Kornimate/medical-research-clean huggingface dataset:
hydrocortisone in patients of out-of-hospital cardiac arrest

Conditions: Heart Arrest

Summary: out-of-hospital cardiac arrest (ohca) is an important issue for the emergency physicians and co-workers. how to improve the return of spontaneous circulation (rosc) rate and prognosis of these patients challenges the emergency team. when encounters stress, the hypothalamus of human releases corticotropin releasing hormone, which in turn stimulates the pituitary gland to release acth. then acth acts on the adrenal gland to release glucocorticoid to against stress. foley pj et al found the dogs with bilateral adrenalectomy had lower rosc rate during resuscitation than those without surgery\[1\]. karl h. linder et al showed ohca patients had high serum vasopressin and acth level but low serum cortisol level. besides, the serum cortisol level had a negative correlation with collapse duration (no cpr duration)\[2\]. studies also revealed the successfully resuscitated patients had higher serum acth and cortisol level than non-resuscitated ones\[2,3\]. in addition, the serum cortisol level was found to be correlated with short term survival rate and hemodynamic status in resuscitated ohca patients\[3\]. animal study also showed mice receiving higher dosage of hydrocortisone had higher rosc rate and lower epinephrine requirement than those receiving lower dosage of hydrocortisone or normal saline. \ 1. foley pj, tacker wa, wortsman j, frank s, cryer pe.;" plasma catecholamine and serum cortisol responses to experimental cardiac arrest in dogs."am j physiol 1987;253:e283-9 2. lindner kh, strohmenger hu, ensinger h, hetzel wd, ahnefeld fw, georgieff m.;" stress hormone response during and after cardiopulmonary resuscitation."anesthesiology 1992;77:662-8 3. schultz ch, rivers ep, feldkamp cs, goad eg, smithline ha, martin gb, fath jj, wortsman j, nowak rm.;"a characterization of hypothalamic-pituitary-adrenal axis function during and after human cardiac arrest."crit care med 1993;21:1339-47 4. smithline h, rivers e, appleton t, nowak r.;"corticosteroid supplementation during cardiac arrest in rats."resuscitation 1993;25:257-64


Eligibility criteria:
inclusion criteria: * out-of-hospital cardiac arrest exclusion criteria: * pregnancy * younger than 18 years old * trauma * concurrent steroid use * ecmo use in resuscitation * allergy to steroid
pmcf study on the safety of linovera emulsion for the prevention of cat-1 pressure ulcers, vascular and dfu

Conditions: Pressure Ulcer

Summary: to assess the safety of linovera® emulsion in the prevention of grade i pressure ulcers, vascular and diabetic foot ulcers. to assess the performance of linovera® emulsion for the prevention of stage 1 pressure ulcers, vascular and diabetic foot ulcers.

diverse parameters are to be used to assess the safety and efficacy of linovera® emulsion for the prevention of stage 1 pressure ulcer, vascular and diabetic foot ulcers. this study is designed to implement an action within the framework of a proactive post market clinical follow up (pmcf) activity as a part of our post market surveillance (pms).

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * signed informed consent * patients with the possibility to participate during up 6 month follow-up. * at least one of these criteria: * patients with medium, high or very high risk of amputation due to a vascular or diabetic foot illness. * patients with medium, high or very high risk of developing a pressure ulcer due to any neuropathic foot pathology * patients with medium, high or very high risk of developing a pressure ulcer following braden scale. exclusion criteria: * age \< 18 years * known allergies and/or hypersensitivity to any component of linovera® emulsion. * any medical or psychological disorder that, in the investigator's opinion, may interfere with the patient's ability to give informed consent and comply with the study procedures. * patients in the terminal stage or receiving chemotherapy. * patients with more than 3 active pressure ulcers.
allogenic bone marrow stem cell transplantation in liver failure

Conditions: Liver Failure

Summary: the purpose of this study is to evaluate the therapeutic efficacy of allogenic bone marrow stem cells (bmscs) transplantation in patients with liver failure caused by hepatitis b infection. the evaluation of the efficacy includes the level of serum alanine aminotransferase (alt), aspartate aminotransferase(ast), total bilirubin (tb),prothrombin time (pt), albumin (alb), prealbumin(pa), liver histological improvement before and 1 week to 1 year after transplantation. child-pugh scores, meld scores and clinical symptoms were also observed simultaneously.


