Kornimate/medical-research-clean huggingface dataset:
high dose therapy and peripheral blood stem cell transplantation in hiv related non hodgkin lymphoma (nhl) at high risk

Conditions: HIV-related Lymphoma; HIV Infections

Summary: the purpose of the study is to evaluate the efficacy of an intensified first-line treatment, with conventional chemotherapy (chop) plus monoclonal antibody anti cd20, followed by high dose chemotherapy and pbsc transplantation in hiv-related aggressive non-hodgkin lymphoma at "high risk" , according to the international prognostic index (ipi).

hiv associated nhl show particularly aggressive clinical features and a worse prognosis compared to the general population. the recent introduction of highly active antiretroviral therapy (haart)has improved hiv positive patients' clinical conditions and reduced the risk of opportunistic infections, thus making hiv+ patients more similar to hiv- patients. several studies have shown that the early use (as first line treatment) of high dose chemotherapy (hdt) with peripheral blood stem cell transplantation (pbsct) is superior in the hiv negative setting to conventional dose chemotherapy, at least in patients with poor prognostic factors at diagnosis. recently, several experiences have shown the feasibility, safety and efficacy of hdt and pbsct, in association with haart, as salvage therapy in hiv positive patients with lymphoma who maintain a chemosensitive disease after first-line treatment failure. it is rationale therefore to explore the use of this treatment strategy earlier, within the upfront treatment of hiv-associated lymphoma, in those patients with poor prognostic factors at diagnosis, according to the international prognostic score (ipi).

Eligibility criteria:
inclusion criteria: * hiv positivity * "large cell"histology (dlbcl, immunoblastic, plasmablastic, anaplastic lymphoma) * age 18-60 years * age-adjusted ipi 2-3 * ann arbor stage i b-iv * written informed consent. exclusion criteria: * burkitt lymphoma * lymphoblastic lymphoma * primary effusion lymphoma * age-adjusted ipi 0-1 * performance status (who) \>2 (if not related to lymphoma) * inadequate cardiac function (v.e.f. \< 50%) or clinically evident cardiac disease * inadequate pulmonary function (dlco \< 50% and/or o2 \< 96%) * inadequate renal function (creatinine \> 2 mg/dl) * inadequate liver function (ast/alt \> 3 uln and/or pt \< 70%, if not related to lymphoma) * inadequate marrow function (neutrophils \< 1500/cmm; platelets \< 100.000/cmm, if not related to lymphoma) * virologic failure to haart (including at least one nrti, one nnrti and two pi) and/or cd4 count \< 50/cmm. * cns or meningeal lymphoma * active opportunistic infections * pregnancy * other evolutive malignancy (except of localized non-melanoma skin cancer and in situ portio carcinoma) * any other condition that contraindicates this treatment program at discretion of physician * hbsag positivity with active viral replication (hbv-dna positivity)

Keywords: hiv non hodgkin lymphoma peripheral blood stem cell transplantation
mother's gift project

Conditions: Pneumococcal Infections

Summary: this prospective randomized evaluation of pneumococcal vaccine immunization of pregnant mothers, followed by pneumococcal conjugate immunization of their children is designed to assess the effects of these strategies on the immunogenicity and safety of both vaccines. we hypothesize that maternal followed by infant immunization will be safe and will provide higher levels of antibody from birth through 12 months of age.

this is a randomized vaccine evaluation in 4 groups of mothers and their infants, to assess the effect of maternal immunization on the infants' response to pneumococcal vaccine.

Eligibility criteria:
inclusion criteria: * mothers from 18 to 14 years of age in the third trimester of pregnancy, * with normal medical and obstetric history, * who plan to deliver their infant in dhaka city and remain there for 12m exclusion criteria: * maternal history of systemic disease, * maternal history of previous complicated pregnancies, preterm delivery, abortions, or birth with congenital anomalies. * maternal hypersensitivity to any vaccination, or * maternal receipt of pneumococcal vaccine in the last 3 years.

