Kornimate/medical-research-clean huggingface dataset:
determining the efficacy of full-time occlusion therapy in severe amblyopia at different ages

Conditions: Amblyopia; Strabismus

Summary: objective: to find out how much visual improvement is possible in severe amblyopia using full-time occlusion therapy with an eye patch and to see if improvement is influenced by the patient's age. methods: an interventional clinical trial of 115 consecutive cases with unilateral, severe amblyopia was conducted at a tertiary referral center from jan 2010 to oct 2012. patients were divided into three age groups: 3-7 years (n= 38), 8-12 years (n=41), 13-35 years (n=36). after a complete ophthalmological examination by a single ophthalmologist, cases with organic visual loss were excluded; cases with previous part-time occlusion therapy that had failed were included in the study. patients were given optimal refractive correction for a month, followed by full-time occlusion therapy along with near visual activities for 3-4 hours/day. the therapy was continued until maximum visual recovery was achieved (6/6 snellen's). therapy was gradually reduced and stopped. patients were followed-up regularly for the next 18 months.

amblyopia, ('blunt vision' in ancient greek), also known as lazy eye, is a visual deficiency in an eye that is otherwise physically normal, or that is greater than would be expected from any structural abnormalities of the eye. there are unsubstantiated beliefs that it is more difficult to treat amblyopia in older age groups, that children that have already received failed amblyopia therapy do not respond to treatment and that full-time occlusion therapy may result in occlusion (disuse) amblyopia of the good eye. the aim of this study was to assess whether these beliefs are true. materials and methods this was a prospective, interventional clinical trial of 115 consecutive cases with unilateral, severe amblyopia conducted at a tertiary referral center in lahore, pakistan, from january 2010 to october 2012. eligibility criteria included an age of over three years, visual acuity in the amblyopic eye from 6/60 snellen's or even counting fingers only, visual acuity in the sound eye of 6/6. a complete ophthalmic examination was performed by only one ophthalmologist (si). this included examining the fixation pattern of both eyes, presence or absence of a phoria or a tropia by a cover-uncover test, fundus examination and color vision using ishihara color plates. any case with an organic cause for visual loss was excluded from the study after a thorough ophthalmological examination. assessment of visual acuity of either eye for both near and distance acuity (snellen's and etdrs charts) refraction and best corrected visual acuity (bcva) was performed by a trained optician who was masked to the study and patient's demographics.

Eligibility criteria:
inclusion criteria: * a visual acuity of 6/60 or 0.1-0.2 etdrs in one eye and 6/6 or 1.0 etdrs in the good eye * strabismic amblyopia * patients of any age were included. exclusion criteria: * structural damage to the eye (organic amblyopia) * ametropic amblyopia

Keywords: amblyopia strabismus occlusion therapy visual improvement
the role of dopamine metabolism in the antidepressant effects of sleep deprivation and sertraline in depressed patients

Conditions: Major Depressive Disorder; Bipolar Disorder

Summary: this study evaluates the efficacy of sleep deprivation treatment in accelerating antidepressant responses when administered during the first week of medications and augmenting a sustained response with chronobiological interventions. sleep deprivation and chronobiological augmentation may offer a rapid and sustained antidepressant response in mood disorder patients treated with medication, sleep deprivation, bright light therapy and sleep phase advance compared with medication only. the chronobiological treatment is rapid, non-invasive and has few side effects and could be of significant clinical benefit.


