Kornimate/medical-research-clean huggingface dataset:
efficacy and safety study of the therapeutic vaccine pep223 in prostate cancer patients

Conditions: Prostate Cancer

Summary: the purpose of this trial is to investigate whether treatment with this new drug will result in lower testosterone levels in men with prostate cancer. at the same time it will be investigated whether the drug induces side effects, and if so, which ones.

prostate cancer growth is influenced by the male hormone testosterone. treatment with drugs that stop the production of testosterone often results in a decrease of the tumor or inhibition of its growth. this is particularly important prior to radiotherapy, since radiation can better be focused on the prostate with as a result less frequent or less severe side effects of the radiation. most of the drugs used to date to stop the production of testosterone have the disadvantage that initially they may cause a rise of testosterone levels before the production is effectively blocked. the new drug that will be investigated in this trial is a vaccine. the vaccine offers a different treatment modality since it interferes at a different level of the hormonal axis that drives the testosterone production; it will not cause an initial surge. in this trial the vaccine will be administered three times, testosterone levels will be monitored for a total period of three months.

Eligibility criteria:
inclusion criteria: * pathological confirmed prostatic adenocarcinoma, clinical stage (c) ct1-3, cn0-1/x, cm0 * baseline testosterone levels of \> 4 nmol/l * baseline psa level of \> 10 microg/l * eligible for hormone therapy * willingness to comply with the protocol conditions and procedures * willing and able to give informed consent exclusion criteria: * clinical evidence of distant metastases * previous hormonal therapy administered specifically for prostatic carcinoma * development of another invasive neoplastic disease during the previous 5 years, or concomitant presence of another invasive neoplastic disease, except basal cell carcinoma or squamous cell carcinoma of the skin * primary or secondary immunodeficiency, including immunosuppressive disease or use of corticosteroids or other immunosuppressive medications * concomitant administration - or administration during the 12 weeks preceding study inclusion - of immune enhancing medication or testosterone supplements * concomitant radiotherapy for prostate cancer * presence of bacterial prostatitis causing a psa increase during the 8 weeks preceding study inclusion * simultaneous participation in another clinical trial or participation in a clinical trial involving investigational drugs within 3 months before enrollment into the present study * bmi \> 30 kg/square meter * previous serious reaction to a vaccine such as angioedema or anaphylaxis

Keywords: prostatic diseases neoplasms prostatic neoplasms hormones androgen antagonists vaccines peptide vaccines adjuvants, immunological
developing & evaluating models for early predicting obstetrical diseases in pregnant women by non-invasive prenatal test

Conditions: Pregnant With Complication; Preeclampsia; Preterm Birth; Gestational Diabetes

Summary: this is observational study, aiming to investigate the potentiality of cffdna and cfrna by a non-invasive test, in combination with clinical characteristics, to establish models for early screening and predicting high-risk pregnancy of pe, spb, and gdm in vietnam.

this study is estimated to enroll 663 pregnant women with adverse pregnancy complications, including 221 cases of pe/eclampsia, 221 cases of spb due to preterm premature rupture of membranes (pprom) or preterm labor, and 221 cases of gdm. furthermore, the control group will enroll 442 participants, who are healthy pregnancies, ≥ 37 weeks of gestation. study subjects who participate should meet the study inclusion and exclusion criteria: as part of the protocol, demographic data, medical and family history, outcomes at delivery, and any relevant prior concomitant medication data will be recorded during follow-up visits. all participants are to be followed until birth delivery. sample collection * at recruitment, 10 ml of peripheral blood is collected for cffdna and cfrna analyses. * an available nipt sample at 1st trimester is processed for cffdna and cfrna analyses. * a case report forms (crf-1 and crf-2) are used to collect demographic data, medical and family history, any relevant prior concomitant medication data, and outcomes at delivery. the study end date of a participant is estimated within 7 months since her enrollment date.

Eligibility criteria:
inclusion criteria: 1. at recruitment, women with singleton pregnancies must fulfill the conditions: cases: diagnosis of preeclampsia/eclampsia, preterm premature rupture of membranes (pprom)/preterm labor leading to spb, and/or gestational diabetes mellitus. controls: healthy pregnancy at ≥ 37 weeks of gestation 2. history of undergoing non-invasive prenatal testing (nipt) at 9-13 weeks 6 days of gestation at gene solutions lab. nipt report was at low-risk. no abnormal fetal and maternal conditions were confirmed at nipt time. 3. nipt blood sample is available according to post-test sample storage procedures at gene solutions lab. 4. consent to voluntarily participate in the study exclusion criteria: 1. multiple pregnancies 2. pregnancy with any genetic abnormality 3. pregnancy with any fetal structural abnormality 4. pregnancy with indications for termination, miscarriage, or stillbirth due to other complications 5. maternal medical history of diabetes mellitus type 1/ type 2, chronic hypertension, and chronic kidney disease. maternal abnormal uterus anatomy and history of cervical cone biopsy sample or loop electrocautery excision procedures (leep).

