Kornimate/medical-research-clean huggingface dataset:
the safety and effectiveness of hby 097 used with or without azt in hiv-infected patients who have mild or no symptoms

Conditions: HIV Infections

Summary: to obtain preliminary information on the safety, tolerability, and antiretroviral activity of hby 097 alone or in combination with zidovudine ( azt ) versus azt alone. per 1/19/96 amendment: azt monotherapy arm was eliminated.

patients are randomized to receive one of three doses of hby 097 with or without azt or azt alone for 12 weeks (azt monotherapy arm eliminated per 1/19/96 amendment). all patients at a given dose level of hby 097 must be enrolled and adequate safety data obtained before escalation in subsequent patients begins. additional patients are entered at the optimal dose of hby 097. patients are evaluated weekly for the first 4 weeks and then every 2 weeks for the next 9 weeks. per amendment: enrollment to the lowest dose cohort is completed.

Eligibility criteria:
inclusion criteria concurrent medication: allowed: * treatment for opportunistic infection that develops on study. recommended: * pcp prophylaxis if cd4 count falls below 200 cells/mm3. patients must have: * hiv infection. * cd4 count 200 - 500 cells/mm3. * hiv-1 rna pcr value of 10000 copies/ml or higher. * asymptomatic or mildly symptomatic disease. * no past or current aids-defining event. * consent of parent or guardian if less than legal age of consent. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * endocrine, hepatic, renal, or gastrointestinal disease. * cardiovascular conduction disease. * concomitant medical illness that may complicate study conduct or interpretation of results. * other factors that may interfere with patient compliance. concurrent medication: excluded: * antiretroviral agents other than study drugs. * oral contraceptives. * cytotoxic chemotherapy. * immunomodulators. * antiproliferative agents. * corticosteroids. * anabolic steroids. * estrogens. * quinoxaline derivatives. concurrent treatment: excluded: * radiation therapy. patients with the following prior conditions are excluded: * history of hypersensitivity to quinoxaline derivatives or intolerance to azt. * history of cardiovascular conduction disease. * prior participation in this study or any study using hby 097. * recent use of a drug that interferes with drug metabolism, absorption, distribution, or excretion. * history of thyroid disease. prior medication: excluded at any time: prior non-nucleoside reverse transcriptase inhibitors. excluded within 30 days prior to study entry: * any antiretroviral therapy. * oral contraceptives. * immunomodulating agents such as systemic corticosteroids, interleukins, or interferons. * cytotoxic chemotherapeutic agents. * other investigational drugs. excluded within 6 months prior to study entry: immunotherapeutic vaccine. prior treatment: excluded within 30 days prior to study entry: * radiation therapy. * an experimental device. current ethanol or illicit drug abuse.

Keywords: drug therapy, combination aids-related complex antiviral agents zidovudine
data analysis for drug repurposing for effective alzheimer's medicines (dream)- anastrozole vs exemestane/letrozole

Conditions: Breast Cancer

Summary: this study aims to evaluate the comparative risk of dementia/alzheimer's disease onset between patients treated with medications that target specific metabolic pathways and patients treated with alternative medications for the same indication.

this is a non-randomized, non-interventional study that is part of the dream study of brigham and women's hospital. dream is led by dr. madhav thambisetty, md, phd, chief of the clinical and translational neuroscience section, laboratory of behavioral neuroscience, national institute on aging (nia) intramural research program. this study aims to evaluate the comparative risk of dementia/alzheimer's disease onset between patients treated with medications that target specific metabolic pathways and patients treated with alternative medications for the same indication using healthcare claims data.

