Kornimate/medical-research-clean huggingface dataset:
expanded access program with nivolumab therapy for treatment of advanced/metastatic sqnsclc or non-sqnsclc after one prior systemic regimen

Conditions: Squamous Non-Small Cell Lung Cancer; Non-squamous Non-Small Cell Lung Cancer

Summary: the purpose of this study is to provide treatment with nivolumab, a fully human monoclonal antibody, to subjects who have relapsed after treatment with a minimum of 1 prior systemic treatment for advanced or metastatic squamous (sq) or non-squamous (non-sq) non-small cell lung cancer (nsclc) , stage iiib/iv and whose physicians believe that nivolumab treatment is appropriate.


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * sq or non-sq nsclc, stage iiib/iv (histologically or cytologically confirmed) * relapsed after 1 prior platinum-based systemic treatment * eastern cooperative oncology group (ecog) performance status \< 2 * cns metastasis must be treated and returned to baseline at least 2 weeks before first dose of nivolumab and off steroids or using stable or decreasing dose of \< 10 mg prednisone or equivalent * prior chemotherapy, tyrosine kinase inhibitor (tki) therapy or immunotherapy (tumor vaccine, cytokine or growth factor to control cancer) must be completed at least 2 weeks before first nivolumab dose exclusion criteria: * cns metastases (untreated and/or symptomatic) * carcinomatous meningitis * ecog performance status \> 3 * corticosteroids \> 10 mg prednisolone/day (or equivalent) * prior treatment with anti-pd-1, anti-pd-l-1, anti-pdl2, anti-ct137 or anti-ctla antibody, including ipilimumab or any other drugs specifically targeting t cell costimulation or checkpoint pathways
low-intensity physical therapy for prevention of pre and postpartum urinary incontinence

Conditions: Urinary Incontinence

Summary: the purpose of this study is to determine if pelvic exercises can reduce the occurrence of urinary incontinence (involuntary loss of urine) before and after delivery. we would also like to see if performing pelvic exercises before birth has an effect on labor and/or delivery, and if there are any specific characteristics for developing urinary incontinence during pregnancy and after delivery.

the studies investigating physiotherapy for prevention of urinary incontinence during and after pregnancy used intensive pelvic floor muscle training. while physical therapy appears to be effective in preventing urinary incontinence, extensive physical therapy is too costly to be implemented as a preventive measure for the general population. thus, we want to asses if non-intensive pelvic floor therapy decreases the urinary incidence of incontinence during pregnancy and postpartum. we propose a prospective randomized controlled trial to obtain baseline data on the effect of non-intensive pelvic floor muscle training of urinary incontinence in primigravid women.

Eligibility criteria:
inclusion criteria: * nulliparous, pregnant women, 18 years or older * less than 20 weeks gestation * able to give consent and who are willing to participate exclusion criteria: * multiparous women * women presenting after 20 weeks gestation * history of urinary incontinence * mentally impaired women and women who have neurological impairment affecting ability to perform pelvic floor muscle training
reliability of methods for determining the vibration threshold

Conditions: Reflex, Abnormal

Summary: it is known that whole-body vibration (tvv) has beneficial neuromuscular effects such as muscle strength increase. these beneficial effects are explained by the muscular reflex response induced by tvv. reflex latency measurement is frequently used in clinical and neurophysiological research. the latency of the reflex response induced by tvv is defined as the period between the onset of the vibration stimulus and the onset point of the spike in the emg signal. the current research aimed to determine whether the cumulative average method is reliable for estimating the est.

this is an experimental study for method development; a self-controlled (single group) study. ten healthy male or female subjects between the ages of 18-45 will be included in the study. after obtaining informed consent from the subjects, 30 hz low amplitude (2 mm) vibration for 30 seconds will be applied on the powerplate pro5 device to meet tvv. after three minutes of rest, two sets of tvv will be applied for test purposes. for the test tvv, vibration will be applied at 25, 30, 35, 40, 45, 50 hz frequencies, each lasting 30 seconds, with low amplitude. vibration stimuli detected by using an accelerometer fixed on the tvv platform will be recorded the data acquisition (powerlab data acquisition system (adinstruments, oxford, united kingdom). soleus emg responses will be recorded using the superficial electrodes (kendall covidien). the sample rate for recordings will be 40khz. latency calculation with cumulative average method: it will be done. an 80-500 hz band-pass filter and full-wave rectification will be applied to emg recordings. the peak of reflex responses (spike) will be marked with the help of labchart7 (ver 7.3.7, adinstruments, oxford, united kingdom). according to this marked point, the averaging process covered 75 ms of the vibration data preceding the trigger and 15 ms after for each vibration frequency separately. then, the average of the five vibration frequencies will be calculated for the accelerometer recordings and emg recordings. the point where the standard error is lowest in the accelerometer recordings will be determined as the "effective stimulation point".

