Kornimate/medical-research-clean huggingface dataset:
zenith® fenestrated+ clinical study

Conditions: Aortic Aneurysm, Abdominal; Juxtarenal Aortic Aneurysm; Extent IV Thoracoabdominal; Pararenal Aneurysm

Summary: the zenith® fenestrated+ endovascular graft clinical study will assess the safety and effectiveness of the zenith® fenestrated+ endovascular graft (zfen+) in combination with the begraft balloon-expandable fevar bridging stent graft system (begraft) and unibody2 for the treatment of patients with aortic aneurysms involving one or more of the major visceral arteries.


Eligibility criteria:
include criteria: 1. thoracoabdominal, pararenal or juxtarenal aortic aneurysm with a diameter ≥ 55 mm for males and ≥ 50 mm for females 2. thoracoabdominal, pararenal or juxtarenal aortic aneurysm with a growth rate of ≥ 5 mm in 6 months 3. thoracoabdominal, pararenal or juxtarenal aortic aneurysm with aortic diameter \> 2x the normal aortic diameter or saccular aneurysm that warrants treatment in the opinion of the investigator exclusion criteria: 1. age \< 18 years 2. life expectancy \< 2 years 3. pregnant, breast-feeding, or planning to become pregnant within 60 months 4. inability or refusal to give informed consent by the patient or legally authorized representative 5. unwilling or unable to comply with the follow-up schedule, required clinical assessments, and imaging 6. simultaneous participation in another investigation study, unless the patient is at least 30 days beyond the primary endpoint of any previous study

Keywords: endovascular vascular diseases cardiovascular diseases fenestration
canhelp working group treatment trials

Conditions: Helicobacter Pylori Infection

Summary: the canhelp working group treatment trials are part of a comprehensive research program carried out by the canadian north helicobacter pylori (canhelp) working group. the treatment component involves a series of community-specific trials designed with community input and varying on the specific treatment regimens and number of treatment arms among other study details.

the canhelp working group is a collaborative team that links university of alberta researchers with canadian northern community leaders and health officials in a collaborative effort to investigate h. pylori infection with the goal of finding solutions to community concerns about health risks. the research program uses a community-driven research approach in northern communities to characterize the burden of disease from h. pylori infection and exchange knowledge with community members and decision makers to identify ways to reduce health risks from this infection. for the participating communities, the treatment trials aim to: 1. estimate the effectiveness of alternate h. pylori treatment regimens to identify optimal regimens for the local setting 2. identify factors external to the treatment regimen that influence short- and long-term treatment success

Eligibility criteria:
inclusion criteria: * over 15 years of age * identified as h. pylori infected with a positive urea breath test and/or biopsy-based evidence of h. pylori infection exclusion criteria: * allergy to amoxicillin, metronidazole or clarithromycin * antibiotic therapy within 4 weeks prior to randomization * pregnant or breastfeeding * severe cardio-respiratory, pulmonary, endocrine, hepatic or renal disease
radtox: measuring radiation toxicity using circulating dna

Conditions: Prostate Cancer

Summary: this research study is being done to develop a new test to identify prostate cancer patients at highest risk of radiotherapy-related complications. this research study would allow monitoring of total tissue damage within 24 hours of radiation exposure in blood samples that could give an initial result within a few days that would help clinicians make treatment decisions. detection of unusual tissue damage at this early time, well before symptoms occur, could allow doctors to tailor interventions that could include patient therapies that would reduce or prevent the problems that occur due to treatment of their cancer.

currently, a patient's risk for toxicity is based almost exclusively on population statistics. radiation (and chemotherapy) dose are based on phase i data and not on the individual's specific genetics or hidden predispositions. radtox measures cell damage within 24 hours of radiation exposure and should help identify patients at higher risk for radiation complications. this should allow physicians to adjust radiation field size and dose to minimize long-term toxicity. patients undergoing radiation treatment for stage i to iii prostate cancer, using protons or x-rays, either as primary treatment or consolidation after prostatectomy (positive margins or prostate-specific assay \[psa\]-related indications) will be eligible. hormone treatment will be allowed.