Keywords: gestational immunization, infant antibody, cord antibody
the effect of reiki on breastfeeding self-efficacy, pregnancy complaints and quality of life

Conditions: Obstetric Complication

Summary: despite the benefits of reiki application, no study has been found that examined the effects of reiki on breastfeeding self-efficacy, complaints during pregnancy and quality of life in pregnant women.

reiki, one of the complementary and alternative therapy (cam) methods; it means "universal life energy" and is natural healing energy (müller \& günther, 2006). this healing method is a way of treating others physically and spiritually (vitale\&o'connor, 2006; yücel, 2007). reiki focuses on energy chakras and bio-psycho-spiritual healing. reiki enables vital signs (blood pressure, pulse rate, respiratory rate) to reach normal levels, reduces acute and chronic pain, facilitates sleep, reduces anxiety and fear, relieves depression, reduces stress, provides relaxation, reduces the use of painkillers and increases coping skills. (anderson \& ameling, 2001; kelley \& william, 2009; lee et al., 2003; pocotte \& salvador, 2008; vitale, 2006). nurses are responsible for increasing the general health level of the mother by detecting and treating the existing diseases in the pregnant, providing timely diagnosis and treatment of potential problems that may arise, monitoring and evaluating the development of the mother and the fetus during pregnancy, giving care to the mother during pregnancy, general body care, nutrition, activity, family planning, it is responsible for providing information on signs of danger, care of the newborn and other issues that the mother may need, preparing the mother for birth physiologically and psychologically, thus increasing the quality of life of the mother (taşkın, 2016).

Eligibility criteria:
inclusion criteria: first pregnancy in 28th and above gestational week able to read and write open to communication exclusion criteria: having psychiatric history diagnosed with risky pregnancy having congenital anomaly in the baby in the postpartum period having the childbirth preparation classes receiving energy therapies before and having reiki training certificate

Keywords: reiki breastfeeding self-efficiency quality of life
acute respiratory distress syndrome(ards) in neonates

Conditions: ARDS; NRDS

Summary: acute respiratory distress syndrome in neonates has been defined in 2015. earlier identification and successful intervention into the potential pregnancy associated risk factors for the conversion from nrds to ards is one of the most important components of ards prevention.

pregnancy risk factors (prf), such as intrahepatic cholestasis during pregnancy(icp), hypertensive disorder complicating pregnancy(hdcp) and gestational diabetes mellitus(gdm), are related to nrds, ards and subsequent death. meantime, it has also been proven that the prevention of prf reduces the risk of nrds and ards. however, few study reported the relations between prf and the conversion from nrds to ards, and it also remains unknown whether treating prf can reduce the progression from nrds to ards. we have found that prf were related to the increase and deterioration of nrds in a chinese cohort. the aims of the present study were: 1). to report the effects of prf on the conversion from nrds to ards. 2). to clarify whether prf treatment could prevention from conversion from nrds to ards in a chinese population.

Eligibility criteria:
inclusion criteria: 1. the gestational age was less than 37 weeks; 2. these neonates were diagnosed with nrds; the diagnosis of nrds was based on clinical manifestations and chest x-ray findings. the clinical signs and symptoms of nrds were respiratory distress, tachypnea, nasal flaring, groan, and cyanosis after birth. the typical x-ray picture of rds showed a grain shadow, air bronchogram or white lung. 3. informed parental consent has been obtained exclusion criteria: 1. parents' decision not to participate; 2. major congenital anomalies; 3. died or left the neonatal intensive care unit(nicu) within 24 hour.
acupuncture therapy for covid-related olfactory loss

Conditions: Olfactory Dysfunction; COVID-19

Summary: this study is looking at the role of acupuncture as a treatment for olfactory dysfunction in patients who tested positive for covid-19.


