Kornimate/medical-research-clean huggingface dataset:
effects of low- or high-glycemic index diets on metabolic and inflammatory responses in diabetics

Conditions: Type 2 Diabetes Mellitus

Summary: background/aims: verify the effects of glycemic index (gi) on body composition, and on inflammatory and metabolic markers concentrations. methods: eighteen type 2 diabetics, (aged 42.4 + 5.1 years, bmi 29.2 + 4.8 kg.m-2) were randomly allocated to low gi (lgi) or high gi (hgi) groups. high or low gi meals were provided in the laboratory twice a day during 30 consecutive days. the other meals were consumed under free living condition and subjects were instructed to select foods presenting gi values corresponding to the allocated group. body composition (body mass index, body fat percentage, waist circumference and waist-hip ratio), and inflammatory markers concentrations (interleukin-6, tumor necrosis factor-alpha, high molecular weight adiponectin, ultra-sensitive c-reactive protein and fibrinogen) and metabolic markers (glucose, insulin, total cholesterol, hdl cholesterol, free fatty acids, triglycerides and fructosamine) were assessed at baseline and after intervention. food intake was monitored during the study. the criterion for statistical significance was p\<0.05.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus * level of physical activity light to moderate * use of sulfonylureas or biguanides oral hypoglycemic drugs * stable medications for the previous 3 months exclusion criteria: * cardiovascular, renal, or liver disease * treatment for cancer * smokers * daily consumption of \> 50g/day of alcohol * pregnant, lactating, postmenopausal women, * hormone replacement therapy * recent change (last three months) in the level of physical activity or diet * weight instability (\> 3 kg in the previous three months), * therapeutic diet * allergies, test foods intolerance * use of drugs affecting body metabolism and/or food intake.
to study the efficacy of bromocriptine in patients with hepatic/cirrhosis related parkinsonism

Conditions: Cirrhosis Related Parkinsonism

Summary: after successful screening of liver cirrhosis patients attending ilbs opd for signs of parkinsonism ( tremor, rigidity or bradykinesia, any 2 of 3). diagnosis of hepatic/cirrhosis related parkinsonism will be made. patients will be randomized into bromocriptine and placebo. patients will be followed up every month in opd (out patient department), ilbs (institute of liver \& biliary sciences) for 3 months. detailed neurological examination will be done at each visit \& updrs (unified parkinson's disease rating scale ) score will be calculated.


Eligibility criteria:
inclusion criteria: * patients with cirrhosis of liver with signs of parkinsonisms * patients consented for the study protocol by signing the informed consent. exclusion criteria: * age \< 18 years. * patient s with hcc (hepatocellular carcinoma). * patients diagnosed as wilsons disease. * patient who withdrew or non complaint to the study protocol. * alf (acute liver failure) * classical parkinsonism * atypical parkinsonism * pregnancy * hypotension * uncontrolled hypertension * cad * psychiatric illness * acute episode of hepatic encephlopathy
incidence of hana conditions in hiv-infected individuals

Conditions: HIV; Metabolic Syndrome; Osteopenia; Osteoporosis; Vitamin D Deficiency; Renal Impairment; Liver Fibroses

Summary: with the availability of effective anti-retroviral therapy, hiv-infected individuals are expected not to die of aids and have longer life expectancy. but at the same time, hiv-associated non-aids (hana) conditions are becoming more important in their clinical management. it is currently uncertain whether patients started on different anti-retroviral regimens will have different incidence of hana conditions. this study aims to evaluate the incidence of various hana conditions in a cohort of newly diagnosed hiv-infected individuals in hong kong initiating anti-retroviral treatment. the incidence of various hana conditions will be evaluated for those receiving insti versus other non-insti-based regimens. the hana conditions evaluated will include 1. hypertension 2. diabetes and insulin resistance 3. dyslipidemia 4. lipodystrophy 5. metabolic syndrome 6. osteopenia and osteoporosis 7. vitamin d deficiency 8. renal impairment and kidney tubular dysfunction and 9. liver fibrosis. patients will be assessed prior to initiation of anti-retroviral therapy, and 48 weeks and 96 weeks after initiation of treatment. the incidence of development of each hana condition will be determined and compared between those initiated different anti-retroviral regimens.


