Kornimate/medical-research-clean huggingface dataset:
housing, insulation and health study

Conditions: Respiratory Illness; Asthma

Summary: in six communities we will seek out households where someone who has a history of respiratory problems. for the first winter we will measure temperature and humidity of the house and health of occupants. we will insulate half the houses and the next winter compare them with the uninsulated houses to see if warmer houses improve health.

damp, cold indoor environments are bad for the health of people who live in them, particularly if they have respiratory problems or are vulnerable, such as the young or the very old. this is a community based study designed to test the hypothesis that insulating domestic houses will make them warmer and that this increase in indoor temperature will improve their health and wellbeing. following two pilot studies, the first among older people in city council flats and the second among home owners in waitara. we have followed the "waitara model" where community networks will be mobilised to identify households in each community where there is someone with a on going respiratory problem. seven communities have been selected to help test these hypotheses and have agreed to participate otara, gisborne, mahia/nuhaka, taranaki, porirua, west coast and christchurch. low income areas with high maori populations have been deliberately selected to maximise the potential health gains. two hundred houses in each community will be insulated free of charge to the occupants. the workers who will insulate the homes will be local people employed through the department of work and income (winz). once the houesholds are selected they will be randomly assigned to intervention or control groups. during the first winter, all 1400 households will be monitored for temperature and humidity and their comfort, health and healthcare utilization will be recorded. half the households, assigned to the intervention group, will be fully insulated during the spring. the following winter, all the initial measurements taken from both the intervention and control group will be repeated. at the end of the study period, all control houses will be insulated. this study has developed from a natural intervention being carried out by the energy efficiency conservation authority (eeca) to insulate domestic houses in new zealand and is a major collaborative effort, which will shed light on the effectiveness of insulation in improving health and wellbeing. the impact of housing refurbishment on health has not previously been examined. there is considerable government and policy interest in promoting healthy housing and there is strong community interest in ensuring the housing stock is improved in order to lower health risks.

Eligibility criteria:
inclusion criteria: * live in study area * at least one person in the household must had had respiratory illness within the last year, well members of the same household may also participate * house currently uninsulated * interested in taking part in research exclusion criteria: * intending to move within study period

Keywords: insulation warmth humidity damp cold respiratory mould
acetylsalicylic acid plus intensive blood pressure treatment in patients with unruptured intracranial aneurysms

Conditions: Unruptured Intracranial Aneurysms

Summary: purpose of this study is to assess the hypothesis that a strategy with acetylsalicylic acid (asa) 100 mg/day, intensive blood pressure treatment (targeted systolic blood pressure below 120 mmhg), and a blood pressure measuring device reduces the risk of aneurysm rupture or growth compared with standard care (i.e. no asa, blood pressure management according to standard blood pressure management, no blood pressure measuring device)


Eligibility criteria:
inclusion criteria: * patients 18 years or older with an intradural, saccular unruptured aneurysm (uia) in whom it is decided not to intervene with preventive endovascular or neurosurgical repair of the aneurysm and who are monitored on a regular base for aneurysm growth * last aneurysm imaging with either cta/mra/dsa within the last 3 months exclusion criteria: * all non-saccular uias or aneurysms related to arteriovenous malformations * frequent asa use and/or indication for a vitamin k antagonist, or direct oral anticoagulant (doac) treatment at baseline * contra-indication for asa * history of hypersensitivity to asa or to any other drug with similar chemical structure or to any excipient present in the pharmaceutical form of asa * chronic kidney disease stage iv and v (gfr \< 30 ml/min/1.73 m2) * pregnancy and lactation * participation in another clinical trial or observation period of competing trials, respectively * life-expectancy \<3 years
evaluation of the postoperative effect of expanded pedicled deltopectoral flap to repair the facial-cervical scars

Conditions: Surgical Flaps; Skin Pigmentation; Sensory Defect

Summary: this study evaluates the effect of expanded pedicled deltopectoral flap on facial-cervical scars repair, including flap sensation, l\*a\*b\* value,flap's elasticity,melanin content, hemoglobin content, and evaluation of scar and patient, doctor, and third-party satisfaction

the scars of face and neck caused by burning often show as large faciocervical scar.important areas of current focus in face and neck scars management are functional outcomes and quality of patient life.the deltopectoral flap was first described by bakamjian in 1965, and was recognized as one of the first choices for facial reconstruction, as the texture, color of the flap skin is similar to the facial skin. since the tissue expansion technique was used to the flap, the flap became one of the best choices for the facial defect reconstruction,especially for asian patients. it can be used with pedicled or free transferred.complications at the donor or recipient site have been widely reported and often include dilator exposure,the flap blood circulation disorder and delayed healing, but the pattern of sensory recovery ,flap's elasticitycolor change have been studied less well.

