Kornimate/medical-research-clean huggingface dataset:
paleolithic diets vs t2d and improvements in the metabolic syndrome

Conditions: Type 2 Diabetes Mellitus

Summary: this study proposes to evaluate the physiological effects of eating paleolithic type diet ("hunter-gatherer's diet") on type 2 diabetic patients. the diet essentially consists of fruits, vegetables, nuts, lean meats, excludes dairy products and grains.subjects will be randomized into taking either ada (american diabetic association) recommended diet or paleolithic diet for 21 days. the research kitchen will provide all food items and total calories in both groups will be adjusted to maintain baseline weight. blood and urine test will be done in the first 3 days, last 3 days and 1 month after the study period to study and compare the effects of the two diets on subjects glucose control, lipid profile and other parameters of cardiovascular physiology. we hypothesize that a palaeolithic diet in subjects with type 2 diabetes mellitis, will result in improvement in above parameters and lead to improvement in glucose control with less need for diabetes medicines (either lower doses or fewer medications) to a greater extent than in subjects fed with ada diet, without any change in weight. we also expect a beneficial effect on blood vessel function, lipid profiles and blood pressure.

this study proposes to evaluate the physiological effects of eating paleolithic type diet ("hunter-gatherer's diet") on type 2 diabetic patients. the diet essentially consists of fruits, vegetables, nuts, lean meats, excludes dairy products and grains.subjects will be randomized into taking either ada (american diabetic association) recommended diet or paleolithic diet for 21 days. the research kitchen will provide all food items and total calories in both groups will be adjusted to maintain baseline weight. blood and urine test will be done in the first 3 days, last 3 days and 1 month after the study period to study and compare the effects of the two diets on subjects glucose control, lipid profile and other parameters of cardiovascular physiology. we hypothesize that a palaeolithic diet in subjects with type 2 diabetes mellitis, will result in improvement in above parameters and lead to improvement in glucose control with less need for diabetes medicines (either lower doses or fewer medications) to a greater extent than in subjects fed with ada diet, without any change in weight. we also expect a beneficial effect on blood vessel function, lipid profiles and blood pressure.

Eligibility criteria:
inclusion criteria: * type 2 diabetic patients * age \>= 18 yrs * bmi \< 40 kg/m2 * normal cardiac, renal and hepatic function exclusion criteria: * subjects on thiazolidinediones ( avandia, actos) or other medications that interfere with the testing procedures * subjects unwilling or unable to follow the diet specified * pregnant women * subjects who are unable to understand the consent form * hematocrit less than 30 * patients with defibrillators
reducing tobacco-associated lung cancer risk: a randomized clinical trial of ab-free kava

Conditions: Smoking

Summary: tobacco use is the leading cause of many preventable diseases, particularly lung cancer. based on the national cancer data in 2020, florida has the highest lung cancer incidence (18,150 cases) with the most deaths (10,580 deaths) among all the states in the united states. unfortunately, around 16% of adults in florida continue to smoke cigarettes due to its addictive nature and the limited success of current cessation strategies. therefore, there is an unmet and urgent need for novel interventions to improve the success of tobacco cessation. if such an intervention can reduce tobacco-associated lung carcinogenesis, that will be more desirable. the ultimate goal of this study is to develop a safe and effective kava-based intervention to enable tobacco cessation and reduce lung cancer risk, which will improve the health of floridians. this study will evaluate the compliance with a daily kava regimen among active smokers who have no intention to quit smoking. this study will also investigate whether kava use can reduce tobacco use and dependence, as well as tobacco-associated lung carcinogenesis.