Eligibility criteria:
inclusion criteria: 1. confirmed hiv infection by hiv antibody or rna test 2. age ≥40 years old 3. anti-retroviral treatment naïve 4. agree to initiate anti-retroviral therapy (art) as determined by in-charge hiv physician exclusion criteria: 1. pregnancy 2. unable to give informed consent
gut microbiota in mood disorders in lebanese population

Conditions: Gut Microbiome; Mood Disorders

Summary: this study aims to evaluate the pathophysiological aspects of the role of inflammation and gut microbiota in mood disorders, in particular in depression, and their therapeutic implications on a cohort of the lebanese population. specific objective: the evaluation of probiotic intake (cerebiome®, lallemand health solutions inc., mirabel, canada) on the inflammatory state, gut bacterial profile and the depressive state. evaluate the effect of oral intake of a probiotic agent on plasma inflammatory markers, gut bacterial profile and depressive state in a subgroup of target patients versus a subgroup treated with placebo, in combination with conventional treatment.


Eligibility criteria:
inclusion criteria: * major depressive disorder: current depressive episode according to mini (dsm-5) with a madrs score of ≥ 20 * males and females between ages 18 and 65 * able to understand and comply with the requirements of the study * provision of written informed consent exclusion criteria: * patients under anti-inflammatory drugs * patients under immuno-suppressants * use of any type of laxative * women who are pregnant, breastfeeding, or planning to become pregnant during the trial * bipolar, schizophrenia, and addiction disorders * any antibiotic therapy in the past 4 weeks

Keywords: gut microbiome mood disorders lebanon depression
performance and acceptance of optive versus hylocomod eyedrops in patients with dry eye symptoms

Conditions: Dry Eye Syndromes

Summary: this study evaluates the performance and acceptance of optive versus hylocomod eyedrops, when administered for one month to patients with mild to moderate dry eye symptoms, with and without contact lenses.


Eligibility criteria:
inclusion criteria: * 18 years or over * contact lens wearer, spectacle wearer or non-spectacle wearer * mild to severe dry eye symptoms, defined as osdi score 13 to 100 * mild to moderate conjunctival staining in each eye and/or mild to moderate corneal staining in each eye * best corrected visual acuity of 6/9 in each eye exclusion criteria: * previously used hylocomod or optive eyedrops * systemic allergy or eye allergy * systemic disease which might have an ocular component and/or interfere with contact lens wear * autoimmune disease which might have an ocular component and/or interfere with contact lens wear * systemic medication which might have eye side effects and or interfere with contact lens wear * eye infection or use of eye medication
submerged versus non-submerged healing of implants subjected to contour augmentation

Conditions: Tooth Loss

Summary: it is a randomized controlled trial to evaluate two surgical techniques for dental implant placement simultaneously with bone augmentation.

implants receiving contour augmentations at the time of placement are randomized into two groups, submerged and non submerged. healing is evaluated at 4 months post op compared to the day of surgery.

Eligibility criteria:
inclusion criteria: * age more than 21 years - asa i or ii. * patient's willingness to participate in this study. * availability for 4-month follow-up. * absence of active periodontal disease. * single tooth replacement is needed with simultaneous contour augmentation. * available pre-operative cbct study. * extraction of tooth at least 8 weeks prior to planned implant therapy. exclusion criteria: * pregnancy at the screening visit. * smoking more than 10 cig/day. * active infection at the site of surgery (teeth involved). * multiple missing teeth adjacent to each other (long span edentulous area). * vertical bone defect less than 2mm (intra surgical assessment)
efficacy of augmentation of cognitive behavioral therapy with transcranial direct current stimulation for obsessive-compulsive disorder (ocd)

Conditions: Obsessive-Compulsive Disorder

Summary: this study aims to evaluate the feasibility and clinical outcome of the exposure-based cognitive-behavioral therapy (cbt) concurrent with transcranial direct current stimulation (tdcs) in treating obsessive-compulsive disorder (ocd) patients, and explores the potential neural mechanisms of treatment effect by magnetic resonance imaging (mri) and electroencephalography (eeg).

