Kornimate/medical-research-clean huggingface dataset:
immunogenicity of fluzone hd,a high dose influenza vaccine, in children with cancer or hiv

Conditions: HIV; Cancer

Summary: this is an open label-study of fluzone hd, a high-dose form of trivalent, inactivated influenza vaccine (tiv), vs. fluzone, a standard-dose form of tiv. subjects with cancer or hiv will be vaccinated twice with one of the two vaccines and evaluated for development of immune responses.

the primary objectives of this study are to compare the immune response of fluzone hd, a high-dose, trivalent influenza vaccine (tiv), to fluzone, a standard-dose tiv, in children with cancer and in children with hiv. the secondary objectives of this study are to: * describe the safety and reactogenicity of high-dose and standard-dose tiv. * compare the immunogenicity induced by 1 dose, compared to 2 doses, of high-dose and standard-dose tiv. * describe the relationship between baseline lymphocyte numbers/function and robustness/durability of the immune response.

Eligibility criteria:
inclusion criteria: * age 3 years (on or past their 3rd birthday) through 21 years of age (not yet reached their 22nd birthday) at the time of entry into the study. * written informed consent (and assent, if applicable) obtained. * participant has a diagnosis of cancer or hiv. * if subject has cancer, currently receiving chemotherapy and /or radiotherapy for the treatment of cancer or has received chemotherapy in the past 12 weeks exclusion criteria * severe hypersensitivity to egg proteins or any component of fluzone, or life-threatening reactions after any previous administration of any influenza vaccine; * history of guillain-barre´ syndrome in the subject or subject's family (parents, siblings, half siblings, or children); * not willing to agree to acceptable birth control for three months after study immunization

Keywords: fluzone trivalent influenza vaccine
a study of bgm0504 injection in participants with obesity or overweight

Conditions: Overweight or Obesity

Summary: this is a multicenter, randomized, double-blind, placebo-controlled phase iii validation clinical study in chinese adult non-diabetic overweight or obese participants. the main purpose is to evaluate the clinical efficacy of bgm0504 injection for 36 weeks of administration as an adjunct to diet, exercise, and behavioral interventions in overweight or obese non-diabetic adults in china for weight management, and to evaluate the clinical efficacy and safety of bgm0504 injection for 52 weeks of administration.


Eligibility criteria:
inclusion criteria: * a male or female aged 18 to 65 years inclusive at screening * bmi≥28 kg/m², or 24.0≤bmi\<28.0 kg/m² and previous diagnosis with at least one of the following comorbidities: i. prediabetes (impaired fasting blood glucose and/or impaired glucose tolerance), hypertension, nonalcoholic fatty liver disease, or one or more of these; ii. joint pain with weight bearing; iii. dyspnea caused by obesity or obstructive sleep apnea syndrome * weight change \< 5.0% (chief complaint) after diet and exercise control for at least 12 weeks before screening * female participants who are not pregnant or lactating. female participants with childbearing potential and their partners should use highly effective, medically accepted contraception, will not have pregnancy and fertility plan, and refrain from donating ovum until one month after the end of the study exclusion criteria: * diabetes mellitus * known to be allergic to 3 or more kinds of foods or medications, or allergic to glp-1 agonist, or have a severe allergic disease (asthma, urticaria, eczematous dermatitis, etc.) at screening * has been treated with glp-1 receptor agonists or similar drugs containing the same target, or drugs used for weight control in the three months prior to screening * secondary disease or drug-induced obesity, including : elevated cortisol (e.g. cushing's syndrome), obesity due to pituitary and hypothalamic damage, obesity due to diet drug reduction/discontinuation, etc.; * history of pancreatitis * have the currently uncontrolled thyroid diseases with stable treatment dose and clinically significant abnormal results of thyroid function test occurred at screening * previous history of moderate or severe depression, or phq-9 score ≥15, or history of other serious mental illness, or any lifetime history of a suicide attempt
duration of adjuvant chemotherapy for gastric cancer patients at pathological n3 stage

Conditions: Gastric Cancer

Summary: the goal of this retrospective study is to compare the efficacy and safety of 3-4 months to 5-6 months of capox/sox adjuvant chemotherapy in pathological n3 gastric cancer patients.

