Kornimate/medical-research-clean huggingface dataset:
clinical response of extor (amlodipine/valsartan) in newly diagnosed hypertensive patients.

Conditions: Hypertension

Summary: the american college of cardiology/american heart association hypertension guidelines recommend treatment initiation with dual antihypertensive therapy in adults with stage 2 hypertension (corresponding to grade 1 and 2 in the esh classification) and an average bp \>20/10 mm hg above target. amlodipine and valsartan are two of the most commonly prescribed medications for the treatment of hypertension (high blood pressure). in pakistan multiple studies were conducted on hypertension and use of single pill combination in uncontrolled hypertension. however, no study was conducted to assess the role of single pill combination (spc) like amlodipine and valsartan in newly diagnosed hypertension and to assess their quality of life by patients' satisfaction with their medication after managing the hypertension with the spc.

to assess the effectiveness of extor (amlodipine/valsartan) in newly diagnosed hypertensive patients in 8 weeks. * change from baseline to 8 weeks in systolic blood pressure (sbp) from standard blood pressure measurement. * change from baseline to 8 weeks in diastolic blood pressure (dbp) from standard blood pressure measurement. * change from baseline to 8 weeks in the health-related quality of life of newly diagnosed hypertensive patients managed by extor: assess by abbreviated treatment satisfaction questionnaire for medication (tsqm-9) * change from baseline to 4 weeks in diastolic blood pressure (sbp) from standard blood pressure measurement * change from baseline to 4 weeks in diastolic blood pressure (dbp) from standard blood pressure measurement * change from baseline to 4 weeks in the health-related quality of life of newly diagnosed hypertensive patients managed by extor: assess by abbreviated treatment satisfaction questionnaire for medication (tsqm-9) * to assess the overall safety of extor (amlodipine/valsartan) in newly diagnosed hypertensive patients. note: the safety is assessed in all subjects who received at least one dose of study drug.

Eligibility criteria:
inclusion criteria: * patient with a clinical history of hypertension (systolic blood pressure greater than or equal to 140 mmhg or a diastolic blood pressure greater than or equal to 90 mmhg) and never had antihypertensive treatment. * patient aged ≥18 and ≤70 years inclusive of either sex. * patient with ability to understand and sign written informed consent form. exclusion criteria: * • patients with already on antihypertensive treatment or secondary hypertension * pregnant women or nursing mothers * patients with acute illnesses or psychiatric diagnosis * known hypersensitivity to extor product, the metabolites, or formulation excipients. * treated with extor to evaluate safety as per approved prescribing information for extor in pakistan.

Keywords: hypertnsion amlodipine valsartan combination quality of life (qol) pakistan
mindfulness therapy in inflammatory bowel disease

Conditions: Bowel Disease

Summary: aim: to compare the effects of a specific application of mindfulness vs. treatment-asusual control group in patients with bowel disease. design: randomized controlled trial. setting: outpatient setting. population: patients who attended bimonthly check up.

background: inflammatory bowel disease (ibd) is a chronic gastrointestinal condition with a relapsing disease course. managing the relapsing nature of the disease causes daily stress for ibd patients. mindfulness-based cognitive therapy (mbct) is an evidence-based psychological program designed to help manage depressive and stress symptoms. aim: to compare the effects of a specific application of mindfulness vs. treatment-as usual control group in patients with bowel disease. outcome measures: quality of life, inflammatory and stress markers. design: randomized controlled trial. setting: outpatient setting. population: patients who attended bimonthly check up.

Eligibility criteria:
inclusion criteria: * patients with bowel disease diagnostic * patients with non active disease symptoms in the last 3 month * patients with access to internet and basic informatic knowledge exclusion criteria: * active disease symptoms * planned surgery * cognitive impairment * previous experience with mindfulness

Keywords: mindfulness quality of life bowel disease
significance of mait cells in inflammatory bowel disease

Conditions: Inflammatory Bowel Diseases

Summary: to examine the level and function of mait cells in ibd patients, and to compare it with disease activity.

