Kornimate/medical-research-clean huggingface dataset:
evaluating the effectiveness of a dichloroacetate in melas syndrome

Conditions: MELAS Syndrome

Summary: patients with the melas syndrome experience devastating mental impairment. this study will evaluate the effectiveness of the drug dichloroacetate (dca) to reduce the symptoms of melas.

although many organ systems are affected by mitochondrial (mt) dna point mutations, the nervous system is particularly vulnerable. maternally inherited mtdna point mutations may cause chronic progressive encephalopathies and mental retardation. patients with melas (mitochondrial myopathy, encephalopathy, lactic acidosis, and stroke-like episodes) syndrome have the a3243g point mutation and elevated brain lactate levels. research has shown that lactic acidosis is associated with progressive impairment in patients with melas. this study will evaluate the effectiveness of dca in lowering lactate levels and slowing the progression of melas. patients with the a3243g mitochondrial mutation and who have had either a stroke or a seizure will be enrolled in this study. patients will be randomized to receive either dca or a placebo. at a predetermined time point, patients receiving dca will be switched to placebo and patients receiving placebo will be switched to dca. patients will have study visits every 3 months for 3 years. study visits will include neurological exams, cognitive testing, nerve conduction tests, and mris. study medicine, testing, hospitalization for research purposes, and travel expenses will be fully covered by the study.

Eligibility criteria:
inclusion criteria * a3243g mtdna point mutation or maternally related to someone who has the mutation * symptomatic with melas, including previous seizure or stroke * certain laboratory values * ability to comply with the study protocol

Keywords: lactic acidosis mitochondrial disorder stroke seizure
observe the effects of the serkel cranial remolding orthosis on infants with deformational plagiocephaly

Conditions: Plagiocephaly, Nonsynostotic

Summary: the purpose of this study is to determine the safety and effectiveness of a specific brand of cranial remolding orthosis (a custom made helmet), which is new to the united states market

the purpose of this study is to determine the safety and effectiveness of a specific brand of cranial remolding orthosis (a custom made helmet), which is new to the united states market. serkel is an australian company that specializes in the fabrication of 3d printed cranial remolding orthoses (cro) to treat infants with deformational head shapes. serkel has made over 600 helmets that have treated children with deformational head shapes in australia, however it's specific helmet design is not fda approved to provide treatment in the united states market. serkel is seeking fda approval of their brand of cro by providing cro's for pre market fitting. the study includes treatment for children who have been screened and diagnosed with a positional deformational head shape. those who qualify for a fda approved cro treatment and were given the option to participate in the study. if they were interested, an inform consent provided and reviewed together. cargivers then had the option to enroll. in total, 18 participants were enrolled. fabrication scans were taken of the subjects head, and they returned 2 weeks later for fitting of the 3d printed cranial remolding orthosis, and seen for follow up every 2-4 weeks until treatment was complete (head shape corrected or participant outgrew cro).

Eligibility criteria:
inclusion criteria: * participants between the ages of 4-18 months at evaluation * participants with physician prescription of cro treatment * participants with physician diagnosis of deformational plagiocephaly * participants who skulls measurements qualify them for standard cro treatment (cva measurement is greater than 6mm and cephalic index is greater than 92%) exclusion criteria: * participants younger than 4 months at evaluation * participants older than 18 months at evaluation * participants without physician prescription for cro treatment * participants without physician diagnosis of deformational plagiocephaly * participants whos skull measurements or asymmetries do not qualify them for standard cro treatment
chronotherapy in acute multiple sclerosis (ms) attack

Conditions: Multiple Sclerosis

Summary: the immunological system is showing a diurnal rhythmicity. the mediators that enhances inflammation are at highest level during the night. at the same time the endogenous production of cortisol is at its lowest. we want to study if there is a better effect of treatment with methylprednisolone for acute ms-attacks if given at nighttime. the effect will be measured in relation to neurological deficits and function with kurtzkes expanded disability status score (edss) and multiple sclerosis functional composite (msfc). we want to see if the mean improvement in edss is greater in the group receiving treatment at night opposed to the group that get treatment during the daytime.


