Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of low-fluence prp for pdr

Conditions: Proliferative Diabetic Retinopathy

Summary: to determine the safety and efficacy of a single session of low-fluence panretinal photocoagulation when compared to full-fluence prp. hypothesis: a single-session of low-fluence prp will be safe regarding the progression of macular edema and the presence of adverse events, and will efficiently induce regression of neovascularization.


Eligibility criteria:
inclusion criteria: * type 1 or type 2 diabetics * proliferative diabetic retinopathy exclusion criteria: * previous treatment with prp * media opacities * previous treatment for macular edema (laser or intravitreal injections) * recent (less than 6 months) ophthalmic surgery * only eyes * intra-retinal or sub-retinal fluid with foveal involvement * chronic renal failure * history of liver or pancreatic transplant

Keywords: proliferative diabetic retinopathy pan-retinal photocoagulation
borderline resectable or resectable or advanced pancreatic adenocarcinoma

Conditions: Pancreatic Adenocarcinoma

Summary: observational study of the clinical practice in patients with borderline resectable or resectable or advanced pancreatic adenocarcinoma.


Eligibility criteria:
inclusion criteria: * patients age 18 or older with histologically confirmed ductal pancreatic adenocarcinoma as a primary tumor * patients with ductal pancreatic adenocarcinoma (borderline resectable or resectable or advanced) * patients that are alive and under treatment or follow up * signed informed consent (icf) exclusion criteria: * presence of other primary tumors * pancreatic adenocarcinoma due to metastasis from other primary tumor(s) * neuroendocrine or other pancreatic carcinoma other than ductal adenocarcinoma * patients who refuse to provide informed consent
impact of duration of absolute voice rest on voice outcome after phonomicrosurgery

Conditions: Benign Neoplasm of True Vocal Cords

Summary: absolute voice rest is commonly prescribed after vocal fold surgery, also known as phonomicrosurgery, for benign vocal fold lesions. this is thought to decrease scarring of vocal folds, which could result in increasing tissue stiffness and limitations in optimal vocal outcome. unfortunately there is no standardized protocol as to how long patients should rest their voice after phonomicrosurgery. to date, there are no studies in the literature directly comparing the impact of short-term and long-term voice rest on vocal fold healing and voice outcome after phonomicrosurgery.

the purpose of this study is to determine whether 3 days versus 7 days of absolute voice rest will result in different voice outcomes in patients who have undergone phonomicrosurgery for benign vocal fold lesions.

Eligibility criteria:
inclusion criteria: 1. patients with benign mid membranous vocal fold lesions such as the following: 1. polyps 2. cysts 3. sub-epithelial fibrous mass 2. undergoing elective phonomicrosurgery for vocal fold lesions, which involves microflap excision +/- truncation +/- steroid injection into the vocal folds. 3. age 18 and older exclusion criteria: patients with any of the following will be excluded from the study: 1. reinke's edema 2. active smokers 3. ligamentous mid membranous vocal fold lesions 4. rrp (recurrent respiratory papillomatosis) 5. dysplasia 6. cis (carcinoma-in-situ) 7. scc (squamous cell carcinoma) 8. extent of surgery exceeds what is mentioned in the inclusion criteria (e.g., co2 laser, balloon dilatation, vocal fold augmentation in addition to phonomicrosurgery) 9. previous vocal fold surgery 10. systemic steroids 11. history of systemic illness that could affect wound healing

Keywords: phonomicrosurgery benign vocal fold lesions voice rest vhi-10 cpp
clinical validation study of comfilcon a multifocal toric contact lenses

Conditions: Presbyopia

Summary: this is a study to evaluate the clinical performance and subjective acceptance of an investigational contact lens (test), compared to a marketed lens (control) in an in-office setting.

this is a study to evaluate the clinical performance (including visual acuity, subjective assessments of visual performance, comfort ratings, vision preference and lens fit) of a comfilcon a investigational contact lens (test) compared to a control contact lens, in a non-dispensing setting. the main study hypothesis is the test contact lens will not be clinically inferior to the control lens.