Eligibility criteria:
inclusion criteria: * aged 16\~65 years. * serum hbsag positive for over six months. * meet the diagnostic criteria of liver failure: exclusion criteria: * history of moderate to severe hepatic encephalopathy or variceal bleeding during the last two months before enrolment. * prothrombin time is over 30s. * cirrhosis caused by other reasons except hbv infection. * severe problems in other vital organs(e.g.the heart,renal or lungs). * liver tumor on ultrasonography, ct or mri examination. * pregnant or lactating women. * imaging evidences of vascular thromboses.

Keywords: abmsc allogenic bone marrow mesenchymal stem cells liver failure transplantation
reducing knee compression when sleeping in those with knee oa

Conditions: Osteoarthritis, Knee

Summary: to determine whether a change in sleeping position so as to prevent the knee being 'pushed' into full extension when lying supine provides pain relief and/or symptom improvement in individuals with knee osteoarthritis (oa).

only those who normally sleep lying on their back will be recruited. participants will be recruited into two groups: group 1, 'intervention'; group 2, 'control'. participants in group 1 will be asked to change the position they lie on their bed when sleeping; that is, to re-position themselves when lying on their back so that their feet (and ankles) hang over the end of the mattress. participants in group 2 will be asked to make no change in the way they normally lie on their mattress when sleeping. participants will be asked to complete a questionnaire, asking them about the pain and/or discomfort they are currently experiencing, and their current level of physical functioning. the questionnaire used will be the knee injury and osteoarthritis outcome score (koos) which has been widely used to assess intervention outcomes in individuals with knee oa. they will be asked to complete this questionnaire three times over a 4-month period; for group 1 this will be before (x2) and after (x1) changing to the new sleeping position (i.e. day of consent, 1 month later on day of change, and 3 months after change); for group 2 this will be matching the intervals in the intervention group. the primary outcome measure will be the koos pain score, which will be compared pre and post- changing to the new sleeping position.

Eligibility criteria:
inclusion criteria: * presence of mild, moderate or severe tibiofemoral-oa (radiologically determined in either or both knees) * regularly (routinely) spend periods lying on their back when sleeping. exclusion criteria: * those with: rheumatoid arthritis * chronic cardiopulmonary problems * lower-limb joint(or joint surface) replacement and/or previous knee surgery within previous 12 months * unable to lie supine in bed (medical or practical reason) * diagnosed with inflammatory arthropathy * peripheral neuropathy or other sensory problems * steroid injection in the knee within previous 3 months * under 18 years of age * unable to give consent due to lack of mental capacity * currently involved in any research study related to knee oa.
a study of the safety, tolerability and pharmacokinetics of aln-ttr02 in japanese healthy volunteers

Conditions: Transthyretin (TTR)-Mediated Amyloidosis

Summary: the purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (pk) of patisiran (aln-ttr02) in japanese subjects


Eligibility criteria:
inclusion criteria: * healthy japanese adult males and females aged 20 to 65 years, inclusive (the subject was born in japan and has lived outside of japan for \<10 years, and subject's biological parents and grandparents are fully japanese and were born in japan); * subjects who are healthy as determined by clinical assessments; * females subjects must be of non-childbearing potential; * males with partners of child-bearing potential, must agree to use appropriate contraception. exclusion criteria: * subjects with a history of serious mental illness; * subjects who have a clinically relevant medical or surgical history; * subjects with a positive screen for alcohol or drugs of abuse; * subjects with safety laboratory test results deemed clinically significant; * subjects with known hepatitis b surface antigen (hbsag), hepatitis b virus (hbv), hepatitis c virus (hcv) or human immunodeficiency virus (hiv) infection; * subjects who have received an investigational agent within the 3 months prior to study entry.

Keywords: rnai therapeutic
a study of dasatinib (bms-354825) in patients with advanced 'triple-negative' breast cancer

Conditions: Breast Cancer; Metastasis

Summary: this study will determine whether the investigational drug dasatinib is effective in treatment of women with progressive advanced triple-negative breast cancer.


