Kornimate/medical-research-clean huggingface dataset:
study to observe the effect of mirapex er® once-daily (qd) versus twice-daily (bid)

Conditions: Parkinson's Disease

Summary: 1. in order to observe the benefit, side effects, and patient preference of mirapex er when used in once-daily (qd) or twice-daily (bid) dosing 2. in order to estimate the conversion rate of dopamine agonists into mirapex er

1. study subjects : parkinson disease who are on requip or mirapex and are considering to change into mirapex er 2. cross over study design: * group 1: once daily dose for 2 month then into bid in divided dose for 2 months * group 2: bid in divided dose for 2 months then into qd dose for 2 months 3. dose adjustment may be done in the first 4 weeks. 4. compare the benefit, side effects, and patient preference between the qd vs bid dosing

Eligibility criteria:
inclusion criteria: 1. age: 30-80 2. parkinson disease 3. on dopamine agonists (requip or mirapex) and are considering to change into mirapex er 4. on stable antiparkinsonian medication for at least 4 weeks 5. who signed consent to the study exclusion criteria: 1. who are on less than 2 mg of requip or 0.375 mg of mirapex 2. who have dementia, psychosis, major depression and other serious neurological or medical problems 3. who are allergic to the similar medications 4. who has history of heavy metal poisoning 5. who were on othe clinical trials of other medications within the last 4 weeks 6. who are pregnant or lactating 7. who are considered not eligible by the investigator

Keywords: parkinson's disease pramipexole
prospective phase ii study for assessment of regulatory immune cell populations after allogeneic hsct

Conditions: Allogeneic Hematopoietic Cell Transplant Recipients

Summary: allogeneic hematopoietic cell transplantation offers high cure rates for patients with hematological and oncological diseases. graft-versus-host disease (attack of donor's white blood cells on patient's tissues) is a serious complication also affecting the patient's immune system. therefore, patients in the early phase after allogeneic cell transplantation are at high risk for severe infectious complications. so far, no predictive biomarkers for the development of the chronic form of graft-versus-host disease are available. by analysing serially immune cell populations of the peripheral blood we will investigate whether certain subsets of cells are associated with development of chronic graft-versus-host disease. in addition, the patients' immune regeneration will be evaluated by serial analyses of peripheral blood immune cell populations 3 months to 2 years after allogeneic cell transplantation.


Eligibility criteria:
inclusion criteria: * receiving grafts from either hla-identical sibling donors or hla-matched unrelated donors * receiving grafts from hla-mismatched sibling donors or hla-mismatched unrelated donors * receiving either bone marrow, peripheral blood stem cells or cord blood grafts * alive on day 100 after transplant * age 18 years or above * signed written informed consent exclusion criteria: * lymphocytopenia not allowing immunophenotyping * treatment with rituximab after hsct until study entry * hepatitis b and c, hiv infection * secondary posttransplant malignancies including ebv-lymphoproliferative disease * karnofsky score of 30 or below * absence of informed consent

Keywords: chronic graft-versus-host disease
a study to learn about the amount of the study medicine (sisunatovir) in blood and its safety in infants and children with pneumonia caused by rsv

Conditions: Respiratory Syncytial Virus Infections

Summary: the purpose of the study is to learn about the safety and amount of sisunatovir in the blood of infants and children up to age 60 months. these children have lower respiratory tract infection (lrti) caused by respiratory syncytial virus (rsv). lrti is the infection to the lower airways such as lungs. this study will help inform the amount of sisunatovir to be used in future studies of sisunatovir in children. this study is seeking for participants who: * are 1 day to less than or equal to 60 months of age * weigh more than or equal to 2.5 kilograms to less than or equal to 23 kilograms. * have been tested to have rsv by medical tests. * show signs of lrti. all participants in the study will receive many amounts of sisunatovir or placebo. placebo is a pill that does not have any medicine in it. up to 7 visits are required for the study. some of these visits include checking participants health over the phone and/or a visit at home. the study will compare the experiences of infants and children receiving sisunatovir to identify the amount of sisunatovir to be used in future studies in infants and children.


