Kornimate/medical-research-clean huggingface dataset:
optical coherence tomography of retinal abnormalities associated with choroidal nevus, choroidal melanoma and choroidal melanoma treated with iodine-125 brachytherapy

Conditions: Ocular Melanoma

Summary: during regularly scheduled appointments, optical coherence tomography (oct) is performed on consented subjects. the oct is a new type of camera that takes very detailed pictures inside of the eye and deeper into eye tissues. optical coherence tomography imaging of intraocular tumors may lead to improved diagnosis and monitoring of tumors within the eye.


Eligibility criteria:
inclusion criteria: * adults (18 years or older) with: * choroidal nevus greater than or equal to 3.0 mm in longest basal diameter, or greater than or equal to 1.25 mm in apical height or: * choroidal melanoma located in the posterior pole (4mm or less from the center of fovea or the border of the optic nerve head) exclusion criteria: * ocular media opacity in the tumor eye that prevents adequate functional testing or imaging and prior or concurrent retinal or choroidal disease in the tumor eye that prevents adequate functional testing or imaging

Keywords: ocular melanoma optical coherence tomography eye tumor choroidal melanoma uveal melanoma
a randomized, double blind, parallel group, placebo controlled, multicenter outpatient trial of pd 0200390 in adults with primary insomnia

Conditions: Insomnia

Summary: to demonstrate efficacy and characterize the dose response relationship of pd 0200390 on subjective wake after sleep onset in subjects with primary insomnia.


Eligibility criteria:
inclusion criteria: * 3 month history of primary insomnia; * 18 to 64 years * for the last 3 months-regularly awake unrefreshed and unrestored * difficulty initiating and maintaining sleep for at least 3 nights/week for the past month (difficulty falling asleep, difficulty staying asleep, early awakening) exclusion criteria: * any history of an axis 1 psychiatric diagnosis; * history or presence of any breathing related sleep disorder; * history or presence of any medical or neurological condition that could interfere with sleep * use of alcohol as a sleep aid or more than 2 standard drinks consumed per day or more than 14 consumed per week
navigating the clinical research process for glioma

Conditions: Glioma

Summary: participation in medical trials usually favors a particular demographic group. but there is limited research available to explain what trial attributes affect the completion of these specific demographic groups. this trial will admit a wide range of data on the clinical trial experience of glioma patients to determine which factors prevail in limiting a patient's ability to join or finish a trial. it will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future glioma patients.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of glioma * participant must be 18 years of age or older * participant must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, and other requirements of the study. exclusion criteria: * pregnant or lactating woman * participant is actively receiving study therapy in another * inability to provide written informed consent

Keywords: glioma
impact of perivascular tissue on endothelial function in coronary artery bypass grafting

Conditions: Myocardial Ischemia

Summary: the success of coronary artery bypass grafting is reliant on the quality of the grafts used. a new technique for harvesting veins used as grafts has been introduced. the study hypothesis is that veins harvested with this technique have an improved endothelial function.


Eligibility criteria:
inclusion criteria: * isolated elective, primary cabg requiring cardiopulmonary bypass * left ventricular ejection fraction \>35% * at least one saphenous vein graft required as part of revascularization strategy exclusion criteria: * acute or chronic inflammatory diseases * malignancies * pregnancy * previous cardiac surgery * serum creatinine \>120 μmol/l * coagulopathy * insulin dependent diabetes mellitus * smoking during last 6 months * leg not suitable for no-touch vein harvesting as judged by the operator. * need for nitrates on operation day * not receiving statins

Keywords: comparative study cardiac surgical procedures
follow-up of sequential chemotherapy and stimulation for fertility preservation in young patients with breast cancer

Conditions: Breast Cancer

Summary: interventional research with low risks and constraints, prospective and monocentric on the assessment of long-term fertility in patients who underwent an adjuvant sequential chemotherapy with or without a controled ovarian hyperstimulation. this study follows a previous one called nct 01614704.

