Kornimate/medical-research-clean huggingface dataset:
x-linked hypohidrotic ectodermal dysplasia (xlhed) carrier outlook toward reproduction survey

Conditions: Hypohidrotic Ectodermal Dysplasia; X-Linked Hypohidrotic Ectodermal Dysplasia

Summary: in this survey of x-lined hypohidrotic ectodermal dysplasia (xlhed) carrier females, edimer proposes to review responses to an xlhed carrier outlook toward reproduction survey in order to understand attitudes toward reproduction, potential treatments and genetic testing in order to improve the understanding of the decisions that xlhed carrier females make regarding their reproductive future.

the full survey is available here: https://www.surveymonkey.com/s/x-cors for more questions or more details you may contact the principal investigator, carrie milliard: millic@mmc.org or 207-662-6712

Eligibility criteria:
inclusion criteria: 1. provide signed informed consent; 2. 18 years of age or older 3. females with: * the clinical characteristics of hed, including at least two of the following characteristics: * clinical signs and symptoms of hed: * a history of decreased sweating; * abnormal teeth (fewer permanent teeth, teeth are smaller than average and often have conical crowns); * sparseness of scalp and body hair; * and * a clinical diagnosis from a healthcare professional; * or at least one hed affected family member * or genetically confirmed hed or xlhed;

Keywords: hed xlhed
crossover bioequivalence study of irbesartan 300 mg tablets under fasted conditions

Conditions: Hypertension

Summary: the objective of this study was to prove the bioequivalence of roxane laboratories' irbesartan 300 mg tablets under fasted conditions


Eligibility criteria:
inclusion criteria: 1. male and female subjects between the ages of 18 and 45 years (inclusive). 2. voluntary consent to participate in the study. 3. body mass index (bmi) between 18 and 30 (inclusive). 4. female subjects of childbearing potential - not surgically sterile or at least 2 years postmenopausal - must agree to utilize one of the following forms of contraception from screening through completion of the study: abstinence, hormonal (oral, implant, transdermal, or injection) for at least 3 months prior to the first dose of the study, barrier (condom with spermicide, diaphragm with spermicide), iud, or vasectomized partner (6 months minimum). 5. no clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. exclusion criteria: 1. a history of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the investigator, would jeopardize the safety of the subject or impact the validity of the study results. 2. a history of allergic or adverse responses to irbesartan, or any comparable or similar product. 3. subjects who (for whatever reason) have been on an abnormal diet or have had substantial changes in eating habits within 30 days prior to study initiation. 4. subjects must not have made a blood donation of one pint or more within 30 days prior to study initiation. 5. subjects must not have made a plasma donation within 14 days of study initiation. 6. participation in a clinical trial within 30 days prior to study initiation. 7. use of any over-the-counter (otc) medication, including vitamins, herbal products, and dietary supplements, within 7 days prior to or during the study. 8. use of any prescription medication within 7 days prior to or during the study, with the exception of hormonal contraceptives for women of childbearing potential, or hormone replacement therapy. 9. treatment with any known enzyme altering drugs such as barbiturates, phenothiazines, cimetidine, carbamazepine, phenytoin, rifampin, rifabutin, glucocorticoids, diltiazem, ketoconazole, maoi, antidepressants, neuroleptics, verapamil, quinidine, erythromycin, etc., within 30 days prior to or during the study. 10. smoking or use of tobacco products within 6 months prior to or during the study. 11. female subjects who are lactating. 12. positive serum pregnancy test for female subjects. 13. positive blood screen for hiv, hepatitis b or hepatitis c. 14. positive screen for alcohol or drugs of abuse, and history or presence of alcoholism or drug abuse within 6 months prior to the study start.
postoperative pain management after minimally invasive esophagectomy

Conditions: Esophageal Cancer

Summary: esophagectomy is a major surgical procedure often associated with significant morbidity and mortality and significant level of postoperative pain. in contrast to open esophagectomy where epidural pain control has been considered as a gold standard and could be crucial in affecting outcome the analgesic scheme for minimally invasive esophagectomy (mie) is yet to be established. we would like to compare continuous epidural analgesia and continuous paravertebral block combined with single shot subcostal transversus abdominis plane (tap) block in the analgesic effects, levels of cytokines, and postoperative complications in patients receiving mie.


