Kornimate/medical-research-clean huggingface dataset:
new tablet containing two fda approved anti-hiv drugs for antiretroviral therapy experienced hiv-1 infected subjects

Conditions: Infection, Human Immunodeficiency Virus I; HIV Infection

Summary: a 48-week study to investigate the safety and effectiveness of a new compact formulation of two already fda-approved anti-hiv drugs in subjects who have already been receiving treatment for their hiv infection.

a phase iii, randomized, open-label, parallel, multicenter study to evaluate treatment with fixed-dose combination of abacavir/lamivudine (600mg/300mg) once-daily versus abacavir (300mg) twice-daily and lamivudine (300mg) once-daily in combination with tenofovir once-daily and a new pi or nnrti for 48 weeks in art-experienced hiv-1 infected patients.

Eligibility criteria:
inclusion criteria: * antiretroviral therapy (art) experienced and currently receiving a stable regimen containing 3 nucleoside reverse transcriptase inhibitors (nrtis), or 2 nrtis plus a protease inhibitor (pi) or non-nucleoside reverse transcriptase inhibitors (nnrti) for at least 3 months (there should be no significant art modifications for at least 3 months and no art change anticipated between screening and initiation of the study therapy). * patients must be naive to tenofovir. * hiv-1 rna level \> 1000 copies/ml on at least one occasion within 21 days of study entry. * a cd4 cell count \> 50 cells/mm3. * specified viral genotypes. exclusion criteria: * pregnant or breast-feeding women. * has an active diagnosis of aids. * additional qualifying criteria to be determined by the physician.

Keywords: hiv-1 abacavir lamivudine tenofovir
acupuncture for peripheral neuropathy induced by paclitaxel in early stage breast cancer

Conditions: Peripheral Neuropathy Due to Chemotherapy

Summary: the present study aims to evaluate the effectiveness of acupuncture in the treatment of chemotherapy drug paclitaxel induced peripheral neuropathy in patients with early stage breast cancer

patients with early stage breast cancer (stages i,ii,iii) who received paclitaxel in neoadjuvant or adjuvant chemotherapy protocol and developed peripheral neuropathy will be randomized to receive true acupuncture (intervention group) vs sham acupuncture (control), once a week, for 8 weeks. the primary outcome is improvement of the symptoms by neuropathic pain symptom inventory (npsi) scale (bouhassira,2004). the secondary outcomes are improvements on visual analog scale (vas) and quality of life by fact-taxane (cella, 2003) questionnaire. these scales will be assessed in the screening visit (baseline), week 4, week 6, week 8 and week 12. the study has duration of 12 weeks.

Eligibility criteria:
inclusion criteria: * age \>= 18 years old. * agreed to sign the informed consent term * ecog 0-1 * breast cancer stages i, ii and iii. * received adjuvant or neoadjuvant chemotherapy containing weekly paclitaxel 80 mg/m2. * peripheral sensory neuropathy grade 2 and 3 by the "common terminology criteria for adverse events" (ctcae) v5.0 exclusion criteria: * previous history of peripheral neuropathy due to other comorbidities. * prior treatment with chemotherapy for cancer other than breast cancer. * use of medications to treat peripheral neuropathy. * metastatic disease. * presence of lymphedema of any degree. * history of coagulopathy or full anticoagulation. * previous acupuncture treatment for any indication within the last 90 days.

Keywords: peripheral neuropathy breast cancer chemotherapy paclitaxel acupuncture
risk factors and prognosis of adverse cardiovascular and kidney events after coronary intervention ii

Conditions: Cardio-Renal Syndrome; Coronary Angiography; Coronary Artery Disease; Kidney Diseases; Metabolic Syndrome

Summary: as a multi-center, retrospective observation study in southern china, this study included the main study population of patients who underwent coronary angiography at 5 hospitals from guangzhou, shenzhen, yangjiang, maoming and longyan from january 2000 to decemeber 2020. the hospitalization information was collected in the form of direct derivation of the case, and cardiac and renal adverse events were collected through outpatient system. data on all-cause death were obtained from the guangdong provincial public security and matched to the electronic clinical management system of the guangdong provincial people's hospital records.

this is a multi-center, retrospective observation study collecting data on 184855 coronary angiography patients from january 2000 to decemeber 2020. data regarding demographic information, admission diagnoses and history of present illness, biomarkers and details on preventive hydration and medications will be collected. the primary endpoint of this study is adverse cardiovascular and kidney events.

