Kornimate/medical-research-clean huggingface dataset:
laparoscopic toupet's fundoplication: is it proper solution of radiological negative, endoscopically positive hiatal hernia patients

Conditions: Laparoscopic Toupet Fundoplication; Radiological Negative; Endoscope; Hiatal Hernia

Summary: this study aims to assess the feasibility and effectiveness of laparoscopic toupet fundoplication (ltf) for treating gastroesophageal reflux disease (gerd) symptoms and disease-specific quality of life (qol).

heartburn, regurgitation, dysphagia, and chest pain are regarded as common esophageal symptoms of gastroesophageal reflux disease (gerd). on the other hand, there are very few reports of laryngopharyngeal reflux (lpr), which is associated with persistent upper airway contact, acidic and non-acidic reflux, and aerosol that results in posterior laryngitis, edema, and glottis erythema. proton-pump inhibitor (ppi) therapy, laparoscopic nissen fundoplication (lnf), and laparoscopic toupet fundoplication (ltf) have been proven to be effective for the treatment of gerd. however, the therapeutic management of patients with hiatal hernia is debated and treatment remains empirical. previous studies on ppi therapy and lnf had been published with promising but controversial results. therefore, the role of ltf is even less explored and evidence is scarce

Eligibility criteria:
inclusion criteria: * age above 18 years old. * both sexes. * hiatal hernia patients (hill's grade iii \& iv) by endoscopy and negative by radiology indicated for toupet fundoplication. exclusion criteria: * recurrent patients. * age above 70 years old * unfit for surgery
measuring adverse pregnancy and newborn congenital outcomes

Conditions: HIV/AIDS; Pregnancy Related; Congenital Disorders; Newborn Morbidity

Summary: the purpose of this study is to develop a pharmacovigilance (pv) surveillance program to monitor adverse pregnancy and infant outcomes, including the presence of congenital abnormalities, among hiv-positive and hiv-negative women and their infants at clinical sites affiliated with the international epidemiology databases to evaluate consortium (iedea).

in part 1 of this study, the investigators will use a mixed prospective and cross-sectional cohort study design to implement a pv program at two health facilities affiliated with the academic model providing access to healthcare (ampath) in western kenya. the investigators will analyze these data to examine any associations between antiretroviral treatment (art) and (a) pregnancy and (b) infant/birth outcomes. in part 2, the investigators will create standardized protocols and data exchange standards within iedea to enable the merging and analysis of multiregional iedea pv data. this will include establishing a data coordinating center based at indiana university (iu) to serve as a hub for collecting, disseminating and archiving data from the study in kenya as well as data collected through a similar, ongoing study at health facilities in south africa affiliated with iedea. this study will establish a multiregional pv infrastructure within iedea that can be further scaled within the broader iedea network.

Eligibility criteria:
c1. prospective recruitment of hiv+ and hiv- pregnant women enrolling in anc at the site: inclusion criteria for women 1. pregnant and enrolled in anc at the study site; 2. understands english or swahili. exclusion criteria for women a. any physical or mental disability that prevents the woman from providing informed consent inclusion criteria for infants a. all infants at any gestational age who are born to enrolled women will be included exclusion criteria for infants (none) c2. data collection for all deliveries at the site: inclusion criteria for women a. woman delivers at the site and the delivery is registered at the site exclusion criteria for women (none) inclusion criteria for live/stillborn infants a. infant is delivered at the site and results in the infant/stillbirth being registered at the site exclusion criteria for infants (none) c3. photos/videos of infants with cas: inclusion criteria for infants 1. the infant is live or stillborn at ≥ 24 weeks estimated gestational age 2. the infant has a suspected ca on surface exam exclusion criteria for infants (none)
a phase i study, evaluating the safety, pharmacokinetics and efficacy of prj1-3024 in subjects with advanced solid tumors

