Kornimate/medical-research-clean huggingface dataset:
phase 1b/2 study of amg 655 with doxorubicin for the first-line treatment of unresectable soft tissue sarcoma

Conditions: Locally Advanced or Metastatic, Unresectable Soft Tissue Sarcoma; Sarcoma; Soft Tissue Sarcoma

Summary: this phase 1/2, multicenter, randomized, double-blind, placebo-controlled trial is designed to evaluate the efficacy and safety of amg 655 when combined with doxorubicin compared with doxorubicin alone in subjects with previously untreated, locally advanced or metastatic, unresectable soft tissue sarcoma.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed soft tissue sarcoma * locally advanced, recurrent, or metastatic, unresectable disease * measurable disease according to modified recist * ecog performance status of 0 or 1 * men or women at least 18 years of age * adequate hematological, renal, hepatic, and coagulation function exclusion criteria: * prior treatment with anthracyclines * uncontrolled cardiovascular disease

Keywords: sarcoma soft tissue sarcoma locally advanced or metastatic, unresectable soft tissue sarcoma amg 655 sts doxorubicin death receptor trail receptor apoptosis
response of pulse pressure variation in pa catheter tracing to iv fluid bolus in the icu

Conditions: Hypovolemia

Summary: the investigators hypothesize that analysis of blood pressure will allow doctors to predict whether or not blood flow from the heart (cardiac output) increases after intravenous fluids are given.

total to expected enrollment: 70

Eligibility criteria:
inclusion criteria: * tcv-po post-operative patients with pa catheters * must be 18 years of age and older exclusion criteria: * history of pulmonary hypertension
effects of berberine hydrochloride and bifidobacterium in diabetes mellitus prevention and treatment

Conditions: Type 2 Diabetes Mellitus

Summary: the aim of this study is to assess the beneficial effects of bifidobacterium hydrochloride and berberine on lowering glucose in patients with type 2 diabetes mellitus and to detect the potential mechanism.

gut microbiota maybe play an important role in patients with type 2 diabetes mellitus (t2dm). berberine, which is usually used as an antibiotic drug, has been reported a potential glucose-lowering effect in vitro and in vivo studies. bifidobacterium, as a familiar probiotics, can modulate gut microbiota and improve glucose and lipid metabolism in animal experiments. therefore, the aim of this study is to assess the beneficial effects of bifidobacterium hydrochloride and berberine on lowering glucose in patients with t2dm and to detect the potential mechanism.

Eligibility criteria:
inclusion criteria: * informed consent obtained before any trial-related activities； * male or female between 18 and 70 years of age * 19≤body mass index(bmi)≤30kg/m2 * no participate in any clinical trial at least 3 months * newly diagnosed t2dm (ogtt) or not received previous pharmacological treatment * 7%≤hba1c≤9% * females in child-bearing period should be given birth control * no severe disease about heart, lung and kidney * ability and willingness to adhere to the protocol including performance of self-monitored blood glucose (smbg) profiles according to the protocol * subject is likely to comply with the investigators instruction exclusion criteria: * type 2 or 1 diabetes mellitus received previous pharmacological treatment * females of childbearing potential who are pregnant，breastfeeding or intend to become pregnant or are not using adequate contraceptive methods * impaired liver function, defined as aspartate aminotransferase（ast） or alanine transaminase (alt)\> 2 times upper limit of normal (central laboratory) * impaired renal function, defined as serum-creatinine≥133μmol/l * uncontrolled treated/untreated severe hypertension (systolic blood pressure≥160mmhg and /or diastolic blood pressure≥95mmhg) * chronic gastrointestinal diseases * cancer and medical history of cancer (except basal cell skin cancer or squamous cell skin cancer) * any clinically significant disease or disorder, which in the investigator's opinion could interfere with the results of the trial * mental incapacity, psychiatric disorder, unwillingness or language barriers precluding adequate understanding or co-operation, including subjects not able to read and write * previous participation in this trial. participation is defined as randomized. re-screening of screening failures is allowed only once within the limits of the recruitment period * known or suspected hypersensitivity to trial products or related products * known or suspected abuse of alcohol, narcotics or illicit drugs

