Kornimate/medical-research-clean huggingface dataset:
apioc contact lens feasibility

Conditions: Ametropia; Myopia; Hyperopia; Astigmatism; Presbyopia

Summary: this clinical trial will document the feasibility of the apioc lens design by assessing which lens shape parameters yield successful on-eye-fit and movement of the apioc contact lens design and evaluate the subjectively-reported comfort of the apioc contact lens design.

this is a one-site, non-dispensing clinical trial using the apioc contact lens design. this soft contact lens study will determine the feasibility of this design by determining which parameters of the shape of the apioc contact lens design will yield a successful fit across subjects. we will also determine the percentage of subjects who can be successfully fitted with the apioc contact lens design. because the feasibility of the lens design may be dependent upon age, a total of 50 subjects (10 subjects each across 5 decades of life) will complete the study. the data will be collected in a single visit for most subjects. a few subjects may be asked to return for a second visit if additional contact lens parameters need to be ordered to achieve a successful fit. the key assessments for this study will be demonstration of feasibility of fit, documentation of movement in all gazes, including translation, and subjective reports of comfort. subjects will only wear contact lenses while in the office.

Eligibility criteria:
inclusion criteria: 1. thirty subjects will be at least 40 years of age and no more than 60 years of age. ten subjects will be at least 18 years of age and no more than 29 years of age. ten subjects will be at least 30 years of age and no more than 39 years of age. 2. the subject must have ≤ 1.50 d of corneal astigmatism. 3. the subject should have clear, healthy corneas. 4. the subject should have a normal, healthy conjunctiva in both eyes. 5. the subject should be free of active ocular disease. refractive error and presbyopia are permitted. 6. the subject must provide written informed consent. 7. the subject must appear willing and able to adhere to the instructions set forth in this protocol. exclusion criteria: 1. no irregular corneal astigmatism is permitted. 2. no pterygia or corneal scarring that would interfere with contact lens wear. 3. no pinguecula or other conjunctival thickness abnormalities are permitted that would interfere with contact lens wear. 4. the subject should not be using any ocular pharmaceutical treatments, including artificial tears in the two weeks prior to the examination.

Keywords: contact lens soft contact lens feasibility
relationship between postpartum mood disorders and delivery experience

Conditions: Postpartum Period; Depression; Stress Disorders, Post-Traumatic

Summary: the purpose of this study is to evaluate potential risk factors for developing postpartum depression or posttraumatic stress disorder during the first year postpartum in patients who have no preexisting history of ptsd or ppd.

it is theorized that poor pain control during labor and cesarean delivery, non-elective inductions, unplanned surgeries such as urgent/emergent cesarean delivery or operating room management of postpartum hemorrhage, and opioid abuse/addiction are risk factors for developing postpartum depression (ppd) or post-traumatic stress disorder (ptsd) after delivery. this study will, through questionnaires, interviews, and examination of the medical record, seek to identify whether and how strongly such correlations exist during the first year postpartum in patients who have no preexisting history of these conditions.

Eligibility criteria:
inclusion criteria: * woman planning on giving birth at the university of michigan * speaks english without translator * live pregnancy not desiring termination * smartphone owner * woman whose delivery date is \>28 weeks gestational age exclusion criteria: * history of previous postpartum depression (ppd) or posttraumatic stress disorder (ptsd) from a birth experience * non-english speaker requiring a translator * patients who have a fetus with major fetal anomalies * positive screening at 28 weeks antepartum for edinburgh postnatal depression scale (epds) or primary care ptsd (pc-ptsd) screen

Keywords: birth experience postpartum depression ptsd pain during labor pain during cesarean delivery non-elective induction of labor unplanned surgery for urgent/emergent cesarean delivery postpartum hemorrhage
efficacy and safety of lcz696 in comparison to olmesartan in asian patients with essential hypertension