Eligibility criteria:
inclusion criteria: * patient has a physical status between asa i and iii * 20 - 75 years of age * patient has signed an informed consent * without contraindication of ga, ea or pvb exclusion criteria: * asa \> iii * inability to provide informed consent * bleeding disorders * being pregnant * contraindications to nonsteroidal anti-inflammatory drugs (nsaids), * allergy to amide-type local anesthetics or nsaids * infection at the thoracic paravertebral injection site * severe spine or chest wall deformity * patients with major psychosis or drug and alcohol abuse * patients with a history of significant neurological, psychiatric, neuromuscular, cardiovascular, pulmonary, renal or hepatic disease * patients with physical disability that precludes complete cooperation
a prospective cohort study on drug-induced liver injury in china（dili-p）

Conditions: Drug-induced Liver Injury

Summary: this is a multi-center, prospective, non-interventional cohort study . its primary objectives are: 1. assess dili patients' clinical characteristics, disease progression and influencing factors in clinical practice; 2. learn about suspected drug caused dili,rechallenging, liver biochemical abnormalities mode, etc.

the main purpose of this study is to understand patients with dili clinical outcome and influencing factors in china's second and tertiary general hospitals (including western medicine hospital, chinese medicine hospital andintegrated traditional chinese and western medicine hospital) and vulnerabilities of drug-induced liver injury specialist hospital (tuberculosis hospital, pulmonary, etc.) in mainland. the main purpose 1. assess the dili patients' clinical outcomes and influencing factors in the real world; 2. learn about suspected drug caused dili,rechallenging, liver biochemical abnormalities mode, etc. secondary objectives 1. assess the compliance of the dili practice to the 2015 vision of the dili guidelines in china.; 2. evaluate the histological features of dili patients; 3. assessment dili characteristics, prognosis and influencing factors in specific populations(such as the elderly, children with underlying liver disease background, etc.)

Eligibility criteria:
inclusion criteria: * diagnosis of dili patients with various types and severity according to the 2015 version of the chinese dili treatment guidelines * rucam ≥6, or rucam between 3-5 is required by the three experts determined that the drug-induced liver injury * patient can provide informed consent form exclusion criteria: * non-drug-induced liver injury
role of cytosorb in left ventricular assist device implantation

Conditions: Heart Failure

Summary: mechanical circulatory support, specifically implantable continuous flow left ventricular assist device (cf-lvad) therapy has been established as a viable treatment for rapidly deteriorating patients suffering from end stage heart failure either as bridge or alternative to heart transplantation. however, a large proportion of these patients experience severe complications in the early postoperative period including right ventricular failure or multi organ failure leading to increased mortality. the leading theory explaining these complications involves exaggerated systemic inflammatory response prior to, during and early after cf-lvad insertion. among the cytokines il-6 appears to play a major role. there is increasing demonstration of the efficacy of a cytokine haemoadsorption (ha) technology in attenuating cytokine response and particularly il-6 in various inflammatory states and emerging data on the safety of the cytosorb® device in routine and complex cardiac surgery. the study team hypothesizes that cytosorb® treatment is feasible and safe in heart failure patients undergoing lvad insertion and that it is effective in attenuating il-6 secretion with benefit in the wider inflammatory and metabolic response to this high-risk surgery.

the principle objectives of this study are: 1. to investigate the efficacy of cytosorb® treatment in attenuating perioperative changes in il-6 during cf-lvad implantation 2. to investigate the feasibility, and safety of cytosorb® treatment during cf-lvad implantation. 3. to pilot the effect of cytosorb® treatment on vasoplegia and organ dysfunction with specific focus on right ventricle failure, liver failure and acute kidney injury (aki). 4. to establish a collaborative biobank of patient's biological samples to allow extensive characterisation of patient phenotype prior to cf-lvad implantation and their individual inflammatory and metabolic responses to surgery and perioperative management.

