Kornimate/medical-research-clean huggingface dataset:
trial of vision therapy for intermittent exotropia

Conditions: Intermittent Exotropia

Summary: the main objective of this randomized trial comparing vision therapy to observation is to determine the short-term effectiveness of vision therapy on distance intermittent exotropia control. the results will help determine whether to proceed to a full-scale, long-term randomized trial.

vision therapy (vt) is a commonly prescribed treatment for children with intermittent exotropia (ixt). the effectiveness of vt as a treatment modality for children with ixt is unknown because previous studies have largely limited observational or retrospective case series without comparison groups. the objective of this multi-centered pilot randomized trial of vt for ixt compared to observation is to 1) determine the short-term effectiveness of vt on distance intermittent exotropia and 2) determine the feasibility of recruitment and retention of children aged 8 to 16 years old with ixt to participate in a randomized trial of 20 weeks of in-office vt. the results of this trial will provide the needed information to plan and conduct a large-scale randomized trial to determine short-term and long-term effectiveness of vt for ixt in children, with the full-scale randomized trial helping to fill in the gaps in scientific knowledge concerning vt as a treatment for ixt.

Eligibility criteria:
major inclusion criteria- * age 8 - 16 years * intermittent exotropia meeting all of the following: * distance exodeviation of 15∆ to 35∆ by prism alternating cover test (pact) * ixt, exophoria, or orthophoria at near * near exodeviation that does not exceed the distance exodeviation by more than 10∆ * mean distance control score of 2 points or more with at least one measure being 3 points or higher * mean near control score less than 5 points * random dot stereopsis of 200" or better on preschool randot stereotest * willingness to accept randomization and no plan to relocate in the next 6 months major exclusion criteria- * treatment for ixt or amblyopia (other than refractive correction) within 3 months prior to enrollment * office-based vision therapy for ixt within 6 months prior to enrollment * prior office-based vision therapy for ixt of ≥10 sessions * prior strabismus, intraocular, or refractive surgery (including botox injection)

Keywords: intermittent exotropia vision therapy
study of association between digital osteoarthritis and lower limb osteoarthritis

Conditions: Digital Arthrosis

Summary: among the risk factors for lower limb osteoarthritis, if obesity is probably the most studied, digital osteoarthritis received increasing interest in recent years. recent publications have highlighted a link between obesity and digital osteoarthritis, but also a very probable link between digital osteoarthritis and structural progression of knee osteoarthritis. few data including hip exist and need to be confirmed on larger scale studies. we have with "khoala" a national multiregional cohort of symptomatic gonarthrosis and coxarthrosis representative of the general population (which is rarely the case in the literature) including x ray, clinical and biological follow-up (hips and / or knees).


Eligibility criteria:
inclusion criteria: * men or women aged 40 to 75 years * with symptomatic osteoarthritis of the hip and / or knee (femoro-tibial), unilateral or bilateral * with a confirmed diagnosis (criteria of the american college of rheumatology :acr) and kellgren and lawrence radiological stage ≥ 2. exclusion criteria: * painful hip or knee prosthesis * osteotomy in the past
comparison of sleep disordered breathing events detected by the cpap device "prismaline" with polysomnography

Conditions: Sleep Apnea Syndromes

Summary: evaluation of residual sleep disordered breathing (sdb) under continuous positive airway pressure (cpap) therapy with comparison of the automatic detected sdb event indices from cpap machines with manual scored polysomnography (psg).

the evaluation of residual sleep disordered breathing (sdb) in sleep apnea (sa) after initiation of continuous positive airway pressure (cpap) therapy is important to verify the therapeutic success. in clinical practice, the internal records of cpap devices are utilized to determine the therapeutic success, during either medical consultations or telemetric observation. this study was designed to evaluate the quality of sdb event indices (ei), which are recorded by the cpap device (prisma, löwenstein medical technology). the detected events of a manual scored polysomnography (psg) in the sleep laboratory will be compared with the simultaneously recorded events of the cpap device. this shall lead to recommendations regarding the situations, and in which degree the event detection of the cpap devices may be meaningful to determine the therapeutic success of home sleep apnea therapy.

