Kornimate/medical-research-clean huggingface dataset:
a clinical study to investigate the effect of sar425899 on energy expenditure in obese subjects

Conditions: Type 2 Diabetes Mellitus

Summary: primary objective: to assess in overweight to obese subjects the change in sleep energy expenditure after repeated subcutaneous (sc) doses of sar425899. secondary objectives: * to assess the change in resting, basal and total daily energy expenditure. * to assess the change in respiratory quotient, fat, protein and carbohydrate oxidation. * to assess the change in body composition and core temperature. * to assess the pharmacodynamic effects on fasting plasma glucose, biomarkers of lipid metabolism and glycated hemoglobin (hba1c). * to assess the pharmacokinetic parameters for sar425899 after repeated sc doses. * to assess the safety and tolerability.

study duration is approximately 7-8 weeks including a screening period, a 19-day treatment period and an end-of-study visit 7 days after last dosing.

Eligibility criteria:
inclusion criteria: * overweight to obese male and female subjects. * body mass index 28 - 40 kg/m2. * 18 to 50 years of age * fasting plasma glucose ≤125 mg/dl. * glycated hemoglobine (hba1c) ≤6.5%. * obesity associated mild concomitant diseases allowed (eg, mild hypertension, mild hypercholesteremia, and hyperlipidemia). * no concomitant medication allowed except stable treatment with statins or antihypertensive drugs (except ß-blocker). * females should be either postmenopausal, or, if perimenopausal should have a normal regular menstrual cycle and should start or continue stable treatment with a monophasic oral contraceptive. exclusion criteria: * elevated liver enzymes, lipase, amylase, or calcitonin at screening. * current participation in an organized diet / weight reduction program or clinical trial of weight control or weight loss attempt, plans for major changes in physical activities or significant change in body weight in the 2 months prior to screening. * any condition possibly affecting gastric emptying or absorption from gastro-intestinal tract (eg, gastric surgery, gastrectomy, bariatric surgery, malabsorption syndromes, gastroparesis, abdominal surgery other than appendectomy or hysterectomy. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
exercise and nutrition interventions for platinum chemotherapy-induced neuropathy r21

Conditions: Chemotherapy-induced Peripheral Neuropathy

Summary: chemotherapy-induced peripheral neuropathy (cipn) is a highly prevalent and severe side-effect of platinum-based chemotherapy, often used to treat gastrointestinal cancers. unfortunately there are very limited treatments for cipn. this is a phase ii randomized controlled trial to test the preliminary efficacy of exercise vs. nutrition education on cipn, to systematically investigate the potential roles of inflammation and interoception, and to obtain data with a more accurate effect size to inform a future study.


Eligibility criteria:
inclusion criteria (subjects must...) 1. have a diagnosis of cancer 2. be scheduled to receive platinum chemotherapy (specifically oxaliplatin or cisplatin) without other neurotoxic chemotherapy (taxanes, bortezomib, thalidomide). patients may be enrolled before their first (preferred), second, or third infusion of neurotoxic chemotherapy 3. be able to read english 4. be ≥18 years exclusion criteria (subjects must not...) 1. be performing regular exercise, which is any planned physical activity (e.g., brisk walking, aerobics, jogging, bicycling, swimming, rowing, weight lifting, resistance training, yoga, pilates, etc.) performed to increase physical fitness. to be considered exercise, physical activity should be performed 3-5 times per week for 20-60 minutes per session and should be done at a level that increases your breathing rate and causes you to break a sweat. 2. have physical limitations (e.g., cardiorespiratory, orthopedic, central nervous system) that contraindicate participation in maximal physiological fitness testing and a low/moderate intensity home-based walking and progressive resistance exercise program. 3. have planned surgery or radiation treatment in the 12 weeks after baseline. additional exclusion criteria only for patients completing mri (approximately 40 of 60 enrolled subjects; subjects must not...) 1. have current or prior cancer in the spine, brainstem, or brain (to allow standard brain mri analysis) 2. have contraindications for mri scanning (pacemaker, ferrous metal implants, pregnancy, etc. note that most port-a-caths are safe for mri scanning)

Keywords: chemotherapy brain exercise nutrition
clinical and laboratory characteristics of polycythemia vera

Conditions: Polycythemia Vera

Summary: the study is observational, longitudinal, retrospective and prospective, on patients with pv. patients with pv diagnosed from 2000 to 2023 according to who2017 criteria will be considered. the main purpose of the study is to determine the impact of clinical and laboratory characteristics of polycythemia vera on patients' prognosis, understood as long-term survival

the structured collection of data necessary for the evaluation of the objectives will take place through the creation of a specific electronic archive with an expected duration of 7 years, possibly extendable. the electronic archive may be used to review case histories and to obtain or confirm new scientific evidence on polycythemia vera. patients will be followed and treated within the care pathway provided by normal clinical practice. the following elements will be considered in each patient: age, recent and remote pathological history, characteristics of pv onset, histological, cytogenetic and molecular investigations of diagnostic definition, medical therapies performed, type of response to the therapies performed, complications of these therapies and pathology. all useful data will be collected exclusively through consultation of outpatient medical records. the planned enrollment period is 60 months (january 2019-december 2023). the observation period of enrolled patients is at least 2 years.