due to a heavy metastatic node burden, pathological stage n3 (pn3) gastric cancer (gc) patients have extremely poor prognoses. except for surgical resection, postoperative adjuvant chemotherapy is the major treatment strategy to improve survival for these patients. capecitabine plus oxaliplatin (capox) and s-1 plus oxaliplatin (sox) were considered the effective treatment for stage ii and iii gc after d2 gastrectomy in the classic and resolve trials. but n3b (positive lymph nodes ≥16) and t1-3n3 patients were omitted in these two trials, respectively. moreover, only 66.5% of patients finished 6 months of chemotherapy in the classic trial, and in the resolve trial, 17-19% of patients required dose reductions and about 19% of patients discontinued chemotherapy due to drug-related toxicity for 6 months of chemotherapy. particularly, cumulative administration of oxaliplatin led to peripheral sensory neurotoxicity, which caused poor quality of life and treatment compliance. recently, a prospective analysis of six randomized, phase 3 trials with 12834 participants (idea trail) for stage iii colon cancer, demonstrated that 3 months of capox was as effective as 6 months with relatively lower recurrence risk, no significantly different overall survival, and fewer adverse effects. however, there were no relevant studies to explore the optimal duration of chemotherapy for pn3 gc patients. this study aims to compare the efficacy and safety of 3-4 months to 5-6 months of capox/sox adjuvant chemotherapy in pathological n3 gastric cancer patients.

Eligibility criteria:
inclusion criteria: 1. 18-80 years old 2. pathological stage n3 gc (≥7 positive lymph nodes) after curative surgery according to the ajcc tnm staging system, 8th edition 3. histologically confirmed r0 resection, defined as no macroscopic or microscopic residual tumor 4. postoperative chemotherapy with capox or sox doublet regimen, initiating within 6 weeks after curative gastrectomy 5. no distant metastases or gastric stump cancer 6. no other malignant tumors exclusion criteria: 1. patients who had undergone neoadjuvant chemotherapy or radiotherapy 2. patients who received capecitabine or s-1 alone or combined with biological therapy, radiation therapy, or immunosuppressive therapy
a cluster randomized trial to evaluate long lasting insecticidal hammocks to prevent forest malaria in vietnam

Conditions: Malaria

Summary: in central vietnam, forest malaria remains difficult to control due to the complex interactions between human, vector and environmental factors. untreated bednets had a significantly protecting effect for villagers, except for those regularly sleeping in the forest, who suffer a significantly higher number of clinical attacks. thus, there is need to target this high-risk group with new intervention based on long-lasting insecticidal materials. hammocks are extensively used by people working in the forest, therefore long-lasting insecticidal hammocks (llih) could achieve a good individual protection. the investigators proposed to evaluate their effectiveness in a community-based trial, comparing them to the standard vector control methods (insecticide-treated nets).

in central vietnam, forest malaria remains difficult to control due to the complex interactions between human, vector and environmental factors. a community-based study carried out between 1999 and 2001 showed that regular forest activity was a strong risk factor for malaria infection. untreated bednets had a significantly protecting effect for villagers, except for those regularly sleeping in the forest, who suffered a significantly higher number of clinical attacks. thus, there is need to target this high-risk group with new intervention based on long-lasting insecticidal materials. hammocks are extensively used by people working in the forest, therefore long-lasting insecticidal hammocks (llih) could achieve a good individual protection. the investigators proposed to evaluate their effectiveness in a community-based trial, comparing them to the standard vector control methods (insecticide-treated nets): communities have been grouped into clusters of about 1000 înhabitants, and clusters were randomized to either the active intervention or the active control, and followed up for 24 month.

