Kornimate/medical-research-clean huggingface dataset:
effects of fruit consumption on risk factors of chronic disease

Conditions: Vascular Stiffness

Summary: acute, randomized, placebo controlled, double blind, postprandial crossover study in male subjects. 4 intervention arms consisting of control, orange juice, whole orange, and processed whole orange to determine the effect of the interventions on the primary measure of flow mediated dilatation (fmd) and additional biomarkers of health. the study will also identify and quantify the main micronutrients and phytochemicals in each of the products and will identify and quantify the main micronutrients and phytochemicals and their metabolites in the subjects' plasma and/or urine. a subset of the study population (n=24) will be invited to participate in an additional arm of the main study which is summarised below.


Eligibility criteria:
inclusion criteria: * males due to potential hormonal fluctuations in female subjects * aged 30-65years * fasting total cholesterol in the upper half of the normal range (6.0-8.0 mmol/l) or triacylglycerol \>0.8 mmol/l or a bmi 25-32 kg/m2. * not having suffered a myocardial infarction/stroke in the past 12 months * not diabetic (diagnosed or fasting glucose \> 7 mmol/l) or suffer from other endocrine disorders * not suffering from renal or bowel disease or have a history of choleostatic liver or pancreatitis * not on drug treatment for hyperlipidaemia, hypertension, inflammation or hypercoagulation * no history of alcohol misuse * not planning or on a weight reducing regime * not taking any fish oil, fatty acid or vitamin and mineral supplements * non smokers * not suffering from depression as indicated by the brief symptom inventory (appendix 11). * not suffering from mild cognitive impairment or dementia according to the mmse (score ≥ 25). exclusion criteria: * females * medication for hypertension, hyperlipidaemia, inflammation or hypercoagulation * hypertension - ace inhibitors (e.g. captopril, cilazapril), angiotensin receptor blockers (valsartan), calcium channel blockers (amlodipine, nicardipine), diuretics (chlortalidone) or beta blockers (sotalol, bisoprolol). * cholesterol lowering (pravastatin, simuvustatin) * anticoagulants (warfarin) * inflammation - nsaid's (tiaprofenic acid, sulindac, ibuprofen), corticosteroids(betamethasone) * strict vegetarians * smokers * those on or planning a weight reducing regime * blood glucose, haemaglobin or liver enzymes outside of the normal range * unable to consume study meals * those suffering from depression as indicated by the brief symptom inventory (appendix 11). * those suffering from mild cognitive impairment or dementia as indicated by the mmse (score \< 25).
enhancement of connect to protect® (c2p)

Conditions: HIV Infection

Summary: the proposed study seeks to continue connect to protect® (c2p) community mobilization efforts that have developed coalitions that plan for and bring about structural changes for purposes of reducing hiv incidence and prevalence among youth in targeted communities at nine sites.

earlier phases of c2p have been outlined in atn protocols 016a, 016b, 040/040b. the c2p community mobilization model entails: determining a geographic area and population of focus for the coalitions to prioritize their planning and action (accomplished in an earlier phase of c2p); coalitions establishing a shared vision and mission; development of a strategic plan focused on structural changes to reduce risks associated with hiv; process documentation; and feedback as technical assistance to the coalitions. the national coordinating center (ncc), operating under the direction of the protocol chair, provides guidance, training, technical assistance and feedback to coalitions. this protocol continues the c2p mobilization effort and includes enhanced strategic planning activities to assist the coalitions in identifying necessary and relevant structural changes. the evaluation of c2p includes both process evaluation (i.e., documentation of coalition actions and achievements of structural changes; and outcome evaluation to qualitatively assess (via key informant (ki) interviews) if and how c2p efforts, including completed structural changes, have influenced the risk environment within each community. in addition, local health surveillance data and hiv testing data will be used to evaluate changes in hiv testing patterns and hiv/sexually transmitted infection (sti) morbidity among youth.

Eligibility criteria:
inclusion criteria: 1. the intervention group = community members who become engaged in the coalitions and in the broader mobilization effort; and 2. the evaluation group = key informants within each c2p community who either work or reside within the sectors or systems where structural changes have been accomplished and/or the coalition has focused their strategic planning efforts.

Keywords: hiv prevention hiv positive communities
assessment of safety and tolerability of chitosan-n-acetylcysteine eye drops in subjects while wearing contact lenses and before insertion of contact lenses

Conditions: Dry Eye Syndrome

Summary: the "dry eye syndrome" des is a highly prevalent ocular disease, in particular in the elderly population. one mainstay of therapy for patients suffering from des is the use of topically administered lubricants. however, despite many efforts, no "ideal" formulation has yet been found. recently, croma pharma has introduced chitosan-n-acetylcysteine eye drops, designed for treatment of symptoms related to des. chemically, chitosan is a polycationic biopolymer with favourable biological properties such as high biocompatibility and low toxicity. additionally, the new formulation comprises n-acetylcysteine, which has been used in ophthalmology because of its mucolytic properties for several years. based on theoretical considerations, one can hypothesize that the new chitosan derivative may show an increased adhesion to mucins of the ocular surface and may therefore be particularly beneficial in reducing the symptoms associated with des. we have recently shown in a phase i trial that single instillation of chitosan-n-acetylcysteine eye drops is well tolerated in young healthy subjects. however, no data is yet available about safety and tolerability of chitosan-n-acetylcysteine in subjects wearing contact lenses. this is of special interest because the tear film is critical to successful contact lens wear. disturbances of the quantity or quality of the tear film results in intolerance of contact lens wear and possible damage to the ocular surface. this trial seeks to investigate the local tolerability and possible ocular discomfort of chitosan-n-acetylcysteine eye drops after repeated instillation .


Eligibility criteria:
inclusion criteria: * regular contact lens wear since 3 years minimum * daily wearing time of the contact lens of 8 hours or more * good tolerability of the contact lenses without ocular discomfort or local signs of chemosis, conjunctival redness or other signs of intolerability as judged by the investigator. * subject willing to continue contact lens use for the study period * normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant * normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant * normal ophthalmic findings except ametropia exclusion criteria: * participation in a clinical trial in the 3 weeks preceding the study * use of colored contact lenses * abuse of alcoholic beverages or other drugs * symptoms of a clinically relevant illness in the 3 weeks before the first study day * pregnancy

Keywords: chitosan-n-acetylcysteine contact lenses safety and tolerability
the epass clinical trial for the treatment of obese subjects

Conditions: Obesity

Summary: to evaluate the safety and efficacy of the endoscopically implanted valentx endopass™ system for treatment of adults with severe obesity. the endopass system is indicated for weight loss in adults with a body mass index (bmi) ≥35 and ≤ 50 kg/m2 who have failed more conservative weight loss methods.

* single-arm, multi-center study conducted in up to 50 subjects at up to 5 sites. * subjects will be implanted with the endopass device for up to 36 months. * body weight, adverse events and device function will be monitored at monthly visits for the first year after implant and quarterly visits thereafter. * additional follow-up data will include vital signs, hip and waist circumference, blood lab tests, endoscopic and esophagram assessments of the condition of the implanted device, quality of life and eating behavior questionnaires. * all subjects will be followed for 12 months after device removal. * a single device renewal may take place as needed after the initial implant. * subject study participation may last up to four years, but is expected to vary with implant duration, which will be determined on a case-by-case basis.

Eligibility criteria:
key inclusion criteria: * 18-60 years of age. * bmi ≥ 35 and ≤ 50 kg/m2 * documented failure with non-surgical weight loss methods * self-reported maximum and minimum body weights during the past 12 months within 10% of current body weight key exclusion criteria: * pregnancy or intention of becoming pregnant. * past history of esophageal, gastric or bariatric surgery. * medical conditions contraindicating elective endoscopic or bariatric procedures. * insulin-dependent diabetes mellitus

Keywords: obesity weight loss hypertension type 2 diabetes mellitus hyperlipidemia
bandgrip® closure of surgical incisions following arthroscopic surgery

Conditions: Surgical Incision

Summary: a single-arm, prospective, unblinded, post marketing, single center study using bandgrip to close incisions post arthroscopic shoulder surgery.

the study objective is to assess the ease of incision closure, the cosmetic appearance of the wounds on follow-up, and general subject satisfaction with the appearance of the healed incisions following use of bandgrip. up to 25 subjects will be enrolled at a single center. subjects who have undergone arthroscopic surgery of the shoulder and require closure of one or two skin puncture sites will be enrolled. following incision closure subjects will be seen at the time of bandgrip removal (approximately 7-14 days after closure) and at 30 days for assessment of the incisions. the incidence of wound closure for each treated puncture site, defined as continuous approximation of wound margins from the time of wound closure until the day of removal of the wound closure device without dehiscence or need for reclosure.

Eligibility criteria:
inclusion criteria: * 1. subject is ≥ 18 years of age. 2. subject had an arthroscopic shoulder procedure and has at least two skin incisions that are assessed as requiring temporary approximation of the skin edges. 3. the length of the subject's surgical incisions is less than or equal to 1.5 inches. 4. subject must be willing to follow instructions for wound care provided by investigator and refrain from picking at the treatment device, applying topical medications to the wound, and swimming or soaking in a tub until the wound closure device is removed. 5. subject agrees to return for all required follow-up evaluations. 6. subject is able to comprehend and give informed consent for participation in this study. exclusion criteria: * 1. subject has a recent history of bleeding, coagulation, and/or clotting disorders. 2. subject is on dialysis. 3. subject has a history of inflammatory and/or allergic diseases or conditions of the skin involving the location of the incisions (e.g., psoriasis, eczema, or dermatitis). 4. subject has a history of drug abuse. 5. subject has a history of chronic use of oral steroids or immunosuppressants. 6. subject has known personal or family history of keloid or hypertrophic scarring. 7. subject has a history of abnormal wound healing. 8. subject's incisions are in a high skin tension area. 9. subject has a known allergy to bandgrip material (polycarbonate). 10. subject has a known cognitive or psychiatric disorder. 11. subject has an incision at site of active rash/skin lesion making evaluation difficult.
gls-1200 topical nasal spray to prevent sinusitis after endoscopic sinus surgery

Conditions: Sinusitis Chronic

Summary: this clinical trial will evaluate the safety, tolerability and effectiveness of gls-1200 nasal spray in addition to the standard of care after endoscopic sinus surgery in people with chronic sinusitis.

subjects will be assigned to treatment via nasal spray with either gls-1200 or placebo in blinded manner in a 2:1 ratio. treatment will commence 1 week post-operatively and continue for 7 weeks.

Eligibility criteria:
inclusion criteria: * age 18 years or older; * able to provide informed consent * able and willing to comply with study procedures * elective fess * able and willing to utilize an approved form of pregnancy prevention for women of child bearing potential exclusion criteria: * pregnancy or documentation of pregnancy by pre-operative pregnancy test * history of primary ciliary dyskinesia * known allergy to quinine, quinidine or mefloquine * know latex allergy * history of hematologic malignancy * history of bone marrow transplantation * current or planned chemotherapy treatment for hematologic or solid tumor during study period * fess performed non-electively and /or in preparation for decontamination of the sinuses related to cystic fibrosis or in preparation for chemotherapy, solid organ transplantation, or bone marrow transplantation

Keywords: surgery
comparing the effectiveness of cyanoacrylate tissue adhesives and conventional sutures

Conditions: Wound Heal

Summary: this study compares the effectiveness of two materials used for intraoral wound closure after removal of impacted mandibular third molar tooth. one group received braided black silk suture and the other group received n-butyl 2-octyl cyanoacrylate tissue adhesives.

conventional method of wound closure after removal of impacted mandibular molar is by suturing the wound using braided black silk suture and allowing for primary healing. suturing in the most posterior region of oral cavity is not easy, it requires more time and additional skills as well. patient has to come for a second visit for removal of suture. moreover tight sutures may lead to ischemia and necrosis. tissue adhesives adopts the idea of sutureless wound closure. they are even sloughed off from the surface of mucosa 7 days after the application. this study compares the effectiveness of conventional sutures and tissue adhesives in closure of intraoral surgical wounds after removal of mandibular third molar.

Eligibility criteria:
inclusion criteria: * patients requiring surgical removal of mesioangular, position a impacted mandibular third molar * clean incisions approximately 2-3 cms in length which can be approximated * healthy (asai) or patients with mild systemic disease no functional limitations * patients not allergic to the drugs or anesthetic agents used in the surgical protocol exclusion criteria: * patients taking any medications that influences wound healing * patients on non steroidal anti inflammatory drugs * smokers * uncooperative patients patients allergic to cyanoacrylate
fertility and ovarian reserve function in the patient with inflammatory bowel disease

Conditions: Fertility Disorders; Ovarian Reserve Function; Pregnancy Outcomes

Summary: ecco consensus, the fertility would decline in activity inflammatory bowel disease(ibd), because of anus lesions and pelvic abscess, or who underwent surgery, especially in patients with ileal pouch anal anastomosis (ipaa) storage.the study on fertility in inflammatory bowel disease were almost epidemiological investigation, the lack of objective evaluation of fertility, and controversial.this study will explore the fertility, ovarian reserve function and the pregnancy outcomes in patients with ibd.


Eligibility criteria:
inclusion criteria: 1. inflammatory bowel disease 2. 17-40 years old 3. female exclusion criteria: 1. in pregnancy or lactation 2. a drug that has been or is being used known to affect ovarian function, such as cyclophosphamide 3. reproductive system diseases unrelated to disease or treatment of inflammatory bowel disease, such as hysterectomy, pelvic radiotherapy after surgery, after ovariectomy, polycystic ovary syndrome, endometriosis, ovarian granulosa cell tumor 4. other endocrine diseases, such as prolactin, hyperthyroidism, lead to endocrine disorders; 5. malignant tumor
phase 3 multicenter comparative study to confirm safety and effectiveness of the f(ab)2 antivenom anavip.

Conditions: Snake Bite

Summary: the purpose of this study is to establish if f(ab)2 antivenom (anavip) is safe for crotalinae envenomation. confirm its effectiveness in preventing the occurrence of delayed coagulopathies and compare the safety and efficacy with fab antivenom (crofab) in patients with crotalinae envenomation.

fewer than 200,000 crotaline envenomations occur annually in the us.crotaline venoms contain a broad variety of toxins, venom variability and injection quantity among individual snakes and across species result in broadly variable patient presentations. clinical consequences of crotaline envenomation include local and systemic effects, both of which may progress for hours to days.the best studied systemic consequence is coagulopathy, which may in its complexity mimic disseminated intravascular coagulation. platelet and clotting disorders respond rapidly to administration of polyvalent antivenom. crotaline viper envenomation in the united states is treated with one of two licensed products: wyeth antivenin (crotalidae) polyvalent (polyvalent), or crofab® (antivenin crotalidae polyvalent immune fab, ovine). in recent years, both of these products have been in critically short supply. use of wyeth polyvalent has been associated with a greater than 75% incidence of adverse reactions, including acute type 1 and delayed type 2 immune reactions.these phenomena are an inherent risk in the use of whole immunoglobulin. crofab´s low molecular weight creates a pharmacokinetic mismatch with crotaline venom which leds to a recurrent venom effects. anavip is pharmacologically and pharmacokinetically different.because of the elimination of the fc portion of the immunoglobulin molecule, anavip is expected to produce far fewer adverse reactions than seen with whole immunoglobulin antivenoms and unlike fab molecules, f(ab)2 molecules exceed the size threshold for renal clearance and thus are expected to remain in circulation for a significantly longer time and substantially reduce the incidence of recurrent coagulopathy.

