Kornimate/medical-research-clean huggingface dataset:
growth-health and development in children exposed to drugs during pregnancy

Conditions: Growth Failure; Mental Health Disorder; Foetal Exposure During Pregnancy

Summary: "children exposed to alcohol or drugs during pregnancy: growth, health and development" background children exposed to drugs during pregnancy are at risk of developmental disorders. the scope and size of this problem is poorly known in norway. alcohol has a known teratogenic effect on the fetus. how other drugs affect the fetus, is associated with more uncertainty. withdrawal in the neonatal period has been perceived as the main problem. there is less knowledge about long-term outcome of exposure to drugs during pregnancy. aim the aim of the study is to investigate the physical and mental health of children exposed to drugs during pregnancy. identify the children's need for measures in the home and school, and how many of the children who are taken care of in fostercare. a sample of the children will be offered radiological examination of the brain (f-mri). the purpose is to study the relationship between exposure to drugs, child development, environment and organic brain dysfunction. design the project is a quantitative study. the relationship between exposure to drugs and development will be measured by questionnaires, clinical examination, neuropsychological tests and radiological examination (f-mri). children aged 2-15years who were referred, examined or treated for drug related problems at the department of pediatrics, haukeland university hospital will be invited to participate in the study. information retrieval and examination of the children are expected to be completed during 2011. data analysis and further processing of data are expected to be completed during 2013.


Eligibility criteria:
inclusion criteria: * foetal exposure of drugs during pregnancy. exclusion criteria: * non exposed children

Keywords: foetal exposure during pregnancy health growth
intraocular pressure in children with acute lymphoblastic leukemia (all) treated with high dose steroids

Conditions: ALL, Childhood; Steroid-Induced Glaucoma

Summary: childhood all patients are treated with high dose steroids. the study will follow the intraocular pressure of children treated in according to an aieop-bfm protocol, during the induction phase that will be compared to the pressure before treatment. potential risk factors for developing elevated intraocular pressure will be estimated.

children with all in israel are treating according to the bfm all protocol which contains high dose steroid therapy. one of the known side effects of high dose steroids is intraocular hypertension, glaucoma, and even irreversible optic nerve injury. early diagnosis of elevated intraocular pressure (iop) and early therapeutic interventions might help to prevent future ocular damage. the purpose of this study is to determine the risk of developing evaluate intraocular pressure during high dose steroid therapy. if elevated iop will be common enough, we will try to corelate the risk of elevated iop with potential risk factors, such as initial iop, wbc at diagnosis, etc. intraocular pressure will be measured by ophthalmologists using icare devise: tonopen during general anesthesia at the day of diagnosis of all before steroid therapy initiation, and then after 15 and 33 days. children with elevated iop will continue ophthalmologists' follow up and treatment as necessary. all parents or patients' guardians will sign informed consent for participating in the study. the study group contains all newly diagnosed children with all in schneider children medical center.

Eligibility criteria:
inclusion criteria: * all diagnosis * treated with an aieop-bfm protocol (including steroids) exclusion criteria: \* any prior eye condition that can affect intra ocular pressure or its measurement
bio-marker analysis using circulating tumor cells in patients with melanoma

Conditions: Melanoma

Summary: this research trial studies the levels of a type of biomarker, circulating tumor cells (ctcs), in the blood of patients with stage i-iv melanoma. a biomarker is a biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease. a biomarker may be used to see how well the body responds to a treatment for a disease or condition. studying samples of blood in the laboratory obtained before and after treatment from patients with melanoma may help doctors learn more about changes that occur in ctc levels and whether they may predict how well patients will respond to therapy.


Eligibility criteria:
inclusion criteria: * subjects must have signed tissue collection consent as described in protocol irb# 703001,upcc# 08607, pi: giorgos karakousis, md * subjects must be competent to consent for themselves. * subjectsmust be adult (18 years or older). * subjects must be initiating a new therapy for melanoma (so a pretreatment ctc count can be obtained). exclusion criteria: * children (less than 18yrs) * patients in whom a pre-treatment ctc level cannot be obtained.
effects of transcranial direct current stimulation in post-stroke aphasia

Conditions: Aphasia

Summary: this study aims to determine whether transcranial direct current stimulation (tdcs) paired with speech-language therapy is more beneficial than speech-language therapy alone in acute and chronic post-stroke aphasia.

this study aims to determine whether behavioral word-retrieval therapy coupled with anodal tdcs will improve the fluency and name retrieval performance of participants with post-stroke aphasia more efficiently and for greater duration than language therapy alone (i.e. in the sham condition). tdcs neuronal targets will be selected in this order: 1. left posterior superior-middle temporal gyrus (an area critical for word retrieval and word comprehension), 2. left posterior frontal areas found to be responsible for lexical selection if the first area is infarcted, or 3. right cerebellum (important for learning, and consistently activated in naming task) if both of the other areas are infarcted. the same areas will be stimulated during the first tdcs and sham periods. if the participant returns for a second period of tdcs and sham with language therapy, the right cerebellum will be stimulated (if it was the only uninfarcted target area investigators will stimulate this area again). for cerebellar stimulation, either anodal or cathodal will be used as studies show that anodal or cathodal stimulation has an effect on cognitive functions.

