Kornimate/medical-research-clean huggingface dataset:
the study aims to show bioequivalence of the test product and the reference reference product in a crossover design study healthy volunteers. additionally, the safeyt profile of test product compared to reference product will be assessed.

Conditions: Diabetes Mellitus

Summary: to evaluate and compare the relative bioavailability and therefore the bioequivalence of vildagliptin tablets 50 mg of aet laboratories private limited, india, with galvus® 50 mg tablets of novartis europharm limited, united kingdom, in normal, healthy, adult, male human subjects under fasting conditions and to evaluate the safety and tolerability of vildagliptin tablets 50 mg in normal, healthy, adult, male human subjects under fasting conditions.


Eligibility criteria:
inclusion criteria: 1. male subjects aged between 18 and 45 years (both inclusive). 2. subjects' weight within the normal range according to normal values for the body mass index (18.5 to 30 kg/m2) with minimum of 50 kg weight. 3. subjects with normal health as determined by personal medical history, clinical examination and laboratory examinations within clinically acceptable normal range. 4. subjects having clinically acceptable 12-lead electrocardiogram (ecg). 5. subjects having clinically acceptable chest x-ray. 6. subjects having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine and morphine). 7. subjects having negative alcohol breath test. 8. subjects willing to adhere to the protocol requirements and to provide written informed consent. 9. no history or presence of smoking. 10. no history or presence of alcoholism and drug of abuse. exclusion criteria: 1. hypersensitivity to vildagliptin or related class of drugs. 2. history or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder. 3. any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month of the study starting. 4. history or presence of asthma, urticaria or other significant allergic reactions. 5. history or presence of significant gastric and/or duodenal ulceration. 6. history or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor. 7. history or presence of cancer. 8. difficulty with donating blood. 9. difficulty in swallowing solids like tablets or capsules. 10. use of any prescribed or otc medication during last two weeks prior to dosing in period 01. 11. major illness during 3 months before screening. 12. participation in a drug research study within past 3 months. 13. donation of blood in the past 3 months before screening. 14. positive screening test for any one or more: hiv, hepatitis b and hepatitis c. 15. history or presence of significant easy bruising or bleeding. 16. history or presence of significant recent trauma. 17. subjects who have been on an abnormal diet (for whatever reason) during the four weeks preceding the study.
daily vitamin d supplementation compared to a loading dose and monthly supplementation in elderly nursing home residents

Conditions: Vitamin D Deficiency in Older Persons

Summary: vitamin d deficiency is common in older persons, in particular in residents of nursing homes. this is mainly explained by the fact that older persons do not often go outside in the sunshine. on top of that the capacity of the skin to synthesize provitamin d is decreased and dietary vitamin d intake is low. vitamin d deficiency leads to osteoporosis, falls and fractures. to prevent morbidity and mortality due to falls and fractures it seems logical to supplement vit d in order to correct the deficiency. the advised daily dose of vit d supplementation is 800 iu. several studies showed that with this dose the required serum 25(oh)d levels will not be reached. primary objective of this study is: * to investigate whether with a loading dose based on body weight and baseline serum 25(oh)d level more patients reach adequate serum 25(oh)d levels compared to 800 iu a day. * to determine the best consolidation treatment. secondary objective * is a loading dose based on body weight and baseline serum 25(oh)d level safe to use in residents of nursing homes. * is there a relation between the increase in serum 25(oh)d level and muscle strength (handgrip strength). * is there a relation between the increase in serum 25(oh)d level and mobility (2 minute walk test). study design: randomised trial with 3 study groups: * group 1a. loading dose based on body weight and baseline serum 25(oh)d level + 50.000 iu vit d3/month consolidation therapy. * group 1b. loading dose based on body weight and baseline serum 25(oh)d level + 25.000 iu vit d3/month consolidation therapy. * group 2. 800 iu vit d3/ dag. study population: vitamine d deficient residents of nursing homes, 65 years or older.


