Kornimate/medical-research-clean huggingface dataset:
physiologic signals and signatures with the accuryn monitoring system - the accuryn registry

Conditions: Intraabdominal Hypertension; Abdominal Compartment Syndrome; Acute Kidney Injury; Cardiovascular Surgery

Summary: the accuryn registry study is an open-ended, global, multi-center, retrospective and prospective, single-arm data collection study with an fda cleared device. the target population are cardiovascular surgery patients. physiologic data measurements will be collected from enrolled subjects using electronic medical records and data streams via the accuryn monitoring system.

the primary objective of the accuryn registry study is to is to track and analyze changes in physiologic data streams using the accuryn monitoring system and correlate these changes to the occurrence of acute kidney injury (aki) following cardiac surgical intervention(s). the secondary objective is to determine the incidence of intraoperative and postoperative intra-abdominal hypertension in the cardiovascular surgery population, analyze what factors may contribute to the development of intra-abdominal hypertension (iah) in this patient population, and analyze associations of iah with organ dysfunctions such as acute kidney injury and other clinical outcomes (e.g. icu length of stay, required hemodialysis, readmission).

Eligibility criteria:
inclusion criteria: 1. signed or verbal informed consent as required by irb (if applicable). 2. adult (age ≥ 18). 3. monitored on the accuryn® monitoring system during their procedure and icu stay (for retrospective enrollment). 4. patient is undergoing cardiac surgical intervention(s). exclusion criteria: 1. known history of advanced chronic kidney disease defined by an estimated glomerular filtration rate (egfr) \<20 ml/min/1.73m2 within 30 days prior to procedure. 2. the patient is unsuitable for the study, in the opinion of the investigator. this may include vulnerable patient populations such as pregnant women, prisoners ,or those detained in a penal institution.

Keywords: acute kidney injury (aki) cabg cardiovascular surgery intraabdominal pressure (iap) urine output (uo) accuryn
effectiveness of two approved drugs in lowering high cholesterol (0733-224)

Conditions: Hypercholesterolemia

Summary: the purpose of this study is to evaluate the safety and effectiveness of two approved drugs in lowering high cholesterol when taken together, compared to taking only one of the drugs.

the duration of treatment is 12 weeks.

Eligibility criteria:
inclusion criteria: * elevated cholesterol level exclusion criteria: * liver disease * known allergies to study drugs

Keywords: high cholesterol
observational study to analyse the impact of nurse support and disease related factors on long- term adherence to betaferon treatment

Conditions: Relapsing Remitting Multiple Sclerosis (RRMS)

Summary: * the study analyses the influence of selected factors on adherence to betaferon treatment in patients with early multiple sclerosis (ms). the investigator will document the relevant medical data regarding multiple sclerosis at every hospital visit, the patient will fill in two questionnaires at every visit: one about coping with the disease and the other about anxiety and depression. * the study particularly looks at the role of the support of the patient given by the multiple sclerosis nurses.the nurse will provide additional standardised information at start of treatment and will regularly phone the patient to ask standardised questions about the general condition with regard to the treatment, the disease and social support. at the end of the study it will be assessed if the supportive measures and the standards in terms of adherence management in the hospital have some influence to increase long-term treatment adherence.


Eligibility criteria:
inclusion criteria: * patients after first clinical event suggestive of multiple sclerosis (ms) (according to smpc) and patients with relapsing / remitting multiple sclerosis (rrms) within the first two years of diagnosis. exclusion criteria: * contra-indications as indicated in betaferon summary of products characteristics (smpc)

Keywords: clinically isolated syndrome (cis)
recurrence and pregnancy post-repair of obstetric fistula in guinea

