Kornimate/medical-research-clean huggingface dataset:
cardiac radiotherapy for heart failure

Conditions: Heart Failure; Non-ischemic Cardiomyopathy; Ischemic Cardiomyopathy

Summary: preliminary data suggests that patients suffering from advanced refractory heart failure (hf) could benefit from single low dose whole heart external beam radiotherapy (ebrt). objective: to explore in our center the efficacy of administering a ebrt treatment of 5gy to the whole heart in patients with advanced and refractory hf. the hypothesis is that 5gy ebrt to the whole heart can improve the left ventricular ejection fraction (lvef) of these patients by a clinically relevant 5%. main study endpoints: the primary aim is to explore the efficacy of ebrt treatment for advanced refractory hf. secondary endpoints include an assessment of safety, overall survival, hospital admissions, late toxicity, quality of life and the effect of the treatment on other heart function indicators (left ventricular volumes, nt-probnp, troponine, high sensitive crp).


Eligibility criteria:
inclusion criteria: * patient ≥ 18 years * advanced refractory hf nyha class ii, iii or iv * stable hf for the last 6 months with maximal guideline-directed hf therapy * ischemic or dilated cardiomyopathy * lvef at baseline ≤ 35% * ability to give a written informed consent and willingness to return for follow-up exclusion criteria: * eligible or in consideration for heart transplantation * pregnancy or breastfeeding * previous radiotherapy with cardiac involvement * any condition that is deemed a contraindication in the judgment of the investigators

Keywords: external beam radiotherapy heart failure
a pharmacokinetic study of an experimental paracetamol formulation

Conditions: Headache, Tension-Type

Summary: this pk study is designed to show bioequivalence between the study treatments.


Eligibility criteria:
inclusion criteria: * healthy volunteer exclusion criteria: -

Keywords: bioequivalence pharmacokinetics healthy volunteers paracetamol caffeine
"nsaids in acute achilles tendinopathy: effect on pain control, leg stiffness and functional recovery in athletes"

Conditions: Achilles Tendinopathy

Summary: the purpose of this study is to evaluate etoricoxib efficacy in pain control, leg stiffness and functional recovery of patients suffering acute achilles tendinopathy. it is hypothesized that etoricoxib (120mg orally/day/7 days) efficacy is not inferior to diclofenac (150mg orally /day/7 days) for pain control in subjects suffering acute achilles tendinopathy.


Eligibility criteria:
inclusion criteria: * patients are eligible if they are male between 18 and 50 years of age and they suffer acute achilles tendinopathy (\<2 weeks). diagnosis of achilles tendinopathy is made by means of activity-related achillodynia, morning stiffness or pain, painful one-legged jumping test, tenderness and decreased sports performance (26). subjects' age, race, affected tendon (right, left), activity, height and weight will be recorded. exclusion criteria: * patients are excluded from the study if they have: * prior lower limb surgery or major trauma. * bilateral achilles tendinopathy. * history of lower limb radiculo-neuropathy or miopathy. * hypersensitivity to any nsaids. * used analgesic agents (nsaids, salicilates, narcotic) within 1 week * concurrent medical/arthritic disease (e.g. gout, lupus, rheumatoid arthritis). * other concurrent medical conditions including diabetes, hypertension, angina or congestive heart failure, ischaemic cardiopathy, malabsorption, morbid - personal history of renal dysfunction, hepatic dysfunction or anemia * used corticosteroids, clopidogrel bisulphate, rifampin, quinolon antibiotics, antiepileptics, muscle relaxants, warfarin, ticlopidine, glucosamine, condroitin sulphate for \< 6 months prior to the study start. patients taking low dose aspirin (100 mg) for cardioprotective benefit will be also excluded. any other medication consumption will be considered by the investigator and the ethical committee. * any other condition which, in the opinion of the investigator, could confound the study results or pose a risk to the patient (for example, co-morbid conditions for which nsaids are contraindicated). * history of psychotic illness, dementia or depression * history of drug or alcohol abuse or dependence. * participated in any previous nsaids study and received active treatment, or in an investigational trial within 30 days prior to the first visit. * inability to communicate or to cooperate with the investigator.

