Kornimate/medical-research-clean huggingface dataset:
a study of prx-03140 in subjects with alzheimer's disease receiving a stable dose of donepezil

Conditions: Alzheimer's Disease

Summary: a randomized placebo-controlled study to evaluate the efficacy of prx-03140 in subjects with alzheimer's disease receiving a stable dose of donepezil. the study consists of a 26-week double-blind treatment period.


Eligibility criteria:
* men or women with a clinical diagnosis of probable ad * mmse score 12 to 22 inclusive * age \>50 and \<90 years * received at least 4 months of a stable dose of donepezil 10mg qd for ad * brain ct or mri scan consistent with a primary diagnosis of ad within 24 months * neurological examination without focal deficits (excluding changes attributable to peripheral nervous system disease, trauma or congenital birth deficits) * no history or evidence of any other cns disorder that could be interpreted as a cause of dementia * no diagnosis of vascular dementia * no history of significant psychiatric illness such as schizophrenia or bipolar affective disorder. subjects with major depressive disorder on a stable dose of an antidepressant for \>6 months may be eligible * no evidence of the following: current vitamin b12 deficiency, positive syphilis serology, positive hiv test, or abnormalities in thyroid function * no cognitive rehabilitation within 6 months of the study * subject has a regular caregiver willing to attend all study visits * signed informed consent by the subject (and legal guardian, if applicable) * no history of drug or alcohol abuse * no clinically significant laboratory abnormalities or medical history * no investigational drug within 30 days of randomization * cannot receive memantine within 2 months of enrollment * no other prescription acetylcholinesterase inhibitors for ad (other than donepezil) within 4 months of enrollment * no clinically significant ecg abnormalities or cardiac history * no history of uncontrolled seizure disorder within 12 months of enrollment * cannot be taking mao inhibitors, bupropion,fluoxetine, paroxetine, quinidine * no history of malignancy within 3 years of randomization * women cannot be pregnant or breastfeeding
bedside ultrasonic assessment for gastric content in patients with upper gi bleeding undergoing endoscopy

Conditions: Upper GI Bleeding; Point of Care Ultrasound; Upper Endoscopy; Gastric Content; GI Bleed

Summary: emerging studies have evaluated pocus (point of care ultrasound) for assessing of gastric content prior to anesthesia to reduce the risk of aspiration and demonstrated that pocus can accurately identify presence of gastric food or fluid. despite accumulating studies evaluating pocus as a diagnostic modality to evaluate for gastric food content prior to anesthesia, there is no study to date that has evaluated the role of pocus prior to endoscopy among patients with upper gi bleeding. therefore, this study is to evaluate the diagnostic accuracy of pocus for retained gastric content prior to endoscopy among patient hospitalized/admitted with upper gi bleeding. this study would take place at loma linda university medical center. subjects will be any one who has upper gi bleed required egd and age of greater than 18 years old. the study will plan for 1 year or reach 50 patients (whichever one comes first). in addition, subjects will be recruited from ed, icu, medicine ward by the pi, subpi, and collaborators. subject will received ultrasound up to 6 hours prior the start of endoscopy. the location of ultrasound would either take place at gi lab prior to scope or at the ward prior to transportation to gi lab or at icu prior to endoscopy. the ultrasound would focus upper abdomen area and look for antrum. the result will be immediately read before endoscopy and fill out on the sheet before the endoscopy. patient then proceed with endoscopy. at the end of the scope, the researcher will ask the endoscopist questions regarding how well they could see each part of the stomach in order to complete the study. both results are compared between us and endoscopy. endoscopist is blinded in this study.


