Kornimate/medical-research-clean huggingface dataset:
study of changes in retrofoveolar choroidal thickness during aerobic exercise

Conditions: Choroid Disease; Hypertension Ocular

Summary: study the change of retrofoveolar choroidal thickness measured by optical coherence tomography during aerobic exercise inducing an increase in systolic blood pressure in healthy subjects.ten healthy participants will perform an exercise (riding a bicycle ergometer) and will be examined with edi-oct. each participant will be scanned before exercise, during the exercise and afterwards at 0 and 5 min. each oct measurement will be coupled to the arterial blood pressure evaluation.

currently there is a growing interest in the study of the choroid in the pathogenesis of many ocular pathologies such as central serous chorioretinitis1, age-related macular degeneration, diabetic retinopathy, and myopia. moreover, the recent development of new imaging methods allows the exploration of the normal and pathological processes of the choroid. in particular, the enhanced depth imaging (edi) mode in optical coherence tomography (oct) provides cross-sectional imaging of the choroid and in vivo measurement of its thickness. understanding the factors that would modify the choroidal thickness would make it possible to better understand the pathophysiology of many chorioretinal pathologies and would help to guide therapeutics in the future. however, systemic changes induced by physical activity, and in particular changes in systolic blood pressure, could be responsible for changes in the choroidal blood flow and thus in the choroidal thickness. the study consists in testing ten patients who will perform an exercise testing as part of the practice of a sportive activity. patients will undergo an oct in edi mode to measure the retrofoveolar choroidal thickness during the exercise. each oct image will be coupled to the evaluation of blood pression and heart rate. patients are treated in the usual way but the study is an interventional study, with minimal risks and constraints, because of the imaging (oct image in edi mode).

Eligibility criteria:
inclusion criteria: * male patients wishing to perform a standardized aerobic exercise stress test best - corrected visual acuity ≥ 10/10 (monoyer scale) * absence of ocular pathologies * absence of previous ocular surgery * refraction between -4 diopters and +4 diopters * absence of alcohol or drug abuse * absence of systemic pathologies * absence of regular doping ; exclusion criteria : * history of ocular pathologies, intraocular surgery * macular or papillary abnormality seen at oct * history of systemic pathology such as high blood pressure, diabetes * exercise \<72 hours * intake of coffee or tea \<48 hours * high myopia (axial length\> 26mm) or high hyperopia (axial length \<19mm) - * professional athlete ;sedentary patient doing sports less than twice a month ; smocking \<24 hours * pharmacological pupillary dilation \<72 hours

Keywords: exercise test blood pressure choroid
pan-european survey on the under treatment of hypercholesterolemia

Conditions: Hypercholesterolemia

Summary: the survey try to establish the proportion of patients on lipid-lowering pharmacological treatment reaching the ldl-c goals according to the third joint european task force guidelines, overall and by country.·


Eligibility criteria:
inclusion criteria: * patients had to be on a lipid-lowering drug treatment for at least 3 months, with no dose change for a minimum of 6 weeks.

Keywords: hypercholesterolemia third joint european task force guidelines survey
characteristics, complications and perinatal outcomes in placenta previa women

Conditions: Placenta Previa

Summary: this study aim to investigate the characteristics, complications and perinatal outcomes in pregnant women with placenta previa.

placenta previa (pp) is defined as the placenta overlying the endocervical os and grades according to the relationship and the distance between the lower placental edge and the internal os of the uterine cervix: low-lying previa, marginal previa, partial previa, and complete previa. cesarean delivery and assisted reproductive technology are associated with an increased risk of placenta previa in subsequent pregnancies. other risk factors for previa include previous spontaneous, elective pregnancy terminations, previous uterine surgery, increasing maternal age and maternal parity, multiple gestations, smoking, cocaine use, and prior previa. it is associated with numerous adverse maternal and fetal-neonatal complications, such as perinatal hemorrhage, preterm birth, blood transfusion, hysterectomy, maternal intensive care unit admission, disseminated intravascular coagulation, septicemia, thrombophlebitis, and even fetal-neonatal and maternal death. this is a 1:2 prospective, matched and hospital-based case-control study to investigate the characteristics, complications and perinatal outcomes in pregnant women with placenta previa. for each placenta previa women, the investigators selected two none-placenta previa pregnant women as control from the same department matched on the mode of delivery, using simple random selection when excess matches are available. the date of their admission is limited to two days. this hospital is a tertiary university-affiliated medical center with a stable number of approximately 12,000 deliveries per year. placenta previa is diagnosed by experienced ultrasonologists based on a transabdominal ultrasonic finding of placental tissue covering the internal cervical os before delivery, and further confirmed by obstetricians at delivery.

