Kornimate/medical-research-clean huggingface dataset:
human intravenous interferon beta-ia safety and preliminary efficacy in hospitalized subjects with covid-19

Conditions: Covid19

Summary: this double-blinded, randomized study is being conducted to see if the investigational new drug called fp-1201-lyo - intravenous interferon beta-1a, hereafter iv ifn beta-1a, can help patients recover more quickly from covid-19 and prevent worsening of the condition. to understand if iv ifn beta-1a can help treat patients with covid-19, this study drug will be compared to dexamethasone. study subjects will be treated daily with iv ifn beta-1a 10 μg or iv dexamethasone for 6 consecutive days while hospitalized and will undergo daily assessments while in hospital for a maximum of 28 days. study specific assessments will be collected at pre-dose day 1 through day 28 (pd and pim assessments), in addition, clinical routine assessments will be utilized for safety and efficacy assessments.


Eligibility criteria:
inclusion criteria: 1. age ≥18 years 2. positive sars-cov-2 test by pcr (polymerase chain reaction) or other diagnostic method within the past 7 days 3. admission to hospital with respiratory symptoms of covid-19 requiring hospital care and oxygen supplementation (≤ 8l/min) 4. respiratory symptom onset no more than 7 days prior to hospital arrival 5. informed consent from the subject or the subject's personal legal representative or a professional legal representative must be available exclusion criteria: 1. unable to screen, randomize and administer study drug within 48 hours from arrival to hospital 2. systemic corticosteroid, baricitinib or tofacitinib (or other jak-stat signalling pathway inhibitors) therapy within 7 days prior to arrival to hospital or planned for the next days 3. known hypersensitivity or contraindication to natural or recombinant ifn-beta-1a or its excipients, or to dexamethasone or its excipients 4. currently receiving ifn-beta-1a therapy 5. home assisted ventilation (via tracheotomy or non-invasive) except for continuous positive airway pressure (cpap) / bilevel positive airway pressure (bipap) used only for sleep-disordered breathing 6. participation in another concurrent interventional pharmacotherapy trial during the study period 7. decision to withhold life-sustaining treatment; patient not committed to full support (except dnr after cardiac arrest only) 8. woman known to be pregnant, lactating or with a positive pregnancy test (urine or serum test) 9. subject is not expected to survive for 24 hours 10. subject has liver failure (child-pugh grade c) 11. any clinical condition that in the opinion of the attending clinician or investigator would present a risk for the subject to participate in the study
long term follow-up of the 23mm portico™ aortic valve implant and the st. jude medical transfemoral delivery system

Conditions: Aortic Valve Stenosis

Summary: collect and evaluate the long term safety data.

the purpose of this study is to collect and evaluate the long term safety data of the 23mm portico™ transcatheter heart valve and the transfemoral delivery system previously implanted in subjects with aortic valve disease.

Eligibility criteria:
inclusion criteria: 1. subject has given written study informed consent for participation prior to any study procedures. 2. subject is ≥ 18 years of age or legal age in host country at time of consent. 3. subject currently has a 23mm sjm portico transfemoral transcatheter heart valve exclusion criteria: 1. subject currently participating in another investigational device or drug study. 2. subject is unable or unwilling to return for the required follow-up visits.
darbepoetin for ischemic neonatal stroke to augment regeneration

Conditions: PAIS; Neonatal Stroke; Perinatal Stroke

Summary: the aim of the study is to perform a randomized double-blind placebo controlled prospective study in newborn infants with mri confirmed middle cerebral artery (mca) perinatal arterial ischemic stroke (pais) with darbepoetin. it will be investigated whether intravenous administered darbepoetin can induce the formation of neuronal tissue and restore brain function in neonates who suffered from pais compared to placebo treated controls. the ultimate goal of this study is therefore to develop a therapy using erythropoiesis-stimulating agents (esa) such as darbepoetin to reduce or even prevent lifelong consequences of pais-related brain injury in this group of term newborns.


Eligibility criteria:
inclusion criteria: * newborns ≥ 36+0 weeks of gestation, both male and female * mri confirmed diagnosis of acute pais, in the mca region with involvement of the cortical spinal tract (e.g. posterior limb of internal capsule \[plic\] or peduncles) within one week after birth * written informed consent from custodial parent(s) exclusion criteria: * moderate -severe hypoxic-ischemic encephalopathy (hie) with or without hypothermia therapy * any proven or suspected major congenital anomaly, chromosomal disorder, metabolic disorder; * presence of a serious infection of the central nervous system; * no realistic prospect of survival, (e.g. severe brain injury), at the discretion of the attending physician. * infant for whom withdrawal of supportive care is being considered.
effects of ultraviolet b exposure using a ultraviolet skin care device on vitamin d production and immune response in healthy adults

Conditions: Skin Inflammation; Skin Melanoma

Summary: vitamin d regulates various physiological functions, including calcium homeostasis, bone health, and potentially reducing cancer risks. its primary source is ultraviolet b radiation, but factors like aging, skin type, and modern lifestyles limit sun exposure, leading to widespread deficiency. this study explores using a daily ultraviolet b light emitting diodes device to improve vitamin d levels while assessing the potential for skin inflammation.


