Kornimate/medical-research-clean huggingface dataset:
mitochondrial dysfunction and insulin resistance in skeletal muscle

Conditions: Insulin Resistance

Summary: the purpose of the study is to evaluate the link between insulin resistance and alterations in skeletal muscle mitochondrial redox homeostasis


Eligibility criteria:
inclusion criteria: * body mass index (bmi) ≥25 and \<40 kg/m2 * fasting plasma glucose ≥ 5.6 mmol/l or hba1c ≥ 5.7% * homa2-ir \> 1.4 * vo2max \<45 ml/kg/min exclusion criteria: * treatment with \>2 antidiabetic medications * insulin usage * chronic disease deemed by the study responsible medical doctor to interfere with any part of the study * chronic use of prescription medicine deemed by the study responsible medical doctor to interfere with any part of the study * smoking
comparison between technosphere/insulin inhalation powder versus rapid acting insulin in subjects with type 2 diabetes mellitus

Conditions: Diabetes Type 2

Summary: to compare the efficacy of prandial ti plus basal insulin versus prandial rapid acting, subcutaneous insulin plus basal insulin in subjects with type 2 diabetes who had an hba1c \>7.0% and \<11.5%.


Eligibility criteria:
inclusion criteria: * at least 2 years since diagnosis of type 2 diabetes mellitus * received subcutaneous (sc) insulin for at least 3 months * body mass index \<44 kg/m2 * hba1c\>7.0% and \<11.5% * serum creatinine \<2.0 mg/dl for males and \<1.8 mg/dl for females * baseline fvc and fev1\>70% and \< 125% of predicted normal exclusion criteria: * significant hepatic disease (ast/alt3 x uln) * diagnosis of type 1 diabetes * severe complications of diabetes * history of moderate to severe ketoacidosis within the past 3 months * upper respiratory infection in the last 15 days or a lower respiratory infection in the past 30 days * diagnosis of hiv * positive serology for hepatitis b or c * copd, emphysema, or asthma * current smokers or smoking history within the past 6 months * major psychiatric disorder precluding satisfactory completion of protocol * clinically significant heart disease disease, stroke or heart attack within the past 6 months * treatment with an investigational drug within 30 days * previous treatment with technosphere/insulin * history of malignancy in the past 5 years except basal cell carcinoma * anemia (hemoglobin \<10.5 g/dl for females and \<11.5 g/dl (for males) * women who were pregnant of lactating * history of hypersensitivity to drugs resembling fdkp carrier products * treatment with another inhaled insulin product during the duration of the study
raman spectroscopy for liver tumours following liver surgery

Conditions: Colorectal Cancer Metastatic

Summary: the aim of the proposed research is to develop a quick and reliable method for automated evaluation of tissue sections for residual tumour in histology specimens following liver surgery. this advanced technology will enable assessment of liver tumours and resection margins following liver surgery. the technology is based on raman spectroscopy (rs) and multivariate spectral analysis to produce 2-dimensional biochemical images that can reliably separate the spectral signal of liver tumours from surrounding normal tissue.

in this proposal, investigators will investigate the ability of rs to distinguish between normal versus cancer in tissue blocks following liver surgery. if successful, this technique can then be investigated for intra-operative assessment efficacy to ensure that the resection margin of the tumour is clear (free of tumour cells), enabling this powerful procedure to be applied to all patients undergoing liver surgery for highest standard of care. this device is an early concept development of an in-vitro diagnostic medical device. in this project investigators will answer the following two questions: * can raman spectroscopy discriminate between healthy tissue and colorectal liver metastases? if yes, with what accuracy? * how fast can a raman spectroscopy image of a tissue section be built? the success of this research will lead to a significant improvement in the quality and efficiency of liver surgery for colorectal liver metastases as it will allow all patients undergoing surgery to benefit from the best treatment available to ensure resection margins are clear. making the best techniques more widely available to all patients who need them reduces inequality in healthcare.

Eligibility criteria:
inclusion criteria: * patients undergoing surgery for liver tumours (colorectal liver metastases). * able to give informed consent. exclusion criteria: • patients where there is any doubt regarding the diagnosis from pathologist as ascertained by previous diagnostic biopsy.
the clinical significance of ovarian function detection and protection in fertility preservation surgery for ovarian malignancy

Conditions: Fertility Preservation Surgery; Ovarian Malignancy

Summary: the design of this prospective interventional study is to investigate the clinical significance of applying gnrha preoperatively and postoperatively and detecting physical and endocrinic change in fertility preservation surgery

20 patients with ovarian maligancies are anticipated to be enrolled in this study within 2 years. with their permission, they will be randomized into the control group and the experimental group when the latter is supposed to receive gnrha preoperatively and postoperatively. and their physical and endocrinic indexes will be monitored. the effect of extra use of gnrha will be observed by comparing these two groups' outcomes.