Eligibility criteria:
inclusion criteria: 1. patients referred to cag or pci; exclusion criteria: -

Keywords: contrast-induced acute kidney injury contrast medium creatinine clearance coronary angiography chronic kidney disease adverse cardiovascular and kidney events
a clinical study of enlicitide in participants with severe renal impairment (mk-0616-032)

Conditions: Healthy; Renal Impairment

Summary: researchers have designed a new study medicine called enlicitide decanoate as a new way to lower the amount of low-density lipoprotein cholesterol (ldl-c) in a person's blood. enlicitide decanoate will be called "enlicitide" from this point forward, the purpose of this study is to learn what happens to enlicitide in a person's body over time (a pharmacokinetic (pk) study). researchers will compare what happens to enlicitide in the body when it is given to people with severe renal impairment (meaning the kidneys do not work properly) and to people who are in good health. the researchers believe that the total amount of enlicitide in a person's body measured during the 24 hours after a dose will be similar in people with severe renal impairment and in healthy people.


Eligibility criteria:
inclusion criteria: the main inclusion criteria include but are not limited to the following: * body mass index (bmi) between 18 and 40 kg/m\^2, inclusive * on a stable dose of statin therapy; no changes to dose or type of statin therapy for at least 2 months exclusion criteria: the main exclusion criteria include but are not limited to the following: * history or presence of renal artery stenosis * had a functioning renal transplant in the past 5 years and is taking transplant medication * history of gastrointestinal (gi) disease which might affect food and drug absorption panel a: participants with severe renal impairment: - history of any illness, other than hypercholesterolemia and renal impairment panel b: healthy participants: - history of clinically significant endocrine, gi, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases, other than hypercholesterolemia
efficacy and long-term safety of vildagliptin as monotherapy in patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: this is a 2-3 period parallel group study with an adaptive element in type 2 diabetes patients receiving vildagliptin as monotherapy.


Eligibility criteria:
inclusion criteria: * patients at least 18 years of age at visit 1 * drug naïve patients with t2dm diagnosed at least 2 months prior to visit 1 * hba1c ≥ 7.0 % and ≤ 10.0% at visit 1 * body mass index (bmi) in the range of 22-45 kg/m2 at visit 1 exclusion criteria: * pregnant or lactating female * fpg ≥ 270 mg/dl (≥15 mmol/l) other protocol-defined inclusion/exclusion criteria may apply

Keywords: type 2 diabetes vildagliptin
the effect of omega 3 on pregnancy complicated by asymmetrical intrauterine growth restriction

Conditions: Intrauterine Growth Restriction

Summary: intrauterine growth restriction is a common and complex obstetric problem. intrauterine growth restriction is noted to affect approximately 10-15 % of pregnant women. intrauterine growth restriction is diagnosed antenatal; however, some of these fetuses, especially if unscreened during pregnancy, may be detected only in the neonatal period. it is very important for obstetricians and perinatologists to identify growth restricted fetuses, because this fetal condition is associated with significant perinatal morbidity and mortality. omega 3 is composed of polyunsaturated fatty acids with a double bond at the third carbon atom from the end of the carbon chain. the fatty acids have two ends, the carboxylic acid end, which is considered the beginning of the chain, thus "alpha", and the methyl end, which is considered the "tail" of the chain, thus "omega." omega3 improve fetal wellbeing by two mechanisms: firstly, maternal and docosahexaenoic acid supplementation during pregnancy and lactation normalizes intrauterine growth restriction induced changes in adipose deposition and visceral pparγ expression. secondly, maternal docosahexaenoic acid supplementation increases serum adiponectin, as well as adipose expression of adiponectin and adiponectin receptors. novel findings suggest that maternal docosahexaenoic acid supplementation normalize adipose dysfunction and promote adiponectin-induced improvements in metabolic function in intrauterine growth restriction


