Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of bumetanide oral liquid formulation in children aged from 2 to less than 7 years old with autism spectrum disorder.

Conditions: Autism Spectrum Disorder (ASD)

Summary: the purpose of this study was to evaluate the efficacity and the safety of bumetanide/s95008 in the improvement of autism spectrum disorder core symptoms.

the present study (cl3-95008-002) was performed in children from 2 to less than 7 years old presenting with asd. a 6-month double-blind treatment period was performed in which efficacy and safety of bumetanide 0.5mg bid were assessed versus placebo. this double-blind period was followed by a 6-month open label treatment period of bumetanide 0.5mg twice daily in which long term safety was evaluated.

Eligibility criteria:
inclusion criteria: * male and female patients from 2 to less than 7 * primary diagnosis of asd as per diagnostic and statistical manual of mental disorders - fifth edition (dsm-5) criteria * criteria met for asd on autism diagnostic observation schedule-generic (ados-2) and autism diagnosis interview revised (adi-r) * cgi (clinical global impression) - severity rating score ≥ 4 * childhood autism rating scale second edition (cars2-st or hf) total raw score ≥ 34 * social responsiveness scale second edition (srs-2) total score ≥ 66 t-score * absence of diagnosis of fragile x or rett syndrome * absence of any clinically significant abnormality likely to interfere with the conduct of the study according to the judgment of the investigator. exclusion criteria: * patients not able to follow the study assessments defined by the protocol, with the exception of self-rating questionnaires which will be assessed by parent/legal representative/caregiver for those patients unable to complete them * patients having a high suicidal risk according to the investigator judgement * chronic renal dysfunction * chronic cardiac dysfunction * patient with unstable psychotherapy, behavioural, cognitive or cognitive-behavioural therapy * severe electrolyte imbalance that is likely to interfere with the study conduct or evaluation
effect of magnesium alginate on gastroesophageal reflux in infants.

Conditions: Gastroesophageal Reflux

Summary: a randomized controlled cross-over trial in full-term infants affected by symptoms suggestive of ger, evaluated through a validated questionnaire (infant gastroesophageal reflux questionnaire revised). the parents of all of the enrolled infants will be reassured on the benign nature of the condition and will advise to apply lifestyle changes for one week. than, the patients will be randomized into one of the two sequence treatment groups. (group a: mg alginate/thickened formula; group b: thickened formula/mg alginate) for two weeks. evaluation of symptom scores will be performed at day 0, day 7, day 21 and day 35.


Eligibility criteria:
inclusion criteria: * full-term ages 3 to 12 months, affected by symptoms suggestive of ger. * infant regurgitation defined according to the rome iv criteria * informed consent exclusion criteria: * evidence of chronic diseases, hepatic, renal, or cardiac diseases, metabolic or central nervous system diseases, or use of acid suppressor treatment (h2-receptor antagonists or proton pump inhibitors \[ppis\]), thickened formula, or a history of prematurity or atopy
study to assess the effects of high protein diet in obesity, the lower study

Conditions: Obesity

Summary: this program is carried out in a dedicated outpatient-clinic in the city of hengelo for the evaluation and treatment of subjects with obesity. the program puts emphasis on intervention with appropriate diet and physical exercise, and supports the patients in achieving long-term behaviour changes. interventions which are compared are normal vs high protein/low carb diets.

assessment focuses on the effect of the specific diets on weight reduction after 3 months, and weight maintenance after 12 months.

Eligibility criteria:
inclusion criteria: * obesity with bmi \> 27 kg/m2 exclusion criteria: * recent loss of body weight (\>10%) * underlying malignancy, hiv infection, psychiatric disease * pregnancy or breast feeding

Keywords: low carbohydrate high protein diet
post hysterectomy pain prevention: pre-op wound infiltration with anesthetic protocol versus standard of care

Conditions: Hysterectomy

Summary: the study is a blinded randomized clinical trial, comparing policies of high volume preemptive wound infiltration with a specific anesthetic cocktail versus standard of care (no wound infiltration and routine anesthesia) for post operative pain management after hysterectomy. morphine use and pain will be measured during index admission, and pain will also be measured six weeks postoperatively. the study will be conducted at a single site, rockyview general hospital.