Eligibility criteria:
inclusion criteria: * psg diagnostic not older than 3 month, * ahi\>15, cpap indication, * age \>18, * nasal cpap mask, * written informed consent exclusion criteria: * cpap contraindication, * participation in another clinical trial

Keywords: cpap apnea hypopnea event detection
visual perceptual learning based digital therapeutics for visual field defect after stroke

Conditions: Visual Fields Hemianopsia; Hemianopsia, Homonymous

Summary: this study evaluates the efficacy of visual perceptual learning for the treatment of visual field defect caused by brain disease. half of participants will receive visual perceptual training using the vivid brain. the other half will not receive any training because there is no standard treatment for visual field defect caused by brain disease.


Eligibility criteria:
inclusion criteria: * 19 years and older * at least 3 months after brain disease related to visual field defect * verified brain disease in visual pathway related to occipital lobe, parietal lobe, temporal lobe or etc. using ct or mri * brain disease induced visual field defect * able to use the vr(virtual reality) device * able to use the app with a smart phone * patient/legally authorized representative has signed the informed consent form exclusion criteria: * complete hemianopsia * epilepsy, photosensitivity, parkinson's disease * bilateral visual field defect * hemispatial neglect * ophthalmologic disorder that may interfere the trial. (ptosis of eyelid, corneal opacity, diabetic retinopathy, glaucoma, macular degeneration etc.) * inability to discontinue psychostimulants such as methylphenidate, modafinil, and amphetamine. * candidate for carotid endarterectomy or stenting * received ophthalmologic surgery or laser surgery within 3 months, except for the cataract surgery * pregnant or breast feeding * participating in other clinical trial * any other condition that, in the opinion of the investigator, precludes participation in the trial

Keywords: visual field defect visual perceptual learning humphrey visual field
effect of weight loss on cholesterol metabolism in hereditary hypercholesterolemias and overweight or obesity.

Conditions: Familial Hypercholesterolemias; Weight Loss; Familial Combined Hypercholesterolemia; Obesity

Summary: background: lipid lowering response to weight loss in subjects with genetic hyperlipidemias and overweight or obesity and its effect on cholesterol metabolism has not been studied. objective: to explore the effects of weight loss on lipid values and cholesterol metabolism, by measuring circulating non-cholesterol sterols, in overweight or obese subjects with genetic hypercholesterolemias. design: the investigators conducted a 6-months weight loss intervention in subjects with the diagnosis of familial hypercholesterolemia (fh) or familial combined hyperlipidemia (fchl), body mass index \>25 kg/m2, steady weight (±3 kg in the last 3 months) and absence of lipid lowering drugs in the previous 5 weeks. they were advised to follow a hypocaloric diet with a deficit of 600 kcal (30% fat, 15% protein, and 55% carbohydrates) per day as calculated from the person's resting energy expenditure and activity level. anthropometric data, biochemical analysis including lipids, apolipoproteins and non-cholesterol sterols were evaluated at baseline, 3 months and 6 months.


Eligibility criteria:
inclusion criteria: * age ≥18 years. * diagnosis of familial combined hyperlipidemia\* and familial hypercholesterolemia\*\*. * body mass index \> 25 kg/m2. * steady weight (±3 kg in the last 3 months). * absence of lipid lowering drugs including sterols supplements in the previous 5 weeks. * familial combined hyperlipidemia diagnosis was based on the presence of primary combined hyperlipidaemia in untreated patients whose serum cholesterol and triglyceride concentrations were above the sex- and age-specific 90th percentiles for the spanish population, serum total apolipoprotein b concentration ≥ 120 mg/dl and there was at least one first-degree relative with hyperlipidemia (total cholesterol and/or triglycerides \>90th percentile) (gómez-gerique ja et al; 1999). * familial hypercholesterolemia was diagnosed in subjects with off-treatment ldl cholesterol concentrations above the age- and sex-specific 95th percentile of a spanish reference population, triglyceride below 200 mg/dl and familial vertical transmission with at least one first-degree relative with ldl cholesterol above age- and sex-specific 95th percentiles (gómez-gerique ja et al; 1999). exclusion criteria: * alcohol consumption \>30 gr/day. * uncontrolled type-2 diabetes (hba1c \>8%). * any other disease that could interfere with the ability to comply with the study protocol were excluded * personal history of cardiovascular disease, very high risk as defined by the presence of ≥ 2 major risk factors, or total cholesterol ≥ 350 mg/dl since lipid-lowering drug were considered highly recommended.

