Kornimate/medical-research-clean huggingface dataset:
the efficacy of esomeprazole premedication on intraoperative bleeding during gastric esd

Conditions: Stomach Neoplasms

Summary: this will be a single-centre, randomised, endoscopist-blind, parallel-group study in patients who are scheduled endoscopic submucosal dissection (esd) for gastric mucosal lesion. the primary objective is to observe whether a regimen of 7-day oral esomeprazole premedication can alleviate intraoperative bleeding in patients scheduled for esd due to gastric mucosal lesions.


Eligibility criteria:
inclusion criteria: * ability to understand and the willingness to sign a written informed consent document. * female or male aged ≥18 years. * patients must have gastric mucosal lesion that are eligible for esd indications (japanese gastric cancer association 2011), including early gastric cancer, polyps, adenoma, and precancerous/suspected lesions diagnosed by endoscopy. exclusion criteria: * malignancy or other advanced disease with a life expectancy of \< 6 months as judged by the investigator. * the asa classification of physical status ≥ 4 as judged by the investigator. * severe hepatic disease or renal disease * ability to understand and the willingness to sign a written informed consent document. * major cardiovascular event at enrollment or within 3 months prior to enrollment such as stroke, myocardial infarction, or hospitalization for treatment of unstable angina pectoris as judged by the investigator. * haemorrhagic disorder. * patients who had a history of gastrectomy or a recurrent lesion. * known or suspected hypersensitivity to any component of any ppi . * planned treatment with: warfarin (including other vitamin k antagonists), cisapride, phenytoin, atazanavir, nelfinavir, digoxin, methotrexate, clopidogrel, tacrolimus, theophylline, lidocaine, nifedipine. * pregnancy, planned pregnancy or lactation. women of childbearing potential must use reliable and medically accepted methods of birth control, as judged by the investigator. * known or suspected alcohol, drug or medication abuse. * any condition associated with poor compliance as judged by the investigator. * participation in any study involving administration of an investigational product or device within the preceding 14 days prior to enrollment. * involvement in the planning and conduct of the study. previous enrollment in the present study.

Keywords: endoscopic submucosal dissection proton pump inhibitor bleeding
alcohol early intervention for freshmen

Conditions: Alcohol Abuse

Summary: alcohol abuse among college students is a significant and long-standing public health issue. the transition into college is marked by substantial increases in alcohol abuse and problems, suggesting the importance of interventions that take place prior to and immediately following matriculation. to date, early interventions with this population have yielded modest results with very little evidence identifying either the factors that are responsible for observed effects or specific individual or situational factors that qualify intervention efficacy. there is preliminary evidence for the efficacy of individualized feedback (if) in reducing college student alcohol abuse. additionally, a sizeable body of research with early adolescents and emerging work with college students point to the utility of parent-based interventions (pbi). the major aim of this research is to provide the first test of the unique and combined efficacy of these two successful interventions in reducing alcohol abuse among matriculating college students.

using a 2 x 2 if (yes; no) x pbi (yes; no) factorial design, this study will determine whether if and pbi with "boosters" are effective in reducing alcohol abuse among incoming college students. it is hypothesized that groups receiving if and pbi will demonstrate lower levels of alcohol abuse over the first two years of college than those not receiving these interventions and that the effects of combining these interventions will be additive (specific aim 1). structural equation modeling techniques will be used to conduct mediational analyses investigating theoretically derived hypotheses about the processes by which intervention factors influence alcohol use and problems (specific aim 2). hierarchical multiple regression analyses will examine hypothesized individual and situational moderators of intervention efficacy (specific aim 3). the use of a factorial design and explicit mediational analyses will allow for very strong inferences regarding the "active ingredients" of intervention efficacy. the long-term objectives of this research are to improve the efficacy of early interventions and to inform research and theory on the etiology of alcoholism. more effective interventions, particularly those that target students during a developmental transition of enhanced risk, will result in fewer injuries from acute intoxication, enhance retention and learning, and lessen the development of alcoholism as a result of chronic alcohol abuse.

