Kornimate/medical-research-clean huggingface dataset:
40% orally administered dextrose gel is more effective than 25% dextrose

Conditions: Acute Pain

Summary: the aim of this study was to evaluate the safe of 40% dextrose oral administration on blood glucose concentration and to reducing of pain before painful procedures on healthy term neonate 72 hours aged.

during the study period around 2000 term neonates were born in the university affiliated hospital. five to 7 term neonates were assessed weekly by the principal investigator (pi) for study eligibility. the parents of neonates who met the inclusion criteria received information about the study after which they were invited to participate. written informed consent from parent was obtained. the pi entered data into the online research randomizer which provided a randomization number corresponding to a numbered treatment pack containing two syringes, each containing 2ml of an identical and therefore blinded liquid. study investigators, clinical staff, parents and monitors remained blinded to treatment allocation until data analysis was completed. to ensure standardization the included term infants were not breastfeed 30' prior to the heel stick and a standardized heel lance was used.each infant was taken to a separate room with the mother by the assigned nurse to provide a quite environment. all infants were awake at the time of the procedure. their clothes were removed and wet diapers were changed. in both groups, the infants were placed in a supine position on a changing table. dextrose administration and the heel stick were undertaken by an experienced staff neonatal nurse. the heel was warmed with a warm wet towel up 2' minutes before the procedure. the heel was disinfected shortly before the procedure started.

Eligibility criteria:
inclusion criteria: * were born at ≥ 37 weeks of gestation were * apgar score of ≥ 7 five minutes after birth * had a postnatal age of ≥ 72 hours * were breastfed (but not 30' prior to the testing hs) * were undergoing a routine heel stick for metabolic screening between the third and fifth postnatal day exclusion criteria: * any kind of medical instabilities needing a transfer to the neonatal intensive care unit (nicu) * severe intrapartum asphyxia defined as a 5' apgar score less than 3 * parenteral nutrition and the presence of neurological symptoms * congenital anomalies * other conditions requiring treatment for hypo- or hyperglycemia * those in which the heel lance procedure failed

Keywords: procedural pain, 40% dextrose, heel lance
adjunctive spd489 to antipsychotic medication in clinically stable adults with persistent predominant negative symptoms of schizophrenia

Conditions: Schizophrenia

Summary: the primary purpose of this study is to determine whether spd489 40 mg, 100 mg, and 160 mg are effective and safe in the treatment of negative symptoms of schizophrenia (nss).


Eligibility criteria:
inclusion criteria: * 18 to 65 years of age * has a reliable informant (eg, family member, social worker, caseworker, or nurse that spends \>4 hours/week with the subject) * fixed home/place of residence and can be reached by telephone * on a stable dose of antipsychotic medications * able to swallow capsules exclusion criteria: * taking lithium, carbamazepine, lamotrigine, gabapentin, cholinesterase inhibitors, modafinil, or other stimulants such as methylphenidate and other amphetamine products * treated with clozapine in past 30 days * lifetime history of stimulant, cocaine, or amphetamine abuse or dependence * history of seizures (other than infantile febrile seizures), any tic disorder, or current diagnosis and/or a known family history of tourette's disorder, serious neurological disease, history of significant head trauma, dementia, cerebrovascular disease, parkinson's disease, or intracranial lesions * uncontrolled hypertension * history of thyroid disorder that has not been stabilized on thyroid medication * glaucoma * pregnant or nursing * subject has received an investigational product or participated in a clinical study within 30 day
comparison of changes in serum 25(oh)d concentrations following vitamin d supplementation with chewable tablets versus pills

Conditions: Vitamin D Deficiency

Summary: this is a 6-month cross-over trial of vitamin d supplementation in 38 healthy men and women aged 18 years and older. the primary aim is to compare the change in serum 25(oh)d concentration following vitamin d supplementation with chewable tablets versus pills. secondary aims are to evaluate satisfaction and adherence to the vitamin d chewable tablet supplement. questionnaires on physical activity, sunlight exposure and dairy product consumption will be administered to adjust for confounding factors. a questionnaire will be administered to assess satisfaction and pill count to evaluate adherence to treatment. this research intends to test the hypothesis that the vitamin d chewable tablet supplement is as effective as a traditional vitamin d pill supplement to increase serum 25(oh)d concentrations.


