Kornimate/medical-research-clean huggingface dataset:
ala-pdt in patients with cin2 in p16-positivity and high-risk hpv infection

Conditions: Cervical Intraepithelial Neoplasia Grade 2; Papillomavirus Infections; p16 Protein

Summary: efficacy and safety of ala-pdt in patients with cervical intraepithelial neoplasia grade 2 (cin2) in p16-positivity and high-risk hpv infection.

a multi-center, randomized, double-blind, placebo-controlled phase iic clinical trial of ala-pdt in patients with cervical intraepithelial neoplasia grade 2 (cin2) in p16-positivity and high-risk hpv infection.

Eligibility criteria:
inclusion criteria: * premenopausal women, 18-45 years of age * satisfactory the colposcopy examination (cervical transformation zone types: type 1 or 2) at screening, and cin2 as verified by cervical biopsy and p16-positivity within the last 3 months * intense desire to retain the cervical structure or function * high-risk (including probably/possibly carcinogenic) hpv-dna (i.e. 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73 or 82) positive within the last 3 months * meet the following conditions: pregnancy test negative; no pregnancy plan during the trial;no sexuality or reliable contraceptive measures taken since last menstruation to the onset of the study, agreeing to adopt reliable contraceptive measures during the study * signed written informed consent exclusion criteria: * atypical glandular cells (ags) or adenocarcinoma in situ (ais) on cytology ,or malignant cells on cytology or histology, or other suspicion of either micro-invasive or invasive disease * invasive carcinoma possibility or lesions extending to the vaginal wall * severe pelvic inflammatory disease, severe cervicitis, or other severe gynaecological infection as per clinical examination * undiagnosed vaginal bleeding within the last 3 months * with allergic disease at present; known or suspected porphyria; known allergy to ala or analogues * with serious cardiovascular, neurologic, psychiatric, endocrine, hematological disease; immunocompromised conditions or long-term glucocorticoid or immunosuppressants exposure; patients with malignant tumors within the last 5 years * hepatic or renal functions abnormal (alanine aminotransferase or aspartate transaminase \> 3 upper limit of normal \[uln\], or total bilirubin \> 1.5 uln, or serum creatinine or blood urea nitrogen \> 1.5 uln) * history of treatment with systemic antivirals (continued for ≥ 14 days) within the last 3 months * pregnancy or nursing * participation in any clinical studies within the last 30 days * poor compliance or inability to complete the trial * subjects that the investigators judged to be not suitable to participate the study besides above
fluorine f18-ef5 and fludeoxyglucose f18 positron emission tomography in assessing hypoxia and glycolysis in patients with stage i, stage ii, or stage iii non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer

Summary: rationale: diagnostic procedures, such as positron emission tomography, using the drug fluorine f18-ef5 to find oxygen and fludeoxyglucose f18 to find sugar in tumor cells may help in planning treatment for patients with non-small cell lung cancer.

purpose: this clinical trial is studying fluorine f18-ef5 and fludeoxyglucose f18 positron emission tomography in assessing hypoxia and glycolysis in patients with stage i, stage ii, or stage iii non-small cell lung cancer.detailed descriptionobjectives: i. to determine whether there is an association between akt activation and hypoxia as determine by 18f-ef5 pet scanning in patients with nsclc. ii. to determine whether there is an association between akt activation and increased glycolysis as determined by 18f-fdg pet imaging in patients with nsclc. outline: within 6 weeks prior to surgery, patients undergo fluorine f18 (18f)-ef5 pet at 10 minutes and 90 minutes after injection of 18f-ef5. patients also undergo fludeoxyglucose f18 (18f-fdg) pet at 1 hour and 3 hours after injection of 18ffdg. after completion of study treatment, patients are followed periodically for 5 years.