Conditions: Essential Hypertension

Summary: this study will assess the efficacy and safety of multiple doses of lcz696 compared to olmesartan in asian patients with essential hypertension


Eligibility criteria:
inclusion criteria: * patients with mild-to-moderate hypertension, untreated or currently taking antihypertensive therapy. * treated patients (using antihypertensive treatments within 4 weeks prior to visit 1) must have an mssbp≥150 mmhg and \<180 mmhg at the randomization visit (visit 201) and mssbp≥140 mmhg \<180 mmhg at the visit immediately preceding visit 201 (visit 102 or 103). * untreated patients (newly diagnosed with essential hypertension or having a history of hypertension but have not been taking any antihypertensive drugs for at least 4 weeks prior to visit 1) must have an mssbp≥150 mmhg and \<180 mmhg at both visit 1 and visit 201. * patients must have an absolute difference of ≤15 mmhg in mssbp between visit 201 and the immediately preceding visit. exclusion criteria: * patients with severe hypertension (msdbp ≥110 mmhg and or mssbp ≥180 mmhg). * history of angioedema, drug-related or otherwise, as reported by the patient. * history or evidence of a secondary form of hypertension, including but not limited to any of the following: renal parenchymal hypertension, renovascular hypertension (unilateral or bilateral renal artery stenosis), coarctation of the aorta, primary hyperaldosteronism, cushing's disease, pheochromocytoma, polycystic kidney disease, and drug-induced hypertension. * patients who previously entered a lcz696 study and had been randomized or enrolled into the active drug treatment epoch. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: essential hypertension lcz696
treatment of irritable bowel syndrome (ibs) with sacral nerve stimulation

Conditions: Irritable Bowel Syndrome

Summary: sacral nerve stimulation (sns) has become a well-established treatment for patients with fecal incontinence since 1995. the mechanism of action of sns is still not fully understood but recent studies have shown that the motility of the whole colon is modulated during the stimulation. this modulation of the colonic motility could be a potential mechanism of an action to relieve the symptoms in patients with ibs. twenty eight patients with ibs will be enrolled in the study. they have to meet the rome iii criteria, and also satisfy the criteria for implantation of a neurostimulator. after a post implantation period where the programming of the neurostimulator is optimised, the patient is randomized in a double blinded design to receive either on-off or off-on stimulation in a 2-month period. at the end of each period (on/off) the patient will be examined with magnet tracking system (mts) for motility and with impedance planimetry including thermal stimulation (circulating water)for multimodal sensory testing of the rectum. this is based on the study hypothesis that the motility of the small intestine and the colon is changed in ibs patients according to their subtype (diarrhoea-ibs, constipation-ibs and disordered bowel habit-ibs) compared to healthy persons. and that sns will affect the motility of the small intestine and the colon in ibs patients as well as sns will affect the perception of pain/discomfort in the rectum in ibs patients. the effect of on-off-sacral nerve stimulation on the ibs patients and thereby their ibs symptoms will also be evaluated by an ibs score (gsrs-ibs)and on quality of life by an ibs impact scale (ibs-is) as well as the significance of placebo effect in the treatment of patients with ibs with sns will be evaluated.


Eligibility criteria:
inclusion criteria: * patients aged over 18 * patients who are psychologically stable and suitable for intervention and able to provide informed consent. * patients who are diagnosed with ibs according to the rome iii criteria * minimum 30% reduction of the ibs symptoms during the pne-test (a criteria for implantation of the neurostimulator) exclusion criteria: * overt bowel diseases including inflammatory bowel disease * pregnant or breast feeding * patients who are considered unable to follow the planned programme of the study, including mentally illness or physiological instability * patients who are on medication with known influence on gastrointestinal motility including those for thyroid disease, diabetes mellitus, celiac disease and neurological disease

Keywords: irritable bowel syndrome sacral nerve stimulation motility pain perception gsrs-ibs ibs-is
chemoradiation versus esophagectomy for locally advanced esophageal cancer