Eligibility criteria:
inclusion criteria: * single pregnancy * informed consent * fetal gestational age 28 to \< 42 weeks exclusion criteria: * multiple pregnancy * refuses to consent

Keywords: placenta previa risk factors perinatal complications perinatal outcomes
flibanserin evaluation over 28 additional weeks in hypoactive sexual desire disorder

Conditions: Sexual Dysfunctions, Psychological

Summary: safety profile of flibanserin over 28 additional weeks distribution of preferred dose regimens


Eligibility criteria:
inclusion criteria: * women with a primary diagnosis of hsdd who still needs to be treated according to the investigator's opinion and willing to continue in this study. this continuation requires adequate compliance, in the investigators judgement, with trial medication and the trial visit required in the parent clinical trial (visit 1 to visit 9). * patients must have used a medically acceptable method of contraception \[i.e., double barrier method (e.g., diaphragm or condom and spermicide), hormonal therapy (subcutaneous, injectable, intra-vaginal, or oral contraceptive), intrauterine device, tubal sterilization, or partner's surgical sterilization\] for at least 3 months before the screen visit and continue to use that medically acceptable method of contraception during the trial. exclusion criteria: * patients with a history of mdd within 6 months prior the screen visit or a score of 14 on the beck depression inventory ii, or a history of suicide attempt according to the beck scale for suicide ideation, or patient with any non-zero statement in the first five items for the beck scale for suicide ideation. * patients must have a clinically acceptable pap smear as read by a cytology facility (no evidence of malignancy or squamous intraepithelial lesions) within 6 months before the inclusion visit. * patients with findings at the screen visit of pelvic inflammatory disease, urinary tract or vaginal infection/vaginitis, cervicitis, interstitial cystitis, vulvodynia, or significant vaginal atrophy. * patients experiencing major life stress (including parenting pressure, eldercare, loss of income, death of a family member, etc.) or relationship discord that could interfere with sexual activity, except distress about hsdd. * clinically significant ecg abnormalities at the screen visit, according to the investigators opinion or the cardiologist who have performed the ecg. the following ecg values are considered to be exclusionary: qtc intervals \>480 milliseconds (ms), pr intervals \>240 ms, and qrs intervals \>110 ms.
effect of hyperbaric therapy on markers of oxidative stress in children with autism

Conditions: Autism; Oxidative Stress

Summary: this study will look at the changes taking place in the blood levels of key markers of oxidative stress. oxidative stress is the biological equivalent of rust on a car. it changes vital cell chemistry. it is known to occur at high pressure oxygen, but little is known about changes at pressures slightly greater than normal atmospheric pressure. hyperbaric therapy is used in a variety of medical conditions. it is being tested in this study only for safety. it is not being assessed for the ability of hyperbaric oxygen to improve the clinical condition of children with autism. this study was felt to be important since autism appears to be associated with oxidative stress and hyperbarics was being used "off-label" for this condition without safety studies.

blood will be drawn immediately prior to a one hour session of hyperbarics (hbt. a catheter will be inserted in to a vein and converted to a heparin lock indwelling port for the next blood draw. the child (ages 5-12 years) will then undergo 1 hour of compression at 1.3 atmospheric pressure (4 psi above room air pressure). supplemental oxygen will be provided to the child. a second blood draw from the catheter site will be accomplished immediately after the child comes out of the hbt chamber. these will be sent to the laboratories for evaluation of changes in reduced glutathione and lipid peroxides.

Eligibility criteria:
inclusion criteria: * children diagnosed with autism ages 5-12 and undergoing hyperbarics exclusion criteria: * seizures, acute uri, or inability to ventilate ears

Keywords: autism oxidative stress hyperbaric oxygen reduced glutathione lipid peroxides
early weight bearing in unicondylar tibial plateau fractures

Conditions: Early Mobilization

Summary: the investigators aim of the study is to assess the effects of early mobilization after surgically treated unicondylar tibia plateau fractures (6 weeks without weight bearing) on gait, patient satisfaction, return to work/sports and complication rate. the data will be compared to a 10-12 week non-weight bearing group (standard of care). it is assumed that earlier mobilization does not lead to an increase in the complications - in particular osteosynthesis failure and infections -, but leads to improved patient satisfaction, reduced return to work/sports times, and has a positive impact on the overall outcome

tibial plateau fractures are common sports injuries caused by accidents such as skiing and mountain biking. thus, young adults with high functional and athletic demands are often affected. the best possible restoration of the original joint function and resilience is therefore particularly important for this group of patients. in addition, prolonged immobilization in this patient group poses a high risk of loss of earnings and a significant impairment in athletic performance. these injuries usually require surgical treatment which is followed by 10-12 weeks without weight bearing. in recent years, there has been a shift towards earlier mobilization with many injuries. in addition, numerous studies showed the negative effects of prolonged immobility. nevertheless, these negative effects must always be weighed against the possibility of osteosynthesis failure.

