Kornimate/medical-research-clean huggingface dataset:
a mother's role in delaying onset of sexual activity in her children

Conditions: Child Behavior; Adolescent Behavior

Summary: the goal of this study is to enhance the mother's role in promoting avoidance of sexual risks and problem behaviors in 6- to 12-year-old children. consenting mothers will attend a 10-session program designed to enhance the quality of mother-child communication, identify sexual risks, and increase parental monitoring and self-efficacy.

this study will identify personal, parental, peer, and community factors that predispose children ages 6 to 12 to early initiation of sexual behavior or that foster resilience to sexual risk taking. the study will then evaluate an intervention designed to enhance resilience factors and reduce risk factors among 6- to 12-year-old children. the study will focus on the mother's role in promoting resilience to sexual risk taking. during the first phase of the study, 300 children and their mothers will be asked to complete a one-time interview that includes an assessment of risk and resilience factors. information from the interviews will be used to modify an intervention currently being used in another study of parent-adolescent pairs. the modified intervention will then be tested to determine the efficacy of the intervention in reducing risk and enhancing resilience among children in this age group. in the second phase of the study, 296 children and their mothers will be randomized to either the intervention or control group. all mothers will complete a baseline interview. mothers in the intervention group will attend 10 group sessions that include short presentations, discussions, media presentations (videotapes), and interactive exercises, including self-assessments, role plays, and games. the group sessions include content and skill development related to parenting, communication, sexuality, peer pressure, and school involvement. mothers in the control group receive written information on diet and physical activity. the written materials are presented in a self-help format to increase physical activity; a cookbook contains low fat recipes designed especially for african american men and women living in the atlanta, ga, area. all participants complete follow-up interviews at 6 and 12 months after the baseline interview. primary outcomes for mothers include measures of resilience and communication related to sexual issues. for children, outcomes include measures related to possible sexual situations.

Eligibility criteria:
inclusion criteria * member of a participating community-based organization * child 6 to 12 years of age and biological mother/legal guardian * ability to read and comprehend english * willing to participate

Keywords: sexual risk taking mother-child communication problem behaviors
new moves - obesity prevention among adolescent girls

Conditions: Obesity

Summary: the new moves study will evaluate the impact of a school based program for inactive high school girls who are overweight or at risk for being overweight due to low levels of physical activity. the primary study hypothesis is that girls in the intervention schools will significantly decrease their percent body fat as compared to girls in the control schools. secondary research hypotheses include that girls in the intervention condition will significantly increase their physical activity levels and improve the quality of their dietary intake.

the purpose of the new moves study is to evaluate the effectiveness of a school-based all girls alternative to regular physical education class for inactive high school girls. new moves uses a large-scale community randomized controlled study involving girls from six intervention schools and six control schools. the new moves class includes physical activity, nutritional guidance, and social support within a supportive, non-competitive environment. in addition the program includes individual counseling sessions. the primary research hypothesis is that girls in the intervention condition will significantly decrease their percent body fat as compared to girls in the control condition. secondary research hypothesis to be tested are that girls in the intervention condition will significantly increase their level of physical activity and improve the quality of their dietary intake as compared to girls in the control condition. in addition a range of socioenvironmental, personal, and behavioral variables will be compared across conditions.

Eligibility criteria:
inclusion criteria: * high school girls * low levels of physical activity - defined as being in precontemplation, contemplation, or preparation stages of change for physical activity with activity levels at, or below, 30 minutes per day/three days per week outside of school physical education class * priority will be given to girls with a body mass index (bmi) greater than or equal to the 75th percentile for age and gender exclusion criteria: * bmi less than the 25th percentile for age and gender

Keywords: adolescent girls physical activity exercise diet body image
comparing the cyberlink control system to the manual letter board for communication purposes in the als patient population

Conditions: Amyotrophic Lateral Sclerosis; Neurodegenerative Disease; Motor Neuron Disease

Summary: new technologies are giving people with motor disabilities alternative communication and control channels. the investigators are interested in using the cyberlink control system as a hands free means to access a computer for people with amyotrophic lateral sclerosis (als). the goal of this project is to determine whether this device is a practical and realistic means for als patients to communicate with only the use of facial muscle, brainwave, and eye movements. the benefit of this study may be of substantial value to many people with severe motor impairment. additionally, it is hoped that some of the study subjects may benefit by incorporating hands-free computer use into their daily lives. this study is intended to evaluate the effectiveness of the cyberlink as a tool for daily communication compared to the standard manual letter board.