Eligibility criteria:
inclusion criteria: * subjects must have a histologically confirmed nsclc or clinical and imaging evidence of a de novo mass that is likely to be a nsclc, stage i, ii, or iiia, for which surgery would be indicated for routine medical indications * ecog performance status between 0 and 2 * subjects must sign an informed consent document that indicates they are aware of the investigational nature of the treatment in this protocol as well as the potential risks and benefits * wbc \> 2,000/mm\^3 * platelet count \> 100,000/mm\^3 * total bilirubin * serum ast and alt * serum creatinine * negative serum pregnancy test if a female of childbearing age exclusion criteria: * history of allergic reactions attributed to flagyl (metronidazole), which has a chemical structure similar to ef5 * uncontrolled intercurrent illness that would limit compliance with study requirements * pregnant women and women who are breastfeeding are excluded * subjects who have been treated with neoadjuvant radiation or chemotherapy prior to their biopsy or excision are excluded because the impact of these therapies upon the degree of hypoxia of the tumor is unknown
pletaal sr post marketing observational study

Conditions: Ischemic Symptoms; Cerebral Infarction

Summary: this is a post marketing observational study of cilostazol (pletaal® sr capsule). as this study is observational in nature to collect the safety data after administrating the pletaal sr capsule, from baseline to 16 weeks.

this study will be conducted in a prospective, single-arm, multi-center format. as this study is observational in nature, the patient's follow-up is not prescriptive in nature and must be left up to the judgment of the physician (investigator), within the period of observation set forth in the protocol.

Eligibility criteria:
inclusion criteria: - patients must meet all of the following inclusion criteria to be eligible for enrollment into the study : 1. patients who are prescribed pletaal® sr capsule treatment as per investigator's medical judgment for adults aged 19 and over. 2. patients who gave written authorization to use their personal and health data physician (investigator) will refer to the product market authorization (package insert) for inclusion criteria. exclusion criteria: * patients presenting with any of the following will not be included in the study 1. patients with hemorrhage 2. patients with congestive heart failure 3. patients with known hypersensitivity to cilostazole or any ingredients of pletaal® 4. women who are pregnant or may possibly become pregnant 5. patients who is not eligible to participate this study as investigator's medical judgment physician (investigator) will refer to the product market authorization (package insert) for exclusion criteria.
coronary physiology peri-transcatheter left-sided valvular interventions

Conditions: Aortic Valve Stenosis; Mitral Regurgitation; Coronary Artery Disease; Fractional Flow Reserve

Summary: prospective, single-arm, observational study with invasive coronary physiology measurements before and after transcatheter left-sided valvular intervention.

the potus study is a prospective, investigator-initiated, single-arm observational study with invasive measurements that will consist of two cohorts. the first cohort consists of 120 patients with intermediate coronary artery disease who undergo a transcatheter aortic valve implantation (tavi) for severe aortic valve stenosis ('tavi cohort'). the second cohort consists of 30 patients with intermediate coronary artery disease who undergo transcatheter mitral valve repair (tmvr) for functional/degenerative mitral regurgitation ('tmvr cohort'). both cohorts will undergo a battery of coronary physiological tests both before and after the valvular intervention. additionally, in the case that the fractional flow reserve (ffr) over a coronary lesion is significant (i.e. ffr ≤ 0.80) during the post valvular intervention measurements, additional percutaneous coronary intervention (pci) will take place during the same procedure.

Eligibility criteria:
inclusion criteria: * age ≥ 18. * a) tavi cohort: severe aortic valve stenosis for which tavi is scheduled after discussion in the heart team. b) tmvr cohort: severe functional/degenerative mitral regurgitation for which tmvr is scheduled after discussion in the heart team. * at least intermediate coronary artery disease, defined as 50-99% diameter stenosis in a vessel ≥ 2.5 mm * elective procedure * written informed consent exclusion criteria: * tavi cohort: height coronary ostia \< 10 mm * severe chronic kidney disease, defined as estimated glomerular filtration rate \< 30 ml/min. * contra-indication for intravenous adenosine: severe asthma or chronic obstructive pulmonary disease, known allergy to adenosine or previous reported bronchospasm in response to adenosine. * degenerated surgical or transcatheter aortic valve bioprosthesis. * vessels that have collaterals to a chronic total occlusion or that are supplied by an arterial or venous bypass graft will not be interrogated in this study.