Eligibility criteria:
inclusion criteria: * all residents in the 20 concerned study clusters and willing to give informed consent to participate exclusion criteria: * people not willing to give informed consent to participate

Keywords: forest malaria prevention long-lasting insecticidal hammocks cluster randomized trial central vietnam
kinesiotaping versus pilate exercises

Conditions: Dysmenorrhea; Exercise

Summary: sixty girls participated in this study and their main complaints were pain and cramping during menstruation. they were divided randomly into two equal groups.

group (a) (30 girls) treated by kinesiotaping during menstruation for 3 successive menstruation. group (b) (30 girls) treated by pilate exercises, 3 sessions per week for 3 months except the days of menstruation. visual analogue scale to assess pain intensity, quality of life enjoyment and satisfaction questionnaire, menstrual distress questionnaire, walidd score, spielberger questionnaire and blood sample analysis to estimate plasma prostaglandin level were applied for each girl in both groups before and after the treatment course.

Eligibility criteria:
inclusion criteria: * their ages ranged from 14 to 20 years old * their body mass index (bmi) would be less than 25 kg/m2 * having primary dysmenorrhoea exclusion criteria: * skin diseases or cardiac diseases * irregular or infrequent menstrual cycles * previous abdominal or back operations

Keywords: kinesiotaping pilate exercises primary dysmenorrhea
effects of optimized antiplatelet treatment after percutaneous coronary intervention

Conditions: Ischemic Heart Disease; Acute Coronary Syndromes

Summary: effects of dual antiplatelet therapy with aspirin and clopidogrel after percutaneous coronary intervention has been proven. however, patients with low response to those agents are reported be associated with adverse clinical outcomes. we suppose that optimized antiplatelet therapy for individual patients based on platelet function assay may improve long-term outcomes especially in patients with high risk of thrombosis. in this prospective randomized study, patients in control group all receive standard dual antiplatelet therapy, and patients in optimized group receive different antiplatelet therapy according to risk stratification.


Eligibility criteria:
inclusion criteria: * non-st-segment elevated acute coronary syndromes * patients undergoing selective or emergent pci exclusion criteria: * administration of clopidogrel or ticlopidine within 2 weeks * st-segment elevated myocardial infarction * contraindications of antiplatelet therapy * history of intracranial bleeding * known bleeding disorders * severe liver or kidney disease

Keywords: ischemic heart disease acute coronary syndromes percutaneous transluminal coronary angioplasty platelet function aspirin clopidogrel cilostazol
the relationship between gastroesophageal reflux and pediatric rhinitis: significance of pale/blue colored turbinate

Conditions: Rhinitis; Nasal Obstruction; GERD

Summary: gastroesophageal(gerd) reflux disease is a very common problem among pediatric population and has be proved to contribute in numerous otolaryngological manifestations. trails of empirical treatment of antireflux medications is often used as a diagnostic test. however, the investigators believe gerd can cause rhinitis and nasal obstruction. nasonex is considered as first line treatment for nasal obstruction. hence, the proposed study aims to define the relationship between gerd and rhinitis using randomize control trial where one group of patients will receive nasonex and placebo, while the other group will receive nasonex and antireflux medications.

the proposed study is a randomized controlled trial in which children with nasal obstruction will be randomized to receive either antireflux medication lansoprazole (prevacid) and mometasone furonate (nasonex) or only nasonex and placebo. the diagnosis of nasal obstruction will be made by history and physical examination. the study will take place at montreal children's hospital. after the patients or parents of the patients agree for their children to take part in the study and sign a consent/assent form, baseline information will be collected and the patients will asked to fill out three questionnaires for gerd symptoms and nasal symptom. after that eligible patients will undergo sinus x-ray, nasal endoscopy and allergy skin test (these test are routine performed for all patients with symptoms of nasal obstruction). then the patients will further be sub-divided into two groups based on the allergic skin prick test (spt); allergy positive and allergy negative group. in each group patients will randomly allocated to one of the two study arms; group a will receive lansoprazole (prevacid) and mometasone furonate (nasonex) and the other group will receive nasonex and placebo. the lansoprazole/placebo will be discontinued after 3 months and the patients will undergo nasal endoscopy and will be asked to fill out the three questionnaires again to assess the improvement. the patients will be follow for another 3 months, the patients will again undergo nasal endoscopy and will asked to fill out the three questionnaires to assess the improvement and sustainability.