Conditions: Fistula

Summary: obstetric fistula, also called vaginal fistula, is a serious medical condition which affects women in low income countries. despite the strengthening of research on fistula, there is little data on the follow-up after fistula repair. the objective of this study is to analyse the factors associated with the recurrence of fistula and the outcomes of pregnancy following fistula repair in guinea. it will target women who got a closed fistula at discharge after repair in 2012/2015 at three fistula repair sites supported by the fistula care project in guinea (kissidougou prefectoral hospital, labé regional hospital and jean paul ii hospital of conakry). the outcomes of interest are fistula recurrence and pregnancy. the predictors of interest will include patient characteristics, fistula characteristics, the context of repair and the context of reintegration. participants giving an informed consent after a home visit by the fistula counsellors who managed women during surgery will be interview at enrolment and every six month from inclusion. the study duration is estimated at 48 months (january 2012 to march 2016) including the retrospective part. a sample size of 364 women will estimate the recurrence of fistula with a plus/minus 2% margin of error (width of confidence interval is 4%) and 95% confidence interval and is sufficient to estimate the rate of pregnancy with a two-sided 95% confidence interval and 10% precision. the cumulative incidence rate of fistula recurrence will be calculated using kaplan-meier methods and the risk factor analysis will be performed using adjusted cox regression. for the outcomes of pregnancy, pearson's chi square (χ2) will be used to compare proportions of pregnancy outcomes between potential predictors and logistic regression models will be used and associations will be reported as risk ratios with 95% confidence intervals. analysis will be done using stata version 13 (stata corporation, college station, tx, usa) with a level of significance set at p\<0.05.


Eligibility criteria:
inclusion criteria: in order to be eligible, study participants must meet the following criteria: * had a fistula closed at discharge, as measured by a dye test (this include women dry and those with residual incontinence); * willing and able to provide written informed consent (assent for minors); * had a urinary or recto-vaginal fistula; * agree to participate in follow-up visits (every six months) from consent date and for the duration of the study; * agree to stay in guinea for the duration of the study. exclusion criteria: potential participants meeting any of the following criteria will not be enrolled in the study: * refusal to give free and informed consent; * surgery done outside the study sites; * incomplete medical records; * incontinence unrelated to urinary or recto-vaginal fistula.
exercise program for itb syndrome

Conditions: Iliotibial Band Syndrome

Summary: patients with diagnosed iliotibial band (itb) syndrome indicated for non-operative management will be randomized to individualized exercise program or standard physical therapy over the course of 3 months to determine any possible difference in clinical outcomes.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of itb syndrome * age 18-65 * ability to comply with a standardized physical therapy protocol * willing and able to provide consent exclusion criteria: * patients at any increased risk of falls or at increased risk from harm due to falling, including issues with vertigo, osteoporosis, or a history of past falls * patient otherwise deemed at increased risk from this investigational rehabilitation program by their referring surgeon or physical therapist * patients who are pregnant
spinal versus general anesthesia for transabdominal preperitoneal (tapp) repair of inguinal hernia

Conditions: Postoperative Pain

Summary: the purpose of the study is to assess whether spinal anesthesia is superior to the standard general anesthesia or not for patients undergoing transabdominal preperitoneal inguinal hernia repair (tapp).

anesthesia for laparoscopic procedures, including transabdominal preperitoneal inguinal hernia repair(tapp) is synonymous with general anesthesia because of the adverse effects of the co2 pneumoperitoneum on the awake patient, and regional anesthesia is preferred only in patients where general anesthesia is contraindicated. α pilot study of our hospital has recently shown the feasibility to perform successfully and safely transabdominal preperitoneal inguinal hernia repair with low pressure co2 pneumoperitoneum under spinal anesthesia.after this pilot study and based on previous experience in regional anesthesia for laparoscopic procedures, we designed a controlled randomized trial in order to compare spinal anesthesia with the standard general anesthesia for patients undergoing transabdominal preperitoneal inguinal hernia repair (tapp).

