Kornimate/medical-research-clean huggingface dataset:
promoting water consumption for prevention of overweight in school children in a controlled intervention trial

Conditions: Overweight

Summary: a major goal in public health is to find effective, feasible and simple programs for overweight prevention among children. this controlled intervention study evaluates a simple environmental and behavioral modification for its efficacy in preventing overweight of children in the school setting. the intervention strategy focuses solely on the promotion of drinking tap water. the study was conducted in 32 elementary schools including about 3000 children in two german cities over 1 school year.

soft drinks and other caloric beverages are supposed to be involved in the development of overweight and obesity in children. the intervention strategy of our study was to promote water consumption by facilitating access to tap water in schools assuming a concomitant decrease in caloric soft drinks at least at school. the environmental modification of installing a water dispenser at school and delivering a special bottle to each child in the intervention schools was supported by a few educational lessons. these lessons were held by the class teachers who received a prepared 6-hour curriculum dealing with the importance of water for the body and of water intake. for the study 17 randomly selected schools were assigned to the intervention group, 15 schools to the control group that did not receive any intervention. body weight and height to calculate bmi as primary outcome were assessed at baseline and after the intervention period of 1 school year. as secondary outcome drinking and physical activity habits were evaluated at baseline and after the intervention. the water flow of the dispenser was measured at regular intervals. in addition, data of process evaluation was collected to measure acceptance and feasibility of the intervention in the school setting. to analyze the efficacy of this primarily environmental and behavioral intervention, incidence and prevalence was compared between intervention and control group.

Eligibility criteria:
inclusion criteria: * all children in 2nd and 3rd grade of selected elementary schools exclusion criteria: * parental consent

Keywords: children primary prevention environmental change behavioural change school setting changing of drinking habits promotion of drinking tap water
feasibility of microdialysis by laparoscopy

Conditions: Rectal Cancer

Summary: the aim of this pilot study is to evaluate the feasibility of microdialysis by laparoscopy in order to identify anastomotic leaks after rectal surgery.


Eligibility criteria:
inclusion criteria: * rectal disease requiring proctectomy with anastomosis and stomy * proctectomy by laparoscopy * written consent exclusion criteria: * history of colorectal surgery * rectal surgery without anastomosis * breastfeeding or pregnancy * asa score iv

Keywords: rectum microdialysis quality of life
study comparing etanercept and methotrexate vs. methotrexate alone in rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: to compare the effects of the combination of etn and mtx to mtx alone on radiographic change and clinical disease activity in subjects with early ra over 12 months.


Eligibility criteria:
inclusion criteria: * satisfies the 1987 acr revised criteria for rheumatoid arthritis * has ra greater than or equal to 3 months and less than or equal to 2 years exclusion criteria: * received any previous treatment with mtx * received any previous treatment with etn or other tumour necrosis factor antagonist

Keywords: rheumatoid arthritis
study in patients with breast cancer leptomeningeal metastasis

Conditions: Leptomeningeal Metastasis of Breast Cancer

Summary: traditional clinical trials in patients with breast cancer leptomeningeal disease (lmd) are challenging as patients often have a rapidly progressive course and prognosis is poor, making meeting standard eligibility difficult. furthermore, there is limited information about the biology of lmd. the investigators thus propose a study that is as inclusive as possible, which will allow the investigators to collect biospecimens and clinical outcomes to learn more about lmd biology, but still potentially provide benefit for patients, by providing patients rapid diagnostics and multi-disciplinary treatment recommendations.

this is a prospective translational observational study for patients with breast cancer leptomeningeal disease (lmd). lmd is notoriously difficult to treat, and prognosis is generally very poor, with most patients typically succumbing to the disease within a few months of its diagnosis. conducting clinical trials is challenging for these reasons, and there are limited data regarding biological processes of lmd. the overarching goal of this study is to be as inclusive as possible to optimize and learn from patients with lmd. the investigators propose a prospective observational study to establish (1) a translational collection protocol to comprehensively collect tissue, blood, and cns samples, and (2) a therapeutic management program utilizing the johns hopkins molecular tumor board, to provide multi-disciplinary treatment recommendations in a timely manner, and (3) collect outcome data that can be correlated with biomarkers.

