Kornimate/medical-research-clean huggingface dataset:
optimox1 in chinese mcrc patients

Conditions: Colorectal Cancer

Summary: previous optimox1 study investigated the use of oxaliplatin discontinuation and reintroduction in a novel stop-and-go strategy. previously untreated patients were randomly assigned to either folfox4 administered every 2 weeks until progression (arm a) or folfox7 for 6 cycles, maintenance without oxaliplatin for 12 cycles, and reintroduction of folfox7 for another 6 cycles (arm b). data showed that there was no significant difference in median progression-free survival (pfs) and overall survival (os) between two arms. furthermore, this study showed lower grade 3 neurotoxicity rate in arm b (17.9% vs 13.3%, p = 0.12).in order to investigate the efficacy and feasibility of the novel "stop and go" strategy in chinese mcrc patients, prof. shu yongqian in jiangshu province hospital plans to conduct a randomized controlled study to compare continuous folfox4 vs. folfox4 in a stop-and-go fashion in 1st line mcrc patients. to avoid the high oxaliplatin dosage related neurotoxicity, folfox4 regimen is chosen in this study.


Eligibility criteria:
inclusion criteria: * patients with histologically confirmed adenocarcinoma of the colon or rectum * unresectable metastases * at least one bidimensionally measurable lesion of ≥ 1 cm * no previous chemotherapy for metastatic disease; completed at least more than 1 year oxaliplatin therapy for adjuvant treatment * 18-75 years old * ecog 0-2 * life expectancy greater than 3 months * hemogram: wbc≥4.0 x109/l, anc ≥2 x109/l, plt ≥100 x109/l, hb ≥90g/l, * adequate renal function * adequate liver function * signed informed consent before the treatment exclusion criteria: * patients with previous oxaliplatin based adjuvant chemotherapy within 1 year * completely or partially bowel obstruction * presence of peripheral neuropathy (ctc\>grade i) * severe mental disorder * cns metastasis * with other severe disease: uncontrolled active infectious disease, uncontrolled hypertension, heart infarction within 1 year, uncontrolled high-risk arrhythmia, unstable angina * with other malignant disease previously or concurrently * receive other anti-tumor treatment * pregnant or lactating women, or women of child bearing potential without contraceptive method.

Keywords: to investigate the efficacy and feasibility of this novel treatment strategy in chinese mcrc patients primary endpoint:ddc secondary endpoint:os, rr,dcr, pfs,safety
bioequivalence of liquid and reconstituted lyophilized subcutaneous formulations of caplacizumab.

Conditions: Healthy Volunteers

Summary: the primary objective of the study is to evaluate the pharmacokinetic characteristics and demonstrate bioequivalence of a reconstituted new lyophilized formulation of caplacizumab for subcutaneous (s.c.) injection as compared to an equal nominal s.c. dose of the reference liquid formulation of caplacizumab. the secondary objective of the study is to compare the safety and tolerability, and the pharmacodynamic parameters of the new formulation with those of the reference formulation.


Eligibility criteria:
inclusion criteria: * male caucasians aged 18 to 55 years, inclusive. * body weight 55 - 100 kg and body mass index (bmi) between 18.5 and 30.0, extremes included. * coagulation and bleeding diathesis variables (as defined in the protocol) within the normal range at screening and on day -1. * others as defined in the protocol. exclusion criteria: * history or presence of diseases in the kidneys and/or heart, lungs, liver, skin, endocrine organs or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs. * history of and/or any sign or symptom indicating current abnormal hemostasis or blood dyscrasia. * others as defined in the protocol
comparison of pk after administration of hcp1201 and co-administration of metformin sr 500mg and rosuvastatin 10mg

Conditions: Diabetes Mellitus

Summary: to compare the pharmacokinetic characteristics between hcp1201 tablet 500/10 mg and co-administration of metformin 500 mg plus rosuvastatin 10 mg under fasted and fed state, respectively.

an open-label, randomized, single-dose crossover study to compare the pharmacokinetics after the administration of hcp1201 tablet 500/10 mg and coadministration of metformin sr 500 mg and rosuvastatin 10 mg in healthy volunteers

Eligibility criteria:
inclusion criteria: * healthy male volunteer, age 20\~55 years * the result of body mass index(bmi) is not less than 19 kg/m2 , no more than 27 kg/m2 * subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial. exclusion criteria: * presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study * history of relevant drug allergies or clinically significant hypersensitivity reaction.
combination of rad001 and erlotinib in patients with advanced non small cell lung cancer previously treated only with chemotherapy

Conditions: Non Small Cell Lung Cancer

Summary: this study aims to assess the value of combined treatment with rad001 and erlotinib in patients with advanced non small cell lung cancer treated only with chemotherapy as systemic therapy.