Eligibility criteria:
inclusion criteria: * long term indication for living in a residential home for the elderly * age \> 65 years * vitamin d deficiency (serum 25- hydroxycholecholecalciferol (25(oh)d3 \< 50 nmol/l) * informed consent exclusion criteria: * hypercalcemia (serum ca \> 2.60 mmol/l) * life expectancy \< 1/2 year * multivitamin use including \> 400 ie vit d * non-functional dominant arm

Keywords: vitamin d colecalciferol nursing home loading dose
handgrip strength (hgs) with hgs asymmetry are associated with all-cause mortality and hospital readmissions

Conditions: Gastric Cancer

Summary: adding the handgrip strength (hgs) asymmetry to the existing measurements of low hgs may improve the assessment of muscle function.

we sought to explore the associations between maximal hgs with hgs asymmetry and mortality, hospital readmissions, total complications, and prolonged length of stay (plos) among elderly patients with gastric cancer.

Eligibility criteria:
inclusion criteria: * with gastric cancer * aged ≥60 years * were scheduled to undergo radical surgery for the first time exclusion criteria: * received preoperative radiotherapy or chemotherapy * combined with other types of malignant tumors
in-hospital cardiac arrest - dynamics and state transitions

Conditions: Heart Arrest; Death, Sudden, Cardiac

Summary: the purpose of this study is to analyse transitions in cardiac rhythm and hemodynamic variables during resuscitation of patients with in-hospital cardiac arrest.

in-hospital cardiac arrest carries a grave prognosis, with survival to discharge in the range of 15-20%. key factors determining outcome include the presenting cardiac rhythm, aetiology, and early initiation of resuscitation. some cardiac rhythms benefit from defibrillation (shockable rhythms). during resuscitation patients may switch between shockable and non-shockable rhythms, and may show signs of spontaneous circulation temporarily. depending on rhythm and according to guidelines, patients receive direct current (dc) shocks (defibrillator) and/or i.v. adrenaline, atropine and amiodarone, which may affect state-transitions. we wish to make statistical analysis (time-series analysis, markov modelling) of these state-transitions and variations in hemodynamic variables during resuscitation, related to cpr interventions and the cause of arrest. the cause of arrest will be determined based on chart records, interview with staff and autopsy if appropriate. one hypothesis is that differences in the patterns of state-transitions may reflect underlying aetiology, which may guide in future decision-making during resuscitation.

Eligibility criteria:
inclusion criteria: * patients with in-hospital cardiac arrest who are resuscitated exclusion criteria: * younger than 18 years old

Keywords: resuscitation cardiac arrest state-transitions markov
study of physical health for women with posttraumatic stress or depression

Conditions: Healthy; Stress, Psychological; Depression; Posttraumatic Stress Disorders

Summary: the purpose of this study is to obtain a better understanding of how stress is related to health risks.

participants complete up to two study visits of approximately 3-4 hours each. the first study visit involves an interview about life experiences and emotions. if the participant is eligible for the second assessment, the average length of time between visit 1 and visit 2 will be 1-7 days. the second visit included physical measurements such as cholesterol and blood pressure, performing math and speaking tasks, and surveys to help us learn about healthy behaviors and emotions. no further follow-up of participants is conducted beyond the two study visits.

Eligibility criteria:
inclusion criteria: * pre-menopausal * must be able to speak and read english fluently exclusion criteria: * specific medications and chronic diseases * history of heart attack (myocardial infarction) * pregnant or given birth in last 3 months * peri-menopausal or post-menopausal
endoscopic direct "draf iia" (carolyn's window approach) versus endoscopic angled "draf iia"approach in chronic rhinosinusitis with frontal sinus affection ( a comparative study ).