Eligibility criteria:
inclusion criteria: * 7 (seven) to 17 (seventeen) years of age. * nasal obstruction as main complaint. exclusion criteria: * structural cause of nasal obstruction (deviated nasal septum, adenoid hypertrophy, nasal polyps, nasal tumors) * received antireflux medication during the last three months. * acute sinusitis

Keywords: rhinitis (nasal obstruction) and gerd
noninvasive monitor of vascular volume fluid shifts

Conditions: Blood Loss

Summary: blood volume measurements are a critical step in the emergency care of trauma patients. the typical approach to this is to rely on historical information, physical examination and metrics such as heart rate. there is currently no good real-time measure to track blood volume. this study investigates the use of phonocardiography (listening to the sounds made by the heart) to track changes in central blood volume.

blood draw subjects: participation in this study group may last up to 60 minutes. participants will begin with a brief medical exam to determine eligibility. this will include a review of any history of cardiovascular disease and of medications. prior to a scheduled blood draw, eligible participates will have physiological measurements taken, which may include phonocardiographic measurements, cardiac output, plethysmography (volume changes), multifrequency bioimpedance, thoracic impedance, heart rate, blood pressure, pulse oximetry, continuous non-invasive hematocrit measurement, and respiration. the phonocardiographic measurements may be taken with both a commercial and a custom-built device. these are all non-invasive measurements. after 15 minutes of baseline measurements, a blood draw will proceed normally while the physiological measurements continue. after the participant is finished donating blood, the participant will be asked to stay in place for an additional 15 minutes to continue to collect physiological data. participants are asked not to eat or drink during the 15 minutes as this will provide better data collection. the information collected as data for this study includes: information about medical history, body measurements, and physiological measurements.

Eligibility criteria:
lower body negative pressure (lbnp) participants: inclusion criteria: * in generally good health * free of systemic diseases * no contraindications to lbnp exposure. * no prior history of cardiovascular disease * normal resting systolic blood pressure (sbp, 100-140 mm hg) and diastolic blood pressure (dbp, 60-90 mm hg). exclusion criteria: * individuals who, after lying supine for five minutes, show a greater than 10 mm hg drop in systolic pressure or a greater than 20 beats/minute increase in heart rate with standing during pre-enrollment evaluation blood draw participants: inclusion criteria: * in generally good health * free of systemic diseases * no current or prior history of cardiovascular disease or cardiovascular reactive drugs * blood donors through the dhmc blood donation center * healthy volunteers * people who are taking part in another study where about 500 ml of blood is being drawn * therapeutic phlebotomy patients (hemochromatosis or polycythemia vera patients) exclusion criteria: * pregnancy

Keywords: phonocardiographic measurements
clinical performance of short fiber reinforced resin modified glass ionomer restorations in cervical carious teeth (1y randomized clinical trial)

Conditions: Cervical Caries

Summary: this research proposal is introduced to clinically test short fiber reinforced glass ionomer material from gc europe due to gap of knowledge present in this area. it is characterized by higher flexural strength compared to resin modified glass ionomer (rmgic). additionally, the short fibers provided effective toughening of the rmgic matrix by a fiber bridging mechanism.


Eligibility criteria:
inclusion criteria: * patients with untreated cervical carious lesions * patients with normal occlusion * vital teeth with carious cervical lesion with asymptomatic vital pulp. * teeth with no or minimum mobility. * teeth with normal occlusion. * teeth with surrounding healthy gingiva and supporting-structures. exclusion criteria: * patients who are unable to return for recall appointments * presence of abnormal oral, medical or mental conditions. * patients with severe medical diseases. * patients with xerostomia * patients with parafunctional habits. * teeth with signs and symptoms of irreversible pulpitis or pulp necrosis. * severe periodontal problems. * non carious cervical lesions.

Keywords: fiber reinforced glass ionomer
the incretin effect in patients with gestational diabetes mellitus

Conditions: Gestational Diabetes

Summary: the aim of this study is to evaluate the reduced incretin effect observed in patients with t2dm in relation to reversibility. the incretin effect will be measured by means of ogtt and iivgtt in 12 women with gdm during pregnancy (third trimester), and again 2-3 months post partum. it is anticipated that the incretin effect in patients with gdm is reduced - like in patients with other forms of dm. the investigators estimate that approximately 90 % of the patients with gdm re-establish a ngt 2-3 months post partum. this particular group of patients provides a unique possibility for demonstrating the reversibility of the reduced incretin effect in relation to optimal glycaemic control.


