Kornimate/medical-research-clean huggingface dataset:
effect of deep brain stimulation on gastrointestinal (gi) motility

Conditions: Parkinson's Disease

Summary: parkinson's disease is characterized by extra-pyramidal symptoms as well as digestive involvement with gastrointestinal motility (gi) impairment. deep brain stimulation has been recently developed as a successful treatment for extrapyramidal symptoms. in addition, preliminary reports suggest that this therapy might be successful to relieve gi symptoms as well. the aim of this study is therefore to assess the effect of deep brain stimulation on gi voluntary as well as involuntary motility.


Eligibility criteria:
inclusion criteria: * patient over 18 yo * patient with parkinson's disease implanted for deep brain stimulation * patient responders to deep brain stimulation (updrs improved by at least 40%) * patient covered by the french health care system * patient not taking anti-parkinsonian medication the day before evaluation * french speaking exclusion criteria: * patient below 18 yo * pregnancy * severe psychiatric or cognitive disorders * diabetes mellitus * morbid obesity * compulsive eating disorders * diffuse gi motility impairment (except parkinson's disease) * other evolutive neurologic disorders * previous history of significant gi resection * inability to swallow or defecate when asked

Keywords: parkinson's disease deep brain stimulation gi motility
clinical study of cmr to evaluate the effect of ivabradine on the improvement of left ventricular remodeling in stemi patients after primary pci

Conditions: Cardiovascular Diseases

Summary: this study aim to investigate the effect of ivabradine on reducing infarct size and improving left ventricular remodeling after in patients undergoing primary pci for st-elevation myocardial infarction through myocardial enhanced mri.

investigators will enroll 240 patients with stemi who were admitted to the chinese pla general hospital between october 2020 and october 2021，the investigators randomly assign eligible patients in a 1:1 ratio to either ivabradine or oral placebo befor primary pci. the treatment was initiated after primary pci with ivabradine orally for 6 months. primary end point of the study was the area of infarct size measured by cardiac magnetic resonance (cmr). cardiovascular events concluding stroke, repeat revascularization, rehospitalization for acute heart failure, nonfatal myocardial infarction, and all cause death. all adverse clinical events as well as study end points were monitored and adjudicated by the independent event committee.

Eligibility criteria:
inclusion criteria: * stemi patients: typical chest pain lasting 30 min within the previous 12 h, a clear st-segment elevation of n0.1 mv in ≥2 contiguous electrocardiographic leads, and elevated blood levels of troponin t * patients were scheduled to undergo diagnostic cardiac angiography or percutaneous coronary interventions exclusion criteria: * had once treated by ivabradine * history of myocardial infarction * mechanical complications * unable to perform myocardial mri * liver and kidney failure * malignant tumor * unconscious
confirmatory study of indacaterol in patients with chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: this study was designed to provide pivotal confirmation of efficacy and safety data for 2 doses of indacaterol (150 and 300 µg once daily \[od\]) in patients with moderate to severe chronic obstructive pulmonary disease (copd). data from this study will be used for the registration of indacaterol in japan.


Eligibility criteria:
inclusion criteria: * diagnosis of moderate-to-severe chronic obstructive pulmonary disease (copd), as classified by the global initiative for chronic obstructive lung disease (gold) guidelines and: 1. smoking history of at least 20 pack-years. 2. post-bronchodilator forced expiratory volume in 1 second (fev1) \< 80% and ≥ 30% of the predicted normal value. 3. post-bronchodilator fev1/fvc (forced vital capacity) \< 70%. exclusion criteria: * patients who have been hospitalized for a copd exacerbation in the 6 weeks prior to screening or during the 14 day run-in period prior to randomization. * patients requiring long-term oxygen therapy (\> 15 hours a day) for chronic hypoxemia. * patients who have had a respiratory tract infection within 6 weeks prior to screening. * patients with concomitant pulmonary disease. * patients with a history of asthma. * patients with diabetes type i or uncontrolled diabetes type ii. * any patient with lung cancer or a history of lung cancer. * any patient with active cancer or a history of cancer with less than 5 years disease-free survival time. * patients with a history of long qt syndrome or whose qtc interval (bazett's) measured at screening or randomization is prolonged. * patients who have been vaccinated with live attenuated vaccines within 30 days prior to screening or during the run-in period. * patients unable to successfully use a dry powder inhaler device or perform spirometry measurements. other protocol-defined inclusion/exclusion criteria applied to the study.

