Kornimate/medical-research-clean huggingface dataset:
safety study of calcineurin inhibitor free gvhd prophylaxis in allogeneic stem cell transplantation

Conditions: Hematologic Diseases

Summary: in stem cell transplantation as treatment for malignant diseases, calcineurin inhibitors like cyclosporine a are commonly used to prevent tissue destruction (gvhd) by activated donor immune cells. the hypothesis for this study is, that replacing calcineurin inhibitors by everolimus and mycophenolate as gvhd prophylaxis not only reduces toxicity of the treatment but also improves tolerance induction of the donor t cells toward the host, eventually increasing the safety of stem cell transplantation.


Eligibility criteria:
inclusion criteria: * diagnosis of hematologic malignancies, indicated for allogeneic stem cell transplantation: * acute myeloid leukemia (aml), in cr1, ≥ cr2, primary refractory, relapse * chronic myeloid leukemia (cml), in chronic phase, in acceleration or blast crisis * myelodysplastic syndrome (mds), ra/rars (transfusion dependent), raeb, raeb-t and cmml * lymphoma: * plasmocytoma * immunocytoma (m. waldenström) * chronic-lymphatic leukemia (cll) * additional low and high grade non-hodgkin lymphoma * hodgkins disease * hla-matched (hla-a, -b, -drb1) related or unrelated donor available * signed informed consent exclusion criteria: * cns involvement by underlying disease * pulmonary disease with vc \< 55%, dlco \< 40% * cardiac ejection fraction \< 30%, uncontrollable arrhythmia * creatinin \> 1,5 mg/dl or creatinin-clearance \< 30 ml/min * bilirubin \> 2 mg/dl * active hepatitis b or c * hiv serologic positive * pregnancy and lactation * pre-menstrual women without medical safe contraception * participation on another clinical trial in between 30 days before start or during the study only if the clinical trial interferes with the outcome measures. * known allergy to study medication or ingredients of the formulation * drug- or alcohol abuse * non-compliance

Keywords: hematopoietic stem cell transplantation drug therapy, combination immunosuppression
pain and stress assessment and rop screening

Conditions: Pain; Stress

Summary: the study will measure the effects of eye exams on markers of stress in the urine. in addition, measurements will be taken to show the effects of stress on brain activity, o2 sats, and blood flow.


Eligibility criteria:
inclusion criteria: * premature infants between 24 -32 weeks of gestational age exclusion criteria: * infants scheduled for laser eye surgery on the day of the examination * infants with intraventricular hemorrhage ≥ grade 3 (papile classification) diagnosed by head ultrasound * infants receiving the following medications: morphine, fentanyl, methadone, midazolam, lorazepam, muscle relaxants, phenobarbital, phenytoin, levetiracetam * renal injury defined with plasma creatinine \> 1.5 mg/dl * severe cyanotic congenital heart disease * unstable respiratory distress (hypoxemia pao2 \< 50 mm hg or spo2 \< 90%)

Keywords: pain and stress assessment in premature infants
intervention to improve engagement in care among newly diagnosed hiv-positive men

Conditions: HIV; Patient Compliance

Summary: the study involves delivering one of two interventions - either promoting action towards health (path) or personalized cognitive counseling (pcc) - to 440 men who have sex with men (msm) who have recently been diagnosed with hiv and assessing whether participants who received path achieve greater suppression of hiv viral load, demonstrate greater uptake of care and adherence to treatment, and engage in less sexual hiv transmission risk behavior than participants who received pcc. * path consists of two preliminary sessions plus "booster" sessions after 1, 3, and 6 months. * personalized cognitive counseling consists of one session. participants will complete assessments before participating in their intervention (i.e., at "baseline") and at 3, 6, 9, and 12 month follow-up points. participants' viral loads will be measured at approximately 6 and 12 months following baseline.

objectives: the investigators will conduct a randomized controlled trial to test the efficacy of promoting action towards health (path), a brief health-enhancement and risk reduction intervention targeting newly hiv diagnosed men who have sex with men (msm). specific aims: the investigators will establish the efficacy of path. the following hypotheses will be tested: participants in the experimental condition will (1) achieve significantly greater suppression of hiv viral load; (2) demonstrate greater uptake of care and adherence to treatment; and (3) engage in less sexual hiv transmission risk behavior across the study duration than participants in the comparison condition. procedures: 440 newly hiv diagnosed (within 12 months) men will be randomly assigned to either: (1) the path experimental condition, or (2) the pcc comparison condition and followed for one year. hiv counselors will be trained to deliver the interventions within each condition. assessments will be conducted at baseline, 3, 6, 9 and 12 months. significance: given increases in hiv incidence among msm, advances in hiv treatment, and the demonstrated efficacy of early treatment in preventing hiv transmission, there is a critical need for effective interventions that can increase engagement and retention of msm in care and reduce sexual hiv transmission risk behavior. path can be seamlessly integrated into medical care and translated into a sustainable model of care for newly diagnosed msm to meet the urgent need for care programs that identify, treat, and prevent hiv infections.