Eligibility criteria:
inclusion criteria: * male or female, aged 18 or older * history of breast cancer (any subtype) * suspected breast cancer-related leptomeningeal metastasis (i.e., by clinical signs or symptoms (i.e., peri-oral dysesthesia, unexplained new neurological symptoms in the absence of brain metastasis), radiographic, or by cerebrospinal fluid analysis), whereby patient will be treated along an leptomeningeal disease paradigm. * previous central nervous system metastasis (including leptomeningeal disease or brain metastasis) is eligible. * eastern cooperative oncology group (ecog) score of ≤3 or karnofsky performance status ≥60. exclusion criteria: * suspected central nervous system recurrence of hematologic malignancy, lymphoma or other solid tumor * not eligible for treatment of leptomeningeal disease.

Keywords: breast cancer
chemotherapy in treating patients with lung cancer

Conditions: Non Small Cell Lung Cancer

Summary: this observational study was planned, with the primary objective to observe patient survival following first-line treatment of patients of stage iiib/iv non-small cell lung cancer (nsclc) with different platinum-based doublets under routine disease management conditions. further secondary objectives of this study are to provide insights to what extent histologic subtyping and the use of additional prognostic or predictive biomarkers are currently considered for differential therapeutic decisions under routine conditions. all of these data are critical to evaluate the factors for differential therapeutic decisions and their effect on patient outcomes in a real life setting, and they can only be obtained through observational research.


Eligibility criteria:
inclusion criteria: * histological or cytological diagnosis of non-small cell lung cancer (nsclc) stage iiib-iv * initiation of first-line treatment for advanced nsclc with any platinum-based doublet chemotherapy, with or without additional targeted agents * 18 years of age or older exclusion criteria: * participating simultaneously in a study including administration of any investigational drug or procedure at entry into this study

Keywords: metastatic advanced stage iiib-iv daily hospital practice setting
the study of efficacy and safety of 2% ketoconazole cream in thai females with mild degree of post - adolescence acne

Conditions: Post - Adolescence Acne

Summary: to study efficacy (total numbers of acne reduction) and safety of 2% ketoconazole cream in thai females with mild degree post-adolescence acne comparing with placebo for a period of 12 weeks.


Eligibility criteria:
inclusion criteria: * regular menstrual cycle with mild degree of post - adolescence acne * agree to stop topical and systemic medication for acne treatment for 2 and 4 weeks respectively. exclusion criteria: * pregnancy or lactation * other active rashes on faces. * allergic to ketoconazole or other ingredients of preparation. * signs of hyperandrogenism * taking anti-androgenic medications.

Keywords: post - adolescence acne topical 2% ketoconazole cream
insulin resistance and insulin secretion

Conditions: Diabetes Mellitus, Type 2

Summary: this is a pilot study to examine the prevalence of metabolic risk factors (impaired insulin release and impaired insulin sensitivity) for type 2 diabetes mellitus in children and adults from a population that is at high risk for this disease. we hypothesize that at least one of these pre-diabetic traits will be evident in a large proportion of relatives of known type 2 diabetic children as compared to a control group of subjects without a family history of type 2 diabetes. by isolating these traits, it will be possible to determine the relative contributions of genes and environment to each trait and to identify those at risk for subsequent development of type 2 diabetes by virtue of having one trait. ultimately, those individuals at risk, especially those with impaired insulin release, would hopefully benefit from intervention to prevent the weight gain that will 'unmask' their underlying pancreatic dysfunction and thus prevent or retard the development of type 2 diabetes.


