Kornimate/medical-research-clean huggingface dataset:
efficacy of probiotic es1 for the treatment of non-celiac gluten sensitivity

Conditions: Non-Celiac Gluten Sensitivity

Summary: study to demonstrate the efficacy of probiotic es1 in alleviating symptoms of gluten sensitivity in non-celiac gluten sensitive subjects exposed to a small, fixed amount of gluten.

this is a randomized, double-blind, placebo-controlled study. sixty non-celiac gluten sensitive subjects will be randomized into one of two groups; probiotic es1 or placebo. for the duration of the study, subjects must adhere to a gluten-free diet, apart from a scheduled fixed gluten exposure of two slices of bread once daily. subjects will be required to take 1 capsule before and after consuming the two slices of bread and score the severity of their symptoms in a diary provided for the duration of the study (7 days).

Eligibility criteria:
inclusion criteria: * age: 18-65 * male or non-pregnant, non-lactating females. * documented or self-diagnosed gluten sensitivity that is well-controlled. * negative celiac serology to eliminate celiac disease at screening. * written informed consent prior to any screening procedure. * ability and willingness to comply with study requirements. * adherence to a gluten-free diet during period of the study and 1 week prior to the first dose. * bmi \< 35 kg/m2. exclusion criteria: * history of diagnosis of celiac disease. * positive pregnancy test at screening. * positive hiv, hepatitis, or tuberculosis infection. * history of substance abuse within last 5 years. * alcohol consumption of \> 2 standard drink equivalents per day. * recent myocardial infarction within past 3 months, recent stroke within past 12 months, recent abdominal surgery within past 12 months, history of any malignancies and/or active treatment for a psychiatric disorder. * use of systemic biologics within 6 months of the study. * use of oral probiotics within 2 weeks of the study. * use of nsaids or aspirin within 7 days of the study. * use of immunosuppressants within 30 days of the study. * family history (first degree relative) of celiac disease. * received an investigational product within 1 month of study. * history of digestive enzyme deficiencies. * history of severe reactions to low doses of gluten/accidental exposure to gluten. * history of wheat allergy (positive reactions to the skin-prick test or the ige blood test). * history of lactose, milk protein and/or fodmap allergies. * subjects who have an immune-compromised condition.

Keywords: gluten non-celiac gluten sensitivity
health outcomes and costs (hoc) in lung cancer (lc)

Conditions: Lung Cancer

Summary: the purpose of this study is to evaluate the costs, health-related quality of life and preference values from lung cancer patients assisted in a brazilian public health care unit.

the costs will be assessed by micro-costing approach. all procedures involved in lung cancer at diagnosis, staging, treatment and best supportive care will be assessed. the health-related quality of life will be assessed by eortc-qlq-c30, eq-5d and eortc-qlq-lc13 in all different stages of lung cancer. an utility measure will be considered. the preference values will be assessed via discrete choice experiment. two scenarios will be designed and the lung cancer patients will be asked about the preferences.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of lung cancer disease * able to understand the overall concept of study and sign the written informed consent exclusion criteria: * illiterate * visible cognitive impaired * non-primary lung tumor
effect of aspirin vs omega 3 fatty acid after scaling and root planing in type ii diabetic patients with chronic periodontitis

Conditions: Periodontitis; Type2 Diabetes

Summary: the main aim and objective of this study is to compare the effectiveness of low dose aspirin vs omega 3 fatty acids as adjuvants to non-surgical periodontal therapy and also to evaluate the levels of pentraxin 3 and glycosylated haemoglobin in diabetic patients with chronic periodontitis

there is an established bi-directional relationship between diabetes mellitus and periodontitis. periodontitis causes systemic inflammation by the entry of oral pathogens and their virulence factors that adversely affect diabetic control in terms of elevated hba1c levels. host modulatory therapy (hmt) is a strategy prescribed as an adjunct to conventional periodontal treatment by downregulating inflammation and promoting protective or regenerative responses. different drugs have been evaluated as hmt including nsaids, doxycycline, bisphosphonates. aspirin has the unique position as hmt drug. it inhibits prostanoid production and induces 15- epi- lipoxins which are bioactive than native lipoxins. omega 3 fatty acids including docosahexaenoic acid and eicosapentaenoic acid due to their anti-inflammatory, antithrombotic, hypolipidemia and vasodilator effect, reduce the inflammatory mediators to levels of healthy tissues. pentraxins(ptx3) are classic acute phase proteins. they are a superfamily of evolutionarily conserved proteins considered to be the markers of acute phase inflammation. ptx3 is also known as tnf stimulated gene. it is produced abundantly in periodontal tissue by neutrophils, fibroblasts, monocytes and epithelial cells. the plasma levels of ptx3 is raised in inflammatory conditions. hence it is taken as a biomarker.

