Kornimate/medical-research-clean huggingface dataset:
an open-label study of once-daily oral administration of esomeprazole 40 mg in patients with symptoms of gastroesophageal reflux disease (gerd)

Conditions: GERD

Summary: the purpose of this study is to evaluate whether there is a difference in proportion of patients with resolution of heartburn and other symptoms related to gastroesophageal reflux disease (gerd) after four weeks of treatment with esomeprazole (nexium®) in those subjects with erosive esophagitis (ee) and those without ee.


Eligibility criteria:
inclusion criteria: * symptoms of gerd as defined in this protocol: heartburn (severity of mild, moderate or severe) 2 or more times in the 7 days prior to the screening visit (visit 1) and, on average, at least 2 times per week over the past 3 months. * male or female, 18 to 70 years old, inclusive. * non-pregnant, non-lactating female patients. female patients must be postmenopausal, surgically sterile, or using a medically acceptable form of birth control, as determined by the investigator. females of childbearing potential must agree to continue using an acceptable form of birth control throughout the conduct of the study. * negative urine pregnancy test for females of childbearing potential. * willingness to adhere to all protocol requirements. exclusion criteria: * previous enrollment in the present study. * significant clinical illness within 2 weeks prior to the first dose of study medication or a significant illness during the study. * use of a ppi, including prilosec otc®, within 21 days of screening (visit 1) or at anytime during the study (visit 1 through visit 4). * daily therapy with an h2 ra within 14 days of screening (visit 1): eg, ranitidine (zantac®), cimetidine (tagamet®), nizatidine (axid®), famotidine (pepcid®) (occasional use; ie, less than daily, is permitted). * use of h2 ras at any frequency are prohibited throughout the entire study (visit 1 through visit 4). * a history of gastric or esophageal surgery (including, but not limited to, nissen fundoplication and bariatric surgery), except for simple closure of a perforated ulcer or procedures that would not affect the study as determined by the clinical study team physician at astrazeneca. * clinically significant gastrointestinal (gi) bleeding (eg, melena, frank hematochezia) within 3 days of screening (visit 1) or noted at the time of baseline egd. * non-acid related etiologies of esophagitis (eg, pill-induced, caustic ingestion or eosinophilic esophagitis). generalized bleeding disorders resulting from hemorrhagic diathesis (such as abnormalities in clotting factors or platelets).
tolerance and safety of a duodenal probe monitoring the microcirculation

Conditions: Multiple Organ Dysfunction Syndrome

Summary: for intensive care units (icu) patients, multiple organ dysfunction syndrome (mods) is a very common complication yielding high morbidity and mortality. inadequate regional perfusion of certain organs (gut, kidney, liver, etc) often caused by shock is the main cause of mods. current practice uses cardiac output data and blood pressure to manage shock but there are still lacks of information about the regional perfusion. this leads to late mods diagnostics preventing the implementation of adequate treatment. gut perfusion monitoring seems to be a good target to assess the microcirculation but, nowadays, no practical methods or devices are available to measure the gut perfusion, and the current monitoring methods are not specific (co, bp, ops-sdf, pco2, etc). "mc monitor" trial is a prospective, multi-center pilot study, enrolling 10 patients. the probe will be used by intensivists on icu patients with a risk of shock and requiring mechanical ventilation. the probe will be placed in the patient with an endoscopic procedure by a gastroenterologist (standard procedure for post-pyloric tubes placement). this procedure will be used to assess the status of the gut mucosa prior to the placement of the apd probe.


Eligibility criteria:
inclusion criteria: * 18 years of age or more, * male or female, * icu patient, on vasoactive amines, under mechanical ventilation, * stable hemodynamic status, * life expectancy expected to exceed 72 hours, * length of icu stay greater than 5 days, * willing to participate and signed informed consent, * affiliation to the french social security system. exclusion criteria: * pregnant or lactating woman, * ongoing enteral nutrition, * risk of gastrointestinal ischemia, * history of pharyngeal surgery surgery, esophageal surgery, radiotherapy of mediastinal area, * known ear-nose-throat malignant disease, * unexplored dysphagia, * known recent gastrointestinal suture, * esophageal varices, * abdominal pain, * unstable cervical fracture, * moribund patient, * active participation in another investigational protocol within the past 30 days, * subject legally protected, under legal guardianship, deprived of his/her liberty by judicial or administrative decision.
evaluation of the efficacy and tolerability of detralex in patients with chronic venous edema in real clinical practice

Conditions: Chronic Venous Disease

Summary: the vap-pro-c3 is a multicenter observational program, which is carried out in the frame of routine consultations and follow-up of patients. the program includes patients with chronic venous diseases (cvds) of ceap class c3. it is scheduled in russia for 2018-2019. the program is expected to enroll 90 phlebologists from 60 cities of russia. the planned number of patients is 900

the study is aimed at evaluating the efficacy and safety of systemic pharmacotherapy (detralex) as a part of combination treatment, and its influence on the general outcomes of treatment of patients with chronic venous edema (ceap class c3) in real clinical practice. each investigator is planned to include in the program 10 patients fulfilling the inclusion criteria. the treatment will be carried out in accordance to the routine clinical practice, instructions for the medical use of drugs, and a specific clinical situation. to assess changes in edema, the method of truncated cones and duplex ultrasound scanning (dus) will be used.