Eligibility criteria:
inclusion criteria: * diagnosis of definite or possible als by the el escorial criteria * between ages of 18 to 89 years. * scored two or less in the als frs category 1 (speech) * scored two or less in the als frs category 4 (handwriting) * cognitively intact with no other neurological diseases * no unstable medical problems exclusion criteria: * any subject not meeting the inclusion criteria * patients unable to give informed consent either themselves or via a legally authorized personnel. * patients diagnosed with neurological problems other than als (upon examination by the principal investigator)

Keywords: amyotrophic lateral sclerosis cerebrospinal fluid neurodegenerative disease motor neuron disease autonomic nervous system neurodegenerative diseases movement disorders
assessment of tele-expertise for second medical opinion on pathological diagnosis

Conditions: Anatomical Pathological Condition

Summary: the purpose of this study is to determine whether digitalizing pathological slides and let it accessible on a server for a second medical opinion (tele-expertise) would reduce the time to diagnosis.


Eligibility criteria:
inclusion criteria: * all patients in need for a second medical opinion on a pathological sample exclusion criteria: * none

Keywords: second opinion
individualized nutrition therapy for preventing or delaying onset of type-2 diabetes

Conditions: PreDiabetes; Cardiovascular Diseases

Summary: the overall aim of this feasibility study is to conduct a randomized, controlled intervention providing adults with prediabetes either an individualized nutrition therapy (int) intervention that contains individualized dietary goal-setting components, the goal being to improve blood glucose, reduce cvd risk factors, and therefore postpone the onset of diabetes and related cardiovascular disease, or standard-of-care generalized dietary recommendation (soc). the hypothesis is that the int arm will experience greater benefits in some or all of the following primary outcome variables: improvement in postprandial blood glucose, oral glucose tolerance test, fasting insulin, and calculated insulin sensitivity (homa) in individuals with prediabetes. secondary outcome variables are improved markers of inflammation, antioxidant status, blood lipids, blood pressure, and endothelial function.


Eligibility criteria:
inclusion criteria: * ages 45-65 years * any race or ethnicity * those who have or may have pre-diabetes (will be screened to confirm) * hba1c level between 5.7%-6.4% (will be screened to confirm) * bmi between 25 and 39.9 kg/m2 * taking stable doses of antihypertensive and/or cholesterol-lowering medications for 3 months or more prior to being enrolled in the study exclusion criteria: * pregnant or lactating * individuals outside of the hba1c and bmi inclusion ranges * those with active cancer, thyroid, kidney, liver, and pancreatic diseases * heavy cigarette smokers (25 cigarettes per day or more) * heavy drinkers (\>12 alcoholic drinks per week on average) * taking more than one hypoglycemic agent (blood sugar lowering medications) * having major dietary restrictions * participating in any weight loss or dietary program/taking prescribed appetite suppressants * participating in another investigational study at the same time as this study * anyone who refuses to follow dietary recommendations * anyone who refuses to wear the continuous glucose monitoring device as instructed * anyone who will not fill out their food dairy and automated self-administered dietary assessment tool
closed-loop control mean arterial pressure in intensive care patients

