Kornimate/medical-research-clean huggingface dataset:
effect of continuous positive airway pressure (cpap) versus auto-titrating continuous positive airway pressure (apap) on resistant hypertension (htn) and arterial stiffness

Conditions: Resistant Hypertension; Obstructive Sleep Apnea

Summary: the primary objective is to evaluate the relative effectiveness of fixed cpap in comparison to apap in reducing arterial blood pressure in patients with resistant hypertension and obstructive sleep apnea (osa). the secondary objectives are: a) to evaluate the relative effectiveness of fixed cpap versus apap in improving arterial stiffness, sleep-disordered breathing, sleep quality, inflammatory markers and glucose regulation; b) to identify specific characteristic of persons who respond to the two cpap modalities in order to identify which device is better for each subject.

the confirmatory hypothesis is that subjects with resistant hypertension and osa will show a greater degree of blood pressure reduction after 6 weeks of treatment with fixed cpap in comparison to those treated with apap. explanatory and exploratory hypotheses are that a greater reduction in arterial stiffness will be noted when compared with the benefit in blood pressure, that reductions in arterial stiffness will be associated with benefits to serum measurements of inflammatory markers and glucose regulation, and that control of sleep apnea and the attendant improvement in sleep quality will be better with fixed cpap than apap.

Eligibility criteria:
inclusion criteria: * resistant hypertension * moderate obstructive sleep apnea exclusion criteria: * creatinine \>150 μmol/l * systolic blood pressure \> 170 mmhg * diastolic blood pressure \> 105 mmhg * secondary cause of hypertension other than osa * treatment within the last 3 months or current treatment for sleep-disordered breathing or some other sleep disorder * current treatment or recent treatment within the last 3 months for any other medical condition which has resulted or would be expected to result in a change in blood pressure medications

Keywords: resistant hypertension obstructive sleep apnea 24 hour blood pressure arterial stiffness insulin resistance cpap apap
ps-341 and doxorubicin in treating patients with advanced solid tumors

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase i trial to study the effectiveness of combining ps-341 and doxorubicin in treating patients who have advanced solid tumors.

objectives: * determine the maximum tolerated dose of ps-341 in combination with doxorubicin in patients with advanced solid tumors. * determine the qualitative and quantitative toxic effects of this regimen in these patients. * determine the antitumor activity of this regimen in these patients. outline: this is a dose-escalation study of ps-341. patients receive ps-341 iv over 3-5 seconds on days 1, 4, 8, and 11; and doxorubicin iv on over 3-5 minutes on days 1 and 8. treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. cohorts of 3-6 patients receive escalating doses of ps-341 until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. projected accrual: a total of 3-31 patients will be accrued for this study within 1 year.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed advanced solid tumor for which no curative treatment exists * measurable or evaluable disease * no brain metastases or primary brain tumors patient characteristics: age: * over 18 performance status: * ecog 0-2 life expectancy: * not specified hematopoietic: * absolute neutrophil count greater than 1,500/mm\^3 * platelet count greater than 100,000/mm\^3 hepatic: * bilirubin normal renal: * creatinine no greater than 1.5 mg/dl or * creatinine clearance at least 60 ml/min cardiovascular: * muga at least 45% other: * no serious active infection * no pre-existing neuropathy grade 2 or greater * no other concurrent illness that would preclude study participation * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception prior concurrent therapy: biologic therapy: * not specified chemotherapy: * at least 4 weeks since prior chemotherapy * no prior cumulative dose of doxorubicin exceeding 280 mg/m\^2 endocrine therapy: * not specified radiotherapy: * at least 4 weeks since prior radiotherapy surgery: * not specified other: * no other concurrent investigational or commercial agents for treatment of this malignancy

Keywords: unspecified adult solid tumor, protocol specific
comparing immunogenicity and safety of different formulations of hbv-mpl vaccine with engerix™-b in adults aged 18-40 y