Eligibility criteria:
inclusion criteria: 1. age \>18 2. patient presents with hematemesis 3. and/or melena 4. and/or hematochezia accompanied by hemodynamic changes (pulse \>100/min and/or systolic blood pressure \<100/min) 5. patient is scheduled for upper endoscopy due to the above. exclusion criteria: 1. decline consent for study 2. patients with last solid meal \<6 hours and clear liquids \<2 hours prior to the endoscopy 3. prior surgery in the stomach 4. patient has duodenum, ileus, or bowel obstruction 5. patient has history of gastric cancer
technology and telephone-based smoking cessation

Conditions: Smoking Cessation

Summary: the goal of the proposed project is to design and assess the acceptability and usability of a mobile technology and telephone-facilitated treatment to improve treatment engagement in adult smokers with posttraumatic stress disorder (ptsd). smokers with ptsd face high rates of treatment failure and require tailored strategies that address both ptsd symptoms and smoking urges. mcfall and saxon designed a protocol combining office-based therapy plus evidence-based pharmacotherapies for smoking cessation that doubled quit rates in veteran smokers with ptsd. however, high rates of attrition limited efficacy. the investigators aim to enhance scalability and engagement in the mcfall/ saxon protocol by (1) adapting the treatment to be delivered over the video or telephone and (2) leveraging innovations in technology by incorporating a mobile application targeting ptsd and smoking and a mobile carbon monoxide (co) monitor into the protocol. the investigators propose a mixed methods study in which the investigators will adapt the office-based treatment into a technology and telephone-facilitated intervention and conduct a pilot rct of the modified intervention with 20 veterans with ptsd. at the outset of the study, the study team will modify the original treatment manual in order for it to be delivered via video or telephone. the investigators will then conduct a pilot rct in which 20 veterans with ptsd will be randomized to receive the modified protocol (intervention condition; n=10) or the original office-based protocol (control condition, n=10). main outcomes are quantitative and qualitative data about the acceptability of the intervention and its individual components, and treatment retention at week 8. secondary outcomes are 7-day bioverified point-prevalence cigarette abstinence, ptsd symptoms, and levels of nicotine dependence at follow-up. results will inform a larger rct to examine efficacy of the intervention in promoting quit attempts in smokers with ptsd.


Eligibility criteria:
inclusion criteria: * are a veteran ages 18-69 meeting lifetime criteria for ptsd using the diagnostic statistical manual of mental disorders, fifth edition (dsm-v) as assessed by the mini international neuropsychiatric interview * have smoked at least five cigarettes per day on at least 15 of 30 days before screening * are interested in smoking cessation * are willing to receive smoking cessation interventions * are a smartphone (ios or android) user exclusion criteria: * women who are pregnant or plan to become pregnant * current and unstable psychotic or bipolar disorder (potential participants whose symptoms are treated and stable may participate) * current severe psychiatric symptoms or psychiatric instability * current severe substance use disorder * cognitive impairment assessed by montreal cognitive assessment (moca) score below 23
effects of drospirenone-ethinylestradiol and/or nomac-valerate estradiol on cardiovascular risk in women with polycystic ovary syndrome

Conditions: Polycystic Ovary Syndrome

Summary: polycystic ovary syndrome (pcos) is often associated with pathological conditions, such as insulin resistance (ir), type 2 diabetes (dm2), obesity and it has potentially increased risk for cardiovascular disease (cvd). of note, risk factors for cvd including dyslipidaemia, hypertension, oxidative stress and inflammation are associated with pcos. the investigators want to evaluate the effects of two different types of e/p therapy on cardiovascular risk in pcos.

pcos is the most common female endocrinopathy in reproductive age. this syndrome is a heterogeneous condition characterized by several symptoms and clinical signs related to reproductive, cardiometabolic and psychological disorders.we recently demonstrated that young pcos women show an expansion of an unusual t-cell population with proinflammatory functions, identified by cd4+cd28null t lymphocytes . of note, this t subpopulation has been found to be expanded in patients with unstable angina, type 2 diabetes (dm2), in absence of clinical evidence of cvd 12, and has been recently associated to recurrent coronary instability .based on the above mentioned evidences, the aim of the present study is to evaluate the effects of drps/ee alone versus metformin alone versus drps/ee plus metformin on the cd4+cd28null t cells frequency and on endocrino-metabolic parameters, in hyperinsulinemic pcos patientsto evaluate long-term effects of drospirenone (drsp)/ethinylestradiol (ee) and nomac-valerate estardiol on some cardiovascular risk factors in pcos patients.