Eligibility criteria:
inclusion criteria: * clinically diagnosed with with post-stroke aphasia and word-retrieval deficits * premorbid speakers of english * diagnosis will be based on neuropsychological testing, language testing (most commonly the western aphasia battery), mri and clinical assessment * stroke size: any l * location: left hemisphere strokes only from any etiology. * time since stroke onset: 1 day to 20 years. exclusion criteria: * uncorrected visual or hearing impairment by self report * other premorbid neurological disorder affecting the brain * any other language-based learning disorder or other neurodegenerative disorder such as alzheimer's disease or primary progressive aphasia * premorbidly diagnosed with a developmental language disorder * pregnant women will also be excluded
multiple chronic diseases: the rith trial

Conditions: Multiple Chronic Diseases

Summary: in this research, investigators pretent to evaluate the effectiveness of clinical, functional, psychological and social impact of an intervention model based on shared care between the mobile rehabilitation and physical therapy team (mrptt) and nurse case managers of primary care in a sample of patients with multiple chronic diseases (comorbidities) and their caregivers. a non-randomised controlled trial.

the experimental group consisted of patients with multiple chronic diseases referred to services in the province of almería that comply the inclusion criteria and their caregivers. outcome measures: sex, age, location, primary caregiver, disabling process, number and type of categories including by multiple pathologies, personal history, assessment (physical and functional), barthel index, lawton and brody index, risk of falls, scale pfeiffer, social support, caregiver burden, hospital readmissions and length, technical aids. quality of life (sf-12) and degree of user satisfaction. regarding the intervention: date of application, date of assessment, objectives, treatment / intervention techniques, number of sessions, staff time spent. control group: patients with multiple diseases and their caregivers, belonging to health centers or areas where there is no figure nurse case manager or mrptt. registration information will consist of the same assessments, questionnaires and scales that are comparable to the experimental and control groups for analysis.

Eligibility criteria:
inclusion criteria: * patients with multiple chronic diseases that are referred to the nurse case managers and home rehabilitation. * detected in hospital or primary care. * to provide informed consent to participate in research. exclusion criteria: * clinical situation of agony; * no acceptance of treatment by the patient or family * refuse to participate in the study * lack of cooperation of the patient or caregiver.

Keywords: home rehabilitation primary health care physiotherapy chronic disease
clinical randomized study of concurrent chemo-radiotherapy vs radiotherapy alone to local-advanced small cell lung cancer (sclc)

Conditions: Small Cell Lung Cancer

Summary: this trial aims to evaluate the efficacy and safety between radiotherapy alone and concurrent chemo-radiotherapy after 3-4 cycles of chemotherapy in ls-sclc.

small cell lung cancer (sclc) represents 15-30% of all lung malignancies in china. limited-stage small cell lung cancer (ls-sclc) represents approximately 40% of cases. the current standard of care in limited-stage disease is systemic chemotherapy plus concurrent thoracic radiotherapy. early concurrent chemo-radiotherapy is recommended for patients with limited-stage sclc based on randomized trials. but, the administration of thoracic radiotherapy requires the assessment of several factors, including the volume of the radiation port, dose of radiation, and fractionation of radiotherapy. parts of the ls-sclc are local advanced stage (stage ⅲa and ⅲb), which can not tolerate concurrent chemo-radiotherapy because of large size in tumor and extensive metastasis of lymph nodes. at present, it is usually use 3-4 cycles of introduction chemotherapy to decrease the tumor size followed by definitive radiotherapy. but it is unclear whether this scheme is tolerant well or it could improve the overall survival in patients with ls-sclc. as a result, we designed a prospective phase ii randomized controlled trial in order to compare the tolerance and therapeutic effects between radiotherapy alone and concurrent chemo-radiotherapy after 3-4 cycles of chemotherapy in ls-sclc.

