Kornimate/medical-research-clean huggingface dataset:
supportive care for patients with hematological malignancies undergoing hematopoietic cell transplant

Conditions: Hematopoietic/Lymphoid Cancer

Summary: this pilot clinical trial studies supportive care for patients with hematological malignancies undergoing hematopoietic cell transplant. supportive care may improve quality of life in this patient population.

primary objectives: i. pilot a supportive care intervention that begins prior to transplantation and continues through the acute peritransplant period. ii. determine the proportion of patients who enroll and the level of comfort / distress of hematopoietic cell transplant (hct) patients who meet with the supportive care team. iii. pilot data collection mechanisms and cost retrieval in preparation for a randomized clinical trial. outline: patients undergo supportive care consultation before transplantation and at least once monthly while they remain at the transplant center.

Eligibility criteria:
inclusion criteria: * written informed consent * english as primary language * planned autologous or allogeneic hematopoietic cell transplantation * presence of co-morbidities (hematopoietic cell transplant co-morbidity index \[hct-ci\] score 3 or greater), high risk disease (relapse risk \> 25%), or a planned type of transplant (human leukocyte antigen \[hla\]-mismatched allogeneic or myeloablative) that places the patient at a higher than average risk of non-relapse mortality or relapse exclusion criteria: * major psychiatric diagnosis that impairs cognitive functioning or is not controlled at the time of the approach, as judged by the patient's medical team * first transplant of a planned tandem procedure (the second transplant is eligible)

Keywords: hematopoietic cell transplantation supportive/palliative care
bivalirudin in patients with acute myocardial infarction (ami) undergoing primary pci

Conditions: Myocardial Infarction

Summary: the purpose of this study is to demonstrate the benefit of bivalirudin in combination with clopidogrel with provisional gpiib/iiia inhibitor use, in reducing the bleeding complications associated with early invasive management of patients presenting with an st elevation myocardial infarction (stemi) and undergoing primary pci, while providing similar rates of ischemic events when compared to published results of relevant trials.


Eligibility criteria:
inclusion criteria: 1. patients \>18 years of age. 2. symptoms of stemi for at least 30 min within previous 12 hours and * st-segment elevation in at least 2 contiguous leads or new left branch bundle block (lbbb), or existing lbbb with positive troponin * residual high grade stenosis and associated abnormalities in regional wall motion. 3. planned primary pci in native coronary vessel. exclusion criteria: 1. confirmed pregnancy 2. fibrinolytic therapy - any alteplase, reteplase, tenectoplase, or streptokinase within the last 24 hours 3. culprit lesion within svg or bypass conduit 4. dependency on renal dialysis 5. administration of lmwh within 8 hours prior to pci 6. administration of abciximab within 7 days prior to pci 7. administration of eptifibatide or tirofiban within 12 hours prior to pci 8. warfarin must be discontinued prior to procedure, and the inr must be ⎕1.5, or the pt\<15, 9. heparin. if heparin is administered in the er as long as it is discontinued at least 30 minutes prior to procedure, or act \<250, a patient may be enrolled. no clotting measurements are required if patient received heparin ⎕30 minutes prior to the initiation of bivalirudin. 10. allergy to heparin or bivalirudin, or known sensitivity to any component of the products 11. allergy to aspirin, clopidogrel, or abciximab 12. contraindication to abciximab 13. angiomax within 24 hours prior to study drug administration 14. neurosurgery with three months 15. severe hypertension not adequately controlled by antihypertensive therapy at the time of study entry (bp \>180/110 mm hg) 16. cardiogenic shock (sbp \ 30 min or a need for intravenous pressors) 17. stroke within three months 18. any hemorrhagic diathesis 19. life expectancy \<1 year 20. participation in another clinical trial

Keywords: st-segment elevation acute myocardial infarction pci percutaneous coronary intervention
plant exosomes and patients diagnosed with polycystic ovary syndrome (pcos) 17

Conditions: Polycystic Ovary Syndrome

Summary: the purpose of this study is to see if substances contained in ginger or aloe plants, called exosomes, will treat and improve the condition polycystic ovary syndrome