Eligibility criteria:
inclusion criteria: * 18 years or older. * patients with post-viral olfactory dysfunction \> 4 weeks. * history of positive covid-19 pcr. exclusion criteria: * less than 18 years of age. * active sinus infection. * new diagnosis of untreated crs. * prior diagnosis of dementia or parkinson's disease. * prior head trauma or neurosurgical procedure resulting in olfactory loss. * patients who do not speak or read english. * patients unable to understand and sign the study consent.
mind-body walking exercise for chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease; Exercise; Anxiety; Depression; Dyspnea; Quality of Life; Heart Rate Variability

Summary: mind-body exercise improves symptom of negative moods, dyspnea and quality of life in chronic diseases, but these improvements for chronic obstructive pulmonary disease (copd) are unproven. this study aims to examine the effects of dyspnea, exercise capacity, heart rate variability(hrv), anxiety, depression, interoceptive awareness, quality of life(qol) in patients with copd across a three-month mind-body exercise program.

chronic obstructive pulmonary disease (copd) is a progressive disease characterized by airflow limitation, has a high prevalence of morbidity and mortality, and results in negative physical, psychological, and quality of life (qol) impacts. patients with copd typically experience dyspnea, exercise intolerance, autonomic dysfunction, anxiety, depression, and poor qol. mind-body intervention with walking, breathing, and mindfulness is beneficial for the health of patients with copd. however, the result of mind-body walking intervention for patients with copd is not clear. thus, this study will evaluate the effects of mind-body walking exercise (mbwe) on the physical psychological wellbeing and qol of patients with copd. this study will be a randomized controlled trial. data will collect from the pulmonary clinics of a medical center in northern taiwan. the participants will recruit and randomly assign into the mbwe group or the control group. participants in the control group will receive their usual care. participants in the mbwe group will receive not only their usual care but also a mbwe program, consisting of walking, breathing, and mindfulness activities, for 30 min per day, 5 days per week, for 8 weeks. data will collect at baseline and follow up on week 4 (wk 4), week 8 (wk 8), and week 12 (wk12). the primary outcome is dyspnea using modified borg scale. the secondary outcomes are dyspnea in daily life using modified medical research council (mmrc), exercise capacity using six minute walk distance (6mwd), heart rate variability (hrv), anxiety and depression using the hospital anxiety and depression scale (hads), interoceptive awareness using the multidimensional assessment of interoceptive awareness- chinese version (maia-c), qol using copd assessment tes (cat). the independent t-test and chi-square test were used to examine the homogeneity of the demographic characteristics of two groups. generalized estimating equations were used to examine the data from repeated measurements.

Eligibility criteria:
inclusion criteria: 1.mild to severe copd exclusion criteria: 1. patients visited the emergency room or were hospitalized previous month; 2. long-term oxygen therapy; 3. atrial fibrillation; 4. severe cognitive impairment; 5. great than class ii heart failure as defined by the new york heart association functional classification in previous six months; 6. pacemaker were excluded; 7. received cancer treatment 8. participated in other exercise trials
phase iii long-term extension study with dexpramipexole

Conditions: Eosinophilic Asthma

Summary: the goal of this clinical trial\] is to evaluate the long term safety of dexpramipexole treatment in participants with severe asthma, aged ≥18 years, on global initiative for asthma (gina) 2021 \[gina, 2021\] step 4 or 5 therapy and who completed either of the phase iii studies exhale-2 or exhale-3.


Eligibility criteria:
inclusion criteria: 1. participants who completed the double-blind study intervention treatment period during either of the phase iii studies exhale-2 or exhale-3. 2. participants capable of giving signed informed consent/assent which includes compliance with the requirements and restrictions listed in the informed consent form (icf) and in this protocol. 3. negative urine pregnancy test for women of childbearing potential (wocbp; after menarche) at the baseline visit/day 1. 4. wocbp (after menarche) must use either of the following methods of birth control, from the baseline visit/day 1 through the end of study visit: 1. a highly effective form of birth control (confirmed by the investigator). highly effective forms of birth control include: true sexual abstinence, a vasectomized sexual partner, implanon, female sterilization by tubal occlusion, any effective intrauterine device (iud), iud/intrauterine system, levonorgestrel intrauterine system, or oral contraceptive. -or- 2. two protocol acceptable methods of contraception in tandem. women not of childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal. women will be considered postmenopausal if they have been amenorrheic for ≥12 months prior to the planned date of the baseline visit/day 1 without an alternative medical cause. the following age specific requirements apply: 3. women \<50 years old will be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatment and follicle stimulating hormone levels in the postmenopausal range. 4. women ≥50 years old will be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatment. exclusion criteria: 1. clinically significant change in health status during either of the phase iii studies exhale-2 or exhale-3 which in the opinion of the investigator would make the participant unsuitable for participation in this study. 2. participants with allergy/intolerance to dexpramipexole or any of its excipients. 3. participants who met permanent discontinuation criteria or permanently discontinued study treatment for any reason in either of the phase iii studies exhale-2 or exhale-3.. 4. treatment with selected drugs known to have a substantial risk of neutropenia in the past 30 days. 5. pregnant or breastfeeding women. 6. males who are unwilling to use an acceptable method of birth control during the entire study period (ie, condom with spermicide).

