Kornimate/medical-research-clean huggingface dataset:
comparison of two treatment regimens of helicobacter pylori infection

Conditions: Helicobacter Pylori Infection

Summary: the goal of this interventional study is to compare the efficacy of clarithromycin vs levofloxacin based regimen in treatment of helicobacter pylori infection in patients presenting to medical opd who are tested positive for h pylori infection.. the main question\[s\] it aims to answer are: • which regimen is superior in terms of efficacy participants will be treated for h pylori infection in with two different regimen if there is a comparison group: researchers will compare two groups group 1 will receive clarithromycin based regimen group 2 will receive levofloxacin based regimen to see the treatment response.

this interventional study will be conducted in department of medicine, rehman medical institute, peshawar. study duration: 10 months after the issuance of ethical approval sample size: sample size is calculated using a two-tailed alpha test with a significance level of 0.05 and 90% power to detect 23% difference in the eradication rate of the two regimens. the total number of patients required to prove the hypothesis is 156, 78 in each group. study population: patients coming to opd with symptoms suggestive of h pylori infection will undergo screening by hpylori stool antigen. if it comes to be positive then they will be enrolled in study after applying inclusion/exclusion criteria. inclusion criteria: all patients who tested positive on stool antigen will be included. age \>12 years and both genders will be included. exclusion criteria: patients under 12 years old. patients who have penicillin allergy. patients who have underlying dysrhythmia forbidding the use of macrolide. patient who have hypersensitivity to any of these antibiotics. study population will be divided in two groups. group 1 will receive regimen number 1 and group 2 will receive regimen number 2.( regimens are described below.) regimen 1 (r1): clarithromycin 500mg bd, plus metronidazole 400mg tds for 14days and omeprazole 40mg bd for 6 weeks. regimen 2(r2): levofloxacin 500mg od plus amoxicillin 1gm bd for 14 days and omeprazole 40mg bd for 6 weeks. the patients will be followed 2 weeks after completion of treatment. on follow up, their symptoms improvement, compliance and side effects will be documented. they will undergo stool ag test again to assess treatment response.

Eligibility criteria:
inclusion criteria: * all patients who tested positive on stool antigen will be included. exclusion criteria: * patients under 12 years old. patients who have penicillin allergy. * patients who have underlying dysrhythmia forbidding the use of macrolide. * patient who have hypersensitivity to any of these antibiotics.

Keywords: clarithromycin levofloxacin helicobacter pylori
effects of vitamin d supplementation in subjects with new onset of type 1 diabetes

Conditions: Type 1 Diabetes

Summary: in this placebo controlled study the investigators aim to investigate the effects of vitamin d supplementation in subjects with new onset of type 1 diabetes on immunological, endocrine and metabolic parameters.

this is a bicentric, randomized placebo controlled, double blind study, with the aim to evaluate the effect of vitamin d supplementation in subjects with new onset of type 1 diabetes on immunological, endocrine and metabolic parameters. the primary study goal is to evaluate the influence of vitamin d supplementation on the number and function of the master regulatory t-cells under controlled conditions within 13 months. the secondary study goals are a comprehensive immune phenotyping to determine whether vit d produces changes consistent with a general improvement in immune homeostasis that supports ß-cell tolerating interventions, the assessment of ß-cell function in all subjects to obtain preliminary data on the effects of vit d on ß-cell survival.

Eligibility criteria:
inclusion criteria: * males or females \> 6 years * new onset of type 1 diabetes (3 months) exclusion criteria: * pregnancy * hypercalcemia (\>2,65 mmol/l) * chronic disease including a long-term medication over 4 weeks per year (except type 1 diabetes)

Keywords: vitamin d autoimmune disease diabetes
study for the recording of adherence to treatment with perindopril/indapamide/amlodipine fixed dose combination

Conditions: Adherence to Medication Regime; Hypertensive Disease

Summary: the main objective of this study is to record, in routine clinical practice, patients' adherence to treatment with perindopril/indapamide/amlodipine fixed dose combination, during 4 months treatment.

this is a non-interventional study aiming to record adherence to treatment with perindopril/indapamide/amlodipine fixed dose combination. in parallel blood pressure levels will be recorded, as well as safety and tolerability of this fixed dose combination.