Eligibility criteria:
inclusion criteria: * patients diagnosed with pv according to who 2017 criteria, * obtaining informed consent for data collection and processing exclusion criteria: * none
the effect of early use of methylene blue on hemodynamics in septic shock

Conditions: Septic Shock

Summary: this study will include patients requiring high dose of norepinephrine (na) to maintain blood pressure after fluid resuscitation. the patients will be randomized into two groups, the study protocol is early combined application of methylene blue. the primary outcome is sequential organ failure assessment (sofa) score 72 hours after admission. second outcome includes duration of shock, length of intensive care unit (icu) hospitalization and so on. to explore the underlying mechanism, the changes of sublingual microcirculation before and after vasopressor combination will be collected, also is the global longitudinal strain of left ventricle.

background: decreased vascular tone is one of the main mechanisms leading to septic shock. the guidelines recommend na as the first-line vasopressor. the benefits of early combination with other vasopressors are not yet known. methods: 1. patients: septic shock patients in need of high dose of na (≥0.5ug/kg.min maintaining more than 2 hours) to maintain blood pressure after fluid resuscitation. 2. intervention: the patients will be randomized into two groups. the study group will receive 2mg/kg methylene blue infusion with 15 minutes, 2 hours laters followed by 0.5mg/kg/h for 4 hours. the control group received conventional treatments, the attending physicians decide the protocol of vasopressors. the data including patients' characters, duration of shock and hospitalization, duration of mechanical ventilation, cumulative dose of vasopressors will be collected. before and 6h after meeting the inclusion standard, sublingual microcirculation and automated function imaging of myocardium will be performed. 3. outcome: the primary outcome is sofa score 72 hours after admission. second outcome includes duration of shock, length of icu hospitalization and so on. the changes of sublingual microcirculation will be collected, also is the global longitudinal strain of left ventricle.

Eligibility criteria:
inclusion criteria: * septic shock, receive 0.5 ug/kg/min na to maintain blood pressure for more than 2 hours after fluid resuscitation. exclusion criteria: * pregnant women * without internal jugular vein or subclavian vein catheterization * child-pugh grade c with liver cirrhosis * severe chronic obstructive pulmonary disease (severe acidosis caused by type ii respiratory failure, paco2 ≥60mmhg and ph\<7.2 ) * end-stage of malignant tumors * glucose-6-phosphate dehydrogenase (g6pd enzyme) deficiency * positive end-respiratory pressure (peep) \>10mmhg, the oxygenation index \<150mmhg under mechanical ventilation * definitive pulmonary hypertension or chronic pulmonary heart disease. * oral use of 5-hydroxytryptamine in recent 3 months

Keywords: septic shock methylene blue vasopressor refractory shock
japanese national computed tomographic (ct) colonography trial

Conditions: Colonic Polyps; Colonic Neoplasms

Summary: the purpose of this study is to evaluate the sensitivity of computed tomographic colonography (ctc) in detecting colorectal polyps and cancers in 1,500 subjects at increased risk of colorectal cancer (crc), using optical colonoscopy as the reference standard.

the investigators will evaluate the sensitivity of ctc in detecting colorectal polyps and cancers (at least 6 mm in diameter) in 1,500 subjects at increased risk of colorectal cancer (crc), using optical colonoscopy as the reference standard. the primary endpoint will be sensitivity in the detection of colorectal polyps and cancers that are at least 6 mm in diameter. the secondary endpoints will include specificity and predictive values in the detection of colorectal polyps and cancers. this clinical study will also evaluate the differences of the detection accuracies between human readings with and without computer-aided detection (cad) that automatically detects colonic lesions in ctc images and presents the detected lesions to the readers. this clinical study will also compare performance between radiologists and gastroenterologists in detecting colorectal lesions in ctc images. all the ctc images and their interpretations, optical colonoscopy reports and images, and pathology reports of resected colorectal lesion will be prospectively collected from 12 japanese hospitals participating in the trial. all patients' information will be completely anonymized at each site before any analysis of the data takes place.

