Kornimate/medical-research-clean huggingface dataset:
effect of menopause relief ep-40 in women with menopausal symptoms

Conditions: Menopause

Summary: this study compares the efficacy of a fixed combination of black cohosh (ep-40) and rhodiola rosea (epr-7) with low (6.5 mg) and high doses (500 mg) of a standardized black cohosh extract only in adult woman with menopausal complaints.

due to the problems caused by hormone replacement therapy with chemical entities, some medicinal plants used in the traditional systems of medicine have shown immense potential in non-hormonal treatment of menopausal symptoms without major adverse events. we hypothesize that menopause relief ep-40 (a fixed combination of cimicifuga ep-40 and rhodiola epr-7 extracts) will significantly relieve menopausal complaints such as hot flushes, profuse sweating hot flushes, excessive perspiration, night sweats, sleep disorders, nervousness, mood swings, physical and mental fatigue as compared to ep-40® capsules or placebo in adult females in menopause.

Eligibility criteria:
inclusion criteria: * diagnosis of menopausal female climacteric states (n95.1 according to the international statistical classification of diseases and related health problems 10th revision, icd-10, version for 2014) which is characterized by symptoms such as flushing, sleeplessness, headache, lack of concentration associated with menopause, etc * patients suffering from menopausal syndrome with neurovegetative components which have been stable anamnestically during the last 2 weeks * no medication taken for management of menopausal syndrome with neurovegetative components during the last 4 weeks * ability to understand and provide signed informed consent * ability to participate in the study * in some cases, diagnosis should be confirmed by blood tests of follicle-stimulating hormone (≥ 40 iu/l) \[postmenopausal status\], thyroid function with normal serum free t4 (ft4), estrogen (estrodiol levels) \[premenopausal 30-400 pg/ml; after menopause \<30 pg/ml\] exclusion criteria: * subjects with previous or current psychological disease that could interfere with their ability to participate in the study * anamnestic or current alcohol or drug abuse * concomitant treatment with psychotropic (in particular benzodiazepines, antidepressants, hypnotics or neuroleptics, tamoxifen, clomiphene, and danazol) or hormonally acting drugs such as hormone replacement therapy (hrt) * hyperthyroidism * malignant tumors * continuous climacteric bleeding and complaints related to myomas * patients who have taken another experimental drug within a 4-week period prior to the trial * pregnancy/lactation * serious internal disease * previous organ transplantation * premenopausal women with insufficient contraceptive protection * hypersensitivity to one of the ingredients of the trial medication * a body mass index of \>30

Keywords: cimicifuga, rhodiola, menopause symptoms
a study of vemurafenib (ro5185426) in comparison with dacarbazine in previously untreated patients with metastatic melanoma (brim 3)

Conditions: Malignant Melanoma

Summary: this randomized, open-label study evaluated the efficacy, safety and tolerability of vemurafenib (ro5185426) as compared to dacarbazine in previously untreated patients with metastatic melanoma. patients were randomized to receive either vemurafenib 960 mg orally twice daily or dacarbazine 1000 mg/m2 intravenously every 3 weeks. study treatment was continued until disease progression or unacceptable toxicity occurred. the data and safety monitoring board recommended that patients in the dacarbazine group be allowed to cross over to receive vemurafenib, and the protocol was amended accordingly on january 14, 2011, as both overall survival and progression-free survival endpoints had met the prespecified criteria for statistical significance in favor of vemurafenib.


Eligibility criteria:
inclusion criteria: * adults, \>/=18 years of age * metastatic melanoma, stage iiic or iv (ajcc) * treatment-naïve (no prior systemic anticancer therapy) * positive for braf v600e mutation * measurable disease by recist criteria * negative pregnancy test and, for fertile men and women, effective contraception during treatment and for 6 months after completion exclusion criteria: * active central nervous system metastases * history of carcinomatous meningitis * severe cardiovascular disease within 6 months prior to study drug administration * previous malignancy within 5 years prior to study, except for basal or squamous cell carcinoma of the skin, melanoma in-situ, or carcinoma in-situ of the cervix
preventing obesity in the worksite: a multi-message, multi-"step" approach

Conditions: Obesity

Summary: the purpose of this research study is to develop, implement, and evaluate a multi-component obesity prevention program in a workplace setting. a quasi-experimental design will be utilized, with hospital employees receiving the intervention and clinic employees serving as the comparison group. it is hypothesized that the intervention group will see greater changes in healthier eating, increased participation in physical activity, and reduced risk for obesity (weight, bmi, waist circumference).

