Kornimate/medical-research-clean huggingface dataset:
effect of daily consumption of glycomacropeptide on gut microbiome and blood functional proteome of subjects with irritable bowel syndrome

Conditions: Inflammatory Bowel Syndrome

Summary: this study investigates the use of glycomacropeptide (gmp) as a means to manipulate the gut microbiome, metabolome and protein profile of subjects with irritable bowel syndrome (ibs).

in vitro assays show that gmp strongly promotes the growth of beneficial bacteria including bifidobacterium breve, b. bifidum, b. infantis and lactococcus lactis. gmp also binds to pathogenic bacteria and prevents their adhesion to intestinal cells, which could prevent enteric infection. gmp also modulates the inflammatory response of key gut immune cells called macrophages. however, the extent to which daily consumption of gmp alters the gut microbiome, metabolome and protein profile of subjects with ibs remains unknown. this study will investigate how daily gmp consumption can alter the gut microbiome, metabolome and protein profile of subjects with ibs.

Eligibility criteria:
inclusion criteria: * fluent in english * ibs diagnosis with rome iv criteria * people who have a primary care provider exclusion criteria: * lactose or milk protein intolerance * any known other gastrointestinal disease or disorder beyond ibs, or major gastrointestinal surgery * habitual use of laxatives or antacids * pregnant or nursing. * use of pre or probiotics within one month prior to the study * use of antibiotics within one month prior to the study
removable walker for neuropathic ulcers

Conditions: Diabetic Foot

Summary: 1. objective: to evaluate the efficacy of removable cast walker compared to non-removable fiberglass off-bearing cast in the treatment of diabetic plantar foot ulcer 2. research design and methods: forty-five adult diabetic patients with non-ischemic, non-infected neuropathic plantar ulcer were randomized to treatment with a non-removable fiberglass off-bearing cast (tcc group) or walker cast (stabil-d group). treatment duration was 90 days. percent reduction in ulcer surface area and total healing rates were evaluated after treatment.

study design: two centers specializing in diabetic foot management (located in sesto s. giovanni and milan, italy) participated to this open, randomized clinical trial. the ethics-committee approved the study on january 10th, 2008. enrollment of consecutive patients began february 2008 and ended march 2009. eligible patients were fully informed of the study aim and procedures and written consent was obtained prior to study participation. patients were then randomly assigned to one of the two treatment groups by opening randomization codebreak envelopes containing one of the two options. separate randomization was performed for each center, and a copy of all randomization envelopes was kept at the statistical department of the multimedica center. the two arms were composed of patients managed with non-removable fiberglass off-bearing cast (tcc group) and patients offloaded with the stabil-d® (podartis srl, montebelluna, treviso, italy) walker cast (stabil-d group).

Eligibility criteria:
inclusion criteria: * the presence of neuropathic plantar ulcer with an area graded ia according to the texas university classification, and * the presence of peripheral neuropathy. peripheral neuropathy was diagnosed based on insensitivity to a 10-g semmes-weinstein monofilament in more than 6 out of 9 areas of the foot and by a vibration perception threshold measured by biothesiometer (neurothesiometer sls, nottingham, uk) at the malleolus \> 25 volts. exclusion criteria: * presence of an ankle-brachial pressure index (abi) \< 0.9 and/or transcutaneous oxygen tension (tcpo2) \< 50 mmhg tested on the dorsum of the foot, * presence of clinical signs of infection, including edema, erythema, increased local skin temperature, or drainage, * the probe-to-bone maneuver was required to be negative, * tthe standard x-ray examination of the foot was required to be negative for osteomyelitis, * use of steroids or cytostatic drugs, * presence of sensory, motor, or visual problems that could impair functional autonomy, * active ulcer on the contralateral foot, * previous major amputation of the contralateral limb, * previous or current deep venous leg thrombosis, or * mental disorders interfering with patient compliance.