Eligibility criteria:
inclusion criteria: * both gender * 20-40 aged * healthy volunteer exclusion criteria: * people with any health problems

Keywords: sensor vibration reflex
effects of mk7418 on diuresis and renal function in congestive heart failure patients

Conditions: Congestive Heart Failure; Renal Impairment

Summary: a study to determine the most appropriate dose of mk7418 in heart failure patients presenting with symptoms of volume overload requiring increased diuretic doses.


Eligibility criteria:
inclusion criteria: * be able to provide written informed consent, * be a male or female at least 18 years of age, * be hospitalized for fluid overload requiring iv diuretic therapy * history of use of diuretic therapy for chf (including this admission), * be admitted to the hospital within 36 hours of the mandatory dose of iv furosemide 40 mg at between 2000 and 2200 hour on day -1 exclusion criteria: * have had a myocardial infarction within 30 days prior to day -1 * be pregnant or breast-feeding * have received intravascular contrast material within the preceding 14 days; or have acute contrast nephropathy * have had implantation of an automated implanted cardiac defibrillator (aicd) or synchronization device within the preceding 7 days * currently require mechanical ventilation, ultrafiltration, or hemodialysis, * have symptomatic ventricular tachycardia * be admitted for heart transplant surgery or have had a heart transplant, * have any other concomitant life-threatening disease, * have participated in a clinical trial of an investigational drug or device within 30 days before randomization * have a positive urine pregnancy test (for women of child-bearing capacity) * have an allergy to soybean oil and/or eggs
sibutramine-metformin combination versus sibutramine and metformin monotherapy in obese patients

Conditions: Obesity

Summary: the aim of this study is to evaluate the effect of sibutramine and metformin combination therapy in comparison with sibutramine or metformin monotherapy over weight, adiposity, glucose metabolism and inflammatory state in obese patients.

the treatment of obesity is strongly recommended because it exacerbates insulin resistance, hypertension, dyslipidemia and atherosclerosis, and represents a risk factor for type 2 diabetes. although diet and exercise are valuable in this treatment, patient compliance is a major problem. sibutramine has been shown to be a highly effective pharmacotherapy for weigh loss in obese patients, mediated by increased satiety and an enhancement of energy expenditure. metformin is widely used for glycemia control and is associated with a small to moderate body weight loss. we are assessing the combination of sibutramine and metformin, two agents with different mechanisms of action for control of body weight and metabolic dysregulation.

Eligibility criteria:
inclusion criteria * age between 30 and 50 years * both genders * bmi between 30 and 40 * stable body weigh defined by over 5 per cent variability during the previous 3 months * fasting serum glucose less than 126 mg per dl * blood pressure over 140 and 90 mmhg * women ensuring contraceptive precautions. * communication and understanding capability. * informed consent awarding. exclusion criteria * women were excluded if they were pregnant or lactating potential while no taking adequate contraceptive precautions * any smoking during the preceding 6 months * no physical activity, defined by less than 15 minutes per day of walking * excessive physical activity equivalent to running over 60 minutes per day * known hypersensitivity to sibutramine or metformin * low commitment to follow the protocol statements * any investigational medication during the preceding 6 months * any drug or substance mayor toxicity exposure during the preceding 3 months * alcohol or any drug abuse during the previous 3 months * current medication of oral corticosteroids, anticoagulants, sympathomimetics, sympatholytics, lipid lowering drugs, any medication for type 2 diabetes, and any sibutramine interaction drug * current or previous evidence of ischemic heart disease, cardiac arrhythmia, cerebrovascular disease, chronic hepatic disease, two fold persistent elevation of alt, ast or fa * carrying a pacemaker or any permanent bioelectronic component that could interfere with bioimpedance process * renal failure defined by serum creatinine equal or ever 1.2 mg per dl * not controlled thyroid disease defined by altered serum t3, t4 and tsh during the previous 3 months * hypertension * type 2 diabetes * anti-depressants, or any psychiatric disturbance treatment

Keywords: sibutramine metformin obesity
azd1152 in patients with advanced solid malignancies

Conditions: Tumors

Summary: the primary purpose of this protocol is to investigate the safety and tolerability of azd1152 when given as a continuous 48-hour infusion every 14 days and as a 2-hour infusion for 2 consecutive days every 14 days in patients with advanced solid malignancies.