Eligibility criteria:
inclusion criteria: * women may be included if they require total abdominal hysterectomies (+/- bso) at rockyview hospital. exclusion criteria: * have endometrial cancer, * require a vertical midline incision, * have any additional surgery planned * have a contraindication to morphine, magnesium sulfate, dexmethasone, lidocaine or marcaine * have difficulty communicating in english

Keywords: hysterectomy pain prevention wound infiltration
evaluation of hypo-safe hypoglycaemia alarm device - the pilot 2 study - healthy subjects

Conditions: Healthy

Summary: the objective of this pilot trial is to demonstrate the safety and the performance of the hyposafe hypoglycaemia alarm device before conducting clinical trials in type 1 diabetes patients.

1. safety: to evaluate safety issues related to implantation and use of the hyposafe hypoglycaemia alarm device. 2. performance: to evaluate the performance of the hyposafe hypoglycaemia alarm device. 3. usability: to obtain information about the subjects use and acceptance of the hyposafe hypoglycaemia alarm device.

Eligibility criteria:
inclusion criteria: * healthy subjects * age 18-70 years * for female participants: not pregnant and, if child bearing potential, usage of reliable anti-contraceptive method during the study period exclusion criteria: * severe cardiac disease * history of myocardial infarction * cardiac arrhythmia * previous stroke or cerebral haemorrhage and any other structural cerebral disease * active cancer or cancer diagnosis within the past five years * uraemia defined as s-creatinine above 3 times upper reference value * liver disease defined as s-alanine aminotransferase (s-alat) above 3 times upper reference interval * epilepsy * use of antiepileptic drugs for any purposes * clinical important hearing impairment * use of active implantable medical device including * pacemaker and implantable cardioverter defibrillator (icd-unit) * cochlear implant * use of following drugs * chemotherapeutic drugs of any kind * methotrexate * third generation antipsychotic drugs (aripiprazole, quetiapine, clozapine, ziprasidone, paliperidone, risperidone, sertindole, amisulpride, olanzapine) * abuse of alcohol (defined as consumption of \> 250g alcohol (in danish: 21 "genstande")) per week or abuse of any other neuro-active substances * infection at the site of device-implantation * any haemorrhagic disease * diving (snorkel diving allowed) or parachute jumping * patients that are judged incapable to understand the patient information or who are unlikely to complete the investigation for any reason * persons operating mri scanners. * persons operating handheld transceivers for communication (e.g. within the police, medical, fire, air traffic control, marine or military). * persons working at broadcast stations for television or fm/dab radio. * persons performing extreme sport.

Keywords: evaluation of subcutaneous eeg recording
computerized treatment for social anxiety

Conditions: Social Anxiety Disorder

Summary: the present study aims to examine the feasibility of a computerized treatment for social anxiety disorder. to evaluate the efficacy of the ibm protocol the investigators have developed in reducing evaluation and social threat biases, they will conduct a two-arm randomized controlled trial. individuals with a diagnosis of social anxiety disorder (n = 50) will be randomized to one of two conditions: 1) ibm or 2) progressive muscle relaxation. each condition will consist of eight 25 minute treatment sessions. participants will complete two sessions per week for four weeks and will be administered assessments at pre-treatment, one week post-treatment and at 3-month follow-up. it is hypothesized that: 1) ibm will lead to greater reductions in social anxiety symptoms than the pmr condition; 2) ibm will lead to greater reductions in depression and anxiety than the pmr condition; 3) ibm will lead to greater reductions in threat interpretations and greater increases in benign interpretations than the pmr condition; 4) the effects of condition on social anxiety symptoms will be mediated by changes in social anxiety-related interpretation bias; and 5) the effects of condition will be maintained at the 3-month follow-up assessment.