Eligibility criteria:
inclusion criteria: * male or female, ambulatory patients \>18 years old. * clinically diagnosed essential arterial hypertension. * under treatment with perindoril/indapamide/amlodipine fixed dose combination. * the patient has given his/her written consent after being informed, before his inclusion in the study. exclusion criteria: * secondary arterial hypertension. * serious end stage diseases, severe neuropsychiatric diseases, cerebrovascular event with serious residual lesions, scheduled procedure or surgical operation or hospital admission. * pregnancy, lactation or intention to become pregnant.
ovarian cancer vaccine for patients who have progressed during the can-003 study

Conditions: Epithelial Ovarian Cancer

Summary: the purpose of this trial is to assess the safety profile of cvac for epithelial ovarian cancer patients who were enrolled in the cvac clinical trial can-003 and are no longer eligible for study participation due to disease progression.


Eligibility criteria:
inclusion criteria: * female patients ≥ 18 years old with histologically confirmed stage iii or iv epithelial ovarian, primary peritoneal, or fallopian tube cancer who were enrolled in can-003 * able and willing to undergo mononuclear cell (mnc) collection (if required for patients who do not have available cvac doses) * were enrolled in can-003 and met protocol criteria for progressive disease * wish to remain in the study and, in the investigator's judgment, the potential benefit of cvac treatment outweighs the risk * must be non-pregnant and, if of childbearing potential, must use adequate birth control (hormonal or barrier method of birth control or abstinence) for the duration of the study and for 3 months after study completion * able to provide written informed consent * white blood cell count (wbc) ≥ 3.0 k/μl, absolute neutrophil count ≥ 1.5 k/μl, hemoglobin ≥ 9.0 g/dl, and platelets ≥100,000/mm\^3 exclusion criteria: * pregnant or breastfeeding * other medical conditions which preclude study participation, in the opinion of the investigator * receiving treatment with any other investigational product

Keywords: cvac
effect of intrathoracic pressure regulation on decreased cerebral perfusion (4hour)

Conditions: Head Injury; Intracranial Pathology; Compromised Cerebral Perfusion

Summary: the purpose of the study is to evaluate the physiological response to application of the intrathoracic pressure regulator (itpr) in patients with compromised cerebral circulation. the study will evaluate the physiological response to intrathoracic pressure regulation (ipr) therapy in hemodynamically stable patients with compromised cerebral circulation who are on ventilatory support.


Eligibility criteria:
inclusion criteria: * ≥18 years of age * intubated and mechanically ventilated on a volume controlled mode * head injury or other intracranial pathology and compromised cerebral perfusion * arterial line in place or alternative with continuous pressure monitoring * spo2 ≥90% * mean arterial pressure \>55 * admission to icu or about to undergo neurosurgery with planned placement of an invasive intracranial pressure monitor * inclusion presents no significant delays to planned emergent neurosurgery * prior written informed consent exclusion criteria: * cardiac or pulmonary injury * confirmed pneumothorax or hemothorax * serious neck injury resulting in neck swelling with jugular venous compression * evidence of ongoing uncontrolled bleeding * respiratory disease such as copd, interstitial lung disease, or other parenchymal or pulmonary vascular disease * marked hypertension at time of device use defined as systolic blood pressure \>180 mmhg * congestive heart failure * women with positive serum or urine pregnancy test or breast feeding

Keywords: itpr cpp tbi traumatic brain injury cerebral perfusion pressure intrathoracic pressure regulator
korean registry of percutaneous evar with incraft stent graft for the treatment of abdominalaortic aneurysm (k-incraft)