Eligibility criteria:
inclusion criteria: * age: from 20 - 35 years old. * pregnant from 30 week to 32 week gestation. * singleton pregnancy with asymmetrical intrauterine growth restriction . * normal uterine and umbilical doppler indices at time of recruitment. exclusion criteria: * multiple gestations. * hypertensive women. * premature rupture of membranes. * abnormal doppler indices in the form of doppler blood flow indices \> 2 standard deviation , absent diastolic flow and lastly; reversed flow. * congenital fetal malformation. * pregnancy complicated by antepartum hemorrhage. * marked decrease in amniotic fluid volume.
impact of an atrial fibrillation decision support tool (afdst) on thromboprophylaxis for atrial fibrillation

Conditions: Atrial Fibrillation; Atrial Flutter

Summary: study objective was to improve decision-making and thromboprophylaxis for patients with atrial fibrillation (af) by developing and implementing a computerized decision support tool for individual patient-level decision-making about oral anticoagulant therapy. to accomplish these goals, the investigators studied the incremental impact of adding a quality-improvement (qi) intervention to an educational package (for practice staff and clinicians) using a computerized aid, the atrial fibrillation decision support tool (afdst) for individual patient-level decision-making about oral anticoagulant therapy in patients with non-valvular af. the decision support tool incorporates individual patients' risk factor profiles for ischemic stroke and bleeding and provides a recommendation for treatment based upon the projected quality-adjusted life expectancy gained or lost with the addition of either oral anticoagulant therapy or aspirin compared with no thromboprophylaxis.

setting - cluster randomized trial. setting - primary care practices of an integrated healthcare system. participants - 1,493 adults with non-valvular af seen between april 2014 and march 2015. intervention - treatment recommendations were made by an atrial fibrillation decision support tool (afdst) based on projections for quality-adjusted life expectancy calculated by a decision analytic model that integrates patient-specific risk factors for stroke and hemorrhage.

Eligibility criteria:
inclusion criteria: * study subjects were physicians in our primary care network. * patients included in the study were identified through our health system's clinical data store with an international classification of diseases, ninth revision, clinical modification (icd-9-cm), diagnosis of atrial fibrillation (427.31) or atrial flutter (427.32) exclusion criteria: diagnoses of mitral valve disease (394.x), aortic valve disease (395.x), heart valve transplant (v42.2) or heart valve replacement (v42.3).
decreasing postoperative complications by goal-directed fluid therapy during esophageal resection

Conditions: Esophageal Cancer

Summary: surgery for cancer of the esophagus is associated with a high risk of postoperative complications. it has been shown that the risk of postoperative complications can be decreased by optimising the amount and type of infusion fluids given during surgery, steered by measurement of cardiac stroke volume, mostly done with a device called esophageal doppler. this device can however not be used during this type of surgery. this study wants to test the hypothesis that postoperative complications in patients operated for esophageal cancer can be partially prevented by using a goal directed strategy for the administration of fluids and drugs influencing the heart and vessels, based on measurement of stroke volume by pulse wave analysis (flotrac).


Eligibility criteria:
inclusion criteria: * patients scheduled for transthoracic esophageal resection because of malignancy, without colonic interposition who leave informed consent exclusion criteria: * asa 4 or 5 * atrial fibrillation * significant aortic or mitral valve insufficiency * preoperative planned extensive monitoring beyond cvp, arterial blood pressure, diuresis, ecg and other standard monitors

Keywords: fluid goal-directed flotrac pulse contour analysis postoperative complications anesthesia esophagus
hypofractionated stereotactic radiotherapy in recurrent glioblastoma multiforme

