Kornimate/medical-research-clean huggingface dataset:
an open randomised trial of the arabin pessary to prevent pre-term birth in twin pregnancy

Conditions: Twin Pregnancy With Antenatal Problem

Summary: this study aims to determine whether the arabin cervical pessary prevents preterm birth in women with a twin pregnancy and a short cervix.

stoppit-2 is a multicentre open label randomised controlled trial of the arabin pessary (ce marked device) versus standard treatment in women with twin pregnancy. the study is in two phases - a screening phase, in which women with a short cervix (cervical length of ( less or equal to 35mm) will be identified, and a treatment phase, in which women with a short cervix will be randomised to treatment with arabin pessary or standard treatment. women will be seen in the antenatal clinic setting. an internal pilot phase will take place, with ten interviews being conducted with pregnant women to explore the acceptability of proposed methods of recruitment, their information requirements, their views of the consent and randomisation processes, and the delivery of the intervention, including the screening component. the interviews will also explore their understanding and expectations of trial participation. the findings of this pilot phase will feed into the next phase of the trial and support the design of the interview guides for the main nested qualitative study. this pilot phase is separate from the main study. later on we will ask both women and healthcare professionals about their experiences of the study, via questionnaires and face-to-face interviews.

Eligibility criteria:
inclusion criteria: * women presenting with twin pregnancy (monochorionic or dichorionic) * women with gestation established by scan at ≤16 weeks according to nice guidelines. * women aged 16 years or older * women wishing to participate in both the screening and randomisation phase of the study exclusion criteria: * women unable to give written informed consent * women with known significant congenital structural or chromosomal fetal anomaly at the time of inclusion * women with existing or planned cervical cerclage in the current pregnancy * women who with existing or planned (prior to 20+6 weeks gestation) treatment for twin to twin transfusion syndrome in the current pregnancy * women with suspected or proven rupture of the fetal membranes at the time of recruitment * women with singleton pregnancy or higher order multiple pregnancies * women with known sensitivity, contraindication or intolerance to silicone * women involved in a clinical trial of an investigational medicinal product (ctimp)

Keywords: twin pregnancy prevention of preterm birth short cervix arabin cervical pessary
luteal phase administration of paroxetine for the treatment of pmdd

Conditions: Premenstrual Dysphoric Disorder

Summary: the efficacy of ssri use to relieve the symptoms associated with premenstrual dysphoric disorder has been established. we proposed to test the hypothesis that intermittent treatment with paroxetine administered during the luteal phase of the menstrual cycle only is more effective than placebo in improving symptoms of pmdd. this was a double-blind, placebo-controlled, three-arm parallel group study of patients with pmdd. menstruating women 18 years of age or older who met criteria for inclusion in the study were randomized to one of three arms: paroxetine 10mg/day during the luteal phase of the menstrual cycle; paroxetine 20mg/day during the luteal phase of the menstrual cycle; placebo daily during the luteal phase of the menstrual cycle. the objective was to evaluate the efficacy and safety of intermittent treatment of paroxetine in women with pmdd.


Eligibility criteria:
inclusion criteria: * pmdd according to dsm-iv criteria exclusion criteria: * women were excluded if they were taking oral contraception, breast-feeding, pregnant, or planning to become pregnant during the study period. * women were also excluded if they met dsm-iv criteria for any axis i disorder, were deemed a suicidal risk, had a history of ssri use for premenstrual symptoms, were taking ongoing medication that could affect pmdd symptoms, had a clinically significant abnormality on screening blood tests, or had a baseline montgomery-asberg depression rating scale score of equal to or greater than 10 during the follicular phase of the menstrual cycle.
identification of the optimal functional lymphatic vessel for lymphaticovenous anastomosis

Conditions: Lymphedema

Summary: the aim of this study is to further explore the optimal screening factors for functional lymphatic vessels in lymphaticovenous anastomosis in patients with lymphedema.

by analyzing the size of lymphatic vessels (0.3-0.6mm), icg imaging, contraction characteristics of lymphatic vessels and lymphatic flow in patients with lymphedema, the effect of functional lymphatic vessel selection on lymphatic drainage in patients with lymphedema was judged during operation, so as to provide a more scientific basis for the selection of functional lymphatic vessels in clinical surgery.