Conditions: Chronic Rhinosinusitis (CRS); Frontal Sinusitis; Draf I or IIa; Functional Endoscopic Sinus Surgery (FESS)

Summary: patients with chronic rhinosinusitis with frontal sinus affection indicated for sinuscopy will be randomly categorized in 2 groups: group a will have endoscopic directdraf iia frontal sinusotomy and group b will have endoscopic angled draf iia frontal sinusotomy, the two groups will be compared according to ostium patency and perioperative morbidity

frontal sinus surgery is a challenging component of endoscopic sinus surgery due to the intricacy and variability of frontal recess and sinus anatomy. before the introduction of endoscopy in sinus surgery, complex cases of the frontal sinus were managed through the anterior wall using an osteoplastic flap approach. this technique was relatively successful in treating frontal sinus pathologies, but was invasive with adverse effects and failure in 6-25 percent of patients. different endoscopic techniques have been introduced for performing frontal sinusotomy. draf categorized them into four techniques (draf i, draf iia, draf iib, draf iii). draf ii procedures widen the frontal sinus outflow tract from the lamina papyracea laterally to the middle turbinate (draf iia) or the nasal septum medially (draf iib). the thickness of the nasofrontal beak, and a limited anterior-posterior dimension of the frontal recess, make the draf iia frontal sinus surgery with angled endoscopy and instrumentation visually diffcult and requires skilled dexterity. the direct access or carolyn's window approach to the frontal recess replicates draf's technique via the endoscopic approach. the approach utilizes only the 0° endoscope. in this approach, the entire frontal process of the maxilla, agger nasi and nasal process of the frontal bone, is removed with a high-speed drill.the goal of the approach is to visualize all walls of the frontal sinus via a ° endoscope. this postoperative view predicts better irrigation access and drainage of the frontal sinuses.

Eligibility criteria:
inclusion criteria: 1. adult patients (aged 18 and above) with chronic rhino sinusitis affecting the frontal sinus with or without nasal polyps confirmed by nasal endoscopy and ct scan. 2. unilateral or bilateral cases. 3. denovo or recurrent cases. exclusion criteria: 1. individuals younger than 18 year-old. 2. neoplasms

Keywords: frontal sinusitis direct draf endoscopic sinus surgery
prospective and randomized study to evaluate interest of ultracision use in inguinal lymph nodes curage

Conditions: Vulvar Neoplasms; Skin Neoplasms

Summary: the purpose of this study is to evaluate the decrease of post-operative morbidity in inguinal lymphadenectomies realised for vulvar tumors and inferior limb skin tumors by use of ultracision with regard to classical operative techniques.


Eligibility criteria:
inclusion criteria: * vulvar neoplasm, inferior limb's skin malignant tumours, with an inguinal curage indication. * age ≥ 18 years * hematological functions : leucocytes \> 1500/mm3, hemoglobin \> 8 g/dl, blood platelets \> 150000/mm3. * well informed written consent signed by the patient * negative pregnancy test for female patient of child-bearing potential. exclusion criteria: * preliminary surgery of inguinal cavity (sentinel lymph node removal accepted) * massive lymph node invasion with femoro-vessels attack * inclusion in another study (excepted study turned to inguinal lymph node) * pregnant or nursing women * patient under guardianship or trusteeship

Keywords: vulvar neoplasms skin neoplasms ultracision lymphadenectomy
genetic polymorphysm of cholesterol 24 s hydroxylase in patients with glaucoma and amd

Conditions: Glaucoma

Summary: the aim of this study is to assess the implicitement of the cholesterol 24 s hydroxylase gene and the 24 s hydroxycholesterol in glaucoma and in age related macular degeneration.


Eligibility criteria:
inclusion criteria: * patient with glaucoma * patient with amd * healthy patient exclusion criteria: * all patients who use any treatment in order to maintain in normal value their blood cholesterol
research study of nutritional methods to reduce body fat percentages in overweight and obese populations

Conditions: Obesity

Summary: the purpose of this study is to compare the use of personalized low-fat meal plans vs. non-personalized low-fat meal plans and the results in body fat reduction in overweight and obese subjects 25 to 45 years of age. compensation to eligible participants: 1. free nutritional services will be provided to eligible participants, which normally have a business value of between $165.00 and $195.00. 2. each eligible participant will receive compensation for mileage directly related to this study up to 35 miles at the 2007 irs business mileage reimbursement rate for medical purposes of $0.20 per mile. this compensation will be provided to each eligible participant in the form of a complimentary wal-mart gift card in the amount of $7.00, contingent upon his or her completion in the study.

study rationale: this experiment on the effect that the use of personalized low-fat meal plans has on body fat reduction is important for several reasons. first, the details of this research study may equip the public with knowledge to select quality nutrition programs for weight loss responsibly. second, it may encourage the wellness and fitness community to reconsider the practice of providing clientele with non-personalized meal plans for weight loss, which are not usually designed by accredited dietetic professionals. third, this study may benefit dietetic professionals by opening the lines of communication between the wellness community and the dietetic community regarding standards of care, and protecting the public by dispelling harmful and erroneous nutrition advice.

Eligibility criteria:
inclusion criteria: * between 25 to 45 years of age * classified as overweight or obese with body mass index (bmi) measurement between 25 and 50 * limited to minor chronic health exclusion criteria: * individuals with the following health conditions: * food allergies * food intolerances * cancer * debilitating joint conditions such as degenerative joint disease (djd) and degenerative disk disease (ddd) * diabetes mellitus receiving insulin therapy * kidney problems * menopause * polycystic ovarian syndrome (pcos) * currently pregnant or breast feeding * using diuretics, chromium, and/or diet pills * participants must: * live in the following oklahoma counties: * canadian, cleveland, logan, lincoln, oklahoma, and pottawatomie * will to travel to edmond and oklahoma city, oklahoma

Keywords: medicaid insurance education clinical trial healthcare reimburse pay free assist study oklahoma edmond oklahoma city diet nutrition weight loss body fat obese overweight health medical therapy meal plan jenny craig weight watcher la weightloss bryan attebery results ymca uco osu ou clinics physicians surgery pills financial money
study evaluating the safety and efficacy of ar-15512

Conditions: Dry Eye Disease

Summary: this will be a phase 3, multicenter, vehicle-controlled, double-masked, randomized study conducted at approximately 20 sites in the united states. all subjects enrolled will have dry eye disease (ded). the study will consist of screening (day -14) and baseline (day 1) visits as well as visits at day 7, day 14, day 28, and day 90 (study exit).


Eligibility criteria:
inclusion criteria: * male or female, 30 years of age or older at the screening visit * signs of ded at the screening and baseline visits assessed by corneal staining and schirmer test * symptoms of ded at both screening and baseline visits assessed by sande questionnaire and ods-vas * corrected visual acuity (+0.70 logmar) or better in both eyes at both the screening and baseline visits exclusion criteria: * history or presence of any ocular disorder or condition (other than ded) in either eye that would, in the opinion of the investigator, likely interfere with the interpretation of the study results or subject safety * regular use of lid hygiene within 14 days prior to the screening visit or any planned use during the study * use of artificial tears within 2 hours prior to the screening visit or anticipated use during the study * use of any topical ocular anti-inflammatory medication within 30 days prior to the screening visit or anticipated use during the study (e.g., ocular cyclosporine \[restasis®, cequa™\], lifitegrast \[xiidra®\], or any other prescription ophthalmic solution for ded, topical ocular corticosteroid- or non-steroidal-anti-inflammatory agents * use of tyrvaya™ (varenicline solution, nasal spray 0.03mg) within 30 days prior to the screening visit or anticipated use during the study * use of medications for the treatment of severe ded and/or meibomian gland disease such as oral tetracyclines, oral tetracycline derivatives and oral retinoids within 30 days prior to the screening visit or anticipated use during the study * initiation, discontinuation, or change in dose of a systemic medication known to cause ocular drying (e.g. antihistamines or tricyclic antidepressants) less than 14 days prior to the screening visit or a change in dosage is anticipated during the study. * initiation, discontinuation, or change in dose of a systemic corticosteroid less than 60 days prior to the screening visit or a change in dosage is anticipated during the study. * initiation, discontinuation, or change in dose of a systemic immunomodulator (e.g., hydroxychloroquine, methotrexate, cyclosporine) less than 60 days prior to the screening visit or a change in dosage is anticipated during the study * history or presence of significant systemic disease (i.e.: cardiovascular, pulmonary, hepatic, renal, hematologic, immunologic)
efficacy of esketamine for patients with irritable bowel syndrome