Eligibility criteria:
inclusion criteria: inclusion criteria include: 1. subjects must be english speaking 2. subjects must have either bipolar or unipolar depression diagnosis or be a normal control. 3. subjects must be between : 18 to 75 non-english speaking subjects will be excluded since scales for measuring depression have not been validated in languages other than english. exclusion criteria: exclusion criteria include: 1. suicidality, or psychosis 2. unstable medical conditions 3. epilepsy, serious head injury, or other significant neurological disorders 4. dementia, mental retardation (moderate or severe), coma 5. prior exposure to radiation which might cause the subject to exceed standard guidelines 6. substance abuse or alcoholism in the past six months 7. unreliability or inability to adhere to the requirements of the study 8. irregular sleep-wake schedules (nightshift, jet lag) 9. use of cns medications which may affect sleep or functional brain imaging (i.e., use of sleeping pills, antidepressants or other mood stabilizers or other medications which may affect the sleep eeg) 10. sleep apnea, periodic limb movements of sleep, narcolepsy, circadian sleep phase disorders 11. donation or loss of blood (\>400 ml) within the past month 12. current or very recent intercurrent illnesses, painful conditions or other disorders, which in the judgement of the investigators, might invalidate the scientific goals of the study or pose undesirable difficulties or risks for the subject. 13. hamilton rating scale of depression (hrsd-17 items)\<17 unless subject is a normal control subject. 14. pregnancy or breast feeding 15. individuals who would be unable to undergo a magnetic resonance imaging (mri) scan, for example, individuals who suffer from claustrophobia, or who have metal clips in their body. 16. unable to cease taking psychoactive medications which are not part of this protocol (2-5 weeks) prior to pet scans. 17. patients with previous history of significant adverse reactions to sertraline or sertraline-like drugs or other ssri's such as paxil or prozac 18. subjects with diagnosis of eating disorder/bulimia

Keywords: sleep deprivation antidepressant depression chronobiological
relation between anthropometric measurements and balance in children with type 1 diabetes relation between anthropometric measurements and balance in children with type 1 diabetes

Conditions: Diabetes Mellitus, Type 1

Summary: type 1 diabetes mellitus is the most common chronic metabolic disorder in children. diabetic children who take proper nutrition and good care attain normal growth status. factors affecting growth in diabetic patients include gender, age at diagnosis, duration of disease, glycemic control, and puberty status. moreover, diabetes mellitus has negative impact on vestibular system, affect proprioception and lower limb muscle fatigue resulting in reduced balance.

limited literature is available regarding the relation between anthropometric measurements and balance in children with diabetes mellitus. therefore, the current study will be conducted to investigate the relation between anthropometric measurements (weight, height and body mass index) and balance in children with diabetes mellitus.

Eligibility criteria:
inclusion criteria: * diagnosed as controlled t1dm. * age ranges from 7 to 11 years. * from both sexes. * duration of the disease 3 to \< 5 years. * same socioeconomic level. exclusion criteria: * other hormonal diseases (hypothyroidism or hyperthyroidism). * hereditary sensory and autonomic neuropathy * significant visual disorders. * subjects participating in regular sports activities. * history of fracture or surgery in the lower extremities in the past 12 months.

Keywords: diabetes mellitus anthropometric measurements balance diabetes mellitus, type 1
effect of blood donation on blood pressure, iron metabolism, oxidative stress

Conditions: Hypertension

Summary: the investigators want to investigate the effects of blood donation to blood pressure, to iron metabolism and oxidative stress. there are results of other studies that show, that there is a positive effect of blood donation to high blood pressure, iron metabolism and oxidative stress.

the regular application flow of blood donation at that blood bank of charité is not disturbed. there are only some more questions and measurement of blood pressure, iron metabolism, fat metabolism and oxidative stress. no extra puncture of the vein is necessary.

