Kornimate/medical-research-clean huggingface dataset:
bleeding of unknown cause: a swiss case-control study

Conditions: Bleeding Disorder

Summary: the goal of this prospective cohort is to identified specific biological patterns in patients with a bleeding of unknown cause and to study the specific mechanisms of the bleeding disorder for each subset of patients.

patients with bleeding of unknown cause are included. at baseline, blood will be drawn to evaluate the hemostatic profile. findings are compared to a control group of healthy individuals. patients and controls are followed for 3 years.

Eligibility criteria:
inclusion criteria: * man with isth bat\>3. if the calculated score includes a surgical bleeding, then two other items of the score should be \>0 * woman with isth bat \>5 points. if the calculated score includes a surgical or a postpartum bleeding, then two other items of the score should be \>0 exclusion criteria: * ongoing pregnancy * intake of antithrombotic treatment or non-steroidal anti-inflammatory drugs for least 10 days at time of blood collection * intake of antifibrinolytic or blood product administration (factor concentrate, frozen fresh plasma, prothrombin complex concentrate) for least 14 days before blood collection * active cancer (defined as cancer diagnosis within the last five years or treatment within the two last years before study inclusion) * active autoimmune disease * active chronic inflammatory disease * severe liver disease (cirrhosis \> child a) * renal insufficiency stage 3 * active or recent infection (within the last 30 days) * recent hospitalization (\<3 months) * recent surgery (\<3 months) * recent trauma requiring medical intervention (\<3 months)

Keywords: bleeding hemostatics fibrin fibrinolysis thrombin
investigating the performance of a new adhesive strip

Conditions: Ileostomy - Stoma

Summary: this study investigates the performance of a new adhesive


Eligibility criteria:
inclusion criteria: 1. have given written informed consent 2. be at least 18 years of age and have full legal capacity 3. have had a stoma for more than one year 4. have intact skin on the area used in the evaluation 5. has a stoma with a diameter up to (≤) 35 mm 6. have a peristomal area accessible for application of patches/adhesive strips (assessed by investigating scientist) exclusion criteria: 1. currently receiving or have within the past 2 month received radio- and/or chemotherapy 2. currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment. 3. are pregnant or breastfeeding 4. having dermatological problems in the peristomal- or abdominal area (assessed by investigating scientist) 5. actively participating in other interventional clinical investigations or have previously participated in this investigation. 5.1. exception: participation in other coloplast in-house clinical investigations are accepted under the circumstances of otherwise complying with the inclusion and exclusion criteria of this protocol (cp265)
cognitive function and patient-reported quality of life outcomes investigation in patients taking vorinostat

Conditions: Quality of Life; Graft-vs-Host Disease

Summary: psychological well-being and cognitive function will be measured in patients enrolled on the primary study, nct01790568, a phase 2 trial of vorinostat plus tacrolimus and methotrexate to prevent graft versus host disease following unrelated donor hematopoietic stem cell transplantation. validated questionnaires will be administered to assess patients' level of depression, anxiety, quality of life, perceived cognitive functioning, and sleep quality. cognitive testing will include reliable and valid measures of processing speed, attention, executive function, episodic memory, and visual learning and memory. the purpose of this study is to determine whether these measures are feasible to administer in patients before and at early time points after bone marrow transplantation .


Eligibility criteria:
inclusion criteria: * patients must be enrolled on the parent study (nct01790568; a phase 2 clinical trial of vorinostat plus tacrolimus and methotrexate to prevent graft versus host disease following unrelated donor hematopoietic stem cell transplantation) * must speak, read and understand english exclusion criteria: * documented evidence of cognitive impairment prior to enrollment on this study (diagnosis of dementia, mild cognitive impairment, or other neurological illnesses that impact cognition).

Keywords: bone marrow transplantation hematologic malignancies adults cognition
effects of telmisartan/hydrochlorothiazide treatment in hypertensive patients under real-life setting

Conditions: Primary Hypertension

Summary: one of the most common adverse effects resulting from the therapy with thiazides, thiazide-like diuretics and loop diuretics is increased potassium secretion. disregulation of plasma potassium may be a life-threatening condition due to increased risk of arrythmias. moreover, it has been postulated that decrease in plasma potassium level may negatively affect glucose metabolism resulting in the increased risk of new-onset type 2 diabetes.the main goal of this study is to assess the efficacy and safety of telmisartan/hydrochlorothiazide in a broad population of hypertensive patients, including the effects of the therapy on plasma potassium level and also on selected parameters of glucose and lipid metabolism.