Eligibility criteria:
inclusion criteria: * age over 18 years * advanced non small cell lung cancer which is not responding to chemotherapy treatment including either cisplatin or carboplatin * only 1-2 previous chemotherapy regimens for advanced disease * more than 2 weeks from previous surgery, radiation or chemotherapy * ability to perform normal daily functions exclusion criteria: * chronic steroid treatment * prior treatment with egfr inhibitors * active bleeding conditions, skin conditions, gastrointestinal disorders, mouth ulcers, eye conditions or other severe medical conditions * other cancers within the past 2 years * pregnant or breastfeeding women other protocol-defined inclusion/exclusion criteria may apply

Keywords: non small cell lung cancer nsclc advanced lung cancer rad rad001 erlotinib
anovo™ surgical system - registry study

Conditions: GYN Disorders

Summary: to collect real-world data (rwd) on the ongoing safety and effectiveness of the anovo surgical system in transvaginal gynecological laparoscopic surgical procedures and to obtain information on the impact of the anovo skills development pathway on user behavior and performance (where performance is measured by the learning curve of the surgeons and procedure outcomes).

specific aims: 1. to collect rwd from surgeons with varying experience and expertise on their learning curve and time to achieve competency, and as such assess the success of the skills development pathway. 2. collect safety information and analyze the causality between type and frequency of adverse events to surgeons' experience. 3. evaluate the effectiveness of the device while minimizing bias by enrolling "all comers", which will represent the general patient population.

Eligibility criteria:
all patients receiving gynecological surgical procedure with the anovo surgical system by their surgeon will be offered to participate in the registry. inclusion criteria: * patients must understand and sign the informed consent form, including data privacy authorization, indicating their consent to participate in the registry study. * willing to complete post-operative questionnaire exclusion criteria: -none
serum biomarkers in diagnosis and predicting prognosis of ovarian cancers

Conditions: Endometrial Neoplasms; Ovarian Neoplasms

Summary: this study evaluates the usefulness of serum levels of trefoil factor 3 (tff3), secreted frizzled related protein 4 (sfrp-4), reactive oxygen species modulator 1 (romo1) and nuclear factor (nf)-κb as potential diagnostic and prognostic biomarkers in ovarian carcinoma.


Eligibility criteria:
inclusion criteria: * primary diagnosis of epithelial ovarian carcinoma. exclusion criteria: * patients with recurrence. * patients who received neoadjuvant chemotherapy or radiotherapy * presence of any secondary malignancy
vaginal progesterone for the prolongation of pregnancy after arrested pre-term labor

Conditions: Preterm Labor

Summary: patients diagnosed with arrested pre-term labor following tocolytics at 24-34 gestational weeks will be randomly allocated to receive either vaginal micronized progesterone 400 mg/day or no treatment.

since progesterone derivatives are useful in preventing preterm labor in cases of risk factors or previous preterm labor, we hypothesize that they will also show efficacy in pregnancy prolongation in women whose preterm labor was arrested following tocolytic treatment. patients diagnosed with arrested pre-term labor following tocolytics at 24-34 gestational weeks will be randomly allocated to receive either vaginal micronized progesterone 400 mg/day or no treatment. this study has the potential to find a treatment to prevent preterm labor and thus to reduce neonatal morbidity and mortality.

Eligibility criteria:
inclusion criteria: 1. 18 years of age 2. tocolytic treatment between 24+0 and 34+0 weeks 3. patient's consent to participate in this study 4. 24 hours after tocolytic initiation and up to 3 days after finishing the tocolytic treatment 5. arrest of preterm labor exclusion criteria 1. contraindication to ongoing pregnancy including: 1. suspected amnionitis during testing for eligibility- evidence of active infection including temperature ≥ 38.0°c and uterine tenderness, foul-smelling vaginal discharge, maternal tachycardia of 120 beats per minute or greater, or sustained fetal tachycardia of 160 beats per minute or greater 2. evidence of significant placental abruption (contractions and significant bleeding from placental origin) 3. intrauterine fetal death diagnosed at the time of admission 2. major fetal malformation 3. known maternal allergy to progesterone 4. current use of progesterone at the time of admission 5. epilepsy 6. breast cancer 7. pprom (preterm premature rupture of membranes) during testing for eligibility 8. age below 18 years 9. known active liver disease (elevated liver enzymes at twice the upper normal limit according to medical history or blood test that were taking doring standard medical care) 10. history of deep vein thrombosis 11. major active psychiatric disorders (major affective disorders and psychotic disorders) 12. uncontrolled chronic hypertension 13. heart failure 14. chronic renal failure 15. pre-gestational diabetes with known target organ damage 16. history of spontaneous preterm delivery 17. previous tocolytic treatment during the current pregnancy
cervical cancer screening among hispanic women