Eligibility criteria:
inclusion criteria: 1. volunteer to participate in the study with informed consent; 2. females aged 10-90 who are confirmed with ovarian malignancy and are willing to receive gnrha experimentally to preserve their fertility function. exclusion criteria: 1. pregnancy, lactation and postmenopause; 2. suspected or identified as other tumors of genital tract; 3. history of hyperparathyroidism, infectious diseases (tuberculosis, aids), autoimmune diseases, or digestive system diseases (malabsorption, crohn disease and dysentery); 4. other diseases or heavy injuries that will interfere with the results; 5. simultaneous participation in another clinical study with investigational medicinal product(s) or researcher thinks the subjects are not suitable for this trial.
effects of cognitive remediation therapy on schizophrenia patients through functional magnetic resonance imaging

Conditions: Schizophrenia

Summary: cognitive remediation therapy (crt) can enhance cognitive performance in patients with schizophrenia improving clinical outcome. however, the neurobiological mechanism underlying cognitive improvement is not well understood. the aim of this study is to investigate functional connectivity patterns before and after the neurocognitive rehabilitation therapy, especially in fronto-temporal circuitry.

a controlled randomized study will be carry out with three different groups: patients receiving cognitive rehabilitation treatment (crt), patients receiving another psychological intervention of control and a healthy control group. a descriptive study of cases will be also carried out. the functional mri (frmi) techniques as well as voxel-based morphometry allow individual analysis of cases. the independent variable is the cognitive rehabilitation treatment. the crt will be applied according to the manual of wykes \& reeder (2005) cognitive remediation therapy: theory and practice, ed: routledge. the program has a duration of 40 sessions (one hour of duration), with two sessions for week during four months. it is carried out individually and utilizes paper and pencil tasks. the main technique utilized is the scaffolding (to provide strategies when the patient cannot carry out the task and to withdraw him when he is yet able of doing it alone) in a context of learning without errors. the main dependent variable is the functional connectivity cerebral pattern obtained by means of functional magnetic resonance. other secondary dependent variables are neurocognitive functioning, the symptomatic pattern and the psychosocial functioning obtained from the psychometric evaluation. all the participants will be evaluated before and after the experimental intervention in neurocognitive areas (battery will be composed by wais-iii, ravlt, trail making test, stroop color word, wcst, fas-cowat), symptomatic area (panss) and in social functioning (social functioning scale sfs; birchwood et al. 1990). the evaluations will be carried out by expert evaluators that will be blind to the experimental distribution. the statistics results analysis will be carry out by means of the statistical package spss 15.

Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia according to dsm-iv-tr and confirmed by the semi-structured interview (scid) for the axis 1. * presence of cognitive deficit confirmed by the neuropsychological battery. * stable symptomatology at least during the last six months and the estimation of not modifying pharmacological antipsychotic treatment. exclusion criteria: * presence of organic-cerebral affectation due to neurological or traumatic conditions * abuse of psychotropic substances * presence of other psychiatric symptomatology

Keywords: schizophrenia cognitive remediation fmri
expanded access program: safety of erythrocytes encapsulating l-asparaginase (graspa®) in combination with polychemotherapy in patients under 55 years old with acute lymphoblastic leukemia (all) at risk to receive other formulation of asparaginase

Conditions: Acute Lymphoblastic Leukemia

Summary: early access program to provide l-asparaginase encapsulated in erythrocyte (graspa®) for patient unable to receive any other form of asparaginase.

some patients can not be eligible to other clinical trials / program sponsored by erytech pharma but could have a benefit to be treated with graspa. following discussion with french regulatory authorities, it has been suggested to propose access to graspa to patients unable to receive any other form of l-asparaginase and not eligible to the ongoing study or other program. this exploratory study should allow it in an "expended access program" framework.

Eligibility criteria:
inclusion criteria: * patients with all de novo or in relapse or refractory * eligible to a chemotherapy treatment including l-asparaginase * known contraindication and/or at risk of toxicity to other l-asparaginase formulation according to investigator opinion based on information available * patient under 55 years old * patient informed and consent provided (the 2 parents need to consent for children). exclusion criteria: * patient unable to receive graspa due to general or visceral conditions * serum creatinine ≥ 2 x uln unless related to all * alt or ast ≥ 3 x uln unless related to all * active clinical pancreatitis any grade or pancreatic enzyme elevation ≥ 1.5 uln * other serious conditions according to investigator's opinion. * absence of documented serological test for hiv, b and c hepatitis * history of grade 3 transfusional incident or any contraindication to receive blood transfusion * patient under concomitant treatment likely to cause hemolysis * presence of specific anti-erythrocyte antibodies preventing from getting a compatible erythrocyte concentrate for the patient. * patient undergoing yellow fever vaccination. * patient under phenytoin treatment. * women of childbearing potential without effective contraception as well as pregnant or breast feeding women. * patient already included in another clinical trial

