Kornimate/medical-research-clean huggingface dataset:
effect of a high intensity interval training in older adults with coronary artery disease

Conditions: Heart Diseases

Summary: a study comparing 2 groups: interval training and control group. interval training group will perform a physiotherapy program based in exercises, at a high intensity, and stretching of muscles at the end. control group will not perform any physiotherapy program. several parameters will be evaluated at baseline, 2 months and 6 months: anxiety, depression, functional capacity, blood pressure, lipid profile, physical activity, ecc.

a study comparing 2 groups: high intensity interval training and control group. interval training group will perform a two-month physiotherapy program based in exercises, at a high intensity, and stretching of muscles at the end. intensity will be established based on borg scale and an effort test. control group will not perform any physiotherapy program, but will have usual care with medication. several parameters will be evaluated at baseline, 2 months and 6 months: anxiety, depression, functional capacity, blood pressure, lipid profile, physical activity, ecc.

Eligibility criteria:
inclusion criteria: * diagnosed of coronary artery disease * discharged from hospital, less than 2 months exclusion criteria: * not able to move by themselves
efficacy of antiviral therapy after radical resection for hepatitis b virus-related hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma; Hepatitis B Virus; Recurrence

Summary: most hepatocellular carcinomas are associated with hepatitis b virus, it is hypothesized that anti-viral treatment may be helpful in treating hbv-related hepatocellular carcinoma.

as we know, recurrence and metastasis could happen in hepatocellular carcinoma even after radical resection.one reason is that virus hepatitis b could be one factor contributing to the carcinogenesis of hepatocellular carcinoma.to investigated whether anti-viral therapy could improve the efficacy of radical resection of hepatitis b virus (hbv)-related hepatocellular carcinoma(hcc),we planed to conduct this clinical trial.

Eligibility criteria:
inclusion criteria: 1. patients who did not receive antiviral therapy prior to the resection of hepatocellular carcinoma 2. patients who underwent radical resection of hcc, and 1 month after surgery,dynamic computed tomography showed on lesion in the liver and no signs of extrahepatic metastasis. 3. hepatitis b surface antigen should be positive before surgery hbv-dna level between 100000 copies/ml and 10000000copies/ml anti-hcv negative exclusion criteria: 1. previous history of antiviral therapy 2. a baseline serum alanine aminotransferase level 2.5 times the uln or higher 3. positive for anti-hcv or anti-hiv 4. child-pugh classification b or c after surgery 5. preexisting evidence of hepatic decompensation, including encephalopathy,ascites,a bilirubin level more than 2 times the uln, or a prolonged prothrombin time of more than 3 seconds 6. signs showing recurrence or metastasis oen month after surgery 7. underlying cardiac or renal diseases

Keywords: hepatocellular carcinoma hepatitis b virus surgery anti-virus recurrence
text-message reminders to increase rates of postpartum diabetes screening in women with gestational diabetes

Conditions: Diabetes, Gestational

Summary: purpose: the purpose of this study is to see whether a text-message reminder system will increase the number of women who complete their diabetes screening after delivery. study design: prospective randomized control trial hypothesis: gestational diabetics will be significantly more likely to follow up with their postpartum screening for diabetes if they receive text-message reminders to set up their lab appointment compared to those who receive usual care.

eligible participants will be recruited after delivery while on the postpartum ward. recruitment will be conducted by the pi or a member of the study team. after informed consent is obtained, the patients will be randomized into one of two study groups: the intervention group or the control group. women in the intervention group will receive a test text-message reminder at the time of enrollment. they will then receive a text-reminder to schedule their oral glucose tolerance test at 6 weeks postpartum, with further reminders at 3 months and 6 months if they have not completed their testing. women in the control group will only receive the test text-message reminder. the pi or member of the study team obtaining the informed consent will verify the participant has received the text-message prior to completing enrollment. a computer-generated randomization list will be generated according to intervention vs. control group. simple randomization will be used for the purposes of this study. 316 participants will be recruited based on the sample size calculations already performed. one group of 316 randomized opaque envelopes will be prepared. these sealed envelopes will be stored in a secured designated area at tampa general hospital. once a patient has agreed to participate and is consented an envelope will be selected from the next sequentially numbered envelope and the number on the envelope will be recorded on their study sheet. enrollment will continue until 316 participants have been recruited.