Eligibility criteria:
inclusion criteria: * current diagnosis of social anxiety disorder according to dsm-5 criteria * spin score greater than or equal to 30 * must report sufficient motivation to complete treatment (i.e., score of at least 5 on a 10 point scale (0 = no motivation and 10 = extreme motivation)) exclusion criteria: * concurrent psychotherapy or treatment for social anxiety disorder * clinically significant suicidality * current alcohol use disorder of "severe" severity or higher * current non-alcohol substance use disorder of "moderate" severity or higher * recent changes (less than four weeks) in psychiatric medication * history of psychotic symptoms * may not have participated in a similar computerized treatment program
epidemiological study on the relationship between respiratory health and air pollution from industrial sources

Conditions: Airway Obstruction; Hypertension; Diabetes Mellitus; Dyslipidemias; Pulmonary Disease, Chronic Obstructive

Summary: the elisabet study is across sectional survey on a representative sample of two urban area conduct on a representative sample. the main objective of the project is to compare the prevalence of the obstructive ventilatory disorders (ovd) in the urban community of dunkirk touched by the industrial pollution in relation to the one recovered in the urban community of lille (cudl) less industrialized.

airflow obstruction include pulmonary disease, chronic obstruction and asthma. identification of airflow obstruction is through functional tests lung. in the 1950s, high pollution levels were associated with increased mortality. despite a reduction of air pollution, it has been established that pollution peaks have short-term effects on acute respiratory episodes. the urban community of dunkirk (cud) focuses many large pollutant emitters. the long term effects of industrial pollution on tvo are unknown. the main objective of the project is to compare the prevalence of airflow obstruction in the urban community of dunkirk affected by industrial pollution compared to that found in the urban community of lille (cudl) less industrialized. secondary objectives are: 1) to assess the relationship between air pollution from industrial and biological markers, particularly the plasma concentrations of heavy metals 2) to assess the prevalence of tvo general population in french populations 3) establish a baseline epidemiological and biological bank.

Eligibility criteria:
inclusion criteria: * had lived for at least 5 years in the same city or its surrounding urban area (either lille or dunkirk) in the northern of france * agreed to participate and signed contentment exclusion criteria: * the detainees * people under legal protection * individuals unable to consent

Keywords: air pollution epidemiological survey representative sample
fluoroscopically-guided versus landmark-guided sacroiliac joint injections

Conditions: Sacroiliac Joint Pain

Summary: in this study, the investigators are attempting to determine whether intra- or extra-articular injections are more effective; the relative prevalence rate of intra-articular and extra-articular si joint pain; and the accuracy of extra-articular injections using fluoroscopy as the reference standard. 124 consecutive patients with mechanical low back pain below l5, tenderness overlying the si joint(s) and at least 3 positive provocative maneuvers will be randomized to receive si joint injections by 2 different approaches. group 1 will receive fluoroscopically-guided injections into the joint. group 2 will receive landmark-guided injections into the tender area around the joint. in order to determine whether the injection in group 2 was intra-articular or extra-articular, an x-ray will be done after the injection to ascertain the location of contrast spread. the primary outcome measure will be pain relief at 1-month. patients who obtain benefit at 1-month will be followed at 3-months, while those who fail to obtain benefit will exit the study to receive alternative care.


Eligibility criteria:
inclusion criteria: 1. age \> 18; 2. low back pain principally below the l5 vertebra; 3. three out of 6 positive si joint provocative maneuvers; 4. agreed to undergo si joint injection for diagnostic/ therapeutic purposes; 5. average pain score \> 3/10 over the past week; 6. pain duration \> 6 weeks; exclusion criteria: 1. previous si joint injection; 2. leg pain \> back pain or lower leg pain \> upper leg pain 3. active inflammatory spondyloarthropathy (e.g. ankylosing spondylitis); 4. untreated coagulopathy; 5. allergy to contrast dye or bupivacaine; 6. pain \> 20 years in duration; 7. poorly controlled psychiatric (e.g. ptsd) or medical (congestive heart failure) condition

Keywords: sacroiliac joint low back pain steroid injection
infusional fluorouracil and weekly docetaxel for gastric cancer with bone marrow involvement and dic

Conditions: Gastric Cancer; Bone Marrow Metastasis; Disseminated Intravascular Coagulation

Summary: a distinctive subtype of gastric adenocarcinoma with extensive bone marrow metastasis and dic has been described. few patients have been treated properly due to the lack of standard care. we designed this phase ii study to evaluate a dose-dense regimen for this kind of highly aggressive gastric cancer (hagc).

