Kornimate/medical-research-clean huggingface dataset:
randomized trial of home versus clinic-based std testing

Conditions: Chlamydia; Gonorrhea

Summary: this study randomizes st. louis men to home-based std screening or clinic-based std screening. home-based screening will be completed through the mail and clinic-based screening in a local clinical setting. we hypothesize that men randomized to home-based screening will be more likely to complete screening.


Eligibility criteria:
inclusion criteria: * men * ages 18-45 * residing in st. louis city or county * english-speaking exclusion criteria: -
study of the iga repertoire during iga deposition nephropathy.

Conditions: Glomerulonephritis, IGA

Summary: iga plays a major role in mucosal and systemic immunity but retains mysterious and ambivalent aspects. they can thus, depending on the situation, prove to be capable of triggering either a protective inflammatory response or, on the contrary, anti-inflammatory and inducing tolerance. similarly, and for reasons that remain very poorly understood, they can be involved in pathologies where the immune system is itself an aggressor of the body and responsible for immunopathological lesions. the investigator formulates the hypothesis that an inappropriate response of the mucosal immune system to one or more antigens leads to a synthesis of iga of bad affinity favoring a deposit at the level of the mesangium. it seems important to verify this point by analyzing the iga repertory of patients with n-iga and comparing it to that of a control population.

iga plays a major role in mucosal and systemic immunity but retains mysterious and ambivalent aspects. they can thus, depending on the situation, prove to be capable of triggering either a protective inflammatory response or, on the contrary, anti-inflammatory and inducing tolerance. similarly, and for reasons that remain very poorly understood, they can be involved in pathologies where the immune system is itself an aggressor of the body and responsible for immunopathological lesions. the investigator formulates the hypothesis that an inappropriate response of the mucosal immune system to one or more antigens leads to a synthesis of iga of bad affinity favoring a deposit at the level of the mesangium. it seems important to verify this point by analyzing the iga repertory of patients with n-iga and comparing it to that of a control population.

Eligibility criteria:
inclusion criteria: * control population: * person between the ages of 18 and 55 (persons matched to age and sex (75% male) (n-iga is more common in humans) free from any pathology. oabsence of proteinuria and hematuria on urine sample (search by strip). * patients with n-iga * 40 patients with n-iga whose diagnosis was confirmed by renal biopsy. these may be previously known patients who have not received treatment with corticosteroids or immunosuppressants for 12 months or new patients. the incidence of n-iga is 20 patients per mh; the number of incident patients with n-iga is 10-15 per year in the nephrology department. the recruitment of 40 patients over 1 year is feasible. * participant's written consent exclusion criteria: * secondary or associated n-iga (infection, malignant disease, inflammatory bowel disease, * rheumatic autoimmune disease or other; * treatment with corticosteroids or immunosuppressants for less than 12 months. * person on dialysis

Keywords: iga nephropathy
intra incisional infiltration of bupivacaine versus meloxicam on post cesarean section pain relief

Conditions: Cesarean Section Pain

Summary: investigation: compare the effect of local infiltration of incision site with bupivacaine and local infiltration with meloxicam in women undergoing cesarean sections on postoperative pain relief and analgesic requirement. condition: post cesarean sections analgesia intervention: infiltration of incision bupivacaine versus meloxicam phase: not applicable

study type: randomized clinical trial actual enrollment: 119 allocation: random intervention model: three groups assignment masking: open lebal primary purpose: pain relief after cesarean section actual study start: march 3, 2019 primary completion: march 5, 2020 actual study completion date: may 9, 2020

Eligibility criteria:
inclusion criteria: * age between 21-40 years * elective c.s at term * patient having no medical disorders * patient with no obstetrical complications exclusion criteria: * extreme of reproductive age * allergy to local anesthetic infiltration agent * any medical disorders or obstetrical complications as ante partum hemorrhag, pre-eclampsia * refusal to participate in the trial.
effect of tourniquet application on optic nerve sheath diameter

Conditions: Intracranial Pressure Increase

Summary: the aim of the study to investigate the effect of tourniquet application on optic nerve sheath diameter (onsd) and cerebral oxygenation during lower extremity surgery.