Eligibility criteria:
please see https://docs.google.com/spreadsheets/d/1grnvspcockqqdfxc9lwd6ndbzs2wpjvvtbcoahn4dlm/edit?usp=sharing or appendix a (https://drive.google.com/drive/folders/1i8fvmppzc5wqn9dfiv1rbwh1n0slev0b?usp=sharing) for full code and algorithm definitions. medicare timeframe: 2008 to 2018 (end of data availability) inclusion criteria: * 1. aged \>/= 65 years on the index date * 2. enrollment in medicare part a, b, and d with no hmo coverage for 365 days prior to and including cohort entry date * 3. at least two claims with breast cancer diagnosis measured 365 days prior to drug initiation exclusion criteria: * 1. prior history of dementia measured anytime prior to cohort entry date * 2. prior history of nursing home admission anytime prior to cohort entry date * 3. prior history of anastrozole or exemestane/letrozole use anytime prior to cohort entry date
anticoagulation after gi bleeding pilot study and registry

Conditions: GastroIntestinal Bleeding; Anticoagulant-induced Bleeding

Summary: panther-gi pilot study will assess the feasibility of a full-scale multicentre cohort management study evaluating the safety of a standardized strategy for resuming direct oral anticoagulants (doacs) after major doac-related gastrointestinal (gi) bleeding among patients at moderate to high risk of re-bleeding and thrombosis. a parallel registry will assess whether eligible patients who are not enrolled in the panther-gi pilot study are systematically different than enrolled patients and to explore barriers to enrolment.

this pilot cohort management study will evaluate a protocolized strategy for resuming doacs after major gi bleeding based on thrombotic risk among patients at moderate to high risk of rebleeding. the timeframe for resuming doacs will be determined based on the patient's underlying thrombotic risk.

Eligibility criteria:
inclusion criteria: 1. male or female subjects aged 18 years or older 2. hospitalized with acute major non-variceal gi bleeding (defined as per isth criteria) while receiving oac therapy (warfarin or doac). 3. oac therapy discontinued for current acute gi bleed and not yet resumed 4. ongoing indication for long-term anticoagulation of atrial fibrillation (moderate to high risk of stroke/systemic embolism with cha2ds2vasc score of 3 or higher) or vte (as per clinical care team) 5. planned to resume doac post-bleed 6. at moderate to high risk of re-bleeding as per clinical care team 7. clinical hemostasis achieved as per clinical care team 8. able and willing to comply with follow-up examinations contained within the consent form exclusion criteria: 1. mechanical heart valve 2. vte in the context of major transient risk factor and completed 3 months of treatment 3. gi bleeding managed surgically (e.g. gastrectomy, colectomy) 4. active or previously treated gastrointestinal cancer 5. life expectancy from other causes of less than 3 months 6. platelet count \< 50,000/µl (or \< 50x109/l) 7. renal dysfunction (creatine clearance \<30 ml/min as calculated by the cockcroft-gault formula)
trial to assess immunogenicity and safety of glaxosmithkline (gsk) biologicals' meningococcal abcwy vaccine as compared to meningococcal b vaccine in adolescents

Conditions: Infections, Meningococcal

Summary: the main purposes for conducting the study are firstly to assess immunological non-inferiority of the menabcwy vaccine, administered according to 0, 2 month schedule to healthy adolescents 10 to 18 years of age, to those of the licensed rmenb+omv vaccine (bexsero™) in terms of hsba gmts at one month after the second vaccination, secondly to give the flexibility for the national vaccination program by showing the safety and immunogenicity of menabcwy administrated according to four different vaccination schedules and additionally to evaluate a potential benefit of the 3-dose vaccination series.


Eligibility criteria:
inclusion criteria: 1. adolecents from 10-18 yearsof age, generally in good health, and available for all study visits, and who/whose legally acceptable representative has given written informed consent at the time of enrollment. 2. individuals of who the investigator believes can and will comply with the requirements of the protocol (e.g. use of an ediary, return for follow-up visits, available for phone contacts). 3. female subjects of childbearing potential must have a negative urine preganancy test. exclusion criteria: 1. serious, acute, or chronic illness. previous or suspected disease caused by n. meningitidis. previous immunization with any menincococcal or hepatitis a vaccines. 2. exposure to individuals with clicically proven meningococcal disease or clinical bacterial meningitis without further microbiologic characteriszation.
a multi-component intervention to improve medication adherence in people with depressive disorders

Conditions: Depressive Disorder

Summary: objective: the study of medication adherence in depression (mapdep study) aims to evaluate the effectiveness and cost-effectiveness of a multi-component strategy to enhance patient-centered care to improve adherence toward medications in patients with depression, formed by an educational intervention to psychiatrists and/or a collaborative care intervention group to patients and relatives plus a reminder system through the use of a mobile app. methods: the objective will be assessed under an open multicenter, clinical controlled trial with random allocation by clusters to one of three interventions or to usual care (control arm). in group 1 only patients and family members receive intervention, in group 2 only psychiatrists receive intervention, and group 3 is a combined intervention for patients and psychiatrists. the main measure will be the change in medication adherence rate. secondary endpoints are depression, emotional distress, health-related quality of life, physical functioning, patients' knowledge about their medications, provider beliefs regarding patient-centeredness, and healthcare resource utilization.