Conditions: Hepatitis B

Summary: this study will evaluate the immunogenicity and safety of different formulations of the candidate hbv-mpl vaccine administered according to a 2-dose schedule and compare it to that of engerix™-b administered according to a 3-dose schedule in order to determine the optimal dose of each component of the candidate hbv-mpl vaccine when administered at 0 and 6 months

at the time of conduct of this study, the sponsor glaxosmithkline was known by its former name smithkline beecham

Eligibility criteria:
inclusion criteria: * age: between 18 and 40 years old. * good physical condition as established by clinical examination and history taking at the time of entry. * female participants who are at risk to become pregnant will be on a contraceptive programme if necessary during the study period. * written informed consent obtained from the subjects exclusion criteria: * positive titres at screening for anti-hepatitis antibodies. * elevated serum liver enzymes * history of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease. * any acute disease at the moment of entry. * chronic alcohol consumption. * hepatomegaly, right upper quadrant abdominal pain or tenderness. * any chronic drug treatment, including any treatment with immunosuppressive drugs, which in the investigator's opinion, precludes inclusion into the study. * history of allergic disease likely to be stimulated by any component of the vaccine. * simultaneous participation in any other clinical trial. * previous vaccination with a hepatitis b vaccine. * previous vaccination with an mpl containing vaccine. * administration of immunoglobulins in the past 6 months and during the whole study period * vaccination one month before and one month after each dose of the study vaccine

Keywords: hepatitis b hbv-mpl recombinant hepatitis b vaccine
telemonitoring in patients with heart failure

Conditions: Heart Failure, Congestive

Summary: the purpose of this study is to investigate if telemonitoring results in a decrease in hospital admissions, with equal quality of care defined as mortality, quality of life and unplanned visits with caregivers. telemonitoring is expected to be more cost-effective than usual care in patients with heart failure.


Eligibility criteria:
inclusion criteria: * patients \> 18 years * patients with heart failure nyha classification ii-iii-iv * patient experienced a period of fluid retention * patient is treated by a cardiologist * patient is followed-up by a heart failure nurse * adequate knowledge of the dutch language * patient has an active telephone connection, preferably analogue * patient is mental competent * patient has the disposal of a balance exclusion criteria: * patients suffering from copd, gold classification 3 or 4 * patient is a dialysis patient * patient has a visual restriction to read the dialogues on the health buddy * patient is hard of hearing or deaf * patient suffers from a lethal sickness with a prognosis \< 1 year * patient participates in another trial * patient needs a hospital admission on short time, i.e., \< 3 months * patient used the health buddy in an earlier stage * patient is an illiterate person.

Keywords: telemonitoring cost-effectiveness heart failure case management
study of isis 703802 in participants with hypertriglyceridemia, type 2 diabetes mellitus, and nonalcoholic fatty liver disease

Conditions: NAFLD; Diabetes Mellitus, Type 2; Hypertriglyceridemia; Fatty Liver, Nonalcoholic

Summary: this is a multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the safety, including tolerability, of isis 703802 and to assess the efficacy of different doses and dosing regimens of isis 703802 on glucose and lipid metabolism, and liver fat in participants with hypertriglyceridemia, type 2 diabetes mellitus (t2dm), and nonalcoholic fatty liver disease (nafld).


Eligibility criteria:
key inclusion criteria: * plasma triglycerides (tg) at screening greater than (\>)150 milligrams per deciliter (mg/dl) and at qualification of \>150 mg/dl. * documented history of hepatic steatosis with baseline magnetic resonance imaging (mri) indicating hepatic fat fraction (hff) greater than (\>) 8%. * diagnosis of type 2 diabetes mellitus with hemoglobin a1c (hba1c) \>6.5 and less than or equal to (≤) 10% at screening. * must have been on a stable dose of oral antidiabetic therapy for a minimum of 3 months prior to screening. * body mass index between 27- 40 kilograms per meter square (kg/m\^2), inclusive, at screening. key exclusion criteria: * type 1 diabetes mellitus. * active chronic liver disease, alcoholic liver disease, wilson's disease hemochromatosis, primary biliary cirrhosis, primary sclerosing cholangitis, genetic hemochromatosis, known or suspected hepatocellular carcinoma, history of or planned liver transplant for end-stage liver disease of any etiology. * documented history of advanced liver fibrosis. * history of cirrhosis and/or hepatic decompensation including ascites, hepatic encephalopathy, or variceal bleeding. * history of clinically significant acute cardiac event within 6 months before screening. * history of heart failure with new york heart association (nyha) greater than class ii. * use of insulin or insulin analogs, glucagon-like peptide-1 (glp-1) agonists, and peroxisome proliferator-activated receptor gamma (pparᵞ) agonists (pioglitazone or rosiglitazone). * weight change \>5% within 3 months before screening. * conditions contraindicated for magnetic resonance imaging (mri) procedures including any metal implant (example, heart pacemaker, rods, screws, aneurysm clips).

