Kornimate/medical-research-clean huggingface dataset:
does what you eat affect your brain

Conditions: Gliosis; Obesity; Eating

Summary: the purpose of this study is to use magnetic resonance imaging (mri) to evaluate the human hypothalamus for signs of inflammation in response to specific diets. this research may lead to a better understanding of how poor nutritional quality may lead to obesity through effects on regions of the brain known to regulate body weight.


Eligibility criteria:
inclusion criteria: * age 20-40 years * overweight: bmi 25-29.9 kg/m2 * willing to undergo randomly assigned 14-day diet modification exclusion criteria: * history of bariatric surgery or active participation in weight-loss program * major medical or neurological disorder (e.g., diabetes, multiple sclerosis) * anemia or impaired kidney or liver function * known gallbladder disease or gallstones * hypertriglyceridemia (\>350 mg/dl) * current use of orlistat or other weight-loss medications or other medications known to alter appetite (e.g., atypical anti-psychotics) * more than moderate level of physical activity (\>1000 met-min/wk) * pregnancy, menopause, or breastfeeding * mri contraindication (e.g., implanted metal, claustrophobia) * lifetime eating disorder * current smoking or heavy alcohol use (≥ 2 drinks per day for females and ≥ 3 drinks per day for males) * weight \> 350 pounds (mri limit) * dietary restrictions (e.g., vegan) incompatible with controlled diets
atherosclerosis monitoring and atherogenicity reduction study

Conditions: Carotid Atherosclerosis

Summary: this study was designed to estimate the effect of two-year treatment with time-released garlic-based drug allicor on the progression of carotid atherosclerosis in double-blinded placebo-controlled randomized clinical trial.


Eligibility criteria:
inclusion criteria: * men aged 40 to 74 years * subclinical carotid atherosclerosis detected by b-mode ultrasound (increased intima-media thickness 1100-2000 mcm) * arterial normotension or mild arterial hypertension (systolic blood pressure \<160 mm hg, diastolic blood pressure \<90 mm hg) * absence of chronic diseases demanding permanent drug administration (more than 2 month per year) exclusion criteria: * personal history or diagnostic of following diseases: 1. transient ischemic attacks 2. presence of chronic diseases demanding permanent drug administration (more than 2 month per year) 3. condition of patients moderate to severe * indications for surgical treatment of atherosclerotic lesions localized in the extracranial brachiocephalic system. * individual intolerance of allicor or appearance of side effects

Keywords: atherosclerosis regression allicor garlic intima-media thickness
adjunctive bright light therapy for patients with depression

Conditions: Depressive Disorder; Light Therapy

Summary: the study would enroll depressed adolescents and adults with bipolar i or ii disorder or major depressive disorder who are receiving stable psychiatric medication (excluding patients with hypomania or mania, mixed symptoms, or rapid cycling). participants would be randomly assigned to treatment with either 1,0000-lux bright white light therapy in the morning or 1,0000-lux bright white light therapy in the afternoon, or \<100-lux dim red placebo light therapy in the afternoon (n=59 for each group). participants would be treated for 6 weeks. symptoms would be assessed every two weeks with the 24-items hamilton depression scale, the young mania rating scale, and the pittsburgh sleep quality index; salivary melatonin and cortisol concentrations will be also measured.

the investigators would divide the participants enrolled into three groups: adjunctive morning bright light therapy (blt) group (light intensity: 10000lux, color: white light, duration of each intervention session: 30min, time period of intervention: 7:00\~9:00 a.m.), adjunctive afternoon blt group (light intensity: 10000lux, color: white light, duration of each intervention session: 30min, time period of intervention: 12:00\~14:00 p.m.), adjunctive placebo therapy group (light intensity: \<100lux, color: dark red, duration of each intervention session: 30min, time period of intervention: 12:00\~14:00 p.m.).