Eligibility criteria:
inclusion criteria: * adults aged 21 years or above * self-reported smoking at least 5 cigarettes/day for the past year with no intention to quit at time of screening visit * expired carbon monoxide level of more than 8 ppm at recruitment * willingness to participate in the proposed study, as indicated by signed informed consent * access to a functional telephone * expected presence in the study's geographical area for the next 4 months * not currently enrolled in any smoking cessation programs per self-report * female subjects of childbearing potential will be required to practice acceptable methods of birth control (the acceptable methods of birth control include birth control pills, birth control shot, birth control implant, intrauterine device \[iud\], diaphragm, and cervical cap) exclusion criteria: * history of active cancer (other than non-melanoma skin cancer) within the past 2 years * diagnosed with liver dysfunction or with previous liver diseases * levels of alanine transaminase, aspartate transaminase, alkaline phosphatase, or total bilirubin over limit of normal range at prescreen * inability to refrain from acetaminophen, alcohol (no more than one drink daily via self-report) * are pregnant or nursing (lactating) or of childbearing age planning to become pregnant or unwilling to use adequate contraception during the study * participant answered "yes" to any of the asq questions 1 through 3, or refuses to answer all of the questions. if subject answers 'yes' to question 4 but the most recent suicide attempt took place more than12 months from screening visit then subject is still eligible.

Keywords: tobacco dependence smoking cessation kava
immunogenicity bridge between an investigational monovalent vaccine and the equivalent component of gardasil (v501) a quadrivalent vaccine (v501-012)(completed)

Conditions: Cervical Cancer; Genital Warts

Summary: the purpose of the study is to determine if an investigational vaccine with a single component develops an immune response that is similar to the equivalent investigational vaccine with four components to reduce cervical disease.


Eligibility criteria:
inclusion criteria: * female with an intact uterus with lifetime history of 0-4 sexual partners exclusion criteria: * prior human papillomavirus vaccine (hpv) vaccination; * prior abnormal paps; * prior history of genital warts
comparison of the effects of apixaban on thrombin generation in patients with de novo multiple myeloma

Conditions: Multiple Myeloma; Total Knee Replacement

Summary: patients with multiple myeloma (mm) are at high risk of venous thromboembolism (vte) and these patients require adequate thromboprophylaxis. following the publication of the avert clinical study, apixaban is strongly recommended as a prophylactic treatment option for patients with cancer, based on high quality of evidence and a favorable efficacy/safety profile. a multicenter and ancillary study - apixabor - that measured the plasmatic concentration of apixaban in patients with mm and treated with preventive dose has been conducted. the peak drug concentration was superior in mm plasma, as compared to non-myeloma patients under prophylaxis. therefore, the present study evaluated whether differences in pharmacokinetics have an impact on pharmacodynamics (i.e. decrease in coagulability in mm patients as compared to non-mm patients undergoing a surgery for total knee replacement who also have vte prophylaxis). in fine, this study may inform to better manage thromboprophylaxis in mm patients.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years old, * signed informed consent, * patient covered by a social security scheme. * group 1 : patient with a diagnosis of de novo multiple myeloma, with an indication of thromboprophylaxis with apixaban, * group 2 : patient requiring a surgery for total knee replacement, , with an indication of thromboprophylaxis with apixaban. exclusion criteria: * curative doses of anticoagulation treatment, * contra-indication to apixaban, * pregnant or breastfeeding woman, * refusal to sign consent, * patient under legal protection.

Keywords: multiple myeloma thromboprophylaxis pharmacodynamics coagulability
study of the safety and efficacy of cc-5013 treatment for patients with myelodysplastic syndrome

Conditions: Myelodysplastic Syndrome

Summary: to estimate the percent of patients with myelodysplastic syndromes (mds) who experience erythroid response and the interval to response with daily treatment of 25 mg of cc-5013 .


Eligibility criteria:
* diagnosis of de novo myelodysplastic syndrome of at least 12 weeks duration. * baseline mean hemoglobin \< 10.0 g/dl (untransfused) and/or be transfusion dependent defined by requiring at least 4 units of rbc in the 8 weeks prior to baseline. * more than 30 days must have elapsed since any previous treatment for mds, other than transfusion. * women must not be pregnant or lactating * no use of another experimental study drug within 30 dy\\ays of baseline * understand and sign written informed consent * able to adhere to study visit schedule, understand and comply with other protocol requirements.

