Kornimate/medical-research-clean huggingface dataset:
the effect of acupressure after angiography on pain level and hemodynamic variables

Conditions: Acupressure; Pain; Hemodynamic Instability; Angiopathy, Peripheral

Summary: this randomized controlled study evaluates the effect of acupressure application on the pain level patients after angioography. the hypothesis of this study is that acupressure reduces pain levels and stabilizes hemodynamic variables.

in the study, 124 patients will randomly assigned to acupressure/experimental group and control group. to the acupressure/experimental group (n = 62), an average of 15 minutes will be applied to the li4 (liver, between thumb and forefinger), p6 (pericardium, three fingers above the wrist) and li 11 is located the area where the elbow bend. on the other hand, no other intervention will be applied to the control group other than routine treatment and nursing care. the primary outcome of the research is the effect of acupressure on the pain of patients. the secondary outcome of the study is to determine the effect of acupressure on the hemodynamic variables. the pain and hemodynamic variables will be collected before, immediately after the application, 10th, 20th and 30th minutes after the application. data will also be collected from the control group at the same time.

Eligibility criteria:
inclusion criteria: * agreeing to participate in the research (signing the informed consent form), * conscious and cooperative, * speaks and understands turkish, * over 18 years of age, * stable general condition, * no sensitivity in the area where acupressure will be applied, * no active covid-19 infection, * patients without any psychiatric diagnosis will be included. exclusion criteria: * do not agreeing to participate in the research (signing the informed consent form), * do not conscious and cooperative, * do not speaks and understands turkish, * do not over 18 years of age, * do not stable general condition, * having sensitivity in the area where acupressure will be applied, * having active covid-19 infection, * patients with any psychiatric diagnosis will be included.
safety and efficacy study of autologous stem cell transplantation for early onset type i diabetes mellitus

Conditions: Type 1 Diabetes Mellitus

Summary: the study evaluates the effect of inactivation of the immune system with chemotherapy and immunotherapy and infusion of bone marrow stem cells in early onset type 1 diabetes mellitus. we hypothesize that reprograming the immune system will stop immune aggression to the insulin producing cells allowing their regeneration and thus decreasing or eliminating the need of exogenous insulin.

patients from 12 to 35 years old with type i diabetes mellitus proved by anti-pancreatic beta cell antibodies and recently diagnosed (less than 6 weeks) will be included in this study. peripheral blood hematopoietic stem cells will be mobilized from bone marrow of the patient with cyclophosphamide plus g-csf (granulocyte-colony stimulating factor), collected by leukapheresis and cryopreserved. after 2-3 weeks, high dose immunosuppression is given (cyclophosphamide 200 mg/kg plus rabbit antithymocyte globulin 4.5 mg/kg) and stem cells are thawed and injected intravenously. this procedure is performed in isolated rooms at the bone marrow transplantation unit of the school of medicine of ribeirão preto, university of são paulo, brazil. patients are discharged from the hospital after engraftment and closely followed up to 2 months after transplantation (with at least weekly outpatient visits) and continue the followup for 5 years after transplantation. clinical, hematological, metabolical and immunological evaluations are performed to analyse the effect of the transplant in the disease and in the hematopoetic and immunologic systems of the body. patients fitting the inclusion criteria but not agreeing to perform the transplantation are the control group and they will be followed in parallel with transplanted patients.