Eligibility criteria:
inclusion criteria: * age above 18 years old * gdm diagnosed according to who guidelines (gdm group) or ruled out by ogtt 75g (control group) exclusion criteria: * previous diagnosis of dm * positive gad-65-autoantibodies and/or positive islet cell autoantibodies (ica) * affected biochemical liver parameters (alat \> 2 times normal upper range) * affected biochemical kidney parameters (se-creatinine \> 130 µm) * treatment with medicine interacting with insulin secretion (e.g. steroids) * treatment with medicine that can not be paused for 16 hours

Keywords: gdm incretin effect gestation reversibility
effectiveness and safety study of the dexcom g4 platinum with modified algorithm

Conditions: Diabetes Mellitus

Summary: to establish the performance of the dexcom g4 platinum with a modified algorithm continuous monitoring system when compared to a laboratory reference measurement.

a study to evaluate the performance of a modification to the g4 platinum cgm system in adults with diabetes.

Eligibility criteria:
inclusion criteria: * ages 18 years or older * diagnosis of type 1 diabetes or type 2 diabetes on intensive insulin therapy (itt) * willing to participate in a clinic session exclusion criteria: * use of acetaminophen during study period * pregnancy * hematocrit (hct) \<35% (females) and 38% (males) * dialysis, history of cardiovascular disease, epilepsy, severe migraines in the past 6 months, adrenal disease, syncope, significant hypoglycemia unawareness, or a history of severe hypoglycemia within the last 6 months. * any condition that, in the opinion of the investigator, would interfere with their participation in the study or pose and excessive risk to study staff.

Keywords: diabetes mellitus
physical activity in ibs - a long term follow up

Conditions: Irritable Bowel Syndrome (IBS)

Summary: increased physical activity has in the investigators recent study been shown to improve symptoms in irritable bowel syndrome (ibs). the aim of this study was to assess the long term effects of the investigators previous intervention in ibs patients to improve physical activity. the investigators aimed to assess the long term effects on ibs symptoms as well as quality of life, fatigue, depression and anxiety.

86 patients who had been included in the investigators previous study "physical activity improves symptoms in irritable bowel syndrome: a randomized controlled trial" were contacted and asked to participate in a long term follow up 5 years after the previous study. the subjects attended one visit at which they underwent a bicycle ergometer test to calculate the oxygen uptake and filled out questionnaires.

Eligibility criteria:
inclusion criteria: * baseline data from the previous study exclusion criteria: * pregnancy * organic gastrointestinal disorders * cardiac disease * respiratory disease

Keywords: ibs physical activity exercise
thyroid replacement therapy in patients with subclinical hypothyroidism

Conditions: Subclinical Hypothyroidisms

Summary: the purpose of this experiment is to compared the changes of thyroid function, anti-thyroid peroxidase antibody, anti-thyroglobulin antibody, thyroid magnetic resonance t1-mapping and various metabolic indexes from baseline to the end of treatment (after the thyroid function had been normal for more than three months)

in patients with autoimmune thyroiditis with mild subclinical hypothyroidism, the study period will include a screening period of not more than 30 days, and a 12-week treatment period compared to baseline. at completion of treatment, thyroid stimulating hormone(tsh), free thyroxine (ft4)，free thyroxine (ft3) will be included. the changes of anti-thyroglobulin antibody, anti-thyroglobulin antibody, t1-mapping and metabolic indexes.

Eligibility criteria:
inclusion criteria: * men or women between the ages of 18 and 75; * diagnostic criteria for mild subclinical hypothyroidism :tsh\>10miu/l, thyroxine and free thyroxine levels were normal * positive thyroglobulin antibody and/or thyroperoxidase antibody * no previous use of drugs affecting thyroid function exclusion criteria: * the contraindications indicated in the chinese instructions of the drug * liver function impairment * renal function impairment * claustrophobia * mental disorders