Eligibility criteria:
inclusion criteria: * age 18 years old or above * written informed consent * patient did not receive treatment with venoactive drugs within the past 4 weeks prior to the inclusion in the study * diagnosis of chronic venous disease of class c3 (ceap) * decision of an attending physician to prescribe detralex. exclusion criteria: * age below 18 years old * written informed consent is not obtained * history of alcohol or drug abuse or use of narcotic drugs * history of allergic reaction to diosmin or any other venoactive agent, or their intolerance * history of allergic reaction to anesthetics and/or sclerosing agents * chronic venous disease of сеар class c0-с2 or class с4-с6 * lymphatic edema of the lower extremities * secondary varicose veins, angiodysplasia, or neoplasia * arterial disease (ankle-brachial index \<0.9) * infection within the past 6 weeks * any of the following concomitant diseases, which can affect the results: * connective tissue disease (including rheumatoid arthritis), arthritis * heart failure * intermittent claudication (peripheral artery disease) * diseases of the bones or joints of the lower extremities * malignancy * treatment with drugs potentially causing leg edema (calcium channel blockers, hormonal drugs, nsaids, etc.) * history of deep vein thrombosis (within the past year) * history of superficial thrombophlebitis (within the past 3 months) * patient cannot walk (regardless of the cause) * obesity or body mass index \[bmi\] \>30 kg/m2 \[bmi = body mass (kg)/height (m)2\] * predictable poor adherence to treatment * participation of the patient in the intervention study within the previous 3 months * for women: pregnancy or breastfeeding, the desire to become pregnant within at least 2 months after the study * patient cannot attend a follow-up visit * patients with a contraindication to diosmin-containing agents, including detralex
investigation of core endurance in fibromyalgia

Conditions: Fibromyalgia

Summary: the aim of this study is to compare core endurance and balance in patients with fibromyalgia syndrome (fms) with healthy subjects and to evaluate the relationship between core endurance and balance.the study will include 44 fms patients and 44 age- and sex-matched healthy controls. demographic data of the participants will be recorded. then, core endurance will be assessed with mcgill core endurance tests, balance will be evaluated with hur btg4 balance master system and berg balance scale (bbs), and function will be assessed with fibromyalgia impact questionnaire (fiq).

fibromyalgia syndrome (fms) is defined as a chronic disease with an unclear etiology, which is characterized by widespread musculoskeletal pain, mainly non-inflammatory, in females between 40-60 years of age, accompanied by fatigue, weakness, sleep problems, depression, anxiety and various cognitive and somatic disorders. the etiology and pathophysiology are still unclear. balance is a key component of activities of daily living such as walking, running and climbing stairs. maintaining an upright posture is a complex process that involves perceiving and integrating sensory inputs, planning movements, and executing them effectively. it is also defined as the ability to control the center of gravity within the base of support. the aim of this study is to compare core endurance and balance in patients with fibromyalgia syndrome (fms) with healthy subjects and to evaluate the relationship between core endurance and balance.the study will include 44 fms patients and 44 age- and sex-matched healthy controls. demographic data of the participants will be recorded. then, core endurance will be assessed with mcgill core endurance tests, balance will be evaluated with hur btg4 balance master system and berg balance scale (bbs), and function will be assessed with fibromyalgia impact questionnaire (fiq).

Eligibility criteria:
inclusion criteria: * patients who were aged between 18-65 years, * patients who got diagnosed with fibromyalgia syndrome exclusion criteria: * patients who had regular exercise habits, malignancy, pregnancy, incorporation * patients who had changes of medical treatment in last 3 months * patients who had dysfunction that can prevent physical activity

Keywords: fibromyalgia core endurance test balance
dextrose effect on postoperative nausea and vomiting (ponv)

Conditions: Postoperative Nausea and Vomiting

Summary: the aim of this study to assess which time and dose of dextrose solution more effective in decreasing postoperative nausea and vomiting.

all patients signed informed consent after excluding patients not candidate for the study.patients were divided to three groups, taking either 0.9% saline as control group(group c), dextrose 5%(group d5) or dextrose 10%(group d10).