Eligibility criteria:
inclusion criteria: * relapsing remitting ms * edss-score before the actual attack \< 6.0 * acute ms-attack with indication for treatment with steroids * symptoms \>24 hours \< 4 weeks * age 18 years or older exclusion criteria: * prior enrollment in this study * ongoing serious infection that is a contraindication for treatment with steroids * pregnancy * medical situations (prior acute diseases) where treatment with intravenous steroids over short period of time is contraindicated or not favorable. * enhanced cognitive dysfunction * treatment with p.o or i.v steroids within 3 weeks prior to date of inclusion

Keywords: edss methylprednisolone circadian rhythms msfc
the use of an esthetic twin block for patients with mandibular retrusion

Conditions: Class II Malocclusion

Summary: this experimental study will evaluate the effect of an esthetic twin-block appliance on the correction of class ii malocclusion compared with the traditional twin-block appliance. the study sample will consist of 50 patients with class ii malocclusion. the sample will be allocated randomly into two groups: the control group and the experimental group. the traditional twin-block appliance will be applied for the control group patients, while the esthetic twin-block appliance will be applied for the experimental group patients. the dentoskeletal, soft tissue changes and esthetic and functional efficacy occurring after functional treatment will be assessed using cephalometric radiographs and profile photographs, pre and post-treatment, and a questionnaire. changes for each group will be evaluated individually, and the two groups will be compared.

class ii malocclusion is one of the most frequent orthodontic problems, and most class ii malocclusion cases are the result of mandibular deficiency. twin block (tb) is one of the most popular functional appliances to treat this condition. despite excellent treatment results with tb, its acceptance and compliance may be hampered by its wiry structure and appearance. furthermore, it has a side effect of causing the proclination of lower incisors, which reduces skeletal change. various modifications were proposed to reduce lower incisors proclination but had no significant effect. patient cooperation is one of the most important factors for successful functional appliance treatment, and it depends upon comfort and esthetic acceptability, which ensures good patient compliance. so, in order to enhance the esthetic appearance and overcome the disadvantages of a conventional twin-block (ctb), a novel esthetic twin-block (etb) was fabricated from a specific material using a pressure molding device and acrylic bite blocks. there is only one study that evaluated this appliance which is a pilot study that compared the treatment effects of the (etb) and (ctb) in the treatment of class ii malocclusions. however, this study has a lot of limitations, making it difficult to evaluate this appliance's efficiency accurately. the aim of this study is to study the dento-skeletal, soft tissue changes, and esthetic and functional efficacy that result from treatment by this appliance (etb) and to compare them to the changes in the matched group will be treated with (ctb), by studying the cephalometric radiographs, profile photographs, and a questionnaire.

Eligibility criteria:
inclusion criteria: * angle class ii malocclusion because of mandibular retrognathia * o.j \> 5 , snb \< 78 * patient during growth spurt * normal or horizontal growth pattern björk \> 402 exclusion criteria: * tmj disorders * poor oral hygiene * previous orthodontic treatment. * patients with syndromes, clefts, or craniofacial abnormalities. * reason of contraindication of functional treatment

Keywords: class ii twin block functional therapy
influence of cyp3a5 polymorphism on liver function abnormality and the trough level change after conversion

Conditions: Liver Dysfunction

Summary: this study is a multicenter, single-arm, open-label, 24 weeks, and investigator-initiated clinical trial to assess the influence of cyp3a5 polymorphism on liver function abnormality and the trough level change after conversion to advagraf® in liver transplant recipients.

all subjects who are liver transplant recipients taking tacrolimus bid and adaptable to be registered for the study will be classified by expressive or non-expressive cyp3a5 polymorphism genotype and advagraf® will be administered same dose as tacrolimus bid der day in 24 weeks. all subjects should check whether being registered in the hospital based on cyp3a5 polymorphism genotype during screening visit. registered subjects will visit seven times to the hospital during the study which includes screening visit and adverse reaction, acute rejection, and trough level will be tested during this period. subjects who are additionally agreed for pk study will be hospitalized with the state of tacrolimus bid therapy one day ago before taking ip. on the first day of hospitalization, his/her blood will be collected. at week 1 (plus seven days) after conversion to advagraf®, his/her blood will be collected for pk analysis.

Eligibility criteria:
inclusion criteria: * 19 years old and above. * patients who previously have received a liver transplant over the last six months and within last three years. * patients who are on tacrolimus immunosuppressive therapy twice a day for at least two weeks. * during tacrolimus immunosuppressive therapy twice a day for at least two weeks, patients who have following conditions. * patients who have normal liver function and renal function. * patients who have been monitored without complication such as acute rejection. * patients willing to sign his/her consent. exclusion criteria: * patients who have tacrolimus trough level resulted as 2 ng/mg at the baseline. * patients who are on steroid therapy due to positive result of acute rejection test before the baseline. * patients who have received a transplant besides liver. * patients who are allergic to ip or macrolide compounds. * patients who are on cyclosporine, bosentan, or potassium sparing diuretic. * patients with genetic diseases such as galactose intolerance, lapp lactase deficiency, or glucose-galactose malabsorption. * pregnant or lactating women. * patients not willing to adhere to study procedures/treatments.
biofeedback balance exercises in parkinson's disease

Conditions: Parkinson Disease; Balance; Distorted

Summary: the aim of this study was to evaluate the effectiveness of static posturography-assisted biofeedback exercises in pd-related balance disorder.