Eligibility criteria:
inclusion criteria: * type 1 diabetes mellitus diagnosed by clinical/metabolic parameters and positive anti-gad antibodies * less than 12 weeks from diagnosis exclusion criteria: * previous diabetic ketoacidosis * pregnancy * severe psychiatric disorder * severe organic impairment (renal, hepatic, cardiac, pulmonary) * active infectious disease * previous or present neoplastic disease

Keywords: diabetes mellitus stem cells autologous stem cell transplantation autoimmune diseases
ablation in patients with hf and symptomatic af: pulverise-af-crt

Conditions: Atrial Fibrillation; Heart Failure

Summary: pulmonary vein isolation (pvi) is currently the cornerstone non pharmacological therapy for drug-refractory atrial fibrillation (af). where rhythm control has been shown to be inferior as compared to rate control in older trials. new data suggest that for patients with heart failure and af pvi may improve prognosis (mortality) as compared to medical rate or rhythm control. whether optimal rate control as can be achieved with atrioventricular node ablation is comparable with regard to all-cause mortality of heart failure hospitalization to pvi in patients with heart failure and af is unknown.


Eligibility criteria:
inclusion criteria: * presence of a cardiac resynchronization therapy device (crt-d or crt-p) and optimal medical therapy according to current guidelines. * patients with paroxysmal or persistent af, having af or hf related symptoms. * patient with paroxysmal af should have \>25% burden or inadequate biventricular pacing (\<95%) based on device counters. * the patient is willing and able to comply with the protocol and has provided written informed consent. * age ≥ 18 years exclusion criteria: * documented left atrial diameter \> 6 cm (parasternal long axis). * longstanding persistent af longer than 2 years. * contraindication to chronic anticoagulation therapy or heparin * previous left heart ablation procedure for af * acute coronary syndrome, cardiac surgery, angioplasty or stroke within 2 months prior to enrolment * untreated hypothyroidism or hyperthyroidism * enrolment in another investigational drug or device study. * woman currently pregnant or breastfeeding or not using reliable contraceptive measures during fertility age. * mental or physical inability to participate in the study. * listed for heart transplant. * cardiac assist device implanted. * planned cardiovascular intervention. * life expectancy ≤ 12 months. * uncontrolled hypertension. * requirement for dialysis due to terminal renal failure. * participation in another telemonitoring concept
efficacy and safety study of olaparib in combination with paclitaxel to treat advanced gastric cancer.

Conditions: Gastric Cancer

Summary: this study is a phase iii, multi-centre study of olaparib in combination with paclitaxel, compared with placebo in combination with paclitaxel in patients with advanced gastric cancer who have progressed following first-line therapy. patients will be from china, japan , korea and taiwan.

a randomized, double-blinded, multicentre phase iii study to access the efficacy and safety of olaparib in combination with paclitaxel, compared with placebo in combination with paclitaxel in asian patients with advanced gastric cancer (including gastro-oesophageal junction) who have progressed following first line therapy.

Eligibility criteria:
inclusion criteria: * advanced gastric cancer (including gej) that has progressed following first-line therapy. * patients must be ≥18 years of age. age ≥20 if japanese * provision of tumour sample (from either a resection or biopsy). * at least one lesion (measurable and/or non-measurable) that can be accurately assessed by imaging (ct/mri) at baseline and following up visits. exclusion criteria: * more than one prior chemotherapy regimen (except for adjuvant/neoadjuvant chemotherapy with more than 6 month wash out period) for the treatment of gastric cancer in the advanced setting. * any previous treatment with a polyadenosine 5'-diphosphoribose \[poly-(adp-ribose)\] polymerisation (parp) inhibitor, including olaparib. * patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≥5 years. * human epidermalgrowth factor receptor-2 (her2) positive patients.
a premarket, prospective, randomized, single-blind study to compare the veriset™ hemostatic patch to tachosil® as an adjunct to hemostasis in subjects undergoing cardiovascular surgery

Conditions: Cardiac Surgical Procedures; Hemorrhage

Summary: the objective of this study is to assess the safety and effectiveness of veriset™ hemostatic patch in cardiovascular procedures by comparing veriset™ hemostatic patch to tachosil® in subjects undergoing open cardiovascular surgery involving the aorta (e.g., aortic valve replacement (avr), david procedure, bentall procedure, abdominal aortic aneurysm repair, etc.), or cabg.