Eligibility criteria:
inclusion criteria: * first time donating blood or after a break of 12 months to last blood donation * voluntary attending blood donation and study * fulfilling the criteria of the blood donation center exclusion criteria: * criteria of the blood donation center (e. g. low haemoglobin, fever, acute infection, having spent in tropical countries for the last months,general bad health condition,...) * missing informed consent to the study

Keywords: hypertension ferritin phlebotomy blood donation
role of core exercise in treatment of fibromyalgia patients

Conditions: Fibromyalgia

Summary: the purpose of this study is to investigate the effect of core exercises on health status, pain, pressure pain thresholds and functional capacity in patients with fm

fibromyalgia (fm) is a chronic non-degenerative disease of unknown etiology without effective medical treatment that mostly affects women. at present, the diagnostic and classification criteria are still under debate. as a result, the treatments for fm are also under investigation. no single treatment has achieved a reduction in the symptoms. its occurrence increases with age. exercise is one of the treatment approaches where effectiveness in the management of fm is supported by stronger evidence. besides, recent reviews found that exercise has a positive effect on pain, physical function and health-related quality of life .with no associated adverse effects. among the different exercise modalities available, core stability training has shown its effectiveness by improving static and dynamic balance, functionality and risk of falls, pain and quality of life. so this study will be conducted to investigate the effect of core exercises on health status, pain, pressure pain thresholds and functional capacity in patients with fm

Eligibility criteria:
inclusion criteria: * 1. patient referred from rheumatologist with a history of widespread bilateral musculoskeletal pain both above and below the waist for a minimum of three months and pain in at least 11 of 18 specific tender points 2. moderate or greater tenderness reported on digital palpation with 4 kg/cm2 of force 3. 21_43 years old patients exclusion criteria: - 1. presence of other systemic, somatic, or psychiatric diseases. 2. pregnant or were planning a pregnancy during the study period. 3. patients with acute disease including high fever and uncontrolled medical conditions (such as severe infection and cardiovascular disease including unstable angina. 4. surgical history for previous 6 months.

Keywords: fibromyalgia syndrome core exercise aerobic exercise pressure pain threshold
effect of neck extension exercise using 8 channel surface electromyography

Conditions: Neck Syndrome

Summary: analysis of abnormal muscle activities on forward neck posture syndrome patients and effect of neck extension exercise using 8 channel surface electromyography

in this study, the investigators investigate the muscle contraction according to posture change in patients with forward neck posture syndrome which was not revealed by 8 channel surface electromyography and provide accurate evaluation of forward neck posture syndrome in comparison with normal group and to be used as basic research data for the development of 8 channel electric stimulation therapy device.

Eligibility criteria:
inclusion criteria: * healthy adults over the age of 20 who do not have any underlying disease that does not appeal to forward neck posture syndrome 2) among adults who complained of chronic pain over three months, patients aged 20 years and over who were diagnosed with forward neck posture syndrome in a simple x-ray of the lumbar spine exclusion criteria: * patients with severe neurological disorders (procedural hypertrophy), previous cervical surgery, impaired eye diseases, spinal deformations, rehabilitation for strengthening spinal muscles within the last three months and pregnant women

Keywords: 8 channel surface electromyography forward neck posture syndrome
a study of dalotuzumab (mk-0646) in breast cancer patients (mk-0646-013)

Conditions: Breast Cancer

Summary: a study to evaluate the response of growth factor signatures (gfs) to a single dose of dalotuzumab in participants with triple negative (tn) or estrogen receptor (er)-positive luminal b breast cancer. the primary hypothesis is that dalotuzumab will induce a decrease in the gfs in at least 40% of participants.


Eligibility criteria:
inclusion criteria: * participant has operable stage i-iiia breast cancer of the following subtypes: (1) estrogen receptor (er)-negative, progesterone receptor (pr)-negative, and human epidermal growth factor receptor 2 (her2)-negative breast cancer; (2) er-positive tumor meeting one of the following criteria: histologic grade 3; histologic grade 2 and pr-negative; histologic grade 2 and ki67 antigen ≥10%. tumor is at least 2 cm in diameter as assessed by physical or radiographic exam * participant is female and ≥18 years of age exclusion criteria: * participant is pregnant, breastfeeding or planning to become pregnant while in the study * participant has received prior chemotherapy, biological therapy or radiation * participant has participated in a clinical trial in the last 30 days * participant has a history of drug or alcohol abuse in the last year * participant is human immunodeficiency virus (hiv) positive. patient has a history of hepatitis b or c * participant has poorly controlled diabetes mellitus
exogenous surfactant in very preterm neonates in prevention of bronchopulmonary dysplasia