Eligibility criteria:
inclusion criteria: * caucasian men and women; * aged 18 years and older; * having a serum 25(oh)d concentration of 75 nmol/l or less. exclusion criteria: * regular consumption of a supplement containing \> 400 iu/d of vitamin d over the last 2 months; * intestinal malabsorption; * cirrhosis; * renal insufficiency (creatinine clearance \<60 ml/min); * hypercalcemia; * pregnancy; * breastfeeding; * inability to provide informed consent.
study on the mechanism of lcn2 in obesity

Conditions: Obesity; Endocrine

Summary: obesity is now becoming a worldwide serious problem. obesity is associated with a spectrum of severe diseases, including diabetes, cardiovascular diseases, and cancers. lipocalin 2 (lcn2), also known as neutrophil gelatinase associated lipocalin (ngal), is a member of the lipocalin family. due to its upregulated expression in infection, lcn2 is originally considered to be a key regulator of immune response. subsequent investigations revealed that lcn2 is expressed in many tissues and is related to a variety of diseases, including obesity. lcn2 was reported to be increased in obesity individuals. thus, the investigators decide to investigate the relationship between lcn2 and obesity.


Eligibility criteria:
inclusion criteria: 1) age ranged from 16-65 years old, 2) bmi over 37.5kg/m2, or bmi over 32.5kg/m2 with diabetes which meets the recommended cut off bariatric surgery of the guidelines for surgical treatment of obesity accompanied with or without type 2 diabetes in china. exclusion criteria: 1) secondary cause of obesity such as hypothalamic obesity, cushing syndrome, and hypophysis dysfunction, etc.,2)pregnancy or location, 3) contraindications for laparoscopic surgery, such as gastrointestinal diseases of intra-abdominal infection, adhesion, etc., 4) severe heart, liver and kidney dysfunction, 5) organic and systemic diseases intolerant of surgery.

Keywords: obesity lcn2
tamoxifen versus etoposide after first recurrence in gbm patients

Conditions: Glioblastoma Multiforme

Summary: the investigator propose a single-center randomized phase ii controlled study designed to compare the management of first recurrence of gbm using etoposide versus tamoxifen.


Eligibility criteria:
inclusion criteria: 1. histologically proven gbm with progression after previous first line chemoradiotherapy with temozolomide. 2. progression documented by mri with at least one bi-dimensionally measurable target lesion with one diameter of at least 10 mm, visible on two or more axial slices 5 mm apart. 3. not received radiotherapy within the three months before the diagnosis of progression. 4. stable or decreasing dose of corticosteroids prior to randomization: corticosteroids (dexamethasone) should be given at the lowest dose needed to control symptoms arising from increased intracerebral edema. 5. ecog performance 0-2 (appendix 2). 6. age from 18-65 years. 7. women of child bearing potential (wocbp) must have a negative serum (or urine) pregnancy test within 72 hours prior to the first dose of study treatment. wocbp is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy or bilateral salpingectomy) and is not postmenopausal. menopause is defined as 12 months of amenorrhea in a woman over age 45 years in the absence of other biological or physiological causes. 8. patients of childbearing / reproductive potential should use adequate birth control methods, as defined by the investigator, during the study treatment period and for a period of 60 days after the last dose of study drug. a highly effective method of birth control is defined as those that result in low failure rate (i.e. less than 1% per year) when used consistently and correctly. note: abstinence is acceptable if this is established and preferred contraception for the patient and is accepted as a local standard. 9. laboratory evaluation obtained within 7 days prior to randomization, with adequate function as defined below: * anc ≥ 1.5 x 109/l * platelets ≥ 100 x 109/l * serum creatinine ≤ 1.5 times uln * total serum bilirubin ≤ 1.5 times uln * alt \< 3 times uln * ast \< 3 times uln * alkaline phosphatase \< 3 times uln 10. patient must understand and sign an informed consent prior to study registration. exclusion criteria: 1. history of another malignancy or a concurrent malignancy (exceptions include patients who have been disease-free for 3 years, or patients with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible, for example cervical cancer in situ. 2. uncontrolled hypertension (systolic blood pressure \>150 mm hg or diastolic blood pressure \>100 mm hg). 3. any arterial or venous thrombosis up to 6 months before registration. 4. evidence of recent hemorrhage on brain mri. 5. substantial cardiovascular disease: cerebral vascular accident/stroke (\ new york heart association classification class ii), or serious cardiac arrhythmia requiring medication.
post marketing surveillance study of remicade in patients with chronic inflammatory diseases (p04840)

