Kornimate/medical-research-clean huggingface dataset:
effectiveness of intracavitary manual lymphatic drainage

Conditions: Lymphatic Diseases

Summary: the aim of this study was to determine the effectiveness of intracavitary manual lymphatic drainage (imld) in the reduction of the perineal trauma and the symptoms of vaginal edema, the prevention of complications during the expulsive and the improvement in the postpartum recovery, compared to conventional treatment during the gestation, in women with the second partum. the weekly treatment is performed from the 25th gestational week in women with vulvar edema.


Eligibility criteria:
inclusion criteria: * a sample of 49 second-trimester pregnant women with gestational edema with more than 18 years of age exclusion criteria: * primiparous women
placebo controlled double-blind dose ranging study of the efficacy and safety of ssr149744c 50, 100, 200 or 300 mg od with amiodarone as calibrator for the maintenance of sinus rhythm in patients with recent atrial fibrillation/flutter

Conditions: Atrial Fibrillation; Atrial Flutter

Summary: double blind study to evaluate the efficacy and tolerability of ssr149744c and select a dose to be further investigated in the maintenance of sinus rhythm after electrical, pharmacological or spontaneous conversion of af/afl.

this is a dose-ranging multicenter, multinational, randomized, double-blind, placebo-controlled, parallel arm study with 4 ssr149744c dose regimens and amiodarone as a calibrator.to be eligible, patients must be in normal sinus rhythm for at least one hour at randomization and must have an electrocardiogram documented history of recent af/afl reverted to normal sinus rhythm by electrical, pharmacological or spontaneous conversion.

Eligibility criteria:
inclusion criteria: * patients aged 21 years or more of either sex with documented sinus rhythm for at least 1 hour at the time of randomization with at least one ecg-documented af/afl episode in the last 3 months. exclusion criteria: * main criteria (non-exhaustive list):women of childbearing potential without adequate birthcontrol, pregnant women, breastfeeding women, contraindications to amiodarone, conditions which increase the risk of severe antiarrhythmic drug side effects, severe left ventricular dysfunction, severe associated conditions.

Keywords: atrial fibrillation atrial flutter arrhythmia anti-arrhythmia agents
clinical evaluation of backstop in patients undergoing ureteroscopic lithotripsy

Conditions: Kidney Stones

Summary: the purpose of this clinical study is to evaluate backstop, a polymer-based device that is intended to be used during ureteroscopic lithotripsy to prevent retrograde stone migration.

during ureteroscopic treatment for ureteral stones, lithotripsy, irrigation, and manipulation of the stone often pushes stone away into the kidney itself. this phenomenon is called retropulsion, which is defined as clinically significant retrograde migration of stone or stone fragments. movement of stones retrograde into the renal pelvis could potentially add and complicate the surgery further. often scopes need to be changed in order to reach the stone, and chasing these stones will add time to the surgery and require more valuable resources. furthermore, sometimes a second operation will need to be done when these retropulsed fragments could not be all found and cleaned out. a number of devices have been developed to prevent such migration including stone baskets and conical devices. these are wire-based devices which have the potential of injuring the ureter. because of safety concerns and that there is limited data available on the effectiveness of these devices; these are not widely used by urologists. backstop has recently been developed as another tool to prevent retropulsion. it is a water soluble gel that is injected proximal to the stone. this creates a physical barrier that prevents stone migration during ureteroscopic lithotripsy for ureteral calculus.

Eligibility criteria:
inclusion criteria: * patient with solitary ureteral stone ranging from 5mm to 15mm diameter * able to tolerate general anesthesia * clinical indication for treatment by ureteroscopic lithotripsy * must be willing and able to participate in any follow-up visits * provide informed consent * have a ct scan demonstrating the stone exclusion criteria: * patients undergoing extracorporeal shock wave lithotripsy (eswl) or any other extracorporeal or percutaneous lithotripsy procedure as primary procedure * any co-morbidity or condition that would necessitate exclusion of patient (physician opinion) * renal or ureteral anatomical abnormality * multiple stones in the indicated ureter * stones in the indicated kidney * patient is immunocompromised * multiple organ dysfunction syndrome * has an absolute or relative solitary kidney mass * \>= stage 3 chronic kidney disease * bilateral ureteral obstructing stones * staghorn calculi * impaction of several stone fragments (steinstrasse) * uncorrected coagulopathy/thrombocytopenia * urethral and/or ureteral stricture * reconstructive urinary surgery
comparing virtual reality (vr) to non-vr for decreasing preoperative/procedural anxiety