Eligibility criteria:
inclusion criteria: * women diagnosed with gestational diabetes (gdm) based on a 100-g, 3-hour glucose tolerance test with 2 or more abnormal values according to the carpenter-coustan criteria or women with a 50-g, 1-hour loading test \>200mg/dl. * diagnosed with gdm at least at 24 weeks gestation or later * access to a personal mobile phone with text-messaging capabilities. * age 18 or greater * able to provide written and informed consent in english or spanish language exclusion criteria: * women that were ever diagnosed with diabetes outside of pregnancy.

Keywords: gestational diabetes postpartum screening text-messages 75-g oral glucose tolerance test
dysregulated cns inflammation after acute brain injury

Conditions: Traumatic Brain Injury; Aneurysmal Subarachnoid Hemorrhage

Summary: by doing this study, the investigator hopes to learn how the levels of important proteins involved in inflammation change over time in patients with acute brain injury. the total amount of time participants will be asked to volunteer for this study is approximately two hours over a five day period.

this pilot project is a prospective, observational study in 20 patients who are admitted to university of kentucky (uk) chandler medical center with a diagnosis of severe, non-penetrating traumatic brain injury (tbi) or aneurysmal subarachnoid hemorrhage (asah). all adult participants with a primary diagnosis of severe, non-penetrating tbi or asah who are admitted to the neuroscience or trauma intensive care units will be screened for potential inclusion into this study. once a potential participant is identified, the legally-authorized representative will be approached for study consent and hipaa authorization. if the participant regains consent capacity before the end of the cerebrospinal fluid (csf) collection period, assent will be obtained from the research participant. in this research study, up to 5 small samples of csf, will be carefully removed from the device, already in place, that drains excess csf from the participant's head. the samples will be less than 1 teaspoon (\< 5 ml) each. these samples will be frozen and stored until samples from approximately 20 participants have been obtained. these samples will then be prepared and sent to a research laboratory to analyze the proteins in the samples collected from each research participant. because the results of this study will not affect the treatment participants receive in or outside of the hospital, the investigator will not share the results of this study with the participant, their doctor or their family member(s).

Eligibility criteria:
inclusion criteria: * severe, non-penetrating tbi or asah * must have a ventriculostomy (evd) placed by the uk neurosurgery service within 12 hours of primary traumatic episode exclusion criteria: * non-survivable brain injury or other organ system injury * life expectancy is five days or less * penetrating tbi * status epilepticus upon arrival to the hospital * severe ischemic heart disease or congestive heart failure, myocardial infarction, or spinal cord injury * takotsubo cardiomyopathy secondary to the sah * active cancer or have been treated for cancer within the previous 6 months
peep for lung recruitment in preterm infants-eit study

Conditions: PreTerm Neonate; Positive End Expiratory Pressure (PEEP); Lung Recruitment; Electrical Impedance Tomography (EIT)