5-fluorouracil 200mg/square metre/day continuously venous infusion on days 1-21; docetaxel 25mg/square metre, on days 1, 8 and 15; this regimen repeats every 4 weeks.

Eligibility criteria:
inclusion criteria: * ecog ps 0-3; * pathologically confirmed adenocarcinoma in stomach or esophagogastric junction; * bone marrow metastasis confirmed by aspiration, biopsy or pet/ct scan; * overt dic according to the international society on thrombosis and haemostasis (isth) criteria; * treatment-naive after the diagnosis of metastasis; * platelet ≤ 50 \* 10e9/l; * alt≤5×uln, ast≤5×uln, bilirubin≤5×uln, creatinine≤3×uln; * written informed consent. exclusion criteria: * concurrent aggressive malignancy; * docetaxel containing perioperative treatment within 6 months; * allergic to the study drugs; * serious medical conditions, including severe heart disease, severe cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection,etc. * hiv positive; * msi-h; * her-2 gene overexpression; * inadequate contraceptive measures.

Keywords: 5-fluorouracil docetaxel
study to evaluate the leish-111f + mpl-se vaccine in the treatment of cutaneous leishmaniasis

Conditions: Leishmaniasis, Cutaneous

Summary: this study will evaluate the safety of the leish-111f + mpl-se vaccine in adult patients with cutaneous leishmaniasis.

cutaneous leishmaniasis is a disfiguring infection that can progress to mucosal leishmaniasis, a more serious and possibly fatal form of leishmania infection. all available medical therapies require weeks of treatment and cause significant toxicity. in brazil, a standard therapy is glucantime treatment, administered in cycles of 10 consecutive, once daily, intramuscular injections (glucantime 10 mg/kg, maximum of 850 mg), followed by 11 consecutive days without glucantime injections (rest days). at the completion of each cycle, a study physician examines the patient to determine if a further cycle of glucantime treatment is indicated. it appears that leishmania infections can be eliminated by t helper 1 immune responses. this finding argues that a vaccine that augments cutaneous leishmaniasis patients' t helper 1 response will eliminate the infection and disease. this study is a phase 1, randomized, double-blind, placebo controlled, sequential dose-escalating trial to evaluate the safety and immunogenicity of three injections of 5, 10, or 20 μg of leish-111f protein + 25 μg of mpl-se adjuvant given at 4 week intervals as an adjunct to the standard chemotherapy with glucantime cycles, as described above in patients with cutaneous leishmaniasis.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of cutaneous leishmaniasis defined as positive identification of parasite from lesion biopsy * normal lab values and electrocardiogram (ecg) * negative for hiv, hepatitis b and c, and chagas disease exclusion criteria: * nine or more active cutaneous lesions * lesion diameter \>60mm * previous exposure to leishmania vaccines or to mpl-se * pregnant or breastfeeding female

Keywords: leishmaniasis subunit vaccine therapeutic t cell antimony
autoantibodies and clinical symptoms in infective endocarditis patients

Conditions: Infective Endocarditis

Summary: the purpose is to evaluate autoantibodies in infective endocarditis patients before, at the beginning of treatment, and after the end of the treatment, and to correlate the autoantibodies in the presence of clinical symptoms.


Eligibility criteria:
inclusion criteria: * infective endocarditis patients by dukes criteria exclusion criteria: * hiv positive * patients suffering from other infective diseases other than endocarditis. * patient suffering from collagen diseases for example: systemic lupus erythematosus (sle), rheumatoid arthritis (ra), mixed connective tissue disease, and scleroderma.

Keywords: profile autoantibodies clinical symptoms
safety, tolerability and pharmacokinetics study of egt0001474 in subjects with type 2 diabetes

Conditions: Diabetes Mellitus Type 2

Summary: the purpose of this study is to determine the safety, tolerability and pharmacokinetics (how much of the drug gets into the blood and how long it takes the body to get rid of it) of single doses of egt0001474 given to patients with type 2 diabetes. the study will also evaluate how egt0001474 affects the amount of glucose produced by the body in the urine.

egt0001474 is a compound that may inhibit the effect of other compounds in the body known as sugar transporters. the use of egt0001474 may enhance the elimination of glucose from the blood by increasing the amount of urine produced. this would help prevent an abnormal decrease in blood sugar (hypoglycemia) both during fasting and after meals without increasing insulin secretion (which may result in weight gain or an abnormal increase in blood sugar known as type 2 diabetes).