Conditions: Advanced Solid Tumor; Advanced Solid Malignancies

Summary: this is a phase i, multicenter, open-label, 3+3 dose escalation study to determine the safety and preliminary efficacy of prj1-3024 in subjects with relapsed/refractory solid tumors.

the study will evaluate the safety, tolerability, pk, and pharmacodynamics of prj1-3024 and will determine the maximum tolerated dose in subjects with advanced solid tumors. prj1-3024 will be evaluated as an oral therapeutic that tests the anti-tumor activity of prj1-3024 in patients with solid tumors and has not yet been tested in humans. this study will find the safe and tolerable recommended dose in subjects with advanced solid tumors as a open-label, 3+3 dose escalation study.

Eligibility criteria:
key inclusion criteria: * histologically or cytologically confirmed locally advanced (unresectable) or metastatic r/r solid tumors for which no standard therapy is available or for whom standard therapy is considered unsuitable or intolerable. * male or non-pregnant, non-lactating female subjects age ≥18 years. * ecog performance status 0\~2. * has at least 1 measurable lesion as defined by recist 1.1 criteria . * life expectancy of \>3 months, in the opinion of the investigator. * able to take oral medications and willing to record daily adherence to investigational product. * adequate hematologic parameters unless clearly due to the disease under study. * adequate renal and hepatic function * able to understand and willing to sign a written informed consent form. key exclusion criteria: * history of another malignancy * known symptomatic brain metastases requiring \>10 mg/day of prednisolone. * significant cardiovascular disease * known active hbv, hcv, aids-related illness. * has received a live vaccine within 30 days * history of active autoimmune disorders or ongoing immunosuppressive therapy. * receiving concurrent anti-cancer therapy, investigational product, strong inhibitors or inducers of cytochrome p450 3a (cyp3a) . * prior treatment with hematopoietic progenitor kinase 1 (hpk1) inhibitors.

Keywords: first in human maximum tolerated dose recommended phase 2 dose dose escalation hematopoietic progenitor kinase 1 prj1-3024
prolonged infusion cefepime and nosocomial infections

Conditions: Urinary Tract Infection; Respiratory Tract Infection

Summary: it is advocated that prolonged infusion of beta-lactamic antibiotics provides better bactericidal effect. the aim of the present study is to randomize patients a to extended cefepime infusion regimen (lasting four hours) or to a usual infusion regimen (not lasting more than thirty minutes) and evaluate the clinical efficacy of this theoretical pharmacokinetic advantage.

introduction: it has been proved that the main determinant for microbiological cure gram-negative infections treated with cefepime is the time above minimal inhibitory concentration (t\>mic). although this particular pharmacokinetic property have never been proved in clinical trials utilizing cefepime, intervention studies with other betalactamic antibiotics, such as pipercillin-tazobactam, showed clinical benefit. objective: to evaluate if prolonged infusion (lasting 4 hours) with cefepime translate into better clinical outcomes. methods: the investigators aim to conduct an open-label, unique-centered, randomized controlled trial using cefepime in prolonged infusions in patients being treated for urinary or respiratory tract infections. patients developing these infections after 72 hours of hospital admission, requiring the use of broader spectrum antibiotics after clinical failure or isolating gram-negative bacteria from adequate sample sensible to cefepime will be enrolled. the use of a second antibiotic such as clindamycin, vancomycin or metronidazole will be allowed. interventions: the investigators aim to randomize 134 patients to two different treatment arms, the intervention arm who will receive the medication in a four hour lasting infusion, and the active control arm who will receive the medication in a 30 minutes lasting infusion. the randomization will be conducted in blocks of ten patients each, and it will be balance according to the patients age (older or younger than 65 years old) and presence of sirs criteria.