Eligibility criteria:
inclusion criteria: * asa i-ii risk group over the age of 18 * operation planned under general anesthesia * lower extremity surgery with a tourniquet * agreeing to volunteer for research with an informed consent form exclusion criteria: * emergency surgical procedures * neurological disease, carotid disease * previous intracranial or ocular surgery * neurological symptoms * cerebral edema, high intracranial pressure * presence of glaucoma * body mass index (bmi)\> 35 * uncontrolled hypertension * diabetic retinopathy * anemia * coronary artery disease * peripheral artery disease

Keywords: optic nerve sheath diameter tourniquet cerebral oxygenation
effects of raw versus other milk sources on lactose digestion

Conditions: Lactose Intolerance

Summary: the purpose of this small, short pilot study is to determine the feasibility (e.g., recruitment, dose acceptance, retention) of a future longer trial comparing the effects of different types of milk (raw milk, cow's milk, nondairy-milk) on lactose maldigestion.

the goal is to determine if raw milk consumption intake will benefit humans with lactose maldigestion, a common human response to the intake of dairy products during adult years. an increasing number of people are consuming raw unpasteurized milk. enhanced nutritional qualities, taste, and health benefits have all been advocated as reasons for increased interest in raw milk consumption. however, science-based data to substantiate these claims are limited or anecdotal. raw milk may differ in its ability to improve lactose maldigestion related symptoms from other milk types. adult lactose maldigestion affects the majority of the world adult population. it appears that consumption of lactose containing foods by those who cannot digest lactose is a relatively common cause of irritable bowel syndrome.

Eligibility criteria:
inclusion criteria: * gender: both women and men * age: \> or = 18 years * ethnicity and race: all ethnic and racial backgrounds welcome * elevation of breath hydrogen after ingestion of 25 g of lactose \> 20 ppm over baseline * planning to be available for clinic visits for the 6 weeks of study participation * ability and willingness to give written informed consent * no known active psychiatric illness. exclusion criteria: * intake of antibiotics or other medications within the past month * history of diarrheal illness within past month * secondary lactase deficiency * self reported personal history of: \*gastrointestinal conditions other than related with lactose maldigestion (ibs, irb, short bowel, malabsorption, celiac disease, gi surgery) * pregnant or lactating * inability to communicate effectively with study personnel * protein allergy related to cow 's milk proteins or soybean proteins

Keywords: lactose intolerance dairy products raw milk adults
vitamin d treating patients with chronic heart failure

Conditions: Chronic Heart Failure

Summary: despite recent advances and even when receiving optimal therapy, patients with chronic heart failure (chf) suffer poor quality of life, with recurrent hospitalisations and persistent symptoms. the investigators have shown that patients attending the leeds integrated heart failure service are also frequently deficient in vitamin d and that the severity of the deficiency relates to the levels of symptoms, exercise capacity, diuretic requirements and response to optimal medical therapy. vitamin d contributes to cardiac and skeletal muscle contractile function, immune function, pancreatic insulin release, and neuro-hormonal homeostasis. a randomised, placebo-controlled proof of concept study in 60 chf patients has demonstrated improvements in submaximal exercise capacity and symptoms. vindicate will be a randomised, placebo-controlled developmental clinical study in 250 patients with chf and vitamin d deficiency. the present study is designed to detect whether vitamin d has pathophysiologically important effects, as well as providing preliminary evidence of efficacy and safety by examining cardiac function (using cardiac magnetic resonance imaging) and submaximal exercise capacity (by 6-minute walk test). this will provide pertinent data to inform a larger multi-centre efficacy and effectiveness study.

this is a randomized placebo-controlled trial of vitamin d versus placebo in people with heart failure. primary endpoint is 6 minute walk distance.

Eligibility criteria:
inclusion criteria: * class ii or iii chf * stable symptoms (on otherwise optimally tolerated medical therapy) * able to give written informed consent exclusion criteria: * currently taking vitamin d supplementation * untreated valvular heart disease * existing class i indication for vitamin d therapy * history of primary hyperparathyroidism, tuberculosis, sarcoidosis, malignancy or hypercalcaemia * heart failure due to anaemia or thyrotoxicosis * renal failure (gfr \<30l/min)
neoneur feeding system functionality in the clinic

Conditions: Feeding Patterns; Feeding; Difficult, Newborn; Feeding Disorder Neonatal

Summary: prospective data collection using the neoneur feeding system to demonstrate device functionality, correlation to historic data, and prepare for a more extensive phase ii sbir trial

the consented infant's assigned speech language pathologist will use the neoneur feeding system 2-3 times a week from initiation of oral feeding until discharge, if oral feeding is prescribed. it can be used either as a special consult, or during routine care. the feeding is performed by the speech language pathologist assigned to the infant. there will be no change in the infant's feeding plan. for infants consented to participate in the study, their feeding will include the neoneur feeding system inserted between the nipple and bottle. when the neoneur is inserted, it will capture both the suck and swallow changes (oral cavity pressure), and respiration (temperature changes) patterns.

