Cavity Squamous Cell Carcinoma

Summary: this clinical trial studies how well helical computed tomography (ct), positron emission tomography (pet)/ct, magnetic resonance imaging (mri), and cone beam computed tomography (cbct) work alone or in combination in predicting whether tumor cells have spread to the jaw bone (jaw invasion) in patients with oral cancer. imaging, such as helical ct, pet/ct, mri, and cbct, may help find out how far cancer has spread. accurate prediction of the presence or absence of jaw invasion may help create a better surgical treatment plan for patients with oral cancer.

primary objectives: i. to determine which imaging modality or combination of imaging methods, in conjunction with clinical and histological examination, will most accurately predict the presence or absence of invasion of the mandible or maxilla by intraoral squamous cell carcinoma (scc). secondary objectives: i. to compare the histopathologic findings to the radiologic findings.

Eligibility criteria:
inclusion criteria: * diagnosis of squamous cell carcinoma of the oral cavity * able to read and sign and informed consent exclusion criteria: * prior mandibular surgery * primary intraosseous carcinoma * prior history of radiation to the mandible * obvious finding of clinical invasion of the mandible
safety and efficacy of rrg001 gene therapy in subjects with neovascular age-related macular degeneration (namd)

Conditions: Neovascular Age-related Macular Degeneration

Summary: a phase i/iia, dose-escalation and dose-expansion study to evaluate the safety and efficacy of single subretinal injection of rrg001 in subjects with neovascular age-related macular degeneration

this study adopts a multicenter, single-arm, open-label phase i/iia seamless study design and comprises two stages, i.e., phase i 3+3 dose escalation study and a phase iia dose expansion study. four dose groups are preset for the phase i dose escalation study; 3-6 subjects will be enrolled for each dose group, and it is planned to enroll 12-24 subjects. the phase iia dose expansion study will be conducted successively at the doses after safety assessments of dose 2 and/or dose 3 in phase i are completed. twelve subjects are expected to be enrolled for each dose group, with a total of 24 subjects will be enrolled overall. the sponsor will assess whether or not to adjust the dose(s) and sample size for the exploration study based on the results in the phase i exploration study.

Eligibility criteria:
inclusion criteria: * subjects that are willing and able to follow study procedures. * patinets ≥50 years old. * clinically diagnosed with cnv secondary to namd. * bcva of the study eye is ≥5 letters and ≤73 letters(snellen 20/800\~20/40), as well as that of the other eye ≥19 letters(snellen 20/400). * responding to anti-vegf exclusion criteria: * presence of any other eye diseases other than namd in study eye that would affect the treatment or confusing the interpretation of the study results , as judged by the investigator. * cnv or macular edema in the study eye secondary to any causes other than amd. * uncontrolled glaucoma. * uncontrolled hypertension despite medication. * pregnant or lactating women or individuals with reproductive potential who are unwilling to take effective contraception during the study period.
mor and comt snp polymorphism and pain

Conditions: Pain Relief

Summary: patients with certain polymorphism in the mor and comt genes will display differences in their response to analgesics.

after tissue injury, there is great interindividual variability among patients in the amount of pain experienced (pain intensity and duration of pain) and in the degree of pain relief from analgesics. in experimental settings, single nucleotide polymorphisms (snp) at the mor and comt genes have been found to alter the response to opioids in in vitro models and in human.we will collect clinical data on one hundred patients undergoing surgery. we will obtain dna extracted via pcr techniques from the patients' blood and we will identify snps at the mu opioid receptor and catechol-o-methyltransferase genes. we will analyze the data to search for correlation between clinical patterns of postoperative pain and opioid effects and snps.

Eligibility criteria:
inclusion criteria: * 18 years of age and older * give informed consent to participate in this study exclusion criteria: * neurologic or psychiatric disease sufficient, in the clinical judgment of the investigator, to compromise informed consent or data collection * asa classification score 3 or above * patients with past or present history of substance abuse. * patients with a history of chronic pain requiring daily analgesic use for more then one month. * patients with a current diagnosis of anxiety or depression requiring medical treatment * patients allergic to morphine

Keywords: opioids comt snp analgesia postoperative pain
long term safety follow up of haematopoietic stem cell gene therapy for the wiskott aldrich syndrome

Conditions: Wiskott-Aldrich Syndrome

Summary: an open follow up study of patients enrolled in the phase 1/2 clinical trial of haematopoietic stem cell gene therapy for the wiskott-aldrich syndrome and treated with autologous cd34+ cells transduced with the w1.6_hwasp_wpre (vsvg) lentiviral vector.