Eligibility criteria:
inclusion criteria: * urinary tract infection after 48-72 hours of hospital stay * respiratory tract infection after 48-72 hours of hospital stay * catheter related urinary tract infection after 48-72 hours of hospital stay * urinary or respiratory infections not responding to a narrower spectrum antibiotic * isolation of bacteria sensible to cefepime in blood, urine or sputum in a clinical context of infection exclusion criteria: * glomerular filtration rate lower than 30 ml.min/1,73m² * icu admission for at least 72 hours before randomization * neutrophil count lower than 1000 cels per mm³ * hematologic malignancy, bronchiectasis and cystic fibrosis * patients allergic to cefepime * concomitant treatment to another infectious disease * central nervous system, cutaneous or intrabdominal infections * solid organ transplantation * hiv with a cluster differentiation 4 (cd4) lower than 100 cels per mm³
induction chemotherapy followed by cetuximab plus definitive radiotherapy versus radiation plus cisplatin

Conditions: Squamous Cell Carcinoma of the Head and Neck

Summary: a phase iii trial of induction chemotherapy followed by definitive radiotherapy plus cetuximab versus chemoradiation in unresectable, locally advanced, squamous cell carcinoma of the head and neck (hnc).

the objective of this trial is to determine whether cetuximab and radiation preceded by an induction chemotherapy, may be superior to an established chemoradiation program for hnc (rtog regimen, adelstein dj j.clin.oncol. 2003;21:92-98).

Eligibility criteria:
inclusion criteria: * \> 18 years of age * histologically or cytologically confirmed diagnosis of hnscc * stage iii/iv, not suitable for surgery (definitive cure rate improbable, technically unresectable or medical contraindication for surgery) * at least one uni-dimensional measurable lesion either by ct scan or mri * signed written informed consents prior to beginning protocol specific procedures: * tumor tissue available for immunohistochemical staining of egfr expression and hpv * life expectancy of \> 3 months at study entry * ecog performance status of \<2 at study entry. * effective contraception if risk of conception exists. * neutrophils \> 2.0/mm³, platelet count \> 100,000/mm³, and hemoglobin \> 10 g/dl * normal liver function * serum creatinine \> 1.25 x uln and/or creatinine clearance \> 60 ml/min exclusion criteria: * prior systemic chemotherapy and/or radiotherapy * known peripheral neuropathy \> grade 2 nci-ctc version 3.0 * known chronic heart failure * prior surgery, excluding prior diagnostic biopsy * known drug abuse * active uncontrolled infection * other concomitant anticancer therapy * distant metastasis * concurrent chronic systemic immune therapy, chemotherapy for disease other than cancer, or hormone therapy not indicated in the study protocol * clinically relevant coronary artery disease or history of a myocardial infarction within the last 12 months before study entry * medical or psychological condition that would not permit the patient to complete the trial or sign informed consent * nasopharyngeal carcinoma who type ii or iii * known allergic reaction against any of the components of the treatment * pregnancy (absence confirmed by beta-hcg test) or lactation period * any prior or on-going investigational medication * previous or current malignancy except basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix

Keywords: locally advanced hnscc chemo-radiation induction chemotherapy stage iii/iv unresectable disease
rheumatoid arthritis patients in training

Conditions: Rheumatoid Arthritis

Summary: aim of the study was to investigate the effectiveness (functional ability and physical capacity) and safety (disease activity and damage of the joints) of long-term high-intensity weight-bearing exercises in patients with rheumatoid arthritis (ra).the training proved to be safe and effective.

the 300 patients with ra were randomized into two groups; exercise group and usual care group. the patients who participated in the 2 years intensive exercise training (2 times a week, training duration 65 minutes) improved their functional capacity and functional ability without detrimental effects on the large joints damage or on disease activity. only patients with excessive large joint damage at baseline were at risk to develop additional damage when participating in intensive weight-bearing exercises. patients who exercised were able to delay the decrease of bone mineral density of the hips.

