Kornimate/medical-research-clean huggingface dataset:
prevention of type 2 diabetes with vitamin d supplementation

Conditions: Prediabetes

Summary: prevent-win study has three components. the work plan will have the following s\&t components. component 1: cross-sectional study cross-sectional study will be of 1.5 years where 400 women from rural will be screened randomly for the vitamin d deficiency and its determinants including duration of sun exposure. component 2: prospective study this open-label randomized placebo-controlled trial would be done in 150 pre-diabetic women with vitamin d deficiency. the women will be recruited from cross-sectional study, out patient department and health camps and they will be followed up for 2 years. the women will be randomized into two groups; lifestyle modification counseling along with intervention with either vitamin d or placebo. the levels of vitamin d and blood glucose will be assessed periodically (every 6 months). in those having recurrent vitamin d deficiency, the course of vitamin d will be repeated. at the end of the study, incidence of t2dm in both groups will be compared. component 3: information education and communication (iec) activities: there is a paucity of iec material on vitamin d deficiency in women residing in rural areas. iec material will be developed and iec activities through various modes like lectures, workshops, group discussions, leaflets/booklets distribution and audio video media shows (hindi and english) will be used for educating health professionals, medical and paramedical workers and various village level health functionaries like, multi purpose workers, anganwadi workers, accredited social health activist under national rural health mission of government of india (asha). besides this, self help groups (shgs) and women will be told about the benefits of balance diet, dietary intake of calcium, vitamin d, benefits of sun exposure and adverse health effects of vitamin d deficiency.


Eligibility criteria:
inclusion criteria: * 1. prediabetes: 1. fasting blood glucose ≥100mg/dl and \<126mg/dl, or 2. 2-h plasma glucose ≥140mg/dl and \<200mg/dl (after ingestion of 75 g anhydrous oral glucose), and 2. baseline level of 25 hydroxy vitamin d \<30ng/dl. 3. women aged 20-60 years exclusion criteria: 1. received vitamin d and/or calcium supplementation in the previous six months. 2. on any medication within last one month which could potentially influence insulin secretion, insulin sensitivity, vitamin d or calcium metabolism (eg metformin, thiazolidione, steroids etc) and on any medication that activate steroid and xenobiotic receptor and drugs used in transplantation (e.g. steriods, calcitonin etc.) 3. pregnancy and lactation at the time of study. 4. severe end organ damage or chronic diseases: renal/ hepatic failure, any malignancy, nephrotic syndrome, malabsorption etc. 5. known case of hiv infection. 6. primary or tertiary hyperparathyroidism, granulomatous disorders (e.g. sarcoidosis) and any lymphomas 7. known case of diabetes mellitus. -
scd use to prevent deep venous thrombosis (dvt) in patients with picc lines

Conditions: Deep Vein Thrombosis

Summary: the purpose of this study is to see if a compression device on the arm where a peripherally inserted central catheter (picc) line has been inserted can prevent the formation of a blood clot around the picc line.

in a pilot prospective randomized controlled trial, consecutive patients requiring placement of a picc line in the neuroscience intensive care unit were randomly assigned to either the scd (intervention) group or a non scd (control) group. standardized vascular access patency protocols was used in all enrolled patients. all patients had an indwelling 5 french, double lumen picc unless additional venous access was required by the primary service. patients randomized to the intervention arm had an scd placed in the arm with the picc within 24 hours of picc placement. five to seven days after placement of the picc, the patients were examined with venous duplex ultrasound of the upper extremity to assess for the presence of venous thrombosis. the patients also had the ultrasound again 12-14 days post insertion if the picc was kept for more than 10 days. if the picc line was removed before 5-7 days, an upper extremity ultrasound was obtained upon picc removal. in case of suspected symptomatic venous thromboembolism, the investigations were performed according to current practice standards. data collection was be considered complete upon removal of the picc line.

