Kornimate/medical-research-clean huggingface dataset:
timing of surgery after neoadjuvant chemotherapy for advanced ovarian cancer

Conditions: Ovarian Epithelial Cancer

Summary: ovarian cancer is among the top five primary causes of cancer-related mortality in women. most ovarian malignant tumours originate from epithelial cells the majority of patients typically have advanced-stage tumours at diagnosis. when complete surgery with no macroscopic visible disease is not feasible due to both the spread of the disease and the patient's general condition, neoadjuvant chemotherapy (nact) of 3 cycles followed by interval cytoreductive surgery (ics) or final cytoreductive surgery (fcs) after 6 cycles of nact followed or not by adjuvant chemotherapy can be offered, with similar overall survival. in our centre, due to logistics, disease, or patient factors, many patients may receive more than 3 cycles of nact before ics. therefore, this randomized controlled trial aims to evaluate the survival benefit of different timings of ics after 3 or 6 cycles of nact in patients not eligible for upfront cytoreductive surgery (ucs).


Eligibility criteria:
inclusion criteria: 1. female patients aged 18 to 75 years. 2. international federation of gynecology and obstetrics (figo) stage iiib-iv unsuitable for ucs. 3. histologically confirmed high-grade serous (hgs) ovarian, fallopian tube, or primary peritoneal carcinoma. 4. ecog performance status: 0 or 1. 5. resectable disease by laparoscopic assessment after 3 cycles of nact. 6. adequate haematology, bone marrow, respiratory, hepatic, cardiac and renal functions. 7. estimated life expectancy of \> 3 months according to age-adjusted charlston co-morbidity index (acci), included patients should have a low or intermediate comorbidity score; acci 0-3. exclusion criteria: 1. metastatic ovarian carcinoma. 2. patients with primary ovarian carcinoma other than high-grade serous (low-grade serous, endometrioid, mucinous, clear cell, and non-epithelial ovarian carcinoma). 3. presence of pregnancy or breast-feeding. 4. history of other invasive malignancies in the previous 5 years. 5. history of a recent \< 6 month cerebrovascular accident. 6. uncontrolled systemic disease or contraindication to chemotherapy. 7. progressive disease on nact. 8. worsening eastern cooperative oncology group (ecog) performance status (ecog 2-4). 9. severe comorbidities (acci \>= 4)

Keywords: high grade serous advanced primary ovarian cancer interval cytoreduction
gastrointestinal stimulation as a treatment of postoperative ileus following extensive surgery

Conditions: Postoperative Ileus; Bowel Paralysis

Summary: the goal of this clinical trial is to investigate the effect of gastrointestinal stimulation with a pacemaker on the length of postoperative bowel paralysis in patients undergoing major abdominal surgery due to metastasizing colorectal cancer, appendiceal cancer or pseudomyxoma peritonei. the main question it aims to answer is if the length of postoperative ileus is reduced when the gastrointestinal tract is stimulated with a pacemaker. all participants will undergo cytoreductive surgery +/- heated intraperitoneal chemotherapy (the standard treatment for colorectal cancer, appendiceal cancer with peritoneal carcinomatosis or pseudomyxoma peritonei). after surgery, but before the abdomen is closed a pace lead will be attached to the stomach, exteriorized trough the abdominal wall and connected to an external pacemaker. the pacemaker is either turned on (experimental group) or off (control group). after surgery, patients will be asked to fill out a diary on bowel movements once a day. once normal bowel function is regained, the pace lead and pacemaker will be removed trough the abdominal wall with a firm pull.