Eligibility criteria:
inclusion criteria: 1. patients who underwent expanded pedicled deltopectoral flap to repair facial-cervical scars in 2006 -2018. 2. in compliance with ethical requirements, patients were voluntarily tested and signed informed consent. exclusion criteria: 1. peripheral neuropathy 2. serious aphasia or cognitive impairment, and first-degree relatives can not get in touch. 3. can not follow up 4. allergic constitution 5. connective tissue disease 6. hormone or chemotherapy drugs are being used. 7. diabetes

Keywords: expanded pedicled deltopectoral flap skin color sensory recovery
d-dimer to predict recurrence in patients with multiple episodes of venous thromboembolism

Conditions: Venous Thromboembolism

Summary: optimal duration of oral anticoagulant therapy in patients with recurrent episodes of venous thromboembolism (vte) is a matter of debate and recommendations are based on inadequate evidence. more than 12 months of treatment are currently recommended, and the grade of recommendation is low. the prolong study has recently evaluated the predictive role of d-dimer measurement after withholding oral anticoagulant treatment in patients with a first episode of vte. patients with a positive d-dimer had a significantly higher incidence of vte recurrences than patients with a negative d-dimer and required resumption of the antithrombotic treatment. based on the results of this and of previous cohort studies, it appears safe to withhold treatment in patients with negative d-dimer values and to continue treatment in patients with altered d-dimer levels. aim of this study is therefore to assess the negative predictive value of d-dimer also in patients with recurrent vte and to evaluate the clinical utility of this approach in this patient setting.


Eligibility criteria:
inclusion criteria: * patients with at least two episodes of objectively documented venous thromboembolism (at least one proximal deep vein thrombosis or pulmonary embolism) * ongoing treatment with oral anticoagulants for at least a) 12 months in case idiopathic dvt was the last event; b) 6 months in all other cases * age \> 18 years * informed consent provided exclusion criteria: * pregnancy/puerperium * one or more episodes of massive pulmonary embolism * last event isolated idiopathic pulmonary embolism * two or more idiopathic vte events * first degree relatives with recurrent vte * right ventricular disfunction or pulmonary hypertension * active cancer * antiphospholipid antibodies syndrome * antithrombin deficiency * homozygous factor v leiden or g20210a prothrombin mutation * heterozygous factor v leiden and g20210a prothrombin mutation * concomitant congenital thrombophilic mutations * concomitant indications to long term oral anticoagulant treatment * severe cardiorespiratory insufficiency * severe liver or renal disease (creatinine clearance \> 2 mg/dl) * limited life expectancy * geographic inaccessibility

Keywords: d-dimer recurrence venous thromboembolism
functionality of male condoms with a silicone elastomer vaginal ring

Conditions: Human Immunodeficiency Virus

Summary: this trial will assess the potential impact of a vaginal ring on condom use by comparing the performance (total clinical failure, clinical slippage, and clinical breakage) of a standard male lubricated latex condom when the female partner is wearing the vaginal ring and when the female partner is not wearing the vaginal ring.