Eligibility criteria:
ascertainment criteria for probands: * age 10-20 years and * obesity (bmi \>85% for sex and age) * diabetic criteria as described above or family history (first or second degree relative) with type 2 diabetes

Keywords: diabetes
steroid-eluting sinus stent for chronic rhinosinusitis patients with uncontrolled postoperative symptoms

Conditions: Chronic Sinusitis

Summary: stent-001 study is a randomized controlled clinical trial with the steroid-eluting sinus in 96 chronic rhinosinusitis patients with uncontrolled postoperative symptoms

stent-001 is a randomized (1:1), sham-controlled, parallel group, single-blind, non-inferiority, multicenter study in 96 chronic rhinosinusitis patients who had prior endoscopic sinus surgery and presented with uncontrolled postoperative symptoms. the objective was to evaluate the safety and clinical efficacy of sinus stents relative to systemic glucocorticoids. the steroid-eluting sinus stent consist of a bioabsorbable self-expanding sinus implant coated with 625 mcg of mometasone furoate (mf) and a single-use delivery system. implant is placed in-office in the ethmoid sinus under local anesthesia. the coating on the sinus stent implant provides controlled release of mf to the sinus mucosa over 30 days.

Eligibility criteria:
inclusion criteria: * the patient underwent pre-functional endoscopic sinus surgery and bilateral ethmoidectomy (for at least 3 months), and was identified by the clinician as having uncontrolled symptoms (diagnostic criteria of epos 2020) with a snot-22 score of at least 20; * edema score of bilateral nasal endoscopy was 2 points both; * understands the purpose and procedures of the trial and voluntarily signs the informed consent form; * the female subjects had no pregnancy or lactation plans during the treatment and follow-up period; * the subject has not participated in other clinical trials in the previous three months and agrees not to participate in other clinical trials until the end point of this trial was reached; * subjects were 18-65 years old, male or non-pregnant women; exclusion criteria: * grade 2 or more nasal polyp scores in either nasal cavity (i.e., polyps extending beyond the middle nasal passage) * the subject has a known allergic reaction or contraindication to the device material and its degradation products (mamethasone citrate, l-polylactic acid, racemic polylactic acid, lactide lactate, lactic acid); * subjects had cystic fibrosis, congenital ciliary dyskinesia, fungal globular sinusitis, systemic vasculitis and granulomatous diseases, tumors, and immune deficiency. * the patient underwent endoscopic nasal surgery within 3 months. * acute exacerbation of allergic rhinitis, acute exacerbation of crs, upper respiratory tract infection, or common cold in the 4 weeks prior to screening visit; * have a clinically serious metabolic, cardiovascular, immune, neurological, blood, digestive, cerebrovascular, or respiratory disease, or any condition that the investigator believes interferes with the evaluation of the study results or affects the safety of the subjects; * symptomatic seasonal allergic rhinitis, and/or, depending on the season, expected to develop symptoms and require nasal spray hormone therapy within 4 weeks of randomization,

Keywords: steroid-eluting sinus stent mucous edema
a comparison of the effect of olmesartan medoxomil, losartan potassium, and atenolol on the ability of overweight patients with high blood pressure to respond to insulin

Conditions: Hypertension; Insulin Resistance; Metabolic Syndrome

Summary: to examine the effect of three different blood pressure medications on the insulin sensitivity in overweight patients with high blood pressure.