Eligibility criteria:
inclusion criteria: * primary hypertension * age\>18 years exclusion criteria: * cholestatic disorders or severe hepatic/renal failure * allergy to telmisartan or hydrochlorothiazide * treatment-resistant hypokalemia or hypercalcemia * pregnancy and lactation period

Keywords: hypertension telmisartan hydrochlorothiazide potassium glucose metabolism lipid metabolism
a study to evaluate whether participants with melanoma prefer subcutaneous vs intravenous administration of nivolumab and nivolumab + relatlimab fixed-dose combinations

Conditions: Melanoma

Summary: the purpose of this study is to assess the patient's preference for nivolumab subcutaneous (sc) or nivolumab + relatlimab fixed-dose combination (fdc) sc and provide patient experience data by route of administration. this study will also generate safety data which will further characterize the safety profile of patients switching the route of administration from intravenous (iv) to sc.


Eligibility criteria:
inclusion criteria: * must have either metastatic melanoma and have not had previous treatment for their cancer, or resected melanoma and have had the cancer removed fully with surgery no later than 12 weeks before the start of treatment and confirmed free of disease * must have a low level of disability and cancer that is considered advanced for metastatic melanoma and at risk for becoming advanced (intermediate) or advanced for resected melanoma exclusion criteria: * must not have any brain cancer/disease treated with radiation, any cancer in the eyes or mucous membranes (cells that cover inside surface of parts of the body and keep it moist), any autoimmune disease, or any condition that is being treated with steroids for inflammation (corticosteroids) or medication to decrease the body's immune system response (immunosuppressive drugs) other protocol-defined inclusion/exclusion criteria apply.

Keywords: patient preference nivolumab relatlimab iv nivolumab relatimab sc melanoma rhuph20 fdc iv fdc sc adjuvant metastatic switch nivolumab relatlimab
vitamin e versus vitamin e plus pentoxiphyllin in patients with nonalcoholic steatohepatitis: a prospective randomized clinical trial

Conditions: Non Alcoholic Steatohepatitis

Summary: nonalcoholic fatty liver disease (nafld) is a spectrum of hepatic pathology, ranging from simple steatosis, steatohepatitis, to cirrhosis. nonalcoholic steatohepatitis (nash) is a more advanced form of disease where steatosis is accompanied by hepatocyte injury as well as infiltration of inflammatory cells. since, both vitamin e and ptx has been found to improve nash when used alone, a combination of these two should be expected to give better results because of targeting two different pathogenetic mechanisms (cytokines amplification and oxidative stress) in nash patients. this will be open labelled, prospective, randomized study. the diagnosis of nafld will be made on the basis of ultrasonographic findings suggestive of fatty liver and presence of insulin resistance or features of metabolic syndrome. subsequently histologic confirmation of the diagnosis of nash will be made in all cases.


Eligibility criteria:
inclusion criteria: * diagnosis of nafld by ultrasonographic * presence of insulin resistance * histological confirmation of nash * increased transaminases (\>1.5 upper limit normal \[uln\]) exclusion criteria: * patients with alcohol \> 20g/ day * other known liver disease * medications known to induce fatty liver
enterovirus surveillance during the perinatal period

Conditions: Enterovirus Infection During Perinatal Period

Summary: neonates could be infected by non-polio enterovirus easily. some of the neonates may develop fatal complications within one week. the objective of this study were as following: 1.to understand the composition and epidemiological characteristics of enterovirus infection in pregnant women in some areas of china; 2.to understand the transmission from mother to their neonates; 3.to understand the pathogenic spectrum composition, epidemiological characteristics and clinical characteristics of enterovirus infection in neonates; 4.to understand the genetic variation and changes of enteroviruses; 5.to establish a quality management system for maternal and neonatal enterovirus laboratory testing and monitoring.


