Kornimate/medical-research-clean huggingface dataset:
a randomized, active-controlled, parallel, open-label, multicenter, phase 4 study to compare the efficacy and safety of pregabalin sustained release tablet and pregabalin immediate release capsule in type ii diabetic patients with peripheral neuropathic pain

Conditions: Neuropathic Pain; Diabetes Mellitus, Type 2

Summary: this study is to compare the efficacy and safety of pregabalin sustained release tablet and pregabalin immediate release capsule in type ii diabetic patients with peripheral neuropathic pain.


Eligibility criteria:
inclusion criteria: 1. aged ≥ 19 years, \< 75 years 2. vas score for diabetic peripheral neuropathy pain ≥ 30 3. patients who have been administering pregabalin immediate release capsule 150 mg/day for more than 4 weeks 4. type ii dm patient and hba1c ≤ 10 % 5. written informed consent exclusion criteria: 1. patient with hypersensitivity to pregabalin 2. patient on anti-epileptic drugs 3. patients with pain caused by other factors than diabetic peripheral neuropathy 4. patients undergoing egfr \<30 ml/min/1.73 m2 (mdrd) at screening 5. ast(aspartate aminotransferase) or alt(alanine aminotransferase) level ≥ 3x uln (upper limit of normal range) or active liver disease 6. drug-abusing patient 7. severe depression or uncontrolled abnormal mood and behavioral changes 8. pregnant and breast-feeding woman 9. patients who participated in other clinical trials for investigational products within 30 days of screening 10. patients deemed to be ineligible to participate in the trial by investigator

Keywords: pregabalin sustained release tablet
a study of pentasa in patients with ulcerative colitis

Conditions: Ulcerative Colitis

Summary: confirmation of safety profile of pentasa slow release tablets 500 mg in patients with ulcerative colitis (uc).


Eligibility criteria:
inclusion criteria: * patients suffering from ulcerative colitis exclusion criteria: * hypersensitivity to mesalazine, salicylates or to any excipient * severe damage to liver or renal functions
musculoskeletal disorders of workers in a production and distribution company in argentina

Conditions: Describe Musculoskeletal Disorders of Workers

Summary: describe musculoskeletal disorders of workers in a company in argentina regarding working areas and demographic carachteristics of the workers.

we are analyzing the first consultation registration of every worker that had been attended by the physiotherapist in a clinic that is located inside the company. these records consist on demographic data and also injury related information.

Eligibility criteria:
inclusion criteria: * workers in a production and distribution company in argentina that walks into the clinic inside the company exclusion criteria: * lack of registered information
study using fluorine-18-labeled fluoro-misonidazole positron emission tomography to detect hypoxia in locally advanced (t3-t4 and./or n1)primary rectal cancer patients

Conditions: Colorectal Cancer

Summary: when used with a different radioactive tracer called fmiso, a pet scan can find areas of low oxygen in the tumor. we think that having areas of low oxygen is a reason why some tumors are hard to treat with radiation. in a past study, fmiso pet scans were performed in 6 patients with rectal cancer that could not be operated on and that had spread to other areas. in this group of patients, fmiso pet scans were able to find the low oxygen areas in their tumors. but this study included only a few patients. in the present study, we want to use fmiso pet scans in patients who have tumors that can be operated on. this group of patients will have radiation, chemotherapy or both before they have their surgery. we want to see if fmiso pet can find low oxygen areas in this distinct group of patients.

hypoxia is a characteristic feature of malignant solid tumors associated with poor prognosis and resistance to chemotherapy and radiation. it has also been shown (6) that the presence of hypoxia may reduce long-term survival post surgery. hypoxia renders tumor cells up to three times more resistant to ionizing radiation than aerobic cells. the presence of hypoxic regions within tumors may be one factor leading to local failure after treatment with standard pre-operative radiotherapy doses. if these regions could be identified and verified using a non-invasive imaging technique prior to surgery, they could be specifically targeted using sophisticated planning techniques such as intensity modulated radiation therapy (imrt) to deliver higher doses ionizing radiation with preoperative radiotherapy. future studies using imrt to "dose paint" areas of hypoxia within tumors will build upon the results of this feasibility study. ultimately, by the delivery of differential dose of radiation to the tumor, in combination with surgery, the local control rates of rectal cancer patients may further be improved.