Keywords: diabetic foot neuropathic plantar ulcer ulcer healing non-removable total contact cast removable cast walker
greater occipital nerve block value in management of postdural puncture headache

Conditions: Postdural Puncture Headache

Summary: neuraxial techniques are well tolerated and effective options for labor analgesia and anesthesia for caesarean section, and may protect high risk women against severe maternal morbidity. however, neuraxial techniques still have drawbacks especially postdural puncture headache (pdph) and may be associated with chronic headache, back pain and postnatal depression. pdph is a relatively common acute complication of neuraxial techniques that was traditionally considered benign and self-limiting, but it significantly impacts patients' general health and quality of life. greater occipital nerve (gon) originates from c2-3 segments and through its muscular relations it is divided as proximal and distal parts; the most proximal part lies between obliquus capitis inferior and semispinalis and then passes through the semispinalis to pierce the trapezius muscle. in distal region of trapezius fascia, the gon is crossed by the occipital artery and exits the trapezius fascia into the nuchal line about 5-cm lateral to midline. functionally, gon provides motor supplies to the muscles while passing through it and its main sensory supply is in the occipital region.


Eligibility criteria:
inclusion criteria: * patients with postdural puncture headache; * patients partially improved on conservative treatment and required a definitive pain relieving management; * patients who were intolerant to conventional analgesics; * patients who did not receive or did not improve on conservative therapies. exclusion criteria: * patients had postdural puncture headache who were improving on conservative treatment and refused further interventions; * patients who had headache secondary to local or systemic disease, cervical radiculopathy, manifest diabetes mellitus; * patients dependent on routine analgesia for other causes were excluded from the study; * patients refused to participate in the study or to sign the written consent; * patients missed during follow-up were not included in the study.
screening and intervention for glaucoma and eye health through telemedicine

Conditions: Glaucoma

Summary: this is a multiple site, randomized study that will assess the effects of personalized ehealth education and motivational-interviewing-based counseling on patient adherence to physician follow-up appointments.

the primary objective of this study is to evaluate the effects of personalized ehealth education and motivational-interviewing-based counseling on adherence to glaucoma follow-up care compared to standard education delivered by a trained staff member. participants will be randomized in a 1:1 ratio to either standard education and care navigation or ehealth education, counseling and care navigation. the outcome measure of the participant seeing an ophthalmologist for follow up care within 3 months was increased to 6 months. this modification was made due to ophthalmology visit appointments not being available within the 3-month timeframe. this study is embedded in a cdc-funded program to engage people from medically underserved areas in glaucoma screening. participants who screened positive for glaucoma or suspected glaucoma were randomized in a 1:1 ratio to either the standard education and care navigation arm or the ehealth education, counseling, and care navigation arm.

Eligibility criteria:
inclusion criteria: - \> or = to 18 years of age exclusion criteria: * sudden vision changes * significant eye pain * pregnant women * prisoners * cognitive impairment

Keywords: telemedicine motivational interviewing health coaching
observational study of the preventive trial with hiv-1 tat protein

Conditions: Healthy Subjects

Summary: the results of the phase i safety and immunogenicity trial of recombinant hiv-1 tat (iss p-001 and iss t-001) indicate that the vaccine based on the recombinant tat protein is safe, well tolerated and immunogenic. the present study is intended to extend the follow-up of the volunteers for additional 3 years to evaluate the persistence of the anti-tat humoral and cellular immune response. the results of the present study will be key for the design of future phase ii trials, particularly for the definition of the optimal schedule for boosting immunizations. all individuals (20) will be enrolled in a 120-weeks observational study and monitored every 24 weeks for the following 3 years. during these visits, in addition to the hematological and biochemical assessment, the anti-tat specific humoral and cellular immune responses will be evaluated.