inflammatory bowel diseases (ibds), including ulcerative colitis (uc) and crohn's disease (cd), are chronic inflammatory diseases of unknown origin. ibd has become a global disease with increasing incidence in newly industrialized and westernized countries. genetic and environmental factors with inadequate host immune response to gut flora appear to play important roles in the pathogenesis of ibd. adaptive immune response has been classically considered to play a major role in ibd pathogenesis . infiltrating lymphocytes including t helper (th) 1 cells and th17 cells can lead to the development of intestinal lesions . however, recent evidences suggest that innate immune response is equally important in inducing gut inflammation . altered epithelial barrier function and aberrant innate immune responses contribute to intestinal inflammation in ibd patients. mucosal-associated invariant t (mait) cells are innate lymphocytes that express a conserved invariant tcell receptor (tcr) vα7.2-jα33 chain paired with a limited set of vβ chains. using distinct pairs of tcr chains, mait cells can recognize bacteria-derived riboflavin (vitamin b2) metabolites presented by mhc(major histocompatibility complex) class 1b-like related protein (mr1). upon mr1-dependent recognition of antigens, mait cells are activated to rapidly release th1/th17 proinflammatory cytokines (i.e., interferon \[ifn\]-γ, tumor necrosis factor \[tnf\]-α, and interleukin \[il\]-17 and cytotoxic molecules (i.e.,granzyme and perforin) to kill infected host cells. mait cells are abundant in peripheral blood where they where they express gut-homing chemokine receptors such as ccr6(chemokine receptor type 6) and ccr9(chemokine receptor type9). they are also abundant in intestinal mucosa where they likely confront normal flora or pathogenic bacteria producing bacterial ligands. given tissue- homing properties and rapid production of proinflammatory cytokines, mait cells may play an important role in infectious diseases and autoimmune disorders. results from experiment with transfer of mait cells to tnbs(trinitrobenzene sulfonic acid)-induced ibd murine models suggest that mait cells might play a protective role in tnbs-induced intestinal inflammation . in addition, previous studies have reported mait cell dysfunction in ibd patients. however, the role of mait cells in ibd patients remains unclear.

Eligibility criteria:
inclusion criteria: * patients with active ibd according to clinical scores with the following: 1. recently discovered. 2. average age (15-50). exclusion criteria: * patient with history of any of the following ; 1. history of respiratory disorders such as chronic obstructive diseases, pulmonary disease or pulmonary embolism. 2. other autoimmune diseases, infectious diseases. 3. recent surgery, malignancies, left ventricular dysfunction, use of immunosuppressive drugs. 4. chronic liver, renal, and endocrine diseases.

Keywords: mucosal associated invariant t cells
the natural history of geographic atrophy progression (gap) study

Conditions: Age-Related Macular Degeneration; Geographic Atrophy

Summary: the objective of the 18-month trial is to evaluate the natural history of geographic atrophy by assessing the rate of progression of the geographic atrophic lesion over time.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of geographic atrophy secondary to age-related macular degeneration with no cnv lesion. exclusion criteria: * age related

Keywords: age-related macular degeneration geographic atrophy
effect of intravenous magnesium on postoperative sore throat after thyroidectomy

Conditions: Thyroid Neoplasms

Summary: the primary purpose of this study is to investigate the effect of intravenous magnesium on postoperative throat pain after thyroidectomy. the secondary purpose of this study is to investigate the effect of intravenous magnesium on total dose of fentanyl in recovery room after thyroidectomy.


Eligibility criteria:
inclusion criteria: * thyroidectomy exclusion criteria: * allergy to magnesium * chronic pain * chronic opioid use * chronic nsaid use * renal dysfunction * liver dysfunction * cardiac arrythmia * seizure
performance of scoring systems in chinese patients with primary biliary cholangitis (pbc) on ursodeoxycholic acid

Conditions: Primary Biliary Cholangitis (PBC)

Summary: several risk assessment scoring systems have been proposed to assess the therapeutic response and predict long term prognosis in ursodeoxycholic acid (udca)-treated primary biliary cholangitis (pbc) patients, in order to risk stratify pbc patients and guide their management. however there scoring systems have not been fully validated in chinese population. this study is going to compare the prognostic ability of these criteria, validate the overseas scoring systems, develop and validate a new scoring system in a cohort of chinese pbc patients.