Conditions: Abdominal Aortic Aneurysm

Summary: the sudy purpose is to investigate efficacy and safety of percutaneous endovascular aortic aneurysm repair using incraft stent graft for korean patients with abdominal aortic aneurysm. this study is designed as an investigator-initiated, multi-center, single-arm, prospective registry study. a total of 100 patients who meet all inclusion criteria, but none of exclusion criteria will be enrolled after the implantation of incraft stent graft. the primary efficacy outcome is technical success defined as successful deployment of the stent-graft with no type i/iii endoleak, unintentional coverage of visceral aortic branches or internal iliac arteries at the end of the procedure, and with successful removal of the delivery system. the primary safety outcome is major vascular complications at 30 days including. the study subjects will be followed for 12 months.

prospective single-arm multicenter registry

Eligibility criteria:
inclusion criteria: * 1. aaa with one of following indications 1. aaa with maximum diameter \> 5 cm, 2. aaa with maximum diameter \> 4 cm with an increase \>0.5 cm during the preceding 6 months 3. saccular type aaa irrespective of the sac diameter. * 2. proximal aortic neck length ≥10 mm with a diameter ≥ 17 and ≤ 31 mm in combination with supra- and infrarenal angulation ≤ 60 degree. * 3. iliac landing zone with a length ≥15 mm and a diameter ≥ 7 and ≤ 22 mm * 4. femoral access vessels should be adequate to fit the selected delivery system * 5. minimum overall aaa treatment length (proximal landing location to distal landing location to distal landing location) ≥128 mm * 6. aortic bifurcation \>18 mm in diameter * 7. patents with age of 19-80 years. * 8. male or non-pregnant female * 9. voluntary participation in the study with signed informed consent form. exclusion criteria: * 1. dissecting or ruptured abdominal aortic aneurysm * 2. presence of connective tissue disease (marfan's syndrome or ehlers-danlos syndrome). * 3. prior aaa or iliac artery repair * 4. active infection or active vasculitis. * 5. myocardial infarction or cerebrovascular accident within 3 months prior to study enrolment. * 6. need for renal artery coverage (e.g. chimney graft) * 7. dialysis-dependent renal failure or serum creatinine \>2.0 mg/dl * 8. intolerance/hypersensitivity to contrast media or antiplatelet drugs. * 9. positive pregnancy test. * 10. participation in another medical research study within 1 month of study enrolment. * 11. planned concomitant surgical procedures (other than left subclavian artery transposition or bypass) or major surgery within 30 days of study enrolment. * 12. patients with life expectancy less than 1 year

Keywords: abdominal aortic aneurysm endovascular repair stent graft
treatment of primary cns lymphoma

Conditions: Primary CNS Lymphoma (PCNSL)

Summary: the purpose of this study is to evaluate the efficacy and safety of fvd regiment (fotemustine, teniposide and dexamethasone ) for patients with primary cns lymphoma.

primary cns lymphoma (pcnsl) is a rare b-cell variant of non-hodgkin lymphoma that is confined to the brain, leptomeninges, spinal cord, and eyes. the optimum treatment for patients with pcnsl remains challenging and at present there is no universally accepted therapeutic approach for patients with newly diagnosed disease. the purpose of this study is to evaluate the efficacy and safety of fvd regiment(fotemustine, teniposide and dexamethasone)contrast with hd-mtx-ara-c program for patients with primary cns lymphoma.

Eligibility criteria:
inclusion criteria:age range 14-60 years old; ecog performance status 0-2; estimated survival time \> 3 months histological confirmed pcnsl none of chemotherapy or radiotherapy has been previously used none of chemotherapy contraindication: hemoglobin ≥ 90 g/dl, neutrophil ≥ 1.5×109/l, platelet ≥ 100×109/l, alt and ast ≤ 2×uln, serum bilirubin ≤ 1.5×uln, serum creatine ≤ 1.5×upper limitation of normal (uln), serum albumin ≥ 30g/l, serum plasminogen is normal (inclusion criteria of 1,3,6 groups ) at least one measurable lesion none of other serious diseases, cardiopulmonary function is normal pregnancy test of women at reproductive age must be negative patients could be followed up none of other relative treatments including the traditional chinese medicine, immunotherapy,biotherapy except anti-bone metastasis therapy and other symptomatic treatments. volunteers who signed informed consent. - exclusion criteria:disagreement on blood sample collection patients allergic of any of drug in this regimen or with metabolic disorder pregnant or lactating women serious medical illness likely to interfere with participation serious infection primitive or secondary tumors of central nervous system chemotherapy or radiotherapy contraindication the evidence of peripheral nervous disorder or dysphrenia patients participating in other clinical trials patients taking other antitumor drugs patients estimated to be unsuitable by investigato -