Eligibility criteria:
inclusion criteria: * receiving an hiv diagnosis within the previous 12 months * entry into hiv primary care * residence in the greater new york metropolitan area * aged 18 or older * provision of written informed consent exclusion criteria: -demonstrating cognitive impairment, acute psychosis, or suicidal intent or plans

Keywords: hiv viral load risk patient compliance homosexuality, male anti-retroviral agents
centella asiatica (gotukola) mouthwash as an adjunct to mechanical plaque control

Conditions: Gingival Diseases

Summary: this study evaluates the adjunctive use of centella asiatica (gotukola) to scaling in the reduction of plaque and gingival inflammation. patients were divided into three groups of which group 1 received scaling and gotukola mouthwash, group 2 received scaling only and group 3 received gotukola mouthwash only.

mechanical plaque control by tooth brushing is considered to be the ideal way of preventing plaque associated gingivitis. however due to various factors individuals fail to perform an adequate quality of self performed plaque control. centella asiatica (gotukola) possess wide range of biological activities like anti-inflammatory, anti-psoriatic, anti-ulcer, hepato-protective, anticonvulsant, immunostimulant, cardioprotective, antidiabetic, antiviral, antibacterial, antifungal, etc. so, it could be used as adjunctive to mechanical periodontal therapy.

Eligibility criteria:
inclusion criteria: * minimum of 22 natural teeth * participants with chronic generalized gingivitis * participants with plaque index score ≥1 exclusion criteria: * participants with fixed or removable appliances * participants with more than full coverage restorations * medically compromised participants * participants on long term medications * smokers * participants who had used any type of antibacterial mouthwash in 4weeks of commencement. * patients with history of recent periodontal therapy

Keywords: antiplaque antigingivitis
intrathecal dexmedetomidine versus transversus abdominus plane block (tap) for postoperative analgesia after cesarean section.

Conditions: Pain Management in Adult Females in Child Bearing Period Aging From 20 to 45 Years Who Are Scheduled for Elective Cesarean Section

Summary: spinal anesthesia is the most commonly used technique for lower abdominal surgeries as it is very economical and easy to administer. however, postoperative pain control is a major problem because spinal anesthesia using only local anesthetics is associated with relatively short duration of action, and thus early analgesic intervention is needed in the postoperative period the transversus abdominus plane (tap) block is a regional analgesic technique which blocks t6-l1 nerve branches and has an evolving role in postoperative analgesia for lower abdominal surgeries


Eligibility criteria:
inclusion criteria: 1. asa physical status classes i and ii 2. scheduled for elective cesarean section 3. aged between 20-45 years . exclusion criteria: 1. patient refusal. 2. patient with significant cardiovascular disease , hepatic dysfunction , renal failure , chronic pulmonary disease . 3. neuromuscular disorder. 4. infection. 5. bleeding disorder. 6. obesity ( bmi \> 30 kg/m2 ) . 7. history of allergy or sensitivity to any of the study drugs in previous surgeries .
heart rate variability biofeedback following traumatic brain injury

Conditions: Traumatic Brain Injury

Summary: individuals with mild traumatic brain injury will be randomly assigned to an active heart rate variability biofeedback condition and a sham condition. the investigators will use a randomized pre-post design that will consist of two data collection phases and a 5-week treatment condition. the heart rate variability biofeedback active condition is designed to increase heart rate oscillations (osc+ condition) consistent with current best practices, while the sham control heart rate variability biofeedback condition is designed to decrease heart rate oscillations (osc- condition).

there are two primary aims of the study: (1) examine whether heart rate variability increases at rest in individuals with mild traumatic brain injury from pre-treatment to post-treatment following heart rate variability biofeedback; (2) to test whether heart rate variability recovery following a stressor improves in individuals with mild traumatic brain injury following heart rate variability biofeedback. regarding the first primary aim, the investigators hypothesize that heart rate variability will be higher in individuals with mild traumatic brain injury following heart rate variability biofeedback compared to those in the control/sham condition where the investigators do not expect such improvement pre- to post-testing. for the second aim, consistent with previous work, the investigators hypothesize that heart rate variability recovery following a stressor will be faster in individuals with mild traumatic brain injury following heart rate variability biofeedback compared to a sham control condition. there are three secondary aims for this study: (1) to evaluate whether improvements in heart rate variability in individuals with mild traumatic brain injury following heart rate variability biofeedback are associated with improvements in physical symptoms common after head injury (i.e., headaches, dizziness, sleep disturbance); (2) to evaluate whether improvements in heart rate variability in individuals with mild traumatic brain injury following heart rate variability biofeedback are associated with improvements in emotional functioning (i.e., life satisfaction, anxiety symptoms, depression symptoms); and (3) to evaluate whether improvements in heart rate variability in individuals with mild traumatic brain injury following heart rate variability biofeedback are associated with improvements in cognitive functioning (i.e., attention, inhibitory control).