Eligibility criteria:
inclusion criteria: * has had a self-reported oculo-visual examination in the last two years. * is between ages 40-75 years, inclusive and has full legal capacity to volunteer. * has read and understood the information consent letter. is willing and able to follow instructions and maintain the appointment schedule. * is able to participate in parts a and b related to this work. * has a contact lens spherical prescription between +10.00 to 10.00d (inclusive). * has an add component to their spectacle refraction (between +0.75 and +2.50ds). * has astigmatism between of -0.75 and -5.75dc (based on the calculated ocular refraction) in each eye. * is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/25 best-corrected. * currently wears soft contact lenses. * has clear corneas and no active ocular disease. * has not worn lenses for at least 12 hours before the examination. exclusion criteria: a person will be excluded from the study if he/she: * has never worn contact lenses before. * has any systemic disease affecting ocular health. * is using any systemic or topical medications that will affect ocular health. * has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses. * has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye. * has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars. * is aphakic. * has undergone corneal refractive surgery. * is participating in any other type of eye related clinical or research study.
gastrointestinal symptom questionnaire validation

Conditions: Those With and Without Gastrointestinal Disorders

Summary: assessment of a new gastrointestinal symptom questionnaire in comparison to 2 well established and validated questionnaires that do not fully fit the requirements of an investigator concerned about gastrointestinal side effects in a patient without primary gastrointestinal disease.

210 subjects healthy (n=70), ill with non-gi disease (n=70), with gi disease (n=70) age above 18 consent after full explanation each subject completes 3 questionnaires glasgow dyspepsia score gastrointestinal symptom rating scale new score this is a total of 48 questions analysis will seek to validate the new score. there is no other intervention and no risks are anticipated.

Eligibility criteria:
inclusion criteria: * as above either healthy or gi disease or non-gi disease exclusion criteria: * unable to provide informed consent
bioequivalence study of dr.reddy's laboratories limited finasteride tablets 1 mg under fed condition

Conditions: Healthy

Summary: the objective of this study was to compare the single-dose relative bioavailability of dr. reddy's laboratories, ltd. and merck \& co. (propecia®) 1 mg finasteride tablets under fed conditions following administration of a 3 mg dose.

detailed description : the study was conducted as an open-label, randomized, single-dose, 2-way crossover, relative bioavailability study performed on 24 healthy adult male volunteers and 2 alternates. a total of 24 subjects completed the clinical phase of the study. in each period, subjects were housed from the evening before dosing until after the 36-hour blood draw. single oral 3 mg doses were separated by a washout period of 7 days.

Eligibility criteria:
inclusion criteria: exclusion criteria: history or presence of significant: • cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease. in addition, history or presence of: * alcoholism or drug abuse within the past year; * hypersensitivity or idiosyncratic reaction to finasteride or any other 5-a reductase inhibitor. subjects who have been on an abnormal diet (for whatever reason) during the 28 days preceding the study. subjects who, through completion of the study, would have donated in excess of: * 500 ml of blood in 14 days, or * 500 - 750 ml of blood in 14 days (unless approved by the principal investigator), * 1000 ml of blood in 90 days, * 1250 ml of blood in 120 days, * 1500 ml of blood in 180 days, * 2000 ml of blood in 270 days, * 2500 ml of blood in 1 year. subjects who have participated in another clinical trial within 28 days prior to the first dosing.

Keywords: bioequivalence,finasteride,crossover
functional assessment of cancer therapy - bone marrow transplant

Conditions: Hodgkin Disease; Lymphoma, Non-Hodgkin

Summary: functional assessment of cancer therapy - bone marrow transplant

functional assessment of cancer therapy - bone marrow transplant (fact-bmt)

Eligibility criteria:
inclusion criteria: * patients with newly diagnosed hodgkin's disease and non-hodgkin's lymphoma exclusion criteria: * patients with diagnosis other than hd and nhl.