Conditions: Infant, Premature, Diseases; Respiratory Distress Syndrome, Newborn; Bronchopulmonary Dysplasia

Summary: advances in perinatal care have made it possible to improve the survival of the most immature neonates, but at the cost of an increase in the population at risk of developing bronchopulmonary dysplasia (bpd). measures that have attempted to limit the development of bpd are not always effective, or related to major side effects. the physiopathological factors that are identified in bpd should, in theory, respond to surfactant. therefore, the use of an exogenous surfactant in neonates presenting with pulmonary disease requiring mechanical ventilation, leading to a significant risk of bpd, should allow earlier extubation and thus promote pulmonary healing and growth.


Eligibility criteria:
inclusion criteria: * any neonate of gestational age less than 33 weeks of amenorrhea still on conventional assisted ventilation or hfov (high frequency oscillatory ventilation), after 14 ± 2 days of life exclusion criteria: * active infection (crp \> 30 mg/l) not controlled by appropriate antibiotic treatment * use of corticosteroids in the postnatal period * significant neurological or malformative disease * surgical intervention \< 72 hours * refusal of parental approval

Keywords: very premature infant surfactant respiratory distress bronchopulmonary dysplasia
study of vx-770 in subjects with moderate hepatic impairment and in matched healthy subjects

Conditions: In Development for Cystic Fibrosis

Summary: the purpose of this study is to investigate the pharmacokinetics and safety of a single dose of vx-770 in subjects with moderate hepatic impairment.


Eligibility criteria:
inclusion criteria: group a (subjects with hepatic impairment): * male or female between 18 and 65 years of age * subjects must have a child-pugh total score of 7 to 9 * subjects must agree to use 1 highly effective method of contraception during the study and for 90 days after the completion of the study * subjects must have a body mass index (bmi) of 18 to 35 kg/m2 group b (healthy subjects): * male or female between 18 and 65 years of age * subjects will match subjects with hepatic impairment for sex, bmi, cigarette smoking habit, and age * subjects must agree to use 1 highly effective method of contraception during the study and for 90 days after the completion of the study exclusion criteria: group a (subjects with hepatic impairment): * subjects who are not clinically stable or who have a history of any illness that, in the opinion of the investigator or the subject's general practitioner, might confound the results of the study or pose an additional risk in administering study drug(s) to the subject * subjects who are unwilling or unable to discontinue use of any inhibitors or inducers of cyp3a * subjects who have a history of alcohol abuse within 1 year or illicit drug abuse within 2 years * subjects who smoke more than 10 cigarettes per day * subjects who have fluctuating or rapidly deteriorating hepatic function * subjects who have significant renal dysfunction * subjects who have hiv, or active hepatitis b * subjects who have previous solid organ or bone marrow transplantation group b (healthy subjects): * subjects who have a history of any illness that, in the opinion of the investigator or the subject's general practitioner, might confound the results of the study or pose an additional risk in administering study drug(s) to the subject * subjects who are unwilling or unable to discontinue use of any inhibitors or inducers of cyp3a * subjects who have a history of alcohol or illicit drug abuse within 2 years * subjects who smoke more than 10 cigarettes per day * subjects who have hiv, hepatitis c, or active hepatitis b
immunogenicity assessment of subjects receiving rabies post-exposure prophylaxis in cambodia