Keywords: copd chronic obstructive pulmonary disease indacaterol long acting β2-agonist
acceptability and continuation rate of implanon in a brazilian public sector

Conditions: Contraceptive Usage; Bleeding Due to Intrauterine Contraceptive Device

Summary: the main side-effect of implanon is the changes induces in bleeding patterns including amenorrhea, infrequent to irregular bleeding and frequent and prolonged bleeding; without any previous symptom and it was characterized as "breakthrough bleeding" (btb). btb is the main causes of early discontinuations. unfortunately, there is no indication to predict prior to insertion what sort of bleeding pattern any individual woman may have after insertion and the proposed treatments were disappointed. nevertheless, previous studies with other progestin-only contraceptives (including implanon) provide evidence that the provision of adequate and intensive counseling to potential users and new acceptors about bleeding changes can help to improve method continuation. the availability of implanon in the public sector could help in the development of strategies to introduce the method in the public sector network and the training of medical residents.

100 women were either allocated to received implanon contraceptive implant, the lng-ius or tcu380a copper-iud. the women were allocated according to their preference on each of the contraceptive methods. half of the women will receive the common counseling at the clinic and the other 50% will receive intense counselling about menstrual changes induced by these three contraceptive methods. the continuation rate up to one year will be evaluated through life-table analysis

Eligibility criteria:
inclusion criteria: * women 18 to 40 years * new users of implanon, iuds and the lng-ius tcu380a exclusion criteria: * contraindications to contraceptive methods
effects of norepinephrine and volume expansion in capillary refill time in septic shock in angers university hospital

Conditions: Septic Shock

Summary: the purpose of this study is to assess the effect of norepinephrine and fluid expansion on capillary refill time during septic shock.

an interventional study compared, in septic shock, the effect of resuscitation strategy targeting normalization of capillary refill time versus strategy targeting serum lactate level. this last highlight a decrease of organ dysfunction at 72 hours with capillary refill time strategy and non-significant trend towards lower 28-day mortality in the capillary refill time strategy group. the strategy guided by the decreasing of capillary refill time allowed the administration of less fluid than that guided by lactate. this is an important advantage when the intensive care doctor know that the mortality of patient in septic shock increases with the amount of fluid administered. however, the variations of capillary refill time induced by the principal treatment in septic shock (norepinephrine and fluid resuscitation) during circulatory failure are actually insufficiently described. the purpose of this study is to assess the effect of norepinephrine and fluid expansion on capillary refill time during septic shock.

Eligibility criteria:
inclusion criteria: * septic shock * presence of a cardiac output monitoring * decision by the physician in charge to perform vascular filling or modification the norepinephrine dose exclusion criteria: * patient under a tutelage measure or placed under judicial protection
predict antidepressant responsiveness using pharmacogenomics

Conditions: Depression; Depressive Symptoms

Summary: the purpose of this study is to determine whether genetic information associated with individual depressive symptoms.

the primary hypothesis is that the variations of the candidate genes are associated with individual symptoms in patients with depression. the second hypothesis is that patients with the associated genetic variation suffer longer from the associated symptom than the patients without the associated genetic variation.

Eligibility criteria:
inclusion criteria: * eligible patients were enrolled in the clinical trials program of hte samsung medical center geropsychiatry and affective disorder clinics(seoul, korea). they received a semistructured diagnostic interview, the samsung psychiatric evaluation schedule. the affective disorder section of the samsung psychiatric evaluation schedule uses the korean version of the structured clinical interview for the diagnostic and statistical manual of mental disorders, fourth edition. * interview with one more patient's family member for objective diagnosis and final diagnosis decision by agreements of two more psychiatric physicians exclusion criteria: * received psychotropic medication within 2 weeks of the study or fluoxetine within 4 weeks * potential study participants for pregnancy, significant medical conditions, abnormal laboratory baseline values, unstable psychiatric features(eg.suicidal), history of alcohol of drug dependence, seizures, head trauma with loss of consciousness, neurological illness, or concomitant axis i psychiatric disorder.

Keywords: pharmacogenomics depressed patients
effects of electrical stimulation on blood circulation and sensibility tactil in lymphadenectomy

Conditions: Breast Cancer

Summary: the aim of this study is to investigate the influence of electrical stimulation at the speed of blood circulation and tactile sensitivity of the arms of women who underwent axillary dissection for breast cancer.