Eligibility criteria:
inclusion criteria: * with liver biopsy proved pbc exclusion criteria: * a positive serological test for hepatitis b or c virus, * comorbidity of primary sclerosing cholangitis, * alcoholic liver disease, * hemochromatosis, * wilson's disease, * a1-antitrypsin deficiency * presence of complications of cirrhosis (total bilirubin \>100 lmol/l, ascites, variceal haemorrhage and hepatic encephalopathy) on admission.
effects of sublingual and transdermal administration of nitroglycerin for coronary ct angiography on image quality

Conditions: Coronary Artery Disease

Summary: to evaluate image quality of coronary ct angiography (ccta) after sublingual and transdermal administration of nitroglycerin. aim of this prospective research study is to investigate equivalence on image quality after sublingual or transdermal nitroglycerin administration (h0). furthermore, the feasibility of transdermal nitroglycerin administration will be evaluated.


Eligibility criteria:
inclusion criteria: 1. scheduled ccta with contrast. 2. able to comprehend and sign the consent form. exclusion criteria: 1. known hypersensitivity to glyceryl trinitrate, and related organic nitrates. 2. acute circulatory failure associated with marked hypotension (shock). 3. conditions associated with elevated intracranial pressure, cerebral haemorrhage and head trauma. 4. closed-angle glaucoma. 5. phosphodiesterase type 5 (pde5) inhibitors such as sildenafil (viagra®), tadalafil (cialis), or vardenafil (levitra) within the last 24 hours 6. unstable clinical conditions (i.e. hemodynamic instability, arrhythmias) 7. critical aortic stenosis 8. systolic blood pressure \< 90 mmhg 9. pregnant or lactating female; premenopausal women with a positive urine pregnancy test. 10. age under 18 11. unwilling or unable to inform consent.
study to evaluate oxervate™ in patients with stage 1 neurotrophic keratitis

Conditions: Neurotrophic Keratitis

Summary: this study is to evaluate the safety and efficacy of oxervate™ 0.002% (20 mcg/ml) cenegermin-bkbj ophthalmic solution in patients with stage 1 neurotrophic keratitis (nk).


Eligibility criteria:
inclusion criteria: 1. male or female aged ≥ 18 years. 2. patients with stage 1 nk defined by the mackie criteria exclusion criteria: 1. evidence of an active ocular infection (bacterial, viral, protozoal) in either eye. 2. have current or history of conditions that may confound the study data including but not limited to ocular cicatricial pemphigoid (ocp), graft versus host disease (gvhd), neuromyelitis optica, uncontrolled dry eye, and steven johnson's syndrome. 3. history of severe systemic allergy or severe ocular allergy (including seasonal conjunctivitis expected during the subject's participation in the trial) or chronic conjunctivitis and/or keratitis other than dry eye disease. 4. patients with severe vision loss with no potential for visual improvement in the study eye, in the opinion of the investigator, or if the subject is deemed legally blind. 5. ocular surgery or elective ocular surgery expected during participation in the trial. 6. patients with eyelid abnormality that may alter eyelid function including but not limited to blepharospasm, cerebrovascular accident, entropion, ectropion, floppy lid syndrome.

Keywords: stage 1 neurotrophic keratitis corneal disease ocular disease
molecular diversity of hiv-1 group o strains and treatment management in cameroon

Conditions: HIV Infections

Summary: infections with hiv-1 group o are found in 1 to 3 % of persons living with hiv in cameroon. the natural history and treatment response is not well understood. the natural resistance to non nucleoside reverse transcriptase inhibitors and their possible low sensitivity to protease inhibitors complicate the choice of an adequate treatment options. this observational study is aimed at evaluating the antiretroviral treatment response of hiv-1 group o infected patients in comparison with hiv-1 group m infected patients. the proposed standardized follow-up will facilitate a better understanding of the natural history and treatment specificities to improve the patients management. this is a non randomized study, open label, with standardized follow-up. a total of 171 patients