Conditions: Esophagus Cancer

Summary: the aim of this study is to compare outcomes in chinese patients with locally advanced resectable esophageal squamous cell cancer who have received either surgery or definitive chemoradiation (crt) by the randomized, open-label, multicenter trial.

background: more than half of global esophageal cancer cases came from china, but the report about definitive chemoradiation (crt) compared with esophagectomy in chinese patients with locally advanced resectable esophageal squamous cell cancer (escc) is limited. aim: to compare outcomes in chinese patients with locally advanced resectable esophageal squamous cell cancer who have received either surgery or definitive chemoradiation (crt). methods: 176 escc patients with t1bn+m0, t2-4an0-2m0 will be randomized to crt group or surgery group.in the crt group, patients will be given intensity modulation radiation therapy (imrt) with 50gy/25 fractions , and current chemotherapy with 5-fluorouracil (5-fu) basic regimens. in the surgery group, patients will received standard esophagectomy. 5 years follow-up for both groups patients. primary endpoints: 2 year and 5 year disease free survival, overall survival second endpoints: treatment-related adverse events; the quality of life

Eligibility criteria:
inclusion criteria: * chinese * esophageal squamous cell cancer * mid or lower esophageal cancer * tumor is resectable disease * clinical stage: ct1bn+mo, or ct2-4an0-2m0 exclusion criteria: * who had distant metastasis to solid visceral organs or local invasion into trachea, descending aorta, or recurrent laryngeal nerve. * who had a serious premorbid condition or a poor physical status that compromised a thoracotomy.

Keywords: esophageal cancer chemoradiation esophagectomy
genetic basis of immunodeficiency

Conditions: Severe Combined Immunodeficiency

Summary: this study will examine the role of hereditary factors in different forms of severe combined immunodeficiency (scid). patients with immunodeficiencies may be eligible for this study. candidates include: * patients with diminished numbers of t cells or nk cells or both, or * patients with normal t cell and nk cell numbers but diminished t cell, b cell, or nk cell function. relatives of patients will also be studied. participants will have blood samples collected for genetic analysis in studies related to scid at the national institutes of health and other institutions.

the goal of this project is to identify the genetic basis of new forms of inherited immunodeficiency. the particular focus relates to cytokines such as il-2, il-4, il-7, il-9, il-15, and il-21 that share the common cytokine receptor (gamma) chain, (gamma c), and to molecules that are important for signaling or gene regulation in response to these cytokines, although other causes of inherited immunodeficiency are also encompassed.

Eligibility criteria:
* inclusion criteria: index cases to be included are those with diminished numbers of t cells and/or nk cells and/or b cells or other immune cells or those who have normal numbers of t cell, b cells, nk cells and other immune cells but diminished function of one or more immune cells. relatives of affected individuals may also be studied * patients (index cases): 6 months of age and older * siblings: 6 months of age and older * non-sibling relatives (biological parent, aunt, uncle or grandparent): 18 years or older exclusion criteria: * patients with a known diagnosis * patients with a particular immunological phenotype that is not of interest to the research conducted under this study. * pregnancy or lactation * adults with current decisional impairment

Keywords: cytokines inherited immunodeficiency natural history
pcc vs. ffp for post cardiopulmonary bypass coagulopathy and bleeding

Conditions: Bleeding; Blood Loss, Surgical; Cardiovascular Surgical Procedures; Prothrombin Complex Concentrates; Fresh Frozen Plasma

Summary: this will be the first prospective randomized controlled clinical trial directly comparing prothrombin complex concentrate (pcc) compared to fresh frozen plasma (ffp) for post cardiopulmonary bypass microvascular bleeding and factor-mediated coagulopathy. is there a difference in bleeding and transfusion requirements in patients received pcc versus ffp?