Summary: babies born early (under 32 weeks) are at risk of developing lung problems after birth. a major reason for this is that the lungs are not fully developed. lungs of preterm babies will often collapse in between breathing due to lung immaturity. applying gentle pressure, using nasal device through their nostril or through the breathing tube helps to prevent this lung collapse. this would help in air-oxygen going to lungs and also makes the babies breathing more comfortable. this gentle pressure is medically called as peep/cpap and could be delivered by breathing machine (ventilator) and cpap machine, collectively called as "continuous distending pressure (cdp)". those babies breathing on their own and receiving inadequate cdp would need more breathing support by placing them on breathing machine (ventilator). the longer the baby receives breathing machine support, higher chance of lung injury . preterm infants who are already on breathing machine, providing sub optimal peep/cpap could also lead to lung damage. providing optimal peep/cpap could prevent these negative outcomes. currently there is not enough evidence to suggest optimal peep/cpap in preterm infants. neonatal units all around the world uses peep/cpap ranging from 4 to 10cm h20 based on their unit practice. currently available investigations provide limited one time information (e.g. chest x-ray) regarding whether baby is receiving optimal peep/cpap. electrical impedance tomography (eit) is a new technology which could provide better information regarding the pressure delivered. also, this device would provide continuous information as if the clinicians are doing continuous chest x-ray but without any radiation. in this study, the team will assess the effect of different levels of peep/cpap (4 to 10cm h20) on prevention of lung collapse using eit. this would be studied in premature infants who are on breathing machine support and cpap machine support.


Eligibility criteria:
inclusion criteria 1. gestational age \<32 weeks based on mother's last menstrual period or first trimester ultrasound dating. 2. receiving either cpap or mechanical ventilation respiratory support. 3. informed written consent from one of the parents. 4. within the first two weeks of life. investigators pragmatically chose this period, as there could be considerable lung injury after the first two weeks of life, making it difficult to test our hypothesis. also, this time period would allow parents to settle down with their stressful preterm delivery and investigators could approach anytime within the first two weeks of life. exclusion criteria 1. major congenital malformations including congenital lung disease and congenital heart disease as ascertained by the medical team. 2. infants diagnosed with pneumothorax i. 3. receiving high frequency mechanical ventilation. 4. infants with concerns of skin integrity.

Keywords: positive end expiratory pressure preterm electrical impedance tomography
a trial of iw-3718 for 8 weeks in patients with symptomatic gastroesophageal reflux disease (gerd)

Conditions: Gastroesophageal Reflux Disease

Summary: the objectives of this study are to evaluate the safety, efficacy, and dose-response relationship of iw-3718 administered orally to participants who have gerd and continue to experience gerd symptoms while receiving once-daily (qd), standard-dose proton pump inhibitors (ppis).


Eligibility criteria:
inclusion criteria: * patient is an ambulatory, community-dwelling male or nonpregnant female and is at least 18 years old at the screening visit. lactating females must agree not to breastfeed. * patient has a diagnosis of gerd and reports experiencing gerd symptoms (heartburn or regurgitation) on ≥ 4 days per week during the 8 weeks before the screening visit while taking standard qd ppi therapy. exclusion criteria: * patient may not meet any of the excluded conditions specified in the protocol * patient has any alarm symptoms including but not limited to gi bleeding, anemia, vomiting, dysphagia, or unexpected weight loss any time during the screening or pretreatment periods * patient has a history of clinically significant hypersensitivity or allergies to any of the excipients contained in the study medication (active or placebo). note: additional inclusion/exclusion criteria may apply.
peripheral neuropathy in patients receiving enfortumab vedotin and pembrolizumab as first line treatment for metastatic or locally advanced urothelial carcinoma

Conditions: Urothelial Cancer

Summary: the p-evolution trial is a prospective, multicenter, non-interventional observational study aimed at investigating peripheral neuropathy in patients receiving first-line treatment for metastatic or locally advanced urothelial carcinoma with enfortumab vedotin (ev) and pembrolizumab (p). conducted at two german university hospitals, the study will track the incidence and severity of peripheral neuropathy, its impact on quality of life, and treatment regimen adjustments due to side effects. approximately 80 patients are expected to be enrolled over one year.