Eligibility criteria:
inclusion criteria: * 1. general parturient: on the first day of the third week of each month, all parturients and their newborns admitted to the hospital (day shift 8:00-18:00) within that day; 2. puerpera with fever: all puerperas with fever (body temperature \>=37.5 degree c) and their newborns were included in summer and autumn (from may); 3. febrile newborns: those included in summer and autumn (from may) with the following clinical characteristics: fever \>=37.5 degree c, lasting for more than one day. and sign the informed consent form with the consent of the guardian. exclusion criteria: * 1. pregnant women with urinary tract infection, chorioamnionitis and bacterial infection; 2. puerpera with fever due to urinary tract infection, chorioamnionitis and bacterial infection; 3. newborns infected with other pathogens.
a study of valacyclovir to suppress hsv and hiv shedding in coinfected persons

Conditions: Herpes Simplex; HIV Infections

Summary: the primary objective of this research study is to assess if daily valacyclovir therapy for suppression of hsv-2 reactivation is associated with a decrease in mucosal hiv shedding in individuals co-infected with both hsv-2 and hiv.

sexually transmitted diseases and genital ulcer disease (gud) contribute significantly to the spread of hiv, as their presence is associated with higher rates of hiv acquisition in susceptible individuals. herpes simplex virus-2 (hsv-2) is a major cause of gud in developed and developing countries. the primary objective of this research study is to assess if daily valacyclovir therapy for suppression of hsv-2 reactivation is associated with a decrease in mucosal hiv shedding in individuals co-infected with both hsv-2 and hiv. this study is a randomized, double-blind, placebo-controlled, crossover trial. sixty men who have sex with men (msm) will be randomized to first receive either valacyclovir, 1 gram once a day, or matching placebo for 8 weeks. after a 2-week washout period during which all participants receive placebo, subjects then switch to the other treatment for the next 8 weeks. at screening, informed consent is obtained and individuals will have blood drawn to test antibody status to hiv and hsv and well as to monitor cd4 count and plasma hiv rna determination. at enrollment, oral, genital, and rectal specimens are obtained and additional blood is drawn. participants are given a two-week supply of study medication and are instructed on the technique of collecting daily home samples and completing a diary. following enrollment, they are asked to collect daily home oral and genital samples, as well as semen samples twice a week, for the full 18 weeks of the study. participants return to the clinic three times per week for follow-up, for collection of oral and rectal specimens, and additional study medication. rectal biopsy is performed at weeks 8 and 18 for those individuals that signed the additional rectal biopsy consent form.

Eligibility criteria:
inclusion criteria: * hiv seropositive and hsv-2 seropositive * msm (men having sex with men) * 18 years old or older exclusion criteria: * known history of adverse reaction to acyclovir or valacyclovir * planned open label use of acyclovir, valacyclovir or famciclovir

Keywords: hiv-1
fashion fabry disease hypertrophic cardiomyopathy and infammation

Conditions: Fabry Disease

Summary: in fabry disease (fd) and hypertrophic cardiomyopathy (hcm) systemic inflammation recently gained attention as a possible key pathophysiologic process involved in the development of cardiac hypertrophy and progression of the disease. differences in inflammatory profile between fd and hcm have never been investigated so far.

this study investigate whether partecipants with fd and hcm have a different inflammatory phenotype defined by plasma biomarkers, serum proteomic profile and transcriptomic analysis in peripheral blood mononuclear cells. moreover, the investigators sought to explore if a correlation exists between the inflammatory phenotype and the severity of cardiac phenotype cardiovascular events during 24 months of follow up. this will be a prospective, multicenter, observational study. adult partecipants with a genetically-proven diagnosis of fd and age-matched patients with a diagnosis of sarcomeric hcm will be enrolled, according to the following exclusion criteria: 1. diagnosis autoinflammatory disorders; 2. history of recurrent infections; 3. hiv infection; 4. active cancer; 5. history of organ transplantation needing chronic immunosuppressor treatment. for each patient, at the time of enrollment, a blood sample will be collected and plasma levels of markers of inflammation, oxidative stress and cardiac remodeling will be determined (c-reactive protein, interleukin \[il\]-6, il-1β, il-2, soluble vascular cell adhesion molecule, tumor necrosis factor \[tnf\], tnf receptor 1 and 2, myeloperoxidase, calprotectin, uric acid, asymmetric dimethyl arginine, symmetric dimethyl arginine, matrix metalloprotease \[mmp\]-2, mmp-8 and mmp-9, galectin-1, galectin-3, b-type natriuretic peptide, midregional pro-atrial natriuretic peptide, monocyte chemoattractant protein. serum proteomic analysis and transcriptomic analysis on peripheral blood mononuclear cells, investigating molecular mediators involved in inflammatory pathways will be also performed. partecipants enrolled will also undergo a comprehensive 2d-echocardiography with doppler, tissue doppler (td) and speckle tracking analysis and 12-leads electrocardiogram.