Keywords: type 2 diabetes mellitus berberine hydrochloride bifidobacterium
three-year follow-up study of subjects who participated in a previous asunaprevir (bms-650032) and/or daclatasvir (bms-790052) chronic hepatitis c clinical trial

Conditions: Hepatitis C

Summary: the primary purpose of this study is to determine whether the hepatitis c virus continues to remain unable to be detected in subjects who were previously treated with asunaprevir (bms-650032) and/or daclatasvir (bms-790052) and achieved sustained virologic response.


Eligibility criteria:
inclusion criteria * signed written informed consent * subjects must have received at least one dose of asunaprevir and/or daclatasvir * subjects participating in daclatasvir and/or asunaprevir studies (ie, protocol numbers beginning with ai443, ai444 or ai447) may enroll regardless of virologic response * completed the required post-treatment follow-up period in previous study * must enroll in this study within 6 months of completing previous bms study or within 6 months of protocol availability at the clinical site * men and women, ages 18 and older exclusion criteria: * subject must not have been treated with any antiviral or immunomodulatory drug for chronic hepatitis c (chc) after completion of the previous study during which asunaprevir and/or daclatasvir were administered * subject must not be participating in any other trial, excluding non-interventional trials * prisoners or subjects who are involuntarily incarcerated * subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness
a 3.0t magnetic resonance imaging study

Conditions: Primary Open Angle Glaucoma

Summary: glaucomatous damage not only occurred to retinal ganglion cells in the eyes, but went across optic nerves, visual chiasm, lateral geniculate nucleus (lgn) and finally the visual cortex; the neural degenerations could be identified through the whole visual tract, which suggests the central nerve system may play a vital role in the progression of glaucoma. the investigators used mri to investigate changes of visual pathway in vivo.


Eligibility criteria:
inclusion criteria: * primary open angle glaucoma diagnosed on the basis of glaucomatous optic disc cupping ratio (in particular, thinning of the inferior and/or superior rim, cup-to-disc ratio asymmetry of \>0.2) * matching glaucomatous visual field defects (european glaucoma society (2008) perimetry ) exclusion criteria: * optic neuropathy * neurological disorder * other diseases and use of systemic medications which affect optic nerve or the visual ﬁeld underwent complete eye examination and visual-field testing.
anti-reflux mucosal ablation(arma) and anti-reflux mucosectomy(arms) in gastroesophageal reflux disease

Conditions: Gastroesophageal Reflux Disease; Endoscopy

Summary: according to the current published data and treatment mechanism, arms may led to more stenosis while arma may be less effective in long term follow-up. the changes of patient's life quality , ugi tract microbiota before and after different endoscopic treatment are also limited. so we want to conduct a exploratory prospective randomized controlled study in evaluating the mucosal healing, demand of ppi, life quality, emotion status, sleep quality, esophageal motility/ acid exposure and saliva microbiota between chronic gerd patients receiving arms and arma treatment.

in this study, we will enroll 150 patients with chronic gerd. estimated 40% of patients will be excluded from the inclusion and exclusion criteria. of 90 patients eligible for the study, estimating 20% may drop out before receiving arms or arma. estimated 72 patients will be randomized to receive arms or arma for gerd treatment. after arma, all patients will receive 4 weeks of ppi treatment. endoscopy and questionnaire follow-up will be performed on week 2, 2 months, 6 months and 12 months after treatment while hrm and 24 hours ph impedance study will be performed 6 months after treatment. the study will be carried out in 4 years. in the 1st to 3rd year of study, estimating 60,60,30 patients will be evaluated and entered the study in the 1st, 2nd and fisr half of 3rd year. then all the patients will be followed until the first half of 4th year. at the second half of the 4th year, the saliva sample will be processed, data will be analyzed, and the result will be written. 1. st year study:60 patients enrollment, evluation and receiving endoscopy treatment with follow-up 2. nd year study:60 patients enrollment, evluation and receiving endoscopy treatment with follow-up 3. rd year study:30 patients enrollment, evluation and receiving endoscopy treatment with follow-up 4. th year study: complete all patients follow-up, sample processing, data analysis and report writing