the current study aims to evaluate feasibility and clinical outcome of exposure-based cbt（erp）combined with tdcs over the prefrontal cortex (mpfc) in treatment of ocd patients. 60 ocd patients whose symptom were mainly associated with "contamination/clean" will be randomized into two groups (i.e. erp+active tdcs or erp+sham tdcs stimulation). over a two-month period, all patients are received 10 sessions of individual cbt, including 8 sessions of concurrent tdcs with erp (tdcs+erp). three independent evaluators will rate the severity of patients' obsessive-compulsive symptoms using y-bocs at four assessment points: baseline (prior to the treatment), after the first (session 2#), fourth (session 5#), and eighth treatment of tdcs+erp (session 10#). the patients will also receive mri scan and eeg. the current study aims to explore whether the administration of online tdcs together with erp (tdcs+erp) will improve the efficacy of erp and tries to provide some early evidience that reveal potential neural mechanisms of the treatment.

Eligibility criteria:
we recruited outpatient adults with ocd confirmed by the mini-international neuropsychiatric interview (mini). the following inclusion and exclusion criteria were also applied: inclusion criteria: (1) 18-50 years old, with at least 9 years of education, (2) y-bocs score ≥16, (3) no history of serious medical, neurological illness or other psychotic disorders other than ocd (anxiety or mild to moderate depression secondary to ocd was not exclusionary), (4) medication-free or had received stable medication for at least 2 months before entering the study and continued the same medication throughout the study (5) no previous exposure to erp or tdcs. exclusion criteria: * history of serious medical, neurological illness or other psychotic disorders other than ocd * the inability to receive tdcs because of metallic implants, or history of seizures，or history of head injury, or history of neurosurgery. * participants who have received ect, rtms, tdcs and cbt in the past. * participants with claustrophobic, heart pacemaker, mechanical heart valve, mechanical implant such as an aneurysm clip, hip replacement, or any other pieces of metal that have accidentally entered their body. * serious suicide risk

Keywords: transcranial direct current stimulation cognitive-behavioral therapy exposure and response /ritual prevention
duration of stay after urologic surgery : neuraxial versus general anesthesia

Conditions: Urinary Retention

Summary: outpatient midurethral surgery is a frequent surgery. it is performed either under general anesthesia or neuraxial anesthesia. a frequent complication is postoperative urinary retention requiring urinary catheterization, which implies a higher infectious risk. the investigators compared the complication rate after tvt surgery depending on the type of anesthesia.


Eligibility criteria:
inclusion criteria: * age \> 18 years * sex: female * patient who has consented to the use of her medical data for research purposes. * patient undergoing outpatient urinary incontinence surgery using tvt between 2012 and 2016 exclusion criteria: * specific clinical forms of the disease, * interfering treatments and associated diseases, history, * refusal of the patient to participate in the study

Keywords: urologic surgery urinary incontinence tension free vaginal tape post-operative urinary retention outpatient surgery
web-based symptom monitoring and survival in advanced stage lung cancer

Conditions: Lung Cancer

Summary: the goal of this clinical trial is to investigate if weekly symptom monitoring of patients with advanced lung cancer is associated with better survival and improved quality of life compared to standard follow-up. each week, participants in the intervention group will be asked to respond to an electronic weekly questionnaire covering 11 items related to current health status.

this is a prospective, multicentre, randomized, two-armed, open-label trial in which participants will be randomised to standard follow-up according to current management guidelines for lung cancer (control arm) or with the addition of weekly web-based symptom monitoring (intervention arm). both study groups will be asked to fill out quality of life questionnaires before randomisation and every three months. in addition to comparing survival and quality of life, the study will also assess progression free survival, performance status, eligibility for second line anti-neoplastic treatment and health care consumption. all subjects will be followed for 24 months. updated data on survival will also be collected up to 5-years. by innovative use of an it platform already in use in swedish cancer care, this trial will evaluate potential benefits of systematic symptom monitoring in patients with advanced lung cancer. if corroborating earlier reports of marked survival benefits, the results of this trial could change clinical practice and current guidelines for follow-up of lung cancer patients.