Keywords: exacerbations severe asthma exhale-2 exhale-3 exhale-4 uncontrolled asthma asthma attack
a study of nvl-520 in patients with advanced nsclc and other solid tumors harboring ros1 rearrangement (arros-1)

Conditions: Locally Advanced Solid Tumor; Metastatic Solid Tumor

Summary: phase 1/2, dose escalation and expansion study designed to evaluate the safety and tolerability of nvl-520, determine the recommended phase 2 dose (rp2d), and evaluate the antitumor activity in patients with advanced ros1-positive (ros1+) nsclc and other advanced ros1-positive solid tumors. phase 1 will determine the rp2d and, if applicable, the maximum tolerated dose (mtd) of nvl-520 in patients with advanced ros1-positive solid tumors. phase 2 will determine the objective response rate (orr) as assessed by blinded independent central review (bicr) of nvl-520 at the rp2d. secondary objectives will include the duration of response (dor), time to response (ttr), progression-free survival (pfs), overall survival (os), and clinical benefit rate (cbr) of nvl-520 in patients with advanced ros1-positive nsclc and other solid tumors.

in phase 2, study patients will be enrolled into 5 distinct expansion cohorts: * cohort 2a: ros1-positive nsclc naïve to tyrosine kinase inhibitor (tki) therapy and up to 1 prior chemotherapy and/or immunotherapy. * cohort 2b: ros1-positive nsclc treated with 1 prior ros1 tki and no prior chemotherapy or immunotherapy. * cohort 2c: ros1-positive nsclc treated with 1 prior ros1 tki and 1 prior platinum-based chemotherapy with or without immunotherapy. * cohort 2d: ros1-positive nsclc treated with ≥2 prior ros1 tkis and up to 1 prior chemotherapy and/or immunotherapy. * cohort 2e: ros1-positive solid tumor and progressed on any prior therapy.

Eligibility criteria:
inclusion criteria: 1. age ≥18 years (cohort 2e only: age ≥12 years and weighing\>40 kg). 2. disease criteria: 1. phase 1: histologically or cytologically confirmed locally advanced or metastatic solid tumor with documented ros1 rearrangement. 2. phase 2: cohorts 2a, 2b, 2c and 2d: histologically or cytologically confirmed locally advanced or metastatic nsclc with ros1 rearrangement. 3. phase 2: cohort 2e: histologically or cytologically confirmed locally advanced or metastatic solid tumor (other than nsclc) with ros1 rearrangement. 3. prior anticancer treatment (except cohort 2a). 4. phase 1: must have evaluable disease (target or nontarget) according to recist 1.1. phase 2: must have measurable disease according to recist 1.1. 5. adequate baseline organ function and bone marrow reserve. exclusion criteria: 1. patient's cancer has a known oncogenic driver alteration other than ros1. 2. known allergy/hypersensitivity to excipients of nvl-520. 3. major surgery within 4 weeks of first dose of study drug. 4. ongoing anticancer therapy. 5. actively receiving systemic treatment or direct medical intervention on another therapeutic clinical study.
resting state electroencephalogram for psychotic disorders

Conditions: Schizophrenia; Bipolar Disorder; Depression

Summary: electroencephalography (eeg) has been proposed as a neurophysiological biomarker to delineate psychotic disorders. meanwhile, the increased appetite, which might related to self-control process, has been an increasing concern for the management of psychotic disorders. in this cross-section study, investigators collect the resting state eeg data, self-control related scale, eating behaviour questionnaire and psychotic syndrome related assessement and try to find the connection between those measurers, in order to provide novel understanding on the mechanism of psychotic diseases.