Keywords: nsaid tendon pain stiffness achilles
a natural history study of aspartylglucosaminuria

Conditions: Aspartylglucosaminuria; Aspartylglucosamidase (AGA) Deficiency; Lysosomal Storage Diseases

Summary: aspartylglucosaminuria (agu) is a rare neurodegenerative lysosomal storage disease (lsd) characterized by developmental delay, psychomotor regression, worsening intellectual disability, gait disturbance and, ultimately, premature death, and has no available treatments. the purpose of this study is to investigate the clinical characteristics and natural clinical progression of symptoms in individuals with agu. this natural history study is important to better understand disease course to be able to determine clinically meaningful outcome measures for use in future clinical trials.

lysosomal storage disorders (lsds) are a group of inherited metabolic diseases caused by a genetic mutation resulting in deficiency or absence of a critical enzyme, leading to the accumulation of toxic deposits in cells across multiple organ systems. aspartylglucosaminuria (agu) is a rare, neurodegenerative, lsd, caused by a deficiency of the aspartylglucosaminidase (aga) enzyme, which leads to toxic accumulation of aspartylglucosamine and subsequent cellular dysfunction. agu has been most commonly reported in people of finnish and nordic descent, but is present across ethnicities and is typically misdiagnosed or undiagnosed. aspartylglucosaminuria (agu) is characterized by developmental delay and intellectual disability that worsens with age. early disease is characterized by increased frequency of bacterial ear infections, recurrent ear tube placement, intestinal dysfunction, disruptive sleep patterns, skeletal abnormalities, and gait disturbances, among others. individuals progressively lose motor and cognitive skills, develop behavioral/emotional lability and their risk of seizures increases with age. people with agu have a shortened life span. no prospective natural history study for agu has been reported. this study aims to prospectively investigate the natural history of agu, and concurrently to identify potential outcome measures that could be used in future clinical trials. no investigational product will be provided in the study.

Eligibility criteria:
inclusion criteria: * participants must have a diagnosis of agu based on clinical presentation and genetic testing (known or suspected pathogenic mutation in aga gene). exclusion criteria: * patients unable to travel to ut southwestern medical center and children's health dallas will not be enrolled in the prospective natural history study collecting standardized clinical data; however, with participant consent, medical records will be obtained, reviewed, and recorded in the natural history database over time.
long term excess mortality of acute myocardial infarction in patients with and without diabetes: a population-based cohort study

Conditions: Effect of Diabetes on Long Term Excess Mortality Following Acute Myocardial Infarction

Summary: diabetes is key risk factor for death following acute myocardial infarction. however, the long-term excess risk of death associated with diabetes following acute myocardial infarction not known. investigators aimed to determine the long-term excess risk of death associated with diabetes among patients with st-elevation myocardial infarction (stemi) and non-stemi (nstemi) after adjustment for multimorbidity, risk factors and cardiac treatments.


Eligibility criteria:
inclusion criteria: * acute myocardial infarction * both sex * 18 years exclusion criteria:

Keywords: diabetes st-elevation myocardial infarction (stemi) non-stemi excess mortality relative survival
a study of jnj-70218902 in participants with advanced stage solid tumors

Conditions: Neoplasms

Summary: the purpose of this study is to determine the recommended phase 2 dose(s) (rp2d\[s\]) and maximum tolerated dose (mtd) of jnj-70218902 in part 1, and to determine the safety of jnj-70218902 rp2d(s) in part 2.

jnj-70218902, the investigational drug, has been shown in pre-clinical studies to work by attaching to cancer cells and activating immune cells to kill these cancer cells. this study will be conducted in 2 parts: dose escalation (part 1) and dose expansion (part 2) and will enroll adult men with metastatic castration-resistant prostate cancer (mcrpc). study evaluations will include preliminary clinical efficacy, safety, pharmacokinetics, biomarkers and immunogenicity evaluations. this study is divided into 3 periods: screening, treatment and post-treatment. the total duration of the study will be 2.5 years approximately.