Eligibility criteria:
inclusion criteria: * patients between the ages of 18 and 75 years (inclusive) * willingness to undergo insulin clamp procedure twice * overweight or obese (bmi=25-39 kg/m2) * subject must meet one of the following two blood pressure criteria at week-2 and at week-1: systolic blood pressure 140-179 mmhg and diastolic blood pressure 85-99 mmhg or systolic blood pressure \< 140 mmhg and diastolic blood pressure 90-99 mmhg * if female, must have negative serum pregnancy test at screening and be either post-menopausal, had a hysterectomy or tubal ligation at least 6 months before consent or if of childbearing potential, must practice approved measures of birth control throughout study exclusion criteria: * systolic blood pressure \> 179 mmhg * diastolic blood pressure \> 99 mmhg or \< 85 mmhg * diagnosis of diabetes mellitus * history of myocardial infraction, percutaneous transluminal coronary revascularization, coronary artery bypass graft, unstable angina pectoris or an episode of heart failure requiring hospitalization * previous history of a cerebrovascular accident or a transient ischemic attack * history of allergic response to atenolol, losartan potassium, olmesartan medoxomil or any of their components * any serious disorder, including pulmonary, hepatic, renal, gastrointestinal (including clinically significant malabsorption), uncontrolled endocrine/metabolic, hematologic/oncologic (within the last 5 years), neurologic, and psychiatric diseases, that would interfere with the conduct of the study or interpretation of the data * laboratory abnormalities that could compromise subject safety
annapurna: a study of the combination of ro5466731, ro5190591, ritonavir and copegus (ribavirin) with or without ro5024048 in patients with chronic hepatitis c who are either treatment-naïve or have previously experienced a null response to interferon-based treatment

Conditions: Hepatitis C, Chronic

Summary: this randomized, open-label, multicenter study will evaluate the safety , efficacy and tolerability of the combination treatment ro5466731, ro5190591, ritonavir and copegus (ribavirin) with or without ro5024048 in patients with chronic hepatitis c genotype 1. in part 1, treatment-naïve patients will be randomized to receive treatment with ro5466731, ro5190591 plus ritonavir, and copegus, with or without ro5024048. in part 2, further treatment-naïve patients will receive a successful regimen from part 1, or a reduced intensity regimen, and patients who have previously experienced null response to interferon-based treatment will be added to the study.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * chronic hepatitis c genotype 1 of \>/= 6 months duration at screening * part 1 and part 2: naïve to treatment with interferon (pegylated or non-pegylated). patients who have participated in studies investigating a direct-acting antiviral agent with or without interferon are excluded * part 2: treatment experienced patients having a previous null response to treatment with interferon containing regimen * liver biopsy or non-invasive (e.g. fibroscan) evaluation in the past 24 calendar months showing absence of cirrhosis or incomplete/transition to cirrhosis * body mass index (bmi) 18 to 35 kg/m2 inclusive and body weight \>/= 45 kg exclusion criteria: * pregnant or lactating women or males with female partners who are pregnant or lactating * decompensated liver disease or impaired liver function (as defined by protocol) * cirrhosis or incomplete/transition to cirrhosis * non- hepatitis c chronic liver disease * positive for hepatitis b or hiv infection * history of pre-existing renal disease * history of severe cardiac disease * history of neoplastic disease within the last 5 years, except for localized or in situ carcinoma of the skin * history of drug abuse within the last year; history of cannabinoid use is not excluded * evidence of alcohol abuse within 1 year of screening and consumption of more than 2 units of alcohol per day * medical condition that requires use of systemic corticosteroids * received warfarin or other anticoagulants during the 21 days immediately prior to screening or is expected to require warfarin or other anticoagulants during the study * anticipated use or need for significant medical treatment during the study or use of concomitant medications or nutrients that are excluded by protocol (e.g. drugs that are contraindicated with ritonavir, hormonal methods of contraception)
maternal health diabetes prevention study

Conditions: Gestational Diabetes; PreDiabetes; Hyperglycemia; Glucose Intolerance During Pregnancy

Summary: the aim of this project is to use the exploration, preparation, implementation, sustainment (epis) framework to collect pilot data on the implementation of a diabetes prevention program-like intervention in the women, infants, and children (wic) program.

in this study, investigators will pilot a 2-month diabetes prevention program-like program (delivered by wic staff) to 20 women with recent gestational diabetes (6 weeks to 12 months postpartum) who receive wic services. the goal of this pilot is to evaluate the feasibility, acceptability, appropriateness, fidelity of implementing this intervention in the setting of wic clinics and feasibility of conducting a larger-scale study.