Eligibility criteria:
inclusion criteria: * adult patients, ≥18 years of age at the time of signing the informed consent form (icf) * patients with histologically confirmed metastatic or locally advanced, unresectable urothelial carcinoma * patients who did not receive any systemic treatment for their lauc or muc (treatment-naïve) * patients who are able to receive enfortumab vedotin and pembrolizumab according to the respective medicinal product information exclusion criteria: * patients with contraindications for enfortumab vedotin and/or pembrolizumab * patients who have received a systemic therapy for their lauc or muc (e.g. platinum-based chemotherapy, checkpoint-inhibitors) * patients who have previously been treated with enfortumab vedotin, other mmae-based antibody-drug-conjugates or pd-(l)1-checkpoint inhibitors * patients who received neoadjuvant or adjuvant platinum-based chemotherapy \<12 months ago

Keywords: enfortumab vedotin pembrolizumab peripheral neuropathy metastatic urothelial carcinoma advanced urothelial carcinoma
progression of active microcavitated carious lesions on primary molar occlusal surfaces

Conditions: Dental Caries in Children; Pit and Fissure Sealant; Toothbrushing

Summary: objective: to verify the progression of active microcavitated carious lesions on occlusal surfaces of primary molars after the orientation of the brushing technique associated with fluoride dentifrice compared to resin sealant, through a 12-month randomized clinical trial. methodology: we selected 22 children from 4 to 9 years old from the public school system of the city of juazeiro do norte-ceará, with at least one primary molar presenting an active caries lesion score 3 of the international caries detection and assessment system (icdas). randomization was performed en bloc and stratified by two conditions (age and caries experience). the selected teeth were divided into two groups: the first (g1) was submitted to brushing with fluoridated toothpaste; and the other group (g2) to the resin sealing technique, whose application of the material was performed under absolute or relative isolation, selected through a second randomization. the molars undergoing treatment were evaluated at 6- and 12-month returns. caries progression was evaluated according to the type of treatment, dental group and sealant retention by the chi-square test. for cost analysis, the variance test (anova) was used.


Eligibility criteria:
inclusion criteria: * at least one primary molar with active caries lesions classified as icdas score 3. exclusion criteria: * children with differentiated management needs and/or systemic diseases with oral involvement. * primary molar with active caries lesions classified as icdas score 3 that had other caries lesions involving dentin, restorations, sealants, or other types of formation defects.

Keywords: pit and fissure sealants pediatric dentistry toothbrushing
a phase 2 trial of fluzoparib combined with apatinib versus fluzoparib monotherapy in treatment with relapsed ovarian cancer patients

Conditions: Relapsed Ovarian Cancer

Summary: this is a multicenter, randomized, open-label, 2-arm phase 2 study to evaluate the efficacy and safety of fluzoparib with apatinib versus fluzoparib alone, as treatment, in relapsed ovarian cancer patients. the study contains a safety lead-in phase in which the safety and tolerability of fluzoparib+apatinib will be assessed prior to the phase 2 portion of the study.


Eligibility criteria:
inclusion criteria: 1. histologically diagnosed high-grade serous or endometrioid recurrent ovarian,fallopian tube,or peritoneal cancer. 2. patients must have received at least 2 previous platinum-containing regimens. 3. at least one target lesion. 4. ecog performance status 0-1. 5. adequate bone marrow, kidney and liver function. exclusion criteria: 1. prior treatment with a poly (adp-ribose) polymerase (parp) inhibitor or apatinib.for exploratory cohort ，patients who received parp inhibitor are eligible; 2. prior malignancy unless curatively treated and disease-free for \> 5 years prior to study entry. prior adequately treated non-melanoma skin cancer, in situ cancer of the cervix allowed; 3. radiation or anti-hormonal therapy or anticancer therapy within 14 days before first administration; 4. known to be human immunodeficiency virus positive; 5. known active hepatitis c virus, or known active hepatitis b virus; 6. untreated and/or uncontrolled brain metastases; 7. patients with clinical symptoms of cancer ascites, pleural effusion, who need to drainage, or who have undergone ascites drainage within 3 months prior to the first administration; 8. pregnant or breast-feeding women.
functional magnetic micturition in patients w/sci