Keywords: type 2 diabetes hepatic steatosis triglycerides akcea-angptl3-lrx ionis-angptl3-lrx fatty liver fatty liver without mention of alcohol liver fat liver diseases diabetes mellitus type 2 in nonobese diabetes mellitus triglycerides high high triglycerides metabolic disease endocrine system diseases digestive system disease glucose metabolism disorders vupanorsen
efficacy of alphanate fviii/vwf concentrate in type 3 von willebrand patients

Conditions: Von Willebrand Disease

Summary: to assess the efficacy of fviii/vwf complex (human), alphanate® as replacement therapy in preventing excessive bleeding in subjects with congenital type 3 von willebrand disease (vwd) who undergo surgical procedures.

for the treatment of surgical procedures the intended dose of alphanate® will be given as a single dose or as multiple doses over several days, depending on the clinical situation, and according to the full prescribing information guideline and the investigator's judgment. for each treated event, the subject's treatment period will be finished when, in the opinion of the local investigator, the participating subject would not benefit from further infusions of the study concentrate.

Eligibility criteria:
inclusion criteria: 1. male or female 7 years of age or older 2. the subject has been diagnosed of inherited vwd of type 3 as determined by subject's medical records. 3. the subject needs a surgical procedure (at least 10 surgical procedures have to be considered as "major" according to the criteria of the protocol). 4. the subject is expected to respond to exogenously administered fviii/vwf according to investigator's judgment. 5. the subject freely gives written informed consent. patients who are not legally permitted to provide written consent must sign a form of assent for study participation, and written consent must be provided by a parent or legal guardian. exclusion criteria: 1. the subject has been diagnosed of acquired vwd. 2. the subject is known to have history of intolerance to any alphanate® containing substance. 3. the subject is known to have history of anaphylactic reaction(s) to blood or blood components. 4. liver function tests (ast, alt, bilirubin) \> 2.5 x upper limit of normal (uln). 5. renal function test (creatinine, bun) \> 1.5 x uln. 6. the subject is known or suspected to have present or past inhibitor activity (antibodies) directed against fviii or vwf. 7. the subject is known to abuse alcohol or illicit drug use within the past 12 months. 8. the subject is participating in another clinical study involving an investigational treatment, or participated within the past 4 weeks (except if the patient is participating in another alphanate® study). studies consisting of data and blood sampling collections on a regular or long-term basis are exempt from this exclusion. 9. the subject is unlikely to adhere to the protocol requirements of the study.

Keywords: factor viii deficiency von willebrand disease fviii/vwf concentrate bleeding disorders blood disorders
efficacy and safety study of inhaled cvt 301 in parkinson's disease patients for treatment of off episodes

Conditions: Idiopathic Parkinson's Disease

Summary: this randomized, multicenter, placebo-controlled, double-blind study will evaluate the efficacy and safety of inhaled cvt 301 compared with placebo in pd patients experiencing motor response fluctuations (off phenomena) as an outpatient (i.e., at home) and in the clinic.