Eligibility criteria:
inclusion criteria: * 12-75 years old * diagnosed using dsm-5 criteria based on the structured clinical interview for patient edition (scid-p) for adults or schedule for affective disorders and schizophrenia for school-age children-present and lifetime version (kiddie-sads-pl) for adolescents for the diagnosis of bipolar i or ii disorder or major depressive disorder * 24-items hamilton depression rating scale score ≥ 20, young mania rating scale score \< 6 * participants with bipolar disorder taking at least one mood stabilizer, and the types of drugs have not changed in one week; * antidepressants can be taken, and the types of antidepressants have not changed in one week * low-dose benzodiazepines can be used, with a maximum of 2 mg of lorazepam equivalent per day * right-handed * primary school education or above * sign informed consents after a full explanation of this study. exclusion criteria: * a history of brain organic disease or severe traumatic brain injury and severe physical disease; * drug, alcohol or other psychoactive substance abusers * severe suicide risk; * received modified electric convulsion therapy (mect) in the past three months * comorbid with ophthalmic diseases (cataract, macular degeneration, glaucoma, retinitis pigmentosa, etc.) and diseases affecting the retina (retinopathy, diabetes, herpes, etc.) * taking photosensitive drugs (phenothiazines, antimalarials, propranolol, melatonin, hypericum, stimulants or nsaids)

Keywords: depression bright light therapy time period
vestibular rehabilitaion in bilateral vestibular hypofunction

Conditions: Bilateral Vestibular Loss; Vestibular Rehabilitation

Summary: the purpose of this study is to determine the etiological factors that constitute bilateral vestibular hypofunction and to investigate the effect of vestibular rehabilitation in these patients. the caloric test and video head impulse test were applied to evaluate the vestibular hypofunction picture of the patients who applied to clinic with complaints of vertigo, dizziness and imbalance. among these patients with bvh, those with vestibular symptoms, imbalance complaints and limited daily living activities were included in rehabilitation. in order to investigate the effectiveness of rehabilitation, oculomotor functions were evaluated using simulation of vestibulo-ocular reflex exercises (svore) system, balance assessment was done with timed balance tests and quality of life assessment was performed with dizziness handicap inventory.


Eligibility criteria:
inclusion criteria: * patients between 18-70 years of age with bilateral vestibular hypofunction and peripheral vestibulopathy exclusion criteria: * patients with unilateral vestibular hypofunction, cerebellar lesion, and cognitive problems were excluded from the study.
dexmedetomidine for prevention of chronic postoperative pain

Conditions: Chronic Postoperative Pain

Summary: chronic postoperative pain (cpsp) is common symptom in patients after surgery, seriously affected the quality of life. accumulating evidences have demonstrated dexmedetomidine can improve chronic pain. however, the prevention of dexmedetomidine on cpsp remain uncertain.

chronic postoperative pain (cpsp) is defined as pain persisting at least 3 months after surgery. it is most common in patients who undergoing breast or thoracic surgery. dexmedetomidine, a adrenergic α2 agonists, can alleviate the postoperative pain 24 h after surgery. in our study, patients were randomly assigned to one of the two group to receive 0.5mg/kg/h infusion dexmedetomidine (group d, n=57) or normal saline (group c, n=57). the pain scales were evaluated day 1, day 2, day 3, month 3, month 6 after surgery.

Eligibility criteria:
inclusion criteria: * patients must have been 18 to 65 yr old, and been scheduled for breast or thoracic surgery. exclusion criteria: * patients with limitations of self-expression or visual dysfunction or having emergency surgery, a severe psychiatric illness, or chronic pain problems in the chest area for longer than 2 months before the surgery,or patients who could not provide informed consent were excluded. * pregnant women and prisoners were also excluded.

Keywords: chronic pain cpsp dexmedetomidine surgery
coronally advanced flap in combination with acellular dermal matrix and enamel matrix derivatives for root coverage

Conditions: Gingival Recession

Summary: the aim of this study is to compare the clinical outcomes of root coverage procedures, using coronally advanced flap in combination with acellular dermal matrix with or without enamel matrix derivatives .

coverage of gingival recession defects has been considered as a matter of interest for dental practitioners.subjects with a paired gingival recession defect will be selected from the patients who sought dental treatment at our department.random allocation of the treatment sites to test (caf+ emd+adm) and control (caf + adm) groups will be performed by a person who is external to the study and using a computerized selection of random numbers for allocation of the study groups.the parameters of the study are as following items: probing depth( pd), clinical attachment level (cal), width of keratinized tissue (wkt), recession depth from cemento- enamel junction (rd), recession width (rw), distance between mucogingival junction and the stent (mgj), plaque (pi) and gingival (gi) indices and root coverage percentage (rc) and the patients will be followed up for 6 months.