Eligibility criteria:
inclusion criteria: * adult patients, at least 18 years of age, max 65 years of age * unilateral tibial plateau fracture ao:41b/c * written consent to participate (consent can be revoked at any time without giving reasons) * surgery during the study period * follow-up on-site (salt lake city, utah, united states) exclusion criteria: * multiple injured or polytraumatized patients * other injuries or illnesses that impair the patient's mobility or gait * cognitive limitations such as dementia, delirium or similar disease * refusal to participate * severe underlying disease with significant limitations in the ability to regenerate e.g. malignancies * pathologic or osteoporotic fractures * unable to attend clinic in person for follow-ups * pregnant women and fetus

Keywords: unicondylar tibia plateau fractures early mobilization gait analysis
defects in opsonophagocytosis in premature infants

Conditions: Prematurity; Neonatal Sepsis

Summary: the purpose of the study is to characterize innate immune function of premature infants, and identify defects that may be responsible for the development of bacterial sepsis.

sepsis is an important problem in preterm infants and carries a significant morbidity and mortality. it is estimated that 20% of premature infants surviving beyond the first three days of life will have one or more culture-proven bacteremic sepsis. there is increasing epidemiologic and biologic evidence suggesting that preterm newborns are more susceptible to infection than term newborns and adults. immaturity of the immune system, and, in particular, defects in innate responses to pathogens are of foremost importance in the pathogenesis of neonatal sepsis. the aims of the study are the: 1. determination of the opsonic capacity of plasma from premature infants, vs. term newborns, and identification possible molecular innate immune defect(s) in preterm plasma. 2. characterization of the role of tlr2 and tlr4 responses in phagocytes from premature infants using classical tlrs agonists. determination of the capacity of plasma from premature infants to sustain tlr pathways, with a particular attention paid to the possible role of soluble md-2 in plasma from premature infants in tlr-dependent opsonophagocytosis. 3. determine prognostic factors for neonatal sepsis. the identification of a quantitative and/or qualitative defect in innate plasma protein(s) in premature newborns has the potential of identifying those infants who are likely to develop a neonatal sepsis.

Eligibility criteria:
inclusion criteria: * premature or term delivery exclusion criteria: * none

Keywords: prematurity vlbw sepsis innate immunity
beyond follow-up: betaferon®/betaseron® efficacy yielding outcomes of a new dose

Conditions: Multiple Sclerosis, Relapsing-Remitting

Summary: the beyond follow-up study will give patients who participated in the preceding beyond study the opportunity to continue treatment with the 500µg dose of interferon beta (ifnb) 1b and will further investigate the safety and tolerability profile of interferon beta 1b 500µg during longer-term treatment.

phase a (3 arm parallel group): all patients randomized during the beyond study (bayer 306440) to either ifnb 1b group (250µg or 500µg) will continue their previously assigned study medication, applying the same level of blinding as during the beyond study, all patients randomized during the beyond study to copaxone and all patients with premature discontinuation of study medication during the beyond study will receive open-label ifnb 1b 250µg. phase b (single arm): all patients will receive open-label ifnb 1b 500µg) randomization: no randomization in this trial, patient's allocation in this follow-up study depends only on prior trial groups. the preceding study was randomized. the trial is sponsored by bayer schering pharma ag, germany, bayer healthcare and bayer healthcare pharmaceuticals inc. secondary outcome measure "assessment of patient-reported outcomes (fams and eq 5d: the variables fams and eq-5d were not analyzed due to the termination of the study before start of phase b.

Eligibility criteria:
inclusion criteria: * completion of the beyond study 306440 as scheduled * relapsing multiple sclerosis * medical assessment by the investigator that there is no objection to the patient's participation in this trial considering the medical experience from study 306440. special attention should be given to laboratory abnormalities and clinically relevant liver, renal and bone-marrow dysfunction. * females of child-bearing potential: * agreement to practice adequate contraception methods and * negative pregnancy test and * no lactation * written informed consent exclusion criteria: * serious or acute heart diseases * history of severe depression or suicide attempt * epilepsy not adequately controlled by treatment * known allergy to ifns, to human albumin or to mannitol * medical, psychiatric or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study

Keywords: relapsing multiple sclerosis interferon beta 1b betaferon betaseron
drainage after rectal excision for rectal cancer

