Kornimate/medical-research-clean huggingface dataset:
analysis of blood metabolomics to identify potential biomarkers of gastrointestinal bleeding

Conditions: GastroIntestinal Bleeding

Summary: despite advances in gastrointestinal endoscopy and pharmaceuticals, gastrointestinal bleeding is still a significant emergency disease with a high mortality rate of 1.9-5 per 100 people due to excessive bleeding and shock. there are several indicators using pulse rate, blood pressure, hemoglobin, etc. to select patients who require endoscopic intervention, or hospitalization, but these are inaccurate and with a high false-positive rate and low specificity at 35-40%. therefore, tests with high diagnostic accuracy for gastrointestinal bleeding patients are required and findings specific biomarkers for gastrointestinal bleeding are of great importance.

recently, with the development of metabolomics, efforts are being made to improve the diagnosis and treatment of diseases through metabolomics analysis, but there are no studies related to gastrointestinal bleeding. if the degradation/metabolism process of blood that accumulates in the gastrointestinal tract is well studied and understood, there is a possibility of finding specific biomarkers for gastrointestinal bleeding. thus, this study aims to analysis of metabolomics of blood degradation/digestion using in vitro digestion model to identify potential biomarkers of gastrointestinal bleeding.

Eligibility criteria:
inclusion criteria: 1. male and female participants, aged between 21 and 55 years old. 2. a body mass index (bmi) between 18.5 and 29.9 kilograms per meter square. 3. english-literate and able to give informed consent in english. exclusion criteria: 1. smokers. 2. clinically significant allergic, renal, cardiac, bronchopulmonary, vascular, gastrointestinal, neurological, metabolic or immunodeficiency disorders, cancer, hepatitis, or cirrhosis. 3. had surgery of the gastrointestinal tract or any other medical condition considered likely to affect the gastrointestinal absorption. 4. use of oral iron supplement within the past 30 days. 5. consumes more than 2 alcoholic drinks per day i.e. one drink is defined as either 150ml of wine, 340ml of beer/cider or 45ml of distilled spirit. 6. significant change in weight (≥ 3 kg body weight) in the past 3 months. 7. significant exercise pattern over the past 3 months defined as high-intensity exercise of more than 3 hours per week. 8. poor peripheral venous access based on past experiences with blood draw

Keywords: in vitro digestion metabolomics gastrointestinal tract
coversin in pnh in patients with resistance to eculizumab due to complement c5 polymorphisms

Conditions: Paroxysmal Nocturnal Hemoglobinuria (PNH)

Summary: coversin in paroxysmal nocturnal hemoglobinuria (pnh) in patients with resistance to eculizumab due to complement c5 polymorphisms.

coversin, a small protein complement c5 inhibitor which prevents the cleavage of c5 by c5 convertase into c5a and c5b, will be used in an open label, non-comparative clinical trial in patients with pnh and proven resistance to eculizumab due to c5 polymorphisms. patients will be treated with coversin by daily subcutaneous injection for 6 months in order to determine the safety and efficacy of the drug in these circumstances. if satisfactory control of the pnh is achieved, and at the discretion of the principal investigator (pi), patients will have the option of remaining on coversin and being entered into the long term follow-up study.

Eligibility criteria:
inclusion criteria: 1. patients with known pnh. 2. aged 18 and above. no upper age limit. 3. lactate dehydrogenase (ldh) ≥1.5 upper limit of normal. 4. must agree to use two methods of contraception that are ≥99% effective in preventing pregnancy. 5. resistance to eculizumab (soliris®). 6. voluntary written informed consent. 7. willing to self-inject coversin daily. 8. willing to receive appropriate prophylaxis against neisseria infection. 9. willing to avoid prohibited medications for duration of study. exclusion criteria: 1. subjects with body weight \ 100 kg (220 lb). 2. pregnancy or breast feeding (females). 3. known allergy to ticks or severe reaction to arthropod venom (e.g. bee or wasp venom). 4. unresolved neisseria meningitidis infection. 5. patients who have not received adequate immunization against neisseria meningitides. 6. impaired hepatic function. 7. patients with impaired renal function. 8. failure to satisfy the principal investigator (pi) of fitness to participate for any other reason.
treatment of a cancerous disease of the peritoneum with complete cytoreductive surgery and intraperitoneal chemohyperthermia

Conditions: Colon Tumors; Rectum Tumors; Appendix Tumors; Peritoneum Tumors; Endocrine Tumors

Summary: the purpose of this study is to evaluate the treatment of a cancerous disease of the peritoneum with complete cytoreductive surgery with intraperitoneal chemohyperthermia using oxaliplatin plus irinotecan. this is a phase ii study with 100 patients. origins of the tumors: these include colon, rectum, appendix, peritoneum, and endocrine tumors.