Eligibility criteria:
inclusion criteria: adult patients (≥18 years), but ≤70 years; scheduled for elective lvad implantation with the use of cardiopulmonary bypass; written informed consent for participation exclusion criteria: * poor spoken and/or written language comprehension * declined or missing informed consent * lvad implant planned without use of cpb * total artificial heart implantation * planned cpb temperature \< 32 °c * aids with a cd4 count of \< 200/μl * severe thrombocytopenia (plt \<50000 * application of contrast medium on the day of surgery * immunosuppressive therapy or long-term therapy with corticosteroids * contraindication to anticoagulation with heparin * participation in another clinical intervention trial

Keywords: cardiac surgery inflammation cytokines bypass artificial heart known as lvad
safety and efficacy study using rexin-g for sarcoma

Conditions: Sarcoma

Summary: rexin-g is a tumor-targeted (pathotropic or disease-seeking) nanoparticle that when injected intravenously, seeks out and accumulates in cancerous lesions, thus enhancing local drug concentration within tumors. the goal of the adaptive trial design is to confirm the over-all safety of rexin-g and to determine the optimal dosing regimen for rexin-g that would document the significant clinical benefits required to support a phase ii registration protocol.

the phase i/ii clinical trial incorporates a phase ii component that will evaluate the efficacy of rexin-g using an adaptive trial design. each treatment cycle will be six weeks: four weeks of treatment and two weeks of rest. unlike a standard phase i protocol, eligible patients may have repeat cycles after the safety data and objective tumor response/s are recorded. continued rexin-g treatment will enable the targeted nanomedicine to catch up with tumor growth, halt disease progression, and reduce tumor burden. the treatment strategy is to achieve tumor control as quickly as safely possible. the goal of the adaptive trial design is to confirm the over-all safety of rexin-g and to determine the optimal dosing regimen for rexin-g that would document the significant clinical benefits required to support a phase ii registration protocol.

Eligibility criteria:
inclusion criteria: 1. histologically or cytologically confirmed recurrent or metastatic sarcoma that is measurable. 2. adequate hepatic function: total bilirubin \ 3.0 mg/dl. there must be no substantial ascites. pt and ptt must be within normal limits. 3. performance status must be \< 1 (ecog 0-1) with a life expectancy of at least 3 months. 4. hemoglobin \> 9 gms% 5. absolute granulocyte count \> 1000/ul, and platelet count \> 100,000/ul. 6. serum creatinine of less than 1.5 mg%. 7. there must be no plans for the patient to receive further cancer therapy from the date of enrollment until the completion of the 6-week follow-up visit. 8. accessibility of peripheral or central iv line 9. age \> 10 years 10. patients will be off chemotherapy for a minimum of 4 weeks prior to initiation of therapy and should have recovered to grade 1 or less toxicity. 11. the ability to understand and the willingness to sign a written informed consent document. exclusion criteria: 1. prior malignancy, except for non-melanoma skin cancer, stage 1 breast cancer, cis of cervix from which the patient has been disease-free for 5 years. 2. woman who are pregnant or nursing 3. fertile patients unless they agree to use barrier contraception (condoms and spermicide jelly) during the vector infusion period and for six weeks after infusion. male patients must agree to use barrier contraception. 4. patients who are transfusion dependent (more than one transfusion per month) 5. patients with medical, psychiatric, or social conditions that would compromise successful adherence to this protocol. 6. patient who do not meet the inclusion criteria.