Conditions: Recurrent Glioblastoma Multiforme

Summary: glioblastoma multiforme (gbm) is the most common primary brain tumor in adults. the treatment comprises maximal safe resection followed by radiotherapy and chemotherapy. despite appropriate management, 90% of the patients will develop relapse or progression. after progression, the median survival is 5.2 months (stupp, 2009). the treatment of gbm relapse remains investigational. reirradiation is an option in selected cases. the objective of this study is to compare 2 schemes of stereotactic hypofractionated radiotherapy in the management of recurrent gbm.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * kps equal or greater than 60 * anatomopathological confirmation of gbm * previous rt with therapeutic doses * at least 5 months from the end of rt course * not a candidate to surgical resection * patients with partial resection after resection of recurrent gbm will be allowed * patients with local progression after resection of recurrent gbm will be allowed * lesion with a maximal 150cc volume, as defined by enhancing portion in contrast enhanced mri * hemoglobin levels (hb) equal or greater than 10ng/dl. blood transfusions to correct the hb will be allowed. exclusion criteria: * important comorbidities * concomitant chemotherapy * contraindication to mri * brainstem glioma

Keywords: malignant glioma glioblastoma radiotherapy randomized
weight loss and physical activity lifestyle interventions in post liver and kidney transplants

Conditions: Weight Loss; Lifestyle Factors

Summary: this research project seeks to learn more about how lifestyle interventions can help liver and kidney transplant recipients achieve weight loss goals. the investigators want to evaluate if an intervention using weight and activity wrist monitors, as well as nutritional coaching group sessions is acceptable and useful for post-transplant patients aiming for weight loss. all participants will be given a wrist activity monitor, and a scale. half of participants will be invited to participate in the nutritional coaching group sessions. the research team will look at weight loss, devices' usage, and satisfaction, and see if there are any difference among the two groups.

this project aims to understand feasibility, acceptability, and appropriateness of using connected health services (use of fitbit and scale), and nutritional coaching group sessions as a lifestyle intervention for post-transplant patients seeking weight loss. secondarily, the investigators aim to assess effectiveness of the intervention to generate weight loss. enrolled patients will receive a wrist activity tracker (fitbit charge 4) and a scale, of which information synchronizes to the electronic health record. steps, usage, and weight values will be recorded and analyzed from the devices. all patients will be followed with monthly calls to assess issues with devices, and address case-specific questions. simultaneously, half of the patients will be randomized to receive every other month nutritional coaching group sessions on topics related to nutrition and physical activity. patients will have an in-person follow-up appointment where laboratory values, body measurements, and physical and mental readiness for weight loss surveys and scales will be applied at 6 and 12-months. patients that don't accomplish weight loss goal at 6 months will be invited to cross over to the nutritional coaching group sessions intervention arm.

Eligibility criteria:
inclusion criteria: * prior liver or kidney transplant recipient * bmi \>=30 * 6 months to 10 years post-transplant * stable immunosuppression as defined by no treatment for rejection in the past 3 months * access to smartphone or computer * able to provide informed consent exclusion criteria: * dual and/or simultaneous organ kidney and liver transplant * any type of other prior transplant * age \<= 18 years old * treatment for rejection within the last 3 months * major infection requiring hospitalization within the last 3 months * relisting for liver transplant or returned to dialysis for kidney transplant * physical inability to participate in lifestyle intervention activity recommendations * patients that are actively enrolled in a weight center program

Keywords: transplant weight loss lifestyle intervention obesity management
andexanet alfa and 4f-pcc use in patients hospitalised with an anticoagulant-related major bleed

Conditions: Anticoagulant-related Major Bleed

Summary: this is an observational study based on data collected via an audit of electronic medical charts. the study population will include adult us patients treated with andexanet alfa or 4f-pcc during a hospitalization for an anticoagulation-related major bleed, and their characteristics, treatments and outcomes will be described.

this observational study will include adult us patients treated with andexanet alfa or 4f-pcc during a hospitalization for an anticoagulation-related major bleed. data will be collected via an audit of electronic medical charts. the primary objectives are to describe the patients' characteristics, treatments and outcomes, including length of stay and in-hospital mortality. secondary objectives include subgroup analyses, including by bleed location. potential differences between patients treated with andexanet alfa versus 4f-pcc, and potential differences in patient characteristics over time, will be assessed. if this assessment confirms that treatment groups can be adequately balanced and that patient characteristics have not substantially changed over time (i.e. no channeling bias is observed), the risk of in-hospital mortality with andexanet alfa versus 4f-pcc will be assessed in a comparative effectiveness analysis. if treatment groups cannot be balanced or clear signs of channelling bias are observed, the comparative analyses will be considered unfeasible and will not be performed.