Keywords: hd nhl
electronic patient reported outcomes in measuring health-related quality of life in patients with stage i-iv prostate cancer undergoing treatment

Conditions: Prostate

Summary: this pilot clinical trial studies how well electronic patient reported outcomes work in measuring health-related quality of life in patients with stage i-iv prostate cancer undergoing treatment. using a smartphone application to measure and monitor symptoms before, during, and after treatment may help patients better detect, understand, and manage their health.

primary objectives: i. to explore the feasibility of collecting electronic patient-reported outcome data using validated health-related quality of life (hrqol) assessment tools at baseline, during, and after treatment through a smartphone application in adult men throughout their course of treatment for prostate cancer.

Eligibility criteria:
inclusion criteria: * self-reported ability to speak and read english * be able to communicate on a touch screen iphone * willing to provide signed informed consent * willing and able to comply with all study activities * access to wifi connection or cellular data * an established clinical history of prostate cancer in a spectrum of severity (all stages) exclusion criteria: * a subject will not be eligible for inclusion in this study if in the investigator's opinion the patient has any concurrent medical or psychiatric condition that may preclude participation in this study or completion of self-administered questionnaires (e.g., moderate to severe dementia and/or severe, uncontrolled schizophrenia, or other condition that would render them unable to complete a questionnaire) * cognitive or other impairment (e.g., visual) that would interfere with completing a self- administered questionnaire and with participating in a group discussion
type 2 diabetes and the effect of probiotics

Conditions: Type 2 Diabetes; Healthy; Endotoxemia

Summary: insulin-resistance in type 2 diabetes is associated with chronic inflammation. anti-inflammatory actions might increase sensitivity to insulin. since some probiotics have anti-inflammatory properties, ingestion of the probiotic bacteria lactobacillus acidophilus ncfm might increase insulin-sensitivity. the inflammatory response to endotoxin injection and the insulin-sensitivity is examined before and after four weeks ingestion of probiotics.

numerous studies have shown an association between insulin-resistance in type 2 diabetes and chronic low-grade inflammation. some probiotics have an anti-inflammatory properties. ingestion of probiotics might therefore, due to this property, increase sensitivity to insulin. in this study type 2 diabetics (n=24) and healthy control (n=24) are given the probiotic bacteria lactobacillus acidophilus ncfm for four weeks. the anti-inflammatory effect is examined by evaluating the inflammatory response (white blood cell count, plasma-cytokines) to an iv injection of endotoxin (0,3 ng/kg) before and after the intervention. also the insulin-sensitivity is measured with an hyperinsulinemic euglycemic clamp before and after l. acidophilus ncfm.

Eligibility criteria:
inclusion criteria: * healthy * type 2 diabetes exclusion criteria: * heart failure * lung disease * infections in the last two weeks before endotoxin injections. * treatment with antibiotics

Keywords: type 2 diabetes probiotics insulin-resistance inflammation hyperinsulinemic euglycemic clamp endotoxin
effect of a dietary supplement on lipid pattern, indexes of nafld and systemic inflammation in healthy subjects with suboptimal ldl-c levels

Conditions: Hypercholesterolemia; Inflammation

Summary: the primary purpose of our research will be to evaluate if, in subjects with a low-moderate cardiovascular risk (cv risk\>1% but \ 115 mg/dl, \< 190 mg/dl) supplementation with a food supplement is able to significantly influence plasma lipid levels. furthermore, the systemic activation status of the inflammatory cascade and the arterial wall stiffness will be investigated.