Eligibility criteria:
inclusion criteria: * histological or cytological confirmation of a solid, malignant tumour * at least one measurable or non-measurable site of disease as defined by response evaluation criteria in solid tumors (recist) criteria. exclusion criteria: * participation in an investigational drug study within the 21 days prior to therapy or those who have not recovered from the effects of an investigational study drug * recent major surgery within 4 weeks prior to entry into the study

Keywords: solid tumor
the effects of probiotics combined with glutamine in the prevention and treatment of radiation proctitis

Conditions: Radiation Proctitis; Probiotics; Glutamine; Gut Microbiota; Bifidobacterium

Summary: radiation proctitis is a common complication after radiation therapy for pelvic tumors. the investigators found that live bifidobacterium and lactobacillus tablets combined with compound glutamine enteric-coated capsules can significantly relieve the symptoms of radiation proctitis through preliminary clinical practice, but the mechanism is unknown. through a prospective randomized controlled study, this study intends to investigate the incidence of grade 2 or higher acute radiation proctitis in patients of locally advanced rectal cancer after radiotherapy with the combined therapy. and through various scales, next-generation sequencing methods and other methods to evaluate the clinical symptoms, colonoscopy, imaging, and changes in the species and abundance of intestinal flora before and after treatment. to further explore the related pathways and mechanisms affecting radiation proctitis.


Eligibility criteria:
inclusion criteria: * locally advanced rectal adenocarcinoma diagnosed by histopathology; clinical stage t3/4 or n+(ajcc,8th), no metastasis; and planned to receive preoperative neoadjuvant concurrent chemoradiotherapy. * without other malignant tumors; * those without serious heart, liver, kidney and other diseases; * ecog score: 0-1. exclusion criteria: * complicated with ulcerative colitis or crohn's disease; * complicated with severe organ insufficiency, severe diabetes, and heart disease; * pregnant and lactating women; * abnormal bowel movements with systemic and metabolic diseases; * the patient has a history of using systemic antibiotics and intestinal active bacteria in the past 1 month.
development of a novel polyherbal lip hydrant for improving biophysical barrier of the lips

Conditions: Cheilitis

Summary: * the goal of this clinical trial is to evaluate the efficacy of the novel polyherbal lip hydrant on dryness, fine lines and color of the lips in 66thai people aged between 18-40 years old. the inclusion criteria will include subjects with subjective complaint of dry lips.the main question it aims to answer is does the novel polyherbal lip hydrant improve biophysical barrier of the lips? * participant will be asked to apply the lip hydrant or the petroleum gel once a day before bedtime, and refrain from using other lip products throughout the clinical trial period (28 days). * researchers will compare control group (petroleum gel) with lip hydrant group to see whether biophysical barrier (wrinkles, colors, fine lines, roughness) improve or not.


Eligibility criteria:
inclusion criteria: * subjects with subjective complaint of dry lips; * agree to comply with the study protocol * agree not to apply any other products such as lipstick, lip gloss, lip conditioner to the lips other than the test product for the duration of the study * provide a written informed consent prior to study enrollment. exclusion criteria: * participants those having visible skin conditions which might interfere with the outcome assessment * having a history of sensitivities to cosmetics products, or moisturizers; - having a known or suspected intolerance or hypersensitivity to herbal products or any of its ingredient * taking medication or under the care of a doctor for one month prior to the commencement of the study, and throughout the entire test period * having other types of cheilitis except cheilitis simplex.

Keywords: cheilitis aging lip roughness prevention
tips for ph patients: an observational, cohort study

Conditions: Cirrhosis Portal

Summary: this is a single-center, prospective, observational study intended to include patients receiving tips for portal hypertension. baseline data of enrolled patients were recorded, and samples of ascites, feces and urine were collected before surgery. venous blood (superior mesenteric vein, hepatic vein, peripheral vein) from different parts of the entero-hepatic axis was retained during operation, and patients were followed up regularly for 2 years. the incidence of infection, hepatic encephalopathy, upper gastrointestinal hemorrhage and ascites in patients with portal hypertension who received tips intervention were observed within 3 months after operation. and the stent patency was observed within 2 years after surgery. to investigate the characteristics of microbial, protein and metabolic components on enterohepatic axis and their relationship with prognosis of patients with cirrhosis by detecting microbiome, proteome and metabolome.


Eligibility criteria:
inclusion criteria: 1. patients undergoing tips due to complications related to portal hypertension； 2. age between 18 to 85 years; 3. signed informed consent; exclusion criteria: 1. combined with liver cancer (out of the milan criteria) or combined with other organ malignancies which had less than 3 months of expected survival; 2. combined with severe cardiopulmonary disease (severe pulmonary hypertension and heart failure or severe heart valve insufficiency or renal insufficiency), the expected survival is less than 3 months; 3. failure of tips procedure; 4. women who plan to become pregnant or who are pregnant or breastfeeding； 5. conditions deemed unsuitable for study participation by the investigator.