Eligibility criteria:
inclusion criteria: * able to provide written informed consent * histologically confirmed diagnosis of stage 2 or stage 3 rectal carcinoma requiring preoperative radiation, chemotherapy or both, per treating physician * 18 years of age or older * karnofsky performance status ≥ or = to 70 exclusion criteria: * women who are pregnant (confirmed by serum b-hcg in women of reproductive age) or breast feeding

Keywords: colorectal cancer 07-151
combined o-(2-[18f]fluoroethyl)-l-tyrosine (fet) positron emission tomography (pet) and simultaneous magnetic resonance imaging (mri) follow-up in re-irradiated recurrent glioblastoma patients

Conditions: Glioblastoma; Nervous System Neoplasms; Central Nervous System Neoplasms; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue

Summary: patients with recurrent glioblastoma who are planned to receive a second course of radiation are to be included into this monocentric cohort trial. due to multiple pre-treatments simultaneous combined positron emission tomography (pet) with o-(2-\[18f\]fluoroethyl)-l-tyrosine (fet) as well as magnetic resonance imaging (mri) is used for treatment planning and follow-up imaging as it allows for a better distinction between treatment-related changes and viable tumor tissue.

for glioblastoma (gbm) patients it has been proven that a \[18f\]fet-pet scan is very helpful especially in target volume definition and after the treatment, in turn, the combination of mri and \[18f\]fet-pet is diagnostically most useful to distinguish between radiation necrosis and a real progressive disease. the response to therapy is based on the newly formulated revised assessment in neuro-oncology (rano) criteria. kinetic and static \[18f\]fet-pet scans are useful to supplement this modality and its own prognostic value concerning relapsing patients will be examined. the special feature of this study is the use of both modalities in parallel, allowing simultaneous acquisition of morphological changes, functional and molecular imaging. secondary methodological issues are dealt with, such as the relationship between contrast uptake, perfusion and \[18f\]fet uptake. in this regard, the hybrid imaging may serve for hypothesis generation, as in parallel in a unique way of contrast enhancement and tracer kinetics can be investigated (simultaneous contrast-enhanced analysis and tracer application). in particular, fet kinetics are examined in more detail (for example, differences between increasing and decreasing kinetics) to find ways of how to use certain mri sequences for better visualization of viable tumor tissue and vice versa .

Eligibility criteria:
inclusion criteria: * 18 - 75 years old * histologically or magnetic resonance imaging proven recurrent glioblastoma * re-irradiation possible * willing and able to give free informed consent exclusion criteria: * not willing or able to give free informed consent * pregnancy * claustrophobia * metallic objects or implanted medical devices in the body

Keywords: recurrent glioblastoma radiotherapy pet-mri fet-pet
the study of npc-06 - investigation of safety, efficacy and pharmacokinetics of fosphenytoin

Conditions: Epilepsy

Summary: the study is to evaluate safety, efficacy and pharmacokinetics of intravenously administered fosphenytoin in patients with neurosurgery, head trauma, epilepsy or status epilepticus who are requiring a loading dose of phenytoin.