Eligibility criteria:
inclusion criteria: * subject has provided informed consent. * subject is ≥18 years of age. * subject is scheduled for surgery involving the aorta (e.g., aortic valve replacement (avr), david procedure, bentall procedure, abdominal aortic aneurysm repair, etc.), or coronary artery bypass graft (cabg) where a topical hemostatic agent would be used to control bleeding via an open approach. * subject is willing and able to comply with all aspects of the treatment and evaluation schedule. * subject is undergoing emergency surgery, i.e. lifesaving procedures performed where patient is in imminent danger of death. * subject has a history of allergic reactions after application of human fibrinogen, human thrombin and/or collagen of any origin. * subject is pregnant (documented by a positive pregnancy test) or is actively breast-feeding. * subject has an estimated life expectancy of less than 6 months. * subject is unwilling to receive blood products. * subject is scheduled for another planned cardiovascular surgery, and subsequent surgery would jeopardize previous application of study treatment. * the subject has participated in another investigational drug or device research study within 30 days of enrollment. exclusion criteria: * subject has an appropriate target bleeding site (tbs) defined as an area of bleeding on the aorta or coronary vessels where hemostasis by conventional methods is ineffective or impractical, and thus necessitates the use of a topical hemostatic agent. * tbs bleeding is type 2 (oozing/mild) or 3 (moderate). * it is possible to hold pressure on veriset™ hemostatic patch or tachosil® for at least 3 minutes. * incidental finding of any other pre-operative exclusion criteria * subject does not have an appropriate tbs. * tbs bleeding assessment is type 1 (no bleeding) or 4 (severe/surgical/life threatening). * subject has an active local infection at the surgical site. * investigator determines that participation in the study may jeopardize the safety or welfare of the subject.
sleep intervention to improve glycemic control in women with gestational diabetes

Conditions: Gestational Diabetes Mellitus in Pregnancy

Summary: this is a pilot randomized controlled trial involving a sleep education intervention in women with gestational diabetes to study whether sleep education during pregnancy leads to improvement in glycemic control in women with gestational diabetes and improvement in sleep duration.

patients will be identified from the maternal-fetal medicine office and the perinatal assessment clinic at magee-womens hospital, university of pittsburgh medical center. patients with gestational diabetes will be recruited following general education regarding gestational diabetes in pregnancy which is universally done for all patients at the time of their diagnosis of gestational diabetes. eligible subjects will be randomized to two groups (usual care vs. sleep education program).

Eligibility criteria:
inclusion criteria: 1. pregnant female 2. ages 18-50 3. gestational age between 16 0/7 weeks and 31 6/7 weeks 4. new diagnosis of gdm, not on treatment (i.e., insulin, glyburide, or metformin) at the time of enrollment exclusion criteria: 1. children less than 18 years of age 2. non-english speaking 3. multiple gestations (twins, triplets, etc)

Keywords: gestational diabetes mellitus sleep education
cardiovascular risk after preeclampsia

Conditions: Preeclampsia

Summary: investigation of cardiovascular risk 5-15 years after early or late-onset preeclampsia by adenosine stress magnetic resonance imaging and non-invasive methods like retinal vessel analysis, skin measurement of advanced glycation end products, flow-mediated dilation or pulse wave analysis in comparison to women after healthy pregnancies.


Eligibility criteria:
inclusion criteria: * women * 18-60 years * 5-15 years postpartum exclusion criteria: * atrioventricular block, chronic obstructive pulmonary disease, bronchial asthma * pregnancy and/or active breastfeeding * glaucoma disease, epilepsy * in addition for mri: metal implants, electric devices, intolerance of contrast media, claustrophobia, renal or hepatic dysfunction (gfr \< 30 ml/min)
influence of pb&cd seminal plasma level & icsi

Conditions: Infertility, Male

Summary: to evaluate the influence of lead (pb) and cadmium (cd) seminal plasma level on embryo development and pregnancy rate during intracytoplasmic sperm injection (icsi).