Eligibility criteria:
inclusion criteria: * histology: metastatic castration-resistant prostate cancer (mcrpc) with histologic confirmation of adenocarcinoma. adenocarcinoma with small-cell or neuroendocrine features is allowed * measurable or evaluable disease * prior treatment with at least 1 prior novel androgen receptor (ar)-targeted therapy or chemotherapy * if the participant is receiving treatment with gonadotropin-releasing hormone agonists or antagonist analogs (gnrh), this therapy must have been initiated prior to first dose of study drug and must be continued throughout the study * eastern cooperative oncology group (ecog) performance status grade of 0 or 1 * adequate organs functions exclusion criteria: * known brain metastases * concurrent use of any other anticancer treatment or investigational agent for the treatment of advanced disease * toxicities related to prior anticancer treatments have not returned to grade less than or equal to (\<=) 1 or baseline, except for alopecia and vitiligo * solid organ or bone marrow transplantation * known allergies, hypersensitivity, or intolerance to jnj-70218902 or its excipients * certain comorbidities

Keywords: metastatic castration-resistant prostate cancer (mcrpc) prostate cancer
clinical effects of gelified ethanol application in cervical disc hernia

Conditions: Pain

Summary: the aim of the study is to evaluate the clinical effects of discogel® radiopaque gelified ethanol as therapeutic substance for nucleolysis application in the patients with cervical disc hernia who had chronic pain and weakness on the neck, shoulders and arms.

this is a retrospective, single-center study that is going to be conducted from november 2013 to may 2016 on patients visiting the pain clinic of the hospital who were treated with discogel® for cervical discogenic or radicular pain that did not resolve after the use of conventional therapy and ozone-oxygen therapy. data collected from medical record forms and electronic medical record system of the hospital were used in the retrospective analysis of medical data with regard to age, gender, complications. a resident who has not involved in the study interviewed each patient by telephone on the follow up to collect the related information.

Eligibility criteria:
inclusion criteria: * continuous radicular pain radiating to the upper limb, with a duration ≥8 weeks and an intensity \>4/10 as rated by the patient on a visual analog scale (vas) * resistant to appropriate conservative treatment combining anti-inflammatory drugs and ozone-oxygen therapy, and confirmed by imaging with ct or mri of a herniated disc putting pressure on a nerve root consistent with the clinical pain. exclusion criteria: * history of surgery at the cervical spine, contraindication to percutaneous chemonucleolysis (coagulopathy or infection), imaging results that did not support the clinical results, the presence of a herniated disc excluded or calcified on imaging, possible interference with pain evaluation due to any medical condition or treatment, involvement of incomplete data collection

Keywords: discogel(r) gelified ethanol percutaneous treatment oswestry disability index (odi) visual analog scale (vas) neuropathic pain questionnaire (dn-4) cervical
open vs robotic-assisted radical cystectomy: a randomized trial

Conditions: Bladder Cancer Requiring Cystectomy

Summary: this is a multi-institutional, randomized trial evaluating oncologic, perioperative, and functional outcomes following two standard care procedures for radical cystectomy. the participants will have one of the standard care procedures as part of their care. the two procedures that will be followed are open radical cystectomy and robotic assisted radical cystectomy (rarc). open cystectomy is considered to be the more traditional approach. while newer, rarc is considered to be equivalent to open surgery when it is performed by a trained robotics surgeon. the reported complication rates of rarc appear comparable to open surgery. this means there is no significant difference in the risk between the two standard procedures. however, despite these potential advantages, true comparison between the open and robotic technique with regards to long term cancer related and functional outcomes has not been accomplished because previous studies did not compare patients of equal health status. the researchers hope to learn whether or not patients undergoing rarc recover more quickly than or at the same rate as patients undergoing an open radical cystectomy while having non inferior cancer related outcomes. this study is funded by the national institutes of health (nih).