over one-third of americans are now considered obese. efforts to prevent obesity involve changing the individual behaviors that contribute to obesity, mainly healthful eating and physical activity, as well as the social and physical context in which those behaviors take place. due to their existing networks and available resources, worksites are a logical place to help individuals make healthy choices through health promotion efforts. the purpose of this project is to partner with a community hospital to plan, implement, and evaluate a multi-component obesity prevention program in their workplace. the prevention program will target individual and interpersonal determinants of eating behavior and physical activity, as well as the context in which these behaviors take place. this intervention will include four integrated components: (1) nutrition labeling (using stoplights, calories, and step equivalents) in the worksite cafeteria, and modifying the cafeteria environment, (2) distributing pedometers to employees, (3) persuasive media messaging, and (4) the use of "influentials" to address social norms around eating and physical activity behaviors. a quasi-experimental design will examine the effectiveness of this multi-component worksite obesity prevention program.

Eligibility criteria:
inclusion criteria: * employee at one of the hospital/clinic locations participating in the study exclusion criteria: * none

Keywords: obesity weight gain prevention workplace intervention diet exercise
nutritional health and satisfaction after bariatric surgery: a five-year retrospective study

Conditions: Obesity and Overweight; Nutritional Deficiency; Bariatric Surgery

Summary: a retrospective study analyzing long-term outcomes of metabolic bariatric surgery (mbs) with a focus on weight loss, nutritional deficiencies, and patient satisfaction over a five-year follow-up. this study evaluates outcomes for different surgical procedures, including laparoscopic sleeve gastrectomy (lsg), roux-en-y gastric bypass (rygb), and other mbs techniques. the findings aim to provide insight into optimal nutritional management and patient care following bariatric surgery.

this study retrospectively examines 249 patients who underwent metabolic bariatric surgery at a specialized center between 2012 and 2017. it evaluates long-term outcomes including weight loss, excess weight loss percentage (%ewl), and nutritional deficiencies, with a specific focus on the effectiveness of targeted supplementation protocols to improve nutritional health post-surgery. the study analyzes different surgical procedures, including lsg, rygb, and others, comparing primary and revision surgeries. nutritional deficiencies in essential vitamins and minerals are assessed, highlighting the need for individualized supplementation based on the type of surgery and patient adherence. key objectives include: 1. assessing long-term weight loss and maintenance across different mbs procedures. 2. identifying the prevalence of nutritional deficiencies, particularly for iron, vitamin d, and b12. 3. evaluating patient satisfaction and quality of life improvements following mbs. data were collected from electronic clinical records and include anthropometric data, biochemical markers, and self-reported supplement use. findings emphasize the importance of targeted supplementation and regular monitoring to address persistent deficiencies. the study contributes to understanding optimal long-term care strategies for mbs patients and underscores the importance of personalized nutritional support post-surgery.

Eligibility criteria:
inclusion criteria: patients aged 18 to 65 years who underwent metabolic bariatric surgery (mbs) at the specialized bariatric center between 2012 and 2017, with a follow-up period of at least five years post-surgery. exclusion criteria: individuals with a history of alcoholism, severe social anxiety impacting post-operative care participation, recent neoplastic disease diagnoses, neurocognitive disorders, or other systemic diseases potentially affecting quality of life and long-term outcomes.

Keywords: metabolic bariatric surgery laparoscopic sleeve gastrectomy roux-en-y gastric bypass excess weight loss iron deficiency vitamin d deficiency quality of life post-surgery targeted supplementation
a study to investigate the pharmacokinetics, safety, and tolerability of emicizumab in healthy chinese volunteers

Conditions: Healthy Volunteers; Hemophilia A

Summary: this single-center, open-label study will evaluate the pharmacokinetics, safety, and tolerability of emicizumab following a single subcutaneous (sc) administration to healthy chinese subjects.


Eligibility criteria:
inclusion criteria: * healthy chinese male subjects, aged 20-45 years inclusive at the time of screening * chinese subjects must have chinese parents and grandparents, all of whom were born in china * a body mass index (bmi) between 19 and 24 kilograms per height in meters squared (kg/m\^2), inclusive * able to participate and willing to give written informed consent and to comply with the study requirements exclusion criteria: * any history or presence of a clinically significant disorder, or any other condition or disease which in the judgement of the investigator would place the subject at undue risk; interfere with absorption, distribution, metabolism, and excretion of emicizumab; or interfere with the ability of the subject to complete the study * major illness within 1 month prior to dosing, and/or any condition which could relapse during or immediately after the study * use of any prescribed or over-the-counter (otc) medication or herbal medicine taken within 14 days prior to dosing or within 5 times the elimination half-life of the medication prior to dosing (whichever is longer), with some exceptions * any significant donation/loss of blood or plasma (greater than 450 milliliters) within the 3 months prior to dosing * regular smoker with consumption of more than 10 cigarettes per day or the equivalent amount of tobacco * participation within a clinical study with an investigational drug or device within the last 3 months prior to dosing * any clinically relevant history of hypersensitivity or allergic reactions, either spontaneous or following drug administration or exposure to foods or environmental agents * previous or concomitant thromboembolic disease such as deep vein thrombosis (dvt) or signs of thromboembolic disease, or family history of thromboembolic disorder such as serious dvt * at high risk for thrombotic microangiopathy (e.g., have a previous medical or family history of thrombotic microangiopathy), in the investigator's judgment * previous or concomitant autoimmune or connective tissue disease * history of tuberculosis or active tuberculosis with positive test result at screening * any other reason that, in the judgment of the investigator, would render the subject unsuitable for study participation
rct of sms for drivers with pre-dm