Eligibility criteria:
inclusion criteria: * previous participation to the phase i clinical trial iss p-001

Keywords: hiv tat protein preventive vaccine
safety and efficacy of conivaptan for the correction of hyponatremia in neurological patients

Conditions: Hyponatremia

Summary: low sodium levels (hyponatremia) are a frequent occurrence in medically ill patients, and in particular those with neurological injury. hyponatremia has been associated with worse outcome, problems with memory and concentration and impaired balance. standard treatment for low sodium (salt) levels is to give the patient a salt containing solution thru a catheter (small flexible tube) in a vein in the arm or leg. one of the major complications of this treatment is excess body fluid which may cause heart problems or accumulation of fluid in the lungs and may require additional medications to remove extra water from the body. fda approval has recently been granted for a new drug - conivaptan - for use in hyponatremic conditions. conivaptan works by excreting free water from the body and thereby produce concurrent rise in serum sodium concentrations. conivaptan has not been evaluated specifically in patients with brain injuries. the primary objective of this study is to demonstrate the safety and efficacy of intravenous conivaptan for the treatment of hyponatremia in patients with brain injury. if effective, conivaptan may represent a safe treatment option.


Eligibility criteria:
inclusion criteria: * acute neurological injury * euvolemia or hypervolemia (defined clinically by examination, recent i+os, bun/creatinine ratio and cvp \[if available\]) * serum sodium less than or equal to 132 meq/l (confirmed as hypoosmolar hyponatremia by a concurrent source: osmolality measurements \[\<280 mosoms/l\] or by a preceding serum na+ value \<135 meq/l0 exclusion criteria: * patients who have uncontrolled hypertension; significant orthostatic hypotension or supine systolic blood pressure less than 85 mm hg; * uncontrolled arrhythmias; * untreated severe hypothyroidism, hyperthyroidism, or adrenal insufficiency; * estimated creatinine clearance less than 20 ml/min; * urinary outflow obstruction unless catheterized; * alanine aminotransferase (alt) \>3x uln * aspartate aminotransferase (ast) \>3x uln * serum albumin of 1.5 g/dl or less; * prothrombin time greater than 22 sec or an international normalized ratio (inr) greater than 2.0 without anticoagulant therapy or 3.0 or more with therapy; a white blood cell count less than 3000/µl; * hiv infection; * active hepatitis. * pregnant or nursing * participation in a clinical trial of an investigational drug or device within 30 days of screening * unable to obtain written consent

Keywords: euvolemic hyponatremia hypervolemic hyponatremia neurological injury
effect on metabolic parameters of abilify in spr

Conditions: Schizophrenia; Metabolic Syndrome

Summary: to measure the long-term changes in weight and plasma lipids after switching antipsychotic treatment to aripiprazole

to measure the long-term changes in weight, plasma lipids and fasting blood glucose after switching antipsychotic treatment to aripiprazole, 1 year, open label studies in out and in-patients with schizophrenia. the measurement of weight and lipid profile and fasting blood glucose will be measured at baseline and every 3 months for 1 year.

Eligibility criteria:
inclusion criteria: * dsm-iv diagnosis with schizophrenia * who signed an informed consent exclusion criteria: * comorbid with substance abuse or substance dependence * pregnancy or lactation

Keywords: schizophrenia metabolic syndrome aripiprazole
florbetapir calibration to the centiloid scale

Conditions: Alzheimer's Disease

Summary: this study is designed to demonstrate the conversion of florbetapir (18f) positron emission tomography (pet) standard uptake value ratio (suvr) to centiloid units.