Eligibility criteria:
inclusion criteria all subjects accepted for this study must: * be 18 years of age * be undergoing elective cardiac surgical procedure utilizing cardiopulmonary bypass * have evidence of excessive microvascular bleeding in the surgical field as determined by the surgical team in addition to a pt \>16.6 sec or inr \>1.6 sec. exclusion criteria subjects who have one or more of the following will be excluded from the study: * are unable to grant informed consent or comply with study procedure * history of hypercoagulable condition (e.g. factor v leiden, at-3 deficiency, prothrombin gene mutation, anti-phospholipid antibody syndrome, etc) or previous unprovoked thromboembolic complications * coagulopathic conditions such as factor deficiencies, factor inhibitors, heparin induced thrombocytopenia, or use of intravenous anticoagulants other than heparin at the time of cardiovascular surgery * thromboembolic event within past 3 months * received oral therapy with clopidogrel, prasugrel, rivaroxaban or dabigatran within the past 5 days * patients taking chronic warfarin therapy who have not discontinued treatment and demonstrated an inr \<1.3 prior to surgery * fibrinogen level \<150 mg/dl on initial post cardiopulmonary bypass labs * antithrombin 3 level \< 80% control (preoperative) * are undergoing emergency open heart-surgery * cardiopulmonary bypass time is expected to be \< 30 minutes * age \< 18 years of age * are pregnant
effects of 8-weeks strength training on strength program, power and agility in traceurs

Conditions: Low Back Pain

Summary: the goal of this randomized controlled trial was to examine effects of 8-weeks strength training program on strength, power and agility in traceurs. the main question it aims to answer is: • to determine the effects of 8-weeks strength training program in traceurs. participants were a given consent form and after subjects read and sign the informed consent, they were included in study according to eligibility criteria. 2 groups were included in study, strength group with parkour routine training was applied on group a and the control group, group b was provided with parkour routine training. outcome was measured through different outcome measure tools.

the parkour is a physical activity that contains exceptional technique applications and requires a major number of jumps. the purpose of this study was to examine the effects of 8-week strength training on strength program, power, and agility in traceurs (parkour practitioners). officially incorporated as a sport in the uk in 2017 but born in france almost 30 years ago. parkour consists of practitioners finding a route through predominantly urban terrain, mastering various physical and psychological skills to overcome obstacles in the most efficient, effective way possible. a randomized controlled trial will be performed in which total 16 traceurs will be observed for 8 weeks. the data was collected from pakistan parkour \& free running academy in quetta, balochistan. participants would be randomly divided into two balanced groups. one group was provided with parkour training sessions, and the other group was provided with both strength and parkour training sessions. the participants, who have done strength training along with the parkour trainings, apply 4 sets of strength training exercises with 10 repetitions determined from acsm two days a week, with a minimum of 72 hours between these days. the control group was applied only two hours of parkour training for two days a week. aim of study was to observe effects of strength training in vertical jump heights at the end of the 8-week strength trainings comparison to the control group and that of the strength training. this study aids in learning of the vertical jump heights by including strength training programs with routine trainings, which is a central parameter for successful performance in traceurs, can enable the coaches and athletes to prepare a better training.

Eligibility criteria:
inclusion criteria: * age (16-30years) * male traceurs * parkour participants had been involved in parkour practice for at least two years (2 times per week for a minimum of 2 hours per day) and did not have any bone, articular or muscular injuries in the previous 6 months. exclusion criteria: * participants been involved in strength training before. * participants not been involved in parkour practice for minimum 2years. * participant who have injuries within previous 6 months. * participants who smokes or were taking medication.
effectiveness of an oral feeding educational nurse program on feeding performance in preterm neonates

Conditions: Preterm Neonates and Feeding

Summary: poor oral motor development in preterm neonates is common. feeding problems lead to longer hospital stay and higher hospital cost. different interventions have shown their efficacy to accelerate transition and move faster to full oral feeding autonomy. our study aimed to evaluate the impact of a 2-year education nurse program on feeding pattern and hospital stay of preterm neonates. this is an interrupted time series study placed in intensive care and neonatal unit of an university hospital located in lyon, france. all preterm neonates are included in the study, from april 2013 to january 2016.