Eligibility criteria:
inclusion criteria: * asa physical status i-iii * bmi ≤ 35 * age ≥ 18 * normal coagulation profile exclusion criteria: * non-reducible/obstructed hernias * previous open surgery in the lower abdomen * contraindication for pneumoperitoneum * contraindication for spinal or/and general anesthesia * history of chronic pain or daily intake of analgesics * psychiatric disorders * inability of patients to use pca pump

Keywords: laparoscopic inguinal hernia repair tapp spinal anesthesia general anesthesia
post market clinical follow-up study on tvt abbrevo® continence system

Conditions: Stress Urinary Incontinence

Summary: the objective of this single arm, post market, clinical study is to evaluate the performance of gynecare tvt abbrevo® continence system in women undergoing mid-urethral sling surgery for stress urinary incontinence (sui).


Eligibility criteria:
inclusion criteria: subjects who satisfy all of the following criteria will be considered eligible for enrollment in this study: 1. stress urinary incontinence symptoms 2. diagnostic evaluation, a positive cough stress rest, to confirm diagnosis of stress urinary incontinence. 3. female subjects ≥ 21 years of age requiring treatment of sui 4. desired surgical correction of stress urinary incontinence using synthetic sub-urethral vaginal slings 5. planned surgery for primary stress incontinence without concomitant prolapse surgery 6. patient able and willing to participate in follow-up 7. subject or authorized representative has signed the approved informed consent exclusion criteria subjects meeting any of the following criteria will be considered not eligible for enrollment in this study: 1. physical or psychological condition which would impair study participation or are unwilling or unable to participate in all required study visits and are unable to complete the questionnaires 2. any pre-operative or intra-operative findings identified by the surgeon that may preclude the use of study product 3. history of previous synthetic, biologic or fascial sub-urethral sling 4. pregnancy or plans for future pregnancy 5. history of bleeding diathesis or current anti-coagulation therapy which cannot be suspended peri-operatively according to site's standard practice. 6. current genitourinary fistula or urethral diverticulum 7. reversible cause of incontinence (i.e. drug effect) 8. contraindication to surgery

Keywords: gynecare tvt abbrevo® continence system sui
sensorimotor affect relationship-based therapy (smart) for children with autism spectrum disorders ages 2-12

Conditions: Autism Spectrum Disorder; Autistic Disorder

Summary: the smart program at nationwide children's hospital is an interdisciplinary social skills group that teaches children with autism spectrum disorders (asd) ages 2-12 the fundamental social skills necessary to build and maintain relationships. the manualized curriculum addresses skills such as joint attention, eye contact, play, and peer engagement. currently individual goals are set for each child who participates and this is documented in the daily treatment note. in order to research group outcomes, the investigators will use parent questionnaires (an addition to current clinical practices) to measure changes in behavior after each 12 week session for up to one year of treatment. the investigators hypothesize that maladaptive behaviors will decrease and adaptive behaviors will increase in children with asd after participation in the smart program.


Eligibility criteria:
inclusion criteria: * ages 2 to 12.5 * diagnosis of asd or who meet a minimum asd cutoff score on a screening questionnaire (scq or asq:se, depending on age) exclusion criteria: * non-english speaking * uncorrected vision disorder * moderate to severe hearing loss * non-ambulatory * previous participation in a smart group * accompaniment by aide * extreme behavioral disorder
serological study in children 12 to 23 months vaccinated with mmr (measles, mumps and rubella)

Conditions: Mumps; Rubella; Measles

Summary: on a previous study conducted in brazil. the mmr vaccine from 2 different producers had a mumps seroconversion much lower (71%) than the expected 95%, according to the package insert. this could indicate that a substantial proportion of children was not protected after mmr dose.

given the above and considering: (1) future clinical study with the mmr vaccine produced entirely in bio-manguinhos/fiocruz from technology transfer from glaxosmithkline (gsk), (2) the importance to the national immunization program (nip) to provide the population a mmr vaccine to ensure high protection against mumps, similar to what occurs with measles and rubella components, it was considered essential to conduct a preliminary immunogenicity assessment of the mmr vaccine produced by biomanguinhos.