Keywords: revimid cc5013 cc-5013
primary prevention of major depression based on the level and profile of risk of primary care attenders: cluster, controlled, randomised trial

Conditions: Depression

Summary: the main objective is to measure the effectiveness of a new intervention for primary prevention of major depression based on the level and profile of risk of primary care attendees. among the secondary objectives is to evaluate the cost-effectiveness and cost-utility of the intervention versus usual care. methods: this is a cluster, randomised controlled trial of a community intervention with cluster at the level of practice. it will be undertaken in primary medical care in 7 spanish cities and 5 autonomous communities.the aim is to evaluate a new intervention for primary prevention of major depression based on patients' level and profile of risk. family doctors in the intervention practices will provide the intervention for patients at risk. patients at risk who are recruited in control practices will receive usual primary care. the main outcome is the accumulated incidence of major depression (measured by cidi) during the follow-up. the investigators will assess main outcomes and other covariables at baseline, 6, 12, and 18 months. a random sample of 3,381 primary care attendees (1,690 for each arm), aged 18-75 and without major depression will be recruited in 70 health centres (140 family doctors) in 7 cities. the investigators shall undertake a logistic regression multilevel model with 4 levels (time, patient, doctor and health centre). the investigators shall also undertake multivariate gamma and quantile regression to assess respectively the cost-effectiveness and cost-utility of the new intervention versus usual care, estimating their standard errors by bootstrap.


Eligibility criteria:
inclusion criteria: * patients among those attending to primary care centers. exclusion criteria: * age under 18 or over 75 years. * unable to understand or speak spanish. * represented patients (that is, someone else comes to visit on behalf of the patient). * cognitive impairment. * psychosis. * terminal illness. * planning to be outside of the the city during 4 or more months during the next 18 months.

Keywords: depression primary prevention. primary health care. randomised controlled trial.
the effect of hormonal contraceptives on breast-milk production and infant growth

Conditions: Underweight

Summary: the investigators propose a randomized clinical trial comparing the effect of 30 mcg ethinyl estradiol and lng 150 combination oral contraceptive pills versus placebo, or lng-ius or etonogestrel-releasing contraceptive implant (implanon)on breast-milk intake and infant growth in exclusively breastfeeding mother-infant pairs. mother-infant pairs will be randomly assigned either 30 microgram ethinyl estradiol combination oral contraceptive pills or identical placebo to start on post-partum day number 42 or implanon implants or a lng-ius. all women will be offered nonhormonal contraceptives prior to randomization. the pairs will then be followed for four weeks. during this follow-up period, breast-milk intake will be quantified by administering deuterium oxide to exclusively breast-feeding mothers and measuring the enrichment of deuterium oxide in the saliva of their infants, otherwise known as the dose-to-mother method of coward.17 additionally, maternal and infant anthropometric measurements will be collected -- both as a value necessary to implement the breast-milk quantification method, as well as an outcome for analysis, and a daily diary will be kept by the women participating in the study that records infant feeds and diaper changes.

women where allocated to an oral combined contraceptive pill, or placebo or a lng-ius or a etonogestrel-releasing subdermal contraceptive implant at day 42 after delivery. after the provision of the contraceptive method a 0.5 mg/kg of deuterium 99.99% according to the weight of the mother will be administer to all women. one sample of saliva from the mother and the child will be collected every day until 21 days after enrollment. additionally, weight, height and size of the leg of each child will be measured at baseline, at the day 11 and at the day 21 after enrollment. also, a diary with information of change of diapers and number of breastfeeding will be kept by each mother.

Eligibility criteria:
inclusion criteria: * women at the day 42th of post-partum fully breastfeeding- exclusion criteria: * baby premature * diabetes * blood hypertension * not breastfeeding or partial breastfeeding

Keywords: contraceptives hormonal breastfeeding infant weight
dynamic hot spring hydrotherapy for gait disorders and balance function recovery after stroke

Conditions: Stroke

Summary: our research aims to analyze and compare the improvement of various indicators of gait disorders and balance function before and after dynamic hot spring hydrotherapy and conventional exercise intervention, and clarify the therapeutic effect of dynamic hot spring hydrotherapy on gait disorders and balance function in stroke patients.