Conditions: Cervical Cancer

Summary: in this study, 400 hispanic women will be recruited and randomized to one of three interventions: 1. control (no change); 2. a low-intensity information program, consisting of a video approach educating women on the importance of cervical cancer screening; 3. a higher intensity program consisting of the video plus a 'promotora' or lay-community health educator led intervention at the participant's home to encourage cervical cancer screening. the investigators will compare which intervention is most effective in encouraging hispanic women to undergo cervical cancer screening (pap test)


Eligibility criteria:
inclusion criteria: * female * 21 - 64 years of age * hispanic or latina * resident of the yakima valley, wa, usa * no hysterectomy * last pap test (cervical screening) more than 3 years ago * last seen at the local clinic less than 5 years ago exclusion criteria: * less than 21 or greater than 64 years of age * pap test less 3 years ago * prior hysterectomy
human mesenchymal stem cells (hmsc) in behavioral problems due to alzheimer's disease.

Conditions: Alzheimer Disease; Agitation in Dementia

Summary: the purpose of this research study is to test if adding one infusion of mesenchymal stem cells to the current treatment with antipsychotic medication may help control behavioral problems in people with a diagnosis of moderate to severe alzheimer's disease.


Eligibility criteria:
inclusion criteria: * adults 55-90 years at the time of signing consent * a diagnosis of probable alzheimer disease (ad), defined by the national institute of neurological and communicative disorders and stroke and the alzheimer's disease and related disorders association (nincds-adrda) criteria * previous computed tomography or magnetic resonance imaging scan of the brain with findings consistent with a diagnosis of alzheimer disease * a diagnosis of behavioral symptoms that include any of the following: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior, sleep and nighttime behavior disorders and appetite and eating disorders * onset of behavioral symptoms at least 4 weeks prior to screening. * treatment with antipsychotic medication for at least 4 weeks prior to the hmsc infusion. * patients unable to consent should have a legally authorized representative or proxy to provide consent on their behalf. * have a family member or friend (study partner) who has frequent and sufficient contact with the patient and able to answer questions about the participant's behavior. exclusion criteria: * dementia other than ad * patient with severe depression. patient with controlled depression is allowed to participate. * recent history of substance abuse * history of bleeding disorders, hiv, hepatitis c virus or hepatitis b virus * recent history (within 3 years) of malignancies, except for treated basal cell, squamous carcinoma or melanoma in situ, prostate in situ, cervical carcinoma in situ. * uncontrolled medical conditions (hypertension, diabetes, unstable angina or myocardial infarction within 1 year prior to screening) * history of bleeding disorder * currently receiving (or received within four weeks of screening) experimental agents for the treatment of alzheimer's disease or enrolled in clinical trials in the prior 3 months. * be a transplant recipient or in any other active medical condition than in the opinion of the investigator may compromise the safety or compliance of the patient or preclude successful completion of the study * be premenopausal

Keywords: aggression behavior agitation
efficacy, tolerability and safety of alna® in patients with benign prostatic syndrome (bps)

Conditions: Prostatic Hyperplasia

Summary: study to assess efficacy, tolerability and safety parameters of a one month alna® - treatment after switch from terazosin-treatment


Eligibility criteria:
inclusion criteria: * suffering from bps symptoms * preceding treating with terazosin for at least one month * ipss sum score \>= 8 points prior to treatment start with alna® or complaints due to bp reduction by terazosin * indication for a switch to treatment with alna® according to its summary of product characteristics (spc) for a minimum period of one month exclusion criteria: * patients fulfilling one of the general or specific contraindications listed in the alna® spc, particularly patients with known hypersensitivities against tamsulosin hydrochloride or any other ingredients of the product, orthostatic dysregulation or severe liver insufficiency could not be included in the post marketing surveillance (pms) study
management of hypertension in the early postpartum: a randomized controlled trial

Conditions: Pregnancy-Induced Hypertension in Postpartum; Postpartum Pre-Eclampsia; Hypertension

Summary: in hypertensive mothers, it is common in clinical practice to substitute methyldopa for another medication, such as captopril, immediately after delivery, which may, as a consequence, cause a rebound effect or an initial lack of blood pressure control until the new medication had a more complete action. thus, the treatment of hypertension in the puerperium is generally guided by expert opinion and recommendations for guidelines, based on non-robust evidence. objective: to evaluate the control of blood pressure in postpartum women with hypertensive syndromes during pregnancy with the maintenance of the continued use of previously used methyldopa compared to switching from antihypertensive regimen to the use of captopril. method: randomized, double-blind, drug controlled clinical trial. expected result: better pressure control with the continued use of methyldopa.