Eligibility criteria:
inclusion criteria: * patients enrolled in the initial phase i/ii was conducted in france and united kingdom (gtg002.07 and gtg003.08). * parents, guardians or patient signed informed consent, guardians or patient signed informed consent exclusion criteria: • parents, guardians, patients unwilling to return for the follow up study period.
fulvestrant plus enzalutamide in er+/her2- advanced breast cancer

Conditions: Breast Cancer

Summary: a phase 2 study to evaluate the tolerability and clinical activity of adding enzalutamide to fulvestrant treatment in women with advanced breast cancer that are er and/or pr positive and her2 normal.

this is a single arm, non-randomized, open-label phase 2 study designed to evaluate the tolerability and clinical activity of adding enzalutamide to fulvestrant treatment in women with advanced breast cancer that are er and/or pr-positive and her2 normal. in this study 500 mg of fulvestrant will be given im on days 1, 15, 28, then every 4 weeks as per standard of care (soc) and 160mg of enzalutamide will be, in conjunction with fulvestrant, po daily.

Eligibility criteria:
inclusion criteria: 1. er+ her2- breast cancer 2. metastatic 3. female, at least 18 years of age 4. candidate for fulvestrant therapy - patients who have started fulvestrant may enter this trial if within 3 months of starting fulvestrant 5. measurable or evaluable by recist 1.1 6. ecog ps 0-2 7. able to swallow study drug and comply with study requirements 8. tumor available for fresh biopsy (two biopsies - pretreatment as regards enzalutamide, and during treatment at 4 weeks). the patient will be also be asked if they would be willing to provide a third biopsy at time of progression. 9. if patient is pre- or peri- menopausal, then will need to have concurrent ovarian suppression. patients may have already gotten the loading dose of ovarian suppression. pre- or peri- menopausal subjects must have a negative urine pregnancy test confirmed at screening. 10. anc \>1000/ul and platelets \>75,000/ul at screening visit 11. total bilirubin \< 1.5 times upper limit of normal (uln) at the screening visit unless an alternate nonmalignant etiology exists (eg, gilbert's disease) 12. aspartate aminotransferase (ast) or alanine aminotransferase (alt) \< 3 times uln or \< 5 times uln if patient has documented liver metastases 13. creatinine \< 1.5 times uln 14. inr \< 1.5 times uln, or if on warfarin, can safely transition off for biopsy 15. willing to donate blood for research at 4 time points 16. written informed consent obtained prior to biopsies and blood samples 17. agreement to exercise appropriate use of contraception. subjects should use 2 acceptable methods of birth control (one of which must include a condom as a barrier method of contraception) starting at the time of screening for an enzalutamide study and continuing throughout the course of treatment and for at least three months after enzalutamide is discontinued. exclusion criteria: 1. current or previously treated brain or leptomeningeal metastases 2. history of seizures 3. prior treatment with an anti-androgen (abiraterone, arn-509, bicalutamide, enzalutamide, odm-201, tak-448, tak-683, tak-700, vt-464) 4. systemic estrogens or androgens within 14 days before initiating therapy. vaginal estrogens are allowed if necessary for patient comfort.

Keywords: advanced breast cancer er+/her2 advanced breast cancer
safety of rel-1017 for major depressive disorder

Conditions: Major Depressive Disorder

Summary: this was a 1-year, multicenter, open-label, long-term study to assess the safety of rel-1017 once daily (qd) as monotherapy or as adjunctive treatment of major depressive disorder. adjunctive study participants continued to take their current antidepressant therapy in addition to the study drug for the duration of the treatment period.

this was a multicenter, open-label, long-term study of rel-1017 to evaluate the long-term safety and long-term durability of response in patients with mdd. patients who completed previous randomized, double-blind phase 3 trials (nct04688164, nct04855747, nct05081167) of rel-1017 as adjunctive therapy or monotherapy for mdd were asked to continue treatment with rel-1017 25 mg daily for up to 1 year. de novo patients who satisfied inclusion/exclusion criteria also were enrolled and received a 75 mg loading dose of rel-1017 on day 1 followed by a maintenance dose of 25 mg rel-1017 daily for the remainder of the study (days 2-365). when rel-1017 was administered as adjunctive treatment, patients continued to use a stable dosage of their concomitant antidepressants.

Eligibility criteria:
inclusion criteria: * adults 18 to 65 years, inclusive. * diagnosed with major depressive disorder (mdd) based on structured clinical interview for dsm-5 (scid-5) for mdd. * current major depressive episode. exclusion criteria: * any current and primary psychiatric disorder other than major depressive disorder. * history of bipolar i and ii disorder, psychosis, and/or mania. * acute or chronic condition that, in the investigator's opinion, would limit the subject's ability to complete or participate in this clinical study.