Eligibility criteria:
inclusion criteria: * patients: * patients with diagnosis of depressive disorder (major depressive disorder mdd and/or dysthymia) under pharmacological treatment * regular users of mobile phones * patients who have consulted their psychiatrist about their depression at least once in the previous 6 months * health professionals: psychiatrists have no intention of moving from their practice during the study period. exclusion criteria: • patient: * patients with history of current bipolar disorder and/or any psychotic disorder * insufficient language skills * pregnancy

Keywords: depression medication adherence multicomponent intervention
a clinical evaluation of the bard® luminexx™ iliac stent and delivery system

Conditions: Iliac Artery Occlusive Disease

Summary: to determine the safety and effectiveness of the luminexx stent for the proposed indication of treatment of common and/or external iliac artery occlusive disease

the study is designed to collect safety and efficacy data on the bard luminexx iliac stent in a broad patient population having indications for iliac stenting. effectiveness in this study will be demonstrated by the prevention of major adverse clinical events (mace). the composite primary endpoint of this clinical trial is freedom from peri-procedural death and freedom from stented segment revascularization or restenosis (\>50%) at nine months.

Eligibility criteria:
inclusion criteria: * patient or legal guardian understands procedure and provides written informed consent prior to study participation. * patient must be able and willing to comply with all study procedures including scheduled follow-up visits and diagnostic tests. * lesion(s) distinctly localized in the common and/or external iliac arteries. * reference lumen diameter (rld) 6 mm and 9 mm. * stenosis 30% and symptomatic ischemic disease (category 1-6 chronic limb ischemia or threatened or irreversible acute limb ischemia). exclusion criteria: * patients diagnosed with preoperative coagulation disorder or with contraindications to antiplatelet or anticoagulant therapy. * patients who are pregnant or planning to become pregnant during the clinical investigation. * patients with a life expectancy \< 3 years. * patients currently or scheduled to be enrolled in another investigation that conflicts with follow-up testing or may confound the study data. * patients with absolute contraindication to x-ray contrast media or medications normally administered during an interventional procedure. * patients with severe tortuosity or angulation of a vessel that may prevent access in the opinion of the investigator. * the presence of soft, thrombotic or embolic material within or adjacent to the lesion(s) being treated with the study device, in the opinion of the investigator.

Keywords: iliac artery occlusive stenosis
partial versus miniature pulpotomy in teeth with irreversible pulpitis

Conditions: Pulpitis - Irreversible

Summary: this study will compare the outcome of partial and miniature pulpotomy in mature permanent molars with symptomatic partial irreversible pulpitis

after thorough history and clinical and radiographic examination, and confirmation of eligibility for the study, written informed consent will be obtained from study participants after explaining the procedure and its associated risks and benefits. clinical diagnosis of symptomatic partial irreversible pulpitis will be established based on a history of spontaneous pain or pain exacerbated by cold stimuli and lasting for a few seconds to several hours (lingering pain) compared to control teeth and which is reproducible using cold testing. once included, study subjects will be randomly allocated to either miniature pulpotomy group or partial pulpotomy group. mta (mineral trioxide aggregate) will be used as pulpotomy agent. a layer of resin modified glass ionomer liner will be placed over the mta and tooth will be permanently restored with composite resin in same appointment. pain analysis will be carried out preoperatively and postoperatively at every 24 hours till 7 days after intervention. all the subjects will be followed up for evaluation of clinical and radiographic success at 6 and 12 months from baseline.