Eligibility criteria:
inclusion criteria: * subject's age is greater than or equal to 18 years * subject is patient in neuro intensive care unit at time of picc placement exclusion criteria: * acute trauma to the upper extremity harboring the picc * current use of prophylactic anticoagulation * inability to fit the scd on the arm because of arm size * documented previous upper extremity dvt in the arm harboring the picc line

Keywords: pneumatic sequential compression device (scd) peripherally inserted central catheters (picc)
arterial stiffness, blood pressure and cardiac output study

Conditions: Infrarenal Abdominal Aortic Aneurysm

Summary: comparison of non-invasively obtained central blood pressure using sphygmocor and invasively recorded central blood pressure in patients with an aaa that will be treated with evar.

primary objective of the first study: validation of non-invasive central pressure parameters in patients treated with evar against invasive measurements. objectives of subsequent studies: do non-invasive central parameters change over time after evar? what is the influence of intraluminal thrombus (presence, amount, configuration) on non-invasive central pressure parameters (and other obtained parameters of arterial stiffness)? prospective study with consecutive, eligible subject enrollment. all subjects will undergo the endovascular aneurysm repair procedure with an endovascular device. subjects will be followed procedurally, at 6-8 weeks and 1 year post implantation. this study is a collaboration of the following departments of the vascular center in the rijnstate hospital arnhem: vascular surgery, interventional radiology, internal vascular medicine, cardiology. patients diagnosed with an abdominal aortic or aortoiliac aneurysm who are considered candidates for endovascular repair and who meet the study eligibility criteria may be screened for enrollment in the study. up to 20 subjects will be enrolled . pre-procedural high resolution, contrast-enhanced ct scan evaluation to determine anatomical eligibility for enrollment will be performed within three months of the study procedure, according to standard care. following ec/irb approval of the study and the written informed consent form, patients will be screened for eligibility. following informed consent, clinical characteristics will be reported (from hospital records). per-procedural pwa measurements will be performed simultaneously with intravascular pressure measurements pre-implantation and after completion of the endocasular implantation. subjects will be followed at 30 days and 1 year post-implantation.

Eligibility criteria:
inclusion criteria: 1. male or female at least 18 years old; 2. informed consent form understood and signed and patient agrees to follow-up visits; 3. have a infrarenal abdominal aortic aneurysm (aaa) with maximum sac diameter ≥ 5.5cm, or an aaa ≥ 4.5 cm which has increased by \> 1.0 cm in the past year with a scheduled endovascular intervention exclusion criteria: 1. life expectancy \< 2 years; 2. psychiatric or other condition that may interfere with the study; 3. participating in another clinical study, interfering on outcomes; 4. irregular pulse; 5. presence of extensive peripheral arterial disease (abi \< 0.9 or obstruction validated on imaging); dated less than 3 months prior to treatment 6. ruptured, leaking or mycotic aneurysm;

Keywords: evar, central pressure, arterial stiffness, aaa, elective surgery
long term follow-up study for subjects previously treated with algenpantucel-l (hyperacute-pancreas) immunotherapy

Conditions: Pancreatic Cancer

Summary: this protocol (nlg0705) provides a mechanism for the 15-year follow-up period that the fda requires for all participants in gene transfer protocols and assures that adequate follow-up can be maintained for subjects who have received at least one dose of algenpantucel-l.


Eligibility criteria:
inclusion criteria: * receipt of at least one dose of algenpantucel-l within the past 15 years * signed consent
phase 2 study of ruxolitinib versus anagrelide in subjects with essential thrombocythemia who are resistant to or intolerant of hydroxyurea (reset-272)

Conditions: MPN (Myeloproliferative Neoplasms)

Summary: the purpose of this study is to evaluate the efficacy and safety of ruxolitinib versus anagrelide in subjects with essential thrombocythemia who are resistant to or intolerant of hydroxyurea.