Eligibility criteria:
inclusion criteria: * age ≥18 years * 6 weeks to 12 months postpartum * medical record documented diagnosis of gdm during most recent pregnancy * access to a device that can access the internet * english speaking exclusion criteria: * pregnant or planning to become pregnant in the next two months * planning to move out of the area in the next two months * self-report of diagnosed diabetes * use of glucose-lowering medications * plasma glucose \>200 mg/dl and classic symptoms of hyperglycemia (thirst, polyuria, weight loss, blurry vision) or hba1c \>6.5% (based on screening visit blood draw) * unable or unwilling to provide informed consent

Keywords: diabetes prevention program behavioral intervention diet physical activity special supplemental nutrition program for women, infants, and children (wic)
effect of acupuncture augmented with pelvic floor exercises on overactive bladder

Conditions: Overactive Bladder Syndrome

Summary: the aim of this study is to investigate the effect of pelvic floor exercises augmented with acupuncture on overactive bladder

overactive bladder syndrome (oab) is a common complaint affecting 11.8% of the population. oab is defined by the international continence society as "urinary urgency, usually accompanied by frequency and nocturia, with or without urgency urinary incontinence, in the absence of urinary tract infection or other obvious pathology."urinary frequency accompanies oab in 20%-25% of cases, and nocturia is present in 70%-75% of cases. around one in three people with oab also experience urinary incontinence. . oab can be further categorized into "oab-dry" (urinary incontinence is absent) and "oab-wet" (urinary incontinence is present). 2 oab is a long-term condition that reduces quality of life, leading to anxiety and depression and a negative effect on self-esteem. pelvic floor exercises and acupuncture play an important role in overactive bladder.this trial has 2 groupes ,one will recieve pelvic floor exercises augmented with acupuncture ,the second will recive pelvic floor exercises only for 12weeks.

Eligibility criteria:
inclusion criteria: patients with a clinical diagnosis of idiopathic oab syndrome. willingness to take part in the study protocol. ability to complete outcome measures. ability to give informed consent. acupuncture not contra-indicated. age:50-60 years. vaginal delivery. -parity:2-3times. body mass index \<35kg/m2. exclusion criteria: * - evidence of other pathology that may be contributing to oab symptoms i.e., urinary tract infection or a neurological condition. * smoking. * taking sedative and hypnotic drugs.

Keywords: pelvic floor exercises and acupuncture
a study to evaluate the efficacy and safety of ak102 in patients with hyperlipidemia

Conditions: Hyperlipidemia

Summary: this is a randomized, double-blind, placebo-controlled phase 3 clinical study evaluating the efficacy and safety of ak102 in patients with primary hypercholesterolemia and mixed hyperlipidemia.

this is a phase 3 clinical study to evaluate the efficacy and safety of ak102, a monoclonal antibody against proprotein convertase subtilisin/kexin type 9 (pcsk9), in subjects with primary hypercholesterolemia and mixed hyperlipidemia.

Eligibility criteria:
inclusion criteria: 1. subject understand and voluntarily sign the written inform consent form (icf). 2. male or female ≥ 18 to ≤ 80 years of age. 3. the fasting serum ldl-c level of subjects did not meet the treatment goal after at least 4 weeks of stable lipid-lowering background treatment. 4. tg ≤ 4.5 mmol/l (400 mg/dl). exclusion criteria: 1. known homozygous familial hypercholesterolemia. 2. received pcsk9 inhibitors within 6 months before randomization. 3. known sensitivity to pcsk9 inhibitors and any substances to be administered. 4. severe renal dysfunction. 5. previously received organ transplantation. 6. uncontrolled hypothyroidism or hyperthyroidism. 7. uncontrolled hypertension. 8. known hyperlipidemia secondary to comorbidity, including nephrotic syndrome, cholestatic liver failure, etc. 9. history of malignancy of any organ system within the past 5 years. 10. pregnant or lactating women.