Eligibility criteria:
inclusion criteria: * male or females between the ages of 18 to 70 diagnosed with type 2 diabetes. * body mass index (bmi) between 18 kg/m2 and 37 kg/m2. * hba1c levels between 6.5 and 9.0 (inclusive) where the upper limit of normal for the hba1c assay is 6.4% or 6.2-9.0% (inclusive) where the upper limit of normal for the hba1c assay is 6.1% and fasting plasma glucose between 110 and 240 mg/dl (inclusive) while on diabetic medications. * if taking drugs for diabetes, must be medically able and willing to discontinue diabetes medications for the duration of the study. * female subjects must be surgically sterilized or postmenopausal. * non-smoker for at least 3 months. * negative alcohol screen. exclusion criteria: * type 1 diabetes. * use of insulin therapy or oral antidiabetic medication other than metformin, sitagliptin or a sulfonylurea. * sitting blood pressure above 150/95 mmhg on 2 evaluations at least 10 minutes apart at screening. * treatment with an investigational drug within 30 days or 7 half-lives, whichever is longer. * previous treatment with egt0001474. * vaccination within 30 days prior to the first dose of study medication.

Keywords: diabetes mellitus type 2
correlations of 3d urethral and paraurethral sonographic findings with urodynamic studies, lower urinary tract symptoms & sexual dysfunction in female patients with lower urinary tract symptoms.

Conditions: Lower Urinary Tract Dysfunction; Overactive Bladder Syndrome

Summary: the main purpose of this study is to get the urethra and pelvic sonographic imaging by 4d ultrasound examinations, and to correlate the sonographic findings with urodynamic variables, pad weights and luts. besides, the associations of the blood flow of vagina/urethra and sexual dysfunction can be explored.

female lower urinary tract dysfunction includes stress urinary incontinence, overactive bladder syndrome and voiding dysfunction. there are a lot of bladder studies, such as researches of bladder wall thickness and bladder volume. however, there were few studies of urethra for female patients with lower urinary tract symptoms (luts), especially for storage disorder. thus, the main purpose of this study is to get the urethra and pelvic sonographic imaging by 4d ultrasound examinations, and to correlate the sonographic findings with urodynamic variables, pad weights and luts. the investigators hope to identify important luts sonographic biomarkers that can be used by primary physicians as a tool for assess female luts, and thus decreasing the need of further invasive urodynamic studies. besides, the associations of the blood flow of vagina/urethra and sexual dysfunction (assessed by female sexual function index) can be explored. in addition, women who receive antimuscarinics treatment will receive follow-up 4d imaging and request to complete questionnaire 12 weeks later.

Eligibility criteria:
inclusion criteria: * women with lower urinary tract symptoms * not less than 20 years-old exclusion criteria: * patients with a history of stroke.

Keywords: lower urinary tract symptoms overactive bladder syndrome antimuscarinic drug three-dimensional power doppler ultrasound sexual dysfunction
autistic women's experiences of self compassion and receiving their diagnosis in adulthood

Conditions: Autism

Summary: research highlights strong links between self-compassion and mental health, but there is very limited research specifically exploring autistic individual's experiences of self-compassion. the process of receiving a diagnosis on the autism spectrum can be complex and autistic women tend to experience several barriers to diagnosis. this study adds to the growing area of research exploring autistic women's experiences of receiving a diagnosis in adulthood. this study employs interpretative phenomenological analysis to explore if receiving a diagnosis of autism influences women's perceptions of self-compassion. the findings may inform client-centred practices in health care settings and potentially present positive aspects of autism diagnosis.


Eligibility criteria:
inclusion criteria: * able to consent to participate * cisgender female (female at birth and raised as female). * speak english fluently * received an autism spectrum disorder diagnosis, aged 18 years old or above exclusion criteria: * lack capacity to consent to participate in the study * unable to speak english fluently * have not received an autism diagnosis * have received autism diagnosis prior to their 18th birthday * have an intellectual disability * born male

Keywords: autism self compassion