Eligibility criteria:
inclusion criteria: * patients with type ii diabetes * patients with chronic periodontitis. * clinical attachment loss ≥ 4 mm * probing depths ≥ 5mm. * 14 teeth should be present * diabetic patients having hba1c levels ≥ 6% exclusion criteria: * pregnant and lactating women * smokers * patients with any auto immune or systemic disorder other than type ii diabetes * use of medicines or antibiotic 3 months before * history of periodontal treatment within 12 months * suspected intolerance to aspirin
le gel for the treatment of ocular inflammation and pain following cataract surgery

Conditions: Cataract; Pain; Ocular Inflammation

Summary: loteprednol etabonate ophthalmic gel, (bid and tid) versus vehicle group for the treatment of ocular inflammation and pain following cataract surgery.

a phase 3, multi-center, double-masked, vehicle controlled, randomized, parallel-group study to assess loteprednol etabonate ophthalmic gel, (bid and tid) versus vehicle group for the treatment of ocular inflammation and pain following cataract surgery.

Eligibility criteria:
key inclusion criteria: 1. be 18 years or older on the date the informed consent form (icf) is signed and with the capacity to provide voluntary informed consent. 2. be able to read, understand, and provide written informed consent on the institutional review board (irb)/ethics committee (ec) approved icf and provide health insurance portability and accountability act (hipaa) authorization. 3. be willing and able to comply with all treatment and follow-up/study procedures. 4. be a candidate for routine, uncomplicated cataract surgery (phaco-emulsification with posterior chamber intraocular lens \[iol\] implantation, not combined with any other surgery). 5. in the investigator's opinion, have potential postoperative pin-holed snellen visual acuity (va) of at least 20/200 in the study eye at visit 1 (screening) and at least 20/200 in the fellow eye. key exclusion criteria: 1. have a severe/serious ocular condition or history/presence of chronic generalized systemic disease that the investigator feels might increase the risk to the subject or confound the result(s) of the study. 2. be a female subject who is pregnant or breastfeeding. 3. be monocular (fellow eye is nonfunctional or fellow eye's pinhole vision is worse than snellen 20/200). 4. have had ocular surgery (including laser surgery) in the study eye within 3 months or in the fellow eye within 2 weeks prior to visit 1 (screening).
whenii - early response evaluation with fdg-pet/ct and liquid biopsy in patients with nsclc

Conditions: Non Small Cell Lung Cancer; Circulating Tumor Cell; Circulating Tumor DNA

Summary: response evaluation with fdg-pet and free circulating dna in patients with inoperable lung cancer of non small cell type during first treatment with chemotherapy or immunotherapy.

interventional study of patients with inoperable lung cancer of non small cell type undergoing 1st treatment of either chemotherapy or immunotherapy. patients are evaluated with fdg-pet/ct and blood analyses og circulating tumor dna and cancer markers to determine early response. pet-ct are preceded before and after treatment is given; * day 0 before treatment, * day 2 after treatment and * day 21 just before second treatment. at every fdg-pet/ct scan blood are examined for circulating tumor dna (ctdna) and potentially cancer markers by white genome sequencing. in total 3 pet-ct scans and 4 blood samples are performed. the result are compared with the standard ct scan after 2-3 cycles of treatment. blood analyses are repeated after 2-3 cycles to observe any changes.

Eligibility criteria:
inclusion criteria: * patients with non-small cell lung cancer (nsclc) who is about to start treatment with chemo- or immune therapy. no prior treatment of the one given. * measurable decease according to recist criteria * age \> 18 years * performance status 0-2 (0-1 for immunotherapy) * understands and reads danish exclusion criteria: * poor performance status * secondary active cancer * pregnancy * dysregulated diabetes mellitus

Keywords: early response evaluation immunotherapy chemotherapy liquid biopsy fdg-pet/ct
the impact of vocational rehabilitation on mentally iii veterans

Conditions: Posttraumatic Stress Disorder (PTSD)

Summary: to study the impact of individual placement and support (ips) supported employment (se) compared to treatment-as-usual vocational rehabilitation program (vrp) for veterans with posttraumatic stress disorder (ptsd).

objectives: to study the impact of individual placement and support (ips) supported employment (se) compared to treatment-as-usual vocational rehabilitation program (vrp) for veterans with posttraumatic stress disorder (ptsd). research design: this prospective randomized study evaluates the impact of ips-se compared to vrp on occupational, sobriety, psychiatric, and quality of life outcomes and health care costs for veterans with chronic ptsd who enter the tuscaloosa va medical center's (tvamc) vocational rehabilitation program. methodology: occupational functioning is determined primarily by whether the veteran can obtain and maintain competitive employment, and, secondarily, by time worked and wages earned for those employed. veterans who meet inclusion criteria will be randomized to either ips-se or vrp. outcomes will be assessed over a fixed 12-month observation period (beginning at randomization and computed for the entire 12-month observation period) as percent subjects employed at least one week (employed rate), and monthly employment rates (maintained employed rate). in addition, ptsd symptoms and other health-related quality of life measures will be evaluated. this strategy uses all available data during the 1-year period.