Keywords: primary cns lymphoma;chemotherapy; rr;pfs;os
analysis of the relationship between early postoperative anemia and the evolution of autonomy at 6 months in patients 75 years of age and older operated on following a fracture of the upper end of the femur

Conditions: Femoral Fracture

Summary: fracture of the upper extremity of the femur is a condition whose frequency increases with age. it is a serious disease, with multiple consequences such as a decrease in life expectancy, quality of life and patient autonomy. in this observational study, the investigators wish to evaluate the evolution of the autonomy of very elderly patients operated on for an upper extremity femur fracture as a function of early post-operative anemia.


Eligibility criteria:
inclusion criteria: * age ≥ 75 years * patient operated on a fracture of the upper extremity of the femur * patient, family or close relative who does not object to participation in the study * patient affiliated to a social security system * patient who can be monitored as part of the protocol exclusion criteria: * refusal to participate in the study (patient, family or trusted relative) * patient with support on the operated limb not authorized by the surgeon * patient with an associated fracture (polytrauma, concomitant trauma to the upper limb...) * patient with a pathologic fracture * patient included in category 1 interventional research (involving a drug or medical device) * patient deprived of liberty * patient not affiliated to a social security system
effect of levamisole supplementation on tetanus vaccination response rates in hemodialysis patients

Conditions: Renal Dialysis

Summary: levamisole as an immunomodulator drug has been demonstrated to improve the immune response to hepatitis b virus (hbv) vaccination in hemodialysis patients. the aim of this study was to evaluate the effect of levamisole supplementation on tetanus-diphtheria (td) vaccine response rate in hemodialysis patients.

levamisole as an immunomodulator drug has been demonstrated to improve the immune response to hbv vaccination in hemodialysis patients. the aim of this study was to evaluate the effect of levamisole supplementation on td vaccine response rate in hemodialysis patients. in this randomized double-blind placebo-controlled trial 40 hemodialysis patients who had not received tetanus vaccination in a year before investigation and had unprotective anti-tetanus immunoglobulin g (igg) levels (\<0.1 international unit \[iu\]/ml) were enrolled. these patients were randomized into two equal groups to receive one dose of intramuscular td vaccine supplemented with either levamisole 100 mg or placebo daily, six days before and six days after vaccination. the anti-tetanus igg levels were measured 1 and 6 months after vaccination.

Eligibility criteria:
inclusion criteria: * being under regular hemodialysis for more than 3 months * unprotective baseline levels of antitetanus igg exclusion criteria: * tetanus diphtheria (td) vaccination in past year * leukopenia (wbc\<1500 cells/mcl) * immunosuppressive drug exposure in past 2 months * recent hospitalization or history of transfusion of blood products in the past 3 months.

Keywords: tetanus vaccines renal dialysis levamisole
res prepared with recell® compared to conventional care for healing of donor sites in ages 1-16 years

Conditions: Skin; Deformity

Summary: to evaluate whether the time to complete closure is superior for recell-treated split-thickness donor sites, compared with control (standardized dressings only). the mean time for donor site healing will be compared between treatments.