Conditions: Arthritis, Rheumatoid; Spondylitis, Ankylosing; Arthritis, Psoriatic; Psoriasis; Crohn's Disease

Summary: this study will be performed to evaluate and document the safety and efficacy of infliximab (remicade®) in the treatment of chronic inflammatory diseases in big cohorts in the daily routine practice of rheumatologists, gastroenterologists, and dermatologists.

the study population was chosen from a non-probability sample. the safety population consisted of all participants with at least one documented infusion of infliximab. the evaluable population consisted of all participants that were \>=18 years of age with a recorded indication for infliximab use, that had available baseline data, and with at least 3 infusions of infliximab within the first 16 weeks of the study. baseline characteristics are provided for this population.

Eligibility criteria:
inclusion criteria: * participants treated with infliximab by rheumatologists, gastroenterologists, and dermatologists for chronic inflammatory diseases, such as rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, or crohn's disease. exclusion criteria: * none
comparison of somatometric characteristics between cerebral palsy and normal children, cross-sectional, multi center study

Conditions: Cerebral Palsy

Summary: the purpose of this study is to: 1) secure basic data of patients with cerebral palsy, 2) seek ways to simplify the data for clinical application, 3) progress of hip dislocation, presence or absence of hip surgery, and the purpose of this study is to compare differences in body development according to severity and nutritional methods.


Eligibility criteria:
inclusion criteria: * aged 1 to 13 * experiment group: children with cerebral palsy, control group: normal children * patients who agreed to participate in the study exclusion criteria: * do not agree with the study * those who find it difficult to participate under the judgment of the research director
pre- and intra-operative intravitreal bevacizumab injection in diabetic vitrectomy

Conditions: Proliferative Diabetic Retinopathy; Vitreous Hemorrhage

Summary: the purpose of this study is to determine the effect of pre- and intra-operative bevacizumab injection on postoperative vitreous hemorrhage after diabetic vitrectomy.

postoperative vitreous hemorrhage(vh) is a common complication after vitrectomy for proliferative diabetic retinopathy. persistent or recurrent vh can delay visual rehabilitation and give patients much trouble. there have been efforts to lower the incidence of postoperative vh such as using intraoperative gas tamponade and preoperative bevacizumab injection. bevacizumab(avastin) is a potent inhibitor of angiogenesis and has been shown to decrease retinal and iris neovascularization in proliferative diabetic retinopathy. recently there have been reports showing that preoperative intravitreal bevacizumab (ivb) injection could reduce intraoperative bleeding from abnormal vessels and could make surgery easier and more successful.our hypothesis is that preoperative bevacizumab injection could reduce postoperative vh by way of decreasing the amount of abnormal vessels and intraoperative injection could also reduce postoperative vh by inhibiting the vessel formation after surgery. to prove our hypothesis, we started the prospective randomized comparative study to determine the effect of pre- and intra-operative ivb injection on postoperative vitreous hemorrhage after diabetic vitrectomy.

Eligibility criteria:
inclusion criteria: * patients undergoing first vitrectomy for complications of proliferative diabetic retinopathy such as vitreous hemorrhage, tractional fibrovascular membrane proliferation, tractional or combined retinal detachment) exclusion criteria: * follow-up period of less than 6 months * intraoperative use of long-acting gas or silicone oil * repeat vitrectomy after first vitrectomy for diseases other than vitreous hemorrhage * not first vitrectomy * uncontrolled hypertension * medical history of abnormal blood coagulation * time interval between ivb injection and ppv longer than 2 weeks and recent history (within 3 months) of ivb treatment

Keywords: proliferative diabetic retinopathy vitrectomy bevacizumab vitreous hemorrhage
a clinical evaluation of a vaginal bowel control system for the treatment of fecal incontinence in women (life)

Conditions: Fecal Incontinence

Summary: the objective of this study is to obtain preliminary efficacy and safety data on the use of the livsure system (now called the "eclipse™ system") in women with fecal incontinence.