Eligibility criteria:
inclusion criteria: diagnosed with schizophrenia or bipolar disorder or mdd in accordance with dms-5 informed consent exclusion criteria: diagnosed with other mental disease in accordance with dsm-5 comorbid with other severe physiological disease drug or alcohol abuse pregnant or lactating

Keywords: electroencephalography eating behavior self control
bmt-care: psychosocial intervention for transplant caregivers

Conditions: Bone Marrow Transplant Complications; Hematologic Malignancy

Summary: the goal of this study is to evaluate whether a psychological intervention (bmt-care) is effective at improving the quality of life in caregivers and patients treated with hematopoietic cell transplant compared to usual care, and to identify critical facilitators and barriers for bmt-care implementation and adoption.

this is a randomized clinical trial to determine whether a psychosocial intervention (bmt-care) is effective at improving the quality of life and reducing psychosocial distress of caregivers and patients treated with hematopoietic cell transplant (hct). the bmt-care intervention was developed with the goal of improving the experience and needs of caregivers of patients treated with hct. caregivers will be randomized into one of the two study groups: bmt-care plus usual care, or usual care. participation in this study is expected to last up to 180 days after hct. investigators expect that about 400 caregivers and up to 400 patients treated with hct will take part in this research study. the national institutes of health is supporting this research by providing funding.

Eligibility criteria:
caregiver inclusion criteria: * adult caregivers (≥18 years) who is a relative or friend whom the patient identified as living with them or having in-person contact with them at least twice a week. * caregiver of a patient receiving allogeneic or autologous hct for the treatment of cancer. * ability to read and respond to survey questions in english, spanish or with minimal assistance from an interpreter. caregiver exclusion criteria: * caregivers of patients undergoing hct for a benign hematologic condition or undergoing outpatient hct. * caregivers with a major untreated psychiatric or cognitive condition which the treating oncology clinicians believes interferes with the capacity to provide informed consent. patient inclusion criteria: * adult patients (≥18 years) with a hematologic malignancy and planned admission for autologous or allogeneic hct. * ability to respond to questions in english, spanish, or with minimal assistance from an interpreter.

Keywords: neoplasms by site hematologic diseases neoplasms hematologic neoplasms
binge drinking among youngs is a risk factor for alcohol use disorders

Conditions: Binge Drinking

Summary: the purpose of this study was to assess drinking habits and patterns of alcohol consumption, smoking habits, use of illicit drugs and the prevalence of binge drinking and alcohol use disorders among italian young students. furthermore to investigate the correlation between binge drinking and alcohol use disorders.

this study was performed on 2,704 subjects attending high school, through the administration of questionnaires regarding socio-demographic data, anthropometric characteristics, pattern and amount of alcohol intake, smoking habits, use of illicit drugs and physical activity were administered to students. moreover mood and anxiety were evaluated through audit, stai-y1, stay-y2 and zung. the aim of the study was to assess drinking habits and patterns of alcohol consumption, smoking habits, use of illicit drugs and the prevalence of binge drinking and alcohol use disorders among italian young students. furthermore to investigate the correlation between binge drinking and alcohol use disorders.

Eligibility criteria:
inclusion criteria: * subjects attending high school of three italian cities (rome, latina, frosinone) * subjects aged between 13 and 19 years * subjects that accept the interview exclusion criteria: * subjects that don't accept the interview
atropine versus glycopyrrolate in preventing spinal anesthesia induced hypotension in lower limb surgeries

Conditions: Lower Extremity Fracture

Summary: a study to compare between intravenous atropine and glycopyrrolate in preventing spinal anesthesia induced hypotension in patients undergoing major lower limb orthopedic surgeries. hypotension is the most common complication in spinal anesthesia that can be life threatening. if this can be prevented patients comfort can be increased and satisfaction as well.


Eligibility criteria:
inclusion criteria: * asa ps i and ii, * age 16 to 65, * undergoing lower limb major orthopedic surgery, * willing to participate exclusion criteria: * contra indication to spinal anesthesia, * patient refusal, * asa ps \>iii, * cardiac diseases, * hypertension \>160/ 100, * arrhythmias, * acute coronary syndrome, * patients taking beta-blockers, * hepatic and pulmonary diseases