Keywords: all l-asparaginase encapsulated erythrocytes
prevalence of diabetic retinopathy in são josé do rio preto-sp-brazil

Conditions: Diabetic Retinopathy

Summary: prevalence of diabetic retinopathy in são josé do rio preto-sp-brazil abstract objective: to determine the prevalence and characteristics of diabetic retinopathy (dr) among patients from são josé do rio preto-sp-brazil . local: departamento de retina e vítreo do hospital do olho de rio preto (horp) methods: design: population-based cross-sectional study. the study sample, of 710 patients was derived from the hiperdia (diabetes and high-blood pressure social health care program) of são josé do rio preto . all patients , known to have diabetes , underwent an eye examination by biomicroscope and indirect ophthalmoscope to check for any signs of dr through dilated pupils. participants were also interviewed and examined to determine their demographic characteristics, medical conditions and the realization of previous fundoscopic eye examination. statistical studies were done with t -student test , fisher test or chi-square test.

prevalence of diabetic retinopathy in são josé do rio preto-sp-brazil abstract objective: to determine the prevalence and characteristics of diabetic retinopathy (dr) among patients from são josé do rio preto-sp-brazil . local: departamento de retina e vítreo do hospital do olho de rio preto (horp) methods: design: population-based cross-sectional study. the study sample, of 710 patients was derived from the hiperdia (diabetes and high-blood pressure social health care program) of são josé do rio preto . all patients , known to have diabetes , underwent an eye examination by biomicroscope and indirect ophthalmoscope to check for any signs of dr through dilated pupils. participants were also interviewed and examined to determine their demographic characteristics, medical conditions and the realization of previous fundoscopic eye examination. statistical studies were done with t -student test , fisher test or chi-square test. results: among 710 screened patients 112 had some degree of diabetic retinopathy and the overall standardized prevalence of any retinopathy was 16,3%., including 90 (80,4%) with non-proliferative and (22) 19,6 % with proliferative diabetic retinopathy. only 143 patients (68,7%) had a history of previous fundoscopic eye examination. conclusion: this study demonstrated that dm and their complications are a important public health problem. the duration of dm and glicemic control is strongly associated with dr . prevention programs with periodic fundoscopic exams shows to diminished the prevalence of this ocular disease. keywords: diabetes, retinopathy, prevalence, population.

Eligibility criteria:
inclusion criteria: * patients with diabetes melittus exclusion criteria: * patients without diabetes melittus

Keywords: prevalence of diabetic retinopathy diabetes retinopathy prevalence population
suprazygomatic maxillary nerve block effect on systemic inflammatory response in cleft palate surgeries

Conditions: Perioperative Inflammatory Response; Postoperative Pain

Summary: the aim is to determine the value of adding bilateral supra zygomatic maxillary nerve block to general anesthesia in attenuating the systemic inflammatory response in paediatrics.

cleft lip and palate are some of the most common craniofacial malformations, with an incidence ranging between 0.1 and 1.1 per 1000 births. early surgical intervention for cleft palate (cp) repair is essential for proper feeding and phonation as well as reduction of complications such as frequent sinusitis and other respiratory tract infections. surgical injury stimulates the systemic inflammatory response. the neuroendocrine response leads to stimulation of the sympathetic nervous system resulting in tachycardia, hypertension and activation of the hypothalamic-pituitary adrenal axis. this induces the release of hormones such as adrenocorticotropic hormone (acth), catechol-amines (norepinephrine and epinephrine) and cortisol and increase in white cell count which is proposed to have a detrimental effect on the postoperative immunity. furthermore, the production of pro-inflammatory cytokines including interleukins (il) e.g.il-1, il-6, il-8 and tumour necrosis factor alpha (tnf-α) by innate immune cells such as neutrophils and macrophages, interacting with damaged cells and platelets, leads to the production of acute phase proteins from the liver such as c-reactive protein (crp), fibrinogen and complement proteins. regional blocks provide good pre-emptive analgesia when given in combination with general anaesthesia (ga). it is associated with hemodynamic stability, rapid recovery, reduction of supplemental analgesia consumption in addition to favourable effect on systematic inflammatory response. using bilateral suprazygomatic approach of maxillary nerve block during cp repair is hypothesized to provide such mentioned settlement of a regional block.