Eligibility criteria:
inclusion criteria: * children of both sexes; * age between 12 months to 23 months and 29 days; * child in good health, with no significant past medical history; * have completed blood sampling before vaccination; * have not been vaccinated with mmr. * agreement by parents/tutors with the child's participation in the study and signing of the informed consent form (icf); * parents/tutors provide name, address, telephone number and other information for the contact if necessary; * parents/tutors able to understand the risks of the experiment, although minimal; * parents/tutors able to understand and sign the informed consent form. * availability of return for collecting post-vaccination samples. exclusion criteria: * children with a history of measles, rubella and / or mumps. * having received mmr vaccine previously, as documented in vaccination card. * having received a transfusion of blood or blood products, including immunoglobulins, within last 12 months. * skin lesions at sites of venipuncture. * child subject to abnormal bleeding after injections. * use within 6 months of corticosteroids (excluding topical or aerosol) and immunosuppressants.
preg-ms: new england ms pregnancy registry

Conditions: Multiple Sclerosis; Pregnancy Related

Summary: the purpose of the study is to develop a detailed pregnancy registry of patients with multiple sclerosis in the new england states. women with a diagnosis of ms that are either pregnant or actively planning to become pregnant are eligible to participate. the study will solely take place through phone interviews. one of the study coordinator at the partners ms center will contact the participant for an intake phone interview where general information about the individual, their pregnancy and their ms will be collected. thereafter the coordinator will contact the participant every 3 months for 20 minutes follow up interviews. after birth, the coordinator will collect information on the growth and development of the participant's baby. pediatric interviews will be conducted at 2, 4, 6, 9, 12, 18, 24, 36 months. information from the participant's neurologist and obstetrician, as well as information from the baby's pediatrician, will be made available to the study staff at regular intervals throughout the duration of the study. through this study, the investigators hope to learn more about the effects of ms on pregnancy and pediatric development, and about the effects of pregnancy on the course of ms.


Eligibility criteria:
inclusion criteria: * diagnosis of multiple sclerosis; * pregnant or actively planning to become pregnant. exclusion criteria: -
smart project in preventing skin cancer

Conditions: Skin Carcinoma

Summary: this pilot clinical trial studies how well self monitoring and readiness texting (smart) project works in sun exposure and protection behaviors. measuring how behavior tracking and individually tailored messages affect risk behaviors in patients with skin cancer may help doctors plan the best prevention plan and decrease national melanoma incidence and mortality.

primary objectives: i. to test the effects of a behavior tracking and individually-tailored daily text message intervention on sun protection and exposure behaviors and to see if these techniques will be most effective in conjunction or separately. secondary objectives: i. to examine mediators in the effects of the intervention on safe sun behaviors, based on fishbein?s integrative model. outline: patients are randomized to 1 of 4 study arms. arm i (self-monitoring): patients complete tanning and sun protection usage entries daily for 14 days. arm ii (text messages): patients receive individualized text messages based on baseline assessment of tanning motives (appearance, enjoyment, social) daily for 14 days. arm iii (combined group): patients complete tanning and sun protection usage entries and also receive individualized text messages daily for 14 days. arm iv (control group): patients complete study assessments. after completion of study, patients are followed up at 2 weeks.

Eligibility criteria:
inclusion criteria: * women from the philadelphia metropolitan area who own a mobile phone and who meet criteria for at least moderate risk of skin cancer based on a brief risk assessment tool
influence of perioperative fluid balance on serum concentrations of antibiotics and surgical site infections

Conditions: Antibiotic; Anti-Bacterial Agents; Surgical Wound Infection

Summary: this study evaluates antibiotic serum concentrations in correlation with perioperative fluid balance. patients will be recruited in rectum and esophageal surgery (representative for low blood loss and restrictive fluid management) and in liver surgery (representative for high blood loss and liberal fluid management). the hypothesis is that high blood loss and liberal fluid management dilute antibiotic serum concentrations thereby potentially increasing surgical site infections.