Eligibility criteria:
inclusion criteria: * cognitively normal subjects * males or females ≥ 21 and ≤ 45 years of age * mini-mental state examination (mmse) ≥ 29 * clinically diagnosed ad subject * males or females ≥ 50 years of age * meet clinical criteria for dementia due to probable ad * mmse ≥ 16 and ≤ 26 * possible ad subject * males or females ≥ 50 years of age * meet clinical criteria for dementia due to possible ad * mmse ≥ 16 and ≤ 26 * mci subject * males or females ≥ 60 years of age with cognitive impairment (not dementia) * mmse \>24 and \<29 * at risk elderly subject * cognitively normal males or females that are known apoe4 carriers and ≥ 75 years of age * mmse ≥ 27 exclusion criteria: * have had or currently have a diagnosis of neurodegenerative disorders other than ad * have a current serious or unstable illness that could interfere with completion of the study * subject has a known brain lesion, pathology or traumatic brain injury * have received or participated in a trial with investigational medications in the past 30 days * have had a radiopharmaceutical imaging or treatment procedure within 7 days of study imaging session * females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception
pulsed electromagnetic fields in preventing physical deconditioning in patients undergoing prolonged hospitalization

Conditions: Haematological Cancer; Healthy

Summary: the goal of this clinical trial is to examine if pulsed electromagnetic fields (pemf) can prevent or decrease physical deconditioning associated with prolonged hospitalisation and immobility of haematology patients. the main question\[s\] it aims to answer \[is/are\]: * does haematology patients undergoing prolonged hospitalisation have no or decreased physical deconditioning when exposed to pemf? * what are the changes in muscle secretome at baseline and after exposure to pemf? researchers will compare haematology patients who receive pemf against patients who did not receive the treatment to see if there is a change in physical deconditioning. healthy volunteers will also be recruited and randomized to either exposure to pemf or no exposure. haematology patients will * have their blood taken at baseline, 4 weeks from baseline and 8 weeks from baseline. * undergo sppb test at baseline, 4 weeks and 8 weeks from baseline, and the test comprises of the time up and go test, 4 minute walk test and sit to stand test. * either expose to pemf twice per week for 4 consecutive weeks or no exposure. healthy volunteers will * have their blood taken at baseline, 4 weeks from baseline and 8 weeks from baseline. * either expose to pemf twice per week for 4 consecutive weeks or no exposure.


Eligibility criteria:
inclusion criteria: * haematology patients who are undergoing induction chemotherapy for acute leukemia * haematology patients who are undergoing haematopoietic stem cell transplant * have ecog 0-24. able to walk at baseline to participate in short physical battery test. * for healthy volunteers, subjects have to be healthy without any major disease states, not on any drugs or requiring long term medical attention. exclusion criteria: * patients who do not agree to sign the consent form. * pregnant women will be excluded from the study for healthy volunteers

Keywords: magnetic therapy cancer management muscle atrophy
metformin plus irinotecan for refractory colorectal cancer

Conditions: Colorectal Neoplasms; Adenocarcinoma

Summary: metiri seeks to identify if metformin combined to irinotecan can improve tumor control.

metiri is a two-stage single arm phase ii assessing the role of combination of metformin to irinotecan for colorectal cancer patients already treat with oxaliplatin, fluoropyrimidine, irinotecan and an anti-egfr antibody if kras wild-type.

Eligibility criteria:
inclusion criteria: * 18 years or older * biopsy-proven colorectal adenocarcinoma * ineligibility for curative intent therapy, e.g., surgery or radiation * disease progression after oxaliplatin (either adjuvant or palliative), fluoropyrimidine (either adjuvant or palliative), irinotecan, and if kras wild type a anti-egfr therapy * assessable disease according to recist v1.1 exclusion criteria: * known hypersensitivity to metformin or irinotecan * uncontrolled central nervous system metastasis * acute or chronic severe infection

Keywords: metformin colorectal cancer chemotherapy
use of abbott realtime ct/ng to detect chlamydia trachomatis [ct] & neisseria gonorrhoeae [ng] in men who have sex with men [msm]

Conditions: Chlamydia Infection; Gonococcal Infection; Sexually Transmitted Diseases