Eligibility criteria:
inclusion criteria: * outpatients who are eligible for optical colonoscopy. * aged 20 years or older. * major functions of organs of the subjects are in a good condition. * signed informed consent forms are obtained from the patients. exclusion criteria: * known colorectal polyps or cancers at any site at the time of enrollment. * patients with inflammatory bowel disease. * fulfillment of clinical criteria for diagnosis of fap or hnpcc (amsterdam criteria). * serious medical conditions that may increase the risk of optical colonoscopy or are so severe that screening would have no benefit. * previous colorectal surgery. * gastric or intestinal stenosis, abdominal adhesions, bowel obstruction or perforation, toxic megacolon. * evidence of an increased risk in carrying out bowel preparation or ctc exams. * possibility of pregnancy. * optical colonoscopy or barium enema carried out within the last 3 years. * patients with psychological conditions that contraindicate colonoscopy or that make them irrelevant to participate in the trial. * iodine hypersensitivity. * severe thyroid disease. * claustrophobia. * severe deafness. * subjects whose eligibility for this clinical trial is not appropriate by other reasons.

Keywords: computed tomographic colonography colonic polyps colonic neoplasms computer aided diagnosis
thyroid medication and antidepressants for treating major depression

Conditions: Major Depression

Summary: this study will evaluate the effectiveness of treatment with supplemental triiodothyronine (t3, cytomel) and sertraline (zoloft), a selective serotonin reuptake inhibitor (ssri), in improving symptoms of major depressive disorder (mdd).

the primary hypothesis is that triiodothyronine (cytomel) supplementation of the antidepressant sertraline (zoloft) will result in a greater improvement in ham-d scores compared to placebo in the treatment of major depressive disorder (mdd). the goals of this proposal are to examine the relationship between major depressive disorder (mdd) and abnormalities of the hypothalamic pituitary thyroid (hpt) axis. this protocol will systematically examine the value of supplemental triiodothyronine (t3, cytomel) with sertraline (zoloft), a selective serotonin reuptake inhibitor (ssri) in the treatment of mdd. the focus will be on two overlapping populations: 1) those with evidence of hpt abnormalities, and 2) those who did not respond to a previous adequate ssri trial

Eligibility criteria:
inclusion criteria: * male or female between the ages of 18 and 60. (the upper age is limited to 60 because thyroid changes, including blunting of the tsh response to trh occurs with age and can potentially confound the relationship between the hpt axis and mdd.) * primary diagnosis of unipolar major depressive disorder * ham-d (21 item) score \>18 exclusion criteria: * alcohol abuse or alcohol dependence within the past year. * psychoactive substance abuse or dependence within the past year. * clinical evidence of severe personality disorder that would make study participation and completion unlikely. * ect within the past 6 months. * grade i hypothyroidism defined as low thyroid hormone levels with an associated elevated tsh; hyperthyroidism defined as elevated thyroid hormone concentrations with a low tsh. * serious and unstable medical illnesses.

Keywords: major depressive disorder mental health depression
dcvac/ovca and standard of care (soc) in relapsed ovarian, fallopian tube, and primary peritoneal carcinoma

Conditions: Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Carcinoma

Summary: multi-center, phase iii trial of dcvac/ovca added to standard of care treatments for relapsed ovarian cancer. patients will receive study treatment until all doses are administered, or other criteria are met.

all patients who meet entry criteria will be randomized, and will undergo a leukapheresis procedure. during the induction period, all patients will receive dcvac/ovca or placebo (study treatment) with concurrent standard-of-care platinum-based chemotherapy, with or without use of bevacizumab. in the maintenance period, patients will continue treatment with study treatment in combination with bevacizumab, a poly (adp-ribose) polymerase inhibitor (parpi) or best supportive care only. study treatment will continue irrespective of disease progression

Eligibility criteria:
inclusion criteria: * histologically confirmed high-grade serous or endometrioid carcinoma of the ovary, peritoneum or fallopian tube. * without disease progression during preceding platinum-based chemotherapy * platinum-sensitive patients defined as platinum-free interval of more than 6 months between the end of the last cycle of platinum-based chemotherapy and radiologic evidence of progression. * first relapse identified by the criteria above up to 28 days prior to study randomization * eastern cooperative oncology group (ecog) performance status 0-1 * known brca (breast cancer susceptibility gene) mutation status before randomization * patient is intended to be treated with bevacizumab, best supportive care (bsc) only or parpi exclusion criteria: * tumor-specific: any other histology sub-type that is not high grade serous or endometrioid, however a combination of these is allowed * disease treatment history: started or ongoing systemic treatment for current relapse of epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer before signing informed consent form (icf), concomitant use of anti-neoplastic anti- hormonal therapy * intention to treat with intra-peritoneal chemotherapy

