Kornimate/medical-research-clean huggingface dataset:
whole body vibration training for pelvic floor muscle

Conditions: Healthy

Summary: to study which position on the whole body vibrator machine would stimulate the pelvic floor muscles.

urinary incontinence is a common problem due to a weak pelvic floor muscle associated with decrease quality of life. the vibration exercises have been associated with improvements of the muscle component. due to this, some researches have proposed that this technique could be applied to weak pelvic floor. however, it is unknown which vibration trainings have the highest impact on the pelvic floor muscle and urinary sphincter, more objectives studies to validate these data are necessary. the purpose of our research is to evaluate the activity in the urinary sphincter and the pelvic floor muscle by vibratory platform training in women. subjects will be recruited, criteria exclusion will be evaluated, age, and bmi will be recorded. each subject will exercise on the vibratory platform in 3 different positions, each one with 2 different frequencies and 1 minute each position and frequency. pelvic electromyography (emg) will assess the activity of the urinary sphincter and pelvic floor muscle with vibratory exercise. data will be collected during all procedures. according to our purpose and anticipating the impact of this research extrapolating whole body vibration (wbv) training as program to improve the strength of the pelvic floor muscle elaborating a guided plan to improve clinical outcomes and quality of life of patients suffering from urinary incontinence with this new nonsurgical treatment approach to women with mild to moderate stress urinary incontinence, as well as this research allow us to increase our knowledge in urinary continence and the pelvic floor.

Eligibility criteria:
inclusion criteria: women over 18 years of age exclusion criteria: criteria exclusion like unhealthy condition, acute thrombosis, acute inflammations, implants, fractures, acute tendinopathies, kidney or bladder stones, gallstones, lung disease, heart disease, skin disease, hypertension, any medication or disease known to affect muscle mass or strength and pregnant will be evaluated

Keywords: whole body vibration pelvic floor muscle urinary incontinence urinary sphincter
dbgap protocol: genetic variants associated with pentalogy of cantrell

Conditions: Pentalogy of Cantrell

Summary: background: pentalogy of cantrell (poc) is a syndrome that involves many heart abnormalities as well as large defects in the chest and abdominal wall. this often results in the heart and other organs being present outside the body at birth. surgeons have learned to replace them and repair the heart. researchers want to find possible gene changes that cause poc. to do this, they want to study data from the pediatric cardiovascular genetics consortium (pcgc) cohort. the pcgc collects data and dna samples from people with heart diseases and their families objectives: - to find gene mutations in people with pentalogy of cantrell (poc) or other related syndromes. eligibility: - pcgc data and dna samples that are open to study by the public. design: * researchers will study the data from the pcgc. * the gene testing being done in this study was consented to in the original studies. no new consent or waiver request is required. * the study will last 1 year.

the purpose of this protocol is to identify genetic mutations in patients with the diagnosis of pentalogy of cantrell (poc) or other related syndromes. we will be looking for any exomic/genomic mutations that could be associated with this syndrome. we have produced a mouse model with a mutation in the gene encoding nonmuscle myosin iib which exhibit problems with ventral wall closure, including extrathoracic location of the heart (ectopia cordis) and defects in the abdominal wall with protrusion of the guts and liver. these mice have severe defects in both the heart and brain, and resemble humans born with poc, who manifest these same abnormalities, and so we take a special interest in mutations in nonmuscle myosin proteins.

Eligibility criteria:
* we will analyze data from subjects from congenital cardiovascular disease databases.