the inability to have children, both by natural procreation and medically assisted reproduction, is not only a challenge for medical science but also an economic and social problem. infertility is a complex disorder with multiple genetic and environmental causes (gill et al.,2018) one of the factors that may be responsible for this phenomenon is contamination of the environment with heavy metals two of the most widely-recognized reproductive toxins are lead (pb) and cadmium (cd) (wdowiak et al., 2018). food, water and tobacco and smoking are the primary source of baseline exposure to lead and cadmium (tong et al., 2000; bernard, 2008) each of cadmium and lead were inversely correlated with semen parameters as, ejaculate volume, sperm count, sperm concentration, live sperms and rapid mobility. ( zaki et al.,2018). reproductive contaminants found in follicular fluid (ff) and seminal plasma may compromise the quality of oocytes and or sperm, which may become one of the risk factors for reproductive outcome. the data available suggests certain chemicals or their metabolite reaches the seminal plasma and/or ff, indicating their possible impact in in vitro fertilization (ivf) outcome ,however, more studies are needed with regard to relationship between exposure level and affected parameters. (kumar et al., 2010).

Eligibility criteria:
inclusion criteria: * isolated male infertility (oligozoospermia, astenozoospermia, teratozoospermia) * first icsi cycle * female partner ≤ 35 y-old exclusion criteria: * • wife age \> 35 years * frozen semen samples * male partner with severe oligoasthenoteratozoospermia \<5 × 106 / ml and 5% progressive motility, included globozoospermia and pinhead samples, and surgically retrieved sperms * poor responder women * women with abnormal endometrium at hcg trigger day. * women with bmi \> 31 * women with pcos * previous failed icsi * ohss)overian hyperstimulation syndrome) * patients with systemic diseases affecting fertility * patients on radiotherapy or receiving medications with gonadotoxic effect eg., chemotherapy
evaluation of ultrafast hypothermia before reperfusion in stemi patients

Conditions: ST-elevation MI; Hypothermia

Summary: this study will look at the safety of treating patients with heart attack with mild hypothermia induced using a system of automated peritoneal lavage. the hypothesis is that the velomedix automated peritoneal lavage system can treat patients with heart attack safely and with adequate performance.

the study aims to determine the safety and feasibility of using the velomedix automated peritoneal lavage system to treat patients with stemi using therapeutic hypothermia. patients will undergo cooling, maintenance and rewarming and applicable data will be gathered on device performance and patient safety. patient temperature and vital signs will be monitored in addition to various laboratory values. adverse event reporting will take place at multiple time intervals and follow-up will continue out to 6-months.

Eligibility criteria:
inclusion criteria: * clinical symptoms consistent with acute stemi lasting at least 30 minutes * stemi with st-elevation of ≥2 mm in two or more contiguous ecg leads * patient eligible for pci exclusion criteria: * cardiac arrest with return of spontaneous circulation * known prior history of mi * known history of severe copd requiring supplemental home oxygen * patient experiencing intractable cardiogenic shock, or requiring immediate placement of a mechanical cardiac assist device * known severe anemia or abnormal platelet count * known significant renal insufficiency * known contraindication for mri * known contraindications to hypothermia, such as temperature-sensitive hematological dyscrasias or vasospastic disorders

Keywords: st-elevation mi hypothermia
a long-term study of jr-131 in renal anemia patients with chronic kidney disease (ckd)

Conditions: Anemia

Summary: the purpose of this study is to investigate the safety and efficacy for 52-week dosing of jr-131 in renal anemia patients with chronic kidney disease (ckd).