Eligibility criteria:
inclusion criteria: * histologically or cytology proven non-small cell lung cancer (nsclc) * nsclc stage iii or iv * ≥ 18 years * ecog performance status 0- 2 * eligible patients should have initiated first-line treatment for advanced or metastatic disease with chemotherapy and/or immunotherapy, radiochemotherapy or targeted treatment * patients are eligible for inclusion if they have responded to first-line treatment with stable disease, or better, at the first radiological evaluation performed up to six months after start of treatment * stable disease, or better, on radiological assessment within 28 days of enrolment (ct scan or fdg-pet/ct. cerebral mri if known brain metastasis) * initial web-based application score of ≤ 6 * basic computer literacy * bank-id (electronic identification system) and access to "1177 vårdguiden" * the subject has given written consent to participate in the study exclusion criteria: * symptomatic brain metastases * pregnancy, breastfeeding, or planned pregnancy * persons under guardianship or deprived of liberty * mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation * treatment or disease which, according to the investigator, can affect treatment or study results * ongoing participation in another interventional clinical study

Keywords: sweden
pyrazoloacridine in treating patients with metastatic skin or eye melanoma

Conditions: Intraocular Melanoma; Melanoma (Skin)

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of pyrazoloacridine in treating patients who have metastatic skin or eye melanoma.

objectives: * assess the antitumor activity of pyrazoloacridine (pza) in chemotherapy naive patients with metastatic cutaneous or ocular melanoma. * determine the toxic effects of pza in this patient population. * determine the pharmacokinetic profile of pza in these patients. outline: patients are stratified into cutaneous or ocular melanoma treatment groups. patients receive pyrazoloacridine iv over 3 hours on day 1. treatment continues every 21 days in the absence of disease progression or unacceptable toxicity. projected accrual: approximately 28-70 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed metastatic cutaneous or ocular melanoma that is chemotherapy naive * bidimensionally measurable disease * no pleural effusions or ascites * no untreated cns metastases * stable brain metastases by ct or mri scan * at least 4 weeks since prior steroid therapy patient characteristics: age: * 18 and over performance status: * ecog 0-2 life expectancy: * at least 12 weeks hematopoietic: * wbc at least 4,000/mm\^3 * absolute neutrophil count at least 1,500/mm\^3 * platelet count at least 100,000/mm\^3 hepatic: * bilirubin no greater than 1.5 mg/dl * sgot and sgpt no greater than 2.5 times upper limit of normal (uln) * alkaline phosphatase no greater than 2.5 times uln (unless due to hepatic metastases) renal: * creatinine no greater than 1.5 mg/dl or * creatinine clearance at least 60 ml/min other: * not pregnant or nursing * fertile patients must use effective contraception * no active infection * no known hypersensitivity to e.coli derived proteins * no other serious medical problems * no more than 1 primary malignancy within past 5 years, other than: * nonmelanomatous skin cancer * carcinoma in situ of the cervix * no history of spinal cord compression prior concurrent therapy: biologic therapy: * prior biologic therapy allowed (e.g., interleukin-2, interferon alfa, or vaccine therapy) chemotherapy: * no prior chemotherapy endocrine therapy: * see disease characteristics radiotherapy: * prior radiotherapy for primary ocular melanoma, brain metastases, or to metastatic sites encompassing less than 25% of the bone marrow allowed * no other prior radiotherapy surgery: * at least 2 weeks since prior surgery and recovered

Keywords: iris melanoma ciliary body and choroid melanoma, small size ciliary body and choroid melanoma, medium/large size extraocular extension melanoma recurrent intraocular melanoma stage iv melanoma recurrent melanoma
project starfish - prj0002679

Conditions: SARS-CoV-2 Infection; Influenza A; Influenza Type B; RSV Infection

Summary: this is a non-interventional study to perform the clinical performance evaluation of the starfish test using prospectively collected matched nasopharyngeal and nasal swab samples from the same donor.

the applied biosystems™ taqpath™ covid-19, flu a, flu b, rsv select panel (referred to below as "starfish test") aims to develop a multiplex real-time pcr ivd test for the qualitative detection and identification of sars-cov-2, influenza a virus, influenza b virus, and respiratory syncytial virus (rsv). the purpose of this performance study is to evaluate the clinical performance of the starfish test compared with that of a comparator device using upper respiratory specimens from subjects who have provided consent to participate in the study and meet the inclusion criteria. this clinical performance study protocol (cps protocol) outlines the clinical sample collection and testing protocols which will be used to satisfy the fda 510(k) study requirements in the us.

