Kornimate/medical-research-clean huggingface dataset:
efficacy of exercises in individuals with non-specific chronic low back pain

Conditions: Low Back Pain

Summary: this is a randomized controlled trial project to analyze the effectiveness of lumbar motor control exercises and lumbar resistance training on pain, functional, kinesiophobia and trunk strength in individual with chronic low back pain. the project has two parallel arms and will be supervised by physiotherapists (motor control exercises) and physical education professionals (resistance training). the participants will be militaries of the military fire department of the federal district who presents in the recruitment regular low back pain more than 3 months. the two groups will be supervised in12 weeks of exercises in the physical activity center of military fire department of the federal district. our hypotheses is that the resistance training effects wil be superior to motor control exercises only for trunk strength (isokinetic flexion and extension).


Eligibility criteria:
inclusion criteria: * nonspecific chronic low back pain (defined as pain and discomfort) localized below the costal margin and above the inferior gluteal folds, with or without referred leg pain of at least 3 months' duration. exclusion criteria: * spinal pathology (eg, tumor, infection, fracture, inflammatory disease), pregnancy, nerve root compromise, previous spinal surgery, major surgery scheduled during treatment or follow-up period, and presence of any contraindication to exercise.

Keywords: low back pain exercise
an extension study designed to assess effects of losartan on proteinuria in pediatric populations (mk-0954-326 am1,ext1(am2))

Conditions: Proteinuria

Summary: the purpose of this study is to evaluate the effects of losartan on proteinuria in pediatric patients.

the study included a 12-week double-blind treatment phase and a 36-month open-label extension phase. participants who completed or discontinued the initial 12-week phase of the study and who opted to participate in the open label extension phase were randomized to either losartan or enalapril at a dose of the investigator's choosing for the duration of the extension. the open label extension was designed to continue until the 100th participant completed 3 years of follow-up.

Eligibility criteria:
inclusion criteria: * participant is 1 to 17 years of age * able to provide a first-morning urine sample each day during the study * documented history of proteinuria associated with chronic kidney disease of any origin * signed consent of parent and/or legal guardian exclusion criteria: * pregnant and/or nursing * requires more than 2 medications to control high blood pressure * has undergone major organ transplantation (e.g. heart, kidney, liver) * known sensitivity to losartan or other similar drugs, or any history of angioneurotic edema * known sensitivity to amlodipine or other calcium channel blocker * requires cyclosporine to treat renal disease (kidney disease)
ancillary home airway clearance in cf patients ( homecaresimeox )

Conditions: Pulmonary Cystic Fibrosis

Summary: regular bronchial clearance is essential in patients with cystic fibrosis for their bronchial health. simeox® (physio-assist, aix en provence, france) is an innovative medical device for the drainage of the bronchial tree. by changing the rheological properties of mucus, simeox® helps to mobilize secretions and assists their transport to the upper airways. this technology is based on fundamental research on bronchial mucus rheology. at the present time, simeox® device is mainly used over a short period at the time or after an exacerbation in healthcare structures (hospitals, physiotherapy practices, postcare, and rehabilitation units, etc...). the clinical effects observed in the short term encourages long-term autonomous use by the patients themselves. the overall objective of this study is to evaluate the efficiency and acceptability of simeox® used at home by the patient himself for bronchial clearance in patients with cystic fibrosis.


Eligibility criteria:
inclusion criteria: * one of the 56 first patients of home-care simeox study * same criteria as home-care simeox study exclusion criteria: * same criteria as home-care simeox study

Keywords: bronchial clearance cystic fibrosis
comparison of progressive muscle relaxation and stretching exercises in diabetic population

Conditions: Diabetes Mellitus Type 2

Summary: the goal of this clinical trial is to compare the effects of progressive muscle relaxation and stretching exercises mediated by stress on heart rate variability, cortisol level, galvanic skin response and perceived stress scale. the main questions it aims to answer are, will there be a significant difference between the effects of progressive muscle relaxation and stretching exercises in the diabetic population? can stress mediate the effects of progressive muscle relaxation and stretching exercises in the diabetic population? researchers will compare the effects of progressive muscle relaxation and stretching exercises mediated by stress on heart rate variability, cortisol level, galvanic skin response and perceived stress scale. participants will: be given session of progressive muscle relaxation or stretching exercises or no physical therapy treatment 3 sessions per week for 2 weeks and visit the clinic once every 3 days for 2 weeks for intervention. measurements will be taken before and after every session. perceived stress will be assessed at the start of the intervention at baseline and then after 2 weeks.

the subject of this research is individuals with type 2 diabetes who also experience depression. progressive muscle relaxation (pmr) has the potential to reduce blood sugar levels in type 2 diabetes patients. this reduction is linked to the stress, both physical and psychological, experienced by the patients. when stressors are assessed, muscle tension is created, which signals the brain and creates a feedback. pmr works to interrupt this loop by stimulating the parasympathetic nervous system and influencing the hypothalamus through focused concentration, promoting a positive mindset and reducing stress on the hypothalamus. stretching can also be easily integrated into a diabetic's daily routine promoting both physical and mental wellbeing. most studies focus on pmr or stretching exercises separately in managing stress, but comparing these two interventions in terms of stress reduction and physical outcomes in diabetics is limited. understanding which intervention provides better stress relief could lead to more targeted recommendations in diabetic care.

Eligibility criteria:
inclusion criteria: * age 35-65 years females uncontrolled diabetes mellitus sedentary lifestyle has never undergone progressive muscular relaxation before. exclusion criteria: * unstable angina cardiac arrhythmia postural deformities left ventricular ejection fraction \< 45%

Keywords: perceived stress progressive muscle relaxation stretching exercises heart rate variability cortisol levels galvanic skin response
dental caries prevention by a natural product

Conditions: Dental Caries

Summary: the objective is to conduct an rct to evaluate the effectiveness of licorice in comparison to standard caries preventive measures for the prevention of new carious lesions in high caries risk patients.

research hypothesis (null hypothesis): the present clinical trial will be conducted to reject or accept the null hypothesis that using licorice extract mouth wash in addition to standard preventive measures will not differ from using standard preventive measures alone in preventing incidence of new carious lesions. picots: p: population with high caries risk patients i: use of licorice. i2: use of chlorhexidine c: use of standard preventive measures (tooth brushing, tooth paste, interdental cleaning). o.1: primary outcome is incidence of new carious lesions t: time for measurement is 12 months s: a randomized controlled clinical trial (parallel study)

Eligibility criteria:
inclusion criteria: * patients with high caries risk, * 18-25 years, * males or females, * medically free patients, * patients approving to participate in the study. exclusion criteria: * patients who were on antibiotic therapy or corticosteroid therapy for 30 days before the examination, * patients had history of professional cleaning in the last 15 days, * patients with exposed pulp, * evidence of parafunctional habits, * patients with developmental dental anomalies, * patients undergoing or will start orthodontic treatment, * patients with removable prosthesis, * periapical abscess or fistula.
safety and efficacy study of the combination of cpg 7909 and herceptin in patients with metastatic breast cancer

Conditions: Carcinoma, Metastatic Breast

Summary: the purpose of this study is to determine if the combination of cpg 7909 and herceptin is safe and effective in the treatment of metastatic breast cancer. rationale: there is preclinical data that supports the hypothesis that cpg 7909 may potentiate the action of herceptin. this phase i/ii study is designed to evaluate the safety and efficacy of the combination treatment of cpg 7909 and herceptin in patients with metastatic breast cancer who have previously been treated with herceptin and chemotherapy. schedule: patients will receive cpg 7909 weekly for up to six months.

phase ii part of study not initiated because the development plan modified the route of administration to subcutaneous injection.

Eligibility criteria:
inclusion criteria inclusion criteria * histologically confirmed breast cancer with metastases. * tumor that has overexpression of her2 as documented by being either fish-positive or her2/neu 3+ confirmed by immunohistochemistry. * patients must be candidates for single agent herceptin treatment according to the herceptin® label. exclusion criteria * any prior therapy with anthracycline + herceptin®. * significant cardiovascular disease (e.g., nyha class 3 congestive heart failure, myocardial infarction within the past 6 months, unstable angina; coronary angioplasty within the past 6 months, uncontrolled atrial or ventricular cardiac arrhythmias) or left ventricular ejection fraction \< 50%.

Keywords: metastatic breast cancer immunotherapy cpg 7909
low-dose thalidomide as adjuvant therapy after radiofrequency ablation for hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma; Liver Cancer

Summary: the purpose of the investigators' study is to prospectively evaluate whether low-dose thalidomide adjuvant therapy will improve the outcome of radiofrequency ablation for hepatocellular carcinoma (hcc).

our previous studies showed that radiofrequency ablation (rfa) was as effective as liver resection for small hepatocellular carcinoma (hcc), but the recurrence rates after rfa were relatively high. adjuvant therapies maybe reduce the recurrence rate. phase 1 and 2 studies showed that thalidomide was a safety and effective treatment for hcc, especially for small hcc with liver cirrhosis. so we proposed that low-dose thalidomide adjuvant therapy will improve the disease progress free survivals and overall survivals after rfa for hcc.

Eligibility criteria:
inclusion criteria: * age 18 - 75 years, who refused surgery or first recurrence after hepatectomy * a solitary hcc 3.1-7.0cm in diameter, or 2-3 lesions, sums of diameters ≤ 7.0cm * lesions being visible on ultrasound (us) and with an acceptable/safe path between the lesion and the skin as shown on us * no extrahepatic metastasis * no imaging evidence of invasion into the major portal/hepatic vein branches * no history of encephalopathy, ascites refractory to diuretics or variceal bleeding * a platelet count of \> 40,000/mm3 * no previous treatment of hcc except liver resection exclusion criteria: * patient compliance is poor * previous or concurrent cancer that is distinct in primary site or histology from hcc, except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (ta, tis \& t1). any cancer curatively treated \> 3 years prior to entry is permitted * history of cardiac disease: * congestive heart failure \> new york heart association (nyha) class 2 * active coronary artery disease (myocardial infarction more than 6 months prior to study entry is permitted) * cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers, \*calcium channel blocker or digoxin * uncontrolled hypertension (failure of diastolic blood pressure to fall below 90 mmhg, despite the use of 3 antihypertensive drugs) * active clinically serious infections (\> grade 2 national cancer institute \[nci\]-common terminology criteria for adverse events \[ctcae\] version 3.0) * known history of human immunodeficiency virus (hiv) infection * known central nervous system tumors including metastatic brain disease * patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry * distantly extrahepatic metastasis

Keywords: hepatocellular carcinoma liver cancer radiofrequency ablation thalidomide
reactogenicity, safety and immunogenicity of a tb/flu-01l tuberculosis vaccine

Conditions: Tuberculosis

Summary: the study is a single centre, phase i, open, randomized, by intranasal and sublingual application trial that explored the safety and immunogenicity of 2 doses (day 1 and day 21) tb/flu-01l tuberculosis vaccine in bcg-vaccinated healthy adult subjects aged 18-50 years.


Eligibility criteria:
inclusion criteria: * healthy bcg-vaccinated male or female adult 18 through 50 years of age at the enrollment visit. * literate and willing to provide written informed consent. * a signed informed consent. * capable and willing to complete diary cards and willing to return for all follow-up visits. * for females, willing to take reliable birth control measures throughout the entire period of participation in the study exclusion criteria: * clinical, radiological (chest x-ray) or laboratory evidence of active or past tb disease. * current or past administration of anti-tb therapy. * history of contact with tb patients. * positive quantiferon-tb gold test. * bcg vaccination in less than 6 months prior to study. * practice of nasal irrigation on a regular basis within the past six months or has engaged in nasal irrigation within two weeks prior to enrollment. * recent history of frequent nose bleeds (\>5 within the past year). * clinically relevant abnormal paranasal anatomy. * recent history (within the past month) of rhino or sinus surgery, or surgery for any traumatic injury of the nose. * current or recent (within two weeks of enrollment) acute respiratory illness with or without fever. * hypersensitivity after previous administration of any vaccine. * history of chronic alcohol abuse and/or illegal drug use. * any clinically significant abnormal laboratory finding. * a positive pregnancy test for all women of childbearing potential. * administration of immunosuppressive drugs or other immune modifying drugs within 4 weeks prior to study enrollment. * acute or chronic clinically significant pulmonary disease, cardiovascular disease, gastrointestinal disease, liver disease, neurological illness, liver disease, blood disease, skin disorder, endocrine disorder, neurological illness and psychiatric disorder as determined by medical history, physical examination or clinical laboratory screening tests, which in the opinion of the investigator, might interfere with the study objectives. * history of leukemia or any other blood or solid organ cancer. * seropositive for hiv, hepatitis b surface antigen and/or hepatitis c antibodies. * receipt of antivirals, antibiotics, immunoglobulins or other blood products within 4 weeks prior to study enrollment or planned receipt of such products during the period of subject participation in the study. * participation in another clinical trial within the previous three months or planned enrollment in such a trial during the period of this study. * subjects who are, in the opinion of the investigator, at significantly increased risk of non-cooperation with requirements of the study protocol.

Keywords: influenza vector tuberculosis vaccine
systematic evaluation of continuous glucose monitoring data

Conditions: Diabetes Mellitus

Summary: this study retrospectively evaluates continuous glucose monitoring (cgm) and flash glucose monitoring (fgm) data and pursues two main objectives: first, the investigators analyze if glucose values are better controlled in the days directly before a consultation at our tertiary referral centre (so called "white coat adherence"). second, the investigators use the collected cgm and fgm data to develop a hypoglycemia prediction model.

substudy a.) presence of white coat adherence in diabetic patients: the investigators aim at evaluating the existence of a so called "white coat adherence" with regard to diabetes control, which means that blood-glucose is better controlled in the days immediately prior to a consultation at the diabetes clinic compared to the time-period further back. to analyse this phenomenon, the investigators use continuous glucose monitoring (cgm) and flash glucose monitoring (fgm) of diabetic patients and compare cgm-/fgm data of the last three days prior to the consultation with the cgm-/fgm data of the days 4-28 prior to the consultation, as well as the last seven days prior to the consultation with days 8-28 prior to the consultation. substudy b.) retrospective data collection for the development and evaluation of a hypoglycemia prediction model: scope of the study is to use retrospective data for training and evaluation of a deep recurrent neural network based system for predicting the onset of hypoglycemic event at least 20 min ahead in time. the study aims to: i, assess the ability of deep learning algorithm to predict hypoglycemic events using the data collected during substudy 1. ii, assess the ability of global model to be personalized using the data collected during sub-study 1. iii, investigate the amount of "history" to be involved to achieve maximum performance in terms of prediction ability. iv, develop a global model, which can be easily further personalized to achieve optimum prediction performance per patient.

Eligibility criteria:
inclusion criteria: * diabetes mellitus * cgm and/or fgm available for at least 50% of the time in last 4 weeks before consultation * written informed general consent for the retrospective analysis of data exclusion criteria: * pregnancy

Keywords: white coat adherence continuous glucose monitoring flash glucose monitoring hypoglycemia prediction deep learning algorithm
effect of intermittent versus continuous energy restriction on compensatory mechanisms activated during weight reduction

Conditions: Obesity

Summary: obesity has become a global epidemic with huge public health implications. although clinical significant weight loss can be achieved by a combination of diet and behavioral modification, strong metabolic adaptations, with increased appetite and suppressed energy expenditure, are activated, which compromise weight loss maintenance and increase the risk of relapse. the aim of this project is to compare the effects of intermittent versus continuous energy restriction on the compensatory responses previously described using two low calory diets, with a similar macronutrient distribution. more specifically, this study will analyze, in the short-term, if an intermittent energy restricted diet is associated with less appetite and low reduction in energy expenditure when compared with a continuous energy restricted diet. this project can bring large practical benefits concerning the design of weight loss programs to minimize weight relapse.


Eligibility criteria:
inclusion criteria: * adult (18-50 years old) * obese healthy volunteers (30\<bmi\<40 kg/m2) * weight stable on the last three months (\<2kg), not currently dieting to lose weight and with an inactive lifestyle exclusion criteria: * history of endocrine/cardiovascular/pulmonary/kidney disease * anaemia * milk intolerance * depression or other psychological disorders * eating disorders * drug or alcohol abuse within the last two years * current medication known to affect appetite or induce weight loss * a planned surgery during the study period * participating in another research study

Keywords: weight loss intermittent energy restriction metabolic compensation diet therapy
ethnic/racial differences in metabolism and dna adduct formation

Conditions: Lung Cancer

Summary: the study will investigate the role of 1,3-butadiene metabolic activation and deactivation in lung cancer risk among various ethnic/racial groups. this project will require urine samples from smokers and nonsmokers from the three ethnic/racial groups recruited by the clinical and biomarker core for the analysis of 1,3-butadiene dna adducts. data on nicotine intake (urinary tne) in these subjects as well as in 400 lung cancer cases and 400 controls from project 1 will be also required for this project.


Eligibility criteria:
inclusion criteria: * one of the three targeted ethnic groups: * japanese american - two parents of japanese descent * non-hispanic whites - two parents of non-hispanic white descent * native hawaiians will include individuals with at least one parent of hawaiian descent; * smoke 5 cigarettes per day over the past three months; * \>21 years of age; * consumes 14 or fewer drinks of alcohol per week; * generally stable and good health (determined by review of medical history); * able to provide written voluntary consent before performance of any study related procedure. exclusion criteria: * current use of other nicotine containing products for \> 4 times per month (and no use of any nicotine-containing products except cigarettes for 2 weeks prior to their study visits); * acute or uncontrolled medical or psychiatric conditions; * currently taking any medications that affect relevant metabolic enzymes or anti- inflammatory medications such as ibuprofen (this will be reviewed by study investigators on a case-by-case basis); * active infection (e.g., influenza, cold, respiratory infection, sinus infection) at the time of the visit; * pregnant or nursing or planning on becoming pregnant during the study; * unable to read and understand english.
role of liquid phase concentrated growth factors vs. hypertonic dextrose prolotherapy for management of patients with disc displacement without reduction

Conditions: Temporomandibular Joint Disorders; Temporomandibular Disorder

Summary: purpose of the study is to compare clinically, radiographically and biochemically the effect of intra- articular injection of hypertonic dextrose with a stabilization appliance and the intra- articular injection of 2 ml of liquid phase concentrated growth factor with a stabilization appliance as a prolotherapy for temporomandibular joint anterior disc displacement without reduction.

twenty four patients with anterior disc displacement without reduction will be selected from those attending the prosthodontic department, faculty of dentistry, alexandria university and diagnosed clinically and by magnetic resonance imaging. patients will be randomly assigned into 2 study groups each comprising 12 patients. group i will receive an intra-articular injection of hypertonic dextrose in conjugation with a maxillary cad/cam full-arch hard clear acrylic stabilization appliance while group ii will receive an intra-articular injection of lpcgf in conjugation with a maxillary cad/cam full-arch hard clear acrylic stabilization appliance.

Eligibility criteria:
inclusion criteria: * patients with painful tmj. * patients with limited mouth opening (mmo \<40mm). * patients with anterior disc displacement without reduction confirmed by mri. * presence of full or nearly full complement of natural teeth. * patients with angle class i occlusion. * patients with rcp not greater than 2mm and with no open bite. exclusion criteria: * patients who have anterior disc dislocation with reduction detected by mri. * inability or unwillingness to undergo magnetic resonance imaging (mri) such as implanted electronic devices. * patients having uncontrolled systemic disease, hematologic or neurologic disorders or inflammatory diseases. * patients under anticoagulant drug therapy.