Eligibility criteria:
inclusion criteria: 1. patients with cerebral infarction or cerebral hemorrhage who meet the diagnostic criteria for stroke of the chinese medical association; (2) initial stroke\ 6 months; (3) age\>=18 years old,\ 4, nihss\ =2 points; (6) complete ct or mri; (7) no serious neurological or mental illness; unconscious disorders, able to cooperate with relevant treatments; no severe cognitive impairment (mmse\>=15 points); (8) berg balance scale\>40 points; (9) the patient or family member signs an informed consent form. exclusion criteria: * (1) concurrent major diseases, such as heart, lung, liver, kidney and other organ diseases or failure; (2) there are contraindications for hydrotherapy such as acute infectious diseases, open skin wounds, and severe epilepsy; (3) there are other clinical issues that may affect the assessment results, such as low vision, fractures, vestibular diseases, etc; (4) there are other neurological disorders, such as multiple sclerosis, parkinson's disease, etc; (5) serious mental and psychological problems exist; (6) malignant tumor patients; (7) early pregnancy or high-risk pregnancy; (8) serious alcohol abusers; (9) patients with active bleeding, such as gastrointestinal bleeding, nosebleeds, and excessive menstruation.
anlotinib for patients with platinum resistant or refractory ovarian cancer

Conditions: Ovarian Cancer

Summary: the purpose of the study is to evaluate the efficacy and toxicity of anlotinib in patients with platinum resistant or refractory ovarian cancer

ovarian cancer is the leading cause of death for patients with gynecologic malignancies. in most cases, the disease is diagnosed at an advanced stage and approximately 75% of patients will eventually experience disease recurrence. however, the overall response rates of second-line chemotherapy for recurrent ovarian cancer are only 20-27%. therefore, it is important to seek alternative agent that can improve the outcome. anlotinib is a new, orally administered tyrosine kinase inhibitor that targets vegfr,fgfr,pdgfr,and c-kit,. the preclinical studies suggest anlotinib may be effective in other cancers such as ovarian cancer. therefore, the purpose of this study is to test the efficacy and safety of the study drug anlotinib.

Eligibility criteria:
inclusion criteria: 1. female, age ≥18 years and ≤70 years, signed informed consent. 2. histologically or pathologically confirmed diagnosis of epithelial carcinoma of the ovary. 3. platinum resistant ovarian cancer (defined as relapsing within 6 months after the last administration of platinum-based chemotherapy) or platinum refractory ovarian cancer (defined as progressing while on a platinum-based chemotherapy) 4. at least treated with one line of platinum-based chemotherapy 5. eastern cooperative oncology group (ecog) performance status 0-2 6. measurable disease according to response evaluation criteria in solid tumors (recist) 1.1 version or ca125 7. patients must have a life expectancy of at least 3 months. 8. patients must have adequate organ function. exclusion criteria: 1. had prior exposure to anlotinib or has known allegies to any of the excipients, inadequately controlled hypertension 2. history of myocardial infarction, or unstable angina, or new york heart association (nyha) grade iii-iv within 6 months prior to day 1. 3. history of abdominal fistula or gastrointestinal perforation within 28 days prior to day 1 4. major surgical procedure within 28 days prior to day 1, serious, non-healing wound, active ulcer, bowel obstruction within 28 days prior to day 1 5. symptomatic central nervous system (cns) metastasis

Keywords: anlotinib; ovarian cancer
thoracolumbar burstfractures, orthesis or no orthesis