objective: to evaluate blood pressure control during the immediate postpartum in hypertensive women who had used methyldopa during pregnancy, comparing continuation of that drug with switching it for captopril. methods: a single-blind, randomized clinical trial involving 180 postpartum women with arterial hypertension who had previously used methyldopa during pregnancy at a minimum dose of 750 mg/day for at least one week prior to delivery. following delivery, the patients were randomized either to continue with methyldopa (minimum dose 250 mg, three times a day) (methyldopa group, n=90) or to switch to captopril (at an initial dose of 25 mg, three times a day) (captopril group, n=90). logistic regression will be used to compare the groups regarding the potential to maintain blood pressure below 140/90 mmhg at over 50% of measurements postpartum.

Eligibility criteria:
inclusion criteria: * puerpera; * hypertensive; * use of methyldopa during pregnancy at a minimum dose of 750 mg / day, for at least 07 days before delivery exclusion criteria: * use of other antihypertensive medications or illicit drugs that may interfere with maternal hemodynamics, and / or contraindications to the use of captopril or methyldopa
effect of acute red raspberry consumption on post-prandial oxidative stress

Conditions: Oxidative Stress; Antioxidants

Summary: eight healthy adult subjects will be given a meal of one, two or four cups red raspberries, or two slices white bread with or without 200 mg vitamin c, after an overnight fast and consumption of a low polyphenol diet for two days. blood samples will be taken at various time points over an eight hour period to measure oxidative stress and antioxidant levels in the blood. each subject will attend 5 study visits with one week intervals and be given each meal in a random order. it is hypothesized that raspberry consumption at higher doses will greater protect against meal-induced oxidative stress compared to bread controls.


Eligibility criteria:
inclusion criteria: * healthy adults exclusion criteria: * blood pressure greater than 120/80 mm hg * body mass index greater than 24.9 kg/m\^2 * history of any chronic disease * currently taking medications * allergy to fruit

Keywords: red raspberries post-prandial oxidative stress antioxidants polyphenols vitamin c acute dietary intervention
acute effects of different protein sources and different glycemic index on energy balance, glucose allostasis and amino acid metabolism: a randomized, 4-condition, two cross-over study in adults.

Conditions: Overweight

Summary: the hypothesis is that seafood proteins given in combination with carbohydrates with low gi are superior to seafood proteins in combination with carbohydrates with high gi and meat in combination with both carbohydrates with low and high gi in promoting energy expenditure and satiety. the overall objective of this study is to investigate the acute effects of meals containing fish versus meat proteins on energy balance (thermogenesis, appetite regulating hormones and appetite sensations), markers of glucose allostatis and amino acid metabolism.


Eligibility criteria:
inclusion criteria: * healthy men and women * between 18 and 50 years of age * bmi between 25.0 and 30.0 kg×m-2 * fasting blood glucose \< 5.9 mmol/l (measured at the screenings visit) * non-smoker exclusion criteria: * self-reported eating disorders or irregular eating schedule (e.g. skipping breakfast) * chronic diseases (e.g. cancer, asthma, back pain, thyroid disease, heart disease, diabetes, neurological disorders, or sleep disorders) * use currently or within the previous 3 months of prescription medication that has the potential of affecting body weight or glucose metabolism such as glucocorticoids (but excluding inhaled and topical steroids; bronchodilators are allowed), psychoactive medication, epileptic medication, or weight loss medications (either prescription, over the counter or herbal). low dose antidepressants are allowed if they, in the judgement of the investigator, do not affect weight or participation to the study protocol. levothyroxine for treatment of hypothyroidism is allowed if the participant has been on a stable dose for at least 3 months. * women who are pregnant, breast-feeding or have intention of becoming pregnant during the study period * menopausal women and women with an irregular menstrual cycle * food allergies * substance abuse * vigorous physical activity more than 10 hours/week * alcohol intake above the recommendations from the danish health and medicines authority * caffeine intake above 300 mg/day * night- or shift work * blood donation \<1 month before study commencement and during study period * simultaneous participation in other clinical studies * inability, physically or mentally, to comply with the procedures required by the study protocol, as evaluated by the study staff * subject's general condition contraindicates continuing the study, as judged by the study personnel or the medical expert

Keywords: proteins (seafood and meat) gi energy expenditure energy balance thermogenesis (dit) appetite regulating hormones appetite sensations glucose allostatis amino acid metabolism satiety food preferences