Keywords: familial hypercholesterolemia familial combined hypercholesterolemia weight loss; lipids; phytosterols obesity overweight. lipids
evaluation of long-term safety and efficacy of vanzacaftor/tezacaftor/deutivacaftor in cystic fibrosis participants 1 year of age and older

Conditions: Cystic Fibrosis

Summary: the purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of vanzacaftor/tezacaftor/deutivacaftor (vnz/tez/d-iva) in participants with cystic fibrosis (cf).


Eligibility criteria:
key inclusion criteria: parts a and b: • participants who have completed study drug treatment in the parent study (vx21-121-105; nct number: nct05422222) part b: -meets at least 1 of the following criteria: * completed study drug treatment in part a * had study drug interruption(s) in part a, but did not permanently discontinue study drug and completed study visits up to the last scheduled visit of the treatment period of part a key exclusion criteria: * hepatic cirrhosis with portal hypertension, moderate hepatic impairment, or severe hepatic impairment that might pose an additional risk in administering study drug * history of solid organ, hematological transplantation, or cancer * history of drug intolerance in the parent study other protocol defined inclusion/exclusion criteria may apply.
the canada lymph node score: a feasibility randomized controlled trial

Conditions: Non Small Cell Lung Cancer

Summary: for patients diagnosed with early stage non-small cell lung cancer (nsclc) on preoperative computerized tomography (ct) and positron emission tomography (pet) scans, surgical resection is usually the preferred method of treatment. however, to be eligible for surgery, current guidelines require that the cancer has not spread to the lymph nodes in the chest cavity. to evaluate these lymph nodes, the standard of care is to undergo an endobronchial ultrasound (ebus) procedure, where all the visible lymph nodes in the chest are biopsied (sampled) with a needle. unfortunately, these biopsies are often inconclusive, especially in patients who have no evidence of mediastinal lymph node spread on pre-operative imaging. currently, the standard of care mandates that inconclusive biopsies should be repeated, either through another ebus, or through more invasive procedures. repeat inconclusive biopsies are oftentimes inconclusive as well; leading to a vicious cycle of inconclusive results, a delay in treatment, morbidity for the patient, and increased costs to the healthcare system. to circumvent this issue, the investigators have developed, validated and published a 4-point score, the canada lymph node score (clns), which uses four features observed during ebus to predict whether the cancer has spread to the lymph nodes or not. research has demonstrated that lymph nodes which appear benign on both ct and pet scan that also have a clns of ≤1/4 are almost certainly benign. as such, it is believed that these "triple normal" lymph do not require biopsy (or repeat biopsy). the investigators are challenging the current standard of care in lung cancer, which mandates that all the lymph nodes in the chest need to be biopsied (i.e. systematic sampling) before surgery, by proposing that triple normal lymph nodes can be omitted, and only those with cancer potential should be biopsied (i.e. targeted sampling).to prove this hypothesis, a randomized controlled trial comparing systematic sampling to targeted sampling is required. a feasibility trial is proposed to determine whether this large-scale randomized trial will be possible.


Eligibility criteria:
inclusion criteria: * referred to have ebus for staging of confirmed or suspected nsclc * completed both a ct and pet scans * cn0-cn1 disease indicated on ct and pet scans exclusion criteria: * patients with cn0 disease, peripheral tumours and tumours \< 2 cm in diameter (they do not require staging) * evidence of cn2 disease or higher on ct and pet scan

Keywords: endobronchial ultrasound diagnostic imaging feasibility randomized controlled trial clinical n0-n1 disease
safety and efficacy in a real-life study in patients with haemophilia treated with novoeight® for surgery

Conditions: Hemophilia

Summary: the aim of the seraphine study is to gather data stemming from the french research database berhlingo (= base d'etude et de recherche en hémostase pour les investigateurs du grand-ouest, i.e. database for research on hemostasis for the investigators of western france), in order to get a detailed report about the therapeutic management and use of turoctocog alfa (novoeight®) in surgery in pwha (patient with inherited hemophilia a).