Eligibility criteria:
inclusion criteria: age ranges 19-65 years healthy participants patients who are willing or able to follow the doctor's instructions fully understand the purpose and procedure of this clinical trial exclusion criteria: participants excluded those who have any kind of disease lactating and pregnant women physical disabilities that could interfere with participation, a history of depression, or other psychiatric conditions
homeopathic treatment for depression in peri- and postmenopausal women

Conditions: Moderate Depression; Menopausal and Postmenopausal Disorders

Summary: the aim of this study was to determine whether individualized homeopathic treatment and fluoxetine are more efficient than placebo for moderate to severe depression in peri- and postmenopausal women.

perimenopausal period is characterized by an increased risk of depressive symptoms. major depression is one of the most disabling medical conditions worldwide. at present, it is becoming more difficult to prove that antidepressants actually work better than placebo in clinical trials.use of homeopathy to treat depression is widespread, but there is a lack of clinical trails about its efficacy in depression in peri- and postmenopausal women. previous trials suggest that individualized homeopathic treatments improve depression in general population. the purpose of this study was to determine whether individualized homeopathic treatment and fluoxetine are more efficient than placebo for moderate depression in peri- and postmenopausal women.

Eligibility criteria:
inclusion criteria: * major depression according to dsm-iv * moderate to severe depression according to 17-item hamilton rating scale for depression (14-24 score) * no current use of homeopathic treatment for depression or antidepressants or anxiolytic drugs 3 months prior to study entry * not be currently taking psychotherapy for at least 3 months before study entry * early transition to menopause defined by a change in cycle length of 7 days or longer in either direction from the participant´s own baseline for at least 2 cycles * late transition to menopause defined as 3 to 11 months of amenorrhea * postmenopausal stage defined by 12 months or more of amenorrhea * capability and willingness to give informed consent and to comply with the study procedures exclusion criteria: * pregnancy or breastfeeding * other psychiatric disorders different from moderate to severe depression (severe depression, schizophrenia, psychotic disorders, bipolar affective disorders, suicide attempt) * alcohol or other substance abuse * known allergy to fluoxetine * cancer or hepatic diseases

Keywords: depression perimenopause postmenopause homeopathy
comparison of supervised ground walk training and treadmill walk training in copd patients

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: pulmonary rehabilitation became a vital part of management in copd patients in form of activity modification, dietary and pharmacological optimisation. but access to traditional supervised aerobic (treadmill) walking is debatable fact due to economical and staffing expertise in developing countries like india. the investigators designed a randomised controlled trial to evaluate the effectiveness of ground based walking over traditional treadmill walking in improving quality of life in copd patients.

background: copd is increasing mortality and morbidity globally. pulmonary rehabilitation is a promising management in copd management. exercise training in form of aerobic (walking, cycling) and strength training is an important part of pulmonary rehabilitation. however access to traditional supervised exercise programs is questionable debate even in developed western countries. unsupervised ground walk programs are often told by physicians but not properly prescribed. objective: to assess whether ground or treadmill walk is better in improving functional capacity and quality of life in copd patients design: randomised controlled trial procedure: two arms 1) supervised ground walk training 2) supervised treadmill walk training. the intensity and progression of walk is based on 6 minute walk test. quality of life will be gauged through chronic respiratory questionnaire and functional capacity through 6 minute walk test. statistical analysis: descriptive analysis for characterisation. normality though kolmogorov and variables will be compared through paired and unpaired student t tests

Eligibility criteria:
inclusion criteria: * stable copd * stage ii - iv * both genders exclusion criteria: * cardiovascular diseases uncompensated * uncompensated pleural diseases * uncompensated liver diseases * recent surgeries less than 3 weeks * malignancy receiving chemo and radiotherapy * recent exacerbations less than 3 months

Keywords: ground walk treadmill walk functional walk capacity copd quality of life
a study of the safety, tolerability, and efficacy of ivt pre-op 0.3mg pegaptanib sodium versus sham, for management of tractional retinal detachment and vitreous hemorrhage with proliferative diabetic retinopathy