introduction: the surgical treatment of breast cancer, especially axillary lymphadenectomy (al), can cause blood circulatory changes, also partial or total lesion of the sensory nerve intercostobrachial, often causing anesthesia or hypoesthesia in the corresponding dermatome ipsilateral upper limb surgery. objective: to investigate the influence of high voltage electrical stimulation (hves) in the in the blood flow and tactile sensitivity in nerve path intercostobrachial of women undergoing al. methodology: sample of 30 volunteers, aged between 40 and 60 years, divided into two equal groups (n = 15): women with axillary dissection for breast cancer undergoing therapeutic procedure (gal) and control group (cg) composed of women who did not undergoing axillary surgery. the treatment procedure consist of the application of high voltage electrical simulation for 30 minutes in both limbs twice a week over the course of seven weeks. the profile of blood flow, including speed, direction were evaluated by means of continuous wave doppler ultrasound. the assessment of tactile sensitivity was accomplished through esthesiometer in three stages: before the start of the first therapeutic procedure, after completion of the intervention and 30 days after the end of treatment (wash-out). the data will be analyzed using descriptive statistics (anova) even as the hypothesis testing of shapiro-wilk and if the data are not normally distributed, non-parametric tests will be used. for the analyses will be used spss software with critical level of 5%. the results obtained on this study aim to justify therapies for intervention with that equipment in the treatment of morbidities caused by axillary linfadenectomy.

Eligibility criteria:
inclusion criteria: * women, 40 to 60 years old, with abnormal sensitivity of the ipsilateral upper limb due to type madden modified radical mastectomy for breast cancer with axillary lymphadenectomy exclusion criteria: * patients undergoing other types of surgery that is not considered in the inclusion criteria, bilateral mastectomy, has a diagnosis of metastases, and skin disorders such as ulcers or erysipelas in the region (or nearby) the intercostal nerve pathway. we also excluded volunteers with some sort of cognitive impairment

Keywords: breast cancer physical therapy electrical stimulation tactile sensitivity flow blood
a randomized double-blind, placebo-controlled japanese phase iii trial of arq 197 in hepatocellular carcinoma (hcc)

Conditions: Liver Cancer

Summary: the present clinical trial is aiming to evaluate efficacy of arq 197 in patients with hepatocellular carcinoma (hcc), who were resistant or intolerable to one systemic chemotherapy regimen including sorafenib.


Eligibility criteria:
inclusion criteria: * informed consent form * ≥20 years old * inoperable hcc which is not eligible for locoregional therapy * diagnosed as c-met high in tumor sample * radiographic progression is confirmed during or after systemic chemotherapy including sorafenib, or those who are intolerance to the chemotherapy. * eastern cooperative oncology group performance status (ecog ps) is 0 or 1 * child-pugh class a * having measurable target lesions which are defined by response evaluation criteria in solid tumors (recist) version 1.1, * negative pregnancy test results * adequate organ function * life expectancy of at least 12 weeks exclusion criteria: * more than 2 prior systemic chemotherapy. * prior therapy of c-met inhibitor (including antibody) * any systemic therapy within ≤2 weeks prior to the randomization * locoregional therapy within ≤4 weeks prior to randomization. * major surgery within ≤4 weeks prior to the randomization * concurrent cancer within ≤5 years prior to the randomization * history of cardiac diseases * active clinically serious infections defined as ≥ grade 3 according to common toxicity criteria for adverse effects (ctcae) 4.0 * any psychological disorder affecting informed consent * diagnosis positive for anti-hiv antibody and/or anti-htlv-1 antibody * blood or albumin transfusion within ≤14 days prior to the screening test * concurrent interferon therapy against hepatitis b virus (hbv)/ hepatitis c virus (hcv) * symptomatic brain metastases * history of liver transplantation * inability to swallow oral medications * confirmed interstitial lung disease * pleural effusion and/or clinically significant ascites * pregnancy or breast-feeding * without consent to effective single or combined contraceptive methods
outcome of elderly patients with appendicitis

Conditions: Appendicitis Acute

Summary: this study aims to evaluate factors that predict 30-day complications after the surgical treatment of appendicitis in elderly patients.

appendicitis in elderly patients is more challenging due to delayed presentation and higher comorbidities, which is associated with increased postoperative morbidity and mortality. in this study, we aim to investigate the factors that predict 30-day complications after the surgical treatment of appendicitis in elderly patients. records of patients who underwent appendectomy for appendicitis will be extracted. the primary outcome is 30-day postoperative complications. independent variables examined include demographics, comorbidities, preoperative laboratory values, pathological findings, and surgical features. both univariate and multivariate regression will be performed to identify factors associated with postoperative complications.

Eligibility criteria:
inclusion criteria: * patients aged 65 years and older * patients undergoing appendectomy for acute appendicitis (pathologically confirmed) * patients having complete records of clinical data and postoperative follow-up records exclusion criteria: * patients younger than 65 years * patients undergoing an appendectomy as part of another major operation or those with appendiceal malignancy * patients who are treated nonoperatively for acute appendicitis

Keywords: appendicitis geriatrics
effect of exercise on mir-126 in individuals with prediabetes

Conditions: Prediabetes; microRNA; Exercise

Summary: this study aims to investigate the effect of a structured exercise program on microrna-126 (mir-126) expression in individuals with prediabetes.

this study aims to investigate the effect of a structured exercise program on microrna-126 (mir-126) expression in individuals with prediabetes. the hypothesis of our study is that regular aerobic exercise will increase mir-126 expression. determining the effect of exercise on mir-126 in individuals with prediabetes will contribute to the elucidation of the pathways through which exercise is effective in prediabetes via epigenetic mechanisms.