Eligibility criteria:
inclusion criteria: * patients being treated with erythropoiesis stimulating agent. exclusion criteria: * patients having complication or history of a cardiovascular / lung / brain infarction. * patients having a pronounced hemorrhagic lesion.
prazosin for smoking cessation

Conditions: Nicotine Dependence

Summary: the most likely outcome of smoking cessation attempts is relapse, underscoring the need to advance novel treatments. preclinical research shows that the noradrenergic system is critical for modulating drug-seeking behavior and recent findings indicate that the α1-adrenergic antagonist prazosin reduces nicotine self-administration and reinstatement. presently, data on prazosin's effects on nicotine-related behaviour in humans is lacking. an efficient method for screening novel smoking cessation medications is to integrate human laboratory paradigms in the context of brief, randomized trials of smoking cessation that include smokers motivated to quit. this study aims to provide an initial test of prazosin for smoking cessation by implementing a brief, randomized trial that will include both human laboratory and clinical phenotypes. this approach will allow an efficient but sensitive method for medication screening that maximizes clinical validity.


Eligibility criteria:
inclusion criteria: * greater than or equal to 10 cigarettes per day for past year * baseline fagerstrom test for nicotine dependence (ftnd) score of greater than or equal to four * willing to engage in two practice quit attempts * willingness to forgo other medication based treatments during the trial exclusion criteria: * current illicit drug use * current treatment with psychiatric medications other than selective serotonin re-uptake inhibitors (ssris) * lifetime diagnosis of post-traumatic stress disorder (ptsd) * significant medical/neurological illness * baseline bp outside of normal range * current use of tobacco aids * current use of medications that could interact with prazosin * pregnancy or nursing
trial to evaluate laparoscopy-assisted nerve-preserved total mesorectal excision (lntme) versus open tme for rectal cancer

Conditions: Rectal Cancer

Summary: the purpose of this study is to determine: (1) whether laparoscopy-assisted nerve-preserved total mesorectal excision (lntme) is as safe as open tme for rectal cancer, and (2) whether lntme is more effective for protection of pelvic autonomic nerve function from surgical impairing when comparing to open tme.


Eligibility criteria:
inclusion criteria: 1. male patients 2. from 18 years old to 60 years old 3. normal sexual function 4. tumor located in rectum (defined as 5- to 12-cm from the anal verge) 5. pathological confirmed rectal cancer 6. preoperative t stage ranging from t1 to t4a according to the 7th edition of ajcc cancer staging manual 7. tumor size \< 5 cm 8. asa score was i-ii 9. informed consent was written exclusion criteria: 1. distant cancer metastasis 2. history of abdominal surgery 3. with other type of malignancy 4. preoperative voiding dysfunction 5. preoperative sexual dysfunction 6. refusing to attend this trial

Keywords: laparoscopy rectal cancer pelvic autonomic nerve
aces referral from ped

Conditions: Adverse Childhood Experiences

Summary: adverse childhood experiences (aces) are traumatic exposures that can cause many negative health impacts across life. aces are common in patients who seek out care in pediatric emergency departments (peds); this is an opportunity to connect families with mental health resources to mitigate the effects of aces and improve lifelong health. the goal of this study is to determine if children with high aces have better rates of follow-up with mental health resources when a telehealth option is provided, as previous research has shown that simply making an in-person follow-up appointment is not very helpful.

children 12-17 years old who are receiving care in a ped and their legal guardians will fill out a tablet-based electronic consent/assent and survey that takes no longer than 10 minutes to complete while waiting for treatment once they are in a private patient room. the study team will review the responses to identify children with ace scores 2 or higher and contact the family to help them arrange therapy services. patients will be randomized to in-person versus telehealth therapy. a few months after enrollment, the study team will contact the family and mental health team to find out if the family was able to keep their appointment to start mental health treatment. this will aid future research to identify if and how mental health treatment impacts these patients over the following years.

Eligibility criteria:
inclusion criteria: * patients aged 12-17 years seen in the ped who read and speak english exclusion criteria: * patients already enrolled in outpatient therapy resources, * critically ill patients * patients with significant developmental delays impeding their ability to participate in therapy.

Keywords: teenagers adolescents pediatric emergency department (ped). therapy services