Eligibility criteria:
inclusion criteria: * age ≥18 years; * patients with confirmed genetic diagnosis of fd19; * patients with a known diagnosis of sarcomeric hcm adult (with pathogenic mutation in sarcomeric genes identified); * signed informed consent. exclusion criteria: * age \<18 years; * diagnosis of autoinflammatory disorders; * history of recurrent infections; * hiv infection; * active cancer; * history of organ transplantation needing chronic immunosuppressor treatment; * pregnancy * refusal to sign informed consent to study participation.

Keywords: hypertophic cardiomyopathy
candida therapeutic vaccine in head and neck cancer patients to reduce recurrence

Conditions: Squamous Cell Carcinoma of Head and Neck

Summary: this is a phase ii randomized, double-blind, placebo controlled, multi-site study of candin. it is designed to show the efficacy and safety of a 7-dose regimen of candin over a two-year period in terms of reducing cancer recurrence rate by comparing the recurrence rates between the candin and the placebo arm. the ratio of the number of subjects who will receive candin versus placebo will be 3:1. up to 100 subjects will be screened until 80 subjects are eligible for injection.

this is a phase ii study to evaluate the efficacy and safety of a therapeutic vaccine called candin® (nielsen biosciences, san diego, ca) in adults over a two (2) year period. each subject will be receiving a total of 7 injections of candin (0.5 ml per dose) or placebo (saline) at a 3:1 ratio in a randomized double-blinded design. subjects will receive one injection every 3 weeks until they receive 4 injections. then, subjects will receive one injection every 3 months until they receive a total of 7 injections. subjects will have 2 more visits approximately 6 months apart after the last injection. immunological assessment t-cell repertoire analysis and by fluorescent activated cell sorter analysis (facs) will be made at 4 time points (visits 1, 5, 7, and 8). stool and oral wash samples will be collected at the screening visit, visit 5, visit 7 and visit 8 for microbiome diversity analysis.

Eligibility criteria:
inclusion criteria: * able to provide informed consent * male or female 18 years of age or older * squamous cell carcinoma of the head and neck who have completed curative therapy (surgery and/or radiation and/or chemotherapy) within the previous 120 days. * no evidence of disease (ned) based on clinical and/or radiographic evaluations * willing and able to comply with the requirements of the protocol exclusion criteria: * positive urine pregnancy test for women of childbearing potential * being pregnant or attempting to be pregnant with the period of study participation * women who are breast feeding or plan to breast feed within the period of study participation * patients who are allergic to candin® * if in the opinion of the pis or other investigators, it is not in the best interest of the patient to enter or continue in this study
promiseb topical cream for cradle cap

Conditions: Cradle Cap; Infantile Seborrheic Dermatitis

Summary: the purpose of this study is to evaluate the efficacy and safety of promiseb topical cream in cradle cap.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of cradle cap * must be at least 30 days old * must be in good health as determined by investigator * naive to prior cradle cap therapy (may have used mineral, olive oils) exclusion criteria: * known food, topical product or medicinal allergies. * prior use of corticosteroids, antifungals or keratolytics for cradle cap * weighing less than 7 lbs

Keywords: cradle cap infantile seborrheic dermatitis
high protein, core muscle rehab, muscular electrostimulation in prolonged mechanical ventilation

Conditions: Prolonged Mechanical Ventilation; Protein Deficiency

Summary: the goal of this clinical trial is to learn about in patients with prolong mechanical ventilation. this main questions aims to answer are: * high protein formula intake benefit in successful weaning from ventilator * core muscle rehabilitation benefit in successful weaning from ventilator * neuromuscular electric stimulation benefit in successful weaning from ventilator participants will receive high protein diet, core muscle rehabilitation, neuromuscular electric stimulation (nmes). researchers will compare patients with interventions to control group to see if high protein diet, core muscle rehabilitation, neuromuscular electric stimulation works.