Eligibility criteria:
inclusion criteria: * male or female * age, greater than or equal to 19 and less than 61. * enrollment in the tvamc vrp * signed informed consent * chronic post-traumatic stress disorder * any race or ethnic origin * anticipation of remaining in the catchment area for the 12-month study duration exclusion criteria: * lifetime history of severe traumatic brain injury that has resulted in severe cognitive impairment * history of schizophrenia, schizoaffective, disorder, or bipolar i disorder * pending litigation * in need of immediate detoxification.

Keywords: posttraumatic stress disorder veterans vocational rehabilitation supported employment individual placement and support
¡yo no estoy loc@! improving treatment engagement for latinos using an e-e video

Conditions: Anxiety Depression

Summary: the underutilization of behavioral health services for mood and anxiety disorders by latinos is a public health concern warranting intervention development. perceived stigma associated with the pursuit of behavioral health services disproportionately restricts mental healthcare in latinos. the current study empirically tests an intervention aimed at improving perceptions of behavioral health services for mood and anxiety disorders, ultimately improving latinos' mental health through access to treatment. the experimental intervention is based on the entertainment-education (e-e) model, a popular media campaign that incorporates health and educational messages in an entertaining, story-telling narrative. the e-e model incorporates characters who have characteristics, beliefs, attitudes, and behaviors that are similar to those of the targeted audience to maximize social validity. using data gathered in focus groups with latinos a 3-minute e-e video (in spanish) that aims to reduce stigma towards mental illness and behavioral health services was developed. sixty adult latinos pursuing care at a federally qualified health center, who screen positive for anxiety and/or depression will be invited to participate in the study. participants will be administered a structured demographic interview and measures that assess stigma and attitudes towards mental health and behavioral health services and then randomized to the e-e video or control (structured discussion about depression and anxiety) condition. participants will then complete the study measures and be invited to attend a cognitive behavior therapy (cbt) group for depression or anxiety. consumer satisfaction will also be evaluated.


Eligibility criteria:
inclusion criteria: * spanish-speaking exclusion criteria: * screen positive for suicidality or psychosis
efficacy and safety of acupuncture for functional constipation

Conditions: Constipation

Summary: a multi-center clinical trial done recently by us(nct00508482) shows that needling on st25 has the same effect as lactulose in unaided self-defecation frequency of a week and has better effect in symptoms improvement (in press). the object is to evaluate whether acupuncture is effective for functional constipation. as an explanatory research, it took one single point as its intervention and sham acupuncture as its control group (patients were blinded). on the basis of its confirmed effect, we are taking a pragmatic randomized controlled trial to further evaluate whether acupuncture is more effective than routine treatment. acupuncture prescriptions used in this trial are individually prescribed according to syndrome differentiation, which can improve clinical effect. .

functional constipation,acupuncture,effects and safety,pragmatic rct

Eligibility criteria:
inclusion criteria: * patients who has been diagnosed with functional constipation according to rome ⅲ criteria * patients who are aged 18-75 years old * stop medication or acupuncture (if any) 1 week before randomization and uninvolved in other trials * sign the informed consent out of one's own will exclusion criteria: * secondary constipation * patients with consciousness impairment, psychotic patients or patients unable to express clearly * patients with malignant tumor in progressive stage, severe wasting disease and liable to be infected and bleed * patients with severe cardiovascular disease, hepatic injury, renal damage, digestive disease or hematological diseases * women in pregnancy and lactation period

Keywords: acupuncture functional constipation
a safety and effectiveness study of immediate release tapentadol hydrochloride among filipino patients with moderate to severe acute non-cancer pain

Conditions: Moderate to Severe Acute Non-Cancer Pain

Summary: the purpose of this study is to evaluate the safety and effectiveness of immediate release tapentadol hydrochloride for the relief of moderate to severe acute non-cancer pain among filipino patients.

this is an open-label (all people know the identity of the intervention), multi-center (study conducted at multiple sites), observational study (study in which the investigators/ physicians observe the patients and measure their outcomes). the study will enroll approximately 100 patients who will be taking immediate release tapentadol hydrochloride with a dosing regimen stipulated in the product insert. as this is an observational study, assessment of patients will be based on the accepted clinical practice in the philippines. patients will be monitored at baseline (day 1) and throughout the 28-day treatment period of tapentadol ir (day 7, day 14 and day 28) for effectiveness with the help of short form brief pain inventory questionnaire. safety evaluations will include assessment of adverse events, clinical laboratory tests, and co-morbid conditions. the total study will be conducted for 3 years and the duration of treatment will be for 28 days.