Eligibility criteria:
inclusion criteria: age 18- 75 years; ecog performance status 0 or 1; pathological or cytological confirmation of sclc; local stage small cell lung cancer with stage ⅲa and ⅲb; receive 3-4 cycles of chemotherapy with etoposide plus cisplatin; measurable disease using recist criteria with at least one lesion; adequate hematological, renal, hepatic and pulmonary functions defined as: granulocytes ≥ 2.0×109/l, platelets ≥ 100 x 109/l, hemoglobin ≥ 8g/l, total bilirubin ≤ 1.5 x upper normal limit, aspartate aminotransferase, alanine aminotransferase≤2.5 × upper normal limit,, creatinine ≤ 1.5mg/l, fev1 ≥ 1.5 l ability to understand and willingness to sign a written informed consent form; exclusion criteria: history of operation of lung cancer; pd after 3-4 cycles chemotherapy; patients with sever infection; patients with uncontrollable diabetes; patients in pregnancy or lactation; patients who are currently receiving or have received other clinical trail for radioprotection within the prior six months are excluded; patient with history of malignancy other than skin cancer or carcinoma in-situ within 2 years; history of cardiovascular diseases that might include one of the following: myocardial infraction, angina, coronary angioplasty, congestive heart failure, stroke, or coronary bypass surgery in the last 6 months; concomitant treatment with other anticancer drugs;

Keywords: limited-stage small cell lung cancer concurrent chemo-radiotherapy
erythropoietin therapy in patients with chronic renal failure: a study of time dependent activity

Conditions: Hemodialysis; Chronic Renal Failure; Anemia

Summary: the purpose of this research study was to determine if the activity of erythropoietin (r-huepo) is time dependent when given to chronic renal failure patients at three different times of day.

this phase-ii crossover study was designed to test if the activity of erythropoietin is time dependent. patients with chronic renal failure on hemodialysis requiring r-huepo to maintain adequate levels of hematocrit are eligible for the study. patients were administered r-huepo subcutaneously three times per week, 50 u/kg, rounded to the nearest 2000 units. r-huepo will be administered until the hematocrit rises from the baseline level of 20-24% to the target level of 30-34%. this will be repeated three times, each at different times of day, either 0800, 1500 or 2200 hrs and the order of these will be randomly determined. each patient will complete all three of the phases.

Eligibility criteria:
inclusion criteria: * chronic renal failure patients requiring hemodialysis and requiring r-huepo to maintain adequate hematocrit levels * serum ferritin level \> 200 micrograms/l and transferrin saturation \> 15% * serum erythropoietin level less than 500 mu/ml (when off r-huepo) * prior therapy with r-huepo * an adequate program of dialysis established * informed consent signed exclusion criteria: * adocumented cause of anemia other than chronic renal disease * symptoms of unstable coronary artery disease * poorly controled hypertension * known seizure disorder * other active inflammatory or infective disorders * other disorders that may diminish the response of the bone marrow to r-huepo

Keywords: hemodialysis erythropoietin
appropriate number of endotracheal intubation experience for cpr

Conditions: Cardiopulmonary Arrest

Summary: this is a clinical study based on analysis of video-clip data of intubation and clinical data for cardiopulmonary resuscitation patients between 2011.03.01.-2012.02.28.. aim of this study is to estimate the appropriate number of endotracheal intubation(eti) experience for successful eti at first attempt during cardiopulmonary resuscitation.

endotracheal intubation(eti) has been considered to be the best method of airway management during cardiopulmonary resuscitation(cpr). however, eti during cpr requires high skill and experience. therefore eti during cpr should be performed by expert in eti. but the definition of experts in eti during cpr has not been done yet. this study tried to estimate the appropriate number of eti experience for successful eti at first attempt during cardiopulmonary resuscitation. so the investigators analyze the success rate, speed, trial number, incidence of complications, and hands-off time of eti using direct laryngoscopy (dl) which is standard device, in real clinical setting. in addition, this study analyze the residency training term, total number of eti experience using dl at that time.

Eligibility criteria:
inclusion criteria: * patients who suffer sudden cardiac arrest exclusion criteria: * case of requesting the do-not-attempt resuscitation befor eti * intubated cases before arrival to emergency department

Keywords: intubation cardiopulmonary resuscitation number of endotracheal intubation experience
clinical trial of recombinant adenovirus type 5 aids vaccine

Conditions: Acquired Immunodeficiency Syndrome

Summary: this is a randomized, double-blind placebo-controlled dose-escalation clinical trial to evaluate the safety and the immunogenicity of adenoviral vector 5 hiv-1 vaccines in subjects receiving stable highly active antiretroviral therapy(haart) .

patients continue antiretroviral medications throughout the course of this study. three groups of patients receive dose-escalation (2×10\^9vp, 2×10\^10vp or 2×10\^11vp) injections of adenovirus vector vaccine (ad5-gag). two weeks post immunization of lower dose, if the vaccine is safe and well tolerant, the next dose of immunization will begin. patients are monitored for safety 72 hours after each immunization. in addition, each patient records adverse events in a diary. patients have regular physical exams, pregnancy tests, and blood drawn for virologic and immunologic assessments. the induction of hiv-specific responses will be measured.