Eligibility criteria:
inclusion criteria: * diagnosis of essential thrombocythemia according to revised world health organization (who) 2016 criteria. * resistant to or intolerant of hydroxyurea, that is, fulfilling at least 1 of the following criteria: * platelet count \> 600 × 10\^9/l after 3 months of at least 2 g/day of hydroxyurea (2.5 g/day in subjects with a body weight over 80 kg) or at the subject's maximally tolerated dose if that dose is \< 2 g/day. * platelet count \> 400 × 10\^9/l and wbc count \< 2.5 × 10\^9/l or hemoglobin \< 10 g/dl at any dose of hydroxyurea. * presence of leg ulcers or other unacceptable mucocutaneous manifestations at any dose of hydroxyurea. * hydroxyurea-related fever. * platelet count ≥ 650 × 10\^9/l at screening. * wbc ≥ 11.0 × 10\^9/l at screening. exclusion criteria: * subjects previously treated with anagrelide or hydroxyurea (hu). 1. prior anagrelide use is allowed provided the reason for discontinuation is not ae-related and anagrelide is stopped at least 28 days before the start of study medications (ie, day 1). 2. treatment with hu can be stopped at any time once one of the inclusion criteria for hu refractoriness or resistance have been met, and up to the day before the first dose of study treatment (ie, day 1). * inadequate liver function at screening and day 1 (before drug administration) as demonstrated by: * total bilirubin \> 1.5 × upper limit of normal (uln) * aspartate aminotransferase or alanine aminotransferase \> 1.5 × uln * hepatocellular disease (eg, cirrhosis) * inadequate renal function at screening as demonstrated by creatinine clearance \< 40 ml/min calculated by cockcroft-gault equation.

Keywords: essential thrombocythemia hydroxyurea-resistant hydroxyurea-intolerant ruxolitinib anagrelide
90y-ibritumomab tiuxetan consolidation after 6th r-chop chemotherapy in patients with bulky diffuse large b cell lymphoma

Conditions: Lymphoma, Large B-Cell, Diffuse

Summary: this phase ii study is aimed at the clinical efficacy and toxicity of 6th r-chop chemotherapy followed by ibritumomab tiuxetan (zevalin) consolidation in patients with limited-stage, bulky diffuse large b cell lymphoma (dlbcl).

the patients with limited-stage, bulky diffuse large b cell lymphoma (dlbcl) are known to have a poor prognosis as like to those with advanced disease. however, there are very limited studies to compare the clinical outcome of therapy after chemotherapy only with combined modality using radiation. defining local failure at bulky sites as one component of relapse, radioimmuotherapy appears to reduce the failure rates at previous bulky sites. we assessed the clinical efficacy and toxicity of 6th r-chop chemotherapy and followed by ibritumomab tiuxetan (zevalin) consolidation in patients with limited-stage, bulky dlbcl.

Eligibility criteria:
inclusion criteria: * newly diagnosed cd20+ dlbcl * patients with stage i/ii * bulky disease defined by maximum diameter greater than 10 cm or any mediastinal mass exceeding 1/3 the maximum trans- thoracic diameter (more than 8 cm) * patients that achieved a complete (cr) or partial response (pr) after 6th r-chop chemotherapy * aged over 18 years * ecog performance status 0-2. exclusion criteria: * previous history of chemotherapy for diffuse large b cell lymphoma * prior myeloablative therapy * prior external-beam radiation to \>25% of active bone marrow * pregnancy and lactation * \>25% bone marrow infiltration * platelet counts \<100 000/µl, neutrophil counts \<1500/µl * children and adolescents under 18 years of age * presence of cns involvement with diffuse large b cell lymphoma * positive hiv serology * seriously uncontrolled, current infections or other concomitant

Keywords: bulky diffuse large b cell lymphoma 90y-ibritumomab tiuxetan clinical response safety and toxicity
pediatrics:chlamydia, sickle cell anemia and stroke risk - ancillary to stop ii