Eligibility criteria:
inclusion criteria: * lymphedema paitent exclusion criteria: * myoedema paitent；lipedema paitent
neurophysiology biomarkers of cognitive impairment associated with deep brain stimulation

Conditions: Parkinson Disease

Summary: the study aims to investigate cognitive impairment associated with deep brain stimulation (dbs) in parkinson's disease patients, with a focus on identifying neurophysiology biomarkers of dbs associated cognitive changes. using neurophysiology data recorded during dbs surgeries and post-implantation, the research intends to identify biomarkers in order to optimize electrode placement, enhance programming, and ultimately minimize dbs-related cognitive side effects.


Eligibility criteria:
inclusion criteria: • scheduled to undergo deep brain stimulation surgery under local anesthesia at vanderbilt university medical center (arm 1) * active deep brain stimulation system with implantable pulse generator capable of recording local field potentials (arm 2) * diagnosis of parkinson's disease as determined by a movement disorders specialist neurologist * age at least 18 * able to participate in intraoperative testing * english speaking exclusion criteria: * age less than 18 * not able to participate in intraoperative testing (ex unable to comprehend instructions or follow directions)

Keywords: deep brain stimulation parkinson disease cognitive impairment movement disorders brain diseases
dose response oxidation of a sweet-corn derived sugar (phytospherix) during exercise in endurance trained athletes

Conditions: Hypoglycemia

Summary: phytospherix (phx) is an all-natural, edible polysaccharide extracted from sweet corn. this carbohydrate is the major muscle fuel for intense exercise and its stores are quite small such that one can run out of it during a single exercise bout. therefore, phx should provide significant exercise fuel if consumed during exercise. as a result its intake could enhance intense exercise performance by providing additional fuel. this experiment will investigate the effects of 4 different dosages of phx consumed throughout a prolonged exercise bout on carbohydrate and fat utilization as well as its oxidation rate and perception of effort during prolonged intense exercise in trained cyclists. muscle and liver carbohydrate stores will be examined using a non-invasive ultrasound technique.

carbohydrate (cho) is one of the main substrate oxidized during moderate-to-high intensity, endurance-type exercise. it's been shown that cho feeding during exercise enhances endurance performance and capacity, attributed mainly to the facilitation of greater rates of exogenous cho oxidation, prevention of hypoglycaemia and sparing of muscle glycogen. previous studies based on supplementation of glucose during 180 min. of cycling exercise have reported a maximal rate of exogenous cho oxidation to be about 1 g/min. other studies have shown that cho oxidation rates can reach peak values of about 1.3 g/min when a combination of fructose and glucose is ingested at a rate of 1.8 g/min. the limitation in uptake and oxidation of a single cho source is attributed to its intestinal transporter saturation such that when multiple cho source is used the uptake and oxidation rate is increased to a greater extent. currently there is no information regarding phx uptake or oxidation rate as a cho source during exercise. also, it is important to investigate whether phx as a cho sport drink can increase performance by sparing muscle and liver glycogen during exercise. therefore, the objective of this experiment is to measure dose response of phx oxidation rate during prolonged cycling exercise and its effect on muscle and liver glycogen levels.

Eligibility criteria:
inclusion criteria: * healthy male endurance trained athletes with \>2 y cycling experience; about 2 h/day exclusion criteria: * unhealthy athletes, smokers

Keywords: polysaccharide oxidation endurance exercise
quality of life in children treated for cancer

Conditions: Leukemia; Lymphoma; Unspecified Childhood Solid Tumor, Protocol Specific

Summary: rationale: questionnaires that measure quality of life may improve the ability to plan treatment for children with cancer. purpose: this randomized clinical trial is studying the quality of life in children treated for cancer.

objectives: i. assess the validity and reliability of a quality of life questionnaire (mm-qol) that is being developed for patients with previously or currently treated childhood cancers. outline: this is a randomized, multicenter study. patients are stratified according to age (8-12 vs 13-20) and treatment (current vs previous). patients are randomized to one of two arms of the study. arm i (reliability): patients will complete the same questionnaire two weeks apart. (age 13-20 stratum closed as of 7/14/00) arm ii (validity): patients will complete a study questionnaire plus a child health questionnaire. patients between ages 8-12 are interviewed and patients between ages 13-20 complete a written questionnaire. projected accrual: a total of 716 patients (416 for arm i (208 for 8-12 age group and 208 for 13-20 age group) and 300 for arm ii (150 for 8-12 age group and 150 for 13-20 age group)) will be accrued for this study.