Conditions: Irritable Bowel Syndrome

Summary: to explore the efficacy of a single low dose of esketamine for patients with irritable bowel syndrome (ibs).

the investigators aim to investigate the efficacy of a single low dose of esketamine in patients with irritable bowel syndrome (ibs), and to explore the etiology of ibs and the effective and rapid treatment for this etiology.

Eligibility criteria:
inclusion criteria: 1. age of 18 - 60 years; 2. american society of anesthesiologists (asa) physical status of i - ii; 3. body mass index (bmi) of 15 - 30; 4. scheduled for colonoscopy; 5. positive screening results according to the rome iv diagnostic criteria for ibs; 6. patients who met diagnostic and statistical manual of mental disorders, fifth edition (dsm-5) criteria for anxiety disorder (anxd) and/or major depressive disorder (mdd) . exclusion criteria: 1. gastrointestinaltract (gi) bleeding; 2. any organic lesions confirmed by clinical examination, laboratory examination or colonoscopy； 3. a previous diagnosis of colon cancer, infammatory bowel disease or coeliac disease; 4. a history of weight loss (at least 10%) within six months; 5. a history of abdominal surgery (other than hernia repair or appendectomy); 6. participate in other clinical trials within 3 months; 7. patients older than 55 years of age who have not undergone a colonoscopy in the past 5 years； 8. mental disorder patients with severe personality disorder, active suicidal ideation and history of self-harm within 1 year; 9. allergy or any contraindications to the drugs used in the study, such as severe cardiovascular disease, refractory hypertension, or hyperthyroidism; 10. drinking more than 50 units (1 unit refers to 10ml of pure alcohol) per week; 11. pregnancy or breastfeeding.

Keywords: irritable bowel syndrome esketamine
couples-based mindfulness for young breast cancer survivors

Conditions: Breast Cancer

Summary: this study aims to improve relationship, psychological, and physical adjustment among young breast cancer survivors (ybcs; diagnosed at age 45 or younger) and their committed/life partners. a mindfulness-based stress reduction (mbsr) intervention has been designed to meet the specific needs for young breast cancer survivors and their partners. the intervention will be administered in your home by using recorded videos of a trained mbsr instructor. before, during, and after the 8-week intervention, participants will be asked to complete surveys.

participants will be young breast cancer survivors (ybcs) and their partners. young breast cancer survivors are those diagnosed at age 45 or younger. this study includes stress reducing interventions known to have a positive influence on physical and psychological functioning that will be administered through recorded videos. the interventions include watching an hour-long video stress-reduction class, each week, for 8 weeks and practicing guided meditations. ybcs participants will be randomly assigned to either an 8-week mindfulness-based stress reduction course designed for couples (c-mbsr) or an 8-week mindfulness-based stress reduction course for individuals. at the end of the study all participants (regardless of what assignment) will receive both sets of stress-reducing videos. partners of the ybcs assigned to the couples condition will also be asked to watch the 8 c-mbsr videos. some young breast cancer survivor participants and their partners will be asked to complete provide salivary cortisol and all survivors and partners will be asked to complete the 4 surveys.

Eligibility criteria:
inclusion criteria: 1. age 18 years to 45 years old when diagnosed with breast cancer 2. diagnosed with stage 0, i, ii, iii breast cancer 3. within 1 to 6 years after diagnosis of breast cancer 4. married or unmarried and living together. 5. living anywhere in the united states 6. both members of the couple must understand, read, and speak english 7. both members of the couple must have regular access to email and willingness to use the internet. exclusion criteria: 1. neither members of the couple may be experienced meditators (20 minutes daily, 5 days a week or more, for over a year) or graduates of a former mbsr class.

Keywords: couple functioning stress reduction