Eligibility criteria:
inclusion criteria: * all incoming students who paid their university attendance deposit by may 1st of the recruitment years were eligible for participation. exclusion criteria: * transfer students, * married, * not living with a parent/guardian, * returning students older than 20 years * reached the alcohol use cut-off criteria (40 or more drinks per week and two symptoms of alcohol dependence)

Keywords: alcoholism alcohol abuse prevention behavior modification parent offspring interaction university student substance abuse related behavior adolescence
a study assessing patient handling of flutiform® breath-actuated inhaler (bai) and flutiform® pressurised metered dose inhaler (pmdi)

Conditions: Asthma; COPD

Summary: this study will compare the patient handling of flutiform® pmdi (pressurised metered dose inhaler) and a breath activated device (bai). patient handling will be assessed using assessment criteria which detail the correct handling steps for each inhaler.

approximately 340 subjects aged 12 years and over who have asthma or chronic obstructive pulmonary disease (copd), and are on medication for their condition will be recruited for the study. subjects will be recruited to ensure that different severities of disease are included in the study. severity of disease will be determined by predicted fev1. during the study subjects will be trained to use both the pmdi device and the bai device being compared. following training the subjects' use of each device will be assessed by a trainer/assessor using assessment criteria which cover handling, actuation and inhalation aspects for each of the devices under test. the order in which subjects receive each device will be determined using a randomisation schedule. during the study subjects will continue to take their prescribed asthma or copd medication. the pmdi and bai devices used for the patient handling assessment will only contain placebo. the duration of the study for a subject will be up to 58 days. training and use of each device will be separated by 7 to 21 days

Eligibility criteria:
inclusion criteria: 1. written informed consent/assent. 2. male and female subjects ≥12 years old. 3. documented history of asthma or copd for ≥ 6 months prior to screening visit. 4. subjects receiving ics and laba 5. can perform spirometry adequately. 6. willing and able to attend all study visits exclusion criteria: 1. any severe chronic respiratory disease other than asthma and copd. 2. evidence of a clinically unstable disease as determined by medical history or physical examination that, in the investigator's opinion, precludes entry into the study or may confound between-period comparisons. 'clinically unstable' is defined as any disease that, in the opinion of the investigator, would put the subject at risk through study participation. 3. any serious neuromuscular disorder, or orofacial disease preventing the application of an inhaler to the mouth. 4. known sensitivity to inhaler propellant or excipients. 5. participation in a clinical drug study within 30 days of the screening visit. 6. current participation in a clinical study.

Keywords: flutiform® asthma copd
a national multicentre study to assess the efficacy of the fixed combination of valsartan and amlodipine in hypertensive patients not controlled by monotherapy

Conditions: Primary Hypertension

Summary: this study is to assess the efficacy of the fixed combination of valsartan and amlodipine in hypertensive patients uncontrolled by monotherapy.


Eligibility criteria:
inclusion criteria: * patient uncontrolled by mono-therapy for at least 8 weeks, having b.p.\>/= 140/90 mmhg in non diabetics or \>/= 130/80 mmhg in diabetics exclusion criteria: * patient having b.p.\>= 180/110 mmhg in non diabetics or \>= 160/100 mmhg in diabetics * type 1 diabetes or uncontrolled type 2 diabetes. * pci in last 12 months. * concomitant unstable angina. other protocol-defined inclusion/exclusion criteria may apply

Keywords: hypertension, valsartan/amlodipine,
the effect of integrated neuomuscular inhibition technique on adult females with cervicogenic headache

Conditions: Cervicogenic Headache

Summary: the purpose of the current study is investigating the effect of integrated neuromuscular inhibition technique on adult females with cervicogenic headache. methods: forty females with cervicogenic headache will be recruited. patients will be randomly assigned into two groups, group a and group b . patients in both groups will receive a traditional medical treatment, but group (b) will receive additional integrated neuromuscular inhibition technique.

measurements will be taken for all participants before the start of treatment program then after the end of 4 weeks treatment program, then after another 4 weeks of follow up.all patients will be evaluated for headache pain intensity, cervicogenic headache frequency, cervicogenic headache duration, cervical range of motion in all directions, the isometric endurance capacity of sternocledomastoid and anterior scalene, kinesiophobia, neck disability, and headache impact test-6. all patients will receive a traditional medical program by an experienced neurologist in the form of muscle relaxants tizanidine ,4 mg to 32 mg, three times a day. patients in experimental group (b) will receive the same program as control group (a) plus the init for upper trapezius and suboccipital muscles. the init program will be administrated three times a week for one month.

