Kornimate/medical-research-clean huggingface dataset:
dynamic stabilization versus fusion

Conditions: Degeneration of Lumbar Intervertebral Disc

Summary: the purpose of this study is to compare posterior dynamic stabilization with fusion in the treatment of lumbar degenerative disease.

two strategies for treatment of degenerative lumbar instability are in frequent clinical use: fusion versus dynamic stabilization. up to now it is not clear whether fusion (gold-standard) or the non-fusion technique is superior. nevertheless some data are available that dynamic stabilization as a less invasive technique can achieve similar or better results concerning patient satisfaction and re-op rate compared with fusion as the standard therapy.

Eligibility criteria:
inclusion criteria: * age \>18 years * mono- or bisegmental symptomatic lumbar degenerative disease with or without stenosis * indication for fusion with (i) spondylolisthesis of at least 5mm or segmental vertebral motion of at least 3mm or 10º on flexion/extension radiographs, (ii) predominant low back pain in combination with modic changes * failure of adequate conservative measures for more than 3 months * correctly signed informed consent form exclusion criteria: * olisthesis more than grade i, spondylolisthesis vera, spondylolysis without olisthesis or spinal deformity (i.e. scoliosis of more than 20°, sagittal imbalance) * significant comorbidity impeding with surgical success (e.g. osteoporosis, rheumatoid arthritis, mental illness) * previous fusion or stabilization surgery

Keywords: lumbar degenerative disease
assessment of the efficacy of vitamin d-fortified bread in healthy adults

Conditions: Healthy

Summary: the aim of this study is to evaluate the efficacy of daily intake of fortified bread with vitamin d on serum 25-hydroxyvitamin d level, glycemic and lipidemic status in healthy subjects compared to vitamin d supplement.

sixty apparently healthy subjects will be selected. participants who are receiving vitamin d, calcium or omega-3 supplements within the last three months will be excluded. subjects will be assigned randomly to one of the three intervention groups: 1.fortified bread+placebo,2. plain bread+vitamin d supplements,3. plain bread+placebo. each participant will consume 50 g of bread and supplement or placebo every day for 2 months. at the first and last visits, dietary and laboratory assessments will be performed for all subjects. primary outcomes are improvement in vitamin d status and secondary outcome is improvement of glycemic and lipidemic markers and prevention of problems related to hypovitaminosis d.

Eligibility criteria:
inclusion criteria: * 20 to 50 years * healthy subjects * no receiving vitamin d or omega-3 supplement in past 3 months exclusion criteria: * receiving vitamin d or omega-3 supplement during the study

Keywords: vitamin d fortified bread efficacy vitamin d deficiency
brain imaging and pain in irritable bowel syndrome

Conditions: Irritable Bowel Syndrome

Summary: this study examines the mechanisms, including brain imaging of placebo analgesia


Eligibility criteria:
inclusion criteria: * irritable bowel syndrome * english speaking exclusion criteria: * chronic pain condition other than irritable bowel syndrome * medical condition that would contraindicate use of lidocaine * clinical criteria for fibromyalgia * presence of systemic disease such as diabetes, thyroid, gastrointestinal or liver disease, collagen vascular disease, malignancy, focal or neurological * seropositive hiv * pregnancy

Keywords: placebo analgesia pain brain mechanism expectation
transcranial magnetic stimulation theta burst (tms), depression and smoking.

Conditions: Major Depressive Disorder; Smoking Reduction

Summary: this study evaluates de efficacy of theta burst transcranial magnetic stimulation (tms) applied on the left dorsolateral prefrontal cortex in patients with major depressive disorder and tobacco consumption.

major depressive disorder (mdd) affects 350 million worldwide causing damage on quality of life and risk behavior such as suicide and smoking. smoking is the second leading cause of death causing about 5 million deaths annually. theta burst stimulation (tbs) is a more tolerable protocol administered at lower intensities and shorter intervals than conventional rtms protocols.