Keywords: active cellular immunotherapy dendritic cells platinum-sensitive relapsed ovarian cancer biologic
patients with vulvovaginal candidiasis

Conditions: Vulvovaginal Candidiasis

Summary: the present study aims to evaluate the safety of two mucoadhesive gels containing a propolis standardized extract identified as epp-af, with 1 and 2% of propolis. the efficacy studies with both propolis gels will be performed in comparison with clotrimazole cream in patients presenting vulvovaginal candidiasis.

vaginal candidiasis is the second infection of the genital tract after bacterial vaginosis. up to 75% of women will have at least one episode in their lives, but the clinical manifestations can be very variable. around 10 to 20% will be asymptomatic and 5 to 10% will have the recurrent candidiasis that means 4 or more episodes in a year. the predominant symptoms are pruritus in 89% and burning during urination and sexual intercourse in 66%. the therapeutic regimen for acute fungal infections by c. albicans should consider the intensity of the clinical symptoms, recurrence, patient preference for the route of administration and consequent adherence to treatment, presence of pregnancy and the possibility of side effects. in general, the schemes include anti-fungal substances of the azoles type. intravaginal administration of drugs requires the development of formulations suited to the area and adherence to the treatment can be increased if mucoadhesive formulations are obtained which avoid discomfort and provide adequate release of the active compounds. in this sense, the present project had the objective of developing a mucoadhesive gel containing propolis standardized (epp-af®) for the treatment of vaginal candidiasis, especially since preclinical efficacy and safety data demonstrated the clinical potential of the product. so the present proposal aims at the clinical study evaluate the efficacy of two formulations with 1 and 2% of propolis in comparison with clotrimazole cream treatment (patients affected by candidiasis) and also evaluate the safety of both propolis gels in healthy volunteers. the efficacy protocol of the test product in patients with vaginal candidiasis will be performed in an open-label, randomized, three-arm, clinical trial with active clotrimazole-based control. patients will be recruited (t0) and evaluated at 10 and 30 days after initiation of treatment, and the primary outcome will be the clinical cure rate.

Eligibility criteria:
inclusion criteria: -have performed the clinical and laboratory diagnosis of vulvovaginitis by candida exclusion criteria: * cpatients with recurrent candidiasis; * history of hepatic, renal, hematological, cardiovascular diseases and with decompensated diabetes mellitus (glycemia above 200) and obesity with bmi above 35); * diagnosis of vulvovaginitis by another agent; * make use of chronic antimicrobials (informed by the patient) * be pregnant * allergy to some component of medications given

Keywords: vulvovaginal candidiasis eppaf mucoadhesive gel clotrimazol
the comparison of nerve blocks in cesarean delivery

Conditions: Anesthesia, Obstetrical

Summary: the purpose of this study is to investigate the effect of different kinds of popular peripheral nerve blocks for postoperative analgesia after cesarean delivery is completed, compared with traditional epidual analgesia.

visual analogue scale (vas) and morphine consumption was adopted to evaluate the pain relief.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) physical status i or ii * weight from 50 to 70 kilogrammes * a normal singleton pregnancy * ≥37 weeks gestation exclusion criteria: * congenital coagulopathy * anatomic abnormalities * localized skin infection * allergy to any of the drugs used

Keywords: quadratus lumborum block anesthesia pain, postoperative
user satisfaction survey - personality disorder service

Conditions: Borderline Personality Disorder

Summary: can we improve our community partners satisfaction with a change in how psychiatric consultations are delivered to their clients by our psychiatrist? this survey of users of the service will compare the level of satisfaction before(retrospectively) to after the way the service is provided is changed.

as part of the personality disorder services continuing quality improvement enterprise we sought to review the impact of restructuring on the satisfaction of service community partners with our changed consultation service. the consultation service was changed as the result of administrative review,part of a larger institution wide process. to review how this change was perceived by agency and individual care providers those who had received consult reports from the last fifty consultations were surveyed about their satisfaction and compared prospectively to the satisfaction of the agencies and individual care providers of clients receiving the next fifty consultations delivered in the new format. the administrative review had indicated that the consultation reports were unnecessarily comprehensive and in the process time consuming and thereby interfered with timely access to appointments and involved excessive turn around time in the generation of reports. a new streamlined approach using a fill in the blanks type form and brief cover letter and the use of a follow up phone call to the main care giver the same day was devised to address these concerns. satisfaction in regards to advice received, length of the report, waiting times for the appointment and for the delivery of the report,legibility and overall satisfaction were surveyed. the satisfaction with telephone feed back was also surveyed.

Eligibility criteria:
inclusion criteria: * clients referred to the personality disorder service exclusion criteria: * self referred clients

Keywords: personality disorder user satisfaction