Eligibility criteria:
inclusion criteria: * individuals who were newly diagnosed with prediabetes according to the oral glucose tolerance test (ogtt) and/or hba1c criteria * between the ages of 18-60 * were physically inactive (level 1 according to the international physical activity questionnaire) * were motivated to exercise * individuals who had no obstacle to exercise as a result of the evaluation made by a cardiologist (ecg, exercise ecg test, etc.) * and who did not show a change in body weight of more than ±2.5 kg in the last six months were included in the study. exclusion criteria: * presence of serious medical conditions (e.g. advanced cancer, major neurological or endocrine disorders, respiratory failure) * current cardiovascular disease, bmi \<19 kg/m² * history of metformin use within the last 6 months * receiving hormone replacement therapy * life expectancy less than one year * hiv positivity * substance use * or orthopedic and cognitive disorders that may prevent exercise

Keywords: mir-126 exercise prediabetes microrna
academic-community epinet (ac-epinet)

Conditions: Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorders; Major Depression with Psychotic Features; Bipolar Disorder with Psychotic Features

Summary: the investigators propose to examine the effects of csc services delivered via th (csc-th) versus the standard clinic-based csc model (csc-sd) on engagement and outcomes in a 12-month, randomized trial.

180 subjects will be randomized into a 12 month study, to one of two treatment arms. the investigators will assess four important elements of engagement to determine which are most sensitive to th treatment and mediates effects on hospitalization rates. the investigators will assess acceptability and satisfaction of csc-th compared to csc-sd, and deliver a training manual for implementing th in csc clinics and for use in future research. although this study has exploratory aims consistent with pilot projects, the investigators have incorporated methodological rigor where possible (randomization, powering for hospitalization rate) in order to achieve the most robust data to assess the main study questions and inform future trials.

Eligibility criteria:
inclusion criteria: 1. between 16 and 35 years of age 2. able to give informed consent 3. willing and able to adhere to the study schedule 4. new intakes enrolled in one of the six clinical programs 5. non-affective (schizophrenia, schizoaffective, schizophreniform) and affective (major depression with psychotic features, bipolar disorder with psychotic features) psychotic disorders with onsets within 5 years of enrollment. exclusion criteria: 1. known iq \< 70 based on participant report

Keywords: psychosis
safety and efficacy clinical study of kl-hiv-tri01 in the treatment of hiv infected subjects

Conditions: HIV Infections

Summary: this is an open- label, non- randomized, uncontrolled, dose-escalation pilot study to evaluate the safety and efficacy of kl-hiv-tri01 injection solution in hiv infected subjects treated with haart.

this is an open- label, non- randomized, uncontrolled, dose-escalation pilot study to evaluate the safety and efficacy of kl-hiv-tri01 injection solution expressing triple targets antibodies with broad hiv-1 neutralizing activity in hiv-1 infected adults on anti-retroviral therapy (arv). nine subjects will be enrolled and administered with three different doses of kl-hiv-tri01. subjects will provide informed consent and then undergo screening assessments up to 1 month prior administration of kl-hiv-tri01. all subjects will undergo 52 weeks safety observation and will be encouraged to enroll in an extension study to evaluate long- term safety of kl-hiv-tri01 for total 5 years.

Eligibility criteria:
inclusion criteria: 1.18 (not inclusive) to 80 (inclusive) years of age, both male and female. 2. conform to the chinese aids diagnosis and treatment guidelines (2021), hiv positive, and received haart treatment for ≥ 3 months before enrollment. 3. cd4+t cell count≥500 cells/μl. 4. on a stable antiretroviral regimen before enrollment and viral load less than 40 copies/ml in two consecutive tests one year prior to enrollment. 5. willing to fully understand the purpose, nature, method, and potential adverse reactions that may occur during the discontinuation period of the experiment, voluntarily participate in this experiment and sign an informed consent form. exclusion criteria: 1. bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with im injections or blood draws. 2. active viral infections, such as hbv, hcv, cmv, or other viruses that the investigator believes will affect clinical research. 3. any opportunistic infection in the past one year, such as tuberculosis, cryptococcosis, which is not cured after treatment. 4. currently treated with immunosuppressive medications or steroids. 5. previous receipt of hiv vaccine, antibody or gene therapy.