Eligibility criteria:
inclusion criteria: * patients planned for elective cytoreductive surgery with or without heated intraperitoneal chemotherapy due to either colorectal or appendiceal cancer or with peritoneal metastases or due to pseudomyxoma peritonei * written and orally informed consent * over 18 years of age exclusion criteria: * previous upper gastric or esophageal resection * history of difficulties in swallowing or gastrointestinal stenosis * implanted or portable electrical medical device e.g. cardiac pacemaker, defibrillator or infusion pump etc. * pregnant or breast-feeding women

Keywords: stimulation postoperative ileus
efficacy study of gemox combination and vinorelbine in nscl patients

Conditions: Non Small Cell Lung Cancer

Summary: primary: ·to evaluate the activity of the combination of gemcitabine, oxaliplatin and vinorelbine as first line treatment in patients with non-small cell bronchopulmonary cancer secondary: ·to evaluate the toxicity of the combination


Eligibility criteria:
inclusion criteria: * non-small cell bronchopulmonary cancer established by histological and/or cytological methods; * advanced or metastatic disease (stage iiib or iv); * at least one measurable lesion with one dimension (\>= 20 mm by ct scan or \>=10 mm by ct scan) outside of the irradiated area; * no prior chemotherapy; * previous radiotherapy permitted as long as there has been a washout period of at least 4 weeks; * age \>= 18 years old; * ecog performance status (ps): 0-1; * life expectancy \>3 months; * hepatic and renal functions and blood count satisfactory: * blood counts: white blood cells \>= 3.0 x 10\^9/l, neutrophils \>= 1.5 x 10\^9/l, platelets \>= 150 x 10\^9/l, haemoglobin \>= 9 g/dl, * hepatic function: bilirubin within the limit of the normal upper value, aspartate transaminases (ast) or alanine transaminases (alt) \<= 2.5 times the normal upper value * renal function: creatinine clearance (calculated according to cockroft and gault) \>= 40 ml/min; * patients of reproductive age must use an effective contraceptive method; * informed consent form signed before any procedure undertaken connected with the study exclusion criteria: * pregnant or breastfeeding patient; * past record of other cancers (excluding basocellular or epidermoid cutaneous carcinoma or cured carcinoma of the cervix); * symptomatic cerebral or leptomeningeal metastases; * symptomatic peripheral neuropathy \> 1 (nci-ctc grade); * presence of a serious disease or medical condition incompatible with the study (at the discretion of the investigator); * treatment with another test product or participation in another therapeutic trial in the 4 weeks preceding inclusion in the study; * concomitant treatment by any other anticancer therapy; * concomitant treatment with phenytoin. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
colistin dosage prsonalization approach

Conditions: Colistin Adverse Reaction

Summary: a few studies have evaluated higher doses or the administration or a loading dose, which is routine in adults, in pediatric patients, and reported improved colistin exposure without an increased risk of nephrotoxicity the main questions it aims to answer are what is the optimal dosing strategies of intravenous colistin for the treatment of multidrug-resistant gram-negative bacterial infections in preterm neonates? what is the incidence of aki? what is the factors increasing aki incidence? a single center retrospective and comparative study, cohort study compare low dose 5 mg/kg/day versus 7.5mg/kg/day

retrospective study to measure safety and efficacy of colistin conventional dose versus high dose then prospective design to measure pharmacokinetics parameter of both doses to design optimal dose

Eligibility criteria:
inclusion criteria: * neonates aged between (0-30 days) born before 37 weeks * critically ill patients with nosocomial infection with proven culture-resistant gram-negative bacteria. * neonates who are indicated for colistin and started colistin therapy for at least 48 hr. exclusion criteria: * serum creatinine ≥1.5 baseline before colistin * received colistin before nicu stay * administration of concurrent nephrotoxic drugs including amphotericin, gentamicin, or amikacin. * major congenital anomalies or with previous renal impairment.
taste function and eating habits in polycystic ovary syndrome

Conditions: Polycystic Ovary Syndrome

Summary: this study evaluates taste function and eating habits in patients with pcos compared to healthy women and before and after oral contraceptive use.

the objective of this study is to investigate the taste function and eating habits in patients with pcos in comparison with healthy women at baseline and after routine use of an oral contraceptive (2mg ethinylestradiol and 0.03mg dienogest) along with general lifestyle advice for three months. patients with diagnosis of pcos (rotterdam criteria) will be recruited from hacettepe university outpatient clinics. along with clinical, hormonal and biochemical evaluation, taste function and eating habit tests will be performed at baseline both in patients and healthy volunteers. these tests will be repeated in women with pcos after 3 months of oral contraceptive use.