Eligibility criteria:
inclusion criteria: 1. mutually monogamous heterosexual couples; current relationship ≥3 months; and who can give written informed consent; 2. age ≥18 to ≤45 years (females) or ≥18 to ≤55 years (males) at time of the screening visit; 3. healthy on the basis of medical history; 4. not at risk of pregnancy, i.e., female is surgically sterile, using an iud, or using effective hormonal contraception, or has a vasectomized partner. the use of vaginal contraceptive rings will not be allowed; 5. sexually active and agree to have at least 8 acts of penile-vaginal intercourse using a study condom over 2 periods of up to 4 weeks each; 6. agree to use only the condoms provided by trial personnel during the time of participation. additional lubricant will be provided; use of non-study lubricants will not be allowed; 7. agree to not use other vaginal products, except menstrual absorption products (e.g. tampons) and study lubricant during the trial; 8. available for all visits and consent to follow all procedures scheduled for the trial; 9. at low risk for hiv infection. exclusion criteria: 1. males with untreated erectile dysfunction; 2. female with positive pregnancy test; 3. either partner allergic to natural latex or vaginal lubricants such as astroglide ®; 4. history by self-report of recurrent or a recently-treated (within past 2 weeks) sexually transmitted infection (e.g. gonorrhea, syphilis, chlamydia) or hiv(+); 5. currently using condoms for protection against sexually transmitted infection; 6. either partner taking any topical or oral medication to treat a urogenital condition at enrollment, except medication for the male partner to treat erectile dysfunction (e.g., tadalafil, sildenafil); 7. either partner with a self-reported or clinically diagnosed urogenital condition (e.g. itching, burning, irritation, etc.) that, in the opinion of the investigator, could affect use of the study condoms or ability to interpret trial data; 8. females, based on findings from a pelvic examination, who are not suitable candidates for wearing the vaginal ring (anatomical condition, current vaginal infection, etc.); 9. current participation in a study or other research involving a drug, device or other product; 10. any condition(s) that, in the opinion of the investigator, might interfere with adherence to trial requirements or evaluation of the trial objectives.
acute effects of two different trainings on balance and performance in young footballers

Conditions: Sports Physical Therapy

Summary: the aim of this study is to investigate the acute effect of two different training on the balance and performance of healthy young football players. cognitive-based neuromuscular education (cbne) will be applied to one group and game based education (gbe) will be applied to the other group. in addition to study groups, there will also be a control group. individuals will be randomly placed in groups. sociodemographic data will be recorded at the beginning for all athletes. then the first measurements of dynamic balance and performance will be taken. star balance excursion test will be used to assess the dynamic balance. measurements shall be taken in 8 directions including anterior (a), anterolateral (al), lateral (l), posterolateral (pl), posterior (p), posteromedial (pm), medial (m) and anteromedial (am) for the right and left sides. performance will be evaluated by speed dribbling test. after the first measurements, two study groups will be trained. the control group will spend this time relaxing. after the trainings, the final measurements will be taken. purposes the primary purpose; the aim of this study was to investigate the acute effect of cbne and gbe on dynamic balance and performance in healthy young football players. secondary objectives; the aim of this study is to investigate the relationship between dynamic balance and performance in healthy young football players. hypotheses h0: in healthy young soccer players, cbne and / or gbe has no acute effect on balance. h0: in healthy young soccer players, cbne and / or gbe has no acute effect on performance. h1: cbne and / or gbe have an acute effect on balance in healthy young football players. h2: cbne and / or gbe have an acute effect on performance in healthy young football players.


Eligibility criteria:
inclusion criteria: * to be playing active football for at least three years * males exclusion criteria: * those with orthopedic, neurological or congenital problems * those who have experienced injuries that affect balance and performance in the last 6 months * individuals staying more than two weeks away from sport in the last three months

Keywords: sports athletic injuries exercise
middle term effect of red yeast rice on plasma lipids and proteoma in individuals with suboptimal cholesterolemia

Conditions: Hypercholesterolemia

Summary: the primary purpose of our research will be to evaluate if, in healthy subjects with a low- moderate cardiovascular risk (cv risk\>1% but \ 115 mg/dl, \< 190 mg/dl) supplementation with a red yeast rice food supplement containing less than 3 mg total monacolins per daily dose is able to significantly influence plasma lipid levels. furthermore, liver and muscle proteomic pattern and vascular response to dietary supplementation will be investigated.


Eligibility criteria:
inclusion criteria: * male or female aged ≥ 30 years and ≤ 70 years old. * body mass index included between 18 kg/m2 and 35 kg/m2 * total cholesterolemia between 200 and 280 mg/dl and/or ldl-cholesterol between 130 mg/dl and 190 mg/dl. * tg\<400 mg/dl. * subjects who, according to the score charts, have a low or moderate cardiovascular risk (defined as a total cardiovascular risk \< 5%) and for whom, according to esc/eas guidelines 2012, the intervention strategy does not require a pharmacological lipid-lowering intervention. * subjects who have the capability to communicate, to make themselves understood, and to comply with the study's requirements. * subjects agree to participate in the study and having dated and signed the informed consent form. exclusion criteria: * assumption of lipid lowering drugs or dietary supplements, or drugs potentially affecting the lipid metabolism; * assumption of any kind of drug treatment non-stabilized for at least 3 months; * known current thyroid, gastrointestinal or hepatobiliary diseases (including liver transaminases ≥3uln), as well as any muscular disorders (even subclinical, including serum cpk ≥3uln); * current or previous alcohol abuse; * pregnancy and breastfeeding * known previous intolerance to red yeast rice * history or clinical evidence of any significant concomitant disease that could compromise the safety of the subject or the possibility of completing the study; * any medical or surgical condition that would limit the patient adhesion to the study protocol.