Eligibility criteria:
inclusion criteria: * idiopathic parkinson's disease (pd) diagnosed between the ages of 30 and 80 years; * hoehn and yahr stage 1-3 in an "on" state; * require levodopa-containing medication regimen at least 4 times during the waking day; * experience motor fluctuations with a minimum of 2 hours of average daily "off" time per waking day (excluding early morning "off" time) and demonstrate levodopa responsiveness; * are on stable pd medication regimen. exclusion criteria: * pregnant or lactating females; * previous surgery for pd or plan to have stereotactic surgery during the study period; * history of psychotic symptoms requiring treatment, or suicide ideation or attempt within last year; * adequate lung function as measured by spirometry; * any significant condition, severe concurrent disease, abnormality or finding that would make patients unsuitable or may compromise patient safety.

Keywords: parkinson's disease motor fluctuations levodopa inhaled drugs off episodes
impact of the sflt-1/plgf ratio on medical decision-making and on maternal and neonatal outcomes in women suspected of preeclampsia

Conditions: Preeclampsia Possible

Summary: previous studies demonstrated that placental growth factor (pigf) and vascular endothelial growth factor (vegf) produced by trophoblast cells decreases during preeclampsia, whereas soluble fms-like tyrosine kinase-1 (sflt-1), an antiangiogenic factor, increases. the ratio sflt-1/plgf has a higher positive predictive value than the isolated measurement. a ratio under 38 exclude risk of imminent preeclampsia and allows to outpatient follow-up with a negative predictive value of 99.3%. a ratio equal or higher than 38 permits to direct high-risk patients towards hospitalization with a positive predictive value of 36.7% of preeclampsia at 4 weeks. these findings suggest that the ratio can be used to select more appropriately women needing hospitalization for suspected preeclampsia.

this is a single-center prospective and observational study conducted from the 1rst of october 2019 to the 27th of january 2021, including pregnant women suspected of preeclampsia, above 24 weeks of gestation. values were measured using the elecsys sflt-1/plgf immunoassay ratio. the investigators observed the clinical decision regarding hospitalization, intensive patient monitoring, corticosteroid administration, and labor induction before and after knowing the ratio value.

Eligibility criteria:
inclusion criteria: * pregnant patients over 24 weeks of amenorrhea * aged 18 and over * with suspicion of preeclampsia defined by the appearance of pregnancy-induced hypertension (≥ 140 in systolic and/or 90 mmhg in diastolic pressure over 2 measurements at 4 hours intervals) or proteinuria (≥ 0.3 g per 24 hours). * who systematically gave oral consent after submitting the information sheet exclusion criteria: * pregnant women with both hypertension and proteinuria because they already have a confirmed diagnosis of preeclampsia. * receiving antihypertensive treatment before pregnancy * or refusing to participate in the study the sflt-1/plgf ratio was measured only when clinically indicated as per the investigator's judgment.

Keywords: preeclampsia soluble fms-like tyrosine kinase placental growth factor medical care decision hospitalization
metabolic effects of gh and igf-i in growth hormone deficient(ghd) and diabetes and impaired glucose tolerance(igt)

Conditions: Diabetes

Summary: the aim of this study is to measure effects of the combined treatment with gh and igf-i on glucose sensitivity and body composition in patients with ghd and igt or diabetes.

the study was a 6 months randomised placebo controlled trial of adults with ghd and type 2 diabetes. all receive gh (0.15 mg/day for 1 month, 0.3 mg/day for 5 months) and are randomised to igf-i or placebo (15 µg/kg/day for 1 month and 30 µg/kg/day for 5 months). glucose metabolism is evaluated with euglycemic hyperinsulinemic clamp and body composition by computed tomography (ct) and bio impedance;.