Eligibility criteria:
inclusion criteria: * hiv-1 group o or group m infection * no history of antiretroviral treatment (except for pmtct) * criteria for treatment initiation according to the cameroons national guidelines exclusion criteria: * ongoing traditional treatment which could interfere with hepatic function * ongoing treatment with rifabutin, rifampicin or rifampin * acute hepatitis b infection * pregnancy or lactating mother * hiv-1 group o and group m co-infection

Keywords: hiv-1 group o hiv-1 group m cameroon hiv-1 infection treatment naïve
non-invasive liver screening for risk assessment for coronary heart disease

Conditions: Coronary Disease; Non-alcoholic Fatty Liver Disease; Elasticity Imaging Techniques

Summary: background: non-alcoholic fatty liver disease (nafld) is the hepatic manifestation of the metabolic syndrome, which is one of the major risk factors of coronary heart disease (chd). chd is the most important manifestation of atherosclerosis, because of its immense morbidity and mortality. transient elastography (te, fibroscan®) including the currently developed controlled attenuation parameter (cap) is a non-invasive method for evaluation of liver fibrosis and steatosis, which is already implemented in routine care of patients with nafld. hypothesis: the use of te with cap as screening for nafld might be an easy tool for risk assessment for chd. methods: patients scheduled for routine coronary angiography will be screened for manifestation of nafld by te including cap, conventional ultrasound, clinical and laboratory parameters. patients will be stratified for the presence of chd based on the angiography results and correlation analysis with liver fat content will be performed. nfald screening will be validated in a subgroup by mr-based measurements.


Eligibility criteria:
inclusion criteria: * informed consent * age ≥ 18 years * patients with indication for routine coronary angiography exclusion criteria: * transplanted liver * resection of right liver lobe * transaminases of \> 5-fold upper limit * pregnancy or lactation * choleastasis on ultrasound imaging * active malignant or consuming disease 12 month before inclusion * congestive heart failure (ef\<30%, nyha iii or iv, diastolic dysfunction °iii or iv * pulmonary hypertension (who °iii or iv) exclusion criteria for mr diagnostics * pacemaker or icd * non removable magnetizable metal implants * claustrophobia
hiv non occupational post-exposure prophylaxis (pep)

Conditions: HIV Infections

Summary: this study will evaluate how safe and tolerable a combination of taking three-drugs will be for the purpose of preventing hiv transmission after a high-risk sexual contact exposure in hiv uninfected adults.

this study will evaluate a three drug regimen in the form of two pills which will be taken for 28 days for the prevention of hiv infection. two drugs are combined in an fda-approved pill called truvada, containing the hiv medications, tenofovir disoproxil fumarate 300mg and emtricitabine 200mg, taken as one pill once a day. the third drug is a new formulation, raltegravir 400mg pill taken twice a day.

Eligibility criteria:
inclusion criteria: * hiv uninfected on the basis of a negative hiv rapid test, eia or western blot, and a negative hiv-1 rna assay * possible non-occupational exposure to hiv-1, recent enough to permit receiving the first dose of study medication within 72 hours from the end of the exposure. * able to understand the study procedures and willing to sign informed consent exclusion criteria: * any active psychiatric illness or active drug or alcohol abuse that, in the opinion of the investigator, could prevent compliance with study procedures. * pregnancy. * chronic hepatitis b infection, diagnosed by either positive serum hbsag or positive serum hbv dna; or prior lamivudine therapy for hepatitis b. * creatinine clearance less than 50 ml/min as calculated by cockcroft-gault formula. * unwillingness to participate in study procedures, including mental health referral and intervention. * known intolerance or allergy to tenofovir df, emtricitabine or raltegravir. * use of prohibited concomitant medication: dilantin, phenobarbital and rifampin which cannot be used with raltegravir.