Eligibility criteria:
inclusion criteria: * females, 18 or older * recurrent or progressive locally advanced, or 'triple negative' metastatic breast cancer * paraffin-embedded tissue block must be available * measurable disease * prior chemotherapy with an anthracycline, a taxane, or both (neoadjuvant, adjuvant, or metastatic setting) * 0, 1 or 2 chemotherapies in the metastatic setting * adequate organ function exclusion criteria: * metastatic disease confined to bone only * symptomatic cns metastasis * concurrent medical condition which may increase the risk of toxicity * unable to take oral medication

Keywords: recurrent, locally-advanced, or 'triple negative' metastatic breast cancer
evaluation of analgesia with emla and glucose oral solution

Conditions: Pain

Summary: in this randomized controlled study the investigators intended to compare analgesic effects of emla and/or oral glucose in 60 preterm neonate during arterial function and picc installation.

it is a randomised controlled clinical trial, double blinded, with the purpose to compare the use of eutectic mixture of local anesthetics (lidocaine and prilocaine) and/or the oral solution of glucose 25% in the prevention and treatment of pain in preterm neonates with gestational between 28-37 weeks old. the pain evaluation will be done using nips scale, and also physiologic variables (hr, map, oxygen saturation level and crie) during two painful procedures performed in the neonatal intensive care units:arterial puncture (n=30) and peripherally inserted central catheters (n=30). all procedures will have clinical indication and will not be implemented by the researcher.the newborns will be randomized into three groups: a (emla and glucose; n=20),b (emla and placebo; n=20) and c (anesthetic cream placebo and oral glucose; n=20). all newborns will be subjected to some kind of therapeutic intervention, the objective of this study is validate the application of control measures and treatment of pain for these two procedures that cause mild and moderate pain.

Eligibility criteria:
inclusion criteria: 1. gestational age greater than or equal to 28 weeks and less than 37 weeks 2. admission in the neonatal intensive care unit of the hospital julia kubtischek 3. clinical indication of collection of blood through arterial puncture or peripherally inserted central catheter 4. neonate in the first week of life (first to seventh day of life); 5. informed consent have to be obtained by parents or guardians. exclusion criteria: 1. newborn with broken skin at cream application site; 2. use of sedation or analgesia in the last 72 hours; 3. diagnosis of necrotizing enterocolitis; 4. anemia 5. metabolic acidosis 6. methaemoglobinaemia 7. treatment with agents to induce methemoglobinemia 8. mechanical ventilation in patients using opioids 9. clinical diagnosis of neuromuscular dysfunction 10. any contraindication to suction 11. urgent procedures

Keywords: pain preterm neonate pain assessment emla oral glucose
valacyclovir vs. acyclovir as hsv-2 suppressive therapy: effect on plasma hiv-1 levels among hiv-1/hsv-2 co-infected persons

Conditions: HSV Infection; HIV Infection

Summary: the purpose of this study is to determine whether treating hsv-2 with either valacyclovir or acyclovir is more effective in suppressing hiv-1 virus levels in people co-infected with hiv-1 and hsv-2.

sexual transmission is responsible for the vast majority of hiv-1 infections among adults worldwide. in sub-saharan africa, the region hardest hit by the hiv-1 epidemic, hsv-2 prevalences of 30-50% have been seen in the general population with prevalence up to 90% in infected with hiv-1. hsv-2 is common in those with, or at risk for, hiv-1 infection, and hsv-2 reactivation increases hiv-1 acquisition and infectiousness. recent studies have shown that suppression of hsv-2 has a sustained effect on lowering hiv-1 levels in blood plasma. new data have raised the question whether higher doses of hsv-2 suppressive therapy might be more effective at suppressing hiv-1 levels. acyclovir and valacyclovir, chosen for use in this study, are safe and effective treatments for decreasing the frequency of hsv-2 reactivation and shedding. the standard dose of acyclovir is 400 mg twice a day. valacyclovir, a drug that converts to acyclovir after absorption, delivers higher concentrations of acyclovir. 1.5 grams of valacyclovir, will be used to provide a higher dose of acyclovir, and will be compared with the standard dose of 400 mg twice a day of acyclovir.