Eligibility criteria:
inclusion criteria: * consent to participate in the study and a signed and dated an institutional review board (irb)-approved consent form conforming to federal and institutional guidelines. * ≥ 18 years of age. * patients must have an eastern cooperative oncology group (an ecog) performance status of 0 or 1. * a diagnosis of adenocarcinoma of the prostate. * not yet begun definitive therapy with chemotherapy or radiation but may have hormones or surgery. * clinically stage i to iii tumors. exclusion criteria: * metastatic disease. * a history of invasive rectal malignancy or other pelvic malignancy, regardless of disease-free interval. * active inflammatory bowel disease (i.e., patients requiring current medical interventions or who are symptomatic). * prior pelvic radiation therapy for any reason. * psychiatric or addictive disorders or other conditions that, in the opinion of the principal investigator (pi), would preclude the patient from meeting the study requirements.

Keywords: radiation chemotherapy
liberate trial in covid-19

Conditions: Coronavirus; Respiratory Distress Syndrome; SARS-CoV Infection

Summary: the study aims to evaluate the reduction in severity and progression of lung injury with three doses of lipid ibuprofen in patients with sars-cov-2 infections.


Eligibility criteria:
inclusion criteria: 1. male or female patients aged 18 years and above; 2. hospitalised; 3. confirmed or suspected sars-cov-2 infection; 4. national early warning score (news2) greater than or equal to 3 in a single parameter or news2 \> 5 overall; 5. acute hypoxemic respiratory failure: pao2/fio2 ratio less than or equal to 300 or spo2/fio2 ratio \< 315 (kigali modification) 6. provision of written informed consent by the patient or by the patient's legal representative or professional consultee. exclusion criteria: 1. any of the following contraindications to ibuprofen: * a known hypersensitivity to ibuprofen or any other constituent of the medicinal product; * patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema or urticaria) in response to aspirin or other non-steroidal anti-inflammatory drugs (nsaids); * patients with a history of, or existing gastrointestinal ulceration/perforation or bleeding, including that associated with nsaids; * patients with severe hepatic failure; * patients with acute renal failure; * patients with severe heart failure. 2. participation in any other investigational drug products less than 30 days prior to study enrolment; 3. glasgow coma score \< 12; 4. patients who cannot swallow oral capsules; 5. pregnant or lactating women; 6. any medical history that might, in the opinion of the attending clinician, put the patient at significant risk if he/she were to participate in the trial.
4% intrauterine lidocaine infusion for pain management in first trimester abortions

Conditions: Pain

Summary: recent studies have investigated the use of local anesthetics (i.e. lidocaine, mepivacaine) to lessen the pain experienced with minor gynecologic procedures such as endometrial biopsy and office hysteroscopy. local anesthetic injected into the uterine cavity has been demonstrated effective in some studies at decreasing patient pain associated with these intrauterine procedures at an anesthetic concentration of at least 2%. based on this evidence, we hypothesized that an intrauterine lidocaine infusion may reduce patient pain during first trimester abortions.


Eligibility criteria:
inclusion criteria: * age \> 18 years old * good general health * english speaking * confirmation of gestational age by ultrasound * body weight \> 100 lbs. * pregnancy \< 11 weeks

Keywords: pain with procedures
assessment of dyslipidemic patients' knowledge, quality of life, and adherence

Conditions: Dyslipidemias

Summary: a randomized, parallel two-arm interventional study, the patients were divided into 1:1 ratio, in which both groups offered optimal pharmacological therapy also one group (interventional) offered predesign pharmaceutical care plan aimed to improved patients knowledge, adherence, satisfaction, and quality of life, while the other group (non-interventional) received conventional pharmaceutical care plan.


