Kornimate/medical-research-clean huggingface dataset:
effect of low-dose baclofen administration on the gh-igf1 axis study

Conditions: Spinal Cord Injury

Summary: insulin-like growth factor i (igf-i) is used as a measure of the body's ability to produce growth hormone. growth hormone is important for muscle tissue as well as many other tissues in the body. growth hormone (gh) and igf-i have been shown to be reduced in many persons with sci. baclofen is a fda approved drug that is used to treat spasticity. persons receiving long-term baclofen therapy have been demonstrated to have increased growth hormone and igf-i levels. igf-i levels will be determined before and after treatment with baclofen. in this study, the investigators will determine the minimum dose of baclofen at which improvements in gh and igf-1 levels occur.


Eligibility criteria:
inclusion criteria: * patients with chronic sci (injury greater than 6 months) who have been screened and found to have depressed plasma igf-1 levels and who are not taking baclofen. exclusion criteria: * acute illness of any etiology, * patients with chronic renal, liver, lung, or cardiac disease, * patients receiving any of the following medications: narcotics, or l-dopa, and * alcoholics.

Keywords: spinal cord injury baclofen growth hormone, pituitary insulin-like growth factor i
a 58-week safety and efficacy trial of ferric citrate in patients with esrd on dialysis

Conditions: Hyperphosphatemia; Kidney Failure

Summary: this is up to a 58 week study comparing ferric citrate to active control for 52 weeks in esrd dialysis patients, and subsequently comparing ferric citrate to placebo for 4 weeks.

this trial is a three-period, multicenter, safety and efficacy clinical trial. the first period is a two-week washout period, the second period is a 52-week randomized, open-label, active control safety assessment period, and the third period is a four-week, randomized, open-label, placebo-controlled efficacy assessment period in only the patients who were randomized to treatment with ferric citrate during the safety assessment period. the primary objectives of this trial are to determine the long-term safety over 52 weeks of up to twelve (12) caplets/day of krx-0502 (ferric citrate) in patients with esrd undergoing either hemodialysis or peritoneal dialysis and to determine the efficacy of krx-0502 (ferric citrate) in the four-week, randomized, open-label, placebo-controlled efficacy assessment period.

Eligibility criteria:
inclusion criteria: 1. males or non-pregnant, non-breast-feeding females 2. age ≥18 years 3. on thrice-weekly hemodialysis or on peritoneal dialysis for at least the previous three months prior to screening 4. serum phosphorus ≥6.0 mg/dl for study entry 5. taking less than 3-18 pills/day of current phosphate binder 6. willing to be discontinued from current phosphate binder(s) and initiated on ferric citrate 7. willing and able to give informed consent 8. life expectancy \>1 year exclusion criteria: 1. parathyroidectomy within six months prior to screening 2. actively symptomatic gastrointestinal bleeding or inflammatory bowel disease 3. history of multiple drug allergies or intolerances 4. history of malignancy in the last five years (treated cervical or non-melanomatous skin cancer may be permitted if approved by ccc) 5. previous intolerance to oral ferric citrate 6. intolerance to oral iron-containing products 7. psychiatric disorder that interferes with the patient's ability to comply with the study protocol 8. inability to tolerate oral drug intake 9. intolerance to calcium acetate and sevelamer carbonate 10. any other medical condition that renders the patient unable to or unlikely to complete the trial or that would interfere with optimal participation in the trial or produce significant risk to the patient 11. receipt of any investigational drug within 30 days of screening visit (visit 0) 12. inability to cooperate with study personnel or history of noncompliance 13. unsuitable for this trial per investigator's clinical judgment.

Keywords: esrd end-stage renal disease dialysis hemodialysis peritoneal dialysis hemodialysis (hd) peritoneal dialysis (pd) chronic renal insufficiency phosphate binder kidney failure renal failure
primary liver cancer cohort of south china

Conditions: Primary Liver Cancer

Summary: this longitudinal observational cohort study was designed to investigate factors that influencing the occurrence and long-term survival of patients with primary liver cancer. basic informations and detailed diagnosis informations (ajcc/tnm stage, meld score, child-pugh score, and bclc stage) were collected by professional doctors. clinical outcomes (death, recurrence, and metastasis) will be followed up every two years after therapy.

primary liver cancer (plc) is highly malignant with high mortality which is particularly popular in china. many factors are believed to associate with the occurrence and prognosis of liver cancer. this longitudinal observational cohort study was designed to investigate factors that influencing the occurrence and long-term survival of patients with primary liver cancer.