Eligibility criteria:
inclusion criteria: 1. patient must have biopsy proven bladder cancer. official pathology report reviewed at the participating institution is required. 2. bladder cancer must be clinical stage t1-t4, n0-1, m0. (ajcc 7th edition) or refractory cis (carcinoma in situ). exclusion criteria: 1. inability to give informed consent. 2. prior major abdominal and pelvic open surgical procedures that would preclude a safe robotic approach, as determined by the treating surgeon. 3. at the discretion of the treating surgeon, any pre-existing condition such as severe chronic obstructive pulmonary disease that precludes a safe initiation or maintenance of pneumoperitoneum over a prolonged period of time and during surgery. 4. age \ 99 years. 5. pregnancy.

Keywords: open cystectomy robotic assisted radical cystectomy bladder cancer
expanded access to navitoclax

Conditions: Myelofibrosis; Acute Lymphocytic Leukemia (ALL); Lymphoblastic Lymphoma

Summary: this is an expanded access program (eap) for eligible participants. this program is designed to provide access to navitoclax prior to approval by the local regulatory agency. availability will depend on territory eligibility. a medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.


Eligibility criteria:

Keywords: expanded access pre-approval access compassionate use special access program named patient basis special access scheme
jerusalem handwashing study

Conditions: Illness Absenteeism; Handwashing Behavior

Summary: the primary objective of this preschool intervention trial was to determine whether a hygiene program can promote handwashing and thereby reduce illness absenteeism.

please see citations of published reports.

Eligibility criteria:
inclusion criteria: * preschool teachers of 3- and 4-year-old children in the state-run public system of the jerusalem region, who were recommended by their supervisors as being likely to comply with the protocol. exclusion criteria: * exposure to project during testing phase (n=1 preschool), preschool which included new ethiopian immigrants who were unlikely to have phones or speak hebrew (n=1 preschool) * project staff knew teachers personally and thought they would not comply with protocol (n=2 teachers).

Keywords: handwashing randomized controlled trial cluster randomization community intervention trial disease prevention pediatric communicable disease preschool illness absenteeism
phase i study of opb-51602 in patients with hematologic malignancies

Conditions: Multiple Myeloma; Non-Hodgkin Lymphoma; Acute Myeloid Leukemia; Acute Lymphoid Leukemia; Chronic Myeloid Leukemia

Summary: to determine the maximum tolerated dose (mtd) of opb-51602


Eligibility criteria:
inclusion criteria: 1. patients with a confirmed diagnosis of mm, nhl, aml, all or cml. 2. patients who are responsive or have relapsed following standard treatment 3. patients capable of providing written informed consent 4. japanese patients age 20 to 75 years (inclusive) at time of informed consent 5. ecog performance status score of 0-1 6. life expectancy of at least 3 months 7. adequate vital organ function 8. patients who, together with their partner, are willing and capable of using an appropriate method of contraception throughout the trial period and until at least 12 weeks after final imp administration exclusion criteria: 1. patients with other primary malignant tumors 2. symptomatic cns involvement 3. ongoing or active infection, or complication that is not controllable by medication or other means 4. complication of uncontrolled cardiac disease 5. female patients who are pregnant, possibly pregnant, or lactating, or who wish to become pregnant during the study period 6. patients who have received another study drug, or who have received chemotherapy, immunotherapy, cytokine therapy, surgery, or radiotherapy for treatment of the primary disease, within 4 weeks prior to enrollment

Keywords: multiple myeloma [mm] non-hodgkin lymphoma [nhl] acute myeloid leukemia [aml] acute lymphoid leukemia [all] chronic myeloid leukemia [cml]
waveform capnography compared to colorimetric carbon dioxide detection during tracheal intubation of critically ill adults

Conditions: Acute Respiratory Failure

Summary: this study will compare the sensitivity and specificity of waveform capnography versus colorimetric carbon dioxide detection to identify tracheal placement of the endotracheal tube during intubation of critically ill adults.