Eligibility criteria:
inclusion criteria: * having no systemic disease affecting the periodontium, * no contraindication for elective surgery, * adequate oral hygiene , * no previous surgical attempts for root coverage at the studying sites, * vital teeth and signing a witness letter. exclusion criteria: * smoking, presence of a restorations on tooth surface for test and control teeth, * pregnancy, * being under treatment with steroids, * peri-apical infection, * indication for antibiotic prophylaxis prior to dental treatments

Keywords: coronally advanced flap gingival recession enamel matrix protein acellular dermal matrix root coverage
im neostigmine for accelerating bladder emptying after cs by spinal anesthesia

Conditions: Cesarean Section Complications

Summary: the aim of this study is to assess the efficacy of im neostigmine (0.5 mg) for acceleration of bladder evacuation and prevention of postoperative urine retention following cesarean delivery carried out under spinal anesthesia

following cesarean delivery, women will receive either 0.5 mg im neostigmine (study group) or im nacl 0.9% (control group). bladder ultrasonography will be done every hour until spontaneous voiding occurs. if postoperative urine retention occurred (void inability with bladder volume \> 600 ml by ultrasound), urinary catheterization will be done.

Eligibility criteria:
inclusion criteria: * pregnant women undergoing elective cesarean deliver under spinal anesthesia. exclusion criteria: * the age of the patient is more than 35 years of less than 20 years. * the body mass index of the patient is more than 35 kg/m2 or her height is more than 180 cm or less than 150 cm. * multiple gestation. * the patient is in active labor. * vaginal bleeding, placenta previa or abruption of the placenta. * presence of fetal distress. * urinary symptoms. * medical disorders co-existing with or complicating pregnancy. * contraindications for or history of adverse reaction of neostigmine. * contraindication for spinal anesthesia. * refusal of the patient to receive spinal anesthesia. * intraoperative significant hemorrhage. * duration of the operation is more than one hour. * occurrence of postoperative complications as eclampsia.

Keywords: cesarean section spinal anesthesia postoperative urine retention (pour)
post-marketing surveillance of kiklin capsules in hemodialysis patients

Conditions: Chronic Renal Failure Patients With Hyperphosphataemia Receiving Hemodialysis

Summary: the purpose of this survey is to evaluate the safety and efficacy of long-term use of kiklin® capsules in actual clinical settings.

bixalomer is administered at initial oral dosage of 500 mg three times a day just before a meal. the dosage can be adjusted based on symptoms and serum phosphorus level.

Eligibility criteria:
chronic renal failure patients with hyperphosphataemia receiving hemodialysis

Keywords: hemodialysis ckd (chronic kidney disease) asp1585 hyperphosphatemia
encochleated oral amphotericin for cryptococcal meningitis trial 3

Conditions: Cryptococcal Meningitis

Summary: this pivotal, confirmatory trial seeks to independently verify the results observed in the enact phase ii stage 2 trial (mb-70007).

pivotal, prospective, randomized, open-label, non-inferiority trial to compare the efficacy and safety of step-down induction and consolidation therapy for the treatment of cryptococcal meningitis with oral mat2203 plus flucytosine to standard of care therapy. randomization will by 1:1:1 to one of two experimental arms or standard of care.

