Kornimate/medical-research-clean huggingface dataset:
safety and effectiveness of arcuate incisions performed with the ifs femtosecond laser system

Conditions: Corneal Astigmatism

Summary: to determine if arcuate incisions performed with the ifs femtosecond laser are safe and effective in reducing corneal astigmatism.

surgeons will perform arcuate incisions in the cornea in arc segment patterns using the ifs femtosecond laser to treat subjects with corneal astigmatism.

Eligibility criteria:
inclusion criteria: 1. male or female, of any race, and at least 21 years of age at the time of pre-op exam 2. corneal astigmatism, as determined by topographic keratometry, of 0.75 d to 4.00 diopters (d) 3. best spectacle corrected distance visual acuity (bscva) 1. group 1: * natural astigmatism, no cataract - bscva of 20/25 or better * pre cataract or phakic iol surgery - no bscva criteria 2. group 2: * post iol surgery- bscva of 20/25 or better 4. uncorrected visual acuity (ucva) of 20/40 or worse 5. demonstration of agreement: corneal astigmatism (as determined by topographic keratometry) must be in agreement with refractive astigmatism (as determined by manifest refractions) within \ 1.5 d. 6. preoperative central pachymetry of \>/=480 um 7. keratometry between 38.0 d (flat) to 48.0 d (steep) 8. corneal power (diopters) difference at the 3mm point from topographic center shall be \</= 1d at the steepest meridian 9. intraocular pressure of 12 to 21 mm hg with no glaucomatous retinal/optic nerve changes 10. subjects who have worn a contact lens within the past 30 days must remove the soft lens at least 2 weeks prior and a rigid or toric lens at least 3 weeks prior to baseline measurements 11. willing and capable of returning for follow-up examinations for the duration of the study exclusion criteria: 1. angle kappa of greater than 0.5 mm, absolute value 2. prior implantation of toric or multifocal intraocular lens 3. women who are pregnant, breast-feeding, or intend to become pregnant over the course of the study 4. concurrent use of topical or systemic medications that may impair corneal wound healing 5. history of any ocular or medical conditions that could affect corneal wound healing 6. history of active or recurrent ophthalmic disease, including corneal dystrophy or other non-refractive abnormality such as exposure keratitis or clinically significant dry eye 7. abnormal topography, including evidence of keratoconus or pellucid marginal degeneration in either eye 8. evidence of clinically significant corneal opacity/scar in the operative eye(s) within an 8 mm diameter zone of the visual axis 9. known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course 10. participation in any other conflicting clinical study

Keywords: astigmatism
the activation of hippo pathway in nasal polyps

Conditions: Nasal Polyps

Summary: hippo-yap pathway is a newly discovered pathway controlling the growth, and plays important roles in the regulation of stem cell function and tissue regeneration. previously we found that a higher expression of yap in np, and lps was able to activate the hippo-yap pathway in nescs. thus, we hypothesize that the aberrant proliferation and differentiation of nescs could be regulated via the hippo-yap pathway.

studies have shown that the development of nasal polyps (np) are closely related to the epithelial remodeling.the investigators have shown that nasal epithelial stem cells(nescs) derived from np had reduced growth and proliferation dynamics in vitro culture,and differentiated into ciliated cells with impaired cilia architecture and ciliogenesis.further studies demonstrated that nescs were involved in the aberrant damage repair process of the epithelial remodeling in np.hippo-yap pathway is a newly discovered pathway controlling the growth,and plays important roles in the regulation of stem cell function and tissue regeneration.previously the investigators found that a higher expression of yap in np,and lps was able to activate the hippo-yap pathway in nescs.thus,the investigators hypothesize that the aberrant proliferation and differentiation of nescs could be regulated via the hippo-yap pathway,which may result in the epithelial remodeling.in this study,the investigators intend to investigate the mechanism of the hippo-yap pathway in regulating aberrant proliferation and differentiation of nescs and explore its upstream signaling and downstream target genes,using the nescs gas-liquid interface culture system,and a silencing and overexpression of the hippo-yap pathway component strategy.the investigators aim to unravel the effect and mechanism of the hippo-yap pathway in the epithelial remodeling of np,providing new targets and strategy for the improvement or reversal of np epithelial remodeling.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of nasal polyps or deviation of nasal septum based on ct * must be able to withstand surgery * at least 18 years old * a sufficient level of education to understand study procedures and be able to communicate with site personnel and adhere to the follow-up; * accepted informed consent verbally and in writing exclusion criteria: * the poor health * be allergic to anesthetics