Eligibility criteria:
inclusion criteria: * male or female, hospitalized patients 2 years of age or older * adult patients or guardian for pediatric patients to provide written informed consent exclusion criteria: * patient with a history of hypersensitivity to hydantoins * patient with hypotension, sinus bradycardia, sino-atrial block, second or third degree a-v block, or adams-stokes syndrome * pregnant or nursing female patients

Keywords: npc-06 fosphenytoin phenytoin pharmacokinetics safety
therapy optimisation for the treatment of hairy cell leukemia

Conditions: Hairy Cell Leukemia

Summary: the trial will test the effectiveness and toxicity of subcutaneous treatment with one cycle of cladribine in patients with hairy cell leukemia requiring treatment. they have to be untreated so far or may be pretreated with alpha-interferon.

evaluation of remission status will take place 4 months after treatment. in addition, it will be tested whether patients with non-optimal response will have a benefit from a second cycle of cladribine. non-optimal response is: patients with detectable residual disease; achievement of partial remission or detectable residual infiltration in the bone marrow.

Eligibility criteria:
inclusion criteria: * patients with histologically verified hairy cell leukemia * presence of hairy cells in the bone marrow and peripheral blood detected by positive trap staining and / or co expression if cell surface antigens cluster of differentiation (cd) 19/cd25 or cd19/cd103 (b-ly7) * no previous cytostatic treatment (splenectomy or interferon treatment are allowed) * need for treatment * age at least 18 years old * general state of health according to who 0-2 * current histology, not older than 6 months * written consent by patient exclusion criteria: * patients not fulfilling inclusion criteria above * hairy cell leukemia variants (hcl-v): presence of lymphoid cells in bone marrow and / or peripheral blood, which have an intermediate morphology between hairy cells and prolymphocytes (negative trap staining and co- expression of cd19/cd103 without cd25 * pretreatment with purine analogues or other chemotherapeutics * concomitant corticosteroid therapy * severe dysfunction of the heart (nyha iii or iv), the lung (who-grade iii or iv), the liver, except due to lymphoma (bilirubin \> 2 mg/dl, alkaline phosphatase, glutamate-oxalacetate transaminase and glutamate-pyruvate transaminase \> 2 x upper limit of normal), the kidneys (creatinin \> 2 mg/dl or creatinine clearance \< 50 ml/min), central nervous system diseases including psychoses. * proven hiv infection * active hepatitis * other florid infections * anamnesis / diagnosis of other malignant disease (other than non-melanoma associated skin tumours or stage 0 in situ carcinoma of the cervix) * pregnant or lactating women

Keywords: hairy cell leukemia untreated cladribine subcutaneous
correction of v-pattern strabismus by graded recession of inferior oblique muscle .

Conditions: V Pattern Esotropia; Monocular Exotropia With V Pattern

Summary: v pattern strabismus is the commonest of alphabet pattern. its identification is essential to plan a proper surgical management. graded recession is a very logical approach to treat inferior oblique overaction (iooa). the aim is to evaluate the efficacy of graded recession of inferior oblique muscle for correction of different grades of v pattern.

prospective interventional study for forty patients with v pattern strabismus and primary inferior oblique overeaction will be evaluated by prism cover test to assess the grade of iooa and amplitude of v-pattern. graded recession of io muscle depends on the amplitude of the v-pattern and degree of iooa. eight mm recession for amplitude 7.5 to 10 degree and mild iooa (10 or +1) ,10 mm recession for amplitude 11- 15 degree and moderate iooa (11-15 or +2) and maximum recession for amplitude more than 15 degree and marked iooa ( more than 15 degree or +3). simultaneous correction of the horizontal deviation will be performed at the same sitting. follow up after i week,1 month ,3 month and 6-month.

Eligibility criteria:
inclusion criteria: * cases with v pattern strabismus with the age of the patients will be ≥3 years. exclusion criteria: * - structural ocular pathology * significant neurodevelopmental delay

Keywords: vpattern strabismus inferior oblique overaction graded recession dissociated vertical deviation
blood pressure and weight trajectory on a dual antihypertensive combination plus sibutramine versus placebo in obese hypertensives

Conditions: Obesity; Hypertension

Summary: to study the effect of sibutramine treatment on weight reduction and blood pressure improvement in three groups with antihypertensive therapy whose blood pressure was not adequately controlled with antihypertensive combination treatment.