Eligibility criteria:
inclusion criteria: patients diagnosed with dyslipidemia and received at least one statin therapy (in the previous 6 months), and patients on the same class of pharmacological therapy (statins). exclusion criteria: 1. pregnant women 2. nephrotic syndrome 3. active steroid user 4. hypersensitivity for any mediation during the trial 5. history of a major cardiovascular event in the previous 3 months 6. patients with mental disease or disability 7. had a stroke in the previous 6 months
dyphenhidramine effect on prevention of sevoflurane induced post anesthesia agitation in pediatric

Conditions: Specified Sedative; Hypnotic

Summary: the purpose of this study is to investigate the effect of diphenhydramine on the prevention of sevoflurane induced emergence delirium/ agitation in pediatrics. the investigators hypothesis is that it reduce the incidence of sevoflurane induced emergence delirium/ agitation.

this is an experimental clinical trial in double-blinded randomized controlled design on 50 children aged 10 months to 21 months who underwent general anesthesia with sevoflurane for labioplasty surgery. fifteen minutes before inhalation anesthetics were discontinued, the subjects were randomly given a placebo or a single dose of diphenhydramine 0, 5 mg / kg intravenously. subjects were extubated and observed in the recovered space conscious for any agitation or emergence delirium and feasability to return to the ward. agitation or emergence delirium was assessed by the pediatric emergence agitation and delirium score (paeds) whereas feasability to return to the ward scored with the steward score. when paeds\> 10 patients were assessed to be agitated or having emergence delirium and administeres rescue tranquilizer ketamine 0.1 mg / kg. total rescue tranquilizers and clinically significant adverse effects of drugs also recorded.

Eligibility criteria:
inclusion criteria: asa i or 2 * no cardiovascular, respiratory or neurologic congenital anomalies * no allergic reactions, or any contraindication to drugs used in this trial ever documented exclusion criteria: * congenital anomalies recognized/diagnosed during trial procedures * hemmorhage \> 15% ebv * shock or other major anesthesia or surgical complications during trial procedures (hipoxia, atelectasis, unintended disconection of ett or iv line)

Keywords: diphenhydramine emergence agitation pediatric anesthesia paeds withdrawal
mindfulness in hidradenitis suppurativa

Conditions: Hidradenitis Suppurativa

Summary: the study will investigate the impact of an 8-week-long mindfulness-based stress reduction course on quality of life and disease severity in patients with hidradenitis suppurativa (hs).

this is a voluntary 8-week-long, non-medical intervention study for patients with hidradenitis suppurativa (hs). this study will enroll participants in an 8-week-long mindfulness-based stress reduction course and observed for any changes in validated measures of quality of life. quality of life scores will be evaluated via multiple surveys including the dermatology quality of life index, hs quality of life index, gad7, and phq9. surveys will be collected week 1 of 8 week mbsr course intervention; week 4; end of mbsr course at week 8; and week 12. the first goal is to investigate the effectiveness of the addition of mindfulness-based stress reduction (mbsr) intervention to conventional medical treatment on improving mental health in hs participants. the second goal is to assess participant preference for mbsr intervention.

Eligibility criteria:
inclusion criteria: * this study will only enroll subjects between the ages of 18-years and 89-years of age. * diagnosis of hs * able to read and comprehend study materials in english, ie: surveys exclusion criteria: * those who do not fit inclusion criteria * non-english speaking * patient who recently began any psychotropic medication within 3 months prior to the baseline evaluation visit.