Conditions: Blood Disease; Anemia, Sickle Cell; Chlamydia Infections; Cerebrovascular Accident

Summary: to establish a link among chlamydia infection, sickle cell anemia, and stroke risk.

background: infection with chlamydia pneumoniae (c. pneumoniae) is associated with an increased risk of cerebrovascular disease in the general population. children with sickle cell anemia (sca) are 200 times more likely to have cerebrovascular disease than normal children and are known to have an altered immune response to many infectious pathogens. c. pneumoniae is the leading infectious cause of acute chest syndrome which, interestingly, is a well- established risk factor for stroke in children with sca. preliminary data indicates that sca patients with magnetic resonance imaging (mri)-documented cerebral infarction are 12 times more likely to have c. pneumoniae infection than sca patients with normal mri scans. the investigators hypothesize that sca patients have an abnormal immune response to c. pneumoniae that results in persistent infection which, in turn, triggers the development of cerebrovascular disease. sickle cell anemia patients with an elevated velocity on transcranial doppler ultrasound (tcd) are known to be at high risk to develop stroke and an elevated tcd likely reflects underlying vascular disease. in addition, the stroke prevention in sickle cell anemia trial (stop) demonstrated that almost 40 percent of children with an elevated tcd have evidence of cerebral infarction on mri. children with abnormal tcds are, therefore, an appropriate population to investigate an association between cerebrovascular disease and c. pneumoniae infection. the study is in response to an initiative on ancillary studies in heart, lung, and blood disease trials released in june, 2000. design narrative: the study is ancillary to the stop ii clinical trial. the intent is: 1) to determine if c. pneumoniae infection is associated with cerebral infarction in children with sca; 2) to characterize the immunological response to c. pneumoniae infection in patients with sca. establishing a link between c.pneumoniae infection and cerebral infarction will open the door to novel, less toxic approaches to the treatment and prevention of stroke in sca, including antibiotics and vaccines.

Eligibility criteria:
no eligibility criteria
comparative evaluation of the regenerative capacity of two platelet concentrates

Conditions: Necrotic Pulp

Summary: injectable platelet-rich fibrin (i-prf) is a flowable blood concentrate that is entirely natural and allows ease of access and flow within the root canal. it was first developed in 2014 by modifying the centrifugation parameters. i-prf has great potential in the field of endodontics. at present, it is still in its infancy and needs to be explored with regard to its regenerative efficacy. to the best of our knowledge, this study is the first to clinically and comparatively investigate platelet-rich plasma (prp) and i-prf.

an ideal treatment option for an immature necrotic tooth is the regeneration of pulp-like tissue that is capable of boosting the continuation of normal root development. the use of platelet concentrates for that purpose is a clinically relevant, minimally invasive approach which has a promising potential of reducing the healing period. among which, the most commonly employed is the platelet-rich plasma that is not entirely natural. it involves the use of non-autologous anticoagulants such as bovine thrombin to maintain the fluid consistency which prevents clot formation and thus impairs wound healing, affects the coagulation process and can also trigger an immune reaction, thereby, suppressing regeneration. prp offers a short-term release of most of the growth factors unlike the platelet-rich fibrin which allows for a more sustained release. prf does not require any biochemical handling of blood and is easy to procure but due to the gel-like consistency, its adaptability within the root canal requires excessive removal of root dentin. in addition, the application of recombinant growth factors within the root canal is associated with high cost which hinders its applicability in the common clinical practice. therefore, a new regenerative technique is required that combines the advantages of both prp and prf while overcoming their drawbacks.