Eligibility criteria:
inclusion criteria: * 20-75 years of age, * history of gerd over 1 year exclusion criteria: * body mass index (bmi) \> 35 * hiatal hernia \> 2cm * esophageal ulcer * esophageal stricture * barrett's esophagus (prague criteria: c\>1cm, m\>=2cm) * major esophageal motility disorders * gastroparesis * pregnancy or plans for pregnancy in the next 12 months * immunosuppressive therapy * cirrhosis * portal hypertension and/or varices * previous gastric or esophageal surgery * esophageal diverticulum * scleroderma or dermatomyositis * coagulation disorders * anti-platelet or anticoagulants use

Keywords: anti-reflux mucosal ablation gastroesophageal reflux disease endoscopic intervention anti- reflux mucosectomy
the process of blood collection with a vascular imaging device

Conditions: Phlebotomy

Summary: the study was planned to determine the effect of using a blood vessel imaging device (vid) and venous blood collection procedure on the pain and satisfaction level of the individual during phlebotomy. the randomized controlled experimental design study was carried out in a blood collection unit in a training and research hospital between 1-15 april 2022. the study sample was calculated as 100 people by power analysis and the method of drawing lots was applied to the groups. data were collected using the patient identification form, visual analogue scale (vas), and pain and satisfaction scales.

the population of the study consisted of adult individuals who benefited from polyclinic services and applied to the blood collection unit between the specified dates in a single center.

Eligibility criteria:
inclusion criteria: * individuals between the ages of 18-65, * who wanted peripheral vascular access, * volunteered to participate in the study, * did not have any pain complaints, * did not take analgesics in the last 12 hours, * could be contacted, * did not have obesity, dehydration, peripheral oedema, or a cancer diagnosis and did not need emergency intervention. exclusion criteria: * those who do not meet the criteria for admission

Keywords: phlebotomy blood vessel imaging device pain satisfaction
pelvic floor function after vaginal and cesarean delivery among egyptian women

Conditions: Pelvic Floor Disorders

Summary: a cross sectional study for assessment of pelvic floor functions after 6 months to 4 years after normal vaginal delivery or cesarean section

a cross sectional study for assessment of pelvic floor functions after 6 months to 4 years after normal vaginal delivery or cesarean section four separate entities were evaluated using internationally recognized and validated questionnaires: 1. pelvic organ prolapse evaluated using the pelvic organ prolapse distress inventory 2. urinary functions were evaluated using the international consultation on incontinence questionnaire short form 3. fecal incontinence was evaluated using wexner fecal incontinence score 4. sexual functions were evaluated using female sexual function index

Eligibility criteria:
inclusion criteria: * primiparity, * singleton pregnancy * cephalic presentation * term delivery (38-42 weeks). exclusion criteria: * women with operative vaginal delivery (vacuum extraction or forceps delivery) * women who had another delivery between the time of first one and time of evaluation * women with neurological diseases * women with vascular diseases and diabetes mellitus
stapes footplate thickness measured with uhr-ct

Conditions: Otosclerosis; Otitis Media

Summary: the aim of this study is to compare the thickness of the stapes footplate measured with ultra high resolution ct in control patients, otosclerosis patients and chronic otitis media patients.

stapes footplate thickness will be measured under its anterior crus, its posterior crus and at its midpoint, in both the stapes axial plane and the laletral semi-circular canal planes.