Eligibility criteria:
inclusion criteria: * 1 day to ≤60 months of age and weight ≥2.5 kg to ≤23 kg * positive rsv diagnostic test, antigen or molecular test * evidence of lower respiratory tract infection (lrti) exclusion criteria: * premature infants (gestational age less than 35 weeks) and \<1 year of post-natal age * neonates with intrauterine growth restriction * expected to receive an antiviral for another viral infection within 10 days of screening * suspected or confirmed clinically significant moderate or severe bacterial infection that may interfere with the evaluation of response to the study intervention * known to have significant comorbidities that would limit the ability to administer the study intervention or evaluate the safety or clinical response to the study intervention

Keywords: lower respiratory tract infection
effects a rehabilitation program in patients with left ventricular dysfunction after coronary artery bypass grafting

Conditions: Disorder; Heart, Functional, Postoperative, Cardiac Surgery

Summary: this study aims to analyze effects of three types of cardiac rehabilitation protocol on fuctional capacity, inflammatory markers, pulmonary function and clinical outcomes after coronary artery bypass grafting (cabg) in patients with left ventricular disfunction. patients will be randomized and allocated in three groups according to type of exercise protocol: 1. walk; 2. cycle; 3. functional electrical stimulation.

several studies have been demonstrated beneficial effects of exercise to minimize impact of cabg. however, there is no consensus on what kind of exercise is safe and effective for patients with left ventricular dysfunction. walking

Eligibility criteria:
inclusion criteria: * coronary artery disease proven by coronary angiography; * elective cabg; * no acute or chronic pulmonary disease; * patients after surgery, keep in spontaneous ventilation on first postoperative day; * absence of neurological, neuromuscular, musculoskeletal and osteoarticular incapacitating; * consent form signed for participation in the survey. exclusion criteria: * inability to perform spirometry; * presence of acute lung disease or chronic; * surgical indication of urgency; * morbid obesity; * hemodynamics instability at the time of spirometry or during six minutes walking test; * intraoperative death or until the sixth postoperative day; * patients remaining in mechanical prolonged ventilation for more than 12 hours; * severe cardiac arrhythmia during application of assessment protocols and exercises (ventricular tachycardia, atrioventricular block second or degree) any other condition the investigator's discretion put the patient at increased risk with beginning of the year; any change that may lead to failure of proposed protocols.

Keywords: coronary artery bypass sistemic inflammatory response syndrome left ventricular dysfunction postoperative complications physical fitness
fitness and lung function among survivors of heart transplant, leukemia and infant bpd through exercise

Conditions: Chronic Lung Disease; Chronic Obstructive Pulmonary Disease; Acute Lymphoblastic Leukemia; Heart Transplant

Summary: this study aims to more accurately assess cardiac function, ventilation and exercise capacity in a non-invasive fashion, and to better characterize exercise intolerance in the setting of three populations of individuals with chronic diseases of childhood (acute lymphoblastic leukemia (all), chronic lung disease (cld) of prematurity, and post-heart transplant (ht))

physical activity in childhood is an integral part of maintaining health and quality of life. children who participate in routine physical activity are more likely to maintain a healthy body weight and are less likely to have heart disease, type 2 diabetes and high blood pressure as adults. children with chronic disease are often limited from full participation in exercise for various reasons -perceived physical limitations, either from the patient and family or from their medical provider, or because of symptoms which cause exercise to feel uncomfortable. as the number of children living and aging with chronic disease continues to grow, the researchers are hoping to expand the current exercise testing capabilities for both clinical care and research in order to (i) provide data to permit formulation of evidence-based guidelines for exercise in chronic childhood disease; (ii) improve understanding of limitations to exercise in this growing population; (iii) learn long-term implications of chronic childhood disease as these individuals enter adulthood.