Summary: julius schachter, phd, (department of laboratory medicine, university of california, san francisco) and susan s. philip, md mph (department of medicine, university of california, san francisco) are conducting a study to evaluate the abbott realtime ct/ng polymerase chain reaction \[pcr\] assay (which is a nucleic acid amplification test \[naat\]) for detecting two sexually transmitted bacteria, chlamydia trachomatis \[ct\] and neisseria gonorrhoeae \[ng\], using urine samples and swabs from the throat and rectum of men who have sex with men \[msm\]. using this test on these swabs is experimental because it has not been approved by the food \& drug administration.

for each subject enrolled in the study, the following clinical data information will be obtained: 1) reason for exam, 2) subject's signs and symptoms and 3) clinical assessment. for each subject enrolled in the study, two clinician-collected pharyngeal swabs, two clinician-collected rectal swabs, and a first catch urine specimen (approximately 25 ml) will be obtained. the collection order of the clinician-collected swabs will be randomized. two pharyngeal swabs will be tested at the research laboratory using: 1) aptima combo 2® \[ac2\](gen-probe inc, san diego, ca); and 2) abbott realtime ct/ng \[realtime\](abbott molecular, des plains, il). two rectal swabs will be tested at the research laboratory using: 1) ac2; and 2) realtime. a first-catch urine \[fcu\] specimen will be split out at san francisco department of public health laboratory and sent to the chlamydia research laboratory for analysis using: 1)ac2; and 2) realtime. all naat specimens are collected in the manufacturer's recommended naat transport medium. after specimen processing, samples will be frozen at -70ºc for discrepant analysis.

Eligibility criteria:
inclusion criteria: * a subject must be msm. subjects must provide verbal consent, must be able to submit all required specimens and must not have urinated within 1 hr prior to providing a study urine specimen. exclusion criteria: * subjects are excluded if they do not have sex with men, refuse to give verbal consent or refuse to allow such consent to be documented in their chart, are unable to provide all required specimens and minimum specimen volume, have been on antibiotic therapy within the last 21 days, have urinated within 1 hr prior to submitting study specimens, and have already been evaluated as part of this trial. subjects will be excluded if specimens are mishandled or inappropriately stored.

Keywords: chlamydia trachomatis neisseria gonorrhoeae sexually transmitted diseases
obesity and nonalcoholic fatty liver disease

Conditions: Non-alcoholic Fatty Liver Disease

Summary: the primary goal of this study is to provide a better understanding of: 1) the pathogenesis and pathophysiology of non-alcoholic fatty liver disease (nafld) in obese subjects, and 2) the effect of marked weight loss on the histologic and metabolic abnormalities associated with nafld. the following hypotheses will be tested: 1. obesity causes hepatic fat accumulation because of excessive fatty acid release from fat tissue and increased free fatty acid availability, 2. increased hepatic (liver) fat content causes insulin-resistant glucose (sugar) production by the liver and altered liver protein synthesis, 3. increased hepatic fat content causes increased lipid (fat) peroxidation, hepatic inflammation, necrosis and fibrosis, and 4. marked weight loss improves nafld once patients are weight stable.

obesity is a major risk factor for non-alcoholic fatty liver disease (nafld), which represents a spectrum of liver diseases. nafld is a major health problem in the us because of its high prevalence and causal relationship with serious liver abnormalities. however, the mechanism(s)responsible for developing nafld in obese persons and the effects on liver function are not known. this gap in knowledge has made it difficult to identify effective therapy. the results from these studies will lay the groundwork for the development of novel therapeutic interventions for nafld in obese patients.

Eligibility criteria:
inclusion criteria: all * 18 - 45 years old * class i obesity, i.e. body mass index (bmi) between 30 and 45. * weight less than 300 lbs. exclusion criteria: * active or previous infection with hepatitis b or c, as well as other liver disease. * history of alcohol abuse * diabetes * medications that cause liver damage or steatosis. * women who are pregnant or lactating.

Keywords: non-alcoholic fatty liver disease obesity fatty liver disease