Conditions: Spinal Cord Injury

Summary: this project will determine the ultimate usefulness of functional magnetic stimulation (fms) as an assistive device for voiding in patients with sci.

investigators intend to determine the ultimate usefulness of functional magnetic stimulation (fms) as an assistive device for voiding in patients with sci. thirty six persons will be recruited and will undergo an 8 week protocol for conditioning of the bladder. the investigators propose to: investigate the changes in bladder function in response to long-term bladder conditioning by fms; further optimize the fms technology and parameters for effective bladder emptying in sci; evaluate the role of the external sphincter muscle fatigue by fs in facilitating bladder emptying; critically evaluate the relative response of fms data to existing information using functional electrical stimulation;further develop criteria that will be used to predict which sci patients are optimally suitable for fms; establish a comprehensive stimulation criteria that will reflect the safety and effectiveness of structures associated with the bladder that are exposed to the electro-myographic field.

Eligibility criteria:
patients with sci above t10 level, six months post injury

Keywords: bladder, electromagnetic fields, spinal cord injury
vascular occlusion and rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: resistance exercise plus vascular occlusion may induce greater improvements in strength and muscle mass resistance training alone. the investigators speculate this training strategy could be beneficial in patients with rheumatoid arthritis.


Eligibility criteria:
inclusion criteria: * female with rheumatoid arthritis * disease activity scores \> 2.6 * use of anti-tnf-alpha drugs for at least 8 weeks exclusion criteria: * bmd \< 20 kg/m2 * fibromyalgia * cardiovascular disease
influence of hydroxyehtyl starch (hes) on hemorehology, coagulation and elimination kinetics

Conditions: Stroke Patients Presenting Within 24 Hrs of Onset of Symptoms

Summary: the use of hes has been found clinically to improve patients with stroke if administered within a window period by means of hemodilution to improve rehology. we propose to see the effects of long term administraion of hes in the amounts required for treating stroke patients and study the effects on the kinetics of hes, its effects on coagulation and hemorheology.

patients with stroke benefit with hemodilution when administered hes in a window period and continued for a period of 10 days. hemodilution improves the hemorheology and thus possibly preserves the cerebral tissues in the penumbra regions of affected vessels. we propose to see the effects of prolonged administration of hes from different makes and study the kinetics, hemorehology and coagulation parameters by teg as there is no literature on kinetics and coagulation follwing prolonged use in stroke patients and also study their neurological outcomes. patients presenting to the emergency department or outpatient department within 24 hrs of manifestation of symptoms will be recruited to the study after taking informed consent in a language the patients/ family understand by the study personnel identified and authorized to do the same. the patients will then be randomly allocated to receive hes of either make for 10 day with 10 patients in each group. the randomization is by random number generation by computer. the product is blinded to the patient and observer by black cover with only the label a or b of each group. blood samples will be drawn at time of randomization, after 3, 5 and 10 days for rehological, coagulation effects and kinetics of hes, stored as per requirements and analyzed. routine biochemical tests as prescribed by the physician will be undertaken as required. satistical analysis of data will be done by spss.

Eligibility criteria:
inclusion criteria: age 18 - 70 yrs clinical diagnosis of ischemic stroke no marked spontaneous improvement of symptoms before randomization written informed consent from nearest relative. - exclusion criteria: pregnancy allergy to hes severe impairment of consciousness previous stroke with persistent ipsilateral deficits. seizure at stroke onset. intracranial neoplasm or av malformation. cardiac insufficiency or pulmonary edema myocardial infarction during the previous 3 months or unstable angina. severe dehydration coagulation disorders. uncontrolled hypertension. laboratory findings reflecting severe anemia, renal insufficiency, thrombocytopenia or hepatic insufficiency. participation in another clinical trial within the previous 2 months or concurrent treatment with any other experimental drug. secondary exclusion criteria. cerebral ct at enrolment showing intracranial hemorrhage of any degree-

Keywords: stroke, hes, coagulation, kinetics, hemorehology