Eligibility criteria:
inclusion criteria: * participants of all ages must meet the following inclusion criteria to be eligible for participation in the study. * ability to provide informed consent or assent (as age-appropriate). stated willingness and ability to comply with the study procedures including nasopharyngeal and anterior nasal swab collection. * all-comers phase: individuals suspected to have respiratory tract infection for seven (7) or fewer days. * enrichment phase: individuals suspected to have respiratory tract infection for seven (7) or fewer days, and with a standard of care positive pcr test result within three (3) days. exclusion criteria: * participants meeting the following criterion will be excluded from the study: * suspected to have respiratory tract infection for greater than seven (7) days. * patients not suspected of having a respiratory tract infection.
evaluate the safety and efficacy of cll1 car-t in patients with r/r aml

Conditions: AML

Summary: this is an open label, phase i study to assess the safety and efficacy of cll1 car-t in patients with relapsed and refractory acute myeloid leukemia


Eligibility criteria:
inclusion criteria: 1. all subjects must sign and date the informed consent before initiating any study specific procedures or activities; 2. diagnosed as relapse/refractory (r/r) de novo or secondary acute myeloid leukemia (aml); 3. the expression of cll1 in aml blast is positive ; 4. the patient has recovered from the toxicity of previous treatment; 5. ecog score ≤ 2 and expected survival period is not less than 3 months; 6. adequate organ function defined as: ast ≤3×uln; alt ≤3×uln; total bilirubin ≤1.5×uln; serum creatinine ≤1.5×uln, or ccr≥60 ml/min; hemoglobin ≥60g/l ; indoor oxygen saturation ≥92%; lvef≥45%; 7. pregnancy testing: females of childbearing potential must have a negative serum or urine pregnancy test; 8. from the use of study drug to 2 years after treatment, males and female of childbearing potential must agree to use an effective method of contraception exclusion criteria: 1. diagnosis of acute promyelocytic leukemia; 2. history or presence of a cns disorder; 3. hbsag or hbcab are positive; hcv 、hiv and syphilis antibody are positive, cmv dna in peripheral blood is more than≥500 copies /ml; 4. history of severe hypersensitivity reaction; 5. history of myocardial infarction, cardiac angioplasty or stenting, unstable angina, new york heart association class ii or greater congestive heart failure, atrial fibrillation, or other clinically significant cardiac disease within 12 months before enrollment; 6. history of organ transplant surgery; 7. required systemic application of immunosuppressive or other drugs; 8. auto-sct within the 3 months before enrollment; 9. active autoimmune or inflammatory diseases of the nervous system (e.g., guillain-barre syndrome (gbs), amyotrophic lateral sclerosis (als)) and clinically active cerebrovascular diseases (e.g., cerebral edema, posterior reversible encephalopathy syndrome (pres)); 10. requirement for urgent therapy due to ongoing or impending oncologic emergency (eg, leukostasis or tumor lysis syndrome (tls)) ; 11. presence or suspicion of a fungal, bacterial, viral, or other infection that is uncontrolled or requiring antimicrobials for management; 12. live vaccine received within the ≤ 4 weeks before enrollment; 13. persons with serious mental illness; 14. history of major surgical operations four weeks before enrollment; 15. history of alcoholism or substance abuse; 16. was identified by the investigators as unsuitable to participate in the study
combination chemotherapy of gemcitabine and paclitaxel for metastatic breast cancer

Conditions: Metastatic Breast Cancer

Summary: to investigate efficacy, safety and pk of gemcitabine and paclitaxel combination in patients with metastatic breast cancer after adjuvant/neo-adjuvant chemotherapy with anthracycline regimen


Eligibility criteria:
inclusion criteria: * histologically and/or cytologically confirmed breast cancer * received adjuvant/neo-adjuvant chemotherapy for breast cancer with anthracycline regimen * to have at least one measurable region * eastern cooperative oncology group (ecog) performance status: 0-1 * to have adequate organ function (bone marrow, liver and renal function) exclusion criteria: * to have interstitial pneumonia or pulmonary fibrosis * to have inflammatory breast cancer * within 28 days after the latest chemotherapy or radiotherapy, 14 days after the latest hormonal/immunotherapy or 7 days after surgery * to have brain metastases with symptoms * to have severe complication (cardiac infarction, infection, drug hypersensitivity or diabetes)