Eligibility criteria:
inclusion criteria: * age 18-80 years * consistent with primary liver cancer diagnostic criteria * first diagnosis (from diagnosis to admission interval of less than a month) * did not do any treatment of liver cancer exclusion criteria: * refused to participate in this study * suffering from more than two kinds of primary tumors

Keywords: primary liver cancer; cohort study
relapse markers for colorectal cancer

Conditions: Colorectal Cancer

Summary: this is an observational case-control study which enroll metastatic and non-metastatic colorectal cancer (crc) patients. the objective of this study is to evaluate a novel blood multi-marker test for the detection of relapse in colorectal cancer patients. this test is based on whole-blood transcriptomic signatures and circulating tumor methylated dna markers. the patients will be enrolled into 4 study groups, two cross-sectional and two longitudinal groups, to follow up patients up to 36 months from primary tumor resection.


Eligibility criteria:
inclusion criteria: * male or female ≥ 18 years of age at time of informed consent. * subject has signed the informed consent form (icf) and is able to understand the information provided in it. * at least a blood sample is collected per subject according to the sample collection protocol. * patients enrolled in local prospective protocols, in which samples have been collected according the study procedures may be included. * group 1: patients with a radiologically and, whenever is possible, histologically confirmed relapse (local or distant) of colorectal cancer within 5 years from primary surgery. metachronous primary tumors are not considered as relapse and should be excluded. * group 2: patients declared disease-free for at least 36 months but less than 5 years, as confirmed by radiological examination. * group 3: patients with a stage iii-iv colorectal cancer with a curative treatment and disease-free for at least 3 months but less than 18 months. * group 4: histologically and radiologically confirmed diagnosis of stage i, ii, iii or iv colorectal adenocarcinoma, eligible for a treatment with curative intent. exclusion criteria: * personal history of cancer (non-hematologic) other than crc in complete remission for less than 5 years. * personal history of hematologic cancer. * a blood transfusion within 6 weeks prior to inclusion into the study. * transplant with regular intake of immunosuppressants. * pregnant woman (self-declaration). * conditions or comorbidities that would preclude the compliance with the planned surveillance program or with the protocol as judged by the investigator. * previous inclusion in the relma-c study and/or re-inclusion in a different study group. * group 1: any treatment for crc relapse prior to blood collection. * group 2: patient is disease-free for less than 36 months or more than 5 years. * group 3: patient is disease-free for less than 3 months or more than 18 months * group 3: stage iv patients with detectable residual disease after primary treatment. * group 4: any cancer treatment prior to blood collection.
phone coaching for weight loss maintenance

Conditions: Obesity; Weight Loss

Summary: the purpose of this study was to examine whether 4 consecutive weeks of phone coaching aids in recovery from weight regain during weight loss maintenance. individuals who previously achieved and maintained a \>=5% weight loss in a 1-year behavioral weight loss program were provided with a low-intensity maintenance intervention (monthly newsletters and smart scale). at baseline, participants were randomized to the coaching group or the control group (no coaching). if participants regained \>1.5% of their weight, randomization was "triggered." at this point, participants randomized to the coaching condition received 4 brief weekly coaching calls; participants randomized to the control condition received no additional intervention contact. short-term and long-term weight change was assessed and compared between treatment groups.