Eligibility criteria:
inclusion criteria: * the patient with18 -45 years of age. * restorable molar teeth. * tooth should give positive response to pulp sensibility testing. * clinical diagnosis of symptomatic partial irreversible pulpitis. * tooth with probing pocket depth and mobility are within normal limits. * no signs of pulpal necrosis including sinus tract or swelling. * non-contributory medical history exclusion criteria: * teeth with immature roots. * no pulp exposure after caries excavation. * bleeding could not be controlled in 6 minutes. * insufficient bleeding after pulp exposure, the pulp is judged necrotic or partially necrotic

Keywords: irreversible pulpitis partial pulpotomy miniature pulpotomy vital pulp therapy
stochastic resonance mattress (physiological interventions) and biomarkers for enhancing neonatal health

Conditions: Apnea of Prematurity

Summary: the purpose of this study is to explore physiological interventions and biomarkers for apnea of prematurity in newborn infants.

apnea of prematurity is defined as cessation of breathing that lasts for more than 20 seconds and/or is accompanied by oxygen desaturation or a decrease in heart rate (bradycardia). because apnea presents itself within a variety of diseases in newborns, its diagnosis is based largely on the exclusion of other findings. the difficulty in relating the manifestation of apnea to its cause can lead to issues regarding appropriate medical management and delays in treatment. our exploration of physiological interventions for apnea of prematurity begins with stochastic resonance. stochastic resonance is the introduction of noise to a system, to alter the system's behavior. this technology has been examined in previous medical applications. the hypothesis for this work is that stochastic resonance stimulation, in the form of gentle vibrations, will stabilize immature breathing patterns in infants. in this research study, we will use an apnea mattress developed by engineers at the wyss institute, harvard university, which provides gentle vibrations to the infant. we will closely follow the research protocol from umass medical school. whilst the infant is on the mattress, clinical care data will be collected to determine effect on breathing patterns. we also hope to collect enough baseline and intervention data signals to be able to identify candidate biomarkers for apnea. this will assist in development of predictive algorithms for apnea in infants.

Eligibility criteria:
inclusion criteria: eligible subjects are infants currently inpatient in the nicu at beth israel deaconess medical center and: * born premature, at a gestational age \< 36 weeks * demonstrate irregular breathing by having had at least one documented clinical apnea (\> 20 seconds), bradycardia (\< 100 bpm) and/or desaturation (\< 90%) exclusion criteria: eligible infants meeting the inclusion criteria above will be excluded from participation in the study if he/she: * is at a post conceptual age of \> 45 weeks at time of study (calculated as: weeks of age at birth + weeks of age since birth) * has demonstrable pulmonary disease at time of study, i.e. chronic lung disease, infant respiratory distress syndrome * has hypoxic-ischemic encephalopathy including a cord ph of ≤ 7 * has a congenital abnormality * has a genetic syndrome * has an anatomic brain anomaly * has hydrocephalus or intraventricular hemorrhage \> grade 3 or 4 * is anemic (hemoglobin \< 8g/dl) * has an infection at time of study * is undergoing therapeutic hypothermia

Keywords: apnea prematurity biomarkers stochastic resonance neonatal
the influence of acute hyperglycaemia on brain in t1d

Conditions: Hyperglycemia; Type 1 Diabetes Mellitus

Summary: the study is going to include 20 adolescents, 5-10 years after onset of t1d, aged 12-20 years, on insulin pump. the participants are going to have mri of the head in euglycaemic and hyperglycaemic state. during both mri, the participants are going to preform flanker test, tower of london test and spatial memory test. the investigators are going to evaluate the response of inflammation markers and oxidative stress marekers in blood during hypreglycaemia.

the study is going to include 20 patientswith t1d. the group of patients is going to be homogeneous. the inclusion criteria are going to be: duration of t1d approximately 5 - 10 years, age between 10 and 24 years, without associated clinical complications of t1d, similar value of hba1c and bmi within the normal range (depending on the percentile for age and sex), treatment with an insulin pump. only the patients who are going to give written consent to participate in the form "declaration of conscious and free consent" are going to be included. all selected clinical data to determine the phenotypic characteristics of the patient will be obtained from available medical records or. at their regular outpatient reading. after 12-hour fasting overnight, the patients will undergo 2h hyperglycaemic clamp. during hyperglycemia a sample of venous blood for the evaluation of oxidative stress, inflammatory response and the expression of non-coding rna is going to be drawn. subjects will have 1h-mrs in hyperglycaemic and euglycaemic state and evaluation of executive function (using psychological tests) is going to be preformed. for 1h-mrs, the mri of the head in order to obtain anatomical data is going to be preformed at first .