Eligibility criteria:
inclusion criteria: 1. verified profound gh deficiency. if the patient is already on gh replacement therapy this must have been commenced at least 6 months prior to study entry. 2. impaired glucose tolerance test or diabetes (stable on oral antidiabetic medication for at least 3 months) 3. hba1c\<7.5% 4. age 18-70 years 5. each patient must sign an informed consent document before inclusion in the study 6. women of childbearing potential must provide a negative pregnancy test before study start, and they must agree to use an effective method of contraception such as double barrier contraception, an injectable or implanted hormonal contraceptive, combined oral contraceptive or an intra-uterine device (iud). the patient must agree to continue to use the contraceptive for two weeks after the last injection of imp. women without childbearing potential are defined as being postmenopausal for at least 1 year, or permanently sterilised at least 3 months before study entry. - exclusion criteria: 1. known or suspected allergy to gh or igf-i preparation 2. insulin treatment 3. proliferative retinopathy 4. previous malignancy or other serious diseases (ex severe cardiovascular diseases, severe infections). patients with a history of cancer can be included if they have been treated with curative therapy and have been disease free for more than 5 years. patients with cardiac failure are not included. 5. increased liver enzymes (asat or alat\>2.5 normal range) 6. s-creatinine above 120 umol/l 7. patients with active hyperthyroidism and untreated hypothyroidism 8. pregnancy 9. lactation

Keywords: gh and igf-i growth hormone deficiency and igt or diabetes
efficacy of exclusive enteral nutrition in adult active crohn's disease

Conditions: Crohn's Disease

Summary: patients with crohn's disease (cd) could develop complications such as stricture, intestinal fistula and abdominal abscess. some cd patients had poor response to medical therapy. the efficacy of exclusive enteral nutrition (een) to these adult active cd patients is still unclear. the investigators aim to study the efficacy of een in induction of remission in adult active cd patients with complications or poor response to drugs.

active cd patients following up in our center who had been diagnosed as complicated disease with stricture, intestinal fistula, abdominal abscess and no response to drugs, were recruited since july 2013. patients were only offered een for 12 weeks without using other drugs except that patients with abscess could use antibiotic therapy with or without percutaneous drainage. the disease activity was assessed by the crohn's disease activity index (cdai). cdai\<150 was taken as achieving clinical remission. demographics and clinical variables were recorded. nutritional (body mass index, albumin) and inflammatory (high sensitivity c-reactive protein and platelet) index were evaluated at baseline, week 4 and week 12. some patients performed colonoscopy and/or computed tomography enterography (cte) /resonance enterography(mre) before and after een. mucosal healing was assessed under endoscopy with ses-cd and the size of abscess was detected by cte /mre.

Eligibility criteria:
inclusion criteria: 1. \>18 years old 2. patients with cd was diagnosed clinically according to previously established international criteria \[9\] 3. the diagnosis of stricture, fistula and abdominal abscess was confirmed by ultrasound, ct enterography (cte), and endoscopy. the bowel stricture should mainly cause by inflammation. intolerance or failure to steroids or ifx was judged by medical history 4. the disease was in an active period. exclusion criteria: 1. intolerant to een or need emergency surgery 2. the bowel stricture should mainly cause by fibrosis
dose-escalation study of cg0070 for bladder cancer after bcg (bacillus calmette-guerin) failure

Conditions: Carcinoma, Transitional Cell; Bladder Neoplasms

Summary: the main purpose of this research study is to evaluate the safety and dosing of cg0070.

cohorts of three to six patients will be assigned to receive intravesical (into the bladder) administration of cg0070 either weekly or every 4 weeks for up to a total of 6 doses.

Eligibility criteria:
inclusion criteria: * high grade non-muscle invasive bladder cancer (stages ta, t1 and/or cis - carcinoma in situ). high grade being defined as g2 or g3 disease. * failure of at least one prior treatment with bcg, defined as evidence of tcc on cystoscopic exam and biopsy or cystoscopic exam and urine cytology at least 6 weeks from last bcg treatment * ecog performance status 0-1 * adequate bone marrow, renal, liver and coagulation function exclusion criteria: * pregnant or nursing * hiv positive * use of anticoagulants such as coumadin or heparin * history of bleeding disorder * active systemic autoimmune disease or chronic immunodeficiency * prior gene therapy * uncontrolled cystitis, bladder pain, bladder spasms, urinary incontinence, or reduced bladder volume

Keywords: superficial transitional cell carcinoma bacillus calmette-guerin (bcg) superficial bladder cancer gene therapy vaccine adenovirus carcinoma in situ