Conditions: Pre-diabetes; Diabetes

Summary: the purpose of this study is to prevent the professional drivers from pre-diabetes to diabetes.

mobile phone use is almost a routine part of society worldwide. all mobile phones can deliver and receive short-messaging service text messages, providing a perfect medium for delivering information and support. since short-messaging service is little exploited in clinical research or practice in chinese population, this study examined the effectiveness of one-way messaging which is less expensive and is easier to undertake. we aimed to determine the effectiveness of using sms to provide pre-diabetes and diabetes information by promoting healthy lifestyle modification and reducing the two-hour post-glucose loading plasma glucose, the risk of acquiring type 2 diabetes mellitus among professional drivers with pre-diabetes.

Eligibility criteria:
inclusion criteria: * identified within the last 3 months with pre-diabetes which is defined as a fasting plasma glucose level of 5.6-6.9 mmol/l or a two-hour level after a 75 grams glucose load of 7.8-11 mmol/l based on the world health organization 1998 criteria; * accessible by mobile phone that could receive chinese text messages. exclusion criteria: * a history of diabetes mellitus; * currently on medicines known to alter glucose tolerance; * did not have a mobile phone; * unable to read chinese characters; * refused to take part in current study.

Keywords: drivers chinese short message service cellular phone
deuterium metabolic imaging in people with multiple sclerosis

Conditions: Multiple Sclerosis (MS) - Relapsing-remitting

Summary: the goal of this case-control study is to investigate glucose brain metabolism in people with multiple sclerosis and age- and sex-matched healthy controls. the main questions it aims to answer are: * how does brain glucose metabolism in people with multiple sclerosis compare to age- and sex-matched healthy controls? * how is the brain glucose metabolism of people with multiple sclerosis associated with disease severity? participants will come in for testing lasting approximately three hours and undergo deuterium metabolic imaging, physical function test, cognitive function test, and answer survey.


Eligibility criteria:
inclusion criteria: * aged 18-60 years. * definite relapsing remitting multiple sclerosis diagnosis according to the most recent diagnostic criteria exclusion criteria: * contraindications for mri: pacemaker, neurostimulator or cholera implant. metal foreign bodies such as fragments and irremovable piercings. unsafe medical implants (safety of heart valves, hips and the like must be confirmed). claustrophobia. largest circumference including arms \&gt; 160 cm * pregnancy * competing neurological, psychiatric, or systemic diseases including diabetes (except prior tia, unspecific brain mri findings, hypertension, atherosclerosis and hyperlipidemia/cholesterolemia which are allowed). * participating in other clinical trials with investigational medical products or drugs.
florida cerebrovascular disease biorepository and genomics center

Conditions: Cerebrovascular Disease; Ischemic Stroke; Transient Ischemic Attack; Intracerebral Hemorrhage; Aneurysmal Subarachnoid Hemorrhage; Vascular Dementia; Anoxic Brain Injury; Unruptured Intracranial Aneurysm; Carotid Artery Stenosis Symptomatic; Asymptomatic Carotid Artery Stenosis; Non-Aneurysmal Perimesencephalic Subarachnoid Haemorrhage; Cerebral Venous Thrombosis; Moyamoya Disease; Fibromuscular Dysplasia; Subarachnoid Hemorrhage; Leukoaraiosis; Arteriovenous Fistula; Reversible Cerebral Vasoconstriction Syndrome; CADASIL

Summary: the purpose of this study is to create a state-wide biorepository and resource center for cerebrovascular diseases in florida, which will include collecting medical history information and blood from subjects affected by cerebrovascular disease. the information and blood samples collected may be used in future research for the study of cerebrovascular disease and to learn about, prevent or treat other health problems.