Eligibility criteria:
inclusion criteria: * female non-smokers adults (age 18-65 years) * asa i-ii who were listed for elective surgery under general anesthesia (surgery which is risk for ponv). exclusion criteria: * severe hypertension * coagulopathy * significant hepatic or renal disease * diabetes mellitus or abnormal blood glucose on the morning of surgery * withdrawal of consent * severe intraoperative hypotension requiring large volume intravascular fluid treatment * protocol violations including nitrous oxide administration.
effect of n-acetylcysteine on alcohol and cocaine use disorders: a double-blind randomized controlled trial.

Conditions: Cocaine Addiction; Alcohol Addiction

Summary: this study evaluates the use of n-acetylcysteine in the treatment of alcohol and cocaine use disorders. alcohol users will be split in two groups, one will receive the active n-acetylcysteine and the other placebo. the same division will occur with cocaine users. the effects of n-acetylcysteine in adherence, abstinence, psychiatric symptoms and stress biomarkers will be evaluated.

n-acetylcysteine acts replenishing the human body glutathione storages. glutathione is an important antioxidant agent, and also modulates the n-methyl-d-aspartate (nmda) glutamatergic receptor. glutamate has been associated with the neuroadaptation related to substance use disorders, and thus it is considered a potential target for pharmacological interventions regarding these disorders. n-acetylcysteine also interacts with the cystine-glutamate antiporter on astrocytes hence increasing glutamate release into the extracellular space. n-acetylcysteine effects and its implications in the addiction disorders have been studied initially with animal models. glutamate levels normalization through n-acetylcysteine reduced compulsive drug self-administration and drug-seeking behavior in mice. in addition, there are promising results also with human subjects, showing benefits for cocaine, alcohol and cannabis use disorders. this study consists of a randomized, double-blind, placebo controlled trial with four arms: alcohol users divided into nac vs placebo and cocaine users divided into nac vs placebo.

Eligibility criteria:
inclusion criteria: * diagnostic of alcohol or cocaine use disorder * seven days of inpatient treatment in an addiction treatment specialized unit exclusion criteria: * another substance use disorder (exception: tobacco) * severe medical conditions (cardiac, renal or hepatic), that preclude subject participation * history of asthma or convulsions medication use * recent use (\<14 days) of any medication that could interfere with the study medication * history of anaphylactic reactions with the study medication * suicide risk * inability to understand the informed consent form or to comply with the study requirements * any severe neuropsychiatric condition, not caused by the substance use, that requires specific medication treatments and could interfere with the study development, in the investigators opinion (for instance: dementia, schizophrenia or other psychoses, multiple sclerosis, severe depression, stroke, epilepsy, bipolar disorder) * failing to complete the screening procedures prior to the study first week

Keywords: cocaine alcohol substance use disorders addiction n-acetylcysteine randomized controlled trial
sentinel node in larynx and pharynx cancers

Conditions: Head and Neck Cancer; Lymph Node Metastases

Summary: this study explores the feasibility of sentinel lymph node identification in pharynx and larynx cancers using flexible endoscopy-guided tracer injection.

the presence of lymph node metastases has a large impact on prognosis and treatment in head-and neck cancer (hnc) patients and necessitates treatment intensification. however, despite increased spatial resolution of current imaging techniques, around 20% of patients with a pre-operative clinically negative neck will have occult metastases in the neck dissection specimen. it is therefore that, when patients are treated with radiotherapy, the neck is almost always included in the target volume, also when the tumor is clinically staged n0 (elective neck treatment). as a consequence, large tissue volumes must be treated resulting in significant morbidity such as mucositis, dysphagia, xerostomia and on the long term also hypothyroidism and vascular damage. if the detection of small lymph node metastases can be improved elective neck treatment may be avoided in at least part of the patients resulting in less toxicity and improved quality of life. one promising approach is the sentinel node procedure. thus far, the sentinel node procedure is not employed in patients with larynx and pharynx cancers that are treated with primary radiotherapy. one reason is that these tumors are not easily accessible for tracer injection and this needs to be done under general anesthesia. however, in the past few years there has been progress with instrumentation via flexible endoscopy. the ent-department of radboudumc has developed expertise with endoscopic biopsy taking and even laser surgery of pharynx and larynx cancers. the purpose of this study is to explore the feasibility of sentinel lymph node identification in pharynx and larynx cancers using flexible endoscopy-guided tracer injection.

Eligibility criteria:
inclusion criteria: * male or female aged \>18 years. * mucosal tumor of the oropharynx, hypopharynx or larynx. * patients planned to undergo biopsy via flexible endoscopy. * patients planned to undergo curative radiotherapy with or without concurrent chemotherapy. * patient provided written informed consent. exclusion criteria: * patients who underwent previous surgery or radiotherapy to the neck. * patients with airway obstruction causing stridor. * prior allergic reaction to tc-99m-nanocolloïd. * pregnancy. * unable to provide informed consent.
to calculate the pharmacokinetics (concentration of compound in and rate of excretion from the blood) following a very low dose of compound which will not have any pharmacological activity

Conditions: Healthy

Summary: the purpose of this study is to calculate the pharmacokinetics (concentration of compound in and rate of excretion from the blood) following a very low dose of compound which will not have any pharmacological activity and to monitor for the safety and tolerability of each of the compounds in the study.