Conditions: Cardiovascular Diseases

Summary: the purpose of this case series is to evaluate the performance of a novel closed-loop (automated) vasopressor administration system that delivers norepinephrine using feedback from standard hemodynamic monitor (ev1000 monitor) from edwards lifesciences (irvine, usa) in critically ill patients

in this protocol, the investigators will report the percentage of case time in hypotension (defined as mean arterial pressure (map) \< 72mmhg) during a two hours study protocol in critically ill patients. the target map will be set at 80 mmhg, and the definition of hypotension is a map \< 90% of map target ( 80 mmhg - 10% = 72 mmhg) the investigators want to demonstrate that the closed-loop system can prevent hypotension at this specific set point. the investigators will test the system in a short series of 10-12 critically ill patients in the icu setting during a two hours study protocol. participants will receive standard patient care fluids will be given as a baseline crystalloid administration set at 1-2 ml/kg/h

Eligibility criteria:
inclusion criteria: * all patients in the intensive care unit (awake or under sedation) * requiring norepinephrine to maintain a map of 80 mmhg * equiped with an arterial line exclusion criteria: * subjects under 18 years of age * subject with atrial fibrillation * subjects who are pregnant
study of voreloxin (vosaroxin) in older patients with untreated acute myeloid leukemia

Conditions: Leukemia; Acute Disease; Acute Myeloid Leukemia; Nonlymphocytic Leukemia; Myelodysplastic Syndromes

Summary: this study will evaluate the overall remission rate of treatment with vosaroxin (formerly voreloxin) injection in patients at least 60 years of age with previously untreated aml

other objectives of this study include: 1. assess the safety of treatment with vosaroxin, including the 30 and 60 day all-cause mortality 2. assess leukemia free survival (lfs), event-free survival (efs), overall survival (os), and duration of remission (dr). 3. characterize the pharmacokinetic (pk) profile of vosaroxin in this patient population. 4. evaluate potential stratification biomarkers by evaluating dna-damage and apoptotic pathways in bone marrow samples before and after treatment with vosaroxin

Eligibility criteria:
key inclusion criteria: 1. at least 60 years of age and diagnosis of previously untreated aml (either de novo or from an antecedent hematologic disorder or therapy related aml) 2. at least 20% blasts by bm biopsy or aspirate 3. ecog performance status of 0,1,or 2 4. adequate cardiac, renal and liver function key exclusion criteria: 1. uncontrolled dic 2. active central nervous system involvement by aml 3. requiring hemodialysis or peritoneal dialysis 4. some prior history of heart attack or stroke (depending on how long ago the event occurred)

Keywords: leukemia myeloid elderly hematologic blood cancer malignancy sns-595 sunesis hematologic diseases myelodysplastic syndromes older voreloxin reveal-1
long term follow up for the detection of delayed adverse events in cal-1 recipients

Conditions: HIV-1 Infection; Receipt of Cal-1 Modified Hematopoietic Cellular Products

Summary: long term safety follow-up of cal-1 recipients

long term follow-up for the detection of delayed adverse events in recipients of cd4+ t lymphocytes and/or cd34+ hematopoietic stem/progenitor cells transduced with lvsh5/c46 (cal-1), a dual anti-hiv gene transfer construct

Eligibility criteria:
inclusion criteria: * signed informed consent * previous treatment with the cal-1 modified hematopoietic cellular products exclusion criteria: * inability to understand and provide informed consent
improving health behaviors through telephone linked care

Conditions: Diet; Physical Activity; Smoking; Alcohol Abuse

Summary: the investigators propose to conduct a randomized controlled trial at the patient level of the telephone linked care - behavioral change (tlc-bc) system, which is designed to promote smoking cessation, reduce risky drinking, and improve physical activity and diet. they expect to: 1. successfully integrate an automated telephone behavior change intervention into primary care practices; 2. demonstrate improvement in health behaviors for individuals randomized (assigned by systematic chance) to use the tlc-bc system compared to individuals who receive written health education informational packets; and 3. evaluate the direct costs associated with the use and operation of the tlc-bc system. project aims and hypotheses follow: aim 1: integrate a proven, totally automated computer telephone intervention, telephone linked care - behavior change (tlc-bc), into primary care practices. this will be assessed by the patient and clinician/staff surveys at the end of data collection. aim 2: demonstrate an improvement in health behaviors for individuals randomized to use the tlc-bc system compared to individuals who receive written informational packets. aim 3: evaluate the direct costs associated with the use and operation of the tlc-bc system within the primary care setting. hypothesis 1: the telephone linked care - behavioral change system will be successfully implemented by patients and practices. hypothesis 2: at 6 months a clinically significant improvement in behavioral change rates will be demonstrated for diet, physical activity, and smoking in the intervention group compared to patients in the control group. hypothesis 3: at baseline, 3, 6, and 9 months risky drinking will be identified, but there will be no difference in improvement between the study groups.

