Kornimate/medical-research-clean huggingface dataset:
health after birth intervention trial

Conditions: Obesity

Summary: this trial is to assess the feasibility of a larger, definitive rct and determine the clinical effectiveness of an nhs 1:1 programme versus a modified programme with a low carbohydrate dietary intervention (as per feinman and colleagues classification) with telehealth, physical activity and enhanced behaviour change on specified health outcomes amongst post-partum women living with obesity

for individuals living with obesity, the post-partum period is currently the initial, optimal timeframe for weight management. many women reconceive during the post-partum phase, increasing the risk of between-pregnancy bodyweight retention and even gain. consequentially, many re-enter subsequent pregnancies with a higher bmi often associated with unfavourable obstetric outcome and further cyclical perpetuation. health behaviour change is an important facet within weight management interventions and delivery may be enhanced by digital technologies, for example, telehealth. short messaging service (sms) may be used to enhance communication between patients and practitioner and is relatively inexpensive to use. low carbohydrate diets continue to gain traction however research is arguably confounded by the lack of a universally agreed definition and classification. feinman and colleagues (2015) propose intermediary categories. the experimental arm of this trial will be encouraged to adopt a non-ketogenic lcd as per feinman.

Eligibility criteria:
inclusion criteria: * adult aged 18 or above * ready and motivated to make lifestyle changes * have a body mass index of ≥30 kg/m2 (at initial booking appointment) additional study specific criteria * english speaking and ability to read english language * capacity to consent to participating in the study * are non-diabetic or those with type 2 diabetes which is diet controlled * deemed medically fit by gp/medical professional to participate via email * have recently given birth (within 1 year) * are not receiving weight management support elsewhere e.g. nhs, scottish slimmers, weight watchers * have access to a mobile phone and weighing scales exclusion criteria: * have uncontrolled hypothyroidism * have unstable psychosis or severe and unstable personality disorder * are pregnant * have dementia * have moderate to severe learning disability or learning difficulty which impairs the ability to adhere to the programme (identified by medical history and confirmed with gp) * current alcohol or substance misuse (6 month period of abstinence) * active purging * bulimia nervosa * binge eating disorder additional study specific criteria * known cancers * type 1 diabetes or type 2 diabetes on any diabetic medication (including insulin) * have a pacemaker * renal impairment * taking orlistat or any other weight loss medication or had previous bariatric surgery

Keywords: weight management postpartum
enhancing the amount of physical activity carried out by overweight children at leisure time

Conditions: Obesity

Summary: the purpose of this study is to examine if internet supervised by pedometer will contribute to enhance the amount of physical activity at leisure time by obese children. the investigators hypothesize that using pedometer will increase the amount of physical activity done by obese children in the afternoon and will improve the likelihood of success in the intervention program.

childhood overweight \& obesity is the most common chronic disease in the western society. the prevalence of childhood obesity in israel is among the highest in europe. recent data suggest that the recommended treatment for childhood obesity should be intense, multi-disciplinary intervention, including dietary, behavioral and physical activity components. such a program exists at the meir medical center in israel for a few years with promising results. the program includes: physical activity(pa)exercise (twice a week/1h), dietary guidance, medical supervision and behavioral intervention. the participants are asked to enhance pa at their leisure time, and to report to their coaches. yet, the amount of time they actually exercise is not controled by us. this study will include 3 groups of overweight\& obese children: 1. intervention with pedometers and supervision. 2. intervention with pedometer without supervision. 3. control. obese and overweight children not taking part in a treatment program.

Eligibility criteria:
inclusion criteria: * overweight/obese children * age 5-18 * boys and girls exclusion criteria: * children with genetic obesity or obesity cased by a disease

Keywords: overweight obese children exercise physical activity pedometer
a study to evaluate insulin in the blood after inhalation of a dry powder insulin formulation (called technosphere®/insulin) in non-diabetic patients with & without chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: trial will include 40 subjects and consists of 3 visits: screening, treatment and follow up. a euglycemic clamp procedure and technosphere®/insulin (t/i) administration will occur at visit 2 for both copd and non copd subjects.

trial objectives are to evaluate the impact of a defined lung disease (copd) on pharmacokinetic parameters of insulin and fumaryl diketopiperazine (fdkp) after inhalation of technosphere®/insulin (t/i), the investigational medicinal product. 40 non diabetic subjects, 20 copd and 20 age/gender/bmi-matched non copd subjects will participate in 3 visits: visit 1 (screening), visit 2 (subjects will undergo a euglycemic clamp procedure and be dosed with t/i) and visit 3 (follow up visit).