Eligibility criteria:
inclusion criteria: * at least six months post-injury to account for spontaneous recovery * aged 18-55 years * fluent in english * able to provide informed consent. exclusion criteria: * presence of a pacemaker * previous self-reported heart attack with hospitalization * diagnosed learning disability * other neurological difficulties or diagnoses (i.e., stroke, epilepsy) * participation in current litigation * uncorrected visual impairment.
improving a bayesian model's survival estimates in patients needing surgery for bone metastases

Conditions: Bone Metastases

Summary: the goal of this study is to improve how we estimate survival of people with cancer that has spread to their bone. there have been previous attempts to estimate survival of people with cancer that spread to the bone, but they have not been accurate. this study will try to improve the way we estimate survival in people with cancer that has spread to their bone by looking to see if a physician assessment and a patient assessment of the health status can be blended to give a better estimate of survival than patients or doctors alone.


Eligibility criteria:
inclusion criteria: * ≥ to 18 years of age * diagnosed with a metastatic malignancy * histologically proven in oligometastatic disease or by clinical suspicion in widely metastatic disease * by conventional radiographs, cross sectional imaging and/or scintigraphy * scheduled for an orthopaedic operative intervention for skeletal metastases at mskcc or montefiore medical center including, not limited to the following: * resection * intramedullary fixation * prophylactic fixation * curettage and cementation * internal fixation * arthroplasty * spine stabilization exclusion criteria: * none

Keywords: questionnaire 11-121
efficacy and tolerability of cisplatin plus alternating weekly temozolomide in recurrent high-grade gliomas

Conditions: High-grade Gliomas

Summary: currently, the prognosis of recurrent high-grade gliomas is still dismal with no standard treatment protocol established. cisplatin (cddp), recommended by national comprehensive cancer network (nccn) as a chemotherapeutic agent in salvage treatment for recurrent high-grade gliomas, was shown to reduce o6-alkylguanine dna-alkyl transferase (agat) activity and potentially capable of enhancing the antitumor effects of temozolomide (tmz). compared to the standard 5-day tmz regimen, alternating weekly regimen that deliver more prolonged exposure of tmz may lead to higher cumulative doses, and may deplete more o6-methylguanine dna methyltransferase (mgmt), thus reducing the resistance of tumor cells to tmz. the investigators therefore initiate a single-arm phase ii study to evaluate the efficacy and tolerability of cddp plus alternating weekly tmz regimen in patients with recurrent high-grade gliomas.


Eligibility criteria:
inclusion criteria: * histological diagnosis of primary tumor as high-grade gliomas (who iii or iv) * all patients should complete radiation therapy for primary gliomas. * mri showed unequivocal evidence of tumor recurrence or progression. * the time to be enrolled should be more than 90 days after the radiation therapy. * written informed consent * eastern cooperative oncology group(ecog) score: 0-2 * the patients with recurrent gliomas were treated without dose-dense tmz therapy before enrollment. * surgical interventions for recurrent gliomas are permitted and patients with no residual tumor are permitted exclusion criteria: * abnormal function of liver or renal (value more than 1.5 fold normal upper limit) * blood routing: hb \< 90g/l, absolute neutrophil count≤1.5\*10\^9/l, platelet \< 100\*10\^9/l * pregnant or lactating women * allergic to administered drugs * radiation therapy in the previous 90 days before enrollment * the patients with recurrent gliomas were treated with dose-dense tmz therapy before enrollment. * acute infection in need of antibiotics intravenously * participation in other clinical trials in the 90 days before enrollment

Keywords: recurrent high-grade gliomas cisplatin (cddp) temozolomide (tmz)
open-label extension study to evaluate long-term safety of sacubitril/valsartan in pediatric patients with hf

Conditions: Heart Failure

Summary: the purpose of this study was to evaluate long-term safety and tolerability and to provide post-trial access to sacubitril/valsartan to eligible participants who successfully completed clcz696b2319 (panorama-hf) core study part 2 as per protocol.

this was a multicenter, open-label long-term extension study for participants who successfully completed panorama-hf core study part 2 of the trial or who discontinued study drug treatment early in part 2 due to the implementation of urgent safety measure (usm) of panorama-hf core study. provided that they fulfilled the protocol requirements, these patients were eligible to participate in the ole. depending on when and where the participant was enrolled, the duration of the study was of a minimum of 1 year, or until receipt of local marketing authorization and commercial availability, or reaching the maximum limit allowed by local regulations, or until dec-2023, whichever occurred first.