Eligibility criteria:
inclusion criteria: * preterm infants: requiring tube assisted feeding while in the nicu, gestational age at birth =\<34 week, extubated by term * infants with chd: requiring surgery during the first month of life, gestational age \> 37 weeks exclusion criteria: * premature infants: craniofacial anomalies, infants with grade iv intraventricular hemorrhage, apgar \< 5 at 5 minutes, short gut syndrome, history of nec * infants with chd: no other congenital anomalies, no history of major neurologic insult , listed for heart transplant, history of ecmo, intubated for \> 4 weeks, requiring additional surgery
bikes for life: measuring the effects of a bicycle distribution program on pediatric obesity

Conditions: Obesity, Childhood

Summary: the investigators propose a study to evaluate the success of a bicycle distribution program in increasing physical activity level, decreasing sedentary activity levels and positively affecting body-mass index (bmi) in participants aged 6 to 12 years old with overweight or obesity, who do not already own a bicycle, and are patients at the children's hospital colorado child health clinic (chc), lifestyle medicine clinic, or rocky mountain youth clinics. the investigators anticipate that the receipt of a bicycle will increase physical activity level, decrease sedentary activity time and decrease or stabilize patients' bmi. the investigators will answer this research question by distributing bicycles to 525 children and conducting follow up visits over the course of a year to measure the outcomes of interest.


Eligibility criteria:
inclusion criteria: * ages 6-12 years * do not own a bicycle * bmi over 85% for age (overweight or obese) exclusion criteria: * outside of state age range * not overweight or obese * already own a bicycle.
prospective evaluation of pencil beam scanning proton therapy for previously irradiated tumors

Conditions: CNS Cancer; Head and Neck Cancer; GI Cancer; Gynecologic Cancer; Prostate Cancer; Thoracic Cancer; Breast Cancer

Summary: the goal of this clinical research trial is to study the use of differing investigational doses and scheduling for proton therapy for tumors previously treated with radiation therapy. generally, when patients are first treated for cancer with radiation therapy, they are treated with traditional photon (or x-ray) radiation therapy, which uses high-energy waves to kill tumor cells. in some cases, the cancer either returns or a new tumor can present in a different part of the body. with the usual radiation treatment, the photon beams travel all the way through the body. as a result, healthy tissues in front of and behind the tumor are exposed to radiation. physicians who treat these cases where the tumor has returned often use a much lower dose of radiation to prevent patients from experiencing serious and long-term side-effects. this dose is often not strong enough to destroy the cancerous tumor. alternatively, they may also treat a smaller area than would be indicated for complete tumor eradication, again in an attempt to prevent serious and long-term toxicities, but at the cost of optimally treating the cancer. proton therapy, however, may offer a chance to safely deliver a more effective dose and volume of radiation as it is more targeted and can spare healthy tissues surrounding the tumor. the reason we are conducting this research study is to look at whether proton therapy can be a better way to treat reoccurring tumors in patients who have previously received radiation therapy to the same area, compared to treatment approaches used to date.


Eligibility criteria:
inclusion criteria: * age 18 years * patient provides study specific informed consent prior to study entry. * documented history and physical exam within 90 days prior to registration. * ecog ps 0, 1, or 2 within 90 days prior to registration exclusion criteria: * non malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow up. * prior invasive non study malignancy unless disease free for ≥ 3 years * non melanoma skin cancer, low risk prostate cancer, well differentiated thyroid cancers, in situ carcinomas of the oral cavity, cervix, and other organs, and tumors that are not thought to impact the life expectancy of the patient are permissible. * history of active connective tissue disorder (i.e., systemic lupus erythematosus, scleroderma), dermatomyositis, xeroderma pigmentosum

Keywords: reirradiation cancer proton therapy radiation therapy
identifying genes that predict risk of developing cervical intraepithelial neoplasia or invasive cervical cancer

Conditions: Cervical Cancer; Precancerous Condition

Summary: rationale: finding certain changes in genes may help doctors predict which patients are at risk of developing cervical intraepithelial neoplasia or invasive cervical cancer and may help the study of cancer in the future. purpose: this clinical trial is studying genes that may predict which patients are at risk of developing cervical intraepithelial neoplasia or invasive cervical cancer.

objectives: * utilize molecular assays to identify a panel of hypermethylated genes that are predictive of cervical intraepithelial neoplasia (cin) grade 3 or invasive cervical cancer (icc) among patients with or without hiv infection. * perform a nested case-control study assessing the risk of developing cin3 in relationship to human papillomavirus (hpv) persistence, hiv, and the presence or acquisition of candidate hypermethylated genes in these patients. * identify hiv-related factors (e.g., cd4 counts, viral load, and highly active antiretroviral therapy \[haart\]) that might be associated with the presence or acquisition of specific hypermethylated genes in these patients. outline: this is a longitudinal, multicenter study. patients undergo biopsy for removal of cervical tissue. patients also undergo blood and urine sample collection. samples are analyzed for the presence of cancer or changes that indicate that cancer might develop. patients also undergo colposcopy at baseline and at 3 years. after completion of study procedures, patients are followed every 4 months for up to 3 years. projected accrual: a total of 1,150 patients will be accrued for this study.

Eligibility criteria:
inclusion criteria: * underwent pap smear, human papillomavirus (hpv) testing, and hiv testing and meets any of the following criteria: * biopsy and colposcopy confirmed cervical intraepithelial neoplasia (cin) or invasive cervical cancer (icc), meeting any of the following criteria: * cin grade 2-3 or higher * repeated cin1 (times 6) * abnormal pap smear (atypical squamous cells of undetermined significance \[ascus\] or worse) * hiv seropositive * negative cytology but positive for high-risk human papillomavirus (hpv) * negative cytology and negative hpv * hiv negative (without biopsy-proven cin 3 or worse) and high-risk hpv infection (types 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 55, 56, 58, 59, 68, 82, 83, 73) * \>= 18 years of age * intact cervix * not pregnant * able to provide informed consent exclusion criteria: * \< 18 years of age * pregnant at screening * cervix not intact * not able to provide informed consent

Keywords: cervical cancer atypical squamous cells of undetermined significance stage 0 cervical cancer cervical intraepithelial neoplasia grade 1 cervical intraepithelial neoplasia grade 2 cervical intraepithelial neoplasia grade 3
are there protective effects of antioxidants, calcium channel blocker and angiotensin receptor blocker against extracorporeal shockwaves lithotripsy induced renal injury?

Conditions: Kidney Calculi

Summary: this study will be conducted to evaluate the protective effects and mechanisms of antioxidants (vitamins a, c, e and selenium), calcium channel blocker (verapamil) and angiotensin receptor blocker (lozartan) against shock wave induced renal injuries.

the protective effect will be evaluated via estimation of the changes in renal tubular enzyme (ngal) and detection of albumen levels in urine. the mechanisms of protection will be investigated by estimation of renal perfusion and functional changes using dynamic mri.

Eligibility criteria:
inclusion criteria: 1. well functioning kidney (serum creatinine \<1.2 mg/dl). 2. solitary renal stone. 3. size: 25 mm or less in the largest diameter. exclusion criteria: 1. contraindications to eswl 2. previous surgical treatment of renal stones. 3. congenital renal anomalies. 4. pediatric patients (age \<18 years). 5. patients with diabetes or hypertension

Keywords: extracorporeal shockwave lithotripsy (eswl) kidney calculi renal protection antioxidants calcium channel blockers angiotensin receptor blockers
csbirt to reduce teen tobacco, alcohol and drug use

Conditions: Tobacco Abuse; Alcohol Abuse; Drug Abuse

Summary: in this project we will conduct a pilot study of a brief intervention to reduce teen tobacco, alcohol and drug use that primary care dental practitioners can provide in their offices.

the goal of this project is to prepare for a large multi-site comparative effectiveness trial of a behavioral intervention, computer-facilitated screening, brief intervention, and referral to treatment (csbirt) system that targets tobacco, alcohol, and drug use among adolescent dental patients. this enhanced computerized screening system includes: (1) screening, feedback, and provider talking points for tobacco and non-medical use of prescription drugs, (2) an interactive 2-part motivational enhancement therapy module for adolescents at highest risk to complete from home, and (3) technological extenders (tes), which are computer-generated messages that the provider sends to adolescents during the months following the clinic visit to reinforce the effect of the intervention over time.

Eligibility criteria:
inclusion criteria: * 12-21 years of age * arriving for routine care to dental office exclusion criteria: * dentally, medically, or psychologically unstable at the time of the visit * cannot read or understand english at a 6th grade level * unavailable for 1-month post-visit assessment

Keywords: tobacco use alcohol abuse drug abuse substance use prevention brief intervention screening adolescents
audiological benefit with non-implantable bone conduction hearing systems

Conditions: Hearing Loss, Conductive

Summary: recently, a new non-invasive bone conduction hearing aid was introduced. the system is connected directly to the skin with an adhesive adapter to transmit the sound to the inner ear through bone vibrations. the objective of this study is to evaluate and compare the audiological benefit of the new bone conduction hearing aid and compare it to an existing bone conduction hearing aid in normal hearing adults with bilateral simulated conductive hearing loss. an evaluation of the improvement on speech understanding in noise and sound localization allows to estimate the system performance and enables to derive recommendations for clinical usage of the novel hearing system. it is hypothesized that in the bilateral condition similar speech understanding in noise and sound localization performance can be achieved with the new system compared to existing bone conduction hearing aids that are pressed against the skull using a soft band.


Eligibility criteria:
inclusion criteria: * written informed consent * adults (age ≥ 18 years on the test date) * normal hearing thresholds (ac/bc-thresholds ≤ 20 db hl, 0.25 to 8 khz) * german native speakers * willingness and ability to perform all tests required for the study exclusion criteria: * lack of compliance with any inclusion criteria * allergy against silicon (ear mold casting mass)