Eligibility criteria:
inclusion criteria: * cases: * acute lymphoblastic leukemia survivor, or living with chronic lung disease of prematurity, or living with heart transplant * 8-25 years old * height: ≥ 48 inches * ambulatory without assistance * english speaking * normotensive (\<95th percentile for age; okay if managed with antihypertensive medication) * spo2 \>92% * not pregnant * all survivor specific: must have completed therapy ≥ 3 months prior to study entry * controls * 8-25 years old * height: ≥ 48 inches * ambulatory without assistance * english speaking * no history of arrhythmia or known cardiac dysfunction at baseline * normotensive (\<95th percentile for age; okay if managed with antihypertensive medication) * spo2 \>95% * not pregnant exclusion criteria: * cases: * all specific: received cranial radiation, bone marrow transplant recipients * investigator or patient's primary physician deems the patient unsuitable for the study * controls: * history of malignancy, cld or ht or any other diagnosis which may reduce cardiorespiratory function * investigator deems the patient unsuitable for the study

Keywords: quality of life lung function fitness exercise
comparison of three cannulas for hysterosalpingography

Conditions: Infertility

Summary: the aim of this study is to compare the three commonly used hysterosalpingography (hsg) injection devices on the basis of patient pain perception, total fluoroscopic and procedural time, and side effects in a prospective, randomized study. an important and novel secondary outcome is the comparison of the quality of images obtained with these three devices. the investigators hypothesize that the balloon catheter and cervical vacuum cup will be less painful than the acorn tipped cannula and that there will be no difference in image quality between the three groups.

this study is a prospective, randomized trial of women undergoing hsg as part of their infertility evaluation. at the time of scheduling, the patient will be randomized to either the cervical vacuum cup, balloon catheter (h/s catheter set, ua medical, biotech america), or the acorn-tipped cannula using stratified blocked randomization. 100 subjects will be randomized to one of the three cannulas. patients will be stratified into 4 groups representative of the four reproductive endocrinologists in order to overcome any potential interoperator bias. four reproductive endocrinologists will perform the hsg procedures in a standardized fashion. fluoroscopy will ensure proper location of the cannula and check for uterine filling of contrast. digital images will document tubal filling and spilling of contrast. the patient will be rolled to right and left side to confirm free spillage of contrast in the peritoneal cavity. the last image will be taken after the balloon tip is deflated or the cannulas are removed to best evaluate the lower uterine segment.

Eligibility criteria:
inclusion criteria: * women undergoing hsg at an academic medical center exclusion criteria: * contrast media allergy * prior leep (loop electrosurgical excision procedure) or other cervical procedure * contraindication to nsaid use * known active pelvic infection * active vaginal bleeding

Keywords: hsg cannula hsg procedure infertility evaluation
transplacental transmission of covid-19

Conditions: SARS-COV-2 Infection

Summary: sars-cov-2, the agent responsible for pandemic covid-19 infection, is transmitted mainly by respiratory droplets. regarding maternal-fetal transmission, even if the mode of transmission from mother to fetus is not clear, some cases of perinatal transmission have been described, but without certainty on the routes of placental contamination, trans-cervical or by environmental exposure. . the case described by j. vivanti of a newborn with neonatal neurological involvement and whose mother had been infected during the last trimester of pregnancy reports possible transplacental transmission in a context of positive and elevated viremia in the mother and positive viremia in the newborn.

in 2021, it becomes essential to clarify if and how sars-cov-2 reaches the fetus, in order to prevent neonatal infection, optimize pregnancy management and better understand the pathogenesis of covid-19. sars-cov-2, ace2 and tmprss2 co-receptors are highly expressed in placental tissues and may be actively involved in transplacental transmission of the virus. from a case of materno-fetal transmission described by our team (publication in progress), we observed placental expression of the spike sars-cov-2 protein, but also of the ace2 receptors, tmprss2 and cathepsin l. cytotrophoblast and syncytiotrophoblast cell stains were positive within the placental villi. maternal leukocytes were also labeled for these proteins.