Keywords: non-muscle myosin
impact of glycemic control on skeletal outcomes in adults with type 1 diabetes

Conditions: Diabetes Mellitus, Type 1; Bone Health; Bone Loss; Bone Diseases, Metabolic; Hyperglycaemia Due to Type 1 Diabetes Mellitus

Summary: background : type 1 diabetes (t1d) is associated with an increased risk of fractures. the mechanisms accounting for this bone fragility are not yet fully understood. as t1d is often diagnosed in childhood or early adulthood, the lower bone mineral density (bmd) and deteriorated bone microarchitecture observed in t1d may reflect changes in the bone that occurred before or at the time of peak bone mass achievement. there is a lack of high-quality prospective studies to determine whether adults with t1d continue to lose bmd or deteriorate bone quality compared with controls. moreover, while chronic hyperglycemia is a risk factor for fracture in t1d, it is unknown if better glycemic control affects bone outcomes. this prospective multicenter cohort study aims: (1) to compare the changes in the following outcomes over 4 years in adults with t1d and controls without diabetes of similar age, sex and body-mass index distribution: bmd by dual-energy x-ray absorptiometry (dxa) at the femoral neck, hip, spine, and radius, trabecular bone score (tbs) by dxa, and serum biochemical markers of bone turnover (btms); (2) to evaluate whether long-term glycemic control or the presence of a microvascular complication are independent predictors of the changes in bmd and tbs in people with t1d.


Eligibility criteria:
individuals with type 1 diabetes who have participated in the densify (diabetes spine fractures) study (nct04064437) inclusion criteria: * diagnosis of type 1 diabetes for at least 5 years; * age 20 years and older. exclusion criteria: * pregnancy, delivery or breastfeeding in the past 6 months; * conditions associated with bone disease (significant liver disease, intestinal malabsorption other than celiac disease, organ transplant, active cancer, rheumatoid arthritis, hyperthyroidism, hypothyroidism with abnormal tsh, hyperparathyroidism, hypoparathyroidism, hypogonadism, acromegaly, cushing syndrome, adrenal insufficiency); * any of these medications since the first densify study visit : biphosphonates, teriparatide, denosumab, calcitonin, glucocorticoids ≥ 7,5 mg prednisone/day or equivalency ≥ 3 months, aromatase inhibitors, antiandrogens, antiepileptic drugs, anticoagulants, thiazolidinediones; * inability to consent. healthy controls who have participated in the densify (diabetes spine fractures) study (nct04064437) inclusion criteria: * age 20 years and older. exclusion criteria : * as above (as individuals with diabetes), and : * diagnosis of diabetes or prediabetes; * celiac disease; * chronic kidney disease (crcl \< 60 ml/min).
trial of h3b-6545, in women with locally advanced or metastatic estrogen receptor-positive, her2 negative breast cancer

Conditions: Breast Neoplasms; Breast Cancer; Estrogen-receptor Positive Breast Cancer; Cancer, Breast; Breast Cancer Female; Breast Adenocarcinoma; Estrogen Receptor Positive Tumor; ER Positive

Summary: the primary purpose of phase 1 portion of this study is to determine the maximum tolerated dose (mtd) and recommended phase 2 dose (rp2d) of h3b-6545 in women with locally advanced or metastatic estrogen receptor (er)-positive, human epidermal growth factor 2 (her2)-negative breast cancer. the primary purpose of phase 2 portion of this study is to estimate the efficacy of h3b-6545 in terms of best overall response rate, duration of response (dor), clinical benefit rate (cbr), disease control rate (dcr), progression-free survival (pfs), and overall survival (os) in all participants with er-positive, her2-negative breast cancer and in those with and without er alpha mutation (including a clonal estrogen receptor 1 gene \[esr1\] y537s mutation).