Eligibility criteria:
inclusion criteria: * 18-72 years of age * recent completion of a 1-year behavioral weight loss program * achievement of \>=5% weight loss at the end of the 1-year weight loss program exclusion criteria: * not currently enrolled in another weight management program

Keywords: phone coaching diet exercise
efficacy and safety of aluminaid versus hydrogel wound dressings

Conditions: Partial-thickness Burn

Summary: burn injury is the result of an energy transfer that destroys the skin and adjacent tissues. partial thickness burn wounds are painful and difficult to manage. the aim of burn treatment in partial thickness burns is to promote rapid wound healing, decrease pain, protect wound from infections, minimize scar formation and functional impairment in recent years, there are progressive development of new dressing material with a variety of option for depth adapted wound management. many wound dressings are available for superficial and partial thickness burns. hydrogel based wound dressing provides good biocompatibility with the skin and mucosa and promotes hydration of the wound bed. aluminaid wound dressings is a hydrogel based wound dressing that is integrated with aluminium that was designed to reduce acute pain in the treatment of superficial and partical thickness burn injuries. up to date, no evidence regarding integrated with aluminium sheet in hydrogel based wound dressings for the use in partial thickness burns. therefore this trials is aimed to evaluate the efficacy and safety of aluminaid versus hydrogel for the treatment of partial thickness burns.

this is a prospective, randomized, open label, active controlled trial that aim to evaluate the efficacy and safety of aluminaid versus hydrogel wound dressings in the treatment of partial thickness burns. the study is a multi center trial in children and adults of 12 - 65 years old with partial thickness burns.

Eligibility criteria:
inclusion criteria: * adults and children of 12 - 65 years old * partial thickness thermal burns of minimally 1% total body surface area (tbsa) * admission of less than 4 hours of burn injury * patients/legal guardian still have the ability to undergo examinations and give written informed consent. exclusion criteria: * total body surface area (tbsa) of more than 20% * burns caused by chemicals, electricity or radiation * superficial and partial thickness burns located on the faces, palms, soles, genitalia, perineum and joint areas * superficial and partial thickness burns with compartment syndrome * superficial and partial thickness burns with a history of life-threatening trauma * had concomitant disease such as diabetes mellitus * signs of infected burns * patients with known allergies to product containing aluminium, hydrogel or a history of contact dermatitis * other conditions which according to the investigator's judgment are not appropriate to be included in the study. * treated with other agents before attend to clinic (oil, tooth paste, betadine, rivanol etc)
diagnostic accuracy of lncrna dq786243 and mirna146a in saliva of oral potentially malignant lesions

Conditions: Potentially Malignant Lesions; Oral Lichen Planus; Leukoplakia, Oral

Summary: the aim of this study is to evaluate salivary expression of lncrna dq786243 as a potential marker for diagnosis of oral potentially malignant lesions compared to normal controls and its effect on salivary expression of mirna146a.


Eligibility criteria:
inclusion criteria: * participants will be divided into 3 groups: group i: patients suffering from oral lichen planus group ii: patients suffering from leukoplakia group iii: healthy subjects who are systemically free, non-smokers, and not suffering from any oral mucosal lesions. exclusion criteria: * subjects taking any drugs inducing any changes that could affect the salivary flow. * pregnant females. * subjects have any allergies, infectious diseases or active dental abscesses during one month before saliva sampling. * patients receiving any drugs related to the oral lesions in the past 6 month prior to sample collection.

Keywords: lncrna dq786243 saliva oral potentially malignant lesions mirna146a
evolut™ expand tavr ii pivotal trial

Conditions: Moderate Aortic Valve Stenosis

Summary: obtain safety and effectiveness data to support indication expansion for the medtronic tavr system to include patients with moderate, as.

multi-center, international, prospective, randomized study. subjects will be randomized to either transcatheter aortic valve replacement (tavr) with the evolut pro+ tavr system, or evolut fx system, and guideline-directed management (gdmt) or gdmt alone.