Eligibility criteria:
inclusion criteria: the subjects will have to meet all the following inclusion criteria: 1. subjects agree to participate in the study and having dated and signed the informed consent form. 2. male or female aged ≥ 18 years and ≤ 70 years old. 3. ldl-cholesterol plasma levels \>115 mg/dl and \< 190 mg/dl. 4. tg\<400 mg/dl. 5. subjects who, according to the score charts, have a low or moderate cardiovascular risk (defined as a total cardiovascular risk \< 5%) and for whom, according to esc/eas guidelines 2012, the intervention strategy does not require a pharmacological lipid- lowering intervention. 6. subjects who have the capability to communicate, to make themselves understood, and to comply with the study's requirements. exclusion criteria: subjects fulfilling one or more of the following exclusion criteria will not be included in the study: 1. subjects already affected by cardiovascular diseases (secondary prevention) or with estimated 10 years cardiovascular disease risk \> 5%; 2. obesity (bmi\>30 kg/m2) or diabetes mellitus; 3. assumption of lipid-lowering drugs or food supplements, or drugs potentially affecting the lipid metabolism; 4. antihypertensive treatment not stabilized for at least 3 months; 5. anticoagulant therapy 6. uncontrolled hypertension (systolic blood pressure\> 190 mmhg or diastolic arterial pressure\> 100 mmhg); 7. known current thyroid, gastrointestinal or hepatobiliary diseases; 8. any medical or surgical condition that would limit the participant adhesion to the study protocol; 9. abuse of alcohol or drugs (current or previous); 10. history of malignant neoplasia in the 5 years prior to enrolment in the study; 11. history or clinical evidence of inflammatory diseases such as severe arthritis, systemic lupus erythematosus or chronic inflammatory diseases or current therapy with immunosuppressive agents or long-term glucocorticoids; 12. history or clinical evidence of any significant concomitant disease that could compromise the safety of the subject or the possibility of completing the study; 13. known previous intolerance to one component of the tested nutraceuticals or to one of these plant species: asteraceae or compositae; 14. women in fertile age not using consolidated contraceptive methods 15. pregnancy and breastfeeding.
effect of nutritional counseling on anthropometry and biomarkers in patients diagnosed with schizophrenia/psychosis or bipolar affective disorder

Conditions: Cardiovascular Diseases; Schizophrenia; Psychosis; Bipolar Disorder

Summary: the goal of this clinical trial is to compare the effect of nutritional counseling versus no treatment in patients with schizophenia or bipolar affective disorder. the main question it aims to answer are: • can nutritional counseling have a preventive effect on the development of cardiovascular disease in patients with schizophenia or bipolar affective disorder? participants will meet a nutritionist at baseline to asess nutritional status, biochemical and anthropometric measurements. then, half of the study population will receive nutritional counseling. after six weeks, the same baseline measurements will be repeated to examine any potential differences between the two groups. after the intervention, the control group will be offered the same counseling as the intervention group received during the study.

people with severe mental illness have a shorter life expectancy compared to the general population. individuals with schizophrenia or bipolar affective disorder have an estimated reduce life expectancy by an average of 10-20 years. increased mortality is caused by many factors, but cardiovascular diseases contributes the most. increased prevalence of cardiovascular disease is mainly due to a poor lifestyle, which includes smoking, physical inactivity and an unhealthy diet. it is important to find treatment that can provide better quality of life and longer life expectancy in these patient groups. few clinical studies have been conducted on the effect of nutritional counseling on biochemical and anthropometric measurements related to cardiovascular diseases. therefore, we want to investigate this through a randomized controlled trial.

Eligibility criteria:
inclusion criteria: * \> 18 years * diagnosed with either schizophrenia/psychosis or bipolar affective disorder * patients treatet in vestre viken healthcare company, at either asker district psychiatric center or blakstad hospital exclusion criteria: * none

Keywords: severe mental disorders nutritional counseling cardiovascular disease schizophrenia bipolar affective disorder randomzied controlled trial
detection of msi in circulating tumor dna of colorectal carcinoma patients

Conditions: Microsatellite Instability; Colorectal Cancer Stage IV

Summary: this pilot trial studies how well serial liquid biopsies work in detecting microsatellite instability in participants with stage iv colorectal cancer. serial liquid biopsies may help doctors learn better methods to track cancer in the bloodstream and how to use these to improve cancer treatments.