Eligibility criteria:
inclusion criteria: * ultra high resolution ct of the temporal bone available exclusion criteria: * previous surgery

Keywords: ultra high resolution ct stapes footplate otosclerosis otitis media
effect of cranberry juice on endothelial function

Conditions: Coronary Artery Disease

Summary: a pilot study of 15 subjects will be completed to determine whether acute consumption of cranberry juice has an effect on endothelial function. we will then complete a randomized, double blind, placebo controlled crossover study designed to investigate the effects of cranberry juice consumption on endothelial function. participants (n=40) will drink 480 ml of double strength cranberry juice or a similar appearing and tasting placebo per day for four weeks. after a two week rest period, they will cross over to the other beverage. we will examine endothelial function before and after each of the two treatment periods. the study will provide information about the chronic vascular effects of cranberry juice.


Eligibility criteria:
inclusion criteria: * coronary artery disease exclusion criteria: * pregnant and lactating women * clinical history of other major illness including end-stage cancer, renal failure, hepatic failure, gastrointestinal disorders that may impair absorption, or other conditions that in the opinion of the principal investigator make a clinical study inappropriate * treatment with an investigational new drug within the last 30 days * history of a psychological illness or condition such as to interfere with the subject's ability to understand the requirements of the study. * treatment with vitamin e, vitamin c, beta carotene, lipoic acid, or other food or herbal supplements within 2 weeks of enrollment (subjects taking multivitamins or other forms of vitamin e and c in doses that do not exceed two times the rda will not be excluded).
adiponectin in obese women with t2dn and effects by ras blocker

Conditions: Obese; Type 2 Diabetes; Diabetic Nephropathy; Glucose Metabolism; Angiotensin II Type 1 Receptor Blockers

Summary: insulin resistance typically characterizes type 2 diabetes (t2dm) and prediabetic states and is the prominent feature of the metabolic syndrome.adiponectin plays an important part in glucose metabolism,insulin resistance, the deterioration of renal function.we hypothesize there is a difference serum adiponectin levels between obese and non-obese women with type 2 diabetic nephropathy. furthermore, these two groups would respond difference to the ras blocker(losartan).

it would be a prospective cohort study. according to bmi, all the women, aged\>30yr, diagnosed type 2 diabetic nephropathy, chronic kidney disease stage range from 1 to 4, will be divided to two group. renal function index(included scr, gfr, et al),glucose metabolism index( fasting glucose, plasma insulin et al),and adiponectin concentration will be observed and recorded. both two groups females will accept the treatment of ras blocker(losartan, 100mg daily, 6 month). during the study, the above mentioned parameters will also be recorded 3 month intervals. meanwhile, any side effects would be pay attention.

Eligibility criteria:
inclusion criteria: * type 2 diabetic nephropathy * ckd at stage 1\~4 exclusion criteria: * type 1 diabetes or nondiabetic renal disease * an elevated plasma k level.

Keywords: obese female type 2 diabetes diabetic nephropathy glucose metabolism angiotensin ii type 1 receptor blockers adiponectin
hiv vertical transmission in vietnam

Conditions: HIV Infections

Summary: prevention of hiv-1 transmission from mother-to-child by non-breast-feeding is complicated by increased infant mortality in developing countries. however, extensive counselling about formula feeding turned out safe in vietnam, a middle-income country.extensive counselling together with formula feeding and antiretroviral therapy reduced vertical transmission of hiv-1 considerably.

observation 135 hiv mother to check up and delivery in the obstetric and gynecology in two big city in northern vietnam (hanoi and haiphong)and follow up their children from the birth to 18 months. they were provide the antiretroviral by the national program for prevention of mother-to-child transmission of hiv, also the counseling estimates 6 hours for each mother-child pair while study progressing. using the nested pcr to diagnosis hiv infected in the children in difference time point before 18 months. our outcome are * the rate of hiv transmission form mother to child in our study is 6,7%(9?135). in utero is 1,5% and 5% in gestation. * sixty-nine percent of hiv pregnant women were get antiretroviral. most of them (84%) get nevirapine at delivery (6 children hiv infected). the rest get triple antiretroviral(2 infected child). * selective cesarean section not comment for hiv pregnant women. * non breast feeding were recommended and all mothers chose formula feeding to their child so that we had no data for transmission by breast milk. * two hiv infected child die before 18months versus non die in uninfected child. * cd4 t cell count lower than 200/microliter were observed dominate in mother infected child.