Keywords: coronary physiology
hemodynamic management following acute traumatic spinal cord injury

Conditions: Spinal Cord Injuries

Summary: the purpose of this study is to assess the effect of various hemodynamic management strategies on functional neurologic outcomes and non-neurologic adverse events in the first 5 days following acute spinal cord injury (sci). the hemodynamic management strategies assessed include targeting a mean arterial blood pressure (map) goal of 85-90 mmhg, targeting a spinal cord perfusion pressure (scpp) goal of ≥65 mmhg, or targeting normal hemodynamics, which is a map goal of ≥65 mmhg.


Eligibility criteria:
inclusion criteria: * traumatic spinal cord injury exclusion criteria: * patients with an injury from a trauma that penetrates the spinal cord (i.e., gunshot or knife wound resulting in cord transection) * preexisting neurologic or spinal cord injury * severe traumatic brain injury as measured by a best resuscitated glasgow coma scale (gcs) score of \<8 at 24 hours following injury * presence of traumatic injuries that preclude spine surgery within 24 hours of presentation * concomitant injury/illness requiring targeted blood pressure management (e.g., injury to the aorta, aortic dissection, hemorrhagic stroke) * preexisting history of neuromotor disorders (i.e., cerebral palsy, parkinson disease, etc.) * not expected to survive \>24h * cord transection identified by radiologist and agreed upon by the spine surgery team * injury below spinal cord level l1 * prisoners * pregnant women
comparing over-the-counter dry mouth remedies after radiation

Conditions: Xerostomia

Summary: the purpose of this study is to compare the effectiveness of over-the-counter remedies for dry mouth.

xerostomia (dry mouth) is the most common late complication of radiation therapy for head and neck cancers. when patients are cured or survive for several years, xerostomia often becomes quite bothersome; it affects their quality of life. this study compares the effectiveness of seven over-the-counter remedies, 2 rinses, 3 sprays and 2 chewing gums. a computer program will make random assignments so that the patient nor the physician will choose the order in which the products are tried. the remedies will be used for one week each and at the end of each period the patient will fill out a questionaire.

Eligibility criteria:
inclusion criteria: * suffers from xerostomia * surviver of head and neck cancer that received \>5000 cgy radiation therapy \>1 year prior to study entry. * able to chew, rinse and swallow. * ages 13-99 years of age exclusion criteria: * currently using the following medications: anorexiants, antiacne agents, anticholinergic agents, tricyclic antidepressants, chemotherapy agents. * unable to complete questionnaires

Keywords: head and neck cancer radiation therapy dry mouth remedies dry mouth xerostomia
diffusion mri in heart failure

Conditions: Heart Failure; Myocardial Infarction; Left Ventricular Hypertrophy

Summary: the development of symptomatic heart failure is frequently preceded by a pre-clinical period of structural remodeling in the heart. the remodeling process driving this transition, however, remains poorly understood. the investigators hypothesize that imaging the diffusion of water in the heart with mri will allow its microstructure to be resolved. the investigators further hypothesize that the characterization of microstructural changes in the heart will help elucidate the pathogenesis of heart failure and the transition from a compensated to a decompensated state. patients with recent myocardial infarcts and left ventricular hypertrophy, who are at risk for the development of heart failure, will be enrolled. the participants will undergo serial diffusion tensor mri (dti) imaging of the heart to characterize changes in myocardial microstructure over time.


Eligibility criteria:
inclusion criteria: * healthy adults with no history of hypertension, diabetes or heart disease * patients with st elevation mi within last 6-10 weeks who are angina free, and have been seen by a cardiologist since discharge * patients with episode of heart failure within last 12 months and left ventricular hypertrophy, documented by echocardiogram or mri. exclusion criteria: 1. presence of metallic foreign bodies/objects 2. selected medical devices and implants 3. pacemakers, implantable defibrillators, life vests 4. coronary artery stent within last 6 weeks (unless the stent is a mri-inert chromium-cobalt stent) 5. known untreated ventricular arrhythmia such as sustained ventricular tachycardia within last 12 months 6. atrial fibrillation that is not well rate controlled (heart rate \>125) 7. unstable angina within last 2 months that has not been fully evaluated by a cardiologist 8. syncope within last 6 weeks 9. hemodynamic instability (systolic bp less than 100 or greater than 180) 10. decompensated heart failure (inability to lie flat and perform a breath-hold). 11. glomerular filtration rate (gfr) \< 60 for those receiving gadolinium. 12. labile gfr that is not stable/similar on last 2 measurements (for those receiving gadolinium). 13. patients with gfr \< 20 or on any form of dialysis. 14. infiltrative cardiomyopathy (amyloid, sarcoid, hemachromatosis) 15. recent surgery (within the last 3 months) 16. prior stroke with large residual deficit 17. presence of liver or respiratory failure 18. pregnancy and nursing mothers 19. claustrophobia 20. known seizure disorder