Keywords: cffdna cfrna vietnam
fullscale_intervention study: genetic risk communication in coronary heart disease and wearables

Conditions: Fitness Trackers; Sedentary Time; Genetic Predisposition to Disease; Coronary Heart Disease

Summary: background: this study aims to determine the effects of communicating genetic risk for coronary heart disease (chd) alone or in combination with goal setting and prompts from a wearable device on objectively measured sedentary time (st) in east asians. it is hypothesized that this combination will lead to significant favorable changes in objectively st, and that such changes will be more likely to be sustained over 6-month follow-up. methods: in a parallel group, randomized controlled trial, a total 414 individuals of east asians aged over 60years will be allocated into one of three groups: 1 control and 2 intervention groups. blood samples will be used for estimation of chd genetic and analysis of metabolic risk markers. genetic risk for chd will be estimated based on recently identified 79 snps (associated with chd for east asians) using an established methodology. questionnaires and physical measurement will be administered at before and after the 12-month intervention and at 6-month follow-up. each group will receive a fitbit device. both intervention groups will be given chd genetic risk estimates along with lifestyle advice but one of them will additionally use fitbit's step-goal setting and prompt functions. the primary outcome is objectively measured sedentary time. secondary outcomes include objectively measured mvpa, calories burned, and five intermediate metabolic risk markers (total cholesterol/hdl-c/ldl-c/triglycerides).


Eligibility criteria:
inclusion criteria: * east asian ancestry * do not meet the who-recommended levels of pa (i.e., ≥150 minutes/week of moderate-intensity pa, ≥75 minutes/week of vigorous-intensity pa, or an equivalent combination of the two; determined through the ipaq-short form). exclusion criteria: * previously diagnosed with chd, and/or participation in another exercise-intervention study.

Keywords: coronary heart disease genetic risk sedentary time wearable technology randomized controlled trial
safety, efficacy and tolerability of vilazodone in generalized anxiety disorder

Conditions: Generalized Anxiety Disorder

Summary: the purpose of this study is to evaluate the efficacy, safety and tolerability of vilazodone relative to placebo in the treatment of generalized anxiety disorder (gad)


Eligibility criteria:
inclusion criteria: * male and female, 18 - 70 years of age * currently meet the diagnostic and statistical manual of mental disorders, fourth edition, text revision (dsm-iv-tr) criteria for generalized anxiety disorder (gad) * minimum score of 20 on the hamilton rating scale for anxiety (ham-a) exclusion criteria: * women who are pregnant, women who will be breastfeeding during the study and women of childbearing potential who are not practicing a reliable method of birth control * history of meeting dsm-iv-tr criteria for any of the following: * any manic or hypomanic or mixed episode, including bipolar disorder and substance-induced manic, hypomanic or mixed episode * any depressive episode with psychotic or catatonic features * panic disorder with or without agoraphobia * obsessive-compulsive disorder * schizophrenia, schizoaffective, or other psychotic disorder * bulimia or anorexia nervosa * presence of borderline personality disorder or antisocial personality disorder * mental retardation, dementia, amnesia, or other significant cognitive disorders * patients who are considered a suicide risk

Keywords: generalized anxiety disorder gad
efficacy and safety of fg-4592 for treatment of anemia in participants with lower risk myelodysplastic syndrome (mds)

Conditions: Anemia; Myelodysplastic Syndrome

Summary: the objective of this study to evaluate the efficacy fg-4592 for the treatment of anemia in chinese participants with lower risk mds.

this is a phase 2/3 trial with sequential phase 2 and phase 3 components. in each part, there is an up to 4 weeks screening period followed by a treatment period of 26 weeks and a 4 week follow-up period.

Eligibility criteria:
key inclusion criteria: * diagnosis of primary mds classified as very low, low or intermediate risk with \<5% blasts (documented within 12 weeks prior to day 1) * screening hb \<10 g/dl and ≥6g/dl * transfusion independent defined as no red blood cell transfusions within 12 weeks of day 1 * erythropoiesis-stimulating agent (esa)-naïve (not within 30 days of day 1) * eastern cooperative oncology group (ecog) performance status 0, 1, or 2 key exclusion criteria: * diagnosis of secondary mds * significant myelofibrosis (\>2+fibrosis) * prior therapy with azacitidine, decitabine, antithymocyte globulin, cyclosporine, thalidomide, or lenalidomide within 12 weeks prior to day 1 * baseline erythropoietin level of \>400 units (u)/liter (l) * clinically significant anemia due to non-mds etiologies note: other inclusion and exclusion criteria may apply.