Keywords: hiv prevention non-occupational post-exposure prophylaxis hiv seronegativity
central catheters used for chemotherapy in women with breast cancer

Conditions: Catheter Related Complications

Summary: the overall aim of this study is to evaluate two different central venous lines, picc-lines (picc) and subcutaneous venous access ports (svap) used for chemotherapy in women with breast cancer. the study will compare complications, material wear of the catheters used, patients'- and health care professionals' experiences, and costs. the study will give knowledge about which central venous access that is the most advantageous regarding adjuvant chemotherapy for women with breast cancer in the aspects of safety, quality of care, and quality of life.

n=250 women between 18 and 70 years of age with invasive breast cancer who are allocated to adjuvant or neo adjuvant chemotherapy during 18 weeks at the department of oncology at karolinska university hospital , stockholm sweden are eligible to participate in the present study. exclusion criteria are cognitive dysfunction and/or inability to understand swedish. before participation an informed consent will be collected. the patients will be randomized to receive a picc or a svap. complications will be registered as well as the treatments. bacterial cultures will be taken at removal of picc/svap. the used picc/svap will be transported to the royal institute of technology (kth) and subjected to material analyses. comparison with reference materials from the in-vitro study and with new reference catheters will be performed. patient assessments with questionnaire concerning hrql, illness perception, body imaging, life style and sleep disturbance will be collected at baseline and at the last chemotherapy session. interviews with the patients about life situations will be conducted half through the chemotherapy treatment period.in- and out-patients costs, i.e. medication, materials, costs related to the care of the picc/svap, costs for complications, additional costs for the patients regarding the treatment, etc., will be monitored and registered. in- and out-patient costs will also be monitored. data from medical records concerning treatments for complications will also be taken into consideration.

Eligibility criteria:
inclusion criteria: * adjuvant or neo adjuvant chemotherapy, * speak swedish exclusion criteria: * cognitive dysfunction * and/or inability to understand swedish, * recurrent breast cancer

Keywords: picc-line central venous access port catheter related complications infections thrombosis material degradation health economic costs bio-material health related quality of life
iiib 6 week open label multicentre rosuvastatin & simvastatin

Conditions: Fredrickson Type IIa & Type IIb Dyslipidaemia

Summary: the purpose of this study is to assess the effects on the kidney of rosuvastatin and simvastatin in subjects with fredrickson type iia \& type iib dyslipidaemia


Eligibility criteria:
inclusion criteria: * fasting low density lipoprotein level as defined by the protocol. * fasting triglyceride level as defined by the protocol. exclusion criteria: * the use of lipid lowering drugs or dietary supplements after visit 1. * active arterial disease eg unstable angina, or recent arterial surgery * blood creatine levels above the limits defined in the protocol or +4 proteinuria during dietary lead in period. * uncontrolled hypertension, hypothyroidism, alcohol or drug abuse.

Keywords: cholesterol low density lipoproteins dyslipidaemia rosuvastatin crestor simvastatin zocor renal kidney
a phase 2 study to determine the safety and efficacy of bind-014 (docetaxel nanoparticles for injectable suspension), administered to patients with metastatic castration-resistant prostate cancer

Conditions: CRPC; Prostate Cancer

Summary: the purpose of this study is to evaluate the efficacy and safety bind-014 in patients with metastatic castration-resistant prostate cancer (mcrpc).


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed adenocarcinoma of the prostate * metastatic disease progressing despite castrate levels of testosterone * prostate cancer progression documented by psa * surgically or medically castrated, with testosterone levels of \< 50 ng/dl * previous anti-androgen therapy and progression after withdrawal * ecog performance status of 0 to 1 * adequate organ function * prior radiation therapy allowed to \< 25% of the bone marrow * prior hormonal therapy is allowed * patient compliance and geographic proximity that allow adequate follow-up. * patients with reproductive potential must use contraceptive methods * signed informed consent from patient exclusion criteria: * active infection * any chronic medical condition requiring a high doses of corticosteroid * pathological finding consistent with small cell carcinoma of the prostate * brain metastasis * prior cytotoxic chemotherapy or biologic therapy for the treatment of crpc * radiation therapy for treatment of the primary tumor within 6 weeks * radionuclide therapy for treatment of metastatic crpc * prior systemic treatment with an azole drug * prior flutamide treatment within 4 weeks * prior bicalutamide or nilutamide within 6 weeks * congenital long qt syndrome, congestive heart failure, or bradyarrhythmia * administration of an investigational therapeutic within 2 weeks * second primary malignancy * presence of clinically detectable third-space fluid collections * history of severe hypersensitivity reaction to polysorbate 80 * peripheral neuropathy at study entry