Eligibility criteria:
inclusion criteria: * patients with pcos aged 18-35 years exclusion criteria: * chronic or acute inflammatory disease * cancer * autoimmune disease * treatment with clomiphene citrate * antiandrogens * drugs to control appetite or insulin-sensitizing drugs (metformin, pioglitazone and rosiglitazone) during the last 6 months prior to our evaluation, dm2, hypertension, major surgery in the last 3 months or other hormonal dysfunctions (hypothalamic, pituitary, thyroidal, or adrenal causes)

Keywords: pcos
an extension study evaluating the efficacy and safety of rivastigmine in patients with traumatic brain injury (tbi) with persistent cognitive deficits

Conditions: Traumatic Brain Injury With Persistent Cognitive Deficits

Summary: patients who completed the 12-week double blind protocol may enter this 26-week, open-label extension. this extension will give patients who complete the study an opportunity to receive treatment with open-label rivastigmine 3-12 mg/day and further evaluation for the cognitive deficits related to traumatic brain injury. this extension will enable further evaluation of patients, as well as analyses to be conducted examining response to treatments in the original drug and placebo groups.


Eligibility criteria:
inclusion criteria: * have a deficit in the areas of attention and/or memory. * have current cognitive deficits which were present from the time of the injury, are persistent, and are deemed to be the result of the brain injury; * be at least 12 months post brain injury; exclusion criteria: * a history of a major brain surgery; * a penetrating brain injury (e.g., gun shot wound); * a current diagnosis of epilepsy; * had more than one seizure in the past year (patients who have had a single seizure within a year post-injury will be considered on a case by case basis); * previous exposure to rivastigmine.

Keywords: traumatic brain injury, head trauma, rivastigmine, cognitive deficits
development of "t-sec" questionnaire

Conditions: Asthma

Summary: to design and validate a questionnaire that allows objective assessment of the level of bronchial mucus hypersecretion.

asthma is a chronic inflammatory disease associated with bronchial mucus hypersecretion (mbh) due to various mechanisms, such as increased mucin secretion, plasma exudation and cytokines. it is currently known that mbh in asthmatic patients is associated with increased mortality and reduced pulmonary function, but there is no tool for its objective assessment. the aim of the study is to design and validate a questionnaire to objectively assess the level of bronchial mucus hypersecretion in patients with asthma.

Eligibility criteria:
inclusion criteria: * aged between 30 and 99 years * clinical diagnosis of asthma exclusion criteria: * non-spanish-speaking patients * inability to complete the questionnaires * failure to sign the informed consent form.

Keywords: asthma hypersecretion sputum
selenium and vitamin e in preventing cancer progression and recurrence in patients with early-stage bladder cancer

Conditions: Bladder Cancer

Summary: rationale: chemoprevention is the use of certain drugs to keep cancer from forming. the use of selenium and vitamin e may stop cancer from growing or coming back. purpose: this randomized phase iii trial is studying giving selenium together with vitamin e to see how well it works compared with a placebo in preventing cancer progression and recurrence in patients with early-stage bladder cancer.

objectives: * to investigate whether selenium and/or vitamin e (α-tocopherol) supplementation reduces the risk of recurrence and progression. outline: this is a multicenter study. patients are stratified by recurrence risk group (high vs intermediate) and treatment center and randomized to 1 of 4 treatment arms. * arm i: patients receive oral selenium tablet and oral vitamin e capsule once daily. * arm ii: patients receive oral selenium tablet and oral placebo capsule once daily. * arm iii: patients receive oral placebo tablet and oral vitamin e capsule once daily. * arm iv: patients receive oral placebo tablet and oral placebo capsule once daily. in all arms, treatment continues for up to 5 years in the absence of disease progression or unacceptable toxicity. quality of life is assessed every 6 months for 5 years. peer reviewed and funded or endorsed by cancer research uk.