the investigator aims to investigate the efficacy of below list methods in patients with prolong mechanical ventilator: * high protein formula intake benefit in successful weaning from ventilator * core muscle rehabilitation benefit in successful weaning from ventilator * neuromuscular electric stimulation benefit in successful weaning from ventilator participants will randomly stratify into four groups: (1) usual care (uc), (2) uc + high protein diet (hp), (3) uc + hp + core muscle rehabilitation, (4) uc + hp + core muscle rehabilitation + neuromuscular electric stimulation (nmes). researchers will compare group 2,3,4 to control group (1, usual care) to see if high protein diet, core muscle rehabilitation, neuromuscular electric stimulation works.

Eligibility criteria:
inclusion criteria: 1. age ≥ 20 year old 2. using mechanical ventilator for more than 21 days (including patients under tracheostomy or endotracheal tube) 3. stable clinical condition, without using inotropic agent (arterial blood gas ph : 7.35-7.45, pao2≥60 mm hg at fio2 40%, absence of signs and symptoms of uncontrolled infection, and hemodynamic stability) 4. maximal inspiratory pressure (mip) \< 30mmhg 5. under enteral nutrition (en) via ng tube. exclusion criteria: 1. acute infection and sepsis (fever up to 38.5 degree) 2. severe neuromuscular disease, or uncontrolled epilepsy 3. bony fracture or dvt history 4. wound over the abdomen 5. congestive heart failure with ef \< 40% or using pacemaker 6. bmi\>35 kg/m2, or severe edema 7. patients with hepatic failure, rapid progressed malignancy, or pregnancy were also excluded. 8. under parenteral nutrition (pn) 9. use pacemaker
an english/spanish mobile augmented reality pain assessment app for hispanic/latino pediatric cancer patients

Conditions: Pain; Pediatric Cancer

Summary: in this sbir, altality, inc. ("spellbound") will assess the feasibility of a dual english/spanish language augmented reality(ar)-enabled tool for assessing inpatient postoperative pain/nausea/vomiting in hispanic/latino children and adolescents with cancer in collaboration with bilingual spanish-speaking anesthesiologists at the md anderson cancer center. if successful, the ar app will be an immediately implementable and commercially viable method of providing hispanic/latino pediatric cancer patients with limited english proficiency an adjunctive tool to overcome infrastructural barriers to receiving translation services in acute care settings that put them at higher risk of under and/or overtreatment of pain by prescription opioids and future prescription opioid dependency and misuse, at no cost to them or their families.


Eligibility criteria:
inclusion criteria: * ages 7-17 years old * child able to provide assent, and a legal guardian able to provide informed consent * current diagnosis of pediatric cancer * undergoing surgery for cancer treatment requiring postoperative inpatient hospitalization * prescribed or expected to be prescribed opioids during inpatient perioperative period * sufficient mental capacity to comprehend and interact with the game in english or spanish. exclusion criteria: * the inability to play with the spellbound app from english or spanish instructions * daily opioid use within 30 days prior to surgery * any concerns from the treatment team.
supplemental perioperative oxygen to reduce the incidence of post-cesarean wound infection

Conditions: Surgical Wound Infection

Summary: the purpose of this study is to determine if the use of supplemental oxygen at 80% fio2 can reduce the incidence of surgical site infection after emergency cesarean section.

surgical site infection (ssi) is one of the most important complications that can develop after a cesarean section. ssi can be mild or it can develop into septic shock and death, being cesarean section the most important cause of puerperal infections. supplemental oxygen at high doses has been advocated as a protective factor for ssi. the purpose of this study is to determine if the use of oxygen at high doses (80% fio2)can reduce the incidence of ssi after emergency cesarean section.

Eligibility criteria:
inclusion criteria: * gestational age \> 37 weeks * emergency cesarean section * regional anesthesia exclusion criteria: * elective cesarean section * fever of unknown origin at admission * twin pregnancy * chorioamnionitis * acute fetal distress that requires general anesthesia * immunocompromise * maternal lung/respiratory disease

Keywords: surgical wound infection oxygen cesarean