Eligibility criteria:
inclusion criteria: * social security affiliation * signed informed consent * pregnant woman with proven sars-cov-2 infection during full-term delivery exclusion criteria: * patient vaccinated within 15 days prior to inclusion

Keywords: immune response sars-cov-2 ace2 receptors mprss2 cathepsin l
the significance of a timely food allergy diagnosis and optimal surveillance of nutritional status in children

Conditions: Food Allergy in Children; Food Allergy in Infants

Summary: the aim of this study is to gain more knowledge on the nutritional and immunological aspects of allergy to milk and eggs in children.

food allergy in children is an emerging problem in many countries. milk and eggs are important sources of nutrition in childhood. restricting these products in children's diets can affect the quality of child's life and nutrition, which is paramount to good physical and mental child development during this vulnerable period of life. the aim of this study is to gain more knowledge on the nutritional and immunological aspects of immunoglobulin e (ige) mediated allergy to milk and eggs in children. in this study we will analyze parent perceived child's quality of life, factual nutrition (assessed by 3-day food diaries), food allergy self efficacy measure for parents, parent perceived quality of life will be assessed using food allergy quality of life questionnaire - parent form, anthropometric measures of children (height and weight), serum nutritional markers (vitamin d, calcium, magnesium, iron and phosphorous), sensitization tests (specific immunoglobulin e (sige) to milk and egg and their components) as well as markers of allergic inflammation (interleukin 10, 13, 17, 25 and 33, eosinophil count and serum immunoglobulin e). food allergy will be confirmed by an oral food challenge (ofc), variables will be compared between different ofc outcomes (sensitized-allergic/sensitized-non-allergic).

Eligibility criteria:
inclusion criteria: * subjects from 6 months to 12 years of age and their parents / guardians. * subjects with suspected or confirmed allergy to chicken's egg and/or cow's milk. suspected food allergy is defined as sensitization to a food that has not been consumed recently (in the last 3 months) without symptoms or sensitization to a food that has never been consumed. a confirmed food allergy is defined as a food allergy that has previously been confirmed by a positive result of an oral food challenge. * legal guardians of the subject are capable to sign a written informed consent form. exclusion criteria: * subjects to whom food allergies are unlikely (who have recently eaten a suspected food without symptoms or who have not eaten food recently but have never had symptoms and are not sensitized). * subjects to whom an oral food challenge is contraindicated. * subjects with comorbid chronic diseases affecting the child 's nutrition and growth. * legal guardians of the subject do not wish to participate in the study or are unable to sign a written consent form.

Keywords: food allergy milk egg
soft tissue graft for repair of pelvic organ prolapse

Conditions: Pelvic Organ Prolapse

Summary: the purpose of this study is to collect information about the performance of the surgisis® soft tissue graft ("study product") for the repair of pelvic organ prolapse in women.


Eligibility criteria:
inclusion criteria: * patients in need of transvaginal surgical repair of primary (i.e., de novo) pelvic organ prolapse. * popq = stage 2 or 3 in the vaginal compartment with the leading edge of prolapse (i.e., more severe prolapse) * at least one symptom associated with prolapse (e.g., any of the following including but not limited to vaginal bulge, vaginal pain/discomfort, voiding dysfunction, manual reduction (digitation) needed for defecation, fecal incontinence, dyspareunia) exclusion criteria: * age \< 18 years * bmi \> 40 * not medically fit for transvaginal surgery under general or spinal anesthesia * active uti at the time of the index procedure as determined by urine culture * vaginal atrophy (note: patient may be included after vaginal atrophy has been effectively treated.) * prior placement of synthetic mesh or biologic graft for pelvic organ prolapse * a history of cervical, ovarian, uterine, endometrial, vaginal, vulval, colon, rectal or bladder cancer * currently planned obliterative surgical repair for pelvic organ prolapse * systemic infection at the time of surgery * requires chronic immunosuppressive therapy, including steroids or cytotoxic agents * pregnant, breastfeeding or planning pregnancy during the study period * previous diagnosis of collagen disorder (i.e., marfan's, ehlers-danlos) * physical allergies or cultural objections to the receipt of porcine products * life expectancy of less than 12 months * ongoing participation in an investigational device or drug trial * currently undergoing evaluation or treatment for chronic pelvic pain (e.g., pain as a result of interstitial cystitis, endometriosis, vulvodynia, pelvic congestion syndrome) * active vaginal infection at the time of the index procedure * history of pelvic inflammatory disease