Eligibility criteria:
inclusion criteria: * peritoneal seedings coming from colon, rectum, pseudomyxoma (appendix), peritoneum (mesothelioma and serous tumors), or endocrine tumors. * no extra-abdominal metastases * good general status (american society of anesthesiologists physical status score \[asa\] 1 or 2) * signed consent exclusion criteria: * tumor seedings coming from other origins * huge peritoneal carcinomatosis (peritoneal score \> 25, except for pseudomyxomas) * peritoneal carcinomatosis progressing rapidly * presence of extra-abdominal metastases * patients presenting contraindications to the use of oxaliplatin or irinotecan
pembrolizumab and chemoradiation treatment for advanced cervical cancer

Conditions: Cervical Cancer

Summary: the purpose of this study is to evaluate the safety and effectiveness of immunotherapy in combination with chemotherapy and radiation (chemoradiation) for the treatment of advanced cervical cancer. pembrolizumab, a type of immunotherapy called a checkpoint inhibitor, will be administered after or during chemoradiation.

primary: (1) to estimate the immunologic effects, as assessed in the tumor \& pbmc, of both sequential and concurrent administration of pembrolizumab to crt. change between pre and post measurements of hpv e2, e7 specific cd8+ t cells, regulatory foxp3+ t cells (tregs) and the ratio of cd8+ t cells to tregs are the immune measurements of primary interest. (2) to determine the safety of concurrent chemoradiation in combination with pembrolizumab for the treatment of locally advanced cervical cancer. secondary: (1) to estimate rates of complete metabolic response on pet/ct imaging obtained 12 weeks after crt. (2) to estimate rates of distant metastasis as the first site of recurrence for patients. (3) to estimate the influence of concurrent and consolidative mk-3475 on levels of plasminogen activator inhibitor-1 (pai-1), a marker of immunosuppressive tgf-b. (4) to estimate the influence of concurrent and consolidative mk-3475 on levels of ido, an enzyme that depletes tryptophan, which is essential for t-cell function. (5) to estimate the influence of concurrent and consolidative mk-3475 on levels of mhc class i (cd8+ t cell ligand) and mica (nk ligand), as measured by mhc. (6) to estimate the progression free survival (pfs) in subjects with locally advanced cervical cancer treated with sequential and concurrent administration of pembrolizumab in relation to crt. (7) to estimate the overall survival (os) in subjects with locally advanced cervical cancer treated with sequential and concurrent administration of pembrolizumab in relation to crt.

Eligibility criteria:
inclusion criteria: * confirmed cervical cancer. * must have adequate organ function. exclusion criteria: * subject is pregnant. * recurrent cervical cancer. * distant metastases. * malignancy within the last 5 years; basal cell carcinoma or squamous cell carcinoma of the skin that has undergone potentially curative therapy is permissable. * subject has had prior radiation, chemotherapy, targeted therapy, or investigational therapy for cervical cancer. * subject has a immunodeficiency. * known history of hiv, hepatitis b, hepatitis c, tb, or inflammatory bowel disease. * hypersensitivity to pembrolizumab or similar drugs. * subject has an active autoimmune disease in the past 2 years. * known history of non-infectious pneumonitis. * subject has an active infection. * subject has known active central nervous system (cns) metastases and/or carcinomatous meningitis. subjects with previously treated brain metastases are permissible. talk to study contact for specifics.

Keywords: advanced cervical cancer pembrolizumab chemoradiation immunotherapy
study of protease inhibitor regimen switch in hiv-1 infected patients with undetectable viral load to prove the non-inferiority of once daily dose regimen versus the current twice daily regimen to maintain the viral load under the limit of detection.