Eligibility criteria:
inclusion criteria: * male or female * regardless of age * no inhibitor (anti-fviii alloantibodies) at the time of treatment. * no objections expressed to participate in the study after having been informed of its purposes and the data involved. * no other inherited hemorrhagic disorders than ha exclusion criteria: in order to reflect the reality of daily practice, no criteria for non-inclusion are provided for other than the refusal of the patient or his or her legal representative to participate in the study or the existence in the patient of a contraindication to the use of turoctocog alfa (novoeight®) treatment.
role of epidermal growth factor (egf) in development of necrotizing enterocolitis

Conditions: Necrotizing Enterocolitis; Premature Birth

Summary: necrotizing enterocolitis (nec) is a serious gastrointestinal disorder that primarily affects preterm infants. about 10% of babies less than 32 weeks gestation at birth will develop it. overall, 30% of babies who develop nec will die from it, with many others developing long term gastrointestinal problems. the most important factor in its development is a premature intestinal tract. epidermal growth factor (egf) is an important growth factor in the development and maintenance of the gastrointestinal tract. this study will look for a relationship between egf levels in premature babies and the development of nec.


Eligibility criteria:
inclusion criteria: * gestational age greater than 23 weeks at birth * birth weight greater than 500 grams * age less than 72 hours of life

Keywords: enterocolitis
preeclampsia subtypes and surrogate markers of cvd risk

Conditions: Preeclampsia

Summary: in order to assess surrogate markers of cardiovascular risk in subtypes of preeclampsia, we will conduct a 10-year follow-up study comparing 40 women with a history of early onset preeclampsia; 40 women with a history of late onset preeclampsia and 40 women with a history of normotensive pregnancies. eligible participants delivered at the department of obstetrics at randers regional hospital 1998-2008. early-onset preeclampsia is defined as preeclampsia that develops before 34 weeks of gestation, whereas late-onset preeclampsia develops at or after 34 weeks of gestation.


Eligibility criteria:
inclusion criteria: * women who delievered at the department of obstetrics at randers regional hospital 1998-2008 exclusion criteria: * current pregnancy or breastfeeding

Keywords: preeclampsia. cardiovascular disease (cvd) risk.
cardiovascular vulnerability to particulate exposure

Conditions: Heart Disease; Lung Disease

Summary: this project is part of a program project directed toward assessing cardiac effects of particulate and other ambient air pollutants. in this project active elderly adults living in the communities of boston and steubenville have attended 12 weekly sessions including approximately 40 minutes of holter monitoring, blood pressure, and oximetry evaluation before, during, and after outdoor exercise. to investigate the relation of air pollution to cardiac and pulmonary rehabilitation, a second portion of this study involves abstraction of blood pressure and symptom data and downloading of available repeated measures telemetry data in two populations. these populations include: 1) 200 outpatients attending 8 to 36 repeated weekly exercise training sessions in a major hospital cardiac rehabilitation unit.

approximately 60 subjects have participated fully in boston and steubenville in the repeated 40 minute measurement of continuous ekg (holter), blood pressure, and oximetry. in steubenville we have also measured exhaled nitrogen oxide, an index of pulmonary inflammation. the exposure monitoring has included outdoor particle mass of pm2.5, outdoor gaseous pollutants, and indoor home and personal monitoring to evaluate the indoor contribution of pollution to health effects.

Eligibility criteria:
participants are 50 to 90 years of age, but almost all are 60 and older. they have been enrolled as volunteers from communities in mission park, boston, and steubenville. inclusion criteria includes the ability to walk on level ground. exclusion criteria includes unstable anginal, and baseline ekg patterns such as left bundle branch block that would make difficult the detection of repolarization abnormalities. participants live at or near the study center which was located in an office or apartment in the apartment building of the majority of the participants.