Eligibility criteria:
inclusion criteria: 1. pre- or post-menopausal women. 2. er-positive, her2-negative breast cancer that is advanced or metastatic. 3. progressed on prior therapy. multiple prior lines of therapy allowed in phase 1 and 2. participants under amendment 6 (or subsequent amendments) must have received prior cyclin-dependent kinase (cdk4/6) inhibitor therapy. up to one prior chemotherapy in the metastatic setting is allowed. 4. a recent archival tumor tissue obtained within 6 months prior to enrollment or a fresh tumor biopsy must be provided. a second biopsy after initiating trial therapy is not required. 5. eastern cooperative oncology group (ecog) performance status (ps) of 0 or 1. 6. adequate bone marrow and organ function. 7. participants under amendment 6 (or subsequent amendments) must have measurable disease at baseline as per response evaluation criteria in solid tumors (recist) 1.1 criteria. 8. participants under amendment 6 (or subsequent amendments) must have esr1 y537s mutation in absence of esr1 d538g mutation as per the results of a central laboratory from a nucleic acids whole blood sample. exclusion criteria: 1. participants must have at least one measurable lesion. 2. participant with inflammatory breast cancer. 3. participant has received more than one prior chemotherapy regimen for metastatic disease (phase 2 only). 4. females of childbearing potential who are unable or unwilling to follow adequate contraceptive measures.

Keywords: estrogen receptor h3b-6545 breast cancer endocrine therapy
single ascending dose study to assess the safety, tolerability and pharmacokinetics of azd4451

Conditions: Bipolar Disorder

Summary: this is a single ascending dose study to assess the safety, tolerability and pharmacokinetics of azd4451.


Eligibility criteria:
inclusion criteria: * provide a signed and dated, written informed consent prior to any study specific procedures being performed. including the genetic sampling and analyses. if a volunteer declines to participate in the genetic component of the study, there will be no penalty or loss of benefit to the volunteer. the volunteer will not be excluded from other aspects of the study described in this protocol. * healthy male and female (of non-childbearing potential) volunteers 18 to 55 years old inclusive with suitable veins for cannulation or repeated venipuncture. * females must have a negative pregnancy test at screening and on admission to the unit, must not be nursing and must be of non-childbearing potential, confirmed at screening by fulfilling one of the following criteria: * post-menopausal defined as amenorrhoea for at least 12 months following cessation of all exogenous hormonal treatments and with fsh levels in the laboratory defined post-menopausal range * documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation male volunteers should be willing to use barrier contraception for example, condoms and spermicide, from the day of dosing until at least 3 months after dosing with the investigational product. * have a body mass index (bmi) between 19 and 30 kg/m2 (bmi \<30.5 =30) and weigh at least 50 kg and no more than 100 kg inclusive. exclusion criteria: * history of gastrointestinal surgery (other than cholecystectomy or appendectomy) or unintentional rapid weight loss. * a positive result on screening for serum hepatitis b surface antigen, hepatitis c antibody and human immunodeficiency virus (hiv). * history of any of the following as judged by the investigator: history of psychiatric disorders as defined in the diagnostic and statistical manual of mental disorders text revision; medically diagnosed depression in the 6 months prior to dosing; bipolar disorder; use of psychoactive medication (including mood stabilizers) in the 6 months prior to dosing; electroconvulsive therapy in the 6 months prior to dosing; history of seizures 1 year prior to dosing; history of severe dystonic reaction to other drugs. * history of syncope, fainting or of vasovagal reactions; history of arrhythmias, and/or postural hypotension. the inclusion of volunteers meeting the above criteria may be decided on a case-by-case basis after consultation between the investigator and az cpa physician. * history or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs.

Keywords: azd4451 bipolar depression
comparison of single groin and single trans-septal puncture and conventional bilateral groin puncture and double trans-septal puncture in catheter ablation for atrial fibrillation

Conditions: Paroxysmal Atrial Fibrillation

Summary: the purpose of this study is to compare single groin puncture and bilateral groin puncture during af ablation procedure. the investigators will compare 1) the degree of patients' discomfort during hemostasis by questionaire, 2) procedure time, 3) complication rates, and 4) 1-year clinical recurrence rate of af.