Eligibility criteria:
disease characteristics: prior or current diagnosis of any pediatric cancer current chemoradiotherapy (at least 2 months since start of therapy) or at least 1 year since prior treatment and in remission patient characteristics: age: 8 to 20 performance status: not specified life expectancy: not specified hematopoietic: not specified hepatic: not specified renal: not specified prior concurrent therapy: biologic therapy: not specified chemotherapy: see disease characteristics endocrine therapy: not specified radiotherapy: see disease characteristics surgery: not specified

Keywords: recurrent childhood acute lymphoblastic leukemia childhood burkitt lymphoma stage i childhood lymphoblastic lymphoma stage ii childhood lymphoblastic lymphoma stage iii childhood lymphoblastic lymphoma stage iv childhood lymphoblastic lymphoma recurrent childhood lymphoblastic lymphoma recurrent childhood acute myeloid leukemia childhood diffuse large cell lymphoma childhood immunoblastic large cell lymphoma unspecified childhood solid tumor, protocol specific childhood acute myeloid leukemia in remission stage ii childhood hodgkin lymphoma stage i childhood hodgkin lymphoma stage iii childhood hodgkin lymphoma stage iv childhood hodgkin lymphoma recurrent/refractory childhood hodgkin lymphoma stage i childhood small noncleaved cell lymphoma stage i childhood large cell lymphoma stage ii childhood small noncleaved cell lymphoma stage ii childhood large cell lymphoma stage iii childhood small noncleaved cell lymphoma stage iii childhood large cell lymphoma stage iv childhood small noncleaved cell lymphoma stage iv childhood large cell lymphoma recurrent childhood small noncleaved cell lymphoma recurrent childhood large cell lymphoma
single-probe microwave ablation (mwa) of metastatic liver cancer

Conditions: Liver Neoplasms

Summary: microwave ablation (mwa) is the most recent development in the field of local ablative therapies. the aim of this study was to evaluate the variability and reproducibility of single-probe mwa versus radiofrequency ablation (rfa) of metastatic liver tumours smaller than 3 cm in patients without underlying liver disease.


Eligibility criteria:
inclusion criteria: * unresectable metastatic liver cancer * no invasion of major biliary structures * no invasion of major vascular structures * asa score \< 4 * who score 0-1 * pre-operative chemotherapy is allowed exclusion criteria: * resectable liver metastases * life expectancy less than 3 months * patients with cardiac pacemaker, cerebral aneurysm clips, implanted electronic instruments or other metal materials * coagulopathy with platelet count less than 50000 * active infectious disease * age below 18 years * pregnancy of breastfeeding

Keywords: malignancy liver microwave surgery
camp signaling and muscle adaptations

Conditions: Muscle Hypertrophy in Healthy Young Men

Summary: the role of camp signaling mediated by beta2-adrenergic stimulation with agonists has been well-studied in skeletal muscles of animals. studies in humans are scant and the scope of the present study is thus to investigate the role of camp signaling by beta2-adrenergic stimulation for muscle adaptations in humans.


Eligibility criteria:
inclusion criteria: * healthy young men * 18-35 years of age * informed consent * active 2-5 hours of training pr. week * maximal oxygen uptake (ml/min/kg) of 40-60 * lean body mass of 55-65 kg / lean mass index 14-22 kg/m2 exclusion criteria: * smoker * allergy towards study drugs * chronic disease
single-ascending dose study of kylo-12 in healthy subjects

Conditions: Hypertriglyceridemia

Summary: this is a first-in-human, randomized, double-blind, placebo-controlled, single ascending dose study in healthy volunteers. kylo-12 will be evaluated in approximately 50 subjects to assess safety, tolerability, pharmacokinetics and pharmacodynamic effects.