Keywords: rel-1017
a randomised trial comparing anterior versus posterior approach in total hip replacement

Conditions: Osteoarthritis; Rheumatoid Arthritis

Summary: this is a single-centre, randomised, prospective clinical follow-up study to evaluate clinical outcome and gait analysis after total hip arthroplasty using the standard postero-lateral approach or the minimally invasive anterior approach.


Eligibility criteria:
inclusion criteria: * males and females aged 18-75 years at time of surgery. * those presenting with primary or secondary osteoarthritis and/or rheumatoid arthritis of the hip. * those deemed capable of giving informed consent, understanding the aims of the study and expressing willingness to comply with the post-operative review programme. * patients who signed the study consent form prior to surgery. exclusion criteria: * pregnant women or women who plan to conceive in the future. * those whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems. * those already treated by with a total hip replacement (thr) (i.e. requiring a revision hip replacement). * those with co-existent ipsilateral knee disease or back problems * muscle contracture around the hip joint * individuals who have undergone organ transplant. * those with a known co-existent medical condition where death is anticipated within five years due to the pre-existing medical condition. * individuals who have had a thr on the contra-lateral side within the 6 months. * individuals who have undergone a thr on the contralateral side and whose outcome is considered unsatisfactory or not good. an unsatisfactory or poor result is defined as achieving a total ucla score (including activity) \< 16 points. * individuals requiring bilateral hip replacement. * individuals whose body mass index (bmi; kg/m2) \>35. * individuals with active or suspected infection or sepsis. * individuals with renal failure and/or renal insufficiency. * patients with severe forms of developmental dysplasia of the hip (ddh): crowe types ii, iii, iv.
open trial of behavioral activation and social engagement (base) for posttraumatic stress disorder (ptsd)

Conditions: Post-Traumatic Stress Disorder

Summary: the purpose of the study is to see if "behavioral activation and social engagement for ptsd" (base for ptsd), an individual therapy for ptsd, will help veterans with ptsd 1) through improved understanding of how ptsd affects them, 2) by reducing ways in which they avoid meaningful activity due to ptsd, 3) by enabling them to do more of the things they really care about, and 4) by improving, strengthening, and building up their social supports.

posttraumatic stress disorder (ptsd) is a mental health condition that some people develop following exposure to a traumatic event. ptsd often results in a reduction in feelings of connection to other people and changes in views about others, as well as reduced participation in valued activities. many veterans with ptsd do not seek treatment offered in specialty mental health settings and may forgo treatment of any kind. this study is an open-trial format (no comparison condition) of u.s. military veterans who will participate in a brief psychotherapy treatment for ptsd offered in a primary care setting. this is a pilot trial to see if the treatment is effective at reducing symptoms of ptsd and increasing feelings of social support, and an exploratory aim is to see if veterans engage in additional treatment after completing this treatment.

Eligibility criteria:
inclusion criteria: * veterans who: 1. are currently enrolled in either of the primary care clinics (including women's clinic) or primary care mental health integration clinic at va puget sound health care system - seattle division 2. meet criteria for clinical or subclinical ptsd 3. are willing to have therapy sessions audiotaped for the purposes of supervision 4. plan to live in the seattle area for 6 months following entry into the study exclusion criteria: * veterans who: 1. exhibit the presence of severe mental illness diagnosis (e.g., active psychosis and/or uncontrolled bipolar disorder) 2. have been a psychiatric in-patient admission in the past 30 days 3. have had a suicide attempt in the last 60 days 4. have had a plan or intent to harm self or others in the last 30 days 5. have a behavioral flag in their medical record 6. have had a psychiatric medication dosing or receipt that has changed in the last 30 days 7. are unwilling to provide at least 1 collateral contact 8. have impaired decision making capacity (as measured by evidence in the computerized patient record system record of moderate-severe traumatic brain injury, uncontrolled psychosis, dementia, communication flag, or by clinical judgment in speaking with the participant 9. are prisoners 10. are illiterate or have limited or no english proficiency 11. are terminally ill 12. are currently participating in cognitive processing therapy (cpt) or prolonged exposure therapy (pe)

Keywords: posttraumatic stress disorder social support primary care
phase 3 clinical trial of teriparatide in japan

Conditions: Osteoporosis

Summary: to evaluate the efficacy of teriparatide based on measurements of bone mineral density at lumbar spine


Eligibility criteria:
inclusion criteria: * japanese patients diagnosed with osteoporosis * aged 55 or older * patients who are at high risk for fracture exclusion criteria: * history of metabolic bone disorders other than primary osteoporosis * history of malignant neoplasm in the 5 years, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated. * severe or chronically disabling conditions other than osteoporosis