Keywords: nasal epithelium stem cells hippo-yap pathway proliferation differentiation
whole body vibration versus functional strength training on balance in children with hemiparetic cerebral palsy

Conditions: Cerebral Palsy; Hemiparesis

Summary: the study will be directed to compare which of whole body vibration (wbv) training and functional strength training (fst) has better effect on balance in children with hemiparesis

hemiparesis is a type of hemiplegia where mild muscle weakness causes balance disturbances because one side of the body is affected such as the arm, chest leg or face. muscle weakness is commonly associated with abnormal bone development, leading to increased susceptibility to fractures, most cerebral palsy children have deficits in balance, coordination, and gait throughout childhood and adulthood. so, it is essential to seek an ideal physical therapy program to help in solving such widespread problem. balance control is important for competence in the performance of most functional skills, helping children to recover from unexpected balance disturbances, either due to slips and trips or to self- induced instability when making a movement that brings them toward the edge of their limit of stability whole body vibration is mechanical oscillation, defined by amplitude and frequency, generates a force that acts on whole body. it is a training method for muscle tone modulation that is increasingly used in a variety of clinical situations. functional strength training (fst) is an effective method of exercise therapy. it can be combined with traditional physical therapy methods and can be successfully combined with most rehabilitation and exercise equipment. it provides postural stability while promoting independence with confidence. the current study will be directed to compare which of whole body vibration (wbv) training and functional strength training (fst) has better effect on balance in children with hemiparesis.

Eligibility criteria:
inclusion criteria: * the children in the study will be selected according to the following criteria: 1. their chronological age ranged from five to eight years old. 2. spasticity grade i and ii according to modified ashworth scale. 3. they will be on level ii and iii according to gross motor functional classification system (gmfcs) 4. have the ability to walk independently. 5. they can understand order and follow instruction. 6. the child will be able to follow verbal commands and instructions. 7. they can firmly grasp the rails of biodex device. exclusion criteria: 1. children with visual or auditory problems. 2. children with uncontrolled convulsions. 3. children with fixed contractures and deformities. 4. children with surgical intervention less than one year. 5. children injected by botox in the calf muscle from less than one year. 6. children had heart disease. 7. children with epilepsy. 8. children with severe diabetes. 9. children with severe vascular disease

Keywords: cerebral palsy hemiparesis balance whole body vibration functional strength training
the molecular characterization of multiple myeloma at relapse

Conditions: Multiple Myeloma

Summary: observational study investigating prognostic factors in newly diagnosed and relapsed multiple myeloma patients by use of clinical data, biochemical markers (blood samples), cytogenetic markers and gene expression profiling (myeloma cells from fresh bone marrow samples). enabling future genetic studies by establishing a biobank of bone marrow and peripheral blood samples.

multiple myeloma (mm) is an incurable cancer. the disease can often be brought to a halt with chemotherapy which in younger patients is accompanied by stem cell transplantation. but the disease relapses almost invariably. cytogenetic changes in the myeloma cells can serve as prognostic markers. accordingly, 25% of the patients show changes associated with a prognosis so poor that they should probably receive experimental treatment right from the start. nevertheless, a part of these patients survive much longer than expected. thus, the prognosis must depend on additional genetic events. the aim of this project is to widen the investigators knowledge of the nature, chronology and prognostic value of the genetic events in mm in order to improve the risk stratification of the patients and hence the choice of treatment. using cytogenetics (interphase fish) and molecular biological analyses (snp, gep, mirna) the investigators will study the changes in the myeloma cells. the investigators will search for genetic and clinical differences between patients within the same cytogenetic group and between patients at diagnosis and at relapse. the study population will consist of 100 newly diagnosed patients and 100 relapse patients included prospectively over a 2-year period in a cooperation between the four departments of hematology in zealand, denmark. hypotheses: 1. early relapse depends on a) molecular defects in the myeloma cells detectable with fish, gep, snp and/or mirna analyses, and b) the acquisition of new mutations resulting in chemotherapy resistance and increased prolific capacity. 2. the progressive reduction of event free survival seen with every relapse until the disease turns refractory can be explained by selection of critical mutations. 3. the cytogenetic changes associated with poor prognosis represent a heterogenous group of patients in whom the responsible genetic events remain unknown.