Eligibility criteria:
inclusion criteria: * male and female subjects minimum 18 and maximum 70 years of age * body mass index (bmi) = 36 kg/m2 * subjects with copd: diagnosis of copd (emphysema and/or chronic bronchitis), * smoking history =10 years, chronic cough present intermittently or daily with or without sputum and/or dyspnea upon exertion. * subjects with copd: pulmonary function tests - fev1 =50% (nhanes) iii * predicted; fev1/fvc \< 70 % (nhanes) iii; tlc =80% of predicted (its) and dlco(unc) =50% of predicted (miller) * subjects without copd: pfts: fev1 = 70% nhanes iii predicted; tlc =80% of * predicted (its) and dlco(unc) =80% of predicted (miller) exclusion criteria: * history of pre-diabetes or diabetes * previous or current treatment with any anti-diabetic drugs * serum creatinine \> 2.0 mg/dl in males and \> 1.8 mg/dl in females * active smokers defined as having smoked their last cigarette, pipe, and/or cigar without the previous 6 months * previous exposure to any inhaled insulin product or investigational medicines/devices within the previous 30 days prior to entry or participation * clinically significant major organ disease * female subjects of childbearing potential not practicing adequate birth control * subjects with copd: significant improvement in pre-to post-bronchodilator spirometry (defined as an increase of 12% and 200 ml in either fvc or fev1); * any clinically important pulmonary disease except mild or moderate copd * subjects without copd: any important pulmonary disease confirmed by pulmonary function testing and/or radiologic findings

Keywords: technosphere® insulin inhalation powder
anticaries potential and fluorosis risk from different fluoride toothpastes

Conditions: Dental Caries; Dental Fluorosis

Summary: fluoride toothpaste has been associated not only with declining dental caries prevalence but also with an increase in dental fluorosis. in the balance of benefits/risks of fluoride toothpaste use, the purpose of this study is to evaluate the availability of fluoride concentration in the mouth (biofilm fuild), as an indicator of fluoride benefits (anticaries effect), and the fluoride concentration in urine, as an indicator of fluoride absorption from ingested toothpastes (with potential to cause dental fluorosis), in a sample of young brazilian children using toothpaste formulations representative of those available and most used by this age-group.


Eligibility criteria:
inclusion criteria: * good general health * good oral health

Keywords: toothpastes bioavailability sodium fluoride monofluorphosphate low-fluoride
an open-label study on the clinical efficacy of rtms intervention in pd

Conditions: Transcranial Magnetic Stimulation; Parkinson Disease; Supplementary Motor Area

Summary: to demonstrate that intervention targeting the supplementary motor area (sma) using precise navigation positioning can effectively improve motor symptoms in patients with parkinson's disease.

as an innovative non-invasive neuromodulation technology, repetitive transcranial magnetic stimulation (rtms) has demonstrated efficacy in improving motor symptoms in patients with parkinson's disease (pd). the supplementary motor area (sma) has been identified as a brain region significantly associated with motor symptoms in pd patients. however, no large-sample clinical studies have yet established the clinical efficacy of rtms, guided by neuroimaging navigation, targeting the sma in patients with parkinson's disease. we describe a open-lable study designed to recruit 20 patients with idiopathic parkinson's disease. participants will be randomly assigned to receive either real stimulation or sham stimulation, with the left sma undergoing 7 days of continuous theta burst stimulation (ctbs). the primary outcome measure is the change in the movement disorder society-sponsored revision of the unified parkinson's disease rating scale (mds-updrs) part iii scores from baseline to post-treatment and follow-up. secondary outcomes include changes in scores on other clinical symptom scales.