Keywords: pelvic organ prolapse graft repair
efficacy of aflibercept (eylea®) on choroidal neovascularization (type 3)

Conditions: Type 3 Choroidal Neovascularization

Summary: this is a one-year pilot, interventional, prospective, single arm, non-randomized, multicentric (3 centers) controlled study that aims to evaluate the response of type 3 choroidal neovascularization to treatment by aflibercept following a classic protocol.


Eligibility criteria:
inclusion criteria: * males or females aged more than 50 years * patients with type 3 choroidal neovascularization assessed on fa, icg and oct * exudation on sd-oct scans defined by intraretinal cysts or subretinal fluid. * best corrected visual acuity at inclusion between 24 and 78 letters (etdrs) * media clarity, pupillary dilation and patient cooperation sufficient to allow fundus photographs of adequate quality exclusion criteria: * any contraindications as reported in the labelling of aflibercept (eylea®): ocular or periocular infection, active intraocular inflammation or hypersensitivity. * any previous history of intravitreal injections in the study eye for exudative amd * any secondary chorioretinal anastomosis due to retinal scar or fibrosis * any history of vitrectomy * media opacities preventing accurate imaging of the retina (cataract) * any other retinal disorder possibly associated with type 3 cnv (epiretinal membrane, macular hole) * confirmed intraocular pressure ≥25 mmhg or non-stable glaucoma.
treatment of paradoxical vocal fold motion disorder (pvfmd) with a form of respiratory retraining technique

Conditions: Paradoxical Vocal Fold Motion Disorder; Vocal Cord Dysfunction

Summary: paradoxical vocal fold motion disorder (pvfmd), otherwise known as vocal cord dysfunction (vcd) is a laryngeal breathing disorder that has several potential causes. in some individuals, exertion is the predominant trigger. pvfmd can present like an asthma attack, but asthma medication is ineffective in treating it. the effects of untreated pvfmd can be devastating, leading to harmful, invasive, and ineffective treatments over a period of years. numerous anecdotal reports indicate that several behavioral techniques, may be surprisingly effective and even curative. however, data are lacking. the form of respiratory retraining technique tested in the current study educates people with pvfmd about breathing and teaches them a number of breathing exercises specially designed to restore normal breathing patterns. this case series study will use a dyspnea perception questionnaire, patient daily logs, and physiological measurements of heart rate and breathing to examine whether this form of therapy can improve exertion-induced pvfmd symptoms.


Eligibility criteria:
inclusion criteria: * otherwise healthy according to available medical history or by patient and parent report on the health questionnaire * patients with no history of asthma, or well-controlled asthma * a diagnosis of pvfmd by an otolaryngologist based on set criteria in-line with the national jewish pvfmd diagnostics protocol (based on hicks, 2008; hoyte, 2013, martin, 1987), to be confirmed by an additional otolaryngologist blinded to the initial diagnosis * a score of three or more on the dyspnea index (di) exclusion criteria: * a score of less than three on the di * people diagnosed with hypertension, cardiac disorders or severe pulmonary diseases which affect blood oxygen saturation * uncontrolled asthma

Keywords: paradoxical vocal fold motion disorder (pvfmd) vocal cord dysfunction (vcd) respiratory retraining respiratory disorders
cryo rib fracture study

Conditions: Rib Fractures

Summary: the purpose of this study is to determine if patients with rib fractures who undergo cryoablation of the intercostal nerves have improved pain control 7 days from procedure when compared to those who have a esp catheter.


Eligibility criteria:
inclusion criteria: * patients who are over 18 who have more than one ribs fractured. exclusion criteria: * patients who have an exclusion to regional anesthesia. * patients who are pregnant via self-report or pregnancy test if they take one. * non-english speakers * patients who have cold urticaria * patients with bilateral fractures * patients currently intubated