Eligibility criteria:
inclusion criteria: * with dependence on tobacco use, with depressive symptomatology, that they agree to sign the informed consent letter. exclusion criteria: * history of head trauma with loss of consciousness, with intracranial metallic objects or metallic plates in the skull, patients with structured suicidal ideation or recent attempts, who suffer from uncontrolled chronic diseases at the time of entering the study (for example: hypertension, diabetes, rheumatic diseases), patients with psychotic symptoms. subjects with alterations in electroencephalogram (epileptiform activity), patients with any type of uncontrolled chronic medical or neurological disease, pregnant women.

Keywords: transcranial magnetic stimulation theta burst depression tobacco suicide ideation
sickle cell disease, neurocognitive disorders, social participation

Conditions: Sickle Cell Disease

Summary: this project will promote the development of transdisciplinary analyses. neuropsychological disorders will be explored with the usual appropriate tests done by psychologists and neuropsychologists regularly involved in the management of sickle cell disease affected children. for the social sciences' component, various methods will be used: measure of the life habits (mhavie), measure of environmental quality (mqe) and semi-guided interviews will complete the collection of qualitative data. the expected results concern the identification of the barriers or facilitators the sickle cell patients might face in their social participation, whether they are affected or not by neurological disorders.

sickle cell anaemia, which is the most frequent genetic disease in france, requires an early and optimal care to reduce its morbidity and mortality. children with sickle cell anaemia who are significantly anaemic may present neurological complications including stroke with or without clinical signs. a major risk associated to these strokes is the impairment of the general intellectual ability and learning ability, essentially resulting from neuropsychological disorders affecting intellectual functioning, executive and attentional functions. although the negative impact of sickle cell anemia on the quality of life of the affected children and adolescents is well documented, no study has been focused on the role played by the neurocognitive disorders on their social participation. the objective of this project is the assessment of the influence of neurocognitive disorders in the social participation of children and adolescent with sickle cell anemia (6 to 16 years old), followed in guadeloupe. this project will promote the development of transdisciplinary analyses. neuropsychological disorders will be explored with the usual appropriate tests done by psychologists and neuropsychologists regularly involved in the management of sickle cell disease affected children. for the social sciences' component, various methods will be used: measure of the life habits (mhavie), measure of environmental quality (mqe) and semi-guided interviews will complete the collection of qualitative data. the expected results concern the identification of the barriers or facilitators the sickle cell patients might face in their social participation, whether they are affected or not by neurological disorders

Eligibility criteria:
inclusion criteria: * sickle cell anemia * age between 6 and 16 years inccuded, attending the centre of reference for sickle cell disease in guadeloupe * informed consent * medical insurance exclusion criteria: * other sickle cell syndrome other than ss or sb-thal * less than 6 years old or older than 16 * attending other sickle cell departments * no medical insurance

Keywords: neurocognitive disorders social participation
abscisic acid effects on glucose homeostasis and insulin sensitivity

Conditions: Pre Diabetes

Summary: the purpose of this study is to determine the effects of oral abscisic acid (aba) on glucose metabolism in subjects with defined prediabetes.


Eligibility criteria:
inclusion criteria 1. provision of signed and dated informed consent form 2. stated willingness to comply with all study procedures and availability for the duration of the study 3. male or female, aged 18-65 4. in good general health as evidenced by medical history or diagnosed with \ or exhibiting \ 5. fasting glucose \>5.6 and\ 5.6 and \<6.5 % 6. ability to take oral medication and be willing to adhere to the \ regimen 7. females currently on hormone replacement therapy (hrt) can participate in the study if they have been on hrt for at least 6 months and will continue to be on hrt during the study. 8. for males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner 9. agreement to adhere to lifestyle considerations throughout study duration. exclusion criteria 1. treated or untreated diabetes 2. 19\>bmi\<40.0 kg/m2 3. blood pressure (bp) ≤ 150mmhg systolic and ≤ 95 mmhg diastolic 4. current use of medications or antioxidant vitamins or supplements that would impact dependent variables, including glucose metabolism. 5. past or current ischemic heart disease, stroke, respiratory disease, endocrine or metabolic disease, neurological disease, hematological-oncological disease and free of recent infection (prior 2 weeks) 6. pregnancy or lactation 7. treatment with another investigational drug or other intervention within 1 year. 8. current smoker or tobacco use within the past year. 9. disqualifying findings on physical examination include cardiac murmurs, diminished pulses or the presence of bruits in the lower extremities, lower extremity thrombophlebitis, evidence of peripheral neuropathy, paresis or edema.

Keywords: metabolism
repair of infective wound associated with nerve defect in the finger using a bipedicled nerve flap

Conditions: Infection Wound; Disruption of Nerve Repair

Summary: a combination of soft tissue and digital nerve defects in the finger results in sensory loss of the finger pulp. reconstruction of these combined injuries is difficult. when the neurocutaneous defect is associated with wound infection, reconstructive alternatives are more limited. from july 2008 to may 2010, a retrospective study was conducted with 9 consecutive postinfection patients who had the neurocutaneous defect of the finger following trauma. the purpose of this retrospective study is to report repair of the complicated infected wound in the finger using the bipedicled nerve flap and to evaluate the efficacy of this technique.

sensation of the flaps is assessed using static two-point discrimination (2pd) and semmes-weinstein monofilament (swm) testing at final follow-up. the cold intolerance of the injured finger is measured using the self-administered cold intolerance severity score questionnaire that was rated into mild, moderate, severe, and extreme (0-25, 26-50, 51-75 and 76-100). patients report their satisfaction with functional recovery of the injured finger according to the michigan hand outcomes questionnaire that was based on a 5-point response scale.

Eligibility criteria:
inclusion criteria: * an infective wound with exposed bone or tendon in the finger; * soft tissue defect involving proximal half of the middle phalanx, the proximal phalanx, or both; * associated digital nerve defect 1 to 4 cm in length; * single or double nerve defects; and * simultaneous repair of nerve and soft tissue defects. exclusion criteria: * injury to the course of the pedicle or the donor site; * nerve defect less than 1 cm or larger than 4 cm in length; * occurrence of the defect in a region the flap is unable to reach, such as distal interphalangeal joint region, distal portion of the middle phalanx of the middle finger and the thumb; * no involvement of the digital nerve.

Keywords: defect; dorsal branch of the proper digital nerve; proper digital nerve; finger sensory reconstruction.
effectiveness and safety of yiqitongluo granule for stroke

Conditions: Stroke

Summary: the purpose of the prospective study is to evaluate the effectiveness and safety of yiqitongluo granule in the treatment of stroke with qi-deficiency and blood-stasis in more than sixy hospitals all over china.


Eligibility criteria:
inclusion criteria: * mild and moderate ischemic stroke patient with 4-25 nihss score * stable patients within 1 week to 3 months * sign informed consent before study exclusion criteria: * ct shows cerebral hemorrhage disease: such as hemorrhagic stroke, epidural hematoma, intracranial hematoma, ventricular hemorrhage, and subarachnoid hemorrhage * severe disturbance of consciousness * dysphagia * tia * hemorrhagic diathesis * patient with malignant tumor whose expected lifetime is less than 3 months * allergic constitution * gestation period, lactation period, woman with the possibility or plan of pregnancy * those who participated in other clinical trials within 3 months or taking part in other clinical trials
airway inflammation and remodeling in asthma and copd.

Conditions: Asthma; COPD

Summary: asthma and chronic obstructive pulmonary disease (copd) are inflammatory airway diseases. although the clinical features of asthma and copd may be similar, the pathogenesis of these diseases differs in many aspects. the aim of this study is: * to evaluate airway inflammation in asthma and copd, * to evaluate airway remodeling in asthma and copd as compared to healthy subjects, * to assess the relationship between markers of airway inflammation and airway remodeling in asthma and copd patients. material and methods: * mild to moderate asthma patients diagnosed in accordance with global initiative for asthma (gina) guidelines, * mild to moderate copd patients diagnosed in accordance with global initiative for chronic obstructive lung disease (gold) guidelines, * healthy subjects as controls. airway inflammation is assessed in induced sputum (is), exhaled breath condensate (ebc), bronchoalveolar lavage fluid (balf) and specimens from endobronchial forceps biopsy. airway wall thickness is evaluated in high resolution computed tomography (hrct), endobronchial ultrasound (ebus) and basement membrane thickness (bmt) in biopsy specimens. we plan to compare airway inflammation and features of airway remodeling in asthma and copd patients.


Eligibility criteria:
inclusion criteria: * a clinical diagnosis of asthma or copd in accordance with gina or gold, respectively * control group - healthy volunteers without any history of lung disease exclusion criteria: * age below 18 years * exacerbation in the past 6 weeks * inhaled corticosteroid therapy at least 6 weeks prior to study enrollment * significant co-morbidities

Keywords: asthma copd airway inflammation remodeling cytokines airway wall thickness
hepatitis b vaccination in hiv-infected adults with low cd4 cell counts

Conditions: Hepatitis B

Summary: this study aimed to evaluate the efficacy of different hepatitis b vaccination regimens in hiv-infected adults with low cd4 cell count in northern thailand.

hiv-infected adults with cd4+ cell counts \< 200 cells/mm3, undetectable plasma hiv-1 rna, and negative for all hbv markers were randomly assigned to receive one of these 2 regimens of recombinant hepatitis b vaccine (centro de ingenieria genetica y biotecnologia, la habana, cuba); 1) 20 μg im at months 0, 1, and 6 (3-standard doses group), and 2) 20 μg im at months 0, 1, 2, 6 (4-standard doses group). this study aimed to evaluate the efficacy and safety of these 2 hepatitis b vaccination regimens at month 7 after vaccination.

Eligibility criteria:
inclusion criteria: 1. hiv-infection 2. ≥18 years old 3. received combination antiretroviral therapy for at least 1 year 4. had a cd4+ cell count \< 200 cells/mm3 for at least 1 year 5. undetectable plasma hiv-1 rna for at least 1 year 6. negative for hepatitis b surface antigen (hbsag), antibody to hepatitis b surface antigen (anti-hbs), and antibody to hepatitis b core antigen (anti-hbc), 7. had no history of previous hbv vaccine 8. negative for antibody to hepatitis c virus (anti-hcv) 9. no active opportunistic infections (at the time of screening) 10. willing to sign an informed consent 11. able to return for follow-up. exclusion criteria 1. pregnancy or lactation 2. history of hypersensitivity to any component of the vaccine 3. active malignancy receiving chemotherapy or radiation, or other immunocompromised conditions besides hiv (e.g., solid organ transplant), received immunosuppressive (e.g., corticosteroid ≥ 0.5 mg/kg/day) or immunomodulating treatment in the last six months before screening visit 4. renal insufficiency (creatinine clearance \<30 ml/min) 5. decompensated cirrhosis (child-pugh class c)

Keywords: hbv vaccination, immunity
turkish version of the diabetes quality of life brief clinical inventory validity and reliability

Conditions: Diabetes Mellitus; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetes

Summary: this study aims to develop turkish version of the diabetes quality of life brief clinical inventory (dql-bci) and to perform validity and reliability evaluations.

the study will be carried out in two phases: dql-bci will be translated into turkish and adapted to the cultural context, and the reliability and validity of the turkish version of dql-bci will be investigated. the translation process will be performed in accordance with generally accepted international principles of translation and cultural adaptation of measurement tools. at least 150 subjects with type 2 diabetes will complete the turkish version of dql-bci, the eq-5d-3l questionnaire and the sf-12 quality of life questionnaire. the examination will provide information about the reliability and the construct validity of the studied tool.