Eligibility criteria:
inclusion criteria: * a diagnosis of cgh will be made by an experienced neurologist as per the international classification of headache disorders 3rd edition (ichd-3) , but not including occipital nerve blockage . additional inclusion criteria will include female patients aged\> 18 years and\ 1/week; hypomobility of the upper cervical spine (c0 to c3) on manual examination; and reproduction of the headache on palpation of the upper cervical spine (c0 to c3).in addition, patients should exhibit active trigger points within the suboccipital, and upper trapezius muscles, ipsilaterally over the symptomatic side reproducing their headache symptoms . exclusion criteria: * patients will be excluded if they have any of the following: cervical radiculopathy, history of neck, shoulder trauma or surgery, history of intervention for head or neck pain within the previous 3 months,or a diagnosis of other types of headaches using the criteria of ichd-3.
the effects of added enzyme α-galactosidase at a carbohydrate-rich meal in irritable bowel syndrome (ibs)

Conditions: Irritable Bowel Syndrome

Summary: ibs (irritable bowel syndrome) is a functional gastrointestinal disorder which is characterized by recurrent pain and/or discomfort, altered stool form, and abdominal distension. it has been established that food items such as beans, peas, lentils, peppers, and onions can increase gas production. what these have in common is that they all contain large amounts of complex carbohydrates. the enzymes in the small intestine are not able to fully digest these large molecules, which in turn are fermented by the colonic microflora. this fermentation is conducted through the production of short chain fatty acids and gases such as hydrogen and methane. alpha-galactosidase is an enzyme that has the ability to break down these indigestible carbohydrates to galactose and sucrose in the small intestine and to facilitate the absorption and minimize the gas production from bacteria in the colon. the aim of this study is to assess if the gastrointestinal symptoms, above all problems from gas and distension, is alleviated when the enzyme α-galactosidase (present in nogasin capsules) is ingested with food.


Eligibility criteria:
inclusion criteria: * patients diagnosed with irritable bowel syndrome(ibs), (in accordance with rome iii criteria), and * with the specific symptoms of bloating and/or abdominal distension. exclusion criteria: * the patients should not have any other gastrointestinal diseases such as ibd or celiac disease.

Keywords: gastrointestinal symptoms bloating distention
tb (tuberculosis) preventive therapy for hiv patients with access to haart (highly active antiretroviral therapy)

Conditions: Tuberculosis; HIV Infections

Summary: the purpose of this study is to determine if implementing a policy of widespread inh (isoniazid) prophylaxis therapy in hiv-infected patients with access to antiretroviral therapy reduces the incidence of active tb disease in the hiv clinic population.

tuberculosis remains a major public health problem in brazil. approximately 35% of hiv-infected adults in rio de janeiro are co-infected with latent tb. the brazilian policies for the provision of treatment to hiv-infected people are among the most progressive in the world. brazil provides combination antiretroviral therapy free of charge to all patients who meet clinical criteria and maintains an extensive clinic and laboratory system for the appropriate prescription and monitoring of therapy. the use of ipt, however, has been very limited in brazil and tb remains a prominent disease in aids patients. a clustered randomized trial (crt) will determine if the routine detection of latent tb in hiv-infected patients identified at hiv clinics in rio de janeiro, followed by treatment with isoniazid, will reduce tb incidence in this population. the crt will take a phased-implementation approach to ensure that all clinics will eventually have full coverage. this study will determine if implementing a policy of widespread ipt use in hiv-infected patients with access to arv therapy reduces the incidence of active tb disease in the hiv clinic population. the study population will be comprised of hiv-infected individuals who attend any of the 29 government hiv clinics in rio de janeiro, brazil. we expect that ipt use in addition to arvs will result in a 40-60% reduction in tb incidence, and that approximately 50% of the prevented tb cases will be in patients not yet eligible for haart.