Eligibility criteria:
inclusion criteria: * treated essential hypertension. * obesity: bmi 27-35 kg/m2 exclusion criteria: * secondary hypertension. * stage 3 hypertension. * secondary obesity; bmi \> 35kg/m2. * cad; mi within past 6 months; nyha stage 3 or 4 heart failure; tachyarrhythmia/atrial fibrillation; myocarditis. * kidney failure. * liver failure. * hyperthyroidism. * unstable dm. * carcinoma. * severe chronic infectious disease. * alcohol or drug abuse. * pregnancy. * epilepsy. * psychosis or treatment with antidepressants or major tranquilizers
study of alirocumab (regn727/sar236553) added-on to rosuvastatin versus other lipid modifying treatments (lmt) (odyssey options ii)

Conditions: Hypercholesterolemia

Summary: to evaluate the reduction of low-density lipoprotein cholesterol (ldl-c) by alirocumab (regn727/sar236553) as an add-on therapy to other lmt in patients with hypercholesterolemia at high cardiovascular (cv) risk.


Eligibility criteria:
inclusion criteria: 1. patients with ldl-c greater than or equal to 70 mg/dl at the screening visit and who are not adequately controlled with a stable daily dose of rosuvastatin, with or without other lmt. or 2. patients with screening ldl-c greater than or equal to 100 mg/dl who are not adequately controlled with a stable daily dose of rosuvastatin before the screening visit, with or without other lmt. exclusion criteria: 1. ldl-c less than 70 mg/dl at the screening visit in patients with history of documented cardiovascular disease (cvd) 2. ldl-c less than 100 mg/dl at the screening visit in patients without history of documented coronary heart disease (chd) or non-chd cvd, but with other risk factors 3. homozygous familial hypercholesterolemia (fh) (clinically or previous genotyping) 4. recent (within 3 months prior to the screening visit) myocardial infarction (mi), unstable angina leading to hospitalization, percutaneous coronary intervention (pci), coronary bypass graft surgery (cabg), uncontrolled cardiac arrhythmia, stroke, transient ischemic attack, carotid revascularization, endovascular procedure or surgical intervention for peripheral vascular disease 5. newly diagnosed (within 3 months prior to randomization visit) or poorly controlled diabetes 6. presence of any clinically significant uncontrolled endocrine disease known to influence serum lipids or lipoproteins (the inclusion/ exclusion criteria provided above is not intended to contain all considerations relevant to a patient's potential participation in this clinical trial).
pharmacokinetics, efficacy and safety assessment of t2345 compared with active comparator in newly diagnosed patients with open-angle glaucoma or ocular hypertension

Conditions: Primary Open Angle Glaucoma

Summary: the purpose of this study is to assess the pharmacokinetics, efficacy and safety of t2345 versus an active comparator.


Eligibility criteria:
inclusion criteria: * untreated bilateral newly diagnosed patients with primary open angle glaucoma exclusion criteria: * any ocular hypertension other than chronic open angle glaucoma
helminth infection during pregnancy on vitamin d regulation: helmvit study

Conditions: Vitamin D Deficiency; Immunosuppression

Summary: purpose: to examine whether helminth infection during pregnancy alters vitamin-d-metabolism and reactivity of the child's immune system hypothesis: helminth infection during pregnancy is associated with altered vitamin d levels and vitamin d receptor expression in the placenta and modified immune reactivity in the infant.