Eligibility criteria:
inclusion criteria: 1. age ≥40 years old 2. meet movement disorder society standards; 3. have no history of drug adjustment within 4 weeks before and during treatment; 4. the mds-updrs ⅲ score ≥8, and the hoehn-yahr rating is 1-4 5. mmse ≥24，able to cooperate with the completion of behavioral tests and transcranial magnetic stimulation therapy. exclusion criteria: 1. head mri/ct ruled out focal brain injury or severe leukoencephalopathy (fazekas grade 3); 2. various secondary parkinsonism syndromes (vascular parkinsonism, parkinsonism combined with parkinsonism, drug parkinsonism, etc.); 3. severe craniocerebral trauma, received craniocerebral surgery or deep brain stimulation treatment; 4. there are ferromagnetic implants in the body, such as cochlear implants, cardiac pacemakers, etc. 5. the person or first-degree relatives have a history of epilepsy, unexplained loss of consciousness, or are taking anticonvulsant drugs to treat epileptic seizures; 6. diagnosed with a neuropsychiatric disorder other than pd 7. have a history of drug abuse or drug use; 8. participants in any clinical trial within the previous 6 month; 9. pregnant/lactating women or subjects (including men) who have a birth plan within 6 months; 10. other conditions deemed unsuitable for inclusion by the investigator.

Keywords: transcranial magnetic stimulation parkinson disease supplementary motor area
duke urology database and specimen bank

Conditions: Prostate Cancer; Bladder Cancer; Erectile Dysfunction; Incontinence

Summary: the proposed project is aimed to build a duke university-specific longitudinal urologic surgery database. it will be used as the main resource to support future research within urology and duke university.

specifically, the database will be used for the following future studies. (i) to characterize the biomarkers/protein signature associated with urological diseases; (ii) to clarify the clinical role of the risk factors and their interactions for early detection and optimized treatment of urological diseases, and improvement of post-treatment quality of life; (iii) to develop algorithms and nomograms to accurately predict the outcome of urological diseases. retrospective review of subjects data prior to institutional review board approval and prospective review of data on those consented after institutional review board approval.

Eligibility criteria:
inclusion criteria: * duke urology patients exclusion criteria: * none

Keywords: benign prostate hyperplasia erectile dysfunction
correlation of perioperative brain metabolites with postoperative delirium in elderly oral craniomaxillofacial surgery patients

Conditions: Delirium in Old Age

Summary: in view of the increasingly severe aging situation in china, the perioperative brain health of elderly patients has received increasing attention. postoperative delirium (pod) is a common postoperative complication characterized by acute consciousness and cognitive dysfunction. the incidence of pod in elderly patients undergoing elective non cardiac surgery is 20%\~45%, which often indicates poor cognitive recovery and becomes a heavy burden for family and society. although the weight of human brain only accounts for 2% of body weight, the oxygen consumption accounts for 20% of the total oxygen consumption of the whole body. on july 2, 2022, the british journal of anaesthesia (chinese academy of sciences division 1, anesthesiology division 1, if11.719), the top international journal in the field of anesthesiology, published the scientific research achievements of the first author of the applicant. it was found for the first time that sevoflurane, the most commonly used inhalation anesthetic in clinical practice, can cause the activation of glycolysis and the increase of lactic acid in the brain of elderly non-human primate marmosets, which suggests that general anesthetics will affect brain metabolism in the perioperative period. therefore, we hypothesized that perioperative changes in brain metabolism might be related to the occurrence of pod in elderly patients. the purpose of this study was to study the relationship between the changes of brain metabolites and pod during perioperative period by noninvasive monitoring of the characteristics of brain tissue metabolites 24 hours before and 24 hours after the operation with hydrogen ion proton magnetic resonance spectroscopy (1-hmrs). in order to complete this purpose, this study plans to collect subjects aged 65\~90 years who are scheduled to undergo oral and maxillofacial surgery under general anesthesia. the changes of brain metabolites before and after operation were collected by 1-hmrs, and the postoperative delirium related scale was evaluated to analyze the relationship between perioperative changes of brain metabolites and pod.