Eligibility criteria:
inclusion criteria: * attending 1 of 29 participating hiv clinics * confirmed hiv infection * age \> 15 years exclusion criteria: * current active tb disease * tb infection within 2 years * hepatitis

Keywords: tst isoniazid haart brazil hiv
hyaluronic acid evaluation as adjuvant to temporomandibular joint arthroscopy

Conditions: Temporomandibular Joint Disc Displacement; Temporomandibular Joint Disorders

Summary: this study evaluates the addition of hyaluronic acid to temporomandibular joint arthroscopy in the treatment of internal derangements in adults. a participants group will receive temporomandibular joint arthroscopy plus hyaluronic acid, while the other group will receive temporomandibular joint arthroscopy. hypothesis: hyaluronic acid as an adjunct in temporomandibular joint arthroscopic surgery provides additional benefits in clinical and radiological outcomes in temporomandibular joint internal derangements.


Eligibility criteria:
inclusion criteria: * diagnosis of temporomandibular joint internal derangements in wilkes stages iii and iv by magnetic resonance imaging * limitation of maximum oral opening or duplication of joint pain by palpation * lack of response to conservative therapies exclusion criteria: * any degenerative systemic disease of muscular or joint involvement (rheumatoid arthritis, etc.) * previous temporomandibular joint surgical treatment: arthrocentesis, arthroscopy or open surgery * infection in temporomandibular joint or in puncture site * hyaluronic acid or corticosteroids injection in temporomandibular joint in previous 6 months * pregnant or breastfeeding women * participants who refuse to complete the treatment or unavailable to complete the follow-up

Keywords: hyaluronic acid temporomandibular joint arthroscopy internal derangements disc displacement temporomandibular disorders
a prospective study on the prediction model of para-aortic lymph node metastasis

Conditions: Locally Advanced Cervical Cancer

Summary: the goal of this prospective single-arm trial is to investigate the accuracy and feasibility of the para-aortic lymph node metastasis prediction model in locally advanced cervical cancer, as well as its impact on patients' prognosis. the main questions it aims to answer are: * is the para-aortic lymph node metastasis prediction model accurate and feasible? * whether the para-aortic lymph node metastasis prediction model can affect the prognosis of patients.


Eligibility criteria:
inclusion criteria: * in 2018, the international federation of obstetrics and gynecology (figo) stage was ib3 iia2-iva; * it was treated initially without surgical and chemotherapy. * squamous cell carcinoma, adenocarcinoma and adeno-squamous cell carcinoma were confirmed by histopathology. * pelvic mri ± abdominal ct or mri or pet/ct were performed before treatment. * ecog score:0 \~ 1. * the expected survival time\>6 months; * there is no absolute contraindication of surgery and and chemoradiotherapy and the patients with good compliance. exclusion criteria: * history of immune disease who need to take immunosuppressive drugs. * history of serious mental illness and brain functional disorder. * other malignancies were diagnosed within five years or needed treatments. * those who are unable or unwilling to accept surgical treatment/sign informed consent/comply with research requirements. * without surgical conditions: 1) chronic renal insufficiency or renal failure; 2) liver insufficiency; 3)chronic lung disease with restrictive respiratory dysfunction; 4) cardiac dysfunction (patients with relative and absolute contraindications to surgery after consultation by cardiac physicians. * patients who cannot understand the research regimen and refuse to sign the informed consent form. * other concomitant diseases or special conditions seriously endanger the patient's health or interfere with the trial.
fast track total hip arthroplasty vs standard care