Eligibility criteria:
inclusion criteria: * age 18-40 year * patients must have a confirmed diagnosis of pcos according to the rotterdam criteria. at least 2 of the following 3 characteristics must be present: 1. oligo-anovulation 2. clinical and/or biochemical signs of androgen excess and 3. polycystic ovarian morphology (pcom) (defined by an increased number of small antral follicles \[≥12 follicles that were \ 10 cm3\] in 1 or both ovaries. disorders mimicking pcos must also be excluded, including thyroid dysfunction, hyperprolactinemia, late-onset congenital adrenal hyperplasia, and ovarian or adrenal androgen-producing tumors. * of all subjects screened patients must be informed of the investigational nature of this study and give written informed consent in accordance with institutional and federal guidelines. * ability to understand and willingness to sign a written informed consent document. * absence of life limiting medical conditions exclusion criteria: * • pregnancy * known hiv * patients receiving immunosuppressive drugs * patients taking confounding medications such as sex steroids, infertility medications or insulin sensitizers or any medication deemed to alter glucose and/or insulin levels * active malignancy in the last 5 years * patients receiving any other investigational agent(s) * ginger and/or aloe allergy
influenza imprint cohort: defining the impact of initial influenza exposure on immunity in infants

Conditions: Influenza

Summary: the primary aim is to define the immune responses to the infant's initial influenza exposure (vaccine or infection) and how that affects the immune response to subsequent influenza exposures

vaccination is a leading public health intervention for reducing morbidity and mortality from influenza worldwide. vaccine optimization is hampered by lack of understanding the natural history of infection and immunity, including the full complement of maternal immunity imparted to infants. this gap in understanding can be addressed only through a well-designed birth cohort study. up to 1500 mother-infant pairs will be enrolled at or after week 34 in pregnancy over three flu seasons, up to four years of age depending on birth month, at two sites. follow-up will occur from the third trimester until the child is three to four years of age, along with medical records review to ascertain outcomes not captured through weekly illness and respiratory surveillance, and medical record review up to 18 years of age. the primary aim is to rigorously document the natural history of infection and immune response to influenza in study infants for at least three entire flu seasons.

Eligibility criteria:
inclusion criteria: * mother pregnant and ≥ 34 weeks gestation and ≥ 18 yrs. of age * plans to deliver at local hospital * lives within designated home zip codes: * no plans to move outside study area within study timeframe * cell phone that can be used for text messaging * singleton live born infant, born ≥ 34 weeks gestational age (ga) exclusion criteria: * fetal or infant death prior to maternal hospital discharge * mother known to be infected with hiv based on medical records * major congenital anomalies, prenatally diagnosed or other major disorder or anomaly as determined by the pi * reported use of heroin, cocaine or methamphetamines during pregnancy * adoptive infant * enrolled in any investigational vaccine trial or other interventional randomized, clinical trial involving the mother or infant that the pi's deem to be in conflict with study outcomes

Keywords: influenza, birth cohort
long term evaluation of function and quality of life after pollicisation

Conditions: Patients That Had Pollicization Surgery

Summary: the study aims at describing long term functional outcome of patients that underwent pollicisation surgery. the hypothesis of the study is that there are prognostic factors of good function results of pollicisation (based on t-gap classification for function) that will be searched on univariate and multivariate analysis.


Eligibility criteria:
inclusion criteria: * more than 7 years and less than 50 years * underwent unilateral or bilateral pollicisation surgery * for children : non opposition of the parents * for adults : non opposition exclusion criteria: - patients able to understand the research and to answer to forms
gene expression in ms patients before and during treatment with interferon-beta

Conditions: Multiple Sclerosis

Summary: clinical and experimental evidences suggest that there is a variability in therapeutic response to immunomodulating therapies in multiple sclerosis patients. microarrays is a technology that permits to monitor the expression levels of thousands of genes at a time. the specific aim of this study is to identify predictive factors of therapeutic response in ms patients treated with high-dose interferon-beta.