Eligibility criteria:
inclusion criteria: * the asa grade of the subject is ⅰ - ⅲ; * 65-90 years old; * oral craniomaxillofacial surgery under combined general anesthesia exclusion criteria: * the following medical devices have been installed in the body or are to be installed or implanted in the hospital: various cardiac pacemakers; metal implants (non titanium), ferromagnetic vascular clips in the body * the patient is left-handed; * patients with claustrophobia; * people with vision and hearing impairment, illiterate or difficult to communicate; * the operation plan includes patients with tracheotomy or postoperative catheterization; * refusing to sign the clinical trial consent form.
blood-brain barrier disruption using transcranial mri-guided focused ultrasound

Conditions: Brain Tumor

Summary: the purpose of this study is to evaluate the safety of bbb disruption using transcranial mri-guided focused ultrasound in conjunction with an intravenous ultrasound contrast agent to increase the accumulation of doxorubicin in brain tumours and the adjacent brain using the exablate transcranial system (220 khz). data will be collected to establish the basic safety of this type of treatment as the basis for later studies to evaluate its clinical efficacy.


Eligibility criteria:
inclusion criteria: * men or women. * age between 18 and 70 years, inclusive. * able and willing to give informed consent. * size of the targeted portion of the tumour (i.e. prescribed rot) is less than 2.5 cm in diameter (16 cm3). the non-targeted tumour tissue may exceed the targeted volume. * karnofsky rating 70-100 * asa score 1-3. * able to communicate sensations during the exablate mrgfus procedure. * able to attend all study visits (i.e., life expectancy of at least 3 months). * at least 14 days passed since last brain surgery. exclusion criteria: * the sonication pathway to the tumour involves: i. more than 30% of the skull area traversed by the sonication pathway is covered by scars, scalp disorders (e.g., eczema), or atrophy of the scalp ii. clips or other metallic implanted objects in the skull or the brain, except shunts * the subject presents with symptoms and signs of increased intracranial pressure (e.g., headache, nausea, vomiting, lethargy, and papilledema) * cardiac disease or unstable hemodynamics including: i. documented myocardial infarction within six months of enrolment ii. unstable angina on medication iii. congestive heart failure iv. left ventricular ejection fraction below the lower limit of normal v. history of a hemodynamically unstable cardiac arrythmia vi. cardiac pacemaker * severe hypertension (diastolic bp \> 100 on medication) * anti-coagulant therapy, or medications known to increase risk of hemorrhage, (e.g.:asa, non-steroidal anti-inflammatory drugs (nsaids), statins) * history of a bleeding disorder, coagulopathy or with a history of spontaneous tumour hemorrhage * abnormal level of platelets (\ 14) or ptt (\>36), and inr \> 1.3 * documented cerebral infarction within the past 12 months * tia in the last 1 month * cerebral or systemic vasculopathy * insulin-dependent diabetes mellitus * immunosuppression (corticosteroids to prevent/treat brain edema are permitted) * known sensitivity to gadolinium-dtpa * contraindications to mri such as non-mri-compatible implanted devices * large subjects not fitting comfortably into the mri scanner (generally \>250 lbs) * difficulty lying supine and still for up to 4 hours in the mri unit or claustrophobia * untreated, uncontrolled sleep apnea * positive pregnancy test (for pre-menopausal women) * known life-threatening systemic disease * severely impaired renal function with estimated glomerular filtration rate \<30 ml/min/1.73m2 and/or on dialysis * right to left or bi-directional cardiac shunt * previous full course of doxorubicin chemotherapy * allergy to eggs or egg products
randomized evaluation of d-dimer guiding duration of oral anticoagulation therapy

Conditions: Valve Heart Disease; Anticoagulants; Increased

Summary: guidelines recommended that patients with bioprosthetic heart valves (bhv) only need 6 months oral anticoagulation therapy after operation. however, a small part of patients still suffered thrombotic events after withdrawal of warfarin, which means these patients may need extend anticoagulation therapy. d-dimer, a sensitive marker of thrombosis or prethromboembolism state. previous studies have demostrated that patients with elevated d-dimer levels have significant more clinical outcomes than those with nagative d-dimer levels. the aim of this study was to evaluate whether d-dimer could guide the duration of oral anticoagulation therapy in patients with bhv.

patients with bhv were screened and enrolled in this study. d-dimer levels were measured in the sixth months after bhv operation but before withdrawal of warfarin. patients with elevated d-dimer were randomized to extend anticoagulation therapy group and routine stopping anticoagulation group.