Eligibility criteria:
inclusion criteria: 1. patients agreement of consent 2. patients who age more than 19 3. patients who undergoing catheter ablation of atrial fibrillation 4. patients who are not vascular disease exclusion criteria: 1. patients who do not agree with study inclusion 2. persistent af 3. patients with vascular disease or venous anomaly 4. patients with structural abnormality of the heart
french pediatric helicobacter pylori observatory

Conditions: Helicobacter Pylori Infection

Summary: helicobacter pylori is a major human pathogen associated with significant morbidity. the treatment oriented by the antibiogram or pcr (polymerase chain reaction) should be privileged in children. however, the optimal treatment for the eradication of pediatric h. pylori infection is still not established. no french consensus conference on the management of h. pylori infection in children taking into account the epidemiological data available for this infection has been published. the description of diagnostic and therapeutic management procedures has not yet been specifically described according to the country of birth of children. the main objective is to collect data enabling the establishment of a french observatory of helicobacter pylori in children in order to provide a national database.


Eligibility criteria:
inclusion criteria: * child with confirmed h. pylori infection by direct diagnostic methods after periendoscopic gastric biopsies * age \< 18 * no opposition of at least one of the 2 parents to the use of health data for research purposes exclusion criteria: * child with confirmed h. pylori infection by indirect diagnostic methods

Keywords: children treatment observatory
mirna in fetal overgrowth

Conditions: Obesity

Summary: the purpose of this study is to determine whether placental and umbilical cord blood mirna expression is altered in women with obesity with macrosomic neonates to when compared to mirna expression from control patients.

microrna's are a class of non-coding rna's that function as translational repressors and are thought to modulate tissue development, proliferation, differentiation and function. differential expression of certain placental mirna's has been associated with preeclampsia. the fetal origins of adult disease hypothesis suggests that risk factors from intrauterine environmental exposures affect the fetus' development during sensitive periods, and increases the risk of specific diseases in adult life. our aim is to understand factors that predispose fetuses to fetal overgrowth in utero, especially in women with obesity. the objective of the study is to identify mirna which are differentially expressed in the placenta and cord blood of pregnancies that are affected by fetal macrosomia to determine factors that may predispose fetuses to fetal overgrowth.

Eligibility criteria:
inclusion criteria: * singleton pregnancy * prenatal care \& delivery at the hospital of the university of pennsylvania system * normal glucose tolerance test results (less than 120 mg/dl) exclusion criteria: * multiple gestation * under 18 years old, or over 45 years old * chronic hypertension * preeclampsia * chronic steroid use * diabetes * major fetal anomaly * connective tissue disorder requiring medication * active hiv * hepatitis c

Keywords: maternal obesity macrosomic mirna fetal overgrowth
evaluation of arfc masks equipped with cf5 filter in the care unit to allow a wider distribution of ffp2 masks (covid-19).

Conditions: Nurse

Summary: the current outbreak of covid-19 requires the wearing of ffp2 respiratory protective devices by healthcare personnel to limit their contamination. however, there is currently a shortage of masks in france due to insufficient national stocks while the disease is spreading. there is an urgent need to save ffp2 masks to enable healthcare personnel to continue to provide care in complete safety. contamination of staff due to insufficient masks would have consequences by limiting access to care for infected patients and putting caregivers at potential risk of death. caregiver protection is also intended to contain the risk of nosocomial epidemics. we propose the use of arfc masks by covid-19+ units. these arfc masks provide optimal security against the risk of aerosolization of contaminated biological liquids. they are masks modified to be usable by civilians, resulting from the technology of combat masks, specially designed for use in nrbc (nuclear, radiological, biological and chemical) atmosphere.


Eligibility criteria:
inclusion criteria: * nursing staff working 8 or 12 hours a day for 2 consecutive days in a covid unit at the hospital of saint etienne. * subjects affiliated to or entitled to a social security scheme * subject who received informed information about the study and agreed to participate in the study exclusion criteria: * allergy to arcf mask material: polyurethane * impossibility of supporting a tight mask on the face * potential contraindication to wearing a mask, such as the existence of claustrophobia * beard and moustache wearer * suspicion of covid-19 infection * refusal to participate.