Conditions: HIV-1 Infection; HIV Infections

Summary: darunavir boosted with ritonavir (darunavir/r) is a powerful protease inhibitor, able to reduce the viral load in patients infected with multi-resistant hiv strains; in vitro and in vivo studies have shown that the induction of resistance mutations in the protease gene is much more difficult with the association darunavir/r compared to the other ritonavir-boosted protease inhibitors (pi/r), testifying of a significantly higher genetic barrier to resistance. moreover, the tolerance to darunavir is good, and the pharmacologic profile of this molecule allows a once daily administration with a 800/100 mg dose in patients infected with a wild hiv strain or with a slightly resistant to darunavir/r strain. thus, we propose to evaluate the efficacy of the darunavir/r association once daily as a substitute to a protease inhibitor regimen administered twice daily in patients with undetectable viral load receiving a tritherapy including a protease inhibitor administered twice daily.


Eligibility criteria:
inclusion criteria: * hiv-1 infected patients * treatment with an association of 3 molecules including two nucleotidic reverse trasncriptase inhibitors and a ritonavir-boosted protease inhibitor bid, unchanged for at least one month * at least two documented undetectable viral loads (under 50 copies/ml) within the last 3 months * naiive from darunavir * free from any opportunistic infection * creatinin \< 3n * asat \& alat \< 5n * haemoglobin \> 7 g/dl * platelets \> 50 000/mm3 * negative pregnancy test for women of childbearing potential and use of a mechanic contraceptive during sexual relationships * signed informed consent exclusion criteria: * hiv-2 infected patients * treatment different from the association described in the inclusion criteria (2 nrtis + 1 pi/r bid) * patients with a documented problem of treatment compliance within the last 12 months * ongoing active treatment against any opportunistic infection or tuberculosis * any critic concomitant condition (alcohol consumption, fatigue) that may jeopardize treatment compliance and/olr tolerance, and interfere with the protocol compliance * any concomitant treatment that may potentialize or inhibit hepatic cyotchrome-based enzymes * patient already treated with darunavir * patient treated with tipranavir, enfuvirtide, raltegravir, etravirine, and/or maraviroc

Keywords: treatment experienced
displaced proximal humeral fractures: delta prothesis or philos plate?

Conditions: Proximal Humeral Fractures, AO/OTA (2007) Group B2 and C2

Summary: to investigate the assumption that reversed shoulder prosthetic replacement will give a better functional outcome compared to open reduction and internal fixation with an angular stable plate in displaced proximal humeral fractures. short name: the delphi trial.

reversed total shoulder artroplasty (rtsa) equals delta xtend reversed total shoulder prosthesis. angular stable plate means proximal humerus plate (philos)

Eligibility criteria:
inclusion criteria: patient admitted in hospital with a displaced three- or four part proximal humerus fracture of ota / ao group 11-b2 or 11-c2 (displaced fracture of extra-articular or articular, bifocal type). the subgroups -.1, -.2 and -.3 will be included for both b2 and c2 groups, provided severe displacement: this is defined as a mal-position of at least 45º of angular deviation in valgus or 30º in varus in true frontal projection, regardless of whether the fracture is impacted or not, or less than 50% contact between humeral head and the metaphyseal part of the shaft. the greater or lesser tubercle displaced at least 10 mm. exclusion criteria: patient younger than 65 years or older than 85 years, previous history of injury or illness of the injured shoulder, injuries of other parts of the humerus or the contra-lateral upper extremity, alcohol- or drug abuse, dementia, neurological diseases, or severe cardiovascular or lung diseases that would contraindicate surgery. patients have to understand the norwegian language and be compliant to rehabilitation and follow-ups.

Keywords: reversed prosthesis, philos, severe displaced
a study to evaluate the ocular blood flow effects of unoprostone isopropyl in adults with dry age-related macular degeneration

Conditions: Dry Age-related Macular Degeneration

Summary: the purpose of this study is to determine the pharmacodynamics of ocular blood flow measurements with multiple drop unoprostone isopropyl administration versus placebo in subjects with dry age-related macular degeneration (amd).