primary objectives: i. to test the hypothesis that there is high level of concordance between the electrophoretic mobility profile of microsatellite biomarkers in circulating cell-free deoxyribonucleic acid (ccfdna) versus in primary tumor tissues in patients with colorectal carcinomas displaying microsatellite instability. ii. to test the hypothesis that changes in the electrophoretic mobility profile of microsatellite biomarkers in liquid biopsies from patients with colorectal carcinoma correlate with therapeutic responsiveness measured based on response evaluation criteria in solid tumors (recist) criteria. iii. to determine whether microsatellite alleles generated as a result of microsatellite instability detectable in liquid biopsy specimens from patients with colorectal carcinoma represent the entire cancer cell population or only a subset of cancer cells differentially affected by genomic instability. outline: participants undergo collection of blood samples to evaluate microsatellite instability via serial liquid biopsies at baseline, then every 6 weeks and at progression or 9 months.

Eligibility criteria:
inclusion criteria: * patients newly diagnosed with stage iv colorectal cancer and with defined microsatellite instability status before initiation of systemic immunotherapy. * trackable cancer-driver mutation in the primary tumor documented before initiation of chemotherapy. * zubrod performance status of 0 or 1. * patients have measurable disease according to recist version (v)1.1. * ability to understand and willing to sign a written informed consent. exclusion criteria: * severe anemia (hemoglobin \[hb\] \< 8 g/dl).
mesna for prevention of acute deterioration of renal function following contrast agent application

Conditions: Chronic Renal Insufficiency; Serum Creatinine Concentration; Contrast Media Exposition

Summary: the purpose of this study is to determine wether mesna could prevent contrast-induced nephropathy

contrast-induced nephropathy remains a common complication of radiographic precedures. pretreatment with mesna (sodium 2-mercaptoethane sulfonate) in combination with sodium chloride is more protective than sodium chloride alone in animal models of acute renal failure. the aim of this study is therefore to determine laboratory and clinical benefit of mesna, as an adjunct to saline hydration, in patients with known renal impairment receiving contrast media.

Eligibility criteria:
inclusion criteria: * stable chronic renal insufficiency * serum creatinine concentration \> 1,5 mg/dl exclusion criteria: * dialyzed patients * patients with acute renal failure * received iodinated contrast media within 7 days before study entry * known allery to mesna, pregnancy, and administration of dopamine, mannitol or n-acetylcysteine

Keywords: prophylaxis contrast-induced nephropathy mesna acute renal failure
docetaxel in combination with cisplatin-5-fluorouracil for the induction treatment of nasopharyngeal carcinoma in children and adolescents

Conditions: Nasopharyngeal Neoplasms; Carcinoma

Summary: the primary objective is to estimate the complete response rate of docetaxel to the combination of cisplatin-5-fluorouracil (tcf) compared to cisplatin-5-fluorouracil (cf) in the induction treatment of nasopharyngeal carcinoma (npc). the secondary objectives are to determine: * the safety of tcf in comparison to cf after induction treatment of npc, * the pharmacokinetics of docetaxel when added to cf, * the overall response rate of tcf and cf on completion of induction and consolidation (chemo-radiotherapy) treatment of npc, and to compare overall survival between tcf and cf.

planned treatment duration: * induction period: 9 weeks of induction treatment * consolidation period: 9 weeks of chemoradiation treatment. the consolidation treatment was the same for all participants: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks.

Eligibility criteria:
inclusion criteria: * histological diagnosis of nasopharyngeal carcinoma world health organization (who) type ii or iii * children and adolescents newly diagnosed with stage iib-iv npc with measurable disease, who are \>1 month to ≤21 years of age at the time of diagnosis. in france, participants must be ≥1 year to ≤21 years of age at the time of diagnosis exclusion criteria: * participants with short life expectancy * prior chemotherapy or radiotherapy to the nasopharynx or neck for the treatment of nasopharyngeal carcinoma * inadequate renal function evidenced by unacceptable laboratory results the above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Keywords: nasopharyngeal carcinoma