Keywords: sarcoma rexin-g gene therapy
antiphospholipid syndrome collaborative registry (apscore)

Conditions: Antiphospholipid Syndrome

Summary: antiphospholipid syndrome (aps) is an autoimmune disorder in which the body recognizes certain normal components of blood and/or cell membranes as foreign substances and produces antibodies against them. patients with these antibodies may experience miscarriages and blood clotting disorders, including heart attacks and strokes. aps may occur in people with systemic lupus erythematosus and other autoimmune diseases, or in otherwise healthy individuals. the antiphospholipid syndrome collaborative registry (apscore) is a national registry and tissue repository for patients with aps. this registry will collect clinical information and blood samples from people with aps.

registry participants will have a blood sample drawn and will be interviewed about their medical histories. participants will be asked to return for a follow-up visit after two years. clinical, demographic, and laboratory data will be collected. registry resources will be made available to researchers and medical practitioners to support a broad range of research on the causes, diagnosis, mechanisms, and treatment of aps. the university of north carolina at chapel hill is the coordinating center and an enrollment site for the registry. there are seven other enrollment sites: ball memorial hospital, muncie, in; duke university, durham, nc; hospital for special surgery, new york, ny; johns hopkins university, baltimore, md; morehouse school of medicine, atlanta, ga; university of texas health science center, san antonio, tx; and university of utah health science center, salt lake city, ut.

Eligibility criteria:
inclusion criteria: * antiphospholipid antibodies with or without associated clinical manifestations

Keywords: antiphospholipid
a study to quantify use of anticoagulation to improve management of atrial fibrillation

Conditions: Atrial Fibrillation

Summary: the purpose of this study is to evaluate the impact of a hospital quality improvement (qi) program on the use of guideline-recommended oral anticoagulants (oac) in hospitalized patients with atrial fibrillation (af) at risk for ischemic stroke. specifically, the study will determine whether the intervention, compared to usual care, will result in a greater increase in the proportion of patients with af at risk for ischemic stroke who are appropriately treated with oac.


Eligibility criteria:
inclusion criteria: * inpatient hospitalization * primary or secondary discharge international classification of diseases (icd)-9/10 diagnosis code for af paroxysmal (i48.0), persistent (i48.1), chronic (i48.2), or unspecified (427.31, i48.91) * proxied congestive heart failure (cha2ds2-vasc) score greater than or equal to (\>=) 2 using icd-9 diagnosis scoring algorithm developed previously. the scoring algorithm will be expanded to include icd-10 codes * discharged to home, skilled nursing facility, inpatient rehabilitation, or nursing home exclusion criteria: * presence of artificial mechanical heart valve by icd-9/10 diagnosis or procedure code during comorbid identification period or current hospitalization * surgical procedure during hospitalization for open heart surgery, brain, or spine * intravenous heparin given on the day of discharge without warfarin/oral anticoagulant (oac), antiplatelets, and/or aspirin * history of left atrial appendage occlusion, including the watchman device * any in-hospital (current hospitalization) bleeding identified by icd-9/10 diagnosis codes
turkish cross-cultural adaptation, validation and the reliability of uwri (university of wisconsin running injury and recovery index)

Conditions: Running Related Injuries

Summary: the purpose is to perform a scientific study on turkish cross-cultural adaptation, validation and the reliability of uwri

the primary aim of this study is to perform turkish cross-cultural adaptation, validation and the reliability of uwri in runners. the secondary aim of this study is investigating injury rate and types among runners.

Eligibility criteria:
inclusion criteria: * 14-45 years old female or male * participating in running as amateur, recreational, competitional or professional runner * being a short, mid, or long distance runner * being native turkish speaker * agreed to participate in the research exclusion criteria: * if there is no surgical history related to running injury in the last 12 months * if have chronic metabolic disease * paralympic athletes * pregnant and breastfeeding

Keywords: validity reliability pro patient outcome report turkish adaptation running injury
effect of prednisone ontregs and th17

Conditions: Chronic Rhinosinusitis

Summary: the primary objective of this study is to see whether systemic corticosteroids (such as prednisone) have an effect on the peripheral blood treg and th17 function in patients with crs. patients are taking prednisone as part of their routine medical care.