Eligibility criteria:
inclusion criteria: * t1d on insulin pump, no diabetic complication, normal bmi and blood pressure exclusion criteria: -
the metabolite profiling of obese subjects before and after sleeve gastrectomy

Conditions: Obesity

Summary: the purpose of this prospective observational study is to generate further insight into the numerous metabolic adaptations associated with sleeve gastrectomy surgery in obese subjects by profiled serum metabolites before and after the surgery and integrated metabolite changes with clinical data.

in the present study we examine the metabolic fluctuations of the most important amino acids and fatty acids to better understand the metabolic process in weight reduction in obese subjects that underwent sleeve gastrectomy surgery. the availability of the tandem equipment for amino acids and fatty acids determinations for the medical system gives us an opportunity to investigate the metabolic turmoil of weight reduction seen in obese subjects after sleeve gastrectomy. we evaluated the lipid metabolism by the measurements of the fraction of carnitine fatty acids which is the most available one because only a small blood specimen from a finger puncture is needed. in the present study we measured the blood concentrations of monocarboxylic and dicarboxylic fatty acids bounded to carnitine, free carnitine and also free amino acids 2 weeks before the surgery while subjects eat their regular high caloric diet, one week, one month and 3 month after the procedure. carnitne fatty acids comprise only the tip of the iceberg of all circulating fatty acids in the blood with a roughly distribution of: triglycerides, phospholipids and cholesteryl fatty acids 4 (lipids43-65), free fatty acids 0.6, and carnitne fatty acids 0.005 mm. some additional amount is also circulating in lipoproteins. even carnitine monocarboxylic fatty acids comprise around 1% of the free fatty acids and around 0.1% of all fatty compounds, the fluctuations in their concentrations probably reflect the most dynamics metabolic events because fatty acid oxidation must initiate by binding fatty acid to carnitine. the concentration of dicarboxylic carnitine fatty acids is much higher and comprises about 2% for malic carnitine and about 10% for glutaric carnitine in the total amount of free acids (http://www.hmdb.ca/). yet, as for monocarboxylic fatty acids, a remarkable mass of dicarboxylic acids is still present as free acids. for all carnitne acyl compounds the distribution forms have a high variability on different physiological conditions.

Eligibility criteria:
inclusion criteria: * bmi \> 30 * willing to undergo sleeve gastrectomy exclusion criteria: * inability to sign the informed consent

Keywords: obesity bariatric surgery sleeve gastrectomy metabolite profiling
lung cancer screening study with low-dose ct scan and blood biomarker

Conditions: High Risk of Developing Lung Cancer

Summary: lung cancer is the number one cancer killer in the usa. early stage lung cancer is asymptomatic. most patients with lung cancer are usually symptomatic at diagnosis and already have advanced stage disease. low dose ct screening (ldct) for high risk individuals has recently been shown to decrease lung cancer mortality by 20%. however, 4 out of 5 lung cancer deaths are not prevented with ldct screening alone.

in this trial, the addition of a blood biomarker test is being combined with early ldct to determine if screening with combination may result in detection of more lung cancer at an earlier stage of disease.the study will also assess if the blood test is able to detect lung cancers in high risk individuals when the ldct is negative for cancer. there will be health-economic costs included in the final analysis of study data.

Eligibility criteria:
inclusion criteria: * smokers or former smokers * at least 20 pack year history of smoking * ages 50 - 75 exclusion criteria: * had a ct scan of chest within last 24 months * history of any cancer within 10 yrs (except skin cancer or cervical cancer) * a serious illness that decreases life expectancy to less than 5 years * any current use of oxygen * uncontrolled congestive heart failure or cardiac arrhythmia that would prevent surgery for a lung lesion * severe copd or dyspnea that would prevent lung surgery or stereotactic body radiotherapy

Keywords: lung cancer screening smokers or former smokers family history of lung cancer