see above

Eligibility criteria:
inclusion criteria: * 18 years or older * capable of giving informed consent * reliable access to a phone * able to read english exclusion criteria: * less than 18 years of age * not capable of giving informed consent * no reliable access to a phone * unable to read english (including blindness) * too ill to participate * not willing to allow the telephone linked care - behavior change system to provide health information reports based on responses to physician

Keywords: automated counseling system telephone-based intervention behavior change
a phase ii trial of cyberknife radiosurgery to perioptic tumors

Conditions: Tumor, Benign, Optic Nerve

Summary: the purpose of this study is to find out what effects (good and bad) cyberknife stereotactic radiosurgery has on tumors near the critical structures of the eye (optic apparatus). the investigators hypothesize that hypofractionated stereotactic radiotherapy via the cyberknife ® can deliver tumor ablating doses of radiation to perioptic lesions safely and effectively while sparing the adjacent optic apparatus and normal brain tissues from receiving damaging doses of radiation.

the cyberknife system is a type of radiation machine that uses a special system to precisely focus large doses of x-rays (radiation) on the tumor. the device is designed to concentrate large doses of radiation onto the tumor so that injury from radiation to the nearby normal tissue will be minimal.

Eligibility criteria:
inclusion criteria: * perioptic lesion within 2mm of the optic apparatus * age \>= 21 * kps \>= 50 * planning target volume (ptv) \<= 6.0 cm in maximal diameter exclusion criteria: * malignant histology * age \< 21 * kps \<= 40 * planning target volume (ptv) \> 6.0 cm in maximal diameter * prior whole brain xrt * gross total resection

Keywords: perioptic stereotactic radiation benign brain tumor optic apparatus
periventricular white matter hyperintensities in cerebral amyloid angiopathy and hypertensive arteriopathy

Conditions: Cerebral Amyloid Angiopathy; Hypertensive Arteriopathy

Summary: white matter hyperintensities (wmh) are one of the small vessel disease-related mri characteristics of both cerebral amyloid angiopathy (caa) and hypertensive arteriopathy (ha). wmh tend to show a peri-basal ganglia pattern in ha, whereas a multiple subcortical spots pattern can be observed in caa. periventricular wmh (pvwmh) have been reported to be posterior predominant using a semiautomated segmentation method and logarithmic transformation, not used in daily clinical practice. in these studies including caa patients, patients initially presented with haemorrhage-related symptoms. in another study analysing pvwmh and cerebral amyloid evidence in patients with mild cognitive impairment, frontal pvwmh burden was associated with high uptake on florbetapir-pet whereas parietal and occipital pvwmh burden was associated with low csf-amyloid-beta. the aim of this study is the descriptive comparative analysis of the distribution of pvwmh between caa and ha patients with radiological tools available in daily practice.


Eligibility criteria:
inclusion criteria: caa and ha patients, managed at nîmes university hospital between january 2015 and march 2022. exclusion criteria: caa and ha patients, treated at the chu of nîmes between january 2015 and march 2022, not objecting to the use of their health data
postoperative multiparameter outcomes during the six months after rotator cuff repair

Conditions: Shoulder Pain; Quality of Life; Satisfaction

Summary: rotator cuff tears are common amongst 50-60 year olds with no connection to their physical activity. when symptomatic, the injury affects all aspects of general health, quality of life and function. surgical intervention is recommended only if conservative treatment fails. the purpose of the surgical intervention is to reduce pain, and improve function while improving range of motion and muscle strength around the shoulder. the purpose of the current study is to measure physical, functional, expectation, satisfaction and quality of life outcomes after rotator cuff repair surgery. another purpose is to learn the reproducibility components of the above outcomes.