Keywords: heart failure remodeling myocardial infarction left ventricular hypertrophy diffusion tensor mri
cancer patients' knowledge about fatigue

Conditions: Cancer; Fatigue

Summary: background: result from an earlier study i carried out in the late 1990 showed that cancer patients were overall well informed about diagnoses, prognoses, symptoms, treatment, side-effects of treatment e.g. pain, nausea and vomiting and hair loss. their knowledge about fatigue as a side -effect to cancer and cancer treatment was however different. patients had minimal knowledge about fatigue and they were not prepared for this side-effect and as a result of this they did not know how to handle fatigue and fatigue was seen as a very frightening experience. as a result of the findings i wanted to carry out an intervention study, where the aims were to develop an educational programme about fatigue and to evaluate the effect of the programme. purpose: the purpose of the project is to develop and describe a structured educational programme. the structured educational programme will serve as the intervention. the purpose is also to evaluate whether or not the structured educational programme increase the cancer patients knowledge about cancer related fatigue and to find out if increased knowledge about cancer related fatigue ease the experience of cancer related fatigue. another purpose of the study is to investigate the connection between fatigue and other symptoms and to find out how other symptoms influence the patients experience of fatigue. the study will consist of 3 stages. * development of structured educational programme * implementation of structured educational programme * evaluation of the effect of the structured educational programme materials and methods: the study is a randomised experimental design. an intervention group and a control group, each consisting of 100 breast cancer patients (stadium i or ii) receiving chemotherapy or/and radiation therapy after surgery are included in the study. on a nr-scale (0-10) the patients had a fatigue score of 2,5 or more to be included in the study. the intervention is an educational package of 120 minutes x 3 over three weeks. the intervention is given in groups of 10 patients. both groups are responding to questionnaires just before the intervention, just after the intervention and three months after finishing the intervention. the educational package consisted of basic knowledge about fatigue, and strategies or techniques for coping with fatigue.


Eligibility criteria:
inclusion criteria: * women with breast cancer stage i or ii. * fatigue score more than 2.5 on a nrs (o-10). * give written consent. exclusion criteria: * under the age of 10 years, * not able to read, write or understand norwegian.

Keywords: fatigue cancer radiation therapy chemotherapy hormones surgery breast cancer
evaluation of pain during hysterosalpingography with the use of balloon catheter versus metal cannula

Conditions: Pain During Hysterosalpingography

Summary: the aim of this study is to compare the metal cannula routinely used in our clinical practice with intrauterine hysterosalpingography catheter as a probable alternative device in a prospective, single-blinded, randomized study.


Eligibility criteria:
inclusion criteria: * women aged between 18-47 years, * applying for basic infertility evaluation to the reproductive endocrinology unit exclusion criteria: * the patients with a known hypersensitivity to iodine or radio-opaque contrast dye, * vaginal bleeding, * genital malignancy and * any sign of pelvic inflammatory disease (pid) were excluded

Keywords: hysterosalpingography balloon catheter metal cannula pain assessment
trial of vlts-589 in subjects with intermittent claudication

Conditions: Intermittent Claudication; Peripheral Vascular Disease

Summary: the purpose of this study is to evaluate the safety and tolerability of vlts-589 compared with placebo, administered bilaterally to the lower extremities, in subjects with intermittent claudication and to determine the effect of vlts-589 in peak walking time (pwt) for subjects receiving vlts-589 compared with subjects receiving placebo.