Eligibility criteria:
inclusion criteria: * men and women aged 18 to 55 years old, inclusive; * body mass index (bmi) between 19 kg/m2 and 30 kg/m2, inclusive; * protocol-defined elevated serum tg level; * female subjects must not be able to get pregnant and male subjects must agree to adhere to contraception restrictions; * willing to comply with protocol required visits and assessments, and provide written informed consent. exclusion criteria: * history or evidence of a clinically significant disorder, condition or disease; * received an investigational drug, vaccine or device within 3 months before dosing; * history of evidence of malignant tumor or gilbert syndrome; * positive screen of hepatitis b surface antigen, hepatitis c virus, human immunodeficiency virus or syphilis infection; * history of alcohol abuse within 12 months before dosing; * history of drug abuse within 3 months before screening; * history of blood donations or blood loss of 400 ml and more within 3 months before dosing; * history of stroke or myocardial infarction within 6 months before sceening; * pregnant or breast-feeding women; * other exclusion criteria applied per protocol.
precision radiotherapy for tumours using magnetic resonance-guided linear accelerator (mr-linac)

Conditions: Overall Response Rate; Oncology; Radiation Toxicity; Quality of Life

Summary: aim to observe the application of mr-linac for precision radiotherapy of tumours, analyse its therapeutic effect, toxic and side effects,characteristics of dosimetric parameters etc.

primary endpoint: · overall response rate (orr) : it refers to the proportion of patients whose tumor volume reduction reaches the pre-specified value and can maintain the minimum time requirement, which is a complete response (cr) and a partial response (pr). partial response) sum of the proportions. secondary points: * progression-free survival (pfs) : the time from the start of treatment until objective tumor progression or all-cause death of the patient. * disease control rate (dcr) : the percentage of patients whose cancer shrinks or remains stable over time. * overall survival (os) : the time from the start of treatment to all-cause death. * incidence of adverse reactions: toxicity according to common toxicity criteria for adverse events (ctcae). * quality of life: the eortc quality of life measure -qlq-c30-(v3.0) was used, and the higher the score, the higher the quality of life. * dosimetric parameters： include gross target volume（gtv）， clinical target volume（ctv），internal target volume(itv),planning target volume（ptv），γ-passing rate，and limited dose of organs at risk (including average dose, maximum dose, etc.)

Eligibility criteria:
inclusion criteria: * patients are undergoing or have undergone imaging or treatment at the mr linac; * age 18-75 years, male or female; * ecog score 0-2, life expectancy \> 6 months; * patients provide written informed consent. exclusion criteria: * contraindications to mri, such as claustrophobia and metallic or electronic implants incompatible with mri; * the presence of severe comorbidities that, in the opinion of the investigator, · preclude the toleration or completion of radiotherapy; * acute inflammatory disease requiring systemic therapy; * the presence of active infectious disease; * pregnant women, nursing mothers, and patients planning to have children during the study period.
mity kids (metformin in women with type 2 diabetes in pregnancy kids trial)

Conditions: Type 2 Diabetes

Summary: the prevalence of diabetes in pregnancy is rising in all maternal age groups. there is increasing evidence that in-utero exposure to maternal diabetes is associated with an increased risk of obesity and type 2 diabetes in children and adults. there is an urgent need to reduce these increasing rates of obesity and diabetes in subsequent generations. the mity trial (metformin in women with type 2 diabetes in pregnancy trial) is a cihr-funded multi-centre, randomized controlled trial of women with type 2 diabetes in pregnancy (sample size n=500). the mity trial is looking to determine the effect of the addition of metformin to a standard regimen of insulin in women with diabetes, on perinatal morbidity and mortality. the mity kids trial is a follow-up to the mity trial which will determine whether treatment with metformin during pregnancy in women with type 2 diabetes will lead to a reduction in adiposity and improvement in insulin resistance in the offspring of women with diabetes at 2 years of age.


Eligibility criteria:
inclusion criteria: * offspring of women with type 2 diabetes who participated (or are participating) in the mity trial. exclusion criteria: * offspring with major congenital anomalies.