Eligibility criteria:
inclusion criteria: • affected subjects with diverse cerebrovascular conditions, including, but not limited to, ischemic stroke, transient ischemic attack (tia), intracerebral hemorrhage (ich), aneurysmal subarachnoid hemorrhage (asah), vascular dementia (vad), anoxic brain injury, unruptured intracranial aneurysm (uia), cavernous malformation, arteriovenous malformations (avm), carotid and vertebral arterial dissections, symptomatic and asymptomatic cervical carotid artery atherosclerotic stenosis, non-aneurysmal perimesencephalic subarachnoid hemorrhage (nasah), cerebral venous thrombosis (cvt), moyamoya disease, fibrosmuscular dysplasia (fmd), non-traumatic, angiography-negative subarachnoid hemorrhage, leukoaraiosis, arteriovenous fistula, reversible cerebral vasoconstriction syndrome (rcvs), and cadasil. exclusion criteria: • all patients with the following known or suspected virulent microorganisms causing an active or latent infection will be excluded from the study: * human immunodeficiency virus (hiv); * any viral hepatitis; * west nile virus (wnv); * influenza virus; * tuberculosis (tb); * any bacteremia; * any fungemia; * any prionopathy.
immunogenicity and interchangeability of two inactivated hepatitis a vaccines

Conditions: Hepatitis A

Summary: this is a randomized, double-blind clinical trial of two inactivated hepatitis a vaccines in healthy children, immunogenicity and interchangeability of the two inactivated hepatitis a vaccines were evaluated.

this was a monocenter, comparative trial in which healthy children were randomized to receive two doses of hepatitis a vaccine 6 months apart. the trial was conducted in accordance with the edinburgh version of the declaration of helsinki. the study was approved by the ethics committee. parents or legal guardians of all participants gave written informed consent prior to study entry. eligible subjects were between 18m and 6 years of age, when enrolled, children were randomized to four equal groups with different intervention. immunogenicity and interchangeability of two inactivated hepatitis a vaccines were evaluated.

Eligibility criteria:
inclusion criteria: * healthy children aged between 1.5 and 5 years, with no history of hepatitis a virus infection or hepatitis a vaccine vaccination * provided birth certification or vaccination card * parent(s) or legal guardian(s) are able to understand and sign the informed consent exclusion criteria: * axillary temperature \> 37.0 centigrade at the time of dosing * subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine * serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain * autoimmune disease or immunodeficiency * congenital malformation, developmental disorders or serious chronic diseases (such as down's syndrome, diabetes, sickle cell anemia or neurological disorders) * bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with im injections or blood draws * history or family history of convulsions, epilepsy, brain disease and psychiatric * history of any blood products within 3 months * administration of any other investigational research agents within 30 days * administration of any live attenuated vaccine within 30 days * administration of subunit or inactivated vaccines within 14 days * any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent
improved diagnostics and monitoring of polymyalgia rheumatica

Conditions: Polymyalgia Rheumatica; Giant Cell Arteritis; Adrenal Insufficiency

Summary: background: polymyalgia rheumatica (pmr) is characterised by pain of the proximal muscles, general symptoms, and raised inflammatory markers. treatment with prednisolone has several adverse effects. pmr is an exclusion diagnosis, and methods to diagnose and monitor the disease are lacking. objective: to investigate if ultrasound and pet/ct can be used to diagnose and monitor pmr. in addition, the importance of prednisolone induced adrenal insufficiency is investigated. methods: it is a prospective observational study in patients suspected of pmr. patients diagnosed with pmr continue in the study. ultrasound and pet/ct are performed at baseline, after 8 weeks on prednisolone, and after 10 weeks during a short prednisolone break. adrenal insufficiency is investigated five times throughout the study. after one year the pmr diagnosis is confirmed.


Eligibility criteria:
inclusion criteria: * patients suspected of pmr. * age above 50 * pain of the proximal muscles. exclusion criteria: * peroral, intraarticular, intramuscular and dermal application of glucocorticoids within the last 3 month. * previous prednisolone treatment for gca/pmr * unable to give consent. * symptoms of gca (headache, jaw claudication, vision disturbances). * active malignant cancers within the last 5 years (except basal cell carcinoma). * other inflammatory rheumatic diseases (eg. rheumatoid arthritis, polymyositis, spondyloarthritis, psoriatic arthritits, gout). * uncontrolled diseases (eg severe active astma, cardiac disease with nyha class iv) * treatment with peroral oestrogens, aminogluthethimid, trilostan, ketoconazole, fluconazol, etomidate, phenobarbital, phenytoin, rifampicin, metyrapon, mitotane. * known primary or secondary adrenal insufficiency.

Keywords: positron emission computed tomography ultrasound