Eligibility criteria:
inclusion criteria: * icd-10-cm diagnosis code of d68.32 (hemorrhagic disorder due to extrinsic circulating anticoagulants) as part of an inpatient admission * taking either an oral fxa inhibitor or enoxaparin at the time of hospitalization for their bleeding event * treated with either andexanet alfa or 4f-pcc during the hospitalization for their bleeding event * had documented discharge disposition exclusion criteria: * less than 18 years old * treated with both andexanet alfa and 4f-pcc during the hospitalization for their bleeding event
vitamin d supplement for patients with tibial fracture

Conditions: Tibial Fracture

Summary: the purpose is to study: 1. the frequency of vitamin d deficiency at patients with tibial fracture treated with an external ring fixator 2. if vitamin d supplement facilitates fracture healing 3. a possible relation between vitamin d deficiency and the risk of complications and the time of fracture healing

external ring fixator is a widespread and well-known method to treate complex tibial fractures. the effect of treating proximal and distal intra-articulatio tibial fractures has been positive until now. complications such as malunions, nonunions, re-fractures and extended time of ring fixation will occur in 5-10% of all tibial fractures in patients treated with ring fixator. factors like trauma of soft tissue, smoking and compromised afflux of blood are associated with a higher frequency of nonunion. it has been documented that elderly people with hypovitaminosis d have a higher risk of being affected by osteoporosis and fractures. furthermore, there is a possible association between the severity of fracture and hypovitaminosis. the time of fracture healing is also extended compared to fractures in patients who are not affected by osteoporosis. until now research has not shown whether the fracture healing process is influenzed by vitamin d.

Eligibility criteria:
inclusion criteria: * patients with tibial fracture * a written signed statement of consent * all potential patients primary with osteosynthesis iliazov exclusion criteria: * tumours in bone * metastases to bone marrow * chronic renal disease * drug abuse * abuse of alcohol (\>21 drinks a week for men and \> 14 drinks a week for women) * morbus cushing disease * glandulae thyroid disease * pregnancy * chronic steroid therapy * hepatic insufficiency * sarcoidosis, tuberculosis or silocosis * patients under 18 years * inability to take medicine * adverse effects of vitamin d or allergic to vitamin d

Keywords: vitamin d deficiency ring fixator tibial fracture
institut paoli calmettes cardia cancer database

Conditions: Stomach Neoplasms; Cardia

Summary: database of institut paoli-calmettes patients diagnosed with cardia cancer


Eligibility criteria:
inclusion criteria: * diagnosis of cardia cancer exclusion criteria: -
dxa precision and accuracy comparison study

Conditions: Osteopenia

Summary: this study is being conducted to examine the performance of three common dxa machines (1) lunar idxa, (2) lunar prodigy and (3) hologic discovery a in measuring bone density and body fat.

for this study, two specific groups of volunteers will be recruited. in one group, the scan will measure bone density and in the other group the scan will measure fat. the groups will be broken into weight groups to determine which of the scanners the subject will be scanned on. subjects will have the option to participate in either one or both groups.

Eligibility criteria:
inclusion criteria: 1. men and women \> 20 years old 2. willing to provide consent 3. falls into one of three weight categories, with minimum 30 subjects per category. * less than 200 lbs. * 200 (inclusive) to less than 350 lbs. * 350 (inclusive) to less than 450 lbs. 4. participate in only one weight category in either skeletal or body composition cohort, or both. exclusion criteria: 1. inability to remain still for the duration of the dxa scans as judged by study investigator. 2. un-removable internal / external scan artifacts e.g. plaster casts, metal rodding naso-gastric tubes, etc. 3. females of childbearing potential\* with actual (confirmed by positive urine pregnancy test) or suspected (based on study investigator evaluation despite a negative urine test) pregnancy. 4. subject had already given consent to participate in any aspect of this study.

Keywords: bone mineral density weight body composition dexa dxa