Eligibility criteria:
inclusion criteria: * rheumatoid arthritis exclusion criteria: * prosthesis of a weight bearing joint

Keywords: rheumatoid arthritis exercise damage
tarlatamab (amg 757) expanded access protocol for advanced small cell lung cancer

Conditions: Small Cell Lung Cancer

Summary: the primary objective of the study is to provide expanded access to and characterize the safety profile of tarlatamab in participants with advanced small cell lung cancer (sclc) after two or more prior lines of treatment (including at least one platinum-based regimen). ea may still be available in countries outside of the united states.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * histologically or cytologically confirmed sclc * extensive-stage, unable to be encompassed in a tolerable radiation plan * progressed or recurred following 1 platinum-based regimen and at least 1 other prior line of therapy * eastern cooperative oncology group (ecog) ps of 0 to 1 * minimum life expectancy of 12 weeks exclusion criteria: * any previous diagnosis of transformed non-small cell lung cancer (nsclc), epidermal growth factor receptor (egfr) activating mutation positive nsclc that has transformed to sclc, or mixed sclc nsclc histology * symptomatic central nervous system (cns) metastases * active hepatitis b or hepatitis c virus infection * eligible for participation in any amgen-sponsored ongoing clinical study of the investigational product * currently or previously enrolled in a prior tarlatamab study * female participants and/or male participants with female partners who are pregnant, breastfeeding, planning to become pregnant or donate eggs while on study through 60 days after the last dose of tarlatamab * male and female participants unwilling to practice abstinence and/or use protocol specified method of contraception

Keywords: lung cancer extensive-stage small cell lung cancer tarlatamab amg 757 bispecific t-cell engager bite immunotherapy immuno-oncology delta-like ligand 3
evaluation of a new cardiac biomarker assay

Conditions: Acute Coronary Syndrome; Acute Myocardial Infarction

Summary: the objective of the study is to evaluate the performance and intended use of a new cardiac biomarker test, troponin i, in an intended use population. blood specimens will be tested using the new investigational test that detects the level of troponin i. results will be compared to the diagnosis of whether or not an acute myocardial infarction (mi) occurred.

the purpose of the cardiac biomarker troponin i is to aid in the diagnosis of myocardial infarction.the assay is also intended to assist in the prognosis relative risk to all cause mortality (acm) and major adverse cardiac events (mace) consisting of myocardial infarction, revascularization, and cardiac death in patients who present with symptoms suggestive of acute coronary syndrome (acs) without a diagnosis of myocardial infarction. all specimens were collected under a separate specimen collection protocol (protocol no, 7b5-02-09a01-01: clinical specimen procurement for biomarker evaluation of suspected acs). the specimens that will be tested include approximately 8300 specimens collected from 1101 subjects presenting to emergency departments with signs and symptoms of acute coronary syndrome and will be provided to the clinical sites performing investigational troponin i testing.

Eligibility criteria:
inclusion criteria: * presenting to the emergency department with symptoms consistent with or suggestive of acute coronary syndrome (acs) defined as at least 5 minutes of chest pain (or symptoms consistent with myocardial ischemia) up to 6 hours prior to initial evaluation. * an electrocardiogram (ecg) result within 2 hours of presentation for observation of acute coronary syndrome (acs). * greater than 18 years of age. * not known to be pregnant. * agreement to the follow-up required by the study. exclusion criteria: * prior participation in this study. * require dialysis for end stage renal disease. * history of a previous heart transplant. * coexisting disorder associated with limited life expectancy. * currently participating in another investigational device or drug study.
evaluation of echinacea for the common cold

Conditions: Common Cold

Summary: the purpose of this study is to determine whether three echinacea preparations with different chemical compositions are effective for prevention or treatment of the common cold.

echinacea is a widely used herbal remedy for the common cold. previous clinical trials designed to assess the efficacy of echinacea for prevention or treatment of the common cold have produced inconsistent results. a variety of different echinacea products have been used in these clinical trials. recent studies indicate that different echinacea preparations have dramatically different phytochemical profiles. the available clinical trial data provide no information about the potential role of the different constituents of echinacea in common cold prevention or treatment. our hypothesis is that the variation in reported clinical effectiveness may be due to differences in the phytochemical profile of the echinacea preparations used. this study will address the following specific aims: 1) evaluate the effectiveness of chemically defined extracts of e. angustifolia root which contain alkamides, echinacoside or polysaccharidelglycoprotein for common cold prevention or treatment; 2) assess the correlation between specific echinacea metabolites in serum and nasal secretions and efficacy for prevention and treatment of colds; and 3) determine the effect of different echinacea preparations on the host response to rhinovirus infection.