Eligibility criteria:
inclusion criteria: * are willing to participate this study and available for follow-up for the duration of the study. * men and women aged 18-50 years. * are hiv-positive. * have been taking stable anti-hiv drugs for at least 6 months. * cd4 count ≥ 350 cells/mm3 * plasma viral load \< 50 copies/ml. * willing to use acceptable forms of contraception at least 21 days prior to first vaccination until 56 days after the last vaccination. exclusion criteria: * pregnancy or breast-feeding. * history of previous vaccination with an hiv-1 vaccine. * use of immunoinhibitory agents, such as corticosteroids or cytotoxic drugs by oral administration, injection route or inhalation route within 6 months of study entry (but corticosteroids used for allergic rhinitis and skin topical application of corticosteroids were not included); use of immunomodulatory agents including but not limited to interleukin-2(il-2） and granulocyte-macrophage colony-stimulating factor (gm-csf) within 30 days of study entry. * use of blood products within 3 months of study entry. * use of other experimental drugs within 3 months of study entry. * any immunization within 3 months of study entry. * comply with any of the following items： active pulmonary tuberculosis； history of serious adverse reaction to other vaccines； serious asthma； have untreated thyroid disease; syphilis * laboratory values（comply with any of the following items）: hemoglobin \< 100 g/l (male subjects)，\<90 g/l (female subjects)； absolute neutrophil count ≤ 1000 cells/mm3； serum creatinine ≥15 mg/l，endogenous creatinine clearance rate \<50 ml/min； alanine aminotransferase（alt）, aspartate aminotransferase(ast) ≥3× upper limit of normal range； total bilirubin ≥2× upper limit of normal range * clinically significant electrocardiogram changes. * hypertension ( if it is well controlled by medication and is less than 150/100mmhg , should not be excluded) and other cardiac disease； * any medical, psychiatric, social condition, occupational reason judged by the investigator that would limit the evaluation of a subject.

Keywords: therapeutic vaccine hiv adenovirus type 5 vector
iloprost for the treatment of pulmonary hypertension in adults with congenital heart disease

Conditions: Pulmonary Arterial Hypertension; Congenital Heart Disease; Eisenmenger's Syndrome

Summary: pulmonary arterial hypertension (pah), or high blood pressure in the lungs, is common in patients with congenital heart disease. historically these patients suffered significant morbidity and mortality due to a lack of effective therapies. more recently, advanced therapies which target the mechanisms underlying the development and progression of pah have been introduced into clinical care. oral, intravenous, subcutaneous, and inhaled therapies are all available for the treatment of pah. patients with pah are first treated with oral agents (including sildenafil and bosentan). however, if these agents fail to achieve the desired effect for the patient, intravenous or inhaled therapies may be initiated. combination therapy with multiple agents is common in routine clinical care. however, the most efficacious therapeutic regimen has yet to be delineated. the present study seeks to evaluate the efficacy of one specific regimen: iloprost, an inhaled prostacyclin derivative, used in combination with oral therapy (sildenafil and/or bosentan). iloprost has been approved by the fda for use in this patient population. adults with pah already receiving oral therapy will be invited to participate in this study. iloprost will be added to their current therapeutic regimen for a period of three months, with pre- and post-treatment assessments. these will include a cardiopulmonary exercise test, bnp (a blood test), six minute walking distance, and a quality of life questionnaire.


Eligibility criteria:
inclusion criteria: * age greater than or equal to 18 years old * congenital heart disease with pulmonary arterial hypertension and cyanosis (resting oxygen saturation \< 90% on room air) * stable on oral therapy (pde5 inhibitor and/or endothelin blockade) for at least three months exclusion criteria: * age \< 18 years old * current intravenous or subcutaneous prostacyclin therapy * resting systemic hypotension (systolic blood pressure \< 85 mmhg) * women who are pregnant or may become pregnant (unwilling to utilize effective contraception), as well as nursing mothers * inability to ambulate * planned surgical procedure during the study period

Keywords: pulmonary arterial hypertension congenital heart disease eisenmenger's syndrome prostacyclin iloprost
manual lymphatic drainage for pain, muscle strength, and sensation

Conditions: Manual Lymphatic Drainage Effects

Summary: to evaluate the acute effect of mld on pressure pain threshold (ppt), pain tolerance, tactile sensation, and muscle strength in healthy young adults. healthy young adults were included in the study. before and after mld and plasebo touchs, the same physiotherapist performed ppt and pain tolerance measurements, muscle strength measurements with a hand dynamometer (jamar®) and pinchmeter (baseline®), and two-point discrimination (2pd) evaluation with an esthesiometer.


Eligibility criteria:
inclusion criteria: * being aged 18-30 years * volunteering to participate in the study exclusion criteria: * having any skin disease * having a history of neurological and/or orthopedic disease * having a significant scar or burn tissue in the upper extremity * having any condition that would prevent communication

Keywords: manual lymphatic drainage pain threshold pain tolerance two-point discrimination muscle strength