Eligibility criteria:
inclusion criteria: * age ≥ 50 years at screening * ametropy ≤ 3 diopters * clear ocular media * visual acuity in the study eye \> 20/40 exclusion criteria: * presence of any ocular condition in the study eye (other than amd) that may progress during the course of the study and could affect central vision, or other ocular conditions that may be a confounding factor in this study * blood donation during the previous 3 weeks * current smoker or a history of smoking within 5 years of enrollment * treatment with protocol-specified prohibited concomitant medications * prior exposure to rescula (unoprostone isopropyl) and or a known sensitivity to any of the components of the study medication (e.g. benzalkonium chloride)
a study to evaluate the efficacy and safety of vismodegib in combination with ruxolitinib for the treatment of intermediate- or high-risk myelofibrosis (mf)

Conditions: Myelofibrosis

Summary: this multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of vismodegib plus (+) ruxolitinib versus placebo + ruxolitinib in participants with intermediate- or high-risk mf. the study will be divided into 2 components. the phase ib portion of the study consists of participants receiving open-label vismodegib (150 milligrams \[mg\] orally \[po\] once daily \[qd\]) + ruxolitinib (po twice daily \[bid\]). a safety assessment will be performed after the first 10 participants have been treated for 6 weeks. an analysis for efficacy and safety is planned in the first 10 participants at week 24. there will be a hold on participant screening and enrollment during this assessment. another 10 participants may be enrolled, thereafter, to further assess efficacy and safety (at week 24) before the initiation of the phase iii randomization portion of the study. similarly, there will be another hold on participant screening and enrollment during this assessment. the participants enrolled in the phase ib portion of the study will continue to receive vismodegib (150 mg po qd) + ruxolitinib (po bid) for up to 48 weeks, if clinical benefit is observed after 24 weeks. the phase iii randomized, double-blind portion of the study will enroll approximately 84 participants. participants will be randomly assigned in a 1:1 ratio (double blind) to receive either vismodegib (150 mg po qd) + ruxolitinib (po bid) or placebo (po qd) + ruxolitinib (po bid) for up to 48 weeks.


Eligibility criteria:
inclusion criteria: * pathologically confirmed diagnosis of primary mf, post-polycythemia vera mf, or post-essential thrombocythemia mf, according to the 2008 revised world health organization criteria * intermediate-1, intermediate-2, or high-risk according to the iwg-mrt dynamic international prognostic scoring system * life expectancy \>= 6 months * peripheral blood blast count of less than (\<) 10% * palpable splenomegaly of greater than (\>) 5 centimeters (cm) below the left costal margin * eastern cooperative oncology group performance status of 0 to 2 * adequate hepatic and renal function exclusion criteria: * prior treatment with a hedgehog or janus kinase pathway inhibitor * treatment with strong cytochrome p450 3a4 inhibitors/inducers within 28 days prior to day 1 * prior therapy for the treatment of intermediate- or high-risk mf including chemotherapy, interferon, thalidomide, busulfan, lenalidomide, anagrelide, or androgens within 28 days prior to day 1 * prior splenectomy or splenic irradiation * inadequate bone marrow reserve * participants with any history of platelet counts of \< 50,000/mccl or anc of \< 500/ml, except during treatment for myeloproliferative neoplasm or treatment with cytotoxic therapy for any other reason * planned allogeneic bone marrow transplant during the study
pharmacological treatment of rett syndrome with statins

Conditions: Rett Syndrome

Summary: this is a phase 2 , open label, dose escalating study of lovastatin in rett syndrome.

excess neuronal cholesterol plays a role in the pathophysiology of rett syndrome(rtt) and the investigators hypothesise that inhibition of cholesterol synthesis in the cns will reduce neuronal cholesterol and lead to improvement in rett syndrome related symptoms. goal: to determine the optimal dosing regiment of lovastatin for patients with rtt and to identify the most appropriate primary outcome measure for the subsequent phase 3 study. phase 2, dose escalation study. primary outcome: gait speed secondary outcomes: respiratory function, cognition, eeg (encephalopathy), rett syndrome severity scale, neurodevelopmental assessment (qol) 20 ambulatory female patients with genetically confirmed.

Eligibility criteria:
inclusion criteria: * females patients, * genetically confirmed rtt, * ambulatory. exclusion criteria: * presence of co morbid non-rett related disease, * history of adverse reaction/hypersensitivity to statins, * levels of aspartate-amino trans-ferase (ast), alanine-amino transferase (alt) or creatine kinase (ck) triple the normal values, * active liver disease, * concomitant use of strong cyp3a4 inhibitors, * condition predis-posing to renal failure secondary to rhabdomyolysis (scoliosis surgery within 6 months), * oral contraceptives use.