Eligibility criteria:
inclusion criteria: * patients newly diagnosed with multiple myeloma and at the same time eligible for high dose chemotherapy and autologous stem cell transplantation * patients with multiple myeloma experiencing relapse after high dose chemotherapy and autologous stem cell transplantation exclusion criteria: * for newly diagnosed patients: age or comorbidity preventing high dose chemotherapy and autologous stem cell transplantation, * for all patients: age below 18, physical or psychological incapability to give an informed consent.

Keywords: classification diagnosis genetics mortality pathology
heparin's influence on rotem® analysis

Conditions: Coronary Artery Disease

Summary: coagulopathy with transfusion requirements is frequent during cardiac surgery with cardiopulmonary bypass. rotational thromboelastrometry (rotem®) is a viscoelastic whole blood point of care test used to assess the patient's coagulation status. the purpose of this study is to evaluate the feasibility of rotem® analysis in the presence of very high heparin concentrations as seen during cardiopulmonary bypass.

the society of cardiothoracic surgeons suggest that 50% of patients undergoing cardiac surgery have a blood transfusion. several studies indicate an increase in morbidity and mortality related to blood transfusions. traditionally, the coagulation tests are performed in the hematology laboratory. rotational thromboelastrometry is a useful method of assessing perioperative coagulation function in patients undergoing cardiac surgery. the presence of significant amounts of heparin in blood samples during cardiopulmonary bypass induces artifactual errors when thromboplastin is used as a reagent. for this reason, whole blood coagulation monitoring with rotem® has not been feasible during cardiopulmonary bypass with heparin anticoagulation. recently recombinant thromboplastin has come available. it's stability is guaranteed by the manufacturer for plasmatic heparin concentrations up to 5ui/l . three of the available rotem®-tests are extem (activation by recombinant thromboplastin), intem (activation by elagic acid) and heptem. in the latter, heparinase, added to the intem reagent, eliminates heparin to reveal underlying coagulopathies. the purpose of this study is to evaluate the feasibility of rotem® analysis in the presence of very high concentration of heparin and to evaluate whether heparinase could reverse heparin's effect on extem and intem during cardiopulmonary bypass. arterial blood samples were drawn for analysis after induction of anesthesia (t0),10 minutes after the administration of heparin (t1), at unclamping of the aorta (t2) and after heparin reversal with protamine (t3). the following tests will be performed: extem, intem, heptem and a heparinase modified extem. for the latter, recombinant thromboplatin instead of the elagic acid is used in the heptem test. heparin concentrations are measured at t1 and at the end of bypass (t2). hepcon® was used for heparin management.

Eligibility criteria:
inclusion criteria: * patients ungergoing coronary artery bypass grafting using cardiopulmonary bypass * patients from 18 to 85 years old. exclusion criteria: * patients incapable to consent. * known coagulopathies or platelet dysfunction. * patients treated with antiplatelet drugs other than aspirin. * patients treated with anti vitamine k anticoagulants. * patients treated with heparin less than 6 hours prior to surgery.
calcium supplementation to prevent preeclampsia in sichuan province of china

Conditions: Preeclampsia

Summary: the purpose of this study is to determine whether calcium supplementation is effective to prevent preeclampsia in sichuang province of china and which dose is more suitable