Conditions: Rectal Cancer Surgery; Randomized Clinical Trial; Multicenter Study; Pelvic Drainage

Summary: after rectal excision, the rate of anastomotic leak and abscess is higher than after colic surgery. in order to limit and avoid the risk of pelvic sepsis after rectal excision, a prophylactic pelvic drainage is usually used. if current data have confirmed the uselessness of drainage in colic surgery, the question stay in abeyance in rectal surgery. this practice had never been evaluated in patients with rectal excision and low anastomosis (patients with a high risk of pelvic sepsis)

after rectal excision, the rate of anastomotic leak and abscess is higher than after colic surgery. in order to limit and avoid the risk of pelvic sepsis after rectal excision, a prophylactic pelvic drainage is usually used. if current data have confirmed the uselessness of drainage in colic surgery, the question stay in abeyance in rectal surgery. this practice had never been evaluated in patients with rectal excision and low anastomosis (patients with a high risk of pelvic sepsis) the aim of the study is to assess the impact of pelvic drainage vs. non pelvic drainage on risk of pelvic sepsis after rectal excision for cancer with infraperitoneal anastomosis. the principal objective is to compare the rate of pelvic sepsis until 30 days between the 2 groups of patients who had a rectal excision with and without pelvic drainage. it is a randomized clinical trial of superiority, multicentric, without blinding, in 2 parallel groups with ratio (1:1): distribution of the number of patients in the groups.

Eligibility criteria:
inclusion criteria: * rectal adenocarcinoma, histopathologically proved, with or without neoadjuvant treatment * stapler or manual infraperitoneal anastomosis * with or without stoma * with bowel preparation * open or laparoscopic approach * stage t1-t4 nx mx * age 18 years old or older * information of the patient and signature of informed consent * affiliation to a regime of social insurance exclusion criteria: * colonic cancer (\> 15 cm from anal verge) * abdominoperineal resection * associated resection (prostate, seminal bladder, vagina...) * simultaneous liver resection * total coloproctectomy * emergency * infected rectal tumour * pregnant women, suitable to be, or current suckling * persons deprived of freedom or under guardianship * persons under protection of justice * impossibility to accept the medical follow-up of the study for geographic , social or psychic reasons.

Keywords: rectalneoplasms colorectal neoplasms intestinal neoplasms gastrointestinal neoplasms digestive system neoplasms neoplasms by site digestive system diseases gastrointestinal diseases intestinal diseases rectal diseases
essential coaching postpartum: evaluating a parent-focused postpartum text message program in nova scotia

Conditions: Parenting Self-efficacy; Postpartum Anxiety; Postpartum Depression (PPD); Postpartum Stress; Mental Health; Co-parenting Practices

Summary: the transition to parenthood is often an exciting yet hard period for parents. in the first year after a new baby, many parents feel less confident, have more anxiety and depression, and feel more isolated and alone. during this time, many parents use their phones and the internet to seek out information and support. thus, we are exploring the opportunity of using mhealth, or mobile health, to provide information directly to parents after the birth of their first baby. we have developed a program for both birthing and non-birthing parents called the essential coaching postpartum program. this program provides 332 parents with text messages sent for 6 weeks after birth to share information on newborn care and parent outcomes. this will be tailored based on whether they are the birthing parent (essential coaching for every mother) or non-birthing parent (essential coaching for every partner). we will evaluate this program by comparing a group of parents who receive the messages to a group of parents do not receive any text messages. to determine the success of the essential coaching postpartum program, we will compare parents' confidence, anxiety, depression, and co-parenting between the two groups after six-weeks and six-months. we believe that parents who get the text messages will have higher confidence and co-parenting outcomes and lower anxiety and depression. our goal with the essential coaching postpartum program is to help make the first few weeks after a new baby less stressful by providing information and support directly to parents that they know they can trust.


Eligibility criteria:
inclusion criteria: eligible birthing parents will (1) early postpartum (\<7 days) with their first child; (2) understand english; (3) have a cell phone with text and data; and (4) live in nova scotia. eligible non-birthing parents will (1) be early postpartum (\<7 days) with their first child; (2) understand english; (3) have a cell phone with text and data; and (4) live in nova scotia. exclusion criteria: participants (both birthing and non-birthing parents) will be excluded if: (1) newborn die or are expected to die prior to leaving the hospital; (2) they have no access to mobile phone, either personal or shared; (3) unwilling to receive sms messages; (4) decline or withdraw to participate; or (5) participated in a previous iteration of this project (e.g., either the development or evaluation).

Keywords: text messaging non-birthing parent birthing parents mothers fathers digital health