Eligibility criteria:
inclusion criteria: * patients received bhv within 3 months exclusion criteria: * recently throboemblism within 6 months * recently bleedings within 3 months * evaluated lifetime less than 2 years

Keywords: bioprosthetic heart valves oral anticoagulation thrombotic events
study of talabostat and docetaxel in advanced non-small cell lung cancer

Conditions: Lung Cancer

Summary: the purpose of this study is to determine the antitumor activity (response rate, time to tumor progression, survival) and safety of docetaxel in combination with talabostat in patients with advanced non-small cell lung cancer (nsclc) who have failed a prior platinum-containing regimen.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed stage iiib/iv nsclc * failed or relapsed after receiving a platinum-containing chemotherapy regimen as first-line therapy for advanced nsclc * measurable disease * ecog performance status of 0 or 1 * expected survival ≥12 weeks * provide written informed consent exclusion criteria: * more than 2 prior chemotherapy regimens * brain metastases (exception: patients who have had a resection and/or completed a course of cranial irradiation, have no worsening cns symptoms, and have discontinued all corticosteroids for that indication for at least 1 month) * any malignancy within the 5 years immediately prior to the first dose of study medication with the exception of basal cell or non-metastatic squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix * the need for chronic (i.e., \>7 days) oral or intravenous corticosteroid therapy * a history of severe hypersensitivity reactions to drugs formulated with polysorbate 80 * a history of myocardial infarction within 1 year of study entry, cabg within 6 months of study entry, severe congestive heart failure (ejection fraction \<30%), history of ventricular arrhythmia, or other uncontrolled cardiac arrhythmia * any comorbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this protocol * patients who are within 30 days of chemotherapy, radiation therapy, immunotherapy, or other investigational medication for nsclc. patients must have recovered from all of the side effects of treatment in order to be enrolled. * pregnant or lactating women. * clinically significant laboratory abnormalities, specifically: total bilirubin ≥institutional upper limit of normal (uln); serum alanine aminotransferase (alt) or aspartate aminotransferase (ast) ≥1.5 x uln concomitant with alkaline phosphatase \>2.5 x uln; hepatitis b surface antigen or antibody to hepatitis c (anti-hcv antibody); serum creatinine ≥2.0mg/dl; or granulocytes \<1500/μl or platelets \<100,000/μl.
polyphenols and overfeeding

Conditions: Overfeeding

Summary: obesity is a complex and multifactorial disease representing a major public health challenge. indeed, overweight and obese people carry a major risk of developing insulin resistance and type 2 diabetes mellitus. it has been demonstrated that polyphenols could be used to counteract some of the mechanisms involved in the generation of insulin resistance. the model of overfeeding represents a very good study model of the metabolic complications of obesity, since it has been shown to induce a transient state of insulin resistance in the human. the purpose of this research is to study the effects of a overfeeding (+50% of daily caloric needs over 31 days) with or without polyphenols supplementation (2g/days over 31 days) on insulin sensitivity measured in the setting of a hyperinsulinemic euglycemic clamp and on post prandial partitioning of exogenous lipids after a test meal. during 31 days, the volunteers will consume chocolate bars, chips, chocolate breads and cola in addition to their usual diet and will be supplemented with 2g of grape polyphenols extract or with placebo.


Eligibility criteria:
inclusion criteria: * male * aged from 18 to 55 years * body mass index of 23 to 27 kg/m² * normal blood pressure * fasting glycemia \< 7 mmol/l * crpus \< 10mg/l * triglycerides ≤ 3mmol/l exclusion criteria: * medical or surgical history which may affect the results (renal -cardiovascular - hepatic- endocrine-inflammatory diseases) * subjects under treatment which may interfere with the measured parameters * eating disorder * intensive sportive activity * dairy products allergy or intolerance

Keywords: overfeeding fat distribution subcutaneous and visceral adipose tissue insulin sensitivity insulin resistance peripheral and hepatic insulin sensitivity stable isotopes lipid oxidation energy expenditure muscle and subcutaneous adipose tissue gene expression