Eligibility criteria:
inclusion criteria: * history of fi for at least 6 months * baseline diary requirement for min # of fi episodes in a two-week period * ability to manage investigational device insertion and removal * successful fitting of study device * willing and able to give written informed consent to participate in the study exclusion criteria: * chronic rectal, anal or pelvic pain * any vaginal prolapse that extends beyond the plane of the hymen. * previous rectal or pelvic floor surgery within the last 12 months (24 months in the case of cancer) * congenital anorectal malformation * chronic watery diarrhea unmanageable by drugs or diet as primary cause of fi * inflammatory bowel disease * presence of a vaginal, anal, rectal or urethral fistula or anastomosis * presence of a vaginal, rectal or bladder tumor * presence of an open wound or tear in the vagina or anus by exam * presence or history of rectovaginal fistula * atrophic vaginal tissue as determined by symptoms or visualization * current vaginal or urinary infection requiring treatment * history of recurrent urinary or vaginal infections * subject is currently pregnant or planning pregnancy in next 5 months * concurrent use of any intra-vaginal device that would interfere with livsure (now called eclipse) placement or wearing * any significant medical condition (e.g., significant psychiatric or neurological disorders, active alcohol/drug abuse, etc.) or other factor that the investigator believes would interfere with study participation and/or increase subject risk

Keywords: fecal incontinence bowel control
circulating tumor cells as a biomarker for preoperative prognostic staging in patients with esophageal cancer

Conditions: Resectable Esophageal Cancer

Summary: despite the availability of several preoperative diagnostic techniques, accurate pretreatment staging of esophageal cancer (ec) remains challenging. therefore, the investigators evaluated the prognostic significance of circulating tumor cells (ctcs) in patients with ec.


Eligibility criteria:
inclusion criteria: * \> 18 years * resectable esophageal cancer exclusion criteria: * \< 18 years * esophageal cancer with preoperative distant metastases

Keywords: esophagus carcinoma surgery circulating tumor cells
allogeneic stem cell transplantation (sct) with treosulfan, vp-16 and cyclophosphamid for patients with acute lymphoblastic leukemia (all)

Conditions: Acute Lymphoblastic Leukemia

Summary: the present study is a multicenter, prospective phase ii-study investigating the combination of treosulfan, etoposide, and cyclophosphamide as conditioning regimen for patients with acute lymphoblastic leukemia who are not eligible for a tbi-containing regimen.


Eligibility criteria:
inclusion criteria: * acute lymphoblastic leukemia in first or subsequent complete remission * indication for allogeneic stem cell transplantation according to the actual protocol of the german acute lymphoblastic leukemia study group * patient's age: 18-65 years * hla-identical or compatible related or unrelated donor (hla-a, hla-b, hla-c, hla-drb1 and hla-dqb1) (one antigen-mismatch allowed) * not eligible for total-body irradiation due to one of the following reasons: * prior radiation of the spine \> 30 gy * prior radiation of the mediastinum \> 30 gy * severe pulmonary infection during induction chemotherapy * dlco \> 50% * patient's wishing to avoid total-body irradiation as conditioning regimen * patient's written informed consent * women and men capable of reproduction must agree to use highly effective methods of contraception until six months after treatment termination. for men: vasectomy, sexual abstinence, or partner is using hormonal iud, implants, injectables, oral hormonal contraceptives or is surgically sterilized. for women: hormonal iud, implants, injectables, sexual abstinence, surgical sterilization, vasectomised partner exclusion criteria: * no complete remission at time of registration * severe irreversible renal, hepatic, pulmonary or cardiac disease, such as * total bilirubin, sgpt or sgot \> 3 times upper the normal level * left ventricular ejection fraction \< 30% * creatinine clearance \< 30 ml/min * dlco \< 35% and/ or receiving supplementary continuous oxygen * positive serology hiv * pregnant or lactating women * severe florid infection * experienced hypersensitivity against cyclophosphamid, etoposide, or treosulfan * cystitis * obstructive renal function * participation in any other clinical drug trial * serious psychiatric or psychological disorders * progressive invasive fungal infection at time of registration

Keywords: acute lymphoblastic leukemia hematopoeitic stem cell transplantation
one year follow-up of study 2-79-52030-207 (primarys) in acromegalic patients with macroadenoma

Conditions: Acromegaly

Summary: this non-interventional retrospective study aims to describe the therapeutic procedures and modalities received by patients and the correlation to hormone status, during a one year follow up from completion of the 2-79-52030-207 study.