Eligibility criteria:
inclusion criteria: * csf cryptococcal antigen (crag) positive meningitis * ability and willingness to provide informed consent * willing to receive protocol-specified lumbar punctures exclusion criteria: * glasgow coma scale \< 15 at time of consent * received \>= 3 doses of amphotericin b within prior 30 days * inability to take enteral (oral or nasogastric) medicine * cannot or unlikely to attend regular clinic visits * receiving chemotherapy or corticosteroids * suspected paradoxical immune reconstitution inflammatory syndrome (iris) * pregnancy or breastfeeding * previous administration of mat2203 * any condition for which participation would not be in the best interest of the participant or that could limit protocol specified assessments
study evaluating the efficacy and safety of wid-rgc20(cariprazine) in patients with schizophrenia

Conditions: Schizophrenia

Summary: this study is a randomized, double-blind, placebo-controlled, parallel-group, multi-center, fixed-dose, phase 3 clinical trial evaluating the efficacy and safety of wid-rgc20 3 mg/day and 6 mg/day in patients with acute psychotic episode of schizophrenia.


Eligibility criteria:
inclusion criteria: * male or female patients 19 ≤ age \< 65 years * at least 1 year of schizophrenia diagnosed according to dsm-5 criteria(295.90) * at least 1 psychotic episode within 1 year * current psychotic episode(acute exacerbation of schizophrenia) within 2 weeks * 80 ≤ panss total score ≤ 120 * rating of at least 4(moderate) on at least 2 of the following 4 panss positive symptoms * cgi-s score ≥ 4 * patients who can be hospitalized during the screening period and at least 3 weeks of the initial double-blind treatment phase exclusion criteria: 1. psychiatric criteria * medical history except schizophrenia specified in protocol * first-episode psychosis * treatment-resistant schizophrenia within 2 years * positive result from the blood alcohol concentration(bac) test or the urine drug screen(uds) * have suicide risk 2. treatment-related criteria * electroconvulsive therapy(ect) within 12 weeks or previous lack of response to ect * concomitant treatment with 3 or more antipsychotics within 12 weeks * treatment with flunitrazepam or lai antipsychotics less than 1 cycle or clozapine within 24 weeks * treatment with cyp3a4 inducers or potent cyp3a4 inhibitors * treatment with amiodarone or systemic corticosteroids for ≥ 12 weeks within 1 year * required prohibited concomitant medication during the study period * prior participation in any clinical trials of cariprazine 3. other * ophthalmic medical findings or related history(ex. uncontrolled diabetes or hypertension) * abnormal laboratory findings specified in protocol * not suitable for any other reason, as judged by the investigator
combination chemotherapy in treating patients with newly diagnosed acute myeloid leukemia

Conditions: Leukemia

Summary: rationale: drugs used in chemotherapy, such as mitoxantrone, cytarabine, and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. giving more than one drug (combination chemotherapy) may kill more cancer cells. purpose: this phase ii trial is studying how well combination chemotherapy works in treating patients with newly diagnosed acute myeloid leukemia.

objectives: * determine the complete remission rate in patients with acute myelogenous leukemia treated with induction chemotherapy comprising mitoxantrone hydrochloride, cytarabine, and etoposide. * determine the feasibility and toxicity of this regimen when given to patients with newly diagnosed acute myelogenous leukemia. outline: patients receive induction chemotherapy comprising mitoxantrone hydrochloride iv on days 1-3, cytarabine iv continuously over 72 hours on days 1-3 and 8-10, and etoposide iv continuously over 72 hours on days 8-10. patients also receive filgrastim (g-csf) subcutaneously once daily beginning on day 4 and continuing until blood counts recover. projected accrual: a total of 40 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * diagnosis of acute myeloid leukemia * previously untreated disease * previous hydroxyurea and/or corticosteroids are acceptable * no preexisting history of a hematologic disorder * myelodysplastic features allowed * no acute leukemia secondary to previous therapy * no leukemic meningitis patient characteristics: * bilirubin \< 2.0 mg/dl (unless felt to be increased because of hepatic infiltration with leukemia) * creatinine \< 2.0 mg/dl * pregnant or lactating patients are ineligible * fertile patients must use effective contraception * no history of or active congestive heart failure prior concurrent therapy: * see disease characteristics

Keywords: untreated adult acute myeloid leukemia adult acute myeloid leukemia with 11q23 (mll) abnormalities adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(15;17)(q22;q12) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22)
phase 1 study of belimumab in subjects with systemic lupus erythematosus (sle)

Conditions: Systemic Lupus Erythematosus

Summary: the purpose of thie study is to evaluate the safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of belimumab (lymphostat-b™)in subjects with sle.