Eligibility criteria:
inclusion criteria: * women diagnosed with pcos (rotterdam criteria) who will receive oral contraceptive pill for long-term management exclusion criteria: * any systemic illness * any other medication use * age\ 35 years * pregnant or nursing * untreated hypothyroidism or hyperthyroidism * known rhinoplasty or nasal surgery * known defect in smell or taste function * being active smoker.
study to assess the safety and tolerability after multiple oral doses of azd1656 in patients with type 2 diabetes mellitus treated with metformin

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to assess the 1 month safety and tolerability after multiple oral doses of azd1656 in patients with type 2 diabetes mellitus treated with metformin


Eligibility criteria:
inclusion criteria: * male or women of non-childbearing potential (postmenopausal, and/or have undergone hysterectomy and/or bilateral oophorectomy or salpingectomy/ tubal ligation) * ongoing treatment with metformin on a stable dose of ≥ 1500 mg/day for at least 8 weeks prior to randomisation * hba1c ≤ 10% at enrolment (hba1c value according to international diabetes control and complications trial \[dcct\] standard) exclusion criteria: * history of ischemic heart disease, symptomatic heart failure, stroke, transitory ischemic attack or symptomatic peripheral vascular disease * clinically significant abnormalities in ecg, clinical chemistry, haematology, or urine analysis results. positive test for hepatitis b surface antigen or antibodies to human immunodeficiency virus (hiv) or antibodies to hepatitis c virus

Keywords: type ii diabetes
study of noni in cancer patients

Conditions: Neoplasms; Neoplasm Metastasis

Summary: the purpose of this phase 1 study is to: 1. determine the maximum tolerated dose of capsules containing 500mg of freeze dried noni fruit extract, 2. define toxicities associated with the ingestion of noni, 3. collect preliminary information on the efficacy of noni in respect to anti-tumor and symptom control properties to help select specific patients for subsequent phase 2 studies, 4. identify chemical constituents of the extract that can be used to characterize the bioavailability and pharmacokinetics of noni food supplement.

this phase i study of noni in cancer patients represents a first step in the systematic study of complementary and alternative medicine (cam) practices that draw on asian and pacific island cultural traditions of healing to control cancer and its related symptoms. noni, extracted from morinda citifolia or the indian mulberry plant, is included in the traditional pharmacopoeias of native hawaiians, other pacific islanders and asian populations, and has been used to treat various diseases for hundreds of years. it is now commonly taken by cancer patients based on purported usefulness in the disease although there is little scientific evidence to either support or refute these claims. a large marketing enterprise and at least eleven different suppliers supports the food supplement's popularity. the broad long range objectives which this study will initiate are to define the usefulness of noni extracts for cancer patients. the hypothesis to be tested is that noni at a specified dosing provides cancer patients with a sufficient benefit to toxicity profile to be useful as a therapeutic. specific aims of this study are: 1. determine the maximum tolerated dose of capsules containing 500mg of freeze-dried noni fruit extract. 2. define toxicities associated with the ingestion of noni. 3. collect preliminary information on the efficacy of noni in respect to anti-tumor and symptom control properties to help select specific patients for subsequent phase ii studies. 4. identify chemical constituents of the extract that can be used to characterize the bioavailability and pharmacokinetics of noni food supplement.

Eligibility criteria:
patients must: * have a pathologically or cytologically verified diagnosis of cancer and evidence of disease for which no standard treatment is available; * be ambulatory, capable of self care, and up and about more than 50% of waking hours; * have completed all other cancer treatments at least four weeks previously; * have been on any medications considered by their physician to be essential to their health (e.g. lipid lowering, antidiabetic , antihypertensive) at consistent dosing at least four weeks prior to starting noni; * agree to take no other cam treatments while taking noni and agree to keep a diary, recording all medications taken daily, including all non prescription products and to record the time that noni is taken.