Eligibility criteria:
inclusion criteria: 1. male or female patients aged 1 through 16 years (inclusive) with a skin defect for which autografting is indicated. 2. the area of total injury or planned defect (excluding donor sites) is 5% to 25% total body surface area (tbsa), inclusive. 3. two discrete donor sites of similar size (± 25%) can be created in a similar non-articulating location (excluding the scalp) with each donor site representing a minimum of 1% tbsa. 4. the patient and family member/parent/guardian are able to complete all follow-up evaluations required by the study protocol. 5. in the opinion of the investigator, the patient and/or parent/guardian must be able to: 1. understand the full nature and purpose of the study, including possible risks and adverse events, and 2. provide informed consent/assent as appropriate for study participation. 6. the patient and/or parent/guardian agrees to abstain from any other treatment of the wound(s) for the duration of the study unless medically necessary and comply with all compulsory study procedures. 7. the patient and/or parent/guardian agrees to abstain from enrollment in any other interventional clinical trial for the duration of the study. 8. the patient and/or parent/guardian can read and understand instructions and give informed, voluntary, written consent. 9. life expectancy greater than 52 weeks. exclusion criteria: 1. prior autograft harvest at planned study donor sites. 2. patients with sepsis or hemodynamic instability. 3. the patient has an infection under active management or other dermatologic condition at the planned donor sites or treatment areas. 4. patient (of reasonable age) or parent/guardian is unable to follow the protocol requirements. 5. the patient has other concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives. 6. patients with a known hypersensitivity to trypsin or compound sodium lactate for irrigation. 7. in post-pubescent girls, pregnant or breast-feeding (pregnancy test should be performed in accordance with local institutional requirements). 8. enrollment in a concurrent study in which the study treatment may confound the endpoints of this study.

Keywords: pediatric, complex skin deformities
allergic transfusion reactions in plasma transfusion

Conditions: Allergy; Transfusion Reaction

Summary: allergic transfusion reactions are a common complication of transfusion by blood components containing plasma. this study aims to investigate passive transfer of immunoglobin e antibodies as a risk factor of allergic reactions to plasma transfusion by use of solvent detergent plasma.

prospective observation study, aiming to measure transfer of immunoglobin e antibodies and other factors associated with allergic complications in patients receiving plasma transfusion. samples from patients and plasma units will be investigated. samples frozen until investigation. to assess biological relevance of findings, additional analysis of basophil reactivity will be performed and information on clinical allergy collected by use of a questionaire . in-patients will be recruited if receiving plasma transfusion during surgery or if an allergic transfusion complication occurs.

Eligibility criteria:
inclusion criteria: * patients receiving plasma transfusion exclusion criteria: - patients not able to complete sampling procedure

Keywords: plasma transfusion allergic transfusion reaction transfusion reaction blood transfusion solvent detergent plasma
non-invasive preoperative tissue evaluation in head and neck tumor patients using multispectral optoacoustic tomography (msot)

Conditions: Head and Neck Cancer; Healthy

Summary: multispectral optoacoustic tomography (msot) is a promising imaging technology that utilizes pulsed laser light. one of the key capabilities of this technology is measuring oxygenation within human tissue. this proposed study aims to investigate possible limitations of human tissue used for reconstructive surgery due to flawed tissue perfusion. healthy volunteers as well as patients with a diagnosed head and neck cancer entity will be recruited. both cohorts will then be scanned on different body areas (most common tissue sites used for reconstructive surgery on the back, arms and legs) to assess differences in muscle oxygenation between the healthy and tumor patient cohort using msot. the hypothesis of the study is, that patients with diagnosed head and neck cancer entities are prone to compromised tissue perfusion due to a high prevalence of smoking within the head neck tumor patient cohort and therefore perfusion restirciting diseases e.g. peripheral arterial occlusive disease (paod).


Eligibility criteria:
inclusion criteria: * cohort 1: histopathological diagnosed head and neck tumor patients. * cohort 2: healthy adults. exclusion criteria: * pregnancy / breastfeeding * ink / tattoo in the areas of interest (upper back, distal forearm, upper and lower leg) * missing consent form * cohort 2: chronical abuse of alcohol and nicotine.

Keywords: msot head and neck cancer healthy flap surgery graft perfusion oxygenation