Eligibility criteria:
disease characteristics: * histopathologically confirmed non-muscle-invasive transitional cell carcinoma (\< pt2) * newly diagnosed disease * able to be randomized within twelve months of diagnostic transurethral resection bladder tumor/biopsy * must meet 1 of the following recurrence risk criteria: * intermediate risk * multiple g1 pta (\> 1) * solitary g1 pta (≥ 3 cm) * g2 pta * g1 pt1 * g2 pt1 (1 or 2 tumors) * high risk * g3 pta * g3 pt1 * cis * multiple g2 pt1 (3 or more foci) * low risk * solitary g1 pta \< 3 cm patient characteristics: * not pregnant or breast feeding * no hiv infection * no condition that, in the opinion of the local investigator, might interfere with the safety of the patient or evaluation of the trial objectives prior concurrent therapy: * no concurrent immunosuppressive therapy after organ transplantation * no concurrent cyclosporine * those who currently use or have used selenium and/or vitamin e supplements will not be excluded, however, they must agree not to take supplements containing selenium and vitamin e above a pre-specified dosage

Keywords: transitional cell carcinoma of the bladder stage 0 bladder cancer stage i bladder cancer
telbivudine versus adefovir dipivoxil in adults with hbegag-positive, compensated chronic hepatitis b

Conditions: Chronic Hepatitis B

Summary: this research study is being conducted to compare the safety and effectiveness of the investigational medication, ldt (telbivudine) versus adefovir dipivoxil, a drug approved by the food and drug administration (fda) for the treatment of hepatitis b infection. the results for patients taking ldt will be compared to results for patients taking adefovir dipivoxil.


Eligibility criteria:
inclusion criteria: * documented compensated chronic hepatitis b defined by clinical history compatible with compensated chronic hepatitis b * detectable serum hbsag at the screening visit other protocol-defined inclusion criteria may apply. exclusion criteria: * patient is pregnant or breastfeeding. * patient is coinfected with hepatitis c virus (hcv), hepatitis d virus (hdv) or hiv * patient previously received lamivudine, adefovir dipivoxil, or an investigational anti-hepatitis b virus (hbv) nucleoside or nucleotide analog at any time * patient has received interferon or other immunomodulatory treatment for hbv infection in the 12 months before screening for this study other protocol-defined exclusion criteria may apply.
study to evaluate the efficacy, safety and pharmacokinetics of pt001, pt003, and pt005 following chronic dosing (7 days) in patients with moderate to very severe chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the purpose of this study is to evaluate, after 1 week of dosing, the efficacy and safety of pt003 compared with its individual components (pt001 and pt005), placebo and two active comparators to demonstrate superiority of the combination to its components, and to assess the relative contribution of the components compared with placebo, in patients with moderate to very severe copd.


Eligibility criteria:
inclusion criteria: * signed written informed consent * 40 - 80 years of age * clinical history of copd with airflow limitation that is not fully reversible * females of non-child bearing potential or females of child bearing potential with negative pregnancy test; and acceptable contraceptive methods * current/former smokers with at least a 10 pack-year history of cigarette smoking * a measured post- bronchodilator fev1/fvc ratio of \< or = 0.70 * a measured post- bronchodilator fev1 \> or = 750ml or 30% predicted and \< or = 80% of predicted normal values * able to change copd treatment as required by protocol exclusion criteria: * women who are pregnant or lactating * primary diagnosis of asthma * alpha-1 antitrypsin deficiency as the cause of copd * active pulmonary diseases * prior lung volume reduction surgery * abnormal chest x-ray (or ct scan) not due to the presence of copd * hospitalized due to poorly controlled copd within 3 months of screening * clinically significant medical conditions that preclude participation in the study (e.g. clinically significant abnormal ecg, uncontrolled hypertension, glaucoma, symptomatic prostatic hypertrophy) * cancer that has not been in complete remission for at least 5 years * treatment with investigational study drug or participation in another clinical trial or study within the last 30 days or 5 half lives other protocol defined inclusion/exclusion criteria may apply

Keywords: copd
effect of a stress reduction and lifestyle modification programme on the quality of life of crohn's disease patients

Conditions: Crohn Disease

Summary: patients with crohn's disease often suffer significant limitations to their quality of life, which are also conditioned by particular stress and psychosocial accompanying symptoms of the disease. a multimodal program for stress-reduction and lifestyle-modification has been shown to be effective in promoting the quality of life in patients with uncreative colitis. the study will examine the promotion of the quality of life of patients with crohn's disease and the positive influence on stress, psychological symptoms and physiological parameters.