Eligibility criteria:
inclusion criteria: * hiv-1 seropositive * not on hiv-1 antiretroviral therapy nor planning to initiate antiretroviral therapy during the study period * cd4 cell count \>250 cell/µl * not otherwise eligible for antiretroviral therapy according to uganda national guidelines * detectable hiv-1 plasma viral load * hsv-2 seropositive * not intending to move out of the area for the duration of study participation. * able to participate in the study at the partners in prevention site in thika, kenya exclusion criteria: * known history of adverse reaction to acyclovir, valacyclovir, or famciclovir. * planned use of acyclovir, valacyclovir, or famciclovir * use of ganciclovir, foscarnet, or cidofovir * known medical history of seizures * serum creatinine \>1.5 mg/dl * ast or alt \>3 times upper limit of normal * hematocrit \<30 % * absolute neutrophil count \<1000 * platelet count \<75,000 * history of thrombotic microangiopathy * any other condition which, in the opinion of the principal investigator, may compromise the ability to follow study procedures and complete the study * participation in another hiv therapeutics trial * for women, pregnancy as confirmed by a urine pregnancy test

Keywords: hsv hiv
lung diffusing capacity for nitric oxide and carbon monoxide early after mild-to-severe covid-19

Conditions: COVID-19 Pneumonia

Summary: infection with severe acute respiratory syndrome-cov-2 (sars-cov-2) may be associated with diffuse alveolar damage and pulmonary vasculitis. thus, it is likely that pulmonary function changes may be seen in covid-19 survivors. the aim of the present study was to test that simultaneously-determined lung diffusing capacity for nitric oxide and carbon monoxide may be useful to detect post-viral diffusive gas exchange abnormalities early after mild-to-severe covid-19-related pneumonias.

infection with severe acute respiratory syndrome-cov-2 (sars-cov-2) may be asymptomatic or associated with life-threatening interstitial pneumonia. clinically, patients affected from severe coronavirus disease-19 (covid-19) are described as exhibiting rapidly progressing acute respiratory failure with unusually low oxygen levels in arterial blood. on computed tomography scans, diffuse, peripheral "ground glass" opacities of the lung are seen while autopsy lung specimens showed diffuse alveolar damage and capillary endothelialitis. the objective of the current study, conducted in patients who had recovered from mild-to-severe covid-19 illness, was to test that simultaneously-determined lung diffusing capacity for nitric oxide (no) and carbon monoxide (co) may be of great use to early detect post-infective diffusive gas exchange abnormalities. more specifically, we hypothesized that measurement of membrane diffusive conductance for co and pulmonary capillary volume may provide accurate information on residual changes of peripheral gas exchanging units of the lung related to previous sars-cov-2 infection.

Eligibility criteria:
inclusion criteria: * subjects were selected after two nasopharyngeal swabs negative for sars-cov-2 exclusion criteria: * severe comorbidities potentially affecting pulmonary gas exchange

Keywords: covid-19
study of ibrutinib in combination with rituximab in previously untreated subjects with follicular lymphoma

Conditions: Follicular Lymphoma; B-cell Lymphoma; Non-Hodgkin's Lymphoma

Summary: this is an open-label, phase 2 study designed to assess the efficacy and safety of ibrutinib combined with rituximab in previously untreated subjects with follicular lymphoma (fl).

this is an open-label, phase 2 study designed to assess the efficacy and safety of ibrutinib combined with rituximab in previously untreated subjects with fl. there are two study treatment arms. subjects enrolled into main study treatment arm will receive ibrutinib continuously until disease progression or unacceptable toxicity. in addition, subjects will receive rituximab once weekly for four doses for the first four weeks of study treatment. subjects enrolled into the exploratory study treatment arm will receive ibrutinib continuously as a single agent for the first eight weeks, then ibrutinib concurrently with rituximab once weekly for four doses. after the rituximab treatment, subjects will receive ibrutinib continuously until disease progression or unacceptable toxicity.