Eligibility criteria:
inclusion criteria: * men or women between 40 and 80 years of age, * must give informed consent, * current medical history of peripheral arterial disease, which includes the following symptoms: leg pain, leg discomfort or leg weakness exclusion criteria: * ulcers or gangrene, * history of cancer (except skin cancer) within the past 5 years, * participation in another clinical trial within 30 days of enrollment in this trial, * unwillingness or inability to comply with all study requirements
study to assess safety, tolerability, and efficacy of gmi-1271 in patients with calf-level deep venous thrombosis (dvt)

Conditions: Deep Venous Thrombosis

Summary: this study will evaluate the safety profile of gmi-1271 and its effect on thrombus resolution in patients with distal calf vein deep venous thrombosis (dvt).


Eligibility criteria:
inclusion criteria: * age 18-75 years * male or female * diagnosed with acute isolated calf vein deep venous thrombosis (dvt) * willing and able to participate in all required evaluations and procedures in this study protocol exclusion criteria: * history or presence of clinically significant medical condition or disease in the opinion of the principal investigator * uncontrolled acute life-threatening bacterial, viral or fungal infection * unable to be treated with systemic anticoagulants * current use of immunosuppressants, antiplatelets (other than aspirin), anticoagulants, and/or anti-epileptics * diagnosis of acute leukemia or multiple myeloma undergoing active treatment or maintenance treatment within the past 5 years * current or recent cancer treatment * major surgery within 21 days or planned surgery during the study period * female subjects who are pregnant or breastfeeding * known history of hiv, hepatitis b or hepatitis c * alcoholism or drug use * clinically significant cardiovascular disease

Keywords: dvt
ginger capsules for the prophylactic treatment of migraine

Conditions: Migraine

Summary: the main objective of the study is to evaluate ginger efficacy as an prophylactic treatment of migraine.

patients with the diagnosis of migraine according to the ihs criteria will receive capsules of 200 mg of ginger extract (5% active ingredient) or placebo (cellulose) to be taken three times a day for 12 weeks.

Eligibility criteria:
inclusion criteria: * aged between 18 and 60 years old; * migraine diagnosis; * agree to sign the informed consent. exclusion criteria: * patients with headaches not characterized as migraine; * pregnant or lactating women; * fertile and sexually active women who do not use contraception; * abuse of painkillers, alcohol or other drugs; * people with hypersensitivity to ginger compounds; * people with severe neurological diseases (e.g. epilepsy) * people in use of anticoagulant drugs.

Keywords: migraine ginger prophylactic treatment
a study to evaluate chronic hepatitis c infection in adults with genotype 1a infection

Conditions: Chronic Hepatitis C Infection

Summary: the purpose of this study is to evaluate the safety and antiviral activity of abt-450/ritonavir/abt- 267 (abt-450/r/abt-267; abt-450 also known as paritaprevir; abt-267 also known as ombitasvir) and abt-333 (also known as dasabuvir) with and without ribavirin (rbv) in patients with chronic hepatitis c virus genotype 1a (hcv gt1a) infection without cirrhosis.

a randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and antiviral activity of the combination of abt-450/ritonavir/abt-267 (abt-450/r/abt-267) and abt-333 with and without ribavirin (rbv) in treatment-naive, noncirrhotic participants with chronic hepatitis c virus genotype 1a (hcv gt1a) infection.

Eligibility criteria:
inclusion criteria: * females must be practicing specific forms of birth control on study treatment, or be post-menopausal for more than 2 years or surgically sterile * chronic hepatitis c, genotype 1a-infection (hcv rna level greater than or equal to 10,000 iu/ml at screening) * subject has never received antiviral treatment for hepatitis c infection * no evidence of liver cirrhosis exclusion criteria: * significant liver disease with any cause other than hcv as the primary cause * positive hepatitis b surface antigen or anti-human immunodeficiency virus antibody * positive screen for drugs or alcohol * significant sensitivity to any drug * use of contraindicated medications within 2 weeks of dosing * abnormal laboratory tests

Keywords: chronic hepatitis c hepatitis c virus hepatitis c genotype 1a hepatitis c treatment-naïve interferon-free paritaprevir ombitasvir dasabuvir ribavirin viekira pak