Eligibility criteria:
inclusion criteria: * diagnosis of relapsing-remitting ms (mcdonald criteria) * age between 18-55 * edss less or equal to 5.5 exclusion criteria: * use of any other disease modifying drugs * use of corticosteroids during 3 months before starting protocol * clinical relapse during 1 month before starting protocol * serious heart, renal, hepatic or haematological dysfunction defined by laboratory exams

Keywords: multiple sclerosis microarrays
hyperthermia with flexible electrode-typed 2-mhz device during radiotherapy for solid tumors

Conditions: Solid Tumor

Summary: the main purpose of this study is to evaluate immunogenic effect of hyperthermia applied with flexible electrode-typed 2-mhz device during radiotherapy for solid tumors.


Eligibility criteria:
inclusion criteria: * solid tumor (primary, metastatic) * eastern cooperative oncology group (ecog) score 0-3 * ability to understand and the willingness to sign a written informed consent documents exclusion criteria: * myocardial infarct, unstable angina, heart failure, uncontrolled arrhythmia within 6 months * active infectious disease * pregnant or probability of pregnancy during treatment * obesity (bmi ≥35) * immunosuppressive drug after organ transplantation * autoimmune disease * skin injury on treatment area

Keywords: radiotherapy hyperthermia
tranexamic acid versus epinephrine during exploratory tympanotomy

Conditions: Intraoperative Bleeding

Summary: exploratory tympanotomy is surgical access to the middle ear, made for diagnosis and management of unexplained conductive hearing loss, performed under an oto-microscope across the external auditory canal after tympanic membrane elevation to explore the middle ear structures

epinephrine is a vasoconstrictor searched intensively for ptimization of the surgical field during microscopic ear and sinus surgeries with controversial results given the possible cardiovascular complication in case of systemic absorption,especially in vulnerable cardiac patients.tranexamic acid (txa) as an antifibrinolytic medication is used to treat or prevent excessive bleeding in significant trauma, surgery, tooth removal, or nasal bleeding, discovered by japanese researchers. txa, given either oral or intravenous, is a derivative of lysine amino acid; it acts reversibly on the lysine binding sites to block it on the plasminogen molecules. txa consequently hinders the stimulation of plasminogen competitively, thus reduces its conversion into plasmin. plasminogen is the enzyme that leads to the degradation of a fibrin clot, fibrinogen, and other plasma proteins, such as factors v and viii. more than 95% of txa intravenous administered dose eliminated unchanged through the urinary system. twenty-four hours after intravenous administration of txa has demonstrated accumulative excretion of approximately 90%, whereas only 3% is bound to plasminogen. txa is minimally excreted in breast milk while it can freely cross the blood brain barrier and the placenta .

Eligibility criteria:
inclusion criteria: * 18 - 60 years old * asa (i and ii) * hb level \> 10 mg/dl * elective ear exploratory tympanotomy surgery under general anesthesia. exclusion criteria: * allergy to txa * bleeding/coagulation disorders * psychiatric illness * acute and chronic renal failure * heparin use within 48 hrs or aspirin use within seven days before surgery, * pregnancy * liver cirrhosis * color blindness * cardiac stent.
tenofovir monotherapy in patients with chronic hepatitis b patients who had achieved complete viral suppression on lamivudine plus adefovir

Conditions: Proportion of Patients With a Sustained Virological Response (Serum HBV DNA <20 IU/mL) at Week 48

Summary: little is known about efficacy of switching to tenofovir monotherapy for lam-resistant chronic hepatitis b patients who achieved a complete virological response to lamivudine plus adefovir. this study was to investigate the efficacy of switching to tenofovir monotherapy for lamivudine -resistant chronic hepatitis b patients with undetectable hepatitis b virus dna while on lamivudine plus adefovir combination therapy