Eligibility criteria:
key inclusion criteria: 1. histologically documented fl (grade 1, 2 and 3a) 2. not previously treated with prior anti-cancer therapy for fl 3. stage ii, iii or iv disease 4. at least one measurable lesion ≥ 2 cm in longest diameter by ct and/or mri scan 5. men and women ≥ 18 years of age 6. eastern cooperative oncology group (ecog) performance status of ≤ 2 key exclusion criteria: 1. medically apparent central nervous system lymphoma or leptomeningeal disease 2. fl with evidence of large cell transformation 3. any prior history of other hematologic malignancy besides fl or myelodysplasia 4. history of other malignancies, except 1. malignancy treated with curative intent and with no known active disease present for ≥5 years before the first dose of study drug and felt to be at low risk for recurrence by treating physician. 2. adequately treated non-melanoma skin cancer or lentigomaligna without evidence of disease. 3. adequately treated carcinoma in situ without evidence of disease. 5. currently active, clinically significant cardiovascular disease or myocardial infarction within 6 months of screening 6. known anaphylaxis or immunoglobulin e (ige)-mediated hypersensitivity to murine proteins or to any component of rituximab (rituxan®) 7. requires anti-coagulation with warfarin or a vitamin k antagonist. 8. requires treatment with strong cytochrome p450 (cyp) 3a inhibitors. 9. known bleeding diathesis or hemophilia

Keywords: pharmacyclics (pcyc) pcyc lymphoma follicular lymphoma fl rituximab ibrutinib rituxan non-hodgkin's lymphoma (nhl) nhl b-cell lymphoma
a medical device to treat brain aneurysms

Conditions: Cerebral Aneurysm

Summary: an aneurysm is a bulge in a blood vessel caused by a weakness in the blood vessel wall, usually where it branches. as blood passes through the weakened blood vessel, the blood pressure causes a small area to bulge outwards like a balloon. most brain aneurysms only cause noticeable symptoms if they burst (rupture). this leads to an extremely serious condition known as a subarachnoid hemorrhage, where bleeding caused by the ruptured aneurysm can cause extensive brain damage and symptoms. the study aims to evaluate the safety and effectiveness of a medical device to treat brain aneurysms.

patients will be treated with the nautilus, then will be followed up for up to 6 months.

Eligibility criteria:
inclusion criteria: \* patients who present with intracranial aneurysm exclusion criteria: \* unstable neurological deficit
evaluation of the function "stop before hypoglycemia" on external insulin pump

Conditions: Type I Diabetes

Summary: this study compares the apparition of hypoglycaemia in type i diabetic patients between 2 phases: the one without the use of smartguard® function and the one with the use of smartguard® function.

the aim of this study is to compare smartguard® function with captor and insulin pump to improve the glycemia stability in real condition. there are several phases: * phase 1: insulin pump without captor (12 weeks) * phase 2: insulin pump with captor and without smartguard® function (4x6 days; 4 weeks) * phase 3: insulin pump with captor and with smartguard® function (6x6 days; 6 weeks) * phase 4: insulin pump without captor (4 weeks)

Eligibility criteria:
inclusion criteria: * type i diabetic patients undr basal/prandial diet * treated by insuline * with no insuline pump during at least 3 months * with hba1c dosed during the 3 months before inclusion exclusion criteria: * minor patients * pregnant woman * already participating to another studies
hypic hypnosis for procedural pain in the intensive care unit

Conditions: Invasive Procedure

Summary: procedural pain in resuscitation is common in the conscious patient. however, analgesia and sedation may be impossible because of the acute pathology leading to resuscitation, comorbidities or the urgency of the invasive procedure. in addition, the use of analgesics and sedatives is responsible for adverse effects. in this context, hypnosis appears to be an additional analgesic tool that would reduce the consumption of analgesics and sedatives and thus reduce their side effects.


Eligibility criteria:
inclusion criteria: * major patient admitted to intensive care * glasgow score = 15 * necessity during the stay of making an invasive gesture among: * thoracic drainage * placement of a central venous catheter or a swan-ganz catheter * establishment of a dialysis catheter * introduction of an invasive arterial catheter * patient giving free, informed and written consent * patient affiliated to a social security scheme non inclusion criteria: * procedure to be carried out in extreme urgency * confusional state making hypnosis impossible, evaluated by cam-icu (confusion assessment method for the intensive care unit) * decompensated psychiatric illness * patient sedated or intravenous analgesia continued at the time of the procedure * patient intubated * patient with a contraindication to sedation or analgesia at the time of the procedure * patient receiving topical anesthesia before the start of the procedure * major person subject to legal protection (court bail, curator, guardianship) or deprived of liberty * patient already included in the study during the completion of a previous invasive procedure * patient participating in a research involving an interventional human person (category 1) on an analgesic / sedative drug