Keywords: transjugular intrahepatic porsystemic shunt
protege encore study- clinical trial of teplizumab (mga031) in children and adults with recent-onset type 1 diabetes mellitus

Conditions: Type 1 Diabetes Mellitus

Summary: the primary purpose of this study is to determine whether teplizumab (mga031) infusions lead to greater reductions in insulin requirements in conjunction with near normal blood sugar control compared to placebo in patients recently diagnosed with type 1 diabetes.


Eligibility criteria:
inclusion criteria: 1. subjects 8-35 years old 2. body weight \> 36 kg 3. diagnosis of diabetes mellitus according to the american diabetes association (ada) criteria 4. randomization on study day 0 within 12 weeks of first visit to any physician for symptoms or signs of diabetes 5. requires insulin for t1dm or has required insulin at some time between diagnosis and administration of study drug 6. detectable fasting or stimulated c-peptide level (above the lower limit of the reportable range of the assay) at screening 7. diagnosis of t1dm as evidenced by one positive result on testing for any of the following antibodies at screening: * islet-cell autoantibodies 512 (ica512)/islet antigen-2 (ia-2), * glutamic acid decarboxylase (gad) autoantibodies, or * insulin autoantibodies (in subjects on insulin for more than 2 weeks, ica512/ia-2 or gad must be positive). exclusion criteria: 1. prior administration of a monoclonal antibody-within the 1 year before randomization 2. participation in any type of therapeutic drug or vaccine clinical trial within the last 12 weeks before randomization at study day 0 3. any medical condition that, in the opinion of the investigator, would interfere with safe completion of the trial 4. pregnant females or lactating females who intend to provide their own breast milk to the baby during the study 5. current therapy with glp-1 receptor agonists (e.g., exenatide or pramlintide), or any other agents that might stimulate pancreatic beta cell regeneration or insulin secretion 6. current treatment with oral antidiabetic agents 7. evidence of active or latent tuberculosis 8. vaccination with a live virus or organism within the 8 weeks before randomization continuing through week 52 of the study. * influenza vaccination with a killed virus, including booster vaccinations, within 4 weeks before or after each dosing cycle. * vaccination with other antigens or killed organisms within 8 weeks before or after each dosing cycle 9. any infectious mononucleosis-like illness within the 6 months before randomization
safety and efficacy of exemestane plus dasatinib versus placebo for advanced er+ breast cancer

Conditions: Breast Cancer

Summary: the purpose of this study is to determine whether exemestane plus dasatinib will be well-tolerated and will increase progression-free survival (pfs) in the treatment of advanced estrogen-receptor positive (er+) breast cancer after disease progression (pd) on a non-steroidal aromatase inhibitor (nsai).


Eligibility criteria:
inclusion criteria: * histologically-documented invasive estrogen receptor positive breast cancer , with tumor tissue from prior surgery available for analysis * prior therapy with a non-steroidal aromatase inhibitor * recurrent or progressive advanced breast cancer (locally-advanced or metastatic) * documented breast cancer with tumor ≤ 28 days prior to study entry * women who are not of childbearing potential * must be able to take oral medication * performance status 0 or 1 exclusion criteria: * pleural or pericardial effusion or ascites (of any etiology; grade ≥ 1) within 6 months prior to study entry * any chemotherapy, immunotherapy \< 6 months before study entry. any targeted therapy (eg. lapatinib) \< 6 months before study entry, unless given in combination with an nsai * any antitumor therapy, including radiotherapy or hormonal therapy, within 15 days prior to study entry * prior exposure to exemestane, any src-family kinase inhibitor including dasatinib, to agents intended to control osteolytic disease other than bisphosphonates, or to any investigational agent for breast cancer * concurrent or previous malignant disease requiring chemotherapy or radiation treatment within the prior 3 years * significant bleeding disorder, or ongoing or recent clinically-significant gastrointestinal bleeding * any serious cardiac condition, including congestive heart failure or myocardial infarction within 6 months, uncontrolled angina, or class iii or iv heart disease as defined by the new york heart association, baseline ejection fraction ≤ 40%, diagnosed congenital long qt syndrome, clinically-significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or torsades de pointes), qtc interval \> 450 msec at baseline (fridericia correction) * hematologic abnormality grade ≥ 2 * hypocalcemia of grade ≥ 1 * any chemistry abnormality of grade ≥ 2 \[except grade 2 indirect bilirubin permitted if diagnosed gilbert's disease\] * pregnant women and women of childbearing potential (wocbp) * extremely lactose intolerant, in the judgment of treating physician (100 mg dasatinib contains 135 mg lactose, posing a problem only if intolerance is severe) * receiving any of the following concomitant medications: category i drugs that are generally accepted to have a risk of causing torsades de pointes including: (subjects must discontinue drug use at least 7 days prior to starting dasatinib) * potent inhibitors of cyp3a4 isoenzyme * prisoners or subjects who are involuntarily incarcerated; or subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness

Keywords: advanced estrogen receptor positive breast cancer