Conditions: Proliferative Diabetic Retinopathy

Summary: the purpose of this study is to assess whether preoperative pegaptanib sodium safely improves vitreous hemorrhage prior to surgical intervention and to evaluate the stability of pre-existing tractional retinal detachment.

patients undergoing pars plana vitrectomy for active pdr with trd will receive a single intravitreal pre-operative 0.3mg macugen™ prior to surgery versus sham injection. specific timing of the injection will be at no sooner than 7 days and no longer than 14 days prior to surgery. patients will receive a preinjection fundus photo and another post injection photo the day of surgery as dictated by the operative schedule. some photos may be limited secondary to vitreous hemorrhage. follow up visits after surgery will be one day, one week, one month, and three months.

Eligibility criteria:
inclusion criteria: * best corrected visual acuity in the study eye between 20/30 and light perception (lp) * willingness to provide signed informed consent and health insurance portability and accountability act (hipaa) authorization * age ≥ 18 years * for sexually active women of childbearing potential, agreement to the use of an appropriate form of contraception (or abstinence) for the duration of the study exclusion criteria: * history of anti-vegf treatment in the study eye * history of previous pars plana vitrectomy in the study eye * intraocular surgery in the study eye within one month of the study * patients with extensive vitreous hemorrhage in conjunction with a rhegmatogenous retinal detachment * tractional retinal detachment from causes inconsistent with pdr, such as inflammation or trauma * any concurrent intraocular condition in the study eye that could either require medical or surgical intervention during the study period to prevent or treat visual loss that might result from that condition or if allowed to progress untreated could likely contribute to loss of at least 2 snellen equivalent lines of bcva over the study period. * active intraocular inflammation (grade trace or above) in the study eye * active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye * uncontrolled glaucoma in the study eye (defined as iop≥ 35 mmhg despite treatment with anti-glaucoma medication) * history of glaucoma-filtering surgery in the study eye * history of corneal transplant in the study eye

Keywords: proliferative diabetic retinopathy tractional retinal detachment vitreous hemorrhage
mindfulness-based intervention for teenagers with cancer

Conditions: Pediatric Cancer

Summary: the purpose of this study is to evaluate the effects of a mindfulness-based meditation intervention on quality of life, sleep and mood in adolescents with cancer compared to a control group.


Eligibility criteria:
inclusion criteria: * teenagers (ages 12-18) with cancer exclusion criteria: * no ongoing or lifetime severe psychopathology, such as schizophrenia, psychosis, delusional disorders or organic mental disorders

Keywords: mindfulness-based meditation pediatric cancer adolescence quality of life sleep affect health psychology
research participants' views on the ethics of clinical research

Conditions: Rheumatic Diseases

Summary: this pilot study will explore the usefulness of a series of questions asking about views of research from the perspective of minority and economically disadvantaged research participants. racial and ethnic minorities are consistently under-represented in clinical research. this under-representation has been attributed primarily to an unwillingness to participate in research because of mistrust in the research establishment, especially in light of widely known historical examples of abuse. however, more recent data suggests that not being invited to participate in research, or stringent entry criteria, may contribute substantially to the low numbers of ethnic minority research participants. the perspectives of racial and ethnic minorities who are knowledgeable about or participating in research are important to understanding the kinds of vulnerabilities that exist and any important barriers to participation. people 18 years of age and older from the cardozo clinic in washington, d.c., who are enrolled in the national institute of arthritis and metabolic studies' natural history study are eligible to participate in this protocol. participants are interviewed with questions about their own experiences in clinical research as well as some hypothetical research studies. questions include participants' general views of clinical research, perceived risks and benefits of research, alternatives to research participation, the limits of what they would be willing to accept in research and types of research or research procedures they might perceive as unfair.

in an effort to better understand ethical concerns about clinical research, this pilot study aims to explore the utility of a series of questions asking about views of research from the perspective of minority and economically disadvantaged research participants. cognitive interviews will be conducted in english and spanish with 10 participants of the niams chc at the upper cardozo clinic in washington dc. the interviewer will ask participants about their own experiences as well as some hypothetical research studies. questionnaires will ask participants about their general views of the clinical research, perceived risks and benefits of research, alternatives to participation, the limits of what they would be willing to accept in research and types of research or research procedures they might perceive as unfair.

Eligibility criteria:
* inclusion criteria: adults (18 years and older) from cardozo clinic who are enrolled in the niams natural history study will be invited to participate in this interview study. the sample will include men and women who are primarily african american and hispanic. participants will be eligible if they are able and willing to give informed consent and can participate in an interview in english or spanish.