Eligibility criteria:
inclusion criteria: * elective surgery of rectom, esophagus or liver with indication for a central venous catheter * informed consent exclusion criteria: * pregnancy * medical emergency * participation in another study

Keywords: surgical wound infection antibiotic concentration blood level
the effect of the covid 19 pandemic process on the neuromotor developments of 6-24 month-old babies

Conditions: Development, Infant; Development Delay

Summary: development; it covers the areas of physical, mental, emotional and social development. development in one area affects other areas as well. infancy is the period in which children grow and develop the fastest. babies need many environmental factors and stimulants in order to have a healthy developmental process. for the covid 19 pandemic, many restrictions have been made in turkey to reduce the spread of the epidemic and to maintain social distance between people. it has been suggested that individuals practice their own social isolation. it has also caused babies who spend their time at home during the pandemic process to be deprived of environmental stimuli. in current studies in the literature, it has been reported that the covid-19 pandemic affects infant and child development significantly and negatively. it has been reported that the risk of delay in children who have experienced the covid-19 pandemic is especially in the fine motor and communication areas. there is a limited number of studies in the literature on this subject. no study was found in turkey. the aim of this study is to evaluate the neuromotor development of infants in early childhood (6-24 months) in the covid-19 pandemic and to reveal the effects of the pandemic process. denver ii developmental screening test was used to evaluate the neuromotor development of healthy infants aged 6-24 months, who applied to the healthy pediatric outpatient clinic of acıbadem altunizade hospital, and alberta infant motor scale was used to evaluate gross motor functions.

it is an observational study. purpose of the study: evaluating the neuromotor development of infants in early childhood (6-24 months) in the covid-19 pandemic and revealing the effects of the pandemic process. 75 healthy infants aged 6-24 months were included. * will there be developmental delays in children born in the covid 19 pandemic? * in which parameter delay is observed the most. denver ii developmental screenin test and alberta infant motor scale were applied to the participants.

Eligibility criteria:
inclusion criteria: * 75 healthy infants aged 6-24 months were included. exclusion criteria: * having a physical/mental/neuromotor/psychological problem * not between 6-24 months in the pandemic process * presence of a diagnosed disease * having a vision problem * having a hearing problem

Keywords: alberta infant motor scale denver ii developmental screening test covid-19 pandemic pediatric rehabilitation
effect of preventive analgesia by injection of a local anesthetic before vaginal incision for hysterectomy by vnotes approach

Conditions: Hysterotomy; Affecting Fetus

Summary: the research procedure is the injection of 20 ml of ropivacaine solution (vs. saline) to create a paracervical block at the beginning of surgery, while the patient is already under general anesthesia. this injection will take place 3 minutes before the vaginal incision, via 4 injection points. injections are made 3 mm deep into the vaginal cul de sac. randomization takes place before surgery by vnotes: * experienced group: local anesthesia with injection of ropivacaine (20ml of ropivacaine 7.5 mg/ml, i.e. 150mg) and general anesthesia * control group: injection of 20ml of placebo (saline) and general anesthesia in both groups, systematic intraoperative and postoperative analgesia will be identical.


Eligibility criteria:
inclusion criteria: * adult patients aged 18 to 70 inclusive * patient scheduled for vnotes surgery for total hysterectomy for benign pathology, whether or not associated with an adnexal procedure (unilateral or bilateral salpingectomy or adnexectomy (for cysts smaller than 6 cm)). * person having read and understood the information letter and signed the consent form * person affiliated to a social security scheme exclusion criteria: * suspicion of malignant pathology * history of rectal surgery * history of pelvic inflammatory disease * suspicion of recto-vaginal endometriosis * virginity * contraindication to naropeine 7.5 mg/ml, solution for injection in ampoule * contraindication to proamp sodium chloride 0.9%, solution for injection * patients on a low-salt diet * history of more than 2 caesarean sections * estimated uterine size \> 700 g according to the following formula y = 0.35x + 107 (x = a × b × c), based on measurements taken on preoperative imaging (mri or ultrasound). a=longitudinal diameter, b=sagital diameter, c=transverse diameter.3 * bmi \> 35 * contraindication to analgesic molecules in intraoperative and postoperative protocols.