Conditions: Hip Osteoarthritis; Hip Pain Chronic

Summary: fast-track total hip arthroplasty (tha) is a well-established concept including optimized logistics and evidence-based treatment, focusing on minimizing surgical stress and improved post-operative recovery. the aim of this protocol is to compare the standard care and fast track total hip arthroplasties in terms of functional and subjective outcomes, hospital staying, number of transfusions and analgesic consumption.

the aim of this protocol is to compare standard care and fast track total hip arthroplasties. the fast track care consists of: * preoperative educational lesson in which orthopedic surgeon, anesthesiologist and physiotherapist illustrate the operative and post operative path to the patients * antalgic protocol administered only orally * early rehabilitation care. the day of the surgical operation, the physiotherapist helps the patient reach the upright position. the standard care consists of usual antalgic and physiotherapy post-operative care: * antalgic protocol consist in intravenous drugs * the first physiotherapy session is the day after surgery

Eligibility criteria:
inclusion criteria: * patients affected by hip osteoarthritis, eligible for primary total hip arthroplasty * bmi \< 32 * american society of anesthesiologists physical status classification system (asa) \</= 2 * preoperative hemoglobin (hb) \>13 g/dl * patients eligible for spinal anesthesia * presence of a care-giver exclusion criteria: * psychiatric diseases * preoperative use of crutches * asa \> 3 * preoperative hb \< 13 g/dl

Keywords: fast track care total hip arthroplasty
a multi-center study subjects with dry eye syndrome

Conditions: Dry Eye Syndrome

Summary: this is a phase 1b, multi-center, double-masked, randomized, placebo-controlled, parallel-group study designed to evaluate the safety and biological activity of two doses of ebi-005 ophthalmic solution versus placebo in subjects with moderate to severe dry eye syndrome. approximately 72 subjects will be enrolled and randomized in this study at up to 9 centers located in the united states (us). subjects will be enrolled in two groups or cohorts. the first enrollment group will consist of 33 subjects.

* to investigate the safety and tolerability of ebi-005 ophthalmic solution compared to placebo in the treatment of patients with moderate to severe dry eye syndrome (des). * to evaluate pharmacokinetic (pk) parameters and immunogenicity of two different doses of ebi-005 ophthalmic solution. * to investigate the biological activity of multiple doses of ebi-005 ophthalmic solution compared to placebo as assessed by both objective and subjective assessments. * to investigate the comparative dose response of two different doses of ebi-005 ophthalmic solution. * to investigate the comparative tolerability of two different doses of ebi-005 ophthalmic solution. * to identify key biomarkers in the diagnosis and management of subjects with des.

Eligibility criteria:
inclusion criteria: * provide written informed consent prior to any study related procedures * are 18 years of age or older * are women of child bearing potential (wocbp) who are non-pregnant, non-lactating and sexually inactive (abstinent) for 14 days prior to visit 1 * are willing and able to follow instructions and can be present for the required study visits for the duration of the study * have a history of dry eye syndrome in both eyes supported by a previous clinical diagnosis * have ongoing dry eye syndrome, in the same eye or both eyes, as defined by the following criteria: 1. a score of ≥23 on osdi 2. a corneal fluorescein staining score of ≥6 (nei scale) * have normal lid anatomy * are willing to withhold artificial tears for the duration of the study, with the exception of the study provided artificial tears: refresh plus®. exclusion criteria: subjects may not: * have previously used an il-1 blocker (e.g., anakinra, rilonacept or ilaris). * have an osdi score ≥90 * have a corneal fluorescein staining score of 15 (nei scale). note: if one of two eyes has a corneal fluorescein staining score of 15, the subject may be eligible. * within 30 days prior to the screening visit (visit 1) have taken: topical cyclosporine (restasis®) ocular corticosteroids autologous serum topical ocular antibiotics topical ocular antihistamines or mast cell stabilizers topical or nasal vasoconstrictors * within 30 days prior to the screening visit (visit 1) have altered the dose of tetracycline compounds (tetracycline, doxycycline or minocycline).

Keywords: dry eye syndrome interleukin 1 receptor inhibitor