Eligibility criteria:
inclusion criteria: * patients having necrotic maxillary anterior tooth/teeth due to caries or trauma * radiographic criteria: preoperative radiograph showing incomplete root formation with a wide apical foramen. * positive patient/guardian compliance for participation in the study. exclusion criteria: * uncooperative patient * lack of patient commitment to the treatment plan and the follow-up period * mature necrotic anterior teeth due to caries or trauma * vital maxillary anterior teeth with open apices * non-restorable teeth * grossly decayed or fractured teeth that require post and core as final restorations * presence of periodontal pockets * radiographically: presence of external or internal root resorption, fracture lines or cracks
efficacy of leuconostoc mesenteroides

Conditions: Alcohol Drinking; Alcohol Drinking Related Problems

Summary: excessive alcohol intake can cause dehydration, digestive issues, oxidative stress, and hangover symptoms like headache and fatigue. toxic metabolites like acetaldehyde and ros contribute to liver damage. chronic drinking activates harmful pathways like meos and increases inflammation. gut-liver axis disruption also worsens hangovers. probiotics, such as leuconostoc mesenteroides, may help restore gut health and reduce toxicity, but more clinical research is needed.


Eligibility criteria:
inclusion * healthy adults aged between 30 and 60 years * body mass index (bmi) between 18.5 and 30 kg/m² * individuals with a history of hangover experience * adults with normal results in blood tests and vital signs * no organic gastrointestinal disease found in endoscopy within the past 3 months * able to consume one bottle of soju within 30 minutes * individuals who have personally signed the informed consent form exclusion * individuals who have consumed excessive alcohol within the past week * individuals who participated in a human clinical trial within the past month * individuals taking supplements or medications that may affect alcohol metabolism * individuals with alcohol metabolism disorders, diabetes, hypertension, gallstones, pancreatitis, gout, active tuberculosis, gastrointestinal bleeding or surgery, or those with kidney, liver (e.g., hepatitis b/c carriers, alcoholic liver disease), heart, lung, gastrointestinal, or neurological diseases * pregnant women or those planning to become pregnant * individuals who have taken liver function supplements or similar medications/health products within one month before the study * individuals who consumed excessive alcohol within one week prior to study participation * any other individuals deemed unsuitable for the study by the principal investigator
a trial to assess the pharmacokinetics, pharmacodynamics, safety and tolerability of oral semaglutide in healthy male japanese and caucasian subjects

Conditions: Diabetes; Diabetes Mellitus, Type 2; Healthy

Summary: this trial is conducted in asia. the aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body), pharmacodynamics (the effect of the investigated drug on the body), safety and tolerability of oral semaglutide in healthy male japanese and caucasian subjects.


Eligibility criteria:
inclusion criteria: * healthy male japanese and caucasian subjects * age between 20 and 55 years (both inclusive) at time of signing informed consent * body weight of above or equal to 54.0 kg * body mass index (bmi) between 20.0 and 25.0 kg/m\^2 (both inclusive) * glycosylated haemoglobin a1c (hba1c) below or equal to 6.0% exclusion criteria: * presence or history of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gi (gastrointestinal), endocrine, dermatological, venereal, haematological, neurological, or psychiatric diseases or disorders, as judged by the investigator. any disorder which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol * personal or family history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia type 2 (men2) * history of chronic pancreatitis or idiopathic acute pancreatitis * smoking of more than 5 cigarettes (including nicotine substitute products), or the equivalent, per day or unwilling to refrain from smoking whenever required for the trial procedure * use of prescription drugs within 3 weeks or 5 times the half-life, whichever is longer, prior to visit 2 (day 1), non-prescription drugs within 1 week prior to visit 2 (day 1). the use of vitamins and minerals, and the occasional use of paracetamol (acetaminophen) or acetylsalicylic acid are permitted * any blood drawn in excess of 25 ml in the past month, or donation of blood or plasma in excess of 400 ml within the 3 months preceding screening * previous gi surgery such as invasive and corrective procedures involving the oesophagus, stomach, duodenum, gallbladder (e.g., cholecystectomy), pancreas or intestinal resections. exempt are subjects that underwent uncomplicated surgical and diagnostic procedures such as appendectomy, hernia surgery, polypectomy, biopsies, as wells as colonic and gastric endoscopy