Eligibility criteria:

Keywords: common cold echinacea
terconazole vaginal suppository vs fluconazole for the treatment of severe vulvovaginal candidiasis

Conditions: Vulvovaginal Candidiasis

Summary: the objectives of this study were to demonstrate comparable safety and efficacy of terconazole vaginal suppositories, 80 mg and fluconazole in the treatment of subjects with severe vulvovaginal candidiasis.

this study were to demonstrate comparable safety and efficacy of terconazole vaginal suppository 80 mg inserted intravaginally once daily before bedtime for 6 consecutive days and oral fluconazole 150mg at day 1 and day 4 in the treatment of subjects with severe vulvovaginal candidiasis.

Eligibility criteria:
inclusion criteria: * vulvovaginal candidiasis infection is diagnosed, the symptoms evaluated using a numerical rating system based on severity (absent=0; mild=1; moderate=2; severe=3) with a minimum vvc composite signs/symptoms score of 7 * subject completes the informed consent process * subject agrees to take study medication when scheduled * subject complies with all clinical trial instructions. commits to all follow-up visits * subject agrees to abstain from sexual intercourse from the time of randomization through the first seven days immediately following treatment exclusion criteria: * had any other sexually transmitted disease or gynaecological abnormality requiring treatment * had a disease known to predispose to candidiasis such as diabetes mellitus, or were receiving antibiotics or corticosteriods * had used antifungal medication in the week before entry; or * were expected to menstruate within seven days of the start of treatment * infected more than one candida species
fat reduction intervention trial in african-americans

Conditions: Cardiovascular Diseases; Coronary Heart Disease Risk Reduction; Heart Diseases

Summary: to conduct a randomized controlled trial to evaluate the effectiveness of an intervention to reduce dietary fat.

background: the african-american population of the united states continues to experience high rates of mortality from cardiovascular (cv) disease, including coronary heart disease, stroke and renal failure. the major syndromes which determine cv risk, including obesity, hypercholesterolemia, glucose intolerance, and hypertension, all occur more frequently among african americans. nutritional factors underlie many forms of cv disease and are an important focus of current prevention efforts. very little is currently known, however, about specific nutritional patterns among african americans that might lead to cv risk, or the applicability of structured interventions. the study was conducted in response to an initiative on "collaborative projects on minority health" which was released in october 1992 after review and approval at the september 1992 national heart, lung, and blood advisory council. design narrative: given the growing recognition of the importance of total fat, from the point of view of both disease risk and eating patterns, the primary focus of the intervention was to reduce the percentage of calories in the diet from fat. four hundred households were recruited and randomly assigned to either an active intervention or observation group for a period of 18 months. dietary change consistent with specific recommendations made to the american public for reducing cardiovascular (cv) risk was encouraged, namely, reduction in total fat, saturated fat (sfa), and cholesterol (chol). a practical, community-based program was developed which could be taken into households. nutrition education and enhancement of skills helpful in making behavioral change formed the basis of the intervention. lay educators, recruited from the target neighborhoods, worked under the close supervision of a community nutritionist. changes in reported dietary intake, serum lipids/lipoproteins and body weights were measured. in addition to the formal evaluation of the trial outcome, an important secondary goal was to obtain detailed information about eating patterns in this community and characterize behavior associated with the achievement and maintenance of target nutrient goals. the study was part of a collaborative project on minority health. dr. prewitt collaborated with dr. marian fitzgibbon who was the principal investigator on r01hl51532. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria