Kornimate/medical-research-clean huggingface dataset:
efficacy of a probiotic formulation on energy balance in overweight subjects

Conditions: Healthy

Summary: probiotic administration is associated with health benefits on gut barrier integrity and immunological functions of the gastrointestinal tract. recently, probiotic consumption was proposed to reduce fat mass and body weight in rodents (lee hy. et al. 2006; hamad em. et al. 2009). changes in energy metabolism might be involved in the effects of probiotics on weight control. the objective of this study was to assess the efficacy of the consumption of a probiotic formulation on energy balance in overweight subjects.


Eligibility criteria:
inclusion criteria: * body masss index (bmi) 25 - 30 kg/m2 * healthy (determined by medical questionnaire) * able to commit to the duration of the study * providing consent for participation exclusion criteria: * history of cardiovascular disease (cvd), diabetes, cancer, renal, thyroid or hepatic disease * history of gastrointestinal surgery * history of sleep disorders * recent bacterial infection (\< 2 weeks) * weight loss \> 5 kg in the last 3 months * under antibiotics or treatments (medical or nutritional program) affecting body weight, appetite, energy expenditure lipid-lowering, hypertension or inflammation or glucose control for the last 3 months or taking hormone replacement therapy * excessive consumption of products enriched in probiotics (\> 4 servings per week) within the last 4 weeks before the start of the study * history of drug or alcohol abuse (\> 2 drinks daily) * regular smokers (more than 5 cigarettes a day) * not eating breakfast regularly or eating breakfast before 6h00. * not willing to eat any of the foods to be served in the study for any reason * physical activity level \> 150 min of moderate or intense exercise per week * concurrent or recent intervention study (within 60 days)

Keywords: probiotics energy balance
study medication adherence and its determinants in chronic disease through the example of methotrexate in chronic inflammatory rheumatism

Conditions: Rheumatic Diseases

Summary: the aim of this study is 1) to describe the level and determinants of methotrexate adherence in patients with chronic inflammatory rheumatism (rheumatoid arthritis, spondyloarthritis and psoriatic arthritis) in the department of rheumatology in the nîmes university hospital


Eligibility criteria:
inclusion criteria: * treated by methotrexate * patients with chronic inflammatory rheumatism (rheumatoid arthritis, spondyloarthritis and psoriatic arthritis) exclusion criteria: * methotrexate for other diseases

Keywords: chronic inflammatory rheumatism
topical myristyl nicotinate cream on the skin of healthy volunteers

Conditions: Healthy

Summary: rationale: chemoprevention is the use of certain drugs to keep cancer from forming. the use of topical myristyl nicotinate cream may stop skin cancer from forming. purpose: this randomized phase i trial is studying the side effects and best way to give topical myristyl nicotinate cream on the skin of healthy volunteers.

objectives: * to determine if topical myristyl nicotinate (mn) is a safe, tolerable treatment in healthy volunteers. * to determine if topically administered mn cream is associated with any significant local or systemic toxicity in normal human subjects in a one-month period. outline: participants are randomized to 1 of 2 treatment arms and serve as their own controls. * arm i: participants apply topical myristyl nicotinate to one forearm and topical placebo to the other forearm once daily for 4 weeks. * arm ii: participants receive treatment as in arm i but on opposite forearms. all participants undergo blood collection for chemistry analysis (sma-20 and cbc) at baseline and at 2 and 4 weeks.

Eligibility criteria:
inclusion criteria: * subjects 18 years of age or older with normal skin * have used no topical medications on the skin of the upper extremities, except for emollients or sunscreens, for at least 30 days prior to study entry * agree to limit sun exposure as much as possible and wear protective clothing on the forearms in place of using sunscreens or moisturizers * ability to understand and willingness to sign an informed consent before initiation of therapy after the nature of the study has been explained to them * females must be surgically sterile by hysterectomy or post menopausal exclusion criteria: * subjects with no signs of inflammation or irritation of the skin on the forearms * subjects with prior history of actinic keratosis or skin cancer on the forearm * females of child bearing potential * subjects with any concurrent therapy (e.g., retinoids, fluorouracil) on the forearms that may interfere with clinical evaluations * subjects taking oral supplemental niacin, by itself or in the form of a multi-vitamin that exceeds 40 mg/day * no known immunosuppression by virtue of medication or disease, including aids patients, subjects taking oral prednisone, and subjects on immunosuppressants/immunomodulators( cyclosporine, chemotherapeutic agents, or biologic therapy), determined by the examining investigator/co-investigator * uncontrolled intercurrent illness including, but not limited to any of ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * subjects who have had invasive cancer within the past 5 years * skin conditions felt by the study physician to contraindicate enrollment including, but not limited to, psoriasis or atopic dermatitis within a proposed treatment area * less than 30 days since prior and no concurrent or planned participation in another clinical trial

Keywords: skin cancer healthy, no evidence of disease
comparison of 6 cp-690,550 doses vs.placebo, each combined with methotrexate, for the treatment of rheumatoid arthritis

Conditions: Arthritis, Rheumatoid

Summary: the purpose of this study is to determine the effectiveness and safety, over 6 months, of 6 dose regimens of cp-690,550, combined with methotrexate, for the treatment of adults with active rheumatoid arthritis.


Eligibility criteria:
inclusion criteria: * active rheumatoid arthritis * inadequate response to stably dosed methotrexate exclusion criteria: * current therapy with any dmard or biologic other than methotrexate

Keywords: dmard therapy
impact of tens on postoperative pain and quality of life after inguinal hernia repair

Conditions: Inguinal Hernia; Postoperative Pain; Quality of Life; Transcutaneous Electric Nerve Stimulation

Summary: lichtenstein herniorrhaphy still remains one of the most often performed inguinal hernia repair techniques. it is frequently associated with acute postoperative and chronic pain. due to insufficient effect of non-steroidal anti-inflammatory drugs, they are often overdosed. however opioids have many side effects. interventional treatment, such as transversus abdominis plain (tap) block requires an additional intervention and has relatively short effect, also could not be applied in outpatient conditions. the hypoalgesic effect of transcutaneous electric nerve stimulation (tens) is well known for many years, but effectiveness during postoperative period is still controversial and maybe therefore didn't come to daily practice. however it could be a promising part of multi-modal pain treatment for hernia patients. this study analyse the hypoalgesic effect of tens and its impact on hernia specific quality of life (qol) after lichtenstein hernia repair. aim#1 to determine whether use of tens is effective for acute postoperative pain relief. aim#2 to determine whether use of tens have impact on hernia specific qol in early and late postoperative period. aim#3 to identify factors associated with effectiveness/ineffectiveness of tens procedures. aim#4 to determine whether a psychological condition (depression, anxiety and pain catastrophisation) is somehow associated with tens effectiveness.


Eligibility criteria:
inclusion criteria: * elective lichtenstein repair for primary hernia * male gender * no tens procedures in the past * american society of anesthesiologists physical status i or ii * no cognitive, speaking, hearing or visual disturbances * no movement disorders exclusion criteria: * non lithuanian speaker * known allergy to a patch glue * chronic use of non-steroidal anti inflammatory drugs or opioids * neuropathic diseases * general contraindication for tens procedures (such as skin disorders in site of electrodes application or pacemaker) * not able to complete the questionnaires

Keywords: inguinal hernia transcutaneous electric nerve stimulation postoperative pain quality of life pain threshold algometry
chemotherapy with or without radiosurgery for asymptomatic oligo brain metastasis

Conditions: Nonsmall Cell Lung Cancer

Summary: the need of radiosurgery is controversial for asymptomatic oligo brain metastasis for non small cell lung cancer (nsclc). therefore, the investigators do a randomized study comparing overall survival between two groups with or without radiosurgery for asymptomatic oligo brain metastasis before palliative chemotherapy for nsclc.


Eligibility criteria:
inclusion criteria: 1. histologically confirmed non-small cell lung cancer with synchronous brain metastases 2. one to 4 intraparenchymal brain metastases by contrast-enhanced mri, meeting the following criteria: * well circumscribed tumor(s) with brain edema grade 0-1 * maximum diameter ≤ 3.0 cm 3. no prior surgical treatment or rt for brain metastases 4. no leptomeningeal metastases by mri or cerebrospinal fluid evaluation 5. patients without any symptoms or signs from brain metastases (rtog neurologic functions status of 0) 6. age, 18 and over 7. ecog performance status 0-1 8. written informed consent exclusion criteria: 1. severe co-morbid illness and/or active infections 2. pregnant or lactating women 3. rtog neurologic function status of 1\~4 4. uncontrollable extracranial metastases

Keywords: asymptomatic brain metastasis nsclc gks
bioequivalency study of ramipril 10 mg capsules under fed conditions

Conditions: Hypertension

Summary: the objective of this study was to prove the bioequivalence of ramipril 10 mg capsules under fed conditions.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening exclusion criteria: * positive test for hiv, hepatitis b, or hepatitis c. treatment with known enzyme altering drugs. history of allergic or adverse response to ramipril or any comparable or similar product.
prophylactic antibiotic treatment of patients with chronic obstructive lung disease (cold)

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the purpose of the study is to investigate, in patients with moderate to severe chronic obstructive lung disease, whether intermittent antibiotic treatment leads to: * a slower rate of decline in forced expiratory volume in one second (fev1); * a reduction in the frequency and severity of exacerbations; * fewer hospital admissions for chronic obstructive pulmonary disease (copd); * lower mortality; * an improved quality of life as compared to a group of placebo treated patients.

study population: patients with moderate to severe chronic obstructive lung disease. trial phase: iv study design: prospective, randomised, double-blind, placebo- controlled clinical trial. study medicine: azithromycin. drug administration: oral. drug dose: 500 mg once daily for 3 days every month. duration of treatment: 3 years number of evaluable patients: 200 per treatment arm number of included patients: 400 per treatment arm, 800 patients in total.

Eligibility criteria:
inclusion criteria: * patients above 50 years of age, with a current admission for exacerbation of cold or at least one admission within the previous two years. * current or ex-smoker * postbronchodilator fev1 \ 4 weeks after hospitalisation) * \< 300 ml bronchodilator reversibility in fev1 exclusion criteria: * patients with end-stage cold, who are not expected to survive for 3 years (typically bedridden patients being dyspnoeic in rest). * patients with known other respiratory tract infection, e.g. tuberculosis or aspergillosis, in whom the intervention is known to be inefficient. * patients with pulmonary malignancy * patients with other pulmonary diseases than cold. * patients with immunodeficiency. however, cold patients treated with steroids can be included. * patients with known hereditary disposition to lung infections such as alfa-1-antitrypsin deficiency, cystic fibrosis or primary ciliary dyskinesia. * patients receiving longterm antibiotic treatment ( e.g. recurrent cystitis). * patients with known allergy or intolerance to azithromycin * pregnant or breastfeeding women * manifest heart, liver or renal insufficiency * patients that, for reasons not stated above, are unlikely to be able to participate in a study period of 3 years.
effect of rehabilitation of patients with a central nervous system lesion

Conditions: Stroke

Summary: the purpose of the study is to analyse the prehensions deficits and the effect of prehension rehabilitation in central nervous system lesioned people


Eligibility criteria:
inclusion criteria: * adult minimum 6mounth after first stroke * minimal prehension of both hands exclusion criteria: * diabetuss * other upper limb pathologies * mmse \< 26

Keywords: hand rehabilitation
prt versus cbt on chronic non specific lbp

Conditions: Chronic Non Specific Mechanical Low Back Pain

Summary: the goal of this clinical trial is to compare between the effect of positional release technique and cognitive behavioral therapy in patients with chronic non specific low back pain. the main question aims to answer :is there any differences of using positional release techniques versus cognitive behavioral therapy on patients with chronic low back pain?

design of the study : pretest-posttest randomized controlled trial. subjects selection : sixty patients their age between 25-45 years of both genders with chronic non specific low back pain will participate in this study according tosample size calculation.

Eligibility criteria:
inclusion criteria: * all patients will be clinically diagnosed with chronic non specific low back pain . * their ages will range from 20to40years old. * body mass index will range from 18 to 30 kg/cm². * cognitive score will be 23 or above . * voluntary acceptance of participation in this study. exclusion criteria: * lumbar canal stenosis * lumbar discogenic lesions * lumbar infections,tumors.arthiritis * patients with decreased range of motion due to congenital anamolies. * cognitive and emotional disturbances

Keywords: positional release cognitive behavioral therapy
the success rate of cardiopulmonary resuscitation in patients experiencing in-hospital cardiac arrest

Conditions: Cardiac Arrest, Sudden; Cardiopulmonary Arrest; Cardiopulmonary Failure; In-hospital Cardiac Arrest

Summary: cardiac arrest causes the heart to stop functioning to maintain circulation that provides oxygen to the brain. the global incidence of cardiac arrest is 50 to 60 per 100,000 people per year. the incidence of cardiac arrest in indonesia in 2016 was 350,000 cases, in which 12% were successfully resuscitated, compared to the global success rate of 24.8%. cardiac arrest events urgently require cpr action that is useful to save lives in an emergency. the application of code blue aims to reduce the mortality rate and increase the rate of return of spontaneous circulation. the code blue team itself includes a set of teams who are trained in the handling of cardiorespiratory arrest.


Eligibility criteria:
inclusion criteria: * patients with in-hospital cardiac arrest that were treated at sanglah general hospital exclusion criteria: * patients who upon admission to the hospital already showing cardiac arrest rhythm * patients who were doa (death-on-arrival)

Keywords: in-hospital, cardiac arrest, resuscitation, success rate
using electrocochleography during cochlear implantation of the neuro zti.

Conditions: Cochlear Hearing Loss; Cochlear Trauma

Summary: the main objective of this study is to evaluate the correspondence between ecochg and residual hearing by adding two modifications. first, a novel technique for placing and maintaining the probe in place during the whole insertion will be used. second, a new metric for estimating the ecochg response will be evaluated (ecochg trauma index). the secondary objective is to find other markers of the cochlear trauma insertion associated to ecochg measures. this will be used to evaluate to which extend a traumatic insertion will be deleterious for the patient's post-operative hearing, and ultimately to prevent trauma to the inner ear. finally, the potential differences in cochlear trauma resulting of the electrode array insertion from two different surgery techniques will be investigated; either using a manual insertion or using a robotic arm that will drive the insertion automatically.

main study procedures and assessments: * visit 1 (d-30+/-14) inclusion: subject information/consent, inclusion/exclusion criteria, ct-scan, tonal audiometry * visit 2 (d0+/-14) cochlear implant surgery: ct-scan, intra-op ecochg, ecap, impedance * visit 3 (d+30+/-14) follow-up 1 month: tonal audiometry, impedance, fitting maps * visit 4 (d+60+/-14) follow-up 2 month: tonal audiometry, impedance, fitting maps, phonemes * visit 5 (d+90+/-14) follow-up 3 month: tonal audiometry, impedance, fitting maps, phonemes

Eligibility criteria:
inclusion criteria: * \> or equal 18 years ; * candidate for neuro zti evo cochlear implant system, unilateral or bilateral recipient ; * preoperative residual hearing with audiometric thresholds less or equal than 80 db at 500 hz, or higher frequencies exclusion criteria: * medical or psychological conditions which contraindicate surgery (e.g middle ear infection, tympanic membrane perforation) ; * patient with a psychological or linguistic inability to understand the information sheet ; * patient under legal protection or deprived of liberty * patient included and participating to another trial.
sprayshield as adhesion barrier system for obese patients

Conditions: Severe Obesity

Summary: the application of sprayshield during a laparoscopic band removal (first surgical step) will be evaluated to see if the postoperative adhesions between the stomach, the left liver and the diaphragm are not severe, facilitating the surgical surgical step of a gastric bypass or a sleeve gastrectomy.

monocenter and observational study on 20 obese patients, requiring removal of the gastric band for poor results (weight regain or insufficient weight-loss) or mechanical complications of the band ( slippage, esophageal dilation) and schedule for a second step surgery of gastric bypass or sleeve gastrectomy 2 months later.

Eligibility criteria:
inclusion criteria: * obese male or female who would benefit from a gastric band removal and for whom a second surgical step with conversion to sleeve gastrectomy or bypass is scheduled exclusion criteria: * the patients having an ablation of ring motivated for an infectious complication

Keywords: adhesion barrier system bariatric surgery
study of bird regimen combined with bcma car t-cell therapy in newly diagnosed multiple myeloma (mm) patients

Conditions: Multiple Myeloma

Summary: the purpose of this study is to evaluate the safety and efficacy of bird regimen combined with bcma car t cell therapy in newly diagnosed multiple myeloma patients

this is a phase 3, single arm, multi-center study. the patients will receive bird regimen (clarithromycin,lenalidomide, dexamethasone) combined with infusion of autologous bcma-directed car t-cells in newly diagnosed mm patients. the study participation will be 4 years including treatment and follow-up periods.