Keywords: treatment trial lovastatin
magnesium treating subarachnoid hemorrhage vasospasm

Conditions: Subarachnoid Hemorrhage, Aneurysmal; Cerebral Vasospasm

Summary: a randomized clinical trial investigating magnesium sulphate ability to reduce risk of cerebral vasospasm after acute subarachnoid hemorrhage hence improving outcome particularly in haptoglobin 2-2 patients who are highly susceptible for severe complications after subarachnoid hemorrhage.

study design and location: investigators propose a double blinded, randomized (1:1), placebo-controlled, multicenter, clinical trial including patients with acute asah. participants will be allocated either to mgso4 or placebo. the permission to conduct the study protocol will be considered for approval by the ethics committee of general committee of teaching hospitals and institutes (gcthi), egypt. the study will be conducted in 3 centers; el-materia educational hospital, ain shams university hospitals and nasr city insurance hospital. the assigned centers for this study represent large-volume referral stroke centers that provide comprehensive management protocols for asah.

Eligibility criteria:
inclusion criteria: * patients of both genders * age over 18 years old * diagnosis of acute asah (≤ 48 hours) confirmed with angiographic evidence of cerebral aneurysm and ct brain on admission. exclusion criteria: * subarachnoid hemorrhage due to non-aneurysmal causes * cerebral stroke of any type during past month * decompensated heart failure, renal failure or hepatic failure * difficult bilateral transtemporal transcranial doppler (tcd) insonation of intracranial arteries due to thick temporal bone of the skull.

Keywords: subarachnoid hemorrhage haptoglobin vasospasm
efficacy and safety of leo 152020 tablets for the treatment of adults with moderate to severe atopic dermatitis

Conditions: Atopic Dermatitis

Summary: this is an up to 22-week clinical study in adult participants with moderate to severe atopic dermatitis (ad). the purpose of the study is to test a new tablet (leo 152020) to see if it improves ad and what the side effects are when compared with a placebo tablet with no medical ingredient. during the study, there will be a 16-week treatment period during which the participants will be asked to take the tablets. the participants will regularly visit the clinic for tests and the study doctor will evaluate their ad. the participants will also be asked to answer questions about their ad symptoms, itch, sleep, and quality of life.


Eligibility criteria:
inclusion criteria: * adult, age 18 years or older at screening. * diagnosis of chronic atopic dermatitis (ad). * history of ad ≥1 year prior to baseline. * recent (within 6 months prior to baseline) documented history of inadequate response to topical ad treatments or subject for whom topical ad treatments are medically inadvisable. * 7.1≤ eczema area and severity index (easi) ≤50 at baseline. * validated investigator global assessment scale for atopic dermatitis (viga-ad) score ≥3 at baseline. exclusion criteria: * previous treatment with an oral histidine 4 receptor (h4r) antagonist (including leo 152020) within 6 months prior to baseline. * previous treatment with 3 or more systemic ad treatments prior to screening. * women who are pregnant, intend to become pregnant, or are lactating.
hepatitis c treatment in underserved populations

Conditions: Chronic Hepatitis C; Illicit Drug Use

Summary: the purpose of this study is to examine the feasibility, safety, and effectiveness of treating persons who are actively using illicit drugs for hepatitis c using a collaborative, multidisciplinary, integrated care model. we hypothesize that by maximizing facilitators and minimizing barriers to treatment we can enable drug users to receive effective treatment for hepatitis c.

this study examines the feasibility of integrated treatment for hepatitis c in active idus using a client-centered, multidisciplinary model that combines expert care in five domains: (a) antiviral pharmacotherapy for hcv infection; (b) substance abuse treatment; (c) psychiatric evaluation and treatment; (d) primary medical care; and (e) intensive, client-centered, case management. the weill cornell medical college center for the study of hepatitis c collaborates with community-based organizations providing services to injection drug users to provide multidisciplinary, integrated care using a model that combines the resources of culturally appropriate community-based agencies with those of a state-of-the-art tertiary care center.

Eligibility criteria:
inclusion criteria: * age 18 years or older * used heroin, cocaine, or injected other drugs for at least 1 year * have used heroin, cocaine and/or methamphetamine within the last 30 days * test positive for hcv antibody * are interested in being evaluated for hcv treatment exclusion criteria: * persons who are obviously intoxicated, incoherent or otherwise unable to give informed consent are excluded from participation. such persons may participate in the study if they return at a later date and are capable of providing informed consent.

Keywords: chronic hepatitis c illicit drug use substance-related disorders multidisciplinary care integrated care mental health care intensive case management