Eligibility criteria:
inclusion criteria: * nulliparity;age ≥35 years;previous pre-eclampsia;family history of pre-eclampsia;multiple pregnancy;time between pregnancies ≥10years;body mass index ≥25;diastolic pressure ≥ 80 mm hg before 20 weeks' gestation;proteinuria ≥+ on more than one occasion or ≥ 300 mg/24 h before 20 weeks' gestation;underlying medical conditions(pre-existing hypertension;pre-existing renal disease;pre-existing diabetes;presence of antiphospholipid antibodies;chronic autoimmune disease);male sex partner's predecessor wife has previous pre-eclampsia exclusion criteria: * first prenatal visit after 16 weeks' gestation;severe anemia;other underlying medical conditions which need treatment first (such as uncontrolled hyperthyreosis )
alteration of deep brain stimulation parameters for dystonia

Conditions: Dystonia

Summary: deep brain stimulation (dbs) involves placing electrodes into the brain. through these electrodes, artificial electrical signals are chronically delivered into deep brain regions in order to alter abnormal brain activity. the artificial electrical signals are generated by a battery that is inserted under the skin of the chest. dbs is used to treat several disorders of movement, including dystonia. in dystonia, the electrodes are inserted into a brain region called the globus pallidus. globus pallidus stimulation can be very effective therapy for dystonia. however not all patients are equally responsive and therapeutic outcomes can be frustratingly variable. the reason for this variability is unclear. such variability in response may need to be met by tailoring stimulation to individual patients. another issue with deep brain stimulation is battery life. eventually, batteries become depleted and need to be replaced. such battery replacements require an operation, hospital stay and the risk of introducing infection. the high electrical energy that has been used to treat dystonia means that batteries are typically replaced every year or two. the artificial electrical signals of deep brain stimulation are delivered with three parameters; frequency (hertz - hz), voltage (volts) and pulse width (microseconds). it has recently been reported that lower frequency stimulation, at 60hz rather than 130hz, can be used effectively to treat dystonia. such 60hz stimulation may be more effective for some patients than others. the lower energy demands of 60hz stimulation would also greatly improve battery life (potentially doubling battery life). the aim of this study is to assess if 60hz stimulation is more effective in ameliorating the dystonia of patients who have responded poorly to 130hz pallidal stimulation. the current status of the evidence is one of clinical equipoise (uncertainty) and therefore suits a double blinded randomised trial.


Eligibility criteria:
inclusion criteria: * primary dystonia (focal cervical or generalised dystonia) who are receiving chronic (\>1 year) bilateral pallidal stimulation but have had poor therapeutic responses (\< 50% improvement in relevant dystonia severity rating scale\*) despite confirmation of accurate electrode position. * able to understand study requirements - able to provide consent. * relevant dystonia rating scales: cervical dystonia - severity subsection of the toronto western hospital spasmodic torticollis rating scale; generalised dystonia - severity section of the burke fahn marsden rating scale. exclusion criteria: * none.

Keywords: dystonia
a comprehensive hiv prevention package for south african adolescent girls and young women: imara sa

Conditions: Sexually Transmitted Infection; Hiv

Summary: programs which go beyond individual-level behavior change to reduce hiv and sti infections among adolescent girls and young women in sub-saharan africa are essential to meet global hiv targets. informed, motivated, aware and responsible adolescents and adults- south africa (imara-sa) is an evidence-based hiv-prevention intervention for adolescent girls and young women (agyw) and their female caregivers, which has been adapted for a south african audience. this pilot study will assess feasibility in preparation for a randomized controlled trial (rct). additionally, the pilot will examine the preliminary effectiveness of imara-sa in reducing sexually transmitted infections (sti) and increasing uptake of hiv testing and counseling (htc) and pre-exposure prophylaxis (prep) at follow-up among agyw. about 60 agyw-fc dyads will be enrolled and randomized to imara-sa or a health-promotion control arm. following randomization, the dyads will participate in an \~2-day group workshop (\~10 hours), which includes joint and separate mother and daughter activities. agyw and fc will complete baseline assessments and follow-up assessments approximately 6 months later. assessments will include surveys, stis testing (for chlamydia and gonorrhea), and uptake of htc and a 1-month prep prescription. additionally, the intervention's implementation (e.g., acceptability) will be explored.