Keywords: myelodysplastic syndromes anemia hemoglobin (hb) low risk myelodysplastic syndrome
impact of periodontal disease on outcomes in diabetes

Conditions: Periodontal Disease; Diabetes Mellitus

Summary: this study examines how periodontal disease affects the complications of diabetes and how treatment for periodontal disease affects biomarkers associated with the complications of diabetes.

the goal is to look for predictive factors of poor oral health and the impact of poor oral health on the complications of diabetes. the prevalence of periodontal disease among patients with diabetes is higher than in the general population. periodontal disease is associated with dental loss and increased systemic inflammation which is associated with cardiovascular and bone disease. however, current evidence that treatment of pod will result in improvement of outcomes in patients with diabetes is mixed. identifying patterns of disease and following biomarkers in patients with diabetes and periodontal disease will answer some of the questions and result in more appropriate recommendations and interventions with reduction in morbidity, mortality and healthcare cost. this study will be conducted using a cross-sectional design. investigators will survey 200 consecutive patients with diabetes during routine clinic visits using a questionnaire. investigators will collect data on demographic information, socio-economic status, oral health status/care, diabetes history (duration, control and complications) and bone health. a subgroup of 24 participants with survey responses suggestive of periodontal disease will be selected to receive treatment for periodontal disease. we will measure their hemoglobin a1c and biomarkers before and after treatment and will compare their levels for changes with treatment. investigators will analyze collected data using test of proportions, student's t-test and multivariate regression analyses.

Eligibility criteria:
inclusion criteria: all patients 18 years or older with diabetes for more than 2 years who present for their regular clinic visit will be eligible for inclusion in the survey part of the study. further criteria for enrollment into the subgroup (n = 24) will include; inclusion criteria * answers on the questionnaire suggesting pod or gingivitis. * at least 16 teeth in place * on a stable treatment for their diabetes * hemoglobin a1c between 6 and 10 exclusion criteria: * treatment with anti-inflammatory medications * cigarette smoking * treatment with thiazolidinediones * previous diagnosis of osteoporosis or treatment for osteoporosis with fda approved agents.
effect of acupuncture on heart rate variability in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the objective of this study is to evaluate the heart rate variability in individuals with multiple sclerosis during the applicability of acupuncture, to analyze the behavior of the autonomic nervous system before, during, and after therapy and the changes of the condition.

a double-blinded randomized sham-controlled crossover trial with a 1:1 allocation ratio will be conducted, 40 individuals without previous illness will be evaluated, who will constitute the control group and 40 individuals with ms will constitute the experimental group, paired by age and gender. all participants will undertake active or sham acupuncture sessions. active-sham group will start with 5 sessions (1 per week) of active acupuncture combined with hrv evaluation for 20 min. after a 2-week washout, this group will be reallocated to another 5 sessions (1 per week) of sham acupuncture for 20 min combined with hrv evaluation. meanwhile, sham-active group will carry out the opposite protocol, participants will start an allocated 5 sessions (1 per week) of sham acupuncture combined with hrv evaluation, and after a 1-week washout period will be reallocated to 5 sessions (1 per week) of active acupuncture combined with hrv evaluation.

Eligibility criteria:
inclusion criteria: * individuals diagnosed with multiple sclerosis * aged over 18 years * motor and intellectual capacity to understand the evaluations * light and moderate functional classification levels (edss scale) * who accept to participate in the study through agreement with informed consent form exclusion criteria: * do not understand the evaluations * cardiac diseases that impede the assessment of hrv * have a cardiac pacemaker.
the effect of erythropoietin at the time of reperfusion in acute myocardial infarction

Conditions: Acute Myocardial Infarction

Summary: the purpose of this study is to investigate the effect of intravenous human recombinant erythropoietin on the reperfusion injury at primary percutaneous coronary intervention in patients with acute myocardial infarction.