Eligibility criteria:
inclusion criteria: * men and women 2 to 80 years of age * presenting for emergency treatment of pit viper bite * informed consent document read and signed by patient (or parent/legal guardian) exclusion criteria: * current use of any antivenom, or use within the last month * current participation in a clinical drug study, or participation within the last month * positive urine or blood pregnancy test at screening * breast-feeding * allergy to horse serum, sheep serum, or papaya * underlying medical conditions that significantly alter platelet count or fibrinogen; thrombocytopenia, hemophilia, familial dysfibrinogenemia, leukemia * use of any medication expected to affect platelet count, coagulation factors or fibrinogen: chemotherapeutic agents, warfarin, heparin * no clinical indications of snake bite requiring antivenom for treatment

Keywords: snake bite antivenin treatment
surface electrocardiogram (ecg) signal recording for implantable subcutaneous string defibrillator (issd) development

Conditions: Arrhythmia, Cardiac

Summary: record cutaneous electrocardiogram (ecg) data from positions corresponding to the expected subcutaneous locations of the implantable subcutaneous string defibrillator (issd) using existing, approved ecg recording devices.

2 electrodes places near the sternum and 2 near the midaxillary line, simulating the expected positions of implantable subcutaneous string defibrillator (issd) sense electrodes. reference ecg electrodes are also attached (in most cases). approved ecg recording devices are used to record the signal continuously: during an ep session (different types) a bedside recorder, and a holter monitor is used during holter recordings. ep session recordings are performed in order to capture different types of arrhythmia, and holter recordings are performed to observe changes in ecg morphology due to activity, position changes, circadian cycles etc. the data is saved and used in the development of the issd.

Eligibility criteria:
inclusion criteria: * candidate for icd implantation * candidate for ep study * candidate for 24 hour holter monitor recording exclusion criteria: * age\<18
the ketogenic diet for pediatric acute brain injury

Conditions: Acute Brain Injuries

Summary: this is a prospective pilot study evaluating the safety and feasibility of implementing the ketogenic diet in children admitted to the pediatric intensive care unit with acute brain injury such as stroke, traumatic brain injury, and intracerebral hemorrhage. animal studies suggest that in the aftermath of injury the brain's ability to use glucose as a fuel is impaired. the ketogenic diet is a high fat, low carbohydrate diet which is already used in clinical practice for the treatment of medication resistant epilepsy and is intended to switch the body over to burning fat rather than carbohydrates for fuel. in lieu of their standard tube-feeds, 5-10 children admitted to the picu with these diagnoses will receive low carbohydrate, high fat ketogenic feeds for 2 weeks. we hypothesize that ketones will be detectable through serum tests and mri spectroscopy studies of the brain within several days of diet initiation, and that there will be a low incidence of side effects and adverse events, measures of interest will include the incidence of kidney stones, excessive acidosis and excessive hypoglycemia. the feasibility of implementing this protocol for a larger efficacy trial will be assessed through serial measurements of blood glucose, beta-hydroxybutyrate (a type of ketone body), and serum bicarbonate levels. in addition, levels of ketone bodies within the brain will be measured through mri spectroscopy sequence which will be acquired at the same time as a follow-up mri brain study ordered for clinical purposes.


Eligibility criteria:
inclusion criteria: children age -17 years admitted to the pediatric intensive care unit with acute brain injury such as acute stroke, severe traumatic brain injury, and intracerebral hemorrhage exclusion criteria: 1. true milk allergy (anaphylaxis or severe rash) 2. significant gastrointestinal injury precluding enteral feeding 3. hepatic or renal insufficiency 4. history of nephrolithiasis 5. severe acidosis (serum bicarbonate ≤ 17 meq/l) resistant to correction 6. history of inborn error of metabolism 7. preexisting epilepsy or developmental delay

Keywords: intensive care units pediatric