Eligibility criteria:
key inclusion criteria: * clinical diagnosis of sle by acr criteria * stable sle disease activity * on stable sle treatment regimen * history of measurable autoantibodies key exclusion criteria: * pregnant or nursing * received a non-fda approved investigational agent within last 28 days * received cyclosporin, intravenous immunoglobulin (ivig) or plasmapheresis within last 6 months * active lupus nephritis requiring hemodialysis, intravenous cyclophosphamide (cytoxan™), or high-dose prednisone (\> 100 mg/day) within last 6 months * active central nervous system (cns) lupus requiring medical intervention within last 6 months * history of renal transplant * history of clinical evidence of an active significant acute or chronic diseases * have required management or hospitalization of any infection within last 4 weeks. * history of hypogammaglobulinemia or iga deficiency * have current drug or alcohol addiction * history of or test positive at screening for hiv, hepatitis b or hepatitis c

Keywords: lupus sle
observational study for the evaluation of the role of hiv-1 tat protein and anti-tat immune response in hiv reservoir

Conditions: HIV/AIDS

Summary: a longitudinal observational study in hiv-infected subjects receiving cart addressed to explore the effect of the tat protein and anti-tat immunity on the formation and maintenance of hiv-1 virus reservoir.

the study is designed as a longitudinal observational study addressed to identify the effects of tat protein and humoral/cellular anti-tat immune responses (induced in the natural infection or by tat vaccination) in hiv-1 reservoir dynamics in blood of hiv infected patients receiving cart. hiv dna data will be used for analyzing the decay dynamics. the primary objective of the study is to determine the rate of decay of total hiv dna in blood of anti-tat antibody (ab) positive versus anti-tat ab negative hiv patients receiving cart. the secondary objectives of the study are to relate the hiv dna decay data to: 1. the persistence of anti-tat humoral responses; 2. biomarkers of hiv reservoir stability potentially affected by the tat protein or anti-tat immune responses, including: i) apoptotic/survival index of cd4+ t cells; ii) reactivation dynamics of latent hiv in resting cd4+ t cells upon exposure to tat protein and/or activation stimuli; iii) cellular and humoral biomarkers relevant to inflammation and immune dysregulation.

Eligibility criteria:
inclusion criteria: 1. age ≥18 years 2. diagnosis of hiv-1 infection 3. to be under cart treatment 4. cd4+ t-cell count ≥250 cells/microliters 5. testing for anti-tat ab performed during pre-screening 6. signed informed consent exclusion criteria: 1. current therapy with immunomodulators or immunosuppressive drugs or chemotherapy for neoplastic disorders.

Keywords: hiv/aids immune responses tat hiv reservoire biomarkers
evaluation of a lightweight nasal interface and ventilator in patients with respiratory disease

Conditions: Chronic Obstructive Lung Disease; Interstitial Lung Disease

Summary: a preliminary study to evaluate a new nasal interface and portable ventilator system in comparison to standard oxygen therapy in patients with severe chronic lung disease.

an open-label, randomized, controlled, crossover study in patients with severe chronic lung disease to evaluate exercise tolerance compared to standard nasal cannula oxygen therapy.

Eligibility criteria:
inclusion criteria: * adult male or female (\> 18 years of age) with a diagnosis of severe-to-very severe chronic lung disease * participates in a qualified pulmonary rehabilitation program * requires constant flow oxygen of ≥ 2 lpm (liters per minute) during exercise * able and willing to sign the informed consent * ability to be fitted with the test nasal mask and to use the test ventilator system exclusion criteria: * requires \> 5lpm of constant flow to maintain spo2\> 90% during exercise * reports having serious epistaxis within the last 14 days prior to enrollment * currently enrolled in another clinical study or has participated within 30 days of enrollment * has any condition or abnormality that in the opinion of the investigators may compromise the participant's safety or the quality of the study data