Eligibility criteria:
inclusion criteria: * acute myocardial infarction \<12hr * age \>18yrs * first myocardial infarction * culprit lesion : proximal to mid left anterior descending artery * baseline coronary flow : timi grade 0\~1 exclusion criteria: * patients with previous myocardial infarction * history of thrombotic complication * history of cerebral infarction * uncontrolled hypertension * increased hemoglobin level \>17g/dl * patients with mechanical valve * cardiogenic shock

Keywords: erythropoietin
the use of cooling helmet for neuroprotection management in open heart surgery

Conditions: Heart; Surgery, Heart, Functional Disturbance as Result

Summary: to know the relationship between the use of cooling helmet with the changes of nse level and postoperative delirium event in open heart surgery

subjects were assigned into two groups after giving consent to participate in the study using random allocation, 13 subjects per group. blood sample from cvc were obtained to assess nse preoperative. after induction, cooling helmet with circulating cold water were placed on patients group a and without circulating cold water on group b. blood samples were obtain again 6 hours after cardiopulmonary bypass off to assess nse postoperative. delirium was assessed using confusion assessment method - intensive care unit (cam-icu)

Eligibility criteria:
inclusion criteria: * patient undergoing their first open heart surgery using cardiopulmonary bypass * age ≥18 year-old * patient with american society of anesthesiologists (asa) iii * patient with glasgow coma scale (gcs) 15, fully aware and oriented * patient fluent in indonesia exclusion criteria: * patients did not give consent to participate in the study * patients with central nervous system disease (stroke, intracranial tumor) * patients with psychiatric problem (schizophrenia, depression) * patients with cognitive problem * blind and deaf patient * patient on psychotrophic or narcotics medication drop out criteria * surgery without cardiopulmonary bypass * patient demise after surgery * patients decided to refrain from the study

Keywords: cooling helmet neuron specific enolase delirium open heart surgery
o6-benzylguanine followed by surgery in treating patients with solid tumors that can be removed during surgery

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. giving a chemotherapy drug before surgery may shrink the tumor so that it can be removed during surgery. purpose: phase ii trial to study the effectiveness of o6-benzylguanine followed by surgery in treating patients who have solid tumors that can be removed during surgery.

objectives: i. determine the minimal o6-benzylguanine (o6-bg) dose required to deplete tumor activity to less than 10 fmol/mg protein at a specified time after administration in patients with surgically resectable solid tumors. ii. correlate tumor tissue agt depletion with agt depletion in peripheral blood mononuclear cells (pbmc) obtained at a specified time after o6-bg administration in these patients. outline: this is a dose escalation study. patients receive a single dose of o6-benzylguanine (o6-bg) iv over 1 hour at one of two dose levels. patients undergo surgery 16-20 hours after administration of o6-bg. up to 13 patients receive the lower dose level of o6-bg. if more than 3 patients have detectable agt levels, additional patients receive the higher dose. the optimal biologic dose (obd) is defined as the lowest dose level at which at least 11 of 13 patients have agt activity less than 10 fmol/mg protein after o6-bg dosing. patients are followed at 1 and 3 weeks post surgery. projected accrual: a total of 13-26 patients will be accrued for this study over approximately 10 months.

Eligibility criteria:
disease characteristics: histologically or cytologically confirmed surgically resectable solid tumor patient characteristics: age: not specified performance status: calgb 0-2 life expectancy: not specified hematopoietic: not specified hepatic: bilirubin no greater than 1.5 times upper limit of normal (uln) renal: creatinine no greater than 1.5 times uln other: not pregnant or nursing medically cleared for surgery no active medical or psychiatric disease that would prevent compliance prior concurrent therapy: biologic therapy: not specified chemotherapy: no prior chemotherapy endocrine therapy: not specified radiotherapy: no prior radiotherapy surgery: not specified

Keywords: unspecified adult solid tumor, protocol specific
prediction of abdominal complications after gastroenterological surgery

Conditions: Complication; Anastomotic Leak; Gastrointestinal Cancer

Summary: the aim of this multi-centered study is to understand the epidemiology of infectious complications after gastrointestinal surgery in china. in total, 17 centers from china will prospectively register their patients undergo gastric or colorectal surgeries. patient demographic data, operation information, and postoperative data including the infectious complications and the outcomes will be registered. we expect to include 2000 gastric and 2000 colorectal patients within one year and the study is expected to be finished in 2020.

all participating hospital will log in on a website based e-crf system. researchers need to register the patient information that three time-points: admission, after surgery, after discharge. the detailed registered information includes: i. basic and surgical information: age, height, weight, history of abdominal surgery, asa score, surgical procedure, extent of lymph node dissection, extent of resection, time of surgery, amount of bleeding, whether it is emergency surgery, whether it is combined with organ resection, whether it is palliative resection, whether combined with preoperative treatment, whether combined with preoperative infection and intraoperative complications. ii. postoperative information: primary lesion histological type, margin, pathological stage (ptnm); other complications, postoperative death and discharge time, crp, pct, wbc levels. iii. abdominal infection information: abdominal infection (y/n), anastomotic leakage (y/n), intervention, outcome.

Eligibility criteria:
inclusion criteria: * planned gastrointestinal surgery. * inform consent received. exclusion criteria: * endoscopic surgery. * inform consent denied.