Eligibility criteria:
inclusion criteria: * hiv mother willing to enroll to study and their child for mother: their hiv status was diagnosed by at least one quick test and two different elisa serological tests. for their child: the child had tested hiv at list 3 time one at birth, one at 12 or 18 months and one in between. exclusion criteria: * the child had less than 3 time to test.

Keywords: mother to child transmission of hiv hiv infected children
body first approach in lap cholecystectomy in cases with obscure calot's triangle

Conditions: Cholecystitis, Chronic

Summary: the aim of this study is to evaluate the body first approach on the rate of conversion to open technique \& vbi in patients with obscure calot's triangle.

gallbladder disease is one of the most common reasons patients are referred to a general surgeon. laparoscopic cholecystectomy (lc) is the current standard of care for symptomatic cholelithiasis. despite being considered a low-risk surgery, bile duct injuries (bdis) have occurred at a constant rate in the last 30 years, leaving devastating consequences on the affected patients. however vasculobiliary injury (vbi) is a rare but critical complication of (lc). so we need to follow critical view of safety. the critical view of safety (cvs) described by strasberg is considered as the one of the most important critical factors for overall safety during lc. the cvs consists of three essential component or steps: 1) dissection of the hepatocystic triangle (hct); 2) exposure of at least lower one third of the cystic plate (cp); and 3) demonstration of only two tubular structures (cystic duct and cystic artery) that remain attached to the gallbladder (after components 1 and 2 are achieved). all these three steps must be completed before considering that cvs has been achieved. however in some cases calot's triangle can't be demonstrated due to dense adhesions. conversion with retrograde approach (fundus first) was an option for these cases. however a retrograde approach can be achieved laparoscopically by starting dissection by body to use the fundus attachment for retraction which is called (the "body-first approach") that may decrease the possibility of vbi. recent studies deficient in evaluation of outcome of (body first approach). so the interest of our study is to evaluate the outcome of body first approach in difficult cases and cases with obscure calot's triangle in (lc) and to evaluate its feasibility and safety in (lc).

Eligibility criteria:
inclusion criteria: - all adult patients aging above 18 years old fit for (lc), who presented with symptomatic gall stones by clinical examination and detected by preoperative imaging and intra-operatively have obscure calot's triangle. exclusion criteria: * unfit patients. * patients with calcular obstructive jaundice.
implementing a school prevention program to reduce injuries through neuromuscular training

Conditions: Wounds and Injuries; Adolescent; Athletic Injuries; Sport Injury; Sports Injuries in Children

Summary: the purpose of this study is to evaluate the effectiveness of a neuromuscular training program in decreasing sport and recreational injuries and improving healthy outcomes in junior high school students (grades 7 to 9). the neuromuscular training program is implemented as a 15-minute warm-up at the beginning of the students' physical education classes over a three-month period. this study is a randomized controlled trial design, involving twelve schools over a three-year period. upon enrolment into the study, schools are randomly assigned to the intervention (neuromuscular training) group, or the control group. the control group includes a standard-of practice warm-up consisting of aerobic components and static stretching. a study athletic therapist visits the schools each week to assess and record information on any injuries sustained by study participants. baseline health and physical fitness is measured at baseline, and again at 3-month follow-up in study participants to assess changes over the course of the program.


Eligibility criteria:
inclusion criteria: schools * junior high schools with a minimum of two physical education classes per week, per class * physical education classes that are taught or co-taught by a physical education specialist subjects * students aged 11-15 who are fully participating in physical education curriculum at baseline * students who return completed assent and parental consent forms exclusion criteria: schools * schools that are culturally distinct * schools that have students that are of single sex * schools that cater to students with special needs * schools with incomplete grades subjects * history of musculoskeletal disorders or medical condition that prevents participation in regular physical education curriculum * history of musculoskeletal injury within 6 weeks prior to study commencement that restricts full participation in physical education * at least 80% of participation in physical education classes over the course of the study

Keywords: sport injury injury prevention fitness neuromuscular training implementation