Eligibility criteria:
inclusion criteria: * diagnosis of crs. * a ct scan performed in the last year depicting the severity of the disease or nasal polyps on endoscopy. * symptomatic at the time of entry into the study as determined by scores ≥ 1.4 on the rhinosinusitis disability index exclusion criteria: * women who are pregnant or breastfeeding. * patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (heart, lung, kidney, diabetes, osteoporosis, cataracts, glaucoma, neurological, oncologic, liver disease or a contraindication to taking prednisone). * use of any other investigational agent in the last 30 days. * use of clinical drugs like antihistamines, leukotriene modifiers, intranasal steroids, systemic corticosteroids in the last 15 days or immunotherapy in the last year. * upper respiratory infection within 14 days of study start * smoking within the last 2 months.
itraconazole as a targeted therapy for inhibiting hedgehog pathway signaling in esophageal cancer patients

Conditions: Esophageal Cancer

Summary: the purpose of this study is to demonstrate that orally administered itraconazole, a commonly used antifungal medication, can inhibit hedgehog pathway signaling in patients with esophageal cancer, including adenocarcinoma (eac) and squamous cell carcinoma (escc).


Eligibility criteria:
inclusion criteria: • clinical diagnosis of esophageal cancer, including gastroesophageal junction cancer exclusion criteria: * patients unwilling or unable to provide informed consent * coagulopathy that precludes safe endoscopic/surgical procedure (platelet count \ 1.5) * esophageal varices * comorbidity (e.g. pulmonary, cardiac, renal, or liver disease) that precludes safe participation in the study * qtc\>450 ms * lft's\>3xuln * pregnancy * allergy to itraconazole * history of symptomatic congestive heart failure
prospective study on artelon® tissue reinforcement in repair of chronic ruptures and re-ruptures of the achilles tendon

Conditions: Achilles Tendon Rupture

Summary: the aim of this study is to evaluate the surgical and clinical outcome of artelon® tissue reinforcement in repair of chronic ruptures or re-ruptures of the achilles tendon, with regard to lower leg and foot function, pain and quality of life.


Eligibility criteria:
inclusion criteria: 1. the patient has a clinically confirmed isolated chronic rupture or rerupture of the achilles tendon. 2. the patient has been informed about the study and signed the patient consent form. 3. the patient reads, understands and is able to complete the study questionnaires in english. exclusion criteria: 1. the patient has an ongoing infection of the soft tissues of the ankle. 2. the patient has evidence of severe ankle arthritis. 3. the patient has a multi-system or multi-limb trauma. 4. the patient has a major medical condition that would affect quality of life and influence the results of the study. 5. the patient is pregnant 6. the patient is not expected to complete the study according to the investigation plan.

Keywords: achilles rupture tendon artelon
evaluation of plasma renin concentrations in cardiac surgery

Conditions: Cardiac Surgery With Cardiopulmonary Bypass

Summary: the purpose of this research is to learn more about how renin (a blood test) is affected by cardiopulmonary bypass, the heart-lung machine used during open heart surgery. renin is a protein that may be elevated in response to low blood pressure or situations where organs do not receive sufficient oxygen. renin may potentially be used as an indicator for specific treatments aimed to increase the blood pressure. this study will evaluate blood samples for renin concentration throughout the course of open heart surgery.

the investigator hypothesizes that renin concentrations will increase with exposure to cardiopulmonary bypass and that increased renin concentrations will be associated with the development of vasoplegia. specific aim 1. to characterize the effects of cardiopulmonary bypass on plasma renin concentrations in adults undergoing cardiac surgery. specific aim 2. to test the prognostic value of plasma renin concentrations on outcomes following cardiac surgery.

Eligibility criteria:
inclusion criteria: * adult persons 18 years of age or greater. * scheduled for an elective cardiac surgical procedure involving the use of cardiopulmonary bypass. exclusion criteria: * surgery involving heart or lung transplantation or implant of a durable left ventricular assist device. * emergency cardiac surgery. * established diagnosis of any congenital heart disease. * end-stage kidney disease receiving kidney replacement therapy before surgery.

Keywords: renin-angiotensin system ras hypotension perfusion shock blood pressure