Eligibility criteria:
inclusion criteria for agyw include: 1. black or mixed race; 2. 15-19 years-old; 3. residing in klipfontein/mitchells plain (k/mp); 4. speak isixhosa or english or a combination of these languages. inclusion criteria for fc include: 1. identified by agyw as a fc; 2. 24 years and older; 3. living with or in daily contact with the agyw; 4. speak isixhosa or english or a combination of these languages. exclusion criteria: agyw will be excluded from the study if they do not have a fc to participate in the study. agyw and fc will be excluded from the study if they: 1. are unable to understand the consent/assent process and provide written informed consent; 2. are currently enrolled in another research study addressing hiv/stis/prep; 3. participated in the imara-sa adaptation process. agyw and fc must agree to participate as a dyad. agyw refusal will supersede fc consent.

Keywords: hiv prevention adolescent girls and young women south africa mother-daughter intervention
the prediction of intracranial pressure and clinical outcome by transcranial doppler in neurocritical patients

Conditions: Head Injury; Intracerebral Hemorrhage; Ischemic Stroke; Subarachnoid Hemorrhage; Brain Tumor; Hydrocephalus

Summary: the purpose of this study is to use transcranial doppler (tcd) to predict intracranial pressure (icp) and clinical outcome of neurocritical patients.

transcranial doppler (tcd) and transcranial color-coded duplex sonography (tccs) play an important part in neurocritical monitoring systems. currently there are studies using flow velocities and pulsatility index (pi) to predict intracranial pressure (icp) and clinical outcome. but the use of b-mode in such prediction is not yet investigated. the purposes of this study are to establish the correlation among clinical data, ct findings and information collected by tccs, and to predict icp and neurological outcome using such information. the focus would be on 3rd ventricle size, midline shift and anteroposterior-transverse ration of midbrain (midbrain index) obtained by b-mode of tccs. this study is a prospective clinical study targeting on 30 neurocritical patients admitted to intensive care units in one year. the timing of performance of tccs will be (1) within 6 hours after admission, (2) within 6 hours after each ct examination, and (3) when icp is higher than 20 mmhg for more than 5 minutes. glasgow coma scale (gcs), heart rate, blood pressure (systolic, diastolic, and mean), body temperature, central venous pressure (cvp), brain temperature, icp, cerebral perfusion pressure (cpp), mean velocity (mv) of bilateral middle cerebral arteries (mcas), pi, midline shift, 3rd ventricular dimension, anteroposterior to transverse ratio of midbrain (midbrain index, mi) are recorded. the latter three parameters are also obtained from ct scans, and compared with those obtained from tccs. outcome is evaluated with extended glasgow outcome scale (gose), and analyzed with previous records. this study is going to prove that tccs is a safe, convenient, real-time and cheap tool in clinical care for neurocritical patients. it also provides prediction of icp and clinical outcome.

Eligibility criteria:
inclusion criteria: * aged 16 to 80 years * neurocritical patient (head injury, hemorrhagic or ischemic stroke, subarachnoid hemorrhage, etc.) who was admitted to intensive care unit and had undergone intracranial pressure monitoring exclusion criteria: * associated with multiple organ impairment or failure * single organ failure prior to neurocritical condition, such as cardiac, hepatic, or renal failure * associated with severe infection or sepsis

Keywords: transcranial doppler transcranial color-coded duplex sonography neurocritical patients
lung deposition via different inhalation devices

Conditions: Healthy Volunteers

Summary: the purpose of this study is to assess the deposition of budesonide to the lung after inhalation with 5 different devices and to relate the findings to in vitro properties of inhaled budesonide.


Eligibility criteria:
inclusion criteria: * provision of informed consent prior to any study specific procedures * bmi between 18 and 30 kg/m2 * non-smokers/non-snuffers exclusion criteria: * pregnant and/or lactating women * use of oral contraceptives or hormonal implants * known or suspected hypersensitivity to glucocorticosteroids, inhaled lactose, or other excipients in study drugs

Keywords: inhalation lung deposition