Keywords: mask arfc covid-19 protection
pitolisant in refractory restless legs syndrome

Conditions: Restless Legs Syndrome

Summary: this is an open-label trial in restless legs syndrome (rls) patients inadequately treated with standard therapy, defined by an irls score greater than 15. investigators hypothesize that the study drug, pitolisant (wakix), may improve rls symptoms.

this is an open-label trial in rls patients who have been inadequately treated with standard therapies, defined by an irls \> 15. this trial consists of four study center visits (weeks 0, 4, 8, and 16) and four telephone visits (weeks 1, 3, 11, and a post safety phone call at week 17). subjects will titrate pitolisant for three weeks, starting with a dose of 8.9 mg at week 1, then increase to 17.8 mg at week 2, and a final increase to maximum dosage of 35.6 mg at week 3. if subjects are unable to tolerate the highest dose, they may reduce their dose to 17.8 mg. titration of the drug will be monitored via telephone visits. during weeks 0-8, subjects will continue to take their current rls medications. from week 8-16, subjects may either reduce or stop their other rls medications as mutually agreed upon with investigator. several questionnaire assessments will be conducted throughout the study to monitor the subjects. subjects will complete the international rls rating scale (irls), restless legs syndrome - 6 scale (rls-6), rls quality of life questionnaire (rlsqol), fatigue severity scale (fss), hamilton depression scale (hds), montreal cognitive assessment (moca), epworth sleepiness scale (ess), clinical global impressions (cgi), and clinical global impressions-change (cgi-c).

Eligibility criteria:
inclusion criteria: * rls diagnosed by standard criteria with an irls \> 15 while taking at least 1 rls medication * stable rls medications for at least 2 weeks prior to study entry exclusion criteria: * moca \< 24 * concurrent untreated sleep disorders, not felt to be stable * subjects with any significant, unstable cardiovascular, liver, lung, renal, psychiatric, or neurological diseases (not including rls) * intravenous iron within 4 weeks of study entry * breast feeding or pregnancy determined by urine pregnancy test in subjects where pregnancy is possible (pre-menopausal, sexually active women) * subjects with previous allergic reaction or lack of tolerability to pitolisant

Keywords: refractory
deep brain stimulation vs. vagus nerve stimulation for epileptic spasms

Conditions: Epilepsy; Seizure

Summary: deep brain stimulation vs. vagus nerve stimulation for the treatment of drug-resistant epilepsy and epileptic spasms in children: a randomized control trial

to directly compare the effectiveness and safety of deep brain stimulation (dbs) vs. vagus nerve stimulation (vns) in children with drug-resistant epilepsy (dre) or epileptic spasms. this will be an open, non-blinded randomized control trial. twenty (20) patients will be recruited and enrolled in this pilot study from sickkids. expected study duration is 36-48 months.

Eligibility criteria:
inclusion criteria: * female or male patients 5 years of age and over (17 and 11 months), not including 18 years old * diagnosis of drug-resistant epilepsy with failure after trial of two anti-epileptic * medications (as defined by kwan et al. 20093). all children screened for entry into the study will be re-diagnosed by a neurologist prior to entry. * main seizure type includes epileptic spasms and tonic spasms, as confirmed by electroencephalography. * parents or legal guardians, including caregivers, are informed and able to give written consent. * ability to comply with all testing, follow-ups and study appointments and protocols for 12 months following the end of the duration of the study exclusion criteria: * substance dependence or abuse in the last 6 months, excluding caffeine and nicotine * any contraindication to mri scanning. a preoperative mri scan is essential to * planning dbs and therefore any contraindication to mri is a contraindication to enrollment in the study. * unwillingness or inability to return to sickkids for follow-up visits. * presence of cardiac arrhythmias, or other cardiac, respiratory, renal or endocrine conditions that will result in significant risk from a surgical procedure. * pregnancy * inability to communicate adequately in english in order to complete the baseline and follow-up questionnaires. * a co-morbid condition that requires frequent mri scanning as part of the patient's regular care.