Eligibility criteria:
inclusion criteria: * patients with chronic tears in supraspinatus and infraspinatus tendon * symptoms of up to 12 months * no relief from conservative treatment * complete or almost complete tears of up to 3cm * hebrew speakers exclusion criteria: * previous trauma * shoulder infection * recurrent dislocation * avascular necrosis * frozen shoulder * additional tears * otherwise healthy
factors influencing hemodynamic stability and its management in patients undergoing pelvic surgery under spinal and ga

Conditions: Pelvic Floor Disorders

Summary: patients are at risk for hemodynamic instability both during and after surgery, as it is an independent predictor of long-term patient morbidity and length of hospital stay. the development of hemodynamic instability is caused by a number of factors. when these risk factors are prevented or treated, patients may experience less hemodynamic instability during pelvic surgery, as well as the morbidity and mortality that come with it in both spinal and general anesthesia.

the objective of this study was to evaluate the factors that affect the hemodynamic stability and evaluate the effectiveness of different management strategies employed to maintain hemodynamic stability during spinal and general anesthesia.

Eligibility criteria:
inclusion criteria: * adult patients aged 18 years and older. * asa (american society of anesthesiologists) physical status classification i and ii. * patients scheduled for elective pelvic surgery. * can give informed consent or has a legal representative to give consent. * there are no contraindications to spinal or general anesthesia based on preoperative assessment (e.g, severe cardiovascular disease, no previous history of adverse anesthetic reactions). exclusion criteria: * age below 18 years. * emergency procedures or that require immediate intervention. * pregnancy or breastfeeding status. * conditions such as spinal cord disease and severe coagulopathy that are recognized contraindications to spinal or general anesthesia. * asa physical status classification iii and above. * history of severe adverse reactions to anesthesia or known allergy to anesthetic agents. * concurrent involvement in additional clinical trials that could have an impact on the treatment of anesthesia or hemodynamic results. * individuals with substantial comorbidities (such as uncontrolled hypertension or heart failure) that might complicate hemodynamic responses.
motivational instant messaging and e-diabetes prevention programme for high risk of type 2 diabetes

Conditions: Pre-diabetes

Summary: the overall aim of this feasibility trial is to assess the effectiveness of a wearable technology and an e-diabetes prevention programme delivered via a smartphone application, including motivational messaging, in reducing weight and increasing physical activity in people at risk of developing type 2 diabetes.

the study will examine whether a wearable technology, combined with biofeedback, motivational messaging and an e-diabetes prevention programme, is effective in reducing weight and increasing physical activity after 12 months. the intervention will consist of a wearable technology and a smartphone application made available for a 12 month period. 22 online multimedia sessions targeting diet, physical activity and mental resilience delivered via the smartphone application. motivational messaging based on the diabetes prevention module content and biofeedback will be sent to participants via the application. the control group will receive the wearable technology and will have access to a smartphone application detailing their activity. participants will be directed to the same educational material as is made available via the multimedia sessions, but will not receive motivational messages.

Eligibility criteria:
inclusion criteria: * hba1c between 42 and 47 mmol/mol * bmi≥25 kg/m² * fluent in conversational english * permanent resident in lambeth, southwark or lewisham * ownership of a smartphone (iphone or android only) for communication defined as logging on at least once/day to the internet * ambulatory. exclusion criteria: * known diabetes * pregnancy or planning pregnancy during the duration of the study * severe mental illness (severe depression, psychosis, bipolar affective disorder, dementia, learning difficulties, substance problem use or dependence) * severe physical disability e.g. that would prevent any increased uptake of physical exercise * advanced active disease such as cancer or heart failure * any other condition which requires glucose altering drugs * morbid obesity (bmi ≥50 kg/m²) * current participation in a weight loss programme. when in doubt the investigators will seek the gp opinion and approval.