the patients will have a follow-up once a year during ten years beginning at the end of their chemotherapy. they will have a consultation in oncology consisting of: * a clinical exam, * a collection and follow-up of oncological data * a collection of ongoing cancer treatments and a consultation in gynecology consisting of: * a pelvic ultrasound scan (for afc: antral follicle count) * a biological test (fsh, lh, e2, amh) * a collection of gynecological data, contraception and reproductive medicine

Eligibility criteria:
inclusion criteria: * patients included in the study ct 01614704 * informed and written consent * affiliated to the national social security system exclusion criteria: * impossibility to submit at the study procedures due to geographic, social or mental reasons * patient deprived of their liberty or under guardianship or tutorship.
patient research in self-management of asthma (prisma)

Conditions: Asthma

Summary: the objective of this study was to investigate if a nurse-led telemonitoring programme is effective and cost-effective in asthmatic outpatients, aged seven years and older.

at the present day asthma is one of the most common chronic illnesses worldwide and the prevalence is still increasing. asthma can be treated and controlled with guidance of health care professionals, and self-monitoring is an important aspect in this control. respiratory nurses have become common caregivers in the treatment and control of asthma. advances in information and communication technology have created the potential to monitor the asthma status of patients at a distance, named telemonitoring. these two developments come together in nurse-led telemonitoring programmes. lung function tests, from which the peak expiratory flow (pef) is the most commonly used, are recorded into an electronic monitor. by transferring monitor data to a central database a nurse can continuously supervise the disease status of individual patients. the use of stepwise protocols can enable nurses to independently adjust the medication by one step. design: randomized controlled trial comparing a nurse-led telemonitoring programme versus regular care in asthmatic outpatients aged 7 years and older. primary outcome parameter: asthma-specific quality of life. secondary outcome parameters: symptoms, generic quality of life, direct and indirect costs, satisfaction.

Eligibility criteria:
inclusion criteria: * 7 years or older * asthma severity of stage i - iii as described in the gina guidelines * must be competent to use an asthma monitor * must possess a household phone connection exclusion criteria: * respiratory co-morbidity

Keywords: asthma self-monitoring cost-effectiveness
monitoring arrhythmia patients in in hospital monitoring

Conditions: Arrhythmias

Summary: this is a prospective, single center, non-randomized study to evaluate the arrhythmia monitoring performance of the avivo™ system in a hospital setting.

the avivo™ system will continuously monitor the patient's cardiac activity which will be compared to the performance of standard telemetry system.

Eligibility criteria:
inclusion criteria: * is female or male, 18 years of age or older * undergoing in-hospital electrocardiographic monitoring for primarily cardiac reasons exclusion criteria: * is participating in another clinical study that may confound the results of this study
effects of whey protein pre-meals on post-prandial glucose

Conditions: Prediabetic State

Summary: the aim of this project was to determine if an administration of either 10 g of whey protein isolate or 10 g of whey protein microgels 30 or 10 min before a standard meal could reduce postprandial glucose response in obese subjects.

monocentric, controlled, randomized, open, complete cross-over study design where participants will take 2 test products or water (negative control) at 2 different time points. the targeted population will be 16 completely healthy males and females at risk for pre-diabetes. primary objective: to quantify the effects of whey protein pre-meals administrated at 30 or 10 min before a meal on post-prandial glucose in the interstitial tissue, as compared to water as negative control. secondary objective: to compare glucose response of the different pre-meals (water, whey protein isolate, whey protein micelles).

Eligibility criteria:
inclusion criteria: * male and female participant * age between 40 and 65 years * bmi higher than 27.0 kg/m2 * sedentarity (no more than 30 min of walk per day). * able to understand and sign an informed consent form exclusion criteria: * any known metabolic disease including diabetes or chronic drug intake (aspirin, vitamin c and mineral supplements, steroids, protease inhibitors, antidepressants, anxiolytic, or antipsychotics...) possibly impacting (to the opinion of the medical doctor): * the digestion or absorption of nutrients * the postprandial glucose response * major medical/surgical event requiring hospitalization in the last 3 months, to the opinion of the medical doctor * known allergy and intolerance to products components * medically known cutaneous hypersensitivity to adhesives and plasters * alcohol intake higher than 2 servings per day. a serving is 0.4 dl of strong alcohols, 1 dl of red or white wine, or 3 dl of beer. * smokers * volunteer who cannot be expected to comply with the protocol * subject having a hierarchical link with the research team members
hla matching - unrelated umbilical cord blood transplantation

Conditions: Hematologic Diseases

Summary: the aim of this protocol is to clarify the role of hla matching in unrelated umbilical cord blood (ucb) transplantation and to identify the level of hla matching required assuring successful outcome of unrelated ucb transplantation.

the aim of this protocol is to clarify the role of hla matching in unrelated umbilical cord blood (ucb) transplantation and to identify the level of hla matching required assuring successful outcome of unrelated ucb transplantation. the study will answer the following questions: 1. is hla matching beneficial to unrelated ucb transplantation? 2. which hla loci, hla-a, b, c, drb1, or bqb1 is/are important to math, or alternatively to mismatch, to improve graft survival? 3. which hla loci, hla-a, b, c, drb1, or bqb1 mismatches is/are "permissive mismatches" or well tolerated mismatches? 4. what level of typing resolution (low, intermediate, or hgh) is required to perform patient/donor h:a matching? by studying the cells and blood of donors and recipients, we may learn more about improving the tissue matching between unrelated donors and their recipients. also, we hope to learn if an additional level of matching testing improves the results of the transplant treatment. increasing knowledge about tissue matching could result in the improved long-term survival of cord blood transplant recipients.

Eligibility criteria:
inclusion criteria: * pediatric patients undergoing an unrelated umbilical cord blood transplantation. exclusion criteria: * refusal to participate in study.
kineesiotaping for patients with lcpd

Conditions: Legg-Calve-Perthes Disease

Summary: kinesiotaping is increasingly being used as a complement to musculoskeletal pain management. this study aimed to evaluate the immediate clinical efficacy of kinesiotaping on pain and pain-related symptoms of legg-calvé-perthes disease (lcpd).

kinesio taping is increasingly being used as a complement to musculoskeletal pain management. a randomized, double-blind, placebo-controlled clinical trial was conducted. activity-related hip pain, passive and pain limited hip range of motion, gluteus medius muscle strength, function and balance were assessed.

Eligibility criteria:
inclusion criteria: * having received unilateral lcpd diagnosis, * anterior hip pain minimum three points on 10-cm visual analog scale (vas) over the previous week, * having the following symptoms; weakness of gluteus medius muscle and patient-reported complaints on function or balance exclusion criteria: * having a history of any other hip pathologies, * having allergy to polyacrylate adhesive, * having used analgesic medication within the previous three days.

Keywords: kinesiotape taping pediatric pain hip joint physiotherapy
prevention of postoperative pancreatic fistula by somatostatin

Conditions: Pancreatic Surgery

Summary: the purpose of this study is to determine whether somatostatin is more effective that octreotide in the prevention of post-pancreatectomy pancreatic fistula

prevention of pancreatic fistula remains a major challenge for surgeons, and various technical and pharmacological intervention have been investigated, with conflicting results. despite several prospective studies, and metaanalyses, the prophylactic role on pancreatic fistula of octreotide, remains controversial, even if recommended for routine use in patients undergoing pancreatic resection. in view of recent result, the investigators can hypothesize that higher affinity for somatostatin-receptor lead to stronger pancreatic exocrine secretion inhibition, and better pancreatic fistula prevention. consequently, continuous intravenous infusion of somatostatin-14, the natural peptide hormone, associated with 10 to 50 time stronger affinity with all somatostatin receptor, will be associated with a improved pancreatic fistula prevention compared to octreotide.

Eligibility criteria:
inclusion criteria: * men or women aged 18 years or greater * signed informed consent * candidate for pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy exclusion criteria: * patient with radiation therapy * patient with neoadjuvant chemotherapy within 4 weeks before surgery * pregnancy * breastfeeding * patients who have any current or prior medical condition that may interfere with the conduct of the study or the evaluation of its results in the opinion of the investigator * patients who have participated in any clinical investigation with an investigational drug within 1 month prior to inclusion * known hypersensitivity to somatostatin or somatostatin analogues or any component of the somatostatin or octreotide long-acting release (lar) or s.c. formulations * patient previously treated with somatostatin or somatostatin analogues or any component of the somatostatin or octreotide lar or s.c. formulations * patients treated by ciclosporin * patient without health insurance or social security * patients with a history of non-compliance to medical regimens or who are considered potentially unreliable or will be unable to complete the entire study

Keywords: pancreatectomy somatostatin analogue octreotide pancreatic fistula
double voiding and post-transplant uti

Conditions: Urinary Tract Infections; Kidney Transplant; Complications

Summary: urinary tract infections (uti) are common in kidney transplant recipients and are an important cause of illness and hospital admissions. past studies have shown that about 1 out of 5 of newly transplanted patients develop uti within their first 3 months of transplantation. such utis increase the risk for blood stream infection and acute rejection of the kidney, improvements in urinary voiding techniques may reduce the frequency of uti. the purpose of this study is to evaluate the benefits of "double voiding" in kidney transplant recipients.

urinary tract infections are common in kidney transplant recipients and are an important cause of morbidity and hospital readmissions. several risk factors for uti, both modifiable and unmodifiable, have been described in the literature. in normal (non-transplant) individuals, because of the anatomy of the ureter insertion into the bladder that creates a valve-like effect during voiding, reflux of urine into the kidney is prevented . however, after kidney transplantation, urine refluxing into the transplanted kidney is common. depending on the surgical technique used for connecting the transplant ureter to the urinary bladder, reflux may occur in up to 79% of kidney transplant recipients. in addition, the routine usage of ureteral stents (double j stents) for the first 4-6 weeks after transplantation results in reflux. vesicoureteral reflux increases the risk of uti double voiding, a process of passing urine more than once each time, is a technique that may assist the bladder to empty more effectively when urine is left in the bladder. by reducing the amount of left-over urine in the bladder after each void, double voiding may help reduce the incidence of uti in kidney transplant recipients.

Eligibility criteria:
inclusion criteria: * all adult kidney transplant recipients who undergo routine follow-up at the new york presbyterian - weill cornell medicine (nyp-wcm) transplant clinic. exclusion criteria: * kidney transplant recipients who are discharged after a transplant with an indwelling catheter (foley)
krx-0502 (ferric citrate) in subjects with ndd-ckd and ida (the compass trial)

Conditions: Chronic Kidney Diseases; Iron Deficiency Anemia

Summary: the objectives of this study are to assess the long-term efficacy and safety of different dose regimens of krx-0502 in the treatment of iron deficiency anemia (ida) in adult subjects with non-dialysis dependent chronic kidney disease (ckd).

this is a phase 4, 48-week, randomized, open-label, multicenter clinical study comprised of 2 periods: a 24-week dose titration period, followed by a 24-week dose maintenance period. the study will consist of 12 scheduled clinic visits over a period of 48 weeks and additional visits as needed.

Eligibility criteria:
inclusion criteria: * estimated glomerular filtration rate ≥20 ml/min and \<60 ml/min * hgb ≥8.5 g/dl and ≤11.5 g/dl * serum ferritin ≤500 ng/ml and transferrin saturation (tsat) ≤25% * serum intact parathyroid hormone ≤600 pg/ml exclusion criteria: * serum phosphate \<3.0 mg/dl * intravenous (iv) iron administered within 4 weeks prior to screening * erythropoiesis-stimulating agents (esa) administered within 4 weeks prior to screening * blood transfusion within 4 weeks prior to screening
energy expenditure in icu patients using predictive formulas and various body weights versus indirect calorimetry

Conditions: Critical Illness; Body Weights

Summary: indirect calorimetry is the gold standard to measure energy expenditure. in fact it is not always available and inconstantly feasible. various equations for predicting energy expenditure based on body weights have been created. this study aims at determining the best suitable predictive strategy unless indirect calorimetry is available.

several clinical studies have shown that energy deficit as well as overfeeding lead to an increased risk of complications, especially infections, and increased mortality. the gold standard for determining energy expenditure in intensive care patients is indirect calorimetry. this method is expensive and requires a trained team for its use. in addition the reliability of the measurements depends on the clinical situation and may not be feasible (e.g. inspiratory o2 fraction \>60%, end expiratory pressure \> 9cmh2o, presence of bronchial gap, etc.). moreover, there is no longer on the market valid indirect calorimeter for clinical use in mechanically ventilated patients, and the maintenance of the old valid one (deltatrac ii®) becomes increasingly problematic because the lack of spare parts. intensivists have no more choice and use prediction equations for energy expenditure which are based on imprecise anthropometric data (height, weight). especially for obese or malnourished patients in the intensive care the body weight represents not a reliable data. similarly, secondary water inflation due to metabolic stress and resuscitation complicates the determination of the real body weight. the difficulty is to know which weight to use in predictive equations. due to the paucity in literature on this subject, there is currently no consensus on the reference weight to use in the determination of nutritional needs and medication doses. so each prescriber calculates the energy target by taking a reference weight based on his own convictions. this study is part of a quality process of care and practices harmonization, aiming to identify the reference weight to be used and the best suited predictive equation, to predict energy expenditure for patients who cannot benefit from an indirect calorimetry.

Eligibility criteria:
inclusion criteria: * patients admitted to the geneva icu * length of stay \> 72 hours * mechanical ventilation with: fio2 \< 60%; positive end expiratory pressure \< 9 cmh2o; no air leaks, absence of pulmonary multi-resistant bacteria * without mechanical ventilation: no claustrophobia; no oxygen dependence exclusion criteria: * all patients without inclusion criteria
the effect of parecoxib sodium intravenous patient-controlled analgesia in laparotomic liver resection

Conditions: Pain, Postoperative

Summary: the investigators hypothesized that using new intravenous infusion pump of patient-controlled analgesia (parecoxib sodium 1 mg/ml + normal saline) would significantly improve postoperative pain control compare to conventional intravenous infusion pump of patient-controlled analgesia (fentanyl citrate 20 mg/ml/kg + ondansetron hydrochloride 16 mg/8 ml + normal saline). this prospective randomized controlled trial was designed to evaluate the benefit of new intravenous infusion pump of patient-controlled analgesia (parecoxib sodium 1 mg/ml + normal saline) for postoperative analgesia after laparotomic liver resection.


Eligibility criteria:
inclusion criteria: patients need laparotomic liver resection. exclusion criteria: patients with contraindications to spinal anesthesia or intrathecal morphine, difficulty understanding passive cutaneous anaphylaxis, a history of drug dependence or chronic pain, body mass index greater than 35 kg/m2, or history of sleep apnea were excluded from this study.
efficacy and safety study of qva149 in copd patients

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the purpose of this study is to demonstrate that the efficacy of the combination product qva149 is similar to the efficacy of the combination product umeclidinium/vilanterol on a pre-specified endpoint of fev1 auc0-24h while maintaining an acceptable safety profile.


Eligibility criteria:
inclusion criteria: * male or female adults aged ≥40 yrs * smoking history of at least 10 pack years * diagnosis of stable chronic obstructive pulmonary disease (copd) as classified by the global initiative for chronic obstructive lung disease (gold) guidelines, 2015) * post-bronchodilator forced expiratory volume in 1 second (fev1)\< 80% and ≥ 30% of the predicted normal value and post-bronchodilator fev1/fvc (forced vital capacity) \<70% * modified medical research council questionnaire grade of 2 or higher exclusion criteria: * patients who have had a respiratory tract infection within 4 weeks prior to visit 1 * patients with concomitant pulmonary disease * patients with a history of asthma * any patient with lung cancer or a history of lung cancer * patients with a history of certain cardiovascular co-morbid conditions * patients with a known history and diagnosis of alpha-1 antitrypsin deficiency * patients in the active phase of a supervised pulmonary rehabilitation program * patients contraindicated for inhaled anticholinergic agents and β2 agonists * other protocol-defined inclusion/exclusion criteria may apply

Keywords: chronic obstructive pulmonary disease (copd)