Keywords: holter monitoring ecg cardiac particulate exposure
making calories count: information format and food choice

Conditions: Obesity

Summary: the purpose of the study is to better understand how individuals make decisions regarding the meals they order. participants' ordering decisions at lunchtime at a chain restaurant will be recorded over several weeks to study ordering habits over time. lunch menus will be provided by the study, and the menu format will vary the way in which information on caloric content is displayed. the impact of different labeling formats on total calories in the chosen meal will be assessed.


Eligibility criteria:
inclusion criteria: * customers of two chain restaurants exclusion criteria: * unable to read a written menu

Keywords: obesity
the acute effect of and energy drink vs. water consumption on map, hr, and energy metabolism

Conditions: Cardiovascular Diseases; Hypertension; Diet

Summary: the objective of this protocol is to investigate the effect of consumption of a commercially available energy drink beverage on blood pressure, heart rate, and energy metabolism

energy drink consumption has gained a lot in popularity and represents one of the most rapidly growing segments of the beverage industry. while regularly discussed in media outlets etc. the cardiovascular effects are not well described or well known. for example, the impacts on various cardiovascular parameters range from improved, decreased, to not impacted at all depending on the source. this can be due to a number of reasons including, study protocol design, study population tested, energy drink product used, volume consumed, etc. accordingly, this study aims to investigate the impact of acute consumption of a standard commercially available can of energy drink beverage on the following parameters. * arterial blood pressure * heart rate * energy metabolism (oxygen consumption and carbon dioxide production it is hypothesized that consumption of a 12 oz energy drink will result in modest elevations in arterial blood pressure, heart rate, and energy metabolism relative to when consuming of an equal volume of water.

Eligibility criteria:
inclusion criteria: * between ages 18-30 * must be free of reported cardiovascular, respiratory, and metabolic diseases. * must be caffeine naïve * must be fasted exclusion criteria: * food allergies * pregnant women * breast feeding women * individuals with cardiac, cardiovascular, respiratory, metabolic, and/or neurological disorders * taking any prescription vasoactive medications * allergies to spandex/lycra

Keywords: energy metabolism arterial blood pressure heart rate
study to assess the efficacy and safety of vx-210 in subjects with acute traumatic cervical spinal cord injury

Conditions: Cervical Spinal Cord Injury

Summary: the purpose of this study is to determine the efficacy and safety of vx-210 in subjects with acute traumatic cervical spinal cord injury. secondary objectives include the specific evaluation of the effects of vx-210 on neurological recovery and daily function after spinal cord injury.


Eligibility criteria:
inclusion criteria: * acute traumatic cervical sci, motor level of c4, c5, c6, or c7 on each side: * screening uems score must be ≤16 points on each side. * ais a subjects with a c4 motor level on both sides must have at least 1 point of motor activity between c5 and t1 on at least 1 side. * ais b subjects with a c4 motor level on both sides must have at least 1 point of motor activity between c5 and c7 on at least 1 side. * american spinal injury association impairment scale (ais) grade a or ais grade b. * scheduled and planned to undergo a spinal decompression/stabilization surgery that commences within 72 hours after the initial injury. * computed tomography (ct) scan or magnetic resonance imaging (mri) is consistent with the subject's neurological deficit. exclusion criteria: * participation in any other clinical study for acute sci without approval by the sponsor. * inability to undergo decompression/stabilization surgery that commences within 72 hours after injury. * one or more upper extremity muscle groups untestable during screening isncsci examination. * acute sci from gunshot or penetrating/stab wound; non-traumatic sci (e.g., transverse myelitis, acute disc herniation); brachial plexus injury; complete spinal cord transection; or multifocal sci. * females who are breastfeeding or have a positive serum pregnancy test. * body mass index (bmi) of ≥40 kg/m\^2 at screening. * history of an adverse reaction to a fibrin sealant or its components. * unconsciousness or other mental impairment that precludes reliable international standards for the neurological classification of spinal cord injury (isncsci) examination. * known immunodeficiency, including human immunodeficiency virus, or use of immunosuppressive or cancer chemotherapeutic drugs. * any significant medical or psychiatric comorbidities that would significantly increase the risk of study enrollment and/or significantly interfere with study outcomes or assessments, in the judgment of the investigator. other protocol defined inclusion/exclusion criteria may apply.