Eligibility criteria:
inclusion criteria: 1. newly diagnosed mm according to the criteria by international myeloma working group (imwg) 2. age 18-75 3. eastern cooperative oncology group (ecog) score 0-2 4. bcma positive as detected with flowcytometry or elisa. 5. patients with left ventricular ejection fraction ≥ 0.5 by echocardiography or grade i/ii cardiovascular dysfunction according to the new york heart association classification. 6. patients with aspartate aminotransferase or glutamic-pyruvic transaminase \> 3x upper limit of normal or bilirubin \> 2.0 mg/dl exclusion criteria: 1. patients are pregnant or lactating. 2. nonsecretory mm. 3. history of previous treatment of mm. 4. patients with uncontrolled active infection. 5. patients with active hepatitis b or hepatitis c infection. 6. patients with hiv infection. 7. patients with atrial or venous thrombosis or embolism. 8. patients with myo-infarction or severe arrythmia in the recent 6 months. 9. other comorbidities that investigators considered not suitable for this study.

Keywords: bird cart bcma mm
dehydroepiandrosterone (dhea) against vaginal atrophy

Conditions: Vaginal Atrophy

Summary: the purpose of this phase iii trial is to evaluate the efficacy of intravaginal dehydroepiandrosterone (dhea) in postmenopausal women with vaginal atrophy.


Eligibility criteria:
inclusion criteria: * postmenopausal women (non-hysterectomized or hysterectomized) * women between 40 and 75 years of age * willing to participate in the study and sign an informed consent * women who have self-identified symptom(s) of vaginal atrophy * for non-hysterectomized women, willing to have endometrial biopsy at baseline and end of study exclusion criteria: * undiagnosed abnormal genital bleeding * hypertension equal to or above 140/90 mm hg * the administration of any investigational drug within 30 days of screening visit * endometrial hyperplasia, cancer or endometrial histology showing proliferative, secretory or menstrual type characteristics at histologic evaluation of endometrial biopsy performed at screening

Keywords: vulvar/vaginal atrophy atrophic vaginitis dehydroepiandrosterone dhea prasterone vaginorm menopause intrarosa
risk factors of delirium in sequential sedation patients in intensive care unit

Conditions: Delirium; Mechanical Ventilation; Sedation

Summary: delirium is one of main adverse events in ventilated patients who receive long-term usage of mono-sedative. sequential sedation may reduce these adverse effects. this study aimed to evaluate incidence and risk factors for delirium in sequential sedation patients.

previous studies have showed that patients under mechanical ventilation have a higher risk for experiencing delirium than nonmechanically ventilated patients (20%-50%). its occurrence is also more frequent in elder patients. more than that, it is often hard to identify delirium by physicians, leading to unreasonable management of icu patients. and delirium is one of main adverse events in ventilated patients who receive long-term usage of mono-sedative. sequential sedation may reduce these adverse effects. however, few present studies focus on delirium in sequential sedation patients. thus, in this study, we aimed to determine the factors of delirium in patients who received sequential sedation in icu.

Eligibility criteria:
inclusion criteria: 1. intubated patients; 2. age≥18 years old; 3. anticipated ventilation and sedation duration of at least 72 hours. exclusion criteria: 1. allergy to the study drug; 2. suspected pregnancy; 3. gross obesity; 4. extremely unstable of circulatory system, such as systolic blood pressure less than 90 mm hg despite plasma volume expansion and continuous infusions of vasopressors before the start of study drug infusion; 5. uncontrolled abnormal hypertension, such as systolic blood pressure more than 180 mmhg or diastolic more than105 mmhg; 6. heart rate less than 50 bpm; 7. second or third degree heart block; 8. moribund state; 9. history of alcoholism or intake of anti-anxiety drugs or hypnotics; 10. chronic renal failure; 11. coma by cranial trauma or neurosurgery or unknown etiology or epileptic state; 12. history of neuromuscular disease; 13. unwillingness to provide informed consent by patients or their authorized surrogates following icu admission.