Keywords: advanced cancer
modulation of painful perception

Conditions: Healthy

Summary: the objective of the study is to evaluate in healthy volunteers, the influence of empathy on pain perception. it is widely accepted in the clinical management that the feeling of listening to the patients' pain would have a favorable influence on the pain, and conversely, the lack of listening would be aggravating. in this study, the volunteer will receive painful thermal stimuli in empathetic context (l, empathetic or non-empathetic) two situations will oppose, one where the examiner neglect or minimize the suffering of the voluntary and the other or the contrary, the subject will receive empathy. the first part of the project is to verify that the pain is influenced by the empathetic context. the second part will be conducted functional mri, which should isolate the brain regions affected by other people's empathy for pain.


Eligibility criteria:
inclusion criteria: * right handed exclusion criteria: * pregnant or lactating women, * against-indications to mri * drug intake of less than 12 hours, * neurological history or deficits, psychiatric, auditory or visual. * decline to participate

Keywords: healthy volunteers
safety and tolerability of synb1020-cp-001

Conditions: Healthy Volunteer; Urea Cycle Disorder

Summary: a phase 1, first-in-human, oral single and multiple dose-escalation, randomized, double-blinded, placebo-controlled study of synb1020 in healthy adult volunteers to evaluate safety, tolerability, dosing, and pharmacodynamics

this phase 1, dose-escalating, randomized, double-blinded study will evaluate synb1020 in placebo-controlled cohorts within the following 2 study parts: part 1: a single-ascending dose (sad) study conducted in an inpatient setting over 6 days in healthy volunteer male and female subjects evaluated in up to 7 dose cohorts to identify the maximum tolerated dose (mtd) within the single dose range studied; and part 2: a multiple-ascending dose (mad) study conducted in an inpatient setting over 22 days in healthy volunteer male and female subjects evaluated in up to 4 dose cohorts that were proven tolerable in the sad part of the study to identify the mtd of synb1020 within the multiple-dose range studied. up to 48 subjects may be enrolled in this part of the study. subjects will be screened for eligibility within 30 days prior to enrollment, with evaluations of exercise habits, gastrointestinal (gi) signs and symptoms, fecal patterns (frequency, consistency), recent or current antibiotic exposure, and laboratory measurements. eligible patients will be admitted to an inpatient facility for investigational product (ip) administration, safety monitoring, and collection of blood, urine, and fecal samples for pharmacokinetic and pharmacodynamic evaluations.

Eligibility criteria:
key inclusion criteria: * age 18 to 64 years * healthy volunteer males and females; females must be of non childbearing potential * able and willing to complete informed consent process * available for and agree to all study procedures * screening labs within normal range key exclusion criteria: * acute or chronic medical, surgical, psychiatric, social or laboratory abnormality * body mass index \< 18.5 or ≥ 30 kg/m2 * intolerance of or allergic reaction to e. coli nissle or any of the ingredients in synb1020 or placebo formulations; allergies to common foods (e.g., eggs, milk, soy, nuts). * prior participation in a study with synb1020 * evidence or history of clinical signification hematological, renal, endocrine, pulmonary, gi cardiovascular, hepatic, psychiatric, neurologic or allergic disease * personal or family history of ucd
response prediction in ebv-hlh using metabonomics analysis

Conditions: Hemophagocytic Lymphohistiocytoses; EBV; Metabonomics

Summary: hemophagocytic lymphohistiocytosis (hlh) is a rare, poorly recognized and underdiagnosed syndrome of excessive immune activation, which is rapidly fatal. epstein-barr virus (ebv) is a common trigger of hlh, particularly in asian individuals. we aim to analyze metabolomics and cytokine profiles of patients before and after treatment to explore the metabolomic characteristics of ebv-hlh, and search for pathogenic mechanisms and therapeutic targets.

hemophagocytic lymphohistiocytosis (hlh) is a rare, poorly recognized and underdiagnosed syndrome of excessive immune activation, which is rapidly fatal. without early intervention, the median survival time is less than 2 months.epstein-barr virus (ebv) is a common trigger of hlh, particularly in asian individuals. we aim to analyze metabolomics and cytokine profiles of patients before and after treatment to explore the metabolomic characteristics of ebv-hlh, and search for pathogenic mechanisms and therapeutic targets.