Eligibility criteria:
inclusion criteria: * completed the 2-79-52030-207 study and received 12 injections of lanreotide autogel 120 mg, regardless of efficacy at the end of this period. * subject or in case of subject's death next of kin having given their written informed consent prior to collection of the data by the sponsor (if locally required)
caffeine in children with obstructive sleep apnea, dose response study

Conditions: Obstructive Sleep Apnea; Enlargement of Tonsil or Adenoid

Summary: the aim of this study is to evaluate whether a smaller dose of caffeine sodium benzoate 10 mg/kg iv is as effective as 20 mg/kg iv in decreasing the number of children who develop post extubation adverse upper airway respiratory events compared to placebo.

institutional approval and written informed consent from parents or guardians of healthy children, with obstructive sleep apnea (osa) and/or with increased end-tidal c02 (sleep related hypoventilation, obstructive hypoventilation or sustained alveolar hypoventilation), confirmed with sleep study, scheduled for elective outpatient or inpatient adeno-tonsillectomy at our hospital, will be obtained. the study will be prospective, randomized, double blinded and placebo controlled. a computer generated randomization list will be used, and the study will be registered with clinical.trials.gov. written child assent will be obtained from children 7 years and older. copies of a flyer and an explanation of the study will be provided at the office of all the pediatric ent surgeons who practice at the memorial hermann hospital or. the investigators will communicate with the nurses at the surgeons' office and ask them to give the flyer with an explanation of the study to the parents and children on the day they schedule the surgery. the flyer with an explanation of study will be sent to irb for review and approval. a research assistant will invite parents or guardians in the dsu unit, anesthesia clinic or on the floor to allow their children to be part of the study. children with osa and/or increased end tidal c02 (sleep related hypoventilation, obstructive hypoventilation or sustained alveolar hypoventilation), 2-12 years of age, and both genders will be eligible to be part of the study. osa and its severity will be diagnosed by a preoperative polysomnography. children with compromised cardiovascular, pulmonary or renal function, those with congenital syndromes, sickle cell disease, history of seizures and those receiving theophylline will be excluded.

Eligibility criteria:
inclusion criteria: * children with osa and/or increased end tidal c02 (sleep related hypoventilation, obstructive hypoventilation or sustained alveolar hypoventilation), 2-12 years of age, and both genders will be eligible to be part of the study. osa and its severity will be diagnosed by a preoperative polysomnography. exclusion criteria: * children with compromised cardiovascular, pulmonary or renal function, those with congenital syndromes, sickle cell disease, history of seizures and those receiving theophylline will be excluded.

Keywords: osa caffeine tonsillectomy adenoidectomy sleep study
a study of the effect of taspoglutide on gastric emptying in patients with type 2 diabetes

Conditions: Diabetes Mellitus Type 2

Summary: this 3 arm, placebo-controlled study will investigate the effect of taspoglutide on gastric emptying in patients with type 2 diabetes. patients will be randomized into one of 3 groups to receive a)10mg taspoglutide sc weekly for 12 weeks b)10mg taspoglutide sc weekly for 4 weeks followed by 20mg taspoglutide sc weekly for 8 weeks or c) placebo sc weekly for 12 weeks, with all injections administered in the abdomen.gastric emptying will be assessed by a paracetamol test at intervals during the study. the anticipated time on study treatment is 3 months, and the target sample size is \<100 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, 18-75 years of age; * type 2 diabetes mellitus, treated with stable oral antidiabetic drug therapy for \>=3 months prior to screening; * stable weight +/-10% for \>=3 months before screening. exclusion criteria: * type 1 diabetes mellitus; * acute gastrointestinal symptoms at screening and/or day -1; * clinically relevant cardiovascular, bronchopulmonary, gastrointestinal or neurological disease.