Eligibility criteria:
inclusion criteria: * signed informed consent * on study drug at panorama-hf part 2 eos visit. does not have any significant safety issue exclusion criteria: * subject only participated in panorama-hf part 1 or was a sf in panorama-hf or permanently discontinued study drug in panorma-hf part 2 * use of investigational drugs within 5 half-lives of enrollment or within 30 days (longer duration); with the exception of panorama-hf study drug (requires \>/=36-hour washout before baseline visit) * history of hypersensitivity or allergy to study treatment, its excipients or drugs of similar chemical class, aceis, arbs, or nep inhibitor and known/suspected contraindications to sacubitril/valsartan * renal vascular hypertension (including renal artery stenosis) * significant renal estimated glomerular filtration rate disorder (egfr calculated using modified schwartz formula \ 3 times upper limit of normal); gastrointestinal disorder or biliary disorder * history of angioedema * parents or legal guardians of subject who do not give consent or allow the child to give assent, or inability of patient or parents/legal guardians to follow instructions or comply with follow-up procedures * any medical condition(s) that may put the patient at risk in the investigator's opinion or that the investigator deems unsuitable for the study * other protocol defined inclusion/exclusion criteria may apply

Keywords: heart failure pediatric lcz696 sacubitril/valsartan open-label study angiotensin receptor neprilysin inhibitor panorama-hf
frequency needed for school-based obesity intervention

Conditions: Obesity, Child

Summary: this randomized controlled trial compared changes in mexican-american, adolescent standardized body mass index (zbmi) from a school-based obesity intervention given zero, one, three, or five days a week.

efficacious school-based interventions have been intensive making it difficult for interventions to be scaled. the more components there are to an intervention, typically the better the results. instead of decreasing intensity via the removal of intervention components, this randomized controlled trial aimed to compare changes in mexican-american adolescent standardized body mass index (zbmi) based on the number of days per week they received a multi-component intervention. mexican-american middle school students (n=203) with overweight or obesity were recruited from an independent school district in houston. students were randomized to receive an obesity intervention with established efficacy zero (control), one, three, or five days/week. in each condition, 80% of intervention time was allocated to physical activity and 20% to nutrition. directly measured height and weight were used to calculate zbmi.

Eligibility criteria:
inclusion criteria: 1. bmi-for-age (body mass index) percentile ≥ 85 2. male or female between ages 10 - 17 years 3. self-identified as mexican-american exclusion criteria: 1. student who is pregnant, planning to become pregnant, or becomes pregnant 2. school report of cognitive impairment significantly below average age and/or grade level 3. use of any weight-loss medication (prescription or nonprescription) for at least 6 months prior to screening 4. type 1 or 2 diabetes medical diagnosis
neuromonitoring of hepatic encephalopathy

Conditions: Liver Failure, Acute; Hepatic Encephalopathy

Summary: neuromonitoring of critically ill patients in the intensive care unit (icu) is challenging. clinical scoring systems produce insufficient information with deeply sedated patients, and disturbances of normal hemostasis limit the use of invasive intra-cranial pressure measurements. eeg based monitoring algorithms have been introduced into the operation theater and general anaesthesia, but these algorithms cannot be used in the intensive care setting without modifications. eeg is also susceptible to electrical disturbances, such as those created by patient movement. the study is conducted in finland, in the intensive care unit of the surgical hospital of helsinki. the total number of patients in this study is 20, and it is a part of a larger neuromonitoring study with a total of 110 patients. the patients are divided into four subgroups, as follows: 1. patients admitted to icu with acute liver failure, 2. patients admitted to the postoperative cardio-thoracic icu after cardiac surgery with perioperative total heart arrest, 3. patients admitted to the icu because of status epilepticus and finally 4. patients in critical condition, admitted to the icu after any surgery. this study concentrates on the first group of patients with acute liver failure. clinical care of patients is not altered. when arriving into the icu eeg-monitoring will added to routine monitoring. to evaluate the neurological status the following tests are performed: clinical test, blood tests and transcranial doppler ultrasound. the entropy of eeg is measured along with the raw eeg signal. the recruiting of study patients was begun in december 2005 and the final study patients were recruited in december 2011. ge healthcare finland supplies the entropy monitoring devices and pays the salary of the research nurses who collect the study data. clinical investigators will not receive funding from any commercial company. all patients (or their next of kin) included have given their written informed consent for inclusion in the study. the aim of this study is to find new factors and new non-invasive techniques, which correlate with the neurological state and outcome of patients suffering critical illness.


Eligibility criteria:
inclusion criteria: * age 18 or over * acute liver failure, referred to the icu of the surgical hospital exclusion criteria: -

Keywords: hepatic encephalopathy brain waves electroencephalogram transcranial doppler ultrasonography physiological monitoring intensive care