Conditions: Spinal Fractures

Summary: rationale: thoracolumbar burst fractures are frequently seen in the trauma population, they have a large impact on patient's wellbeing and are a large economic burden to society. thoracolumbar burst fractures might not need the standard care of brace immobilization for adequate treatment and a functional treatment might lead to same or better functional outcomes. besides that, with functional outcome length of hospital stay might decrease and it might also be cost effective compared to bracing. objective: the investigators aim to study the use of braces for thoracolumbar burstfractures, not only by measuring the functional scores and the effect of the bracing or functional treatment on the increase in kyphosis angle, but also on (health related) quality of life and health economics. the investigators hypothesize that no treatment is superior over one other. study design: this project is a randomised controlled trial comparing brace and no brace treatment on function, kyphosis angle, pain, quality of life, and costs. study population: patients between 18 and 65, with a single level thoracolumbar burst fracture will be included. the fracture has to have a kyphosis angle of less than 35 degrees and patient has to be neurologically intact. patients are excluded when they are overweight (bmi\> 35), need multidisciplinary treatment due to multitrauma, or have inadequate knowledge of the dutch language. patients included in the brace group will automatically take part in a brace compliance study. intervention: one group receives a thoracolumbar sacral orthesis (tlso) for 6 weeks, the other group receives no tlso main study parameters/endpoints: the primary outcome of this study is the functional score at six months after trauma. secondary outcomes are pain, kyphosis angle, health related quality of life, healthcare costs and brace compliance. literature shows no difference in pain, functional outcome or kyphosis angle, therefore no potential risks are known comparing a brace and a functional treatment. investigators aim that not using the tlso results in similar functional outcome, pain and kyphosis angle, and less costs. patients will be seen at first presentation and during two year follow up at the outpatient clinic at six standard care follow up moments. at these follow up moments a x-ray as part of standard care is made. at or just before each scheduled appointment they will fill in questionnaires taking from 15-45 minutes.

no extra information

Eligibility criteria:
inclusion criteria: * th10-l4 * ao foundation type a3 or a4 type fractures * single level * kyphosis \< 35 ° at first analysis * neurologically intact * adequate trauma exclusion criteria: * inadequate knowledge of the dutch language * multitrauma, which asks for multidisciplinary treatment * inability to wear a brace due to overweight (bmi\> 35) * known osteoporosis

Keywords: spinal vertebral burstfracture orthesis brace thoracolumbar
health belief model based education on human papilloma virus infection and vaccination

Conditions: Human Papilloma Virus; Health Behavior

Summary: to evaluate impact of health belief model based education on human papilloma virus infection and vaccination among university students

in this randomized controlled study, it aims to evaluate impact of health belief model based virtual education on human papilloma virus infection and vaccination among university students.

Eligibility criteria:
inclusion criteria: * university students aged 18 years or over exclusion criteria: * university students have been received hpv vaccine
impact of massage therapy and music therapy on the quality of life of hospice patients

Conditions: Pain; Anxiety; Depression; Quality of Life

Summary: this is a cohort study where subjects will receive either massage therapy or music therapy interventions to evaluate their impact on hospice patients.

there is growing evidence that integrative therapies such as massage therapy and music therapy can be effective therapeutic tools for relief of pain and non-pain symptoms in hospice and palliative care patients. massage and music therapies can provide comfort, relaxation, and improve quality of life for patients. the investigator's primary aim is to compare the effects of massage and music therapies on the quality of life of hospice patients. the overall goal is to further improve pain, depression, anxiety, and poor well-being or quality of life in hospice patients through the use of integrative therapies, specifically massage and music therapies, as add-on to standard hospice clinical care. patients will be assigned to either the massage therapy or music therapy cohort. questionnaires will be utilized before and after each massage or music therapy intervention to quantify symptom and quality of life levels.

Eligibility criteria:
inclusion criteria: * patient is currently enrolled in mayo clinic hospice * age 18 years or older * esas-r scores of 5 or greater on pain, depression, anxiety, or best well-being (clinical assessment by hospice nursing staff) * patient or caregiver must be able to participate in brief interviews and complete questionnaires (verbally or physically) exclusion criteria: * patients that would not be able to get a massage due to complexity of medical care including complex wound and multiple drains

Keywords: hospice palliative care integrative medicine massage therapy music therapy caregivers