Eligibility criteria:
key inclusion criteria: o moderate as, defined as follows by transthoracic echo (tte) as assessed by the ecl: * ava \>1.0 cm² and \<1.5cm²; or * ava ≤ 1.0 cm² with avai \> 0.6cm²/m² if bmi \< 30 kg/m²: or * ava ≤ 1.0 cm² with avai \> 0.5cm²/m² if bmi ≥ 30 kg/m²: and * max aortic velocity ≥ 3.0 m/sec. and \< 4.0 m/sec. or * mean aortic gradient ≥ 20mmhg and \< 40.0 mmhg any of the following at-risk features: * symptoms of as, defined as: * nyha ≥ class ii, or * reduced functional capacity, defined as * 6mwt \< 300 meters, or * \< 85% of age-sex predicted mets on exercise tolerance testing (ett) * documented heart failure event or hospitalization for heart failure within 1 calendar year prior to consent * nt-probnp ≥ 600 pg/ml (or bnp ≥ 80 pg/ml), or * persistent af or paroxysmal af episode within 6 months prior to consent, or * elevated aortic valve calcium score (\>1200 au for females and \> 2000 au for males) as assessed by the mdct core lab, or * any of the following by the qualifying tte as assessed by the ecl: * global longitudinal strain ≤16% (absolute value), or * e/e' ≥ 14.0 (average of medial and lateral velocities), or * diastolic dysfunction ≥ grade ii, or * lvef \< 60% * stroke volume index \< 35 ml/m² * anatomically suitable for transfemoral tavr using the medtronic evolut pro+ or evolut fx system * the subject and the treating physician agree the subject will return for all required follow-up visits key exclusion criteria: * age \< 65 years * lvef ≤ 20% by 2-d echo * class i indication for cardiac surgery * contraindication for placement of a bioprosthetic valve * documented history of cardiac amyloidosis

Keywords: aortic stenosis moderate valve tavr
mc-19pd1 car-t in relapsed or refractory b cell lymphoma

Conditions: Lymphoma

Summary: this is a single center, single arm, open-lable phase 1 study to determine the safety and efficacy of cd19-car-t cells in patients with relapsed or refractory b-cell lymphoma.

in this single-center, open-label, nonrandomized, no control, prospective clinical trial, appoximately 15 relapsed or refractory b-cell lymphoma patients will be enrolled. side effects of cd19 car t cells therapy will be monitored. the purpose of current study is to determine the clinical efficacy and safety of cd19 car t cells therapy in patients with r/r b-cell lymphoma

Eligibility criteria:
inclusion criteria: （1）cd19 positive b-cell lymphoma; （2）relapsed and refractory b-cell lymphoma: patients previously received at least first-line and second- line treatment and fail to achieve cr; （3）at least 1 measurable tumor foci according to the 2014 lugano treatment response criteria; （4）18 to 70 years old, male and female; （5）expected to survive for more than 3 months; （6）clinical performance status of ecog score 0-1; （7）important organ function is satisfied: cardiac ultrasound indicates cardiac ejection fraction ≥50%; serum cr ≤ 1.25 times normal range or creatinine clearance calculated by cockcroft-gault formula ≥45ml/min; alt and ast≤ 3 times normal range, total bilirubin ≤ 1.5times normal range; （8）hemoglobin ≥ 80 g / l, neutrophils ≥ 1.0 × 10 \^ 9 / l, platelets ≥ 50 × 10 \^ 9 / l. （9）inr≤ 1.5times normal range; aptt≤ 1.5times normal range; （10）women in childbearing age must be not pregnant and do not plan pregnancy within 1 year of their cell transfusion; （11）informed consent is signed by a subject or his lineal relation. exclusion criteria: 1. recent or current use of glucocorticoid or other immunosuppressor or drug that stimulates bone marrow hematopoiesis; 2. uncontrolled systemic active infection: fungi, bacteria, viruses or other infections; 3. active infection with hbv, hcv or hiv; 4. patients with symptoms and disease history of central nervous system; 5. pregnant or lactating female；the patient did not agree to use effective contraception during the treatment period and for the following 1 year； 6. patients receiving allogeneic hematopoietic stem cell transplantation, or organ transplantation 7. a history of other malignant tumors; 8. primary immunodeficiency disease, or autoimmune disease; 9. patients treated with pd-1 inhibitors or pd-l1 inhibitors prior to enrollment; 10. patients who participated in other clinical trials within 4 weeks before blood collection; 11. patients who had used cd19 targeted therapy before enrollment; 12. the investigator believes that there are other factors that are not suitable for inclusion or influence the subject's participation or completion of the study.
randomized trial of advanced provision emergency contraception among women with gonorrhea or chlamydia

Conditions: Pregnancy

Summary: the purpose of this trial is to determine whether providing non-contracepting women with gonorrhea or chlamydial infection with advanced provision emergency contraception (apec) and condoms decreases their risk of becoming pregnant.