Eligibility criteria:
inclusion criteria: * hbsag (+) for \> 6 months age \>19 years antiviral resistance to lam (rtl180m and/or m204v/i) currently receiving lam plus adv for more than 12 months hbv dna levels \<20 iu/ml on two consecutive tests of 3-month interval exclusion criteria: * cr ≥1.5 mg/dl evidence of decompensated liver disease malignant neoplasm coinfection with hiv, hcv
follow up study to assess long term safety and outcomes in infants and children born to mothers participating in retosiban treatment studies

Conditions: Obstetric Labour, Premature

Summary: the primary objective of this study is to assess the safety and outcomes of infants and children who were exposed to retosiban or comparator in utero in the phase iii spontaneous preterm labor (sptl) treatment studies, to provide assurance that treatment is not associated with significant adverse outcomes in early childhood. the enrolled infants and children will be followed at pre-specified intervals until they reach 24 months chronological age. this study does not require medical interventions or study visits to an investigational site, instead, parents or legal guardians will be prompted at certain time points to complete developmental questionnaires and other data on their children's health status via an electronic device. data collected during the infant and child follow up study will be managed by a centralized research coordinating center (rcc). regionally based pediatricians will serve as study principal investigators (referred to as rcc-pis) for this study. all communications the rcc-pi has with the parent/legal guardian or the child's health care provider (hcp) will occur remotely; there will be no clinic visits.


Eligibility criteria:
inclusion criteria: * mother is randomly assigned and dosed (retosiban or comparator) in 1 of the phase iii sptl retosiban clinical studies. * infant is alive at 28 days post edd. * written informed consent is obtained from the parent(s) or legal guardian(s) of the infant. the parent/legal guardian of subjects aged 12 to 17 years must also provide written agreement for the infant to participate in the study where required by applicable regulatory and country or state requirements. exclusion criteria: * there are no formal exclusion criteria for participation.

Keywords: infants retosiban preterm labor long-term safety follow-up
comparing the effects of multicomponent exercise on cardiovascular health and lipid profiles in premenopausal and postmenopausal women

Conditions: Menopause; Cardiovascular

Summary: background: the present study aimed to examine the effects of a 26-week multicomponent exercise program on lipid and lipoprotein profiles, blood pressure, and anthropometric parameters in healthy but sedentary premenopausal and postmenopausal women aged 40-60. method: the program, comprising resistance, balance, flexibility, and aerobic exercises, aimed to identify group-specific responses and establish the program's efficacy in mitigating cardiovascular risks. seventy-five women were recruited, and 38 completed the intervention. participants were categorized into premenopausal (n=18), postmenopausal (n=10), and control groups (n=10). key measures included total cholesterol, low- and high-density lipoprotein cholesterol, triglycerides, glucose, systolic and diastolic blood pressure, and anthropometric variables. statistical analyses employed the shapiro-wilk test, paired t-tests, wilcoxon tests, and kruskal-wallis tests, with α=0.05.


Eligibility criteria:
inclusion criteria: * women aged between 40 and 60 years old; * healthy, asymptomatic, and non-smoking; * medical diagnosis favouring the engagement in physical-sporting activities; * absence of clinical history related to alcoholism or uncontrolled metabolic disease; * no clinical prescription for hypotensive pharmacological intake, cholesterol reduction, hormonal replacement therapy, or any other intervention capable of inducing alterations in lipid and lipoprotein metabolism; or * abnormal blood sample results. exclusion criteria: * non-fulfilment of inclusion criteria; * clinical history characterized by symptoms related to cardiovascular disease (cvd), including stroke (cva) and coronary vascular disease (cvd), renal or hepatic disease, musculoskeletal disorders, or rheumatoid conditions that may impede full participation in the exercise program.
marathon and half marathon runners, older than 70 years old: who are they?

Conditions: Follow-up Care

Summary: through this study, the investigators intend to describe the profile of marathon and half marathon runners older than 70 years old, in terms of medical, social and psychological characteristics. first, in order to acquire a better knowledge of these aged runners: who they are; on a medical, social and psychological point of view; to figure out their motivations; to assess the impact on their life, their health and aging process. then, in order to be able to offer them a better medical care, in terms of prevention, treatment and follow-up care.


Eligibility criteria:
inclusion criteria: * older than 70 years old * marathon or half marathon runner * to give an agreement to use medical datas for research study exclusion criteria: - refusal to give an agreement to participate

Keywords: marathon half marathon runners ederly aging process sport addiction
sib-norwegian version, validation and reliability study

Conditions: Dementia; Diagnostic Tests, Routine

Summary: the purpose of this study is to validate and to test interrater reliability for the norwgian version of severe impairment battery (sib).

the study will include 60 persons with mild to severe dementia. to test the validation of sib, we will interview the included persons with severe impairment battery (sib) and compare the results with clinical dementia rating (cdv)reported by their nurses. to test interrater reliability 30 of the included persons will be interviewed with sib by two different raters, and the two raters results will be compared.

Eligibility criteria:
inclusion criteria: * dementia, mild to severe. * nursing home resident exclusion criteria: * no ability to write or read. * physical handicapped, unable to use hands.

Keywords: severe impairment battery clinical dementia rating
pilot study: the effects of medical music on anxiety in patients with ild

Conditions: Interstitial Lung Disease

Summary: this is uncontrolled, interventional feasibility study for determining the effects medical music on anxiety levels in subjects with ild. enrolled subjects will be asked to complete questionnaires and undergo physiologic measurements prior to listening to medical music. the music intervention will be for approximately 30 minutes. post intervention questionnaires and physiologic measurements will be done.

the medical music intervention includes playlists that contains songs specifically designed, recorded, and optimized through the provisionally-patented methods, to treat their co-morbid anxiety. the duration of the medical music playlist is 30 minutes. enrolled subjects will be asked to complete questionnaires to assess anxiety, a questionnaire related to their music preferences, and undergo physiological measurements (vital signs, galvanic skin response, and heart rate variability) before and after the intervention.

Eligibility criteria:
inclusion criteria: * men and women age 50 to 80 years old * diagnosis of definite or probable interstitial lung disease (ild) * willingness to participate and sign consent exclusion criteria: * patients who are deaf * inability to provide informed consent * pregnant women
efficacy study of multiple micro nutrients supplementation

Conditions: Anemia, Iron-deficiency

Summary: this study is initiated to investigate the effect of multi micronutrient supplementation for 12 months on serum haemoglobin level in indonesian young children.


Eligibility criteria:
inclusion criteria: * apparently healthy indonesian infants * age 8-10 month at baseline visit * willing to take 2 sachets of study product per day * planning to reside in the study area during the next 14-16 months * written informed consent by parent(s) or legally acceptable representative (in icf there is statement that both are agree that child participate in the study) exclusion criteria: * haemoglobin \< 8 g/dl at screening visit\*. * significant congenital abnormality which according to investigator's clinical judgement will interfere the study conduct and assessment * any known conditions likely to affect nutrient absorption diagnosed by the child's physician * disorders requiring a special diet (such as food intolerance or food allergy or complaints such as reflux, constipation and cramps for which special formula is required). * any other current or previous illnesses/conditions or intervention which according to investigator's clinical judgement could interfere the study conduct and assessment (e.g. chronic illness or physical or mental handicaps) * regular use of mmn supplements syrup (every day in \> 1 week) within two weeks prior to entry into the study. * not intending to use micronutrient supplements during the study * participation in any other studies involving similar investigational or marketed products concomitantly or within two weeks prior to entry into the study. * premature birth (gestational age \<37 weeks) * low birth weight (\< 2500 g) * severely under nutrition indicated by any of the following criteria: severely stunted: haz \< -3 sd; severely underweight waz \<-3 sd; wasted: whz \<-2 sd \*subject with haemoglobin level (finger prick blood sample) at screening visit between 8-10 g/dl will be given iron syrup supplementation for 1 month. thereafter, haemoglobin level (whole blood sample) will be checked at baseline visit: * if hb \> 10 g/dl, subject is eligible for randomisation * if hb \< 10 g/dl, subject is not eligible for randomisation and will be given iron syrup supplementation for 2 months

Keywords: healthy infants anemia, iron-deficiency