Eligibility criteria:
inclusion criteria: * healthy male subjects between the ages of 18 and 50 years inclusive. (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination including blood pressure and pulse rate measurement, 12-lead ecg and clinical laboratory tests) * body mass index (bmi) of 17.5 to 30.5kg/m2l and a total body weight of between 50 and 100kg inclusive. * evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial. exclusion criteria: * evidence or history of clinically significant haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, genitourinary, psychiatric, neurologic or allergic disease (including drug allergies, but excluding untreated, symptomatic, seasonal allergies at time of dosing) * history of febrile illness within 5 days prior to the first dose a positive urine drug screen

Keywords: pharmacokinetics safety tolerability chronic pain
predictive model of clinical outcomes using web-based self-reporting symptom diary for crohn's disease

Conditions: Crohn's Disease

Summary: the purpose of this study is to develop and validate a predictive model of clinical outcomes based on the results of web-based self-reporting symptom diary for crohn's disease.


Eligibility criteria:
inclusion criteria: * newly diagnosed of crohn's disease within 6 months * must record their symptom in a web-based symptom diary at least 4 consecutive times for 2 months. exclusion criteria: * not able to use smart phone.

Keywords: crohn's disease disease outcomes
effect of health education on water handling practices in rural pondicherry

Conditions: Drinking Water Handling Practice; Knowledge of Water Borne Diseases; Bacteriological Quality of Water

Summary: the purpose of this study is to assess the drinking water handling practices at household level and to determine the effect of health education on the drinking water handling. participants from study villages, mainly homemakers, school children and water tank operators who are willing to participate, will be targeted. baseline assessment of household practices related to water will be done. followed by a health education regarding the healthy practices will be given to them. practice of household water chlorination will be promoted. the healthy behavior will be reinforced through reminders and community activities of self help groups for one year. the study participants will be benefited from survey in terms of 1. improved knowledge and practices of drinking water handling 2. risk reduction of water borne illness to family members


Eligibility criteria:
inclusion criteria: * subjects of five study villages exclusion criteria: * those who anticipate to move out of study area in next one year

Keywords: health education water handling practices bacteriological quality of water
sentinel node with ultrasound contrast in melanoma

Conditions: Malignant Melanoma

Summary: the purpose is to evaluate,in 20 patients, if the sentinel node(s) in melanoma can be detected by lymph contrast ultrasound. in comparing the patients will also get lymph-scintigraphy and sentinel node detection wiht blue dye. the goal is to improve the method for detecting sentinel node(s) in melanoma.


Eligibility criteria:
inclusion criteria: * malignant melanoma on a extremity, * no spread of the cancer, * patients over 18 years old, exclusion criteria: * pregnancy, * lactating, * severe hart disease,
anesthetics and analgesics in children

Conditions: Anesthesia; Pain

Summary: the purpose of this study is to characterize the pharmacokinetic (pk) and safety profile of anesthetics and analgesics in children and adolescents.

this is a research study to find out what the side effects are of certain drugs that are commonly used for pain and to put people to sleep for surgery. the researchers also want to know how the drug is broken down in the body. participants will be given these drugs as they are prescribed by their regular doctor. as part of the participant's standard of care, doctors will perform tests, ask questions, review medical information and measure vital signs (heart rate, blood pressure, etc). the researchers will collect information that doctors have already written in the medical records. the research study team will collect blood from participants at certain time points depending on when the participant was first given the drug (up to 5 samples over the course of 10 to 48 hours). examples of current and upcoming anesthetics and analgesics include, but are not limited to: ketorolac (toradol), ketamine (ketalar), oxycodone (oxycontin), and morphine (kadian, ms contin).

Eligibility criteria:
inclusion criteria: 1. 0 to \<18 years of age at time of enrollment (must see applicable appendix for details as not all appendices enroll across the entire age range) 2. parent and/or participant (if applicable) is able to understand the consent process and provides informed consent and hipaa authorization (if applicable) 3. participant provides assent as required by the institutional review board (irb) or research ethics board (reb) 4. receiving one or more drugs of interest (doi) per local standard of care 5. meeting doi-specific inclusion criteria (see appendices) exclusion criteria: 1. known pregnancy 2. extracorporeal life support (i.e., ecmo, dialysis, ventricular assist device) 3. any condition which would make the participant, in the opinion of the investigator, unsuitable for the study