Conditions: Preoperative Anxiety

Summary: the primary objective of the study is to utilize the modified yale preoperative anxiety scale (mypas), a validated preoperative/procedural anxiety score, to measure preoperative anxiety via distraction in pediatric oncology patients undergoing port access. the hypothesis is that using virtual reality (vr) will objectively decrease anxiety scores measured by mypas by five percent (primary outcome). the secondary outcome will be the parents or the legally authorized representative (lar) subjective reports of anxiety with the use of vr. the kind vr device is used in house at children's health in the dallas and plano campuses. the vr device used in this study qualifies as exempt from fda ide regulations. it is a non-significant risk, non-invasive, interactive video device the user wears like goggles. the study carries minimal risks to the subjects and is designed to minimize patient discomfort from placement or motion sickness. furthermore, the device has disposable covers for protection against infection and can be sanitized between uses, once the disposable covers are removed. children's health system of texas (chst) and this research group are not partnering entities with the kind vr, and the kind vr device is not being studied. the effect of virtual reality (vr) on preprocedural anxiety as measured by questionnaires and the observations of the modified yale preoperative anxiety scale (mypas) is being studied most patients coming to the clinic of cancer and blood disorders (ccbd) are under chronic care for their ongoing disease and are likely to be coming to the ccbd at least twice in a 6-month period. the ccbd schedule will be reviewed by the researchers for patients age 5-12, requiring port access at least twice during the next six-month period. patient families whose child meets the basic screening criteria, and have no exclusion criteria, will be approached privately as possible participants in the study. up to 100 subjects will be enrolled over a 2-year period. once the subject/parent or lar agrees to participate, study staff will randomize the subjects into which standard of care distraction method for anxiety management they will receive first in this study.


Eligibility criteria:
inclusion criteria: * any patient of the children's medical center ccbd * 5-12 years of age * patient requiring their port accessed twice or more within a 6 months period * ability to understand and the willingness to sign a written informed consent. exclusion criteria * subjects younger than 5 and older than 12 * patients requiring recovery in picu or sites other than pacu * if parents or subject is not willing to participate * subjects with severe developmental delays and subjects with developmental challenges preventing them from keeping the vr device on are also excluded * patients who will not be in ccbd for port access at least twice in 6 months

Keywords: virtual reality preoperative anxiety modified yale preoperative anxiety scale
serum dcamkl1 pre and post treatment in patients with pancreatic cancer

Conditions: Pancreatic Cancer

Summary: the investigators believe dcamkl-1 is a stem cell tumor marker and is elevated in patients with pancreatic cancer. the investigators would like to analyze its expression pre and post treatment, to gauge the correlation between current pancreatic cancer therapies and the expression of dcamkl-1

pancreatic adenocarcinoma has the worst prognosis of any major malignancy with a 3% 5 year survival. major obstacles in treating pancreatic cancer include extensive local invasion and early metastasis. the incidence of pancreatic adenocarcinoma (pac) has been increasing steadily. epithelial-mesenchymal transition (emt) plays a key role in cancer invasion and metastasis. recently, a direct link between emt and the gain of epithelial stem cell properties has been described. we have recently determined that dcamkl-1, a microtubule-associated kinase expressed in post mitotic neurons, is a putative intestinal stem cell marker. we have also demonstrated that dcamkl-1, a protein expressed in both normal stem cells and in cancer, likely promotes tumorigenesis through the regulation of pri-let-7a microrna and c-myc. we have recently demonstrated evidence that dcamkl-1 is a marker for pancreatic cancer stem cells in surgical specimens. this study will investigate expression of dcamkl-1 in pancreatic tissue obtained through eus-fna. furthermore expression of dcamkl-1 will also be investigated in serum obtained simultaneously.

Eligibility criteria:
inclusion criteria: * pancreatic cancer exclusion criteria: * age \< 18, history of other types of cancer
breast lesion analysis for tomosynthesis mammography

Conditions: Breast Cancer; Abnormal Findings on Radiological Examination of Breast

Summary: the purpose of this study is to develop a computer-aided diagnosis system to find breast lesions, including masses and microcalcifications, which hopefully will improve breast cancer detection and classification.

the purpose of this study is to develop a computer-aided diagnosis system to find breast lesions, including masses and microcalcifications, and determine if the lesion is a cancer or not for digital tomosynthesis mammography (dtm).

Eligibility criteria:
inclusion criteria: * subjects scheduled for core biopsy of a breast lesion exclusion criteria: * pregnant females
treatment of slow-flow after primary percutaneous coronary intervention with flow-mediated hyperemia

Conditions: Coronary Microvascular Disease; Myocardial Infarction

Summary: a total of 100 patients with st-elevation myocardial infarction (stemi) presenting slow-flow after primary-percutaneous coronary intervention (ppci) will be randomized to pharmacologic treatment with hyperemic drugs versus flow-mediated hyperemia.

slow-flow phenomena is observed around 15% of patients undergoing ppci and has been associated with poor prognosis. hyperemic drugs, such as nitroprussiate and adenosine, have not yet demonstrated to reduce the infarct size and prognosis in patients with slow flow. controlled flow-mediated hyperemia using a dedicated catheter for intracoronary saline infusion has been shown to stimulate microcirculatory vasodilatation in stable patients similarly as hyperemic drugs. the aims of the study are to compare the absolute microcirculatory resistance of the infarct-related artery presenting with slow flow after ppci, as assessed by intracoronary thermo-dilution, treated with standard pharmacologic hyperemia versus flow-mediated hyperemia; and to compare the angiographic timi frame count after treatment of slow flow phenomena with the two investigated strategies.

Eligibility criteria:
inclusion criteria: 1. st elevation myocardial infarction killip i \<12 hours since symptoms onset. 2. st elevation \> 2 mm anterior leads or \> 1 mm inferior or lateral leads. 3. sustained slow coronary flow (timi flow 0-2) for at least 30 seconds after stent implantation or stent post-dilatation. exclusion criteria: 1. previous myocardial infarction in the culprit artery 2. previous stroke 3. advanced kidney disease (creatinine clearance \<30 ml / min). 4. active bleeding 5. allergy to contrast, nitroprussiate or adenosine. 6. culprit lesion in coronary bypass, left main coronary artery or stent thrombosis 7. macroscopic thrombus embolization in the infarct-related artery

Keywords: coronary microvascular disease myocardial infarction
personalized medicine decision-making in a virtual clinical setting

Conditions: Deep Vein Thrombosis; Blood Clots

Summary: background: -how people respond to drugs depends in part on their genes. for some drugs, doctors can use an individuals genetic background to help in dosing the drug. researchers want to know how doctors incorporate personalized or genomic medicine into clinical practice. objective: -to study how physicians make personalized treatment decisions eligibility: -healthy adult primary care physicians who are internal (or family) medicine residents. design: * participants will complete a screening form. * participants will put on a headset, called a head-mounted display, showing a virtual reality environment. * the environment will contain an exam room and the virtual patient. * after interacting with the virtual patient, participants will complete a series of survey measures. * participation will last for about 60 minutes. the virtual patient interaction and follow-up questions will be audio taped.

this study will examine factors related to primary care physicians clinical decision-making. using a virtual clinical interaction experiment, we aim to better understand physicians decision-making processes and to explore their communication behaviors toward patients in the clinical encounter. physician participants will enter a virtual exam room where they will be asked to respond to a virtual patient, acting as her primary care physician in a follow-up visit to evaluate her for depression. various aspects of physician communication in the virtual clinic and self-report measures related to decision-making will be analyzed.

Eligibility criteria:
* inclusion criteria: * all physicians will be healthy adult volunteers who are medical residents in the internal medicine specialty. exclusion criteria: 1. persons with seizure or vestibular disorders; 2. persons who are highly prone to motion sickness; 3. those without normal or normal to corrected vision or hearing; 4. all current and past employees and contractors of nhgri; and 5. persons who have received information about the study purpose or procedure from a past participant. nhgri employees are excluded for this protocol because they are likely to have specialized genomic knowledge and may think differently about genomics in the clinical interaction.

Keywords: physicians genomics internal medicine warfarin natural history
effect of group patient education on glycemic control among people living with type 2 diabetes in vietnam

Conditions: Type 2 Diabetes

Summary: this study measures the effect of a 3-month patient education and self-management intervention in a low-resource setting, on diabetes knowledge and levels of blood glucose control.

in vietnam, there is a low level of diabetes knowledge among the general population, and significantly lower awareness in rural areas compared with urban areas. this highlights the urgent need for communication and education to improve the knowledge of the vietnamese population of patients with type 2 diabetes on risk factors, complications, prevention and treatment. the main goal of this study is to evaluate the effects of a patient education and self-management intervention as add-on to usual diabetes care in a low-resource setting on diabetes knowledge and blood glucose control parameters in vietnamese patients with type 2 diabetes. this is a single-center, randomized, controlled study among adult out-patients with type 2 diabetes. patients meeting the inclusion criteria are randomly assigned to a community intervention or to usual diabetes care alone (control group) for a period of 3 months. the intervention consists of group education on type 2 diabetes, including, in addition to usual diabetes care: information on diet, exercise, drug therapy, and adherence. each patient should attend the group education monthly over 3 consecutive months. usual diabetes care is consistent with the ada guidelines and comprises standard dietary and exercise advice in addition to antidiabetes treatment. diabetes knowledge is measured with a modified michigan university diabetes knowledge test (mdkt). other study outcomes includes change in mean hba1c, fasting blood glucose, and systolic blood pressure.

Eligibility criteria:
inclusion criteria: * patients diagnosed with type 2 diabetes as defined above * aged 40-80 years old * ability to attend monthly clinic visits and signed informed consent * all antidiabetes treatments were permitted including insulin exclusion criteria: * a diagnosis of mental or neurological diseases that could interfere with the ability to comply with study procedures * pregnancy or lactation * known drug or alcohol dependence * requirement for a change in antidiabetes treatment over the study period

Keywords: type 2 diabetes education glycemic
online suicide prevention campaign aimed at men

Conditions: Help-Seeking Behavior; Suicide

Summary: this study aims to examine whether the online suicide prevention campaign for men could increase openness about emotions and help-seeking behavior, and decrease hopelessness and adherence to traditional gender norms concerning self-reliance among men. the effectiveness of the campaign will be evaluated in adult men using a pre-post questionnaire study design.


Eligibility criteria:
inclusion criteria: * gender identity: male * ≥ 18 years old * have access to internet and a computer/tablet/smartphone * speak dutch exclusion criteria: * gender identity: female or other * \< 18 years old * no acces to internet and a computer/tablet/smartphone * non-dutch speaking
a phase ⅲa study of genetically modified recombinant human interleukin-11

Conditions: Chemotherapy-induced Thrombocytopenia

Summary: this phases ⅲ trials is divided into two stages,ⅲa and ⅲb.the aim of ⅲa is to evaluate the optimal dosing dose of genetically modified recombinant human il-11 (mil-11) in a multicenter randomized self-control trial involving 60 cancer patients undergoing chemotherapy.the aim of ⅲb is to evaluate the efficacy and safety of genetically modified recombinant human il-11 (mil-11), using rhil-11 as an active control, in a multicenter randomized trial involving 240 cancer patients undergoing chemotherapy.

the investigators recently developed a mutant form of rhil-11 with improved stability. in in vitro experimental systems, mil-11 was shown to endure chemical and proteolytic stresses more effectively, while retaining the biological activity of the original rhil-11. the improved stability of mil-11 was also demonstrated in the comparative pharmacokinetic study of subcutaneously delivered mil-11 and rhil-11 in the rodent and primate models. based on its improved pharmacokinetic and pharmacodynamic features. in phase ii study shows that mil-11 is well tolerated and has thrombopoietic activity equivalent to one third of the clinical dose of rhil-11, indicating the potential of mil-11 for use in the treatment of cit. this study is a phase iii, single-blinded, randomized,multicenter,cross-over study designed to evaluate optimal dosing dose and efficacy and safety of mil-11 on cit patients receiving suitable chemotherapeutic regimen for treating cancer.

Eligibility criteria:
inclusion criteria: * histological verification of malignancy at the time of initial diagnosis； * patients (age,18-75 years) receiving chemotherapy, who had experienced platelet counts below 75×10\^9/l； * patients were required to have adequate bone marrow,hepatic, and renal functions at the time of study entry； * ecog ≤2； * patients to have normal laboratory findings:while white blood count \>3.0×10\^9/l,platelet count ≥100×10\^9/l, and ast and/or alt lesser than 2.5 times the upper limit of the normal value； * the estimated life expectancy of the patient was more than 3 months. exclusion criteria:； * patients who received total body irradiation； * patients with childbearing potential； * patients who were breast-feeding or pregnant

Keywords: chemotherapy thrombocytopenia interleukin-11 platelet
evaluation of safety following immune tolerance induction treatment with turoctocog alfa in patients with haemophilia a following inhibitor development in nn7170-4213 trial

Conditions: Haemophilia A

Summary: this trial is conducted in asia, europe and the united states of america (usa). the aim of the trial is to evaluate safety of immune tolerance induction (iti) treatment with turoctocog alfa (a recombinant factor viii) in patients who have developed neutralising antibodies against factor viii after exposure to subcutaneous turoctocog alfa pegol during participation in nn7170-4213 (nct02994407)


Eligibility criteria:
inclusion criteria: * previous participation in the nn7170-4213 trial (male, age at least 18 years (part a) and age at least 12 years (part b)) * development of a confirmed high titre neutralising antibody towards factor viii (greater than 5 bethesda unit) after exposure to subcutaneous turoctocog alfa pegol in the nn7170-4213 trial or development of a confirmed clinically relevant low titre inhibitor (at least 0.6 to below or equal to 5 bethesda unit), defined as factor viii activity measures (recovery) and/or bleedpattern indicating a lack of clinical response to factor viii treatment exclusion criteria: * known or suspected hypersensitivity to trial product(s) or related products, defined as allergic reactions * participation in another clinical trial within 1 month before screening (except participation in nn7170-4213) * any disorder, except for conditions associated with haemophilia a which in the investigator's opinion might jeopardise patients' safety or compliance with the protocol * currently receiving immune tolerance induction treatment with a factor viii containing product other than turoctocog alfa