Keywords: red yeast rice monacolins dietary supplement randomized clinical study
a study to evaluate the pharmacokinetics and safety of br3409 and co-administration of br3409-1 and br3409-2 in healthy volunteers under fasting conditions

Conditions: Type 2 Diabetes

Summary: the purpose of this clinical study is to evaluate the pharmacokinetics and safety of br3409 and co-administration of br3409-1 and br3409-2 in healthy volunteers under fasting conditions


Eligibility criteria:
inclusion criteria: * those have body mass index (bmi: weight(kg)/the square of {height(m)}) within the range of 18.0 to 30.0 at screening visit. * for men, those who weigh 55 kg or more * for women, those who weigh 50 kg or more * those who sign written consent spontaneously after listening to and understanding sufficient explanation of the purpose and contents of this clinical trial, characteristics of the investigational products, expected adverse events, etc. * those who agree to rule out the possibility of their and their spouses' or sexual partners' pregnancy by using methods of contraception accepted in clinical trial\*(except for hormone drugs) from the date of consent to 56 days after the last administration and disagree to provide their sperm or ovum. * methods of contraception accepted in clinical trial: combined use of intrauterine device, vasectomy, tubal ligation, and barrier methods (male condom, female condom, cervical cap, contraceptive diaphragm, sponge, etc.) or combined use of two or more barrier methods if spermicide is used. exclusion criteria: * those who have taken drugs that induce and inhibit metabolizing enzymes such as barbiturate within 30 days before the first administration date or have taken drugs concerned about affecting this clinical trial within 10 days before the first administration date. (however, participation is possible considering pharmacokinetics and pharmacodynamics such as interaction of investigational products, half-life of concomitant drugs, etc.) * those who have participated in other clinical trials(including bioequivalence tests) and administered their investigational products within 6 months before the first day of administration. (however, the termination for participation in other clinical trials are based on the last administration date of their investigational products) * those who have a medical history of gastrointestinal resection or gastrointestinal diseases that may affect the absorption of drugs. (except for simple appendectomy, hernia surgery) * in the case of a female subject, those suspected pregnancy or pregnant woman, lactating woman.
rehab in mild stable dcm: feasibility rct comparing structured rehabilitation to clinical surveillance

Conditions: Degenerative Cervical Myelopathy

Summary: the goal of this feasibility rct is to establish the feasibility of undertaking a rct investigating the effectiveness of a multi component structured rehabilitation intervention aiming at reducing physical disability in people with mild stable degenerative cervical myelopathy. the main question it will answer are what is the incidence of mild stable dcm in the neurosurgical opd clinics, what is the eligibility rate and participate rate of those eligible. it will also investigate the acceptability of the intervention to both participants and clinicians and participant retention. researchers will compare a structured rehabilitation intervention to clinical surveillance. the structured rehabilitation intervention will include education, a physical activity behavioural change intervention, cervical range of motion exercises, neck, upper limb and scapular strengthening exercises and task specific hand function training.


Eligibility criteria:
inclusion criteria: * • diagnosis of dcm (clinical symptom of dcm +/- upper motor neuron sign + imaging evidence of cervical cord compression). diagnosis will be confirmed by a consultant neurosurgeon (19). * modified japanese orthopaedic assessment (mjoa) score of 15-17, indicating mild dcm. the mjoa is a clinician administered validated measure of dcm severity (20) * adequate comprehension of english to understand the purpose of the study and give written informed consent exclusion criteria: * patient or surgeon preference for urgent surgical decompression for progressive dcm, motor radiculopathy or severe unrelenting radicular arm pain or significant risk factors for progression including co-existing cervical radiculopathy and circumferential cord compression. * diagnosis of other neurological condition that could confound assessment. * involvement in another clinical study or trial * pregnancy * if the participant is unable to commit to a 12-week programme of up to 10 sessions of supervised rehabilitation and participating in a regular home exercise programme for the duration of the study.

Keywords: degenerative cervical myelopathy mild dcm rehabilitation clinical surveillance feasibility rct