Keywords: quality of life mindfulness
mdr-tb close contacts tracing in china (tcct study)

Conditions: Multidrug Resistant Tuberculosis

Summary: to investigate the incidence of etiologically confirmed or clinically diagnosed active tuberculosis in close contacts of mdr-tb patients.

this study is a prospective observational cohort study. mdr-tb patients from multi-centers in china were continuously evaluated one by one, their close contacts were screened for elibgility. all subjects were followed for the same length of time: 80 weeks after enrollment. the symptoms and signs of tuberculosis were followed up to monitor the occurrence of tuberculosis. the primary objective is to investigate the incidence of etiologically confirmed or clinically diagnosed active tuberculosis in close contacts of mdr-tb patients. the secondary objective is to assess latent tb infection rates in close contacts of mdr-tb patients; evaluate the high risk factors of tuberculosis in close contact population; assess the loss rate of close contacts within 80 weeks; assess the 80-week mortality rate among close contacts; isolate the mycobacterium tuberculosis from all patients with active tuberculosis and analyze drug resistance to evaluate the homology and drug-resistant transmission pattern of mycobacterium tuberculosis.

Eligibility criteria:
the index patient: inclusion criteria: 1.18-70 years old; 2.has smear-positive pulmonary tuberculosis with initial laboratory results with resistance to rifampicin confirmed by genexpert; 3.have an identifiable address and stay in the area during the study period. exclusion criteria: 1. combined extrapulmonary tuberculosis; 2. hiv antibody positive and aids patients; 3. critically ill patients, and according to the judgment of the research physician, it is impossible to survive for more than 4 months. termination/termination criteria: 1. the patient requests to withdraw from the visit; 2. misdiagnosis and error. the close contacts: inclusion criteria: 1. willing to participate in trial treatment and follow-up and can give informed consent; 2. willing to carry out hiv testing; 3. more than 6 hours of cohabitation per week in the 2 weeks prior to diagnosis of the index case. exclusion criteria: 1. patients with active tuberculosis confirmed clinically or etiologically; 2. mental illness and severe neurosis; 3. the researchers determined that there were any ineligible conditions. termination/termination criteria: 1. the patient requests to withdraw from the visit; 2. find a violation of inclusion or exclusion criteria during treatment.

Keywords: multidrug resistant tuberculosis latent tuberculosis close contacts transmission
making hd voices heard

Conditions: Huntington Disease

Summary: the pilot study, making hd voices heard, will ask people living with hd to report what they experience and how they function.

the huntington study group (hsg) myhdstory™ platform is an online, observational research platform that will host the pilot study, making hd voices heard. the pilot study will ask people living with hd to report what they experience and how they function. participants will provide self-reported information using their own compatible smartphones, laptops, desktops, or tablets. participants will be asked to reply to a series of questions, including open-ended questions that will be transcribed by voice (microphone voice-to-text transcription) or keyboard-entered text to record what they experience in their own words.

Eligibility criteria:
inclusion criteria: * adults age 18 years and older * willing and able to provide informed consent electronically. * individuals answering as a participant must self-report they have been diagnosed with hd by a doctor. * ability to answer online questions or direct someone else to enter answers for them. * ability to ambulate independently and take care of some of his or her personal needs. * ability to read and understand english. * willing to create a unique identifier based on personal demographic information. * residing in the united states or its territories * owning or having access to an electronic device and secure internet connectivity exclusion criteria: an individual who does not meet all the inclusion criteria will be excluded from participation in this study.
effect of advanced hybrid closed loop system, minimed 780g in newly diagnosed children and adolescents with type 1 diabetes on glycemic control and patient reported outcomes compared to standard insulin therapy historical data (ahcl in new onset t1d children study)

Conditions: Diabetes Mellitus, Type I

Summary: the objective of this study is to evaluate glycemic control of users of the ahcl system minimed 780g with gs4 calibration-free sensor in children and adolescents with newly diagnosed t1d implemented directly upon t1d diagnosis in combination with continuous glucose monitoring system (cgms) compared with those treated with mdi retrieved from historical data- in a single- arm open-label prospective observational study, assessed at 3 months. after the initial study period there will be a 3month extension phase of the study.


Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of type 1 diabetes (who criteria). diagnosis of type 1 diabetes is based on international criteria and the investigator's judgment; c peptide level and antibody determinations are not required. 2. age range 7 to 17 years. 3. literate in greek or english. 4. willing to wear study devices. 5. willing to follow study-specific instructions. 6. total daily insulin dose greater than 8.0 units over 1 week period 7. willing and able (access to internet from home) to download information into the medtronic carelink software 8. clinically eligible to start the ahcl system exclusion criteria: * type 2 diabetes mellitus or mody diabetes * any untreated comorbidities of type 1 diabetes * medication affecting metabolic control or interfering in the interpretation of hba1c * pregnancy * untreated diabetes retinopathy, or other causes that in the investigator's opinion, precludes the individual from participating in the trial. * known or suspected allergy to insulin. * regular use of acetaminophen. * lack of reliable telephone facility for contact. * living alone. * severe visual or hearing impairment. * medically documented allergy to the adhesive of plasters or unable to tolerate tape adhesive around sensor placement. * serious skin lesions at areas of the body used for insertion of the glucose sensor. * illicit drugs abuse. * alcohol abuse. * sickle cell disease, haemoglobinopathy, receiving red blood cell transfusion or erythropoietin within 3 months prior to time of enrollment. * eating disorder including anorexia/bulimia. * milk protein allergy.

Keywords: type 1 diabetes advanced hybrid closed loop diabetes onset
health effects of coffee consumption

Conditions: Overweight

Summary: epidemiological studies have indicated a positive health impact of coffee. nevertheless, intervention studies testing the effect of daily coffee consumption over a longer period are lacking so far. moreover, there is a lack of knowledge about the properties of different coffees and their influence on weight development. therefore, we tested the effect of two coffees differing in their alkyl pyridine content over a period of 3 months on weight development.

participants were randomly associated to two groups, a test coffee group and a control coffee group. after coffee abstinence of 1 months, participants in both groups got a coffee machine and coffee pads for three months. clinical data have been assessed before and after coffee abstinence and after 3 months of coffee consumption.

Eligibility criteria:
inclusion criteria: * age 18-69 years * bmi ≥27 kg/m2 * coffee consumption of ≥3 cups per day exclusion criteria: * new diagnosed type 2 diabetes during the last 6 months * severe diseases with hospital stay during the last 3 months * change of body weight of more than 2 kg per week during the last 4 weeks * smoking cessation during the last 3 months or planned during the study * acute infects * chronical diseases with except of type 2 diabetes mellitus * regular pharmacological therapy with except of oral antidiabetic medication or contraception * lack of contraception in women * breastfeeding * physical activity of more than 1 hour per day

Keywords: overweight body weight coffee
the establishment of multiple point prediction model about tacrolimus metabolic differences based on genetic network after liver transplantation and the application of multicenter

Conditions: Cirrhosis, Liver

Summary: combined with the clinical data of fk506 and the database of go and kyoto encyclopedia of genes and genomes（kegg）, the investigators aim to carry out the bioinformatic analysis and build a muti-locus genetic model, then muti-center assess the predictive accuracy of fk506 metabolic differences.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of end-tage liver diseases * 18 years old or above * han nationality * therapeutic regimen：tac exclusion criteria: * less than 18 years old * other races * therapeutic regimen：cyclosporine

Keywords: liver transplantation individualized therapy polymorphism
horizon-pft: pivotal fracture trial

Conditions: Osteoporosis

Summary: horizon-pft (pivotal fracture trial) will study the effect of zoledronic acid, given once per year, on the treatment of osteoporosis in women past menopause. hip and vertebral fractures are the most devastating consequences of osteoporosis. horizon-pft is designed to determine the benefits of zoledronic acid in fracture reduction at both the hip and spine.


Eligibility criteria:
inclusion criteria: * female, 65-89 years old * no history of severe liver, kidney or eye disease exclusion criteria: * current bisphosphonate users such as aredia® (pamidronate), didronel® (etidronate), fosamax® (alendronate), actonel® (risedronate), skelid® (tiludronate) * using hip protectors other protocol-defined inclusion/exclusion criteria may apply.

Keywords: bisphosphonate,bmd,height loss, hip protectors,hrt, osteoporosis