Eligibility criteria:
inclusion criteria: * aged between 18-65 years old * diagnosed with diabetes for one year or more (type 1 or type 2) * literacy * being on at least one anti-diabetes medication exclusion criteria: * not willing to participate in the study

Keywords: diabetes quality of life
effectiveness of laser photobiomodulation therapy in reducing child pain during local anesthesia injection

Conditions: Local Anesthesia Injection Pain

Summary: this study aimed to evaluate the impact of laser photobiomodulation therapy used as pre-anesthetic technique to reduce child pain during local anesthesia administration


Eligibility criteria:
inclusion criteria: * completion of the written informed consent form by parents/guardian. * children with dental behavior score of 3 or 4 according to the frankel behavior rating scale. * patients whom their maxillary primary molars are indicated for pulpotomy and ssc restoration. * lack of history of allergy to the materials used for anesthesia and sulfite * children free of any systemic disease or special health care needs (asa 1) exclusion criteria: * children who receive any analgesic drugs at least 24 hours before treatment. * any inflammation or lesion in the injection site * patients who have previous bad experience of dentistry were excluded to eliminate the possible impact of the child's previous painful or stressful experiences * child coming for emergency treatment of pain
safety and efficacy of carbone dioxide (co2) laser system in treatment of female stress urinary incontinence.

Conditions: Female Stress Urinary Incontinence

Summary: this is a prospective, open-label, multi-center, non-comparative study that will be conducted on female subjects between 30 and 75 years of age, diagnosed with stress urinary incontinence (sui). following the screening period, including urodynamic assessment to confirm sui, each subject will undergo three femilifttm treatment sessions, and will be followed up for a period of one year. the main efficacy endpoint in this study is defined as significant improvement (score of 6 or 7) in the urinary incontinence measured with pgi-i score at the 6 months visit. various subjective and objective measures of incontinence severity, quality of life, sexual function and tissue effects will be performed at follow up.

improvement in sui symptoms as measured by the following parameters: objective parameters: * change from baseline in 3 days urinary diary - at 1, 2, 6 and 12 months: * number of incontinence episodes per day * number of pads used per day * change from baseline in 1 hour pad test 1, 2, 6 and 12 months * change from baseline as assessed with vaginal biopsy subjective parameters: * patient global impression of severity (pgi-s) - 4-point likert scale - at screening, 1, 2, 6 and 12 months * change from baseline in pelvic floor distress inventory questionnaire (pfdi) - at 1, 2, 6 and 12 months * change from baseline in pelvic organ prolapse/urinary incontinence sexual questionnaire (pisq) - at 1, 2, 6 and 12 months * change from baseline in pelvic floor impact questionnaire (pfiq) - at 1, 2, 6 and 12 months

Eligibility criteria:
inclusion criteria: * females between 30 and 75 years of age * provided written informed consent * patients with mild to moderate stress urinary incontinence (sui) \[according to the severity index developed by sandvik\] * patients with mixed urinary incontinence, while the predominant symptoms are stress related, may also be enrolled * normal papanicolaou smear (up to 1 year prior to screening) * negative urine culture * vaginal canal, introitus and vestibule free of injuries and bleeding * positive urinary stress test (urine leakage is demonstrated while the patient is examined with full bladder in lithotomy position, and asked to perform 3 strong coughs). exclusion criteria: * positive pregnancy test * planned pregnancy within the next year * severe prolapse (pop\>= grade 3) * use of photosensitive drugs * injury or/and active infection in the treatment area * active vaginal infection * human papillomavirus/herpes simplex virus * undiagnosed vaginal bleeding * urge or overflow incontinence * patients who are on antidepressants, or α-adrenergic and anticholinergic medications * patients with immune system diseases. * patients with allergic reaction to laser. * patient under treatment with photosensitivity side effects medication. * obese women (bmi \>30) * patient unable to follow post treatment instructions.