Eligibility criteria:
inclusion criteria: * filipino patients with moderate to severe non-cancer pain with an onset of 12 weeks or less from the baseline visit patient is experiencing either an acute exacerbation of non-cancer pain or pain that has progressed to the point with the duration of at least 7 days and in the prescribing physician's judgment requires treatment with a schedule ii opioid * medically stable on the basis of routine physical examination, medical history, and vital signs at the time of baseline visit exclusion criteria: * refuse to protocol-defined use of effective contraception * pregnant and lactating women * patients with severe renal and hepatic impairment, and having or suspected paralytic ileus * patients with conditions where drugs with mu-opioid receptor agonist activity are contraindicated * patients with acute intoxication with alcohol, hypnotics, centrally acting analgesics, or psychotropic drugs or receiving other mu-opioid receptor agonist analgesics, general anesthetics, phenothiazines, other tranquilizers, and sedatives * patients who are receiving monoamine oxidase (mao) inhibitors or who have taken them within the last 14 days * patients with documented history of increased intracranial pressure, impaired consciousness, coma and seizure

Keywords: moderate to severe acute non-cancer pain immediate release tapentadol hydrochloride tapentadol ir nucynta ir
an open label trial to evaluate the effects of a novel renal multivitamin on inflammation and other biomarkers in endstage renal disease patients

Conditions: Hyperphosphatemia; Inflammation; Renal Disease

Summary: the purpose of the study is to determine whether an ingestion of a new renal multivitamin supplement can have a beneficial effect on bone and mineral adn inflammation issues related to patients on dialysis.


Eligibility criteria:
inclusion criteria: * end stage renal disease patients on dialysis for at least 90 days deemed to be at low risk by the investigator for being hospitalized or have concurrent infections * serum phosphorous level \> 5 mg/dl * stable phosphate binder regimen for 2 week prior to enrollment * stable dose of vitamin d for 4 weeks prior to enrollment * stable calcimimetic dose for 4 week prior to enrollment exclusion criteria: * patients who are pregnant * patients who have pre existing thrombocytopenia defined as a platelet count of \<100 x 109/l * abnormal lfts * baseline crp \> 15 g/dl * known sensitivity to any of the active ingredients * patients who are currently enrolled in a clinical trial, or who have been in a clinical trial in the last six months * are currently taking any immunosuppressive medications

Keywords: end stage renal disease inflammation
lateral versus anterior spanning external fixator for tibial plateau fractures

Conditions: Fractures, Closed

Summary: the purpose of this study is to evaluate patients with tibial plateau fractures.

the purpose of this study is to evaluate patients with tibial plateau fractures. the goal is to compare the differences between anteriorly placed (front of leg) femoral external fixator pins and laterally placed (side of leg) femoral external fixator pins. specifically, we are evaluating how this placement affects the quadriceps muscle and knee function. the parameters that will be assessed are knee function, pain, and range of motion.

Eligibility criteria:
inclusion criteria: * 18 years of age and above (adult population) * all open and closed tibial plateau fractures exclusion criteria: * 17 years of age and less (pediatric population) * quadriplegic patients * vascular injury to extremity * ipsilateral femur fractures * ipsilateral hip fractures
h1n1sw vaccine in adult transplant recipients

Conditions: Immunocompromised

Summary: the trial investigates the efficacy of the adjuvanted h1n1 influenza vaccine focetria(r) in immunocompromised adults who have undergone solid organ or bone marrow transplantation. it is expected that when administered twice the vaccine fulfills all serological efficacy criteria required for the elderly population age 60 years and older.


Eligibility criteria:
inclusion criteria: * adult subjects 18-60 years of age who have undergone prior renal, cardiac, liver, lung, or bone marrow transplantation for any reason, more than 3 months prior to enrolment * patients able to visit the outpatient clinic with a life expectancy of at least one year * patients who receive any immunosuppressive treatment currently taken to prevent organ rejection exclusion criteria: * individuals who received any vaccine within 30 days prior to study entry * individuals who received a h1n1 vaccination less than 6 months prior to the study * influenza diagnosed by a physician within 4 months prior to the study start * pregnant or lactating females * history of an anaphylactic (i.e. life-threatening) reaction to any of the components of the vaccines, including egg and chicken proteins, ovalbumin, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide (ctab)

Keywords: solid organ transplantation bone marrow transplantation adults adults with solid organ transplantation adults with bone marrow transplantation