Keywords: trust decision making vulnerability survey
renal failure following lung transplantation in cystic fibrosis patients

Conditions: Cystic Fibrosis

Summary: with this retrospective observational cohort study, we performed a longitudinal assessment of the renal function of the adult cf patients who underwent lutx, aiming 1) to describe possible risk factors associated with perioperative aki and 2) to describe aki short and long term effects on clinical outcomes.

this study is a retrospective analysis of prospectively collected data from medical records of all consecutive cf patients who underwent lutx at our institution from january 2013 to december 2018.

Eligibility criteria:
inclusion criteria: * all patients with cf who underwent lutx during the study period were considered. exclusion criteria: * single lutx * re-transplantation * missing medical records; * age \< 18 years old
effect of epidural hydromorphone combined with ropivacaine in labor analgesia

Conditions: Analgesia; Labor Pain

Summary: the purpose of this study is to compare the effects of three different doses of hydromorphone combined with ropivacaine and sufentanil combined with ropivacaine in epidural labor analgesia through prospective clinical trials, so as to explore whether hydromorphone combined with ropivacaine has advantages in epidural labor analgesia, and find out the optimal dose of hydromorphone. participants will be randomly allocated to four groups: h1 group,h2 group,h3 group and sf group.for those in h1 group: they will be administered with15 ug/ml hydromorphone and 0.08% ropivacaine for epidural labor analgesia, for those in h2 group: they will be administered with17.5 ug/ml hydromorphone and 0.08% ropivacaine for epidural labor analgesia, for those in h3 group: they will be administered with 20 ug/ml hydromorphone and 0.08% ropivacaine for epidural labor analgesia, for those in sf group: they will be administered with 40 ug/ml sufentanil and 0.08% ropivacaine for epidural labor analgesia. the goal of this clinical trial is to provide a new treatment option for pregnant women in epidural labor analgesia, and to provide a basis for hydromorphone combined with ropivacaine in epidural labor analgesia.


Eligibility criteria:
inclusion criteria: no contraindication of intraspinal anesthesia the american society of anesthesiologists(asa) physical status ranked ⅰ-ⅱ competent to provide informed consent exclusion criteria: poor respiratory functions severe cardiovascular diseases
effect of an eaa/whey composition on protein metabolism

Conditions: Sarcopenia

Summary: sarcopenia, a progressive loss of muscle mass, strength and function, is an inevitable natural process of aging. while it may be impossible to completely reverse the progress of sarcopenia, it is well established that intake of dietary protein through essential amino acids (eaas) and whey protein increases anabolic response. the current study will test if a specially formulated mixture of eaas and whey protein can maximally stimulate anabolic responses at the levels of whole body and muscle compared to whey protein alone.

the product composition is protected by intellectual property. it contains a combination of ingredients designed to stimulate anabolic responses at whole body and muscle and to ultimately induce long-term improvements in muscle function and size. eaas are the only dietary macronutrients that are required for survival. they are "essential" because the body cannot produce them. there are 9 dietary eaas while there are 11 dietary non-essential amino acids that are not required in the diet because they can be produced in the body. the composition is based on a blend of 8 of the 9 eaas. in addition to being the "active" components of dietary protein, eaas also have the advantage over intact protein including whey protein because free eaas are absorbed from the intestine more quickly and more completely than amino acids contained in protein, which requires digestion before absorption indicating that intact protein is relatively slowly absorbed. therefore, the combination of free eaas and intact protein give not only an immediate response (from the free eaas) but also a prolonged response (from the intact protein) over time by the slower digestion. the idea of combining a specific formulation of eaas with an intact protein to obtain both an immediate as well as a more sustained response in protein anabolism is novel. investigators propose that consumption of the eaa/protein composition will stimulate the net protein balance at the whole body level in a dose-dependent manner. the investigators further propose that the magnitude of increase in the net protein balance will be greater than induced by the consumption of the same amount of whey protein isolate.

Eligibility criteria:
inclusion criteria: * bmi between 20 and 30 kg/m\^2 exclusion criteria: * current diagnosis of diabetes * history of malignancy in the 6 months prior to enrollment * weight reduction surgery * chronic inflammatory (lupus, hiv/aids) * currently pregnant females * unable to eat dairy protein * unable to stop eating protein or amino acid (aa) supplements during the participation * regular resistance training (\> once per week) * concomitant use of corticosteroids (ingestion, injection or transdermal) * subjects who cannot safely stop using aspirin for 7 days prior to muscle biopsies * hemoglobin less than 9.5 g/dl, and platelets less than 150,000 at the screening visit * any other disease or condition placing the subject at increased risk of harm if they were to participate, at the discretion of the study physician