Keywords: diabetes mity metformin in women type 2 diabetes pregnancy
"red morphine drops" for symptomatic treatment of dyspnoea in lung cancer

Conditions: Dyspnea; Lung Neoplasms

Summary: the purpose of this study is to test whether "red morphine drops" applied in the mouth are superior to an equivalent amount of morphine applied as subcutaneous injection for the relief of breathlessness in terminal patients suffering from primary lung cancer or lung metastases.

breathlessness or dyspnea in terminal cancer patients with lung cancer is common and opioids such as morphine is the mainstay of symptomatic treatment. subcutaneous administration of morphine provides fast symptomatic relief, but it has been the impression in our institution that "red morphine drops" applied orally may have equal or better efficacy and faster onset time. comparison: patients with lung cancer or lung metastases with moderate to severe dyspnea at rest are treated with either orally applied "red morphine drops" or an equivalent amount of morphine applied subcutaneously.

Eligibility criteria:
inclusion criteria: * primary lung cancer or lung metastases and * moderate to severe dyspnea at rest (vas equal to or more than 30) exclusion criteria: * causal treatment of dyspnea possible and indicated * not receiving opioids on a regular basis * methadone treatment * intolerance to morphine * without understanding of patient information * depressed consciousness * oxygen treatment, if changed with-in 20 min before start * short-acting opioids with-in 4 h before start * inhalation therapy for bronchodilation with-in 20 min before start
comparison between different investigations used in intraocular lens calculation in high myopic cataractous patients

Conditions: Calculation of Intraocular Lens in High Myopic Cataractous Patients

Summary: the purpose of the study is to compare the accuracy of optical and ultrasonic biometry in intraocular lens (iol) calculation in high myopic cataractous patients

* prospective interventional (quasi experimental) comparative study * this study will be conducted on high myopic cataractous patients scheduled for phacoemulsification and iol implantation in department of ophthalmology, sohag university * patients will be divided into 2 groups one will be subjected to intraocular lens (iol) calculation by optical biometry the second one will be subjected to intraocular lens (iol) calculation by ultrasonic biometry * postoperative auto refraction after i month

Eligibility criteria:
inclusion criteria: * patients with simple cataract not associated with other pathologies suitable for phacoemulsification and 1ry iol implantation with axial length (axl) equal to or greater than 26.5mm exclusion criteria: 1. history of trauma 2. associated pathologies such as optic neuropathy, age related macular degeneration, macular edema, retinal detachment, , ocular inflammation, retinitis pigmentosa, proliferative diabetic retinopathy 3. corneal opacities or irregularities, scars, dystrophy or ectasia 4. patients who underwent previous corneal surgery (including refractive surgery) 5. patients having intraoperative complications as inability to achieve secure 'in the bag' placement of the iol (i.e. due to posterior capsule rupture, vitreous loss, weak zonules, or zonular rupture)
the clinical response of choline acetyltransferase and apolipoprotein epsilon gene polymorphisms to donepezil in alzheimer's disease

Conditions: Alzheimer's Disease

Summary: this study attempts to differentiate the clinical responses of choline acetyltransferase and apolipoprotein epsilon gene polymorphism to donepezil in alzheimer's disease patients.


Eligibility criteria:
inclusion criteria: 1. age: 60 - 90 years old. 2. cdr: 0.5 - 2.0. 3. patients who do not have severe depressive symptoms that affect cognition on depression scale of cerad-k(c), gds-k: 19 and below. 4. modified hachinski ischemic score (rosen, et. al., 1979): 3 and below. 5. nincds-adrda criteria: probable ad. exclusion criteria: 1. patients who have delusions and other conscious dysfunction. 2. patients who have neurologic diseases such as parkinson's disease, stroke, tumor, normal pressure hydrocephalus, etc., on history and neurologic examination. 3. patients who have history of infectious and inflammatory brain disease owing to virus, fungus and syphilis. 4. patients with severe cerebrovascular pathology. 5. patients who have present history of major psychological diseases such as depression and mania according to dsm-iv criteria. 6. patients who have history of alcoholism or drug addiction. 7. patients who have severe depressive symptoms that affect cognition on depression scale of cerad-k.

Keywords: alzheimer's disease