Eligibility criteria:
inclusion criteria: 1. patient is located in a participating unit (ed or icu) 2. patient is undergoing tracheal intubation. 3. the clinician intends to use an exhaled co2 detection device to confirm tracheal placement of the tube. exclusion criteria: 1. patient is known to be a prisoner 2. patient is known to be \< 18 years old 3. a responsible clinician has determined that sole use of either waveform capnography or colorimetric testing is required for optimal care of the patient.

Keywords: tracheal intubation emergency intubation waveform capnography end-tidal co2 exhaled carbon dioxide colorimetric detection of exhaled carbon dioxide
olga stage is more appropriate in predicting early gastric cancer

Conditions: Early Gastric Cancer

Summary: the aim of the present study was to evaluate characteristics of background mucosa in early gastric cancer (egc), and to seek for the optimal assessment for egc screening.

japanese endoscopic gastric atrophy (ega) classification, operative link on gastritis assessment (olga), operative link on intestinal metaplasia assessment (olgim) and gastritis pattern are used in evaluating the severity of gastritis and intestinal metaplasia in different countries, which are risk factors of gastric cancer. the aim of the present study was to evaluate characteristics of background mucosa in early gastric cancer (egc), and to seek for the optimal assessment for egc screening. a prospective study was conducted encompassing egc patients (cases) and non-egc patients (controls). all patients were performed endoscopic examination and systematically biopsied. outcome measures were assessed and compared, including ega classification as well as the olga/olgim assessment. helicobacter pylori(h. pylori) status was detected in the meantime. a stepwise logistic regression model was performed to analyze correlations between ega, olga, olgim and egc.

Eligibility criteria:
inclusion criteria: * the age of patients is from 40-80 years * must undergo esophagogastroduodenoscopy exclusion criteria: * clinical diagnosis of advanced gastric cancer * post-subtotal gastrectomy * acute upper gastrointestinal bleeding * severe systemic diseases * lack histology
a year long study to evaluate the safety of the combination of valsartan (320 mg) and amlodipine (5 mg) in patients with hypertension

Conditions: HYPERTENSION

Summary: a one year safety study for patients who complete study vaa489a2307.


Eligibility criteria:
inclusion criteria: * successful completion of vaa489a2307 core trial * visit 7 blood pressure must be msdbp ≤ 95 mmhg and mssbp ≤ 150 mmhg exclusion criteria: * patients who experienced any adverse events considered serious and drug related in vaa489a2307 core other protocol-defined exclusion criteria may apply.

Keywords: hypertension, valsartan, amlodipine< safety
a study following males with haemophilia a on prophylaxis with esperoct®

Conditions: Haemophilia A

Summary: this study will collect information on side effects and how well esperoct® (turoctocog alfa pegol (n8-gp)) works during long-term treatment (prophylaxis) in males with haemophilia a. participants in this study will get the same treatment as they would normally get, if they were not participating in the study. all visits at the clinic are done in the same way as participants are used to, when visiting their doctor. during visits at the clinic participants might be asked for some relevant tests if considered useful by the study doctor. during the visits the study doctor might ask if participants had any side effects since the last study visit. participants will be asked to note down in their own diary the number of bleeds and how these were treated, as well as their regular prophylaxis. participation in the study will last for about 5-7 years, depending on when participants join the study. participants are free to leave the study at any time and for any reason. this will not affect their current and future medical care.


Eligibility criteria:
inclusion criteria: * signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol). * the decision to initiate treatment with commercially available esperoct® has been made by the patient/legally acceptable representative (lar) and the treating physician before and independently from the decision to include the patient in this study. * male patients of all ages, according to local label, are allowed in this study * diagnosis of severe or moderate haemophilia a exclusion criteria: * previous participation in this study. participation is defined as having given informed consent in this study * known or suspected hypersensitivity to n8-gp or related products * mental incapacity, unwillingness or language barriers precluding adequate understanding and cooperation * clinical suspicion or presence of fviii inhibitors at time of inclusion