Eligibility criteria:
inclusion criteria: * preterm neonates of less than 34 weeks' of gestation * preterm neonates not requiring surgery with endotracheal intubation * preterm neonates hospitalized in the neonatology and neonatal intensive care unit of an university hospital, lyon. * preterm neonates discharged from hospital during the study period from april 2013 to january 2016 --- exclusion criteria: * preterm neonates presenting delivery age above 34 weeks' of gestation * preterm neonates whose parents have expressed their opposition to participate to the study

Keywords: neonate oral feeding disorder full oral feeding training quality of health care
limpron: limburg pre-eclampsia investigation

Conditions: Pregnancy; Pre-eclampsia

Summary: background: multiple adaptations at the cardiovascular system occurs during pregnancy. in the pregnancy condition pre-eclampsia (pe), this adaptations are abnormal. five to eight percent of all pregnant women worldwide will develop pe. pe is a pregnancy condition which is characterized with a high blood pressure (\>140/90 mm hg) and the occurrence of proteinuria (\>3g/dl/24h) after 20 weeks of gestation. when untreated, this condition can have severe complications for both mother and child. it's important to monitor women with a high risk for developing pe for an early detection and treatment of this condition. for this reason, a multicenter study is set up with the following applications: 1. niccomo and maternal venous doppler echography: impedance cardiograph and an echography of the heart and veins. 2. maltron: bio-electronic impedance analyze 3. remote monitoring of the high risk patients to become a more intensive follow-up number of inclusions: 2000 pregnant women from the prenatal consultations of eight different hospitals:


Eligibility criteria:
inclusion criteria: * \> 10 weeks of pregnancy, primipara and multipara exclusion criteria: * \< 10 weeks of pregnancy and congenital malformations of the fetus
prognostic evaluation of covid-19 in rheumatoid arthritis patients

Conditions: Covid19; Rheumatoid Arthritis

Summary: covid-19 is an infectious disease caused by sars-cov2 virus. the objective of our study is to analyze the progression and the severity of covid-19 in patients with ra. indeed, few data are available on this subject, and this would allow us to improve management of covid-19 in these potential at-risk patients.


Eligibility criteria:
inclusion criteria: - confirmed covid-19 diagnosis (positive pcr or serology) in ra patients or healthy controls. exclusion criteria: * age under 18 years old * suspected covid-19 diagnosis (typical symptoms without a positive pcr or serology)

Keywords: dmards biotherapy
biomarkers in predicting response to chemotherapy in samples from young patients with osteosarcoma

Conditions: Localized Osteosarcoma; Metastatic Osteosarcoma; Osteoblastic Osteosarcoma; Recurrent Osteosarcoma

Summary: this research study is studying biomarkers in predicting response to chemotherapy in samples from young patients with osteosarcoma. studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. it may also help doctors predict how patients will respond to treatment.

study subtype: ancillary/correlative observational study model: cohort time perspective: retrospective biospecimen retention: samples with dna biospecimen description: tissue study population description: children's oncology group sampling method: non-probability sample primary objectives: i. determine whether methylation status predicts response to neoadjuvant chemotherapy in samples from children and young adults with osteosarcoma. outline: patients are stratified according to response to neoadjuvant chemotherapy (good vs poor). dna and rna extracted from biopsy samples are analyzed for methylation changes and transcription changes by ligation-mediated pcr and mass-array genotyping.

Eligibility criteria:
inclusion criteria: * diagnosed with high-grade osteoblastic osteosarcoma * biopsy samples from patients who had good or poor response to neoadjuvant chemotherapy available * all specimens should be from post-menarchal females or age-matched males with appendicular tumors * patients' clinical data including chemotherapy received, event-free survival, and overall survival available * see disease characteristics