objectives the primary objective of the proposed research project is to study the impact of helminth infection in general and particularly of infection with s. haematobium during pregnancy on vitamin d metabolism and its related factors as well as the impact of maternal infection on infants developing immune system and health. specific objectives to assess the effect of maternal helminths infections on vitamin d and vitamin-d-related factors in the serum of pregnant women and cord blood of their infants, to assess the effect of helminth infection on placental biology: determine expression levels of vdr and inflammatory genes investigate histologically the gestational age and other functional aspects of the placenta determine the influence of helminth driven inflammation and helminth antigens on placental tissue by establishing a (co-)culture system using primary placental cells and a placental cell line to assess whether helminth infections influence the infant's peripheral immune system by analyzing composition, reactivity and lineage determination of fetal cord blood mononuclear cells (cbmcs) in relation to the maternal and fetal immune and vitamin d status. current study focusing objectives in the present study the investigators explore if and how vitamin d and its related signals are modulated by helminth infection and how helminth infection could thereby shape the developing immune system of the newborn by analyzing cbmcs.

Eligibility criteria:
inclusion criteria: * pregnant women attending antenatal care from lambaréné and fougamou areas * pregnant women who have given written informed consent to the study for herself and for her unborn child and live infant. exclusion criteria: * known of chronic infections and diseases(e.g. diabetes, hiv, hepatitis b and c, anemia).

Keywords: pregnancy vitamin d helminth schistosomiasis
a study of rapastinel for rapid treatment of depression and suicidality in major depressive disorder

Conditions: Depressive Disorder, Major

Summary: the study will evaluate the efficacy, safety, and tolerability of 450 milligrams (mg) of rapastinel, compared to placebo in adult patients with major depressive disorder (mdd) who are at imminent risk of suicide.


Eligibility criteria:
inclusion criteria: * meet diagnostic and statistical manual of mental disorders - fifth edition (dsm-5) criteria for mdd * current major depressive episode of at least 4 weeks and not exceeding 24 months in duration at visit 1 * have current, ongoing suicidality (ideation or behavior) of sufficient severity to warrant hospitalization based on the judgment of the investigator * if female of childbearing potential, have a negative serum β-human chorionic gonadotropin (β-hcg) pregnancy test. exclusion criteria: * dsm-5-based diagnosis of any disorder other than mdd that was the primary focus of treatment within 1 month before visit 1. * lifetime history or currently meet dsm-5 criteria for: 1. schizophrenia spectrum or other psychotic disorder 2. bipolar or related disorder 3. major neurocognitive disorder 4. neurodevelopmental disorder of greater than mild severity or of a severity that impacts the participant's ability to consent, follow study directions, or otherwise safely participate in the study. 5. dissociative disorder 6. posttraumatic stress disorder 7. mdd with psychotic features * significant homicidal ideation or at imminent risk of injuring others or causing significant damage to property, as judged by the investigator. * prior participation in any investigational study of rapastinel/glyx-13
l-methionine, hibiscus sabdariffa and boswellia leaf extract to prevent postoperative urinary tract infection.

Conditions: Urinary Tract Infection; Pelvic Organ Prolapse; Urinary Incontinence

Summary: this study will include women who will undergo pelvic reconstructive surgery and/or anti-incontinence sling procedures. patients will be randomized to the combination of l-methionine, hibiscus sabdariffa and boswellia leaf extract in tablet or placebo twice a day during the seven days before and after surgery (total of 14 days). in this randomized, double-blind study, the investigators will assess treatment of clinically suspected or culture-proven urinary tract infections within 3 weeks of surgery (primary outcome), and risk factors for treatment for postoperative urinary tract infections (secondary outcomes) between the two study groups.


Eligibility criteria:
inclusion criteria: * postoperative transurethral catheterization after surgery for pelvic organ prolapse and/or urinary incontinence * patients aged ≥ 18 years exclusion criteria: * acute urinary tract infection at the moment of inclusion in the study * antibiotic treatment prescribed for any other cause than urinary tract infection * pregnancy * known allergy to one of the elements of the active compound * surgery for mesh excision * surgery for urethral diverticulum * surgery for fistula repair * surgery for sacral neuromodulation * any condition precluding the acquisition of written consent

Keywords: urinary tract infection pelvic organ prolapse urinary incontinence stress urinary incontinence mixed urinary incontinence l-methionine placebo