Eligibility criteria:
inclusion criteria: non-contracepting women \>15 years of age who were reported to public health seattle \& king county with a diagnosis for gonorrhea or chlamydial infection and who were interviewed by public health staff for purposes of partner notification exclusion criteria: * use of effective contraception (hormonal contraception, iud, diaphragm); sex with only one partner in the preceding 60 days who was status post vasectomy; age \<15; inability to speak english; history of tubal ligation, hysterectomy, or menopause.
gender differences in familial risk

Conditions: Cardiovascular Diseases; Heart Diseases

Summary: to develop, test, and apply comprehensive mathematical models for the interaction of genetic and environmental effect on cardiovascular risk with gender differences.

design narrative: models were developed which allowed for sex difference in the expression of autosomal polygenes, differences in the impact of the paternal and maternal environment on male and female offspring, and for the complex consequences of assortative mating on the correlations among loci and between genes and environment. computer simulations were used to decide which kinds of gender-dependent effects could be resolved with particular constellations of relatives, and to address problems of power and bias resulting from errors of model-specification. the methods developed were applied to data from extensive data already gathered from twins and their relatives to determine the importance of sex differences in genetic and environmental causes of variation in measured aspects of cardiovascular risk including weight, body-mass index, family history of cv disease, smoking, alcohol consumption, exercise, diet, psychosocial variables and lifestyle.

Eligibility criteria:
no eligibility criteria
nissen and gastroplasty in gastroesophageal reflux disease (gerd)

Conditions: Gastroesophageal Reflux Disease; Hiatal Hernia; Barrett's Esophagus; Esophagitis; Dysphagia

Summary: laparoscopic nissen fundoplication has established itself as the procedure of choice in the surgical management of the majority of patients suffering from gastroesophageal reflux disease (gerd). postoperative paraesophageal herniation has incidence ranges up to 7% in the immediate postoperative period. this randomized controlled study was scheduled to investigate the role of the posterior gastropexy, in combination with laparoscopic nissen fundoplication, in prevention of paraesophageal herniation and improvement of postoperative results, in surgical treatment of gerd.


Eligibility criteria:
inclusion criteria: * age \>18 years * indications for surgical treatment of gerd * asa i, ii exclusion criteria: * asa iii, iv * previous gastric procedures * conversion to open procedure
transcutaneous bilirubinometry in neonates

Conditions: Neonatal Hyperbilirubinemia

Summary: objective: to assess the accuracy of transcutaneous bilirubin (tcb) measurements in neonates, in relation to gestational age (ga), time (postnatal hour) and site (forehead, sternum, knee) of measurements. hypothesis: using (or combining) different sites for tcb determination might improve the accuracy of tcb in relation to the time of measurement and the ga of the neonate. methods: the study will include neonates \>32 weeks' gestation cared for in the well-baby nursery and nicu of the university hospital of patras, from september to december 2011. data such as sex, gestational age, gestation and perinatal information, mother's and infant's abo group and rh, g6pd deficiency, coombs test, type of delivery and complications, birthweight, postnatal medications and interventions, type and volume of feeding, and extension of jaundice, will be collected. tcb measurements will be performed using the bilicheck bilirubinometer (according to the standard protocol) at 3 different sites: forehead, sternum and knee. total serum bilirubin (tsb) values will be obtained using the heel stick technique, and measurements will be performed by a direct spectrophotometric device (unistat bilirubinometer, richert, depew, ny). the accuracy of the device has been validated previously. tsb measurements will be performed within 5 minutes of the tcb measurements. at each occasion tcb measurements (3), the corresponding tsb value, the time of measurement (postnatal hours), and the actual weight will be noted. statistics: the agreement between tcb and tsb values will be assessed using the bland-altman % method. the independent and joint effects of ga and time of measurement on bias will be evaluated by multivariate regression analysis.


Eligibility criteria:
inclusion criteria: 1. born at the university hospital of patras 2. ga \>32 weeks 3. parental consent to participate exclusion criteria: 1. under phototherapy 2. congenital infections 3. chromosomal abnormalities 4. congenital abnormalities 5. hepatic dysfunction