Conditions: Rabies Post-exposure Prophylaxis

Summary: a rabies virus neutralizing antibody (rvna) concentration ≥ 0.5 iu/ml at 14 days after immunization is considered a proxy for protection in vaccine efficacy studies. abridged and dose-sparing vaccination regimens increase accessibility and reduce both direct and indirect costs, especially in resource-constrained countries where rabv prevalence is highest. several efficacy studies evaluated safety and immunogenicity of abridged regimens in healthy adult volunteers using either four-site intradermal (id) or intramuscular (im) regimens, showing them to be safe and immunogenic. researchers at the institut pasteur du cambodge (ipc) have previously conducted a retrospective study on clinical outcome at ≥6 months in 3318 cambodians who received intradermal vero cell vaccine post-exposure prophylaxis after a bite by a rabid or sick-looking but untested dog in 2003-2014. here, the investigators could show that there was no significant difference in survival among patients who received 3 versus 4 sessions of the thai red cross (trc) id regimen. in a separate study, investigators measured antibody responses in order to evaluate the immunogenicity of the trc regiment after 3 sessions versus 4 sessions. the investigators did not observe an increase in rabies virus seroneutralization titers 14 days after the fourth immunization compared to 14 days after the third immunization. these results contributed to changes endorsed by the who in its april 2018 guidelines. the "institut pasteur du cambodge (ipc) regimen" of three pep sessions of two-site id 0.1 ml vaccine doses each at days 0, 3 and 7 is the first one-week pep regimen to be recommended. in the current research project, the aim is to compare further different pep vaccination strategies in a real life setting of individuals attending the rabies vaccination center at institut pasteur du cambodge (ipc) in phom penh, cambodia. the antibody kinetics and cellular immune responses in patients following either the one-week, 2-site id regimen (ipc regimen) or the two-week im regimen (4-dose regimen) as well as the participants' survival for both protocols after 6 months are evaluated.


Eligibility criteria:
inclusion criteria: * subjects entering a rabies post-exposure vaccination course whatever the vaccine used with or without administration of rabies immunoglobulin (rigs). * subjects with ability to attend all scheduled visits and to comply with all study procedures exclusion criteria: * subjects with history of previous rabies vaccination
repetitive thinking in fibromyalgia

Conditions: Rumination; Fibromyalgia; Chronic Pain; Repetitive Negative Thinking

Summary: some fibromyalgia patients may use inappropriate emotional regulation strategies to respond to pain. rumination could be one of this inefficient regulation strategies. the investigators believe that the use of rumination strategies to respond to the discomfort of daily physical activity would maintain and aggravate a negative emotional state after the effort. distraction would be a more effective strategy to cope with pain. from this data, the investigators want to explore the causal link between rumination and negative affectivity after physical activity in fibromyalgia using an experimental design.

fibromyalgia is a disorder characterized by widespread musculoskeletal pain accompanied by fatigue, sleep, memory and mood issues. as with any condition of chronic pain, psychological mechanisms can help maintain discomfort and pain. these mechanisms may hinder the recovery of physical activity. some patients may use cognitive strategies of emotional regulation that are ineffective to cope with pain and discomfort of everyday activities, such as rumination. the literature suggests that this process is linked to the physical and psychological difficulties of fibromyalgia. however, no study has revealed a causal link between rumination and negative affectivity in a context of physical activity in this population. the investigators want to test this hypothesis by directly manipulating the style of information processing following a relevant activity for these patients: climbing steps. in one group the investigators will induce rumination right after climbing the steps. in the other group the investigators will induce distraction. patient with fibromyalgia will be recruited at the pain center of chu-amiens. patients will complete different scales before to climb steps and after experimental induction. the investigators hypothesize that patients using a rumination strategy after an uncomfortable physical activity will experience a greater subjective discomfort than patients using a distraction strategy.

Eligibility criteria:
inclusion criteria: * adults patients * free and informed consent signed. * french native speaker, writer and reader. * according 1990 american college of rheumatology criteria : patients with diffuse pain for more than three months and with digital palpation pain on more than 11 insertion points. exclusion criteria: * minor patients * adult major under administrative protection * patient with severe psychosis or depression or severe anxiety or impulsivity as assessed by the clinician

Keywords: rumination fibromyalgia chronic pain affectivity repetitive negative thinking