40 patients with ulcerative colitis will be randomized in an intervention group and a control group for 10 weeks. the primary outcome is the feasibility of the study, the intervention and the examinations. the secondary outcomes are disease-specific quality of life, disease-activity, stress, psychological symptoms, inflammatory parameters, disease activity parameters, bowel parameter and the microbiome. as qualitative parameters, the influence of the disease on everyday life and the experience/ impact/ implementability of the programme will be investigated. lastly, undesirable events will be recorded.

Eligibility criteria:
inclusion criteria: * age between 18 and 75 years * presence of a confirmed diagnosis of crohn's disease * in remission (not longer than 12 months, or mild to moderate clinical activity (hbi \< 16) * medication that has been stable for at least 3 months, regardless of whether glucocorticoids, immunosuppressive drugs, azathioprine, or other drug treatments according to mbmcrohn - version 1.0 from 06.12.2019 page 7 guideline * signed declaration of consent exclusion criteria: * infectious or refractory crohn's disease with severe course * complete colectomy * severe psychological illness (e.g. depression requiring treatment, addiction, schizophrenia) * severe comorbid somatic disease (e.g. diabetes mellitus, oncological disease) * pregnancy * participation in stress reduction programmes or clinical studies on psychological interventions
study of fyu-981 in hyperuricemia with or without gout

Conditions: Hyperuricemia With or Without Gout

Summary: the purpose of this study is confirmatory investigation of safety and efficacy of fyu-981 administered orally to hyperuricemic patients with and without gout for 34 or 58 weeks by the method of multicenter, open label and ascending dose regimen.


Eligibility criteria:
inclusion criteria: * hyperuricemic or gout patients * serum urate level: \>= 7.0mg/dl in patients with history of gout, or \>= 8.0mg/dl in patients with hypertension, diabetes or metabolic syndrome, or \>= 9.0mg/dl exclusion criteria: * gouty arthritis within two weeks before start of study treatment * secondary hyperuricemia * hba1c: \>= 8.4% * uric acid-overproduction type in the classification of hyperuricemia * history of, clinically significant cardiac, hematologic and hepatic disease * kidney calculi or clinically significant urinary calculi * egfr: \< 30ml/min/1.73m\^2 * systolic blood pressure: \>= 180 mmhg * diastolic blood pressure: \>= 110 mmhg
knowledge, attitude and practice of gastrointestinal endoscopists toward ppe in covid-19 era

Conditions: Knowledge, Attitudes, Practice

Summary: assessing the knowledge and practice of git endoscopists toward the use of ppe.

an online questionnaire assessing the knowledge and practice of git endoscopists toward the use of ppe will be used.

Eligibility criteria:
inclusion criteria: * git endoscopists exclusion criteria: * refuse to participate
prevention post operative nausea vomiting in ambulatory gynecologic laparoscopy

Conditions: Postoperative Nausea and Vomiting

Summary: the purpose of this study is to compare the incidence of postoperative nausea and vomiting between the intervention group who received multimodal antiemetic management and the control group who did not get this protocol.


Eligibility criteria:
inclusion criteria: * ambulatory gynecologic laparoscopy * age 18-45 years * asa class 1-2 exclusion criteria: * the patients who take opioid, steroid, pyschotics or antiemetic drug within 24 hours before surgery * history of antiemetic, anesthetic and analgesic drugs allergy * pregnancy or breast feeding * body mass index \>34 kg/square metre

Keywords: postoperative nausea and vomiting ambulatory gynecologic laparoscopy incidence of postoperative nausea and vomiting.