Eligibility criteria:
inclusion criteria: * patients who meet hlh-04 diagnostic criteria * ebv-dna viral load in the peripheral blood \> 500 copies/ml * informed consent obtained. exclusion criteria: * refuse to participate.

Keywords: hemophagocytic lymphohistiocytoses ebv matabonomics
sedline 4 channel electroencephalogram (eeg) monitoring during suppression of unilateral hemispheric function (wada test

Conditions: Seizure

Summary: masimo sedline brain function monitors are sensors (stickers) placed on a the forehead to monitor levels of "sedation" based on a bilateral 4-channel electroencephalogram (eeg). the purpose of this study is to observe the effectiveness of the sedline monitor to detect the unilateral hemispheric eeg changes seen in wada testing


Eligibility criteria:
inclusion criteria: 18 years of age or older scheduled for wada testing at musc exclusion criteria: no exclusions
a methodology development environmental clinical trial of reproxalap in subjects with seasonal allergic conjunctivitis

Conditions: Allergic Conjunctivitis

Summary: a multi-center, double-masked, randomized, parallel-group, vehicle-controlled, methodology development environmental clinical trial with reproxalap ophthalmic solutions (0.25% and 0.5%) in subjects with seasonal allergic conjunctivitis.


Eligibility criteria:
inclusion criteria: * be at least 18 years of age of either gender and any race * have a positive history of ocular allergies and a positive skin test reaction to ragweed pollen as confirmed by the allergic skin test given to the subject within 24 months of the subject's visit 1 * have a calculated visual acuity of 0.7 logmar or better in each eye as measured using an etdrs chart exclusion criteria: * have known contraindications or sensitivities to the use of any of the investigational product medication or components * have any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters (including but not limited to narrow angle glaucoma, clinically significant blepharitis, follicular conjunctivitis, iritis, pterygium, or a diagnosis of dry eye) * have had ocular surgical intervention within three months prior to visit 1, or during the trial, or a history of refractive surgery six months prior to visit 1, or have systemic surgery planned during the clinical trial or within 30 days after; * have a known history of retinal detachment, diabetic retinopathy, or active retinal disease * have an active ocular infection (bacterial, viral or fungal), active uveitis, or positive history of an ocular herpetic infection at any visit; * be a female who is currently pregnant, planning a pregnancy, or lactating
safety and tolerability of liraglutide in japanese subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in japan. the aim of this trial is to assess the safety after multiple s.c. (subcutaneously) doses of liraglutide in japanese subjects with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * duration of diabetes for more than 12 weeks * subjects currently on diet therapy (oha-naïve) or treated with oha (oral hypoglycaemic agent) * monotherapy for more than 12 weeks * hba1c (glycated haemoglobin a1c) between 6.0-9.0 %, both inclusive * body mass index (bmi): 18.5-30.0 kg/m\^2 exclusion criteria: * recurrent severe hypoglycaemia * proliferative retinopathy or maculopathy requiring acute treatment * impaired hepatic function * impaired renal function * cardiac problems * uncontrolled treated/untreated hypertension * current treatment with insulin preparations or tzds (thiazolidinediones) * current treatment or expected at the screening to start treatment with systemic corticosteroids
pressure support reduction versus spontaneous breathing trials in weaning from ventilation

Conditions: Respiration, Artificial; Ventilator Weaning

Summary: this study is a comparison of two most commonly used modes of weaning and the outcomes in the two groups.

patients ventilated for more than 24 hours are randomized into two groups - one group of patients undergo gradual reduction of pressure support and in the other, t tube trials are used for weaning. the outcomes are compared in the two groups.

Eligibility criteria:
inclusion criteria: * mechanically ventilated patients for more than 24 hours * satisfies weaning criteria * rsbi \< 80 * ratio of pao2/fio2 \> 250 * arterial partial pressure of oxygen more than 60 mm hg and carbon dioxide less than 50 mm hg exclusion criteria: * systolic blood pressure of less than 100 * arterial partial pressure of oxygen less than 60 mm hg * poor sensorium

Keywords: weaning mechanical ventilation