Eligibility criteria:
inclusion criteria: * primary and secondary cleft palate surgeries. * american society of anesthesiologists physical status (asa) i to ii patients. * age group: 1-5 years old. exclusion criteria: * presence of coagulation disorders. * peripheral neuropathy. * local infection or lesion in puncture site. * allergy to local anesthetics. * physical status: asa iii or above.
comparison of low against high regimen of proton pump inhibitors for treatment of acute peptic ulcer bleeding

Conditions: Gastroduodenal Ulcer; Marginal Ulcer; Peptic Ulcer Hemorrhage

Summary: evaluate the efficacy of two different regimens of proton pump inhibitors high against low in the management of acute peptic ulcer bleeding

evaluate the efficacy of two different regimens of proton pump inhibitors in the management of acute peptic ulcer bleeding first: loading dose 80 mg then 8mg/h iv continuous infusion for 3 days second loading dose 80 mg the 40 mg every 12 h for 3 days

Eligibility criteria:
inclusion criteria: * high risk ulcers defined according to the forrest classification with respect to high-risk stigmata, * active bleeding was defined as a continuous blood spurting (forrest ia) * oozing (forrest ib) from the ulcer base. * a non-bleeding visible vessel at endoscopy was defined as a discrete protuberance at the ulcer base(forrest iia). * an adherent clot was one that was resistant to forceful irrigation or suction (forrest iib). exclusion criteria: * ulcer was malignant * non ulcerative bleeding such as angiodysplasia , a mallory-weiss tear....

Keywords: gastroduodenal ulcer marginal ulcer peptic ulcer hemorrhage peptic ulcer
pulmonary complications in elderly patients

Conditions: Postoperative Complications

Summary: the incidence of postoperative pulmonary complications in elderly patients undergoing upper abdominal laparoscopic surgery remains high, and the lung protective mechanical ventilation strategy aims to reduce the incidence of lung injury caused by ventilators. peep, as an important protective ventilation strategy, maintains end expiratory alveolar volume to improve intraoperative oxygenation and pulmonary respiratory mechanics, and plays a protective role in the lungs; personalized peep is the most beneficial, especially for elderly patients. however, there is currently no ideal way to achieve precise and personalized regulation of peep. this project aims to target and control intraoperative mechanical ventilation to drive pressure, personalize peep titration, and conduct a randomized controlled study on perioperative changes in pulmonary oxygenation function and pulmonary complications in elderly patients undergoing upper abdominal laparoscopy.


Eligibility criteria:
inclusion criteria: * asa\ 0.5h, laparoscopic surgery on the upper abdomen (stomach, liver, gallbladder) exclusion criteria: * severe anemia (hb\<60g/l), osa, severe copd (fev1\<30% pre), asthma, bronchiectasis, preoperative pulmonary infection, respiratory failure, thoracic deformity, postoperative return to icu, heart function grade iii-iv, severe liver and kidney dysfunction (child b or c, dialysis), intraoperative bleeding greater than 30% of blood volume.
phase 0 of 18f fpm using pet/ct in patients with a variety of malignancies

Conditions: Squamous Cell Carcinoma

Summary: the purpose of this study is to investigate the safety and potential effectiveness of the imaging compound 18f fpm for finding sites of malignancies.


Eligibility criteria:
inclusion criteria: * written informed consent obtained prior to any protocol-specific procedures * male and female patients with histologically confirmed squamous cell carcinoma * at least one site of active malignancy, as demonstrated on the pre-study 18f fdg pet/ct scan performed as part of routine clinical care * age \>/= 18 years * life expectancy \>/= 3 months * ecog performance score of 0-2 exclusion criteria: * pregnant or breastfeeding females * systemic anti-neoplastic therapy within the 2 weeks prior to the pre-study 18f fdg pet/ct scan until after the 18f fpm pet/ct scan * any serious medical condition which the investigator feels may interfere with the procedures or evaluations of the study * patients unwilling or unable to comply with protocol or with a history of non-compliance or inability to grant informed consent

Keywords: 18f fpm pet/ct microdosing
a phase i study of lfa102 in japanese patients

Conditions: Castration-resistant Prostate Cancer, Advanced Breast Cancer

Summary: this study will evaluate safety and tolerability to determine the mtd/rd.

this is a phase i open-label, multi-center, dose escalation study in japanese patients with crpc or advanced bc. lfa102 will be administered intravenously once every 4 weeks during the study. all patients will remain on treatment until they meet the criteria for study discontinuation (e.g. disease progression, unacceptable toxicity, patient withdrawal) or study closure. this study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of lfa102. each cohort will enroll a minimum of 3 patients. a two-parameter bayesian logistic regression model employing the escalation with overdose control principle will be used during the escalation phase for dose level selection and for determination of the mtd or rd.

Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of prostate cancer * histologically or cytologically confirmed locally advanced or metastatic breast cancer exclusion criteria: * patients with untreated and/or symptomatic metastatic cns disease * prior anaphylactic or other severe infusion reaction * treatment with agent which affect prolactin levels * active autoimmune disease other protcol-defined inclusion/exclusion criteria may apply.

Keywords: castration-resistant prostate cancer, advanced breast cancer