parkinson's disease (pd) is a chronic, progressive, degenerative movement disorder, the incidence of which increases with age, characterized by motor and non-motor findings. cardinal motor findings such as bradykinesia, rigidity, rest tremor, postural instability, and gait dysfunction and secondary motor symptoms additional to these such as dysarthria, and associated movements in the arms may be seen throughout the course of the disease. progressive loss of dopaminergic neurons occurs in the basal ganglia, together with a decrease in the speed and angle of movement. loss of postural reflexes causes balance disturbance findings such as impaired postural control, rigidity in the extremities, and akinesia.falls, decreased mobility, disability and quality of life impairment occur as a result of balance disorder. higher rates of falls or fall-related fractures have been reported in pd compared to the non-pd elderly population.there are several exercise applications aimed at balance improving strategies in pd. strengthening exercises combined with conventional balance exercises, treadmill walking training, tai chi, and biofeedback have been shown to improve gait and and balance control in pd. various publications have shown that biofeedback therapy in elderly individuals and in healthy individuals with postural disorder exhibits positive effects on balance by enhancing postural stability and reducing body tremor. the basic aim of this study was to investigate the effects of static posturography-assisted visual and auditory biofeedback therapy on balance and the risk of falls in pd. in addition, the study was intended to determine the effects of balance training on the individual's daily living activities, perceived safety level, and emotional state.

Eligibility criteria:
inclusion criteria: * diagnosis of parkinson's disease, * age 40 - 85 exclusion criteria: * presence of systemic or neurological disease capable of causing balance disorder, * postural hypotension, * presence of cardiovascular or musculoskeletal system disease capable of affecting locomotion, * presence of advanced dementia or mental disability
myo vs. myofascial injection for myofascial trigger points

Conditions: Myofascial Pain; Myofascial Trigger Point Pain; Trigger Point Pain, Myofascial

Summary: in this study, the effectiveness of two different application methods that can be used in myofascial trigger point injection treatment will be compared.

this study aims to compare the intramuscular trigger point injection, which is traditionally used in the treatment of myofascial trigger points with the method in which facial layers are also included in the application.

Eligibility criteria:
inclusion criteria: pain in the upper back area detection of active trigger point in upper back muscles (trapezius, levator scapula, rhomboids, supraspinatus and infraspinatus) presence of at least two of the three criteria recommended for the diagnosis of trigger point: 1. taut band 2. hypersensitive point 3. referred pain pain vas score ≥ 4 between the ages of 18-65 - exclusion criteria: using analgesics or anti-inflammatory medicines. having received physical therapy for the same symptoms in the past 3 months serious psychiatric illness presence of malignancy or infection coagulation disorder pregnancy history of operation in the relevant region presence of fibromyalgia syndrome history of allergy to local anesthetics -

Keywords: usg-guided trigger point injections myofascial pain myofascial trigger point fascial hydrodilatation
efficacy of bilateral stimulation with task-oriented training in improving lower limb motor functions in patients with stroke

Conditions: Stroke

Summary: this proposed study aims to compare the effects of unilateral and bilateral transcutaneous electrical nerve stimulation (tens). it will compare the effectiveness of bilateral tens + task-oriented training (tot) with unilateral tens+totin improving muscle strength, co-ordination, dynamic standing balance, walking performance, and functional mobility in patients with chronic stroke. the null hypothesis will be that bilateral tens+tot and unilateral tens+tot are not significantly different in promoting the recovery of these functions.

this proposed study aims to compare the effects of unilateral and bilateral transcutaneous electrical nerve stimulation (tens). it will compare the effectiveness of bilateral tens + task-oriented training (tot) with unilateral tens+totin improving muscle strength, co-ordination, dynamic standing balance, walking performance, and functional mobility in patients with chronic stroke. the null hypothesis will be that bilateral tens+tot and unilateral tens+tot are not significantly different in promoting the recovery of these functions.

Eligibility criteria:
inclusion criteria: * subjects will be recruited from local self-help groups through poster advertising. \\ * subjects will be included if they (1) are between 55 and 85 years of age * have been diagnosed with ischaemic brain injury or intracerebral hemorrhage by mri or computed tomography within the previous 1 to 10 years * are able to walk 3 metres independently with or without a walking aid * are able to score \> 6 out of 10 on the abbreviated mental test * are able to follow instructions and give informed consent * have no skin allergy which would prevent electrical stimulation. exclusion criteria: * subjects will be excluded if they have any additional medical, cardiovascular or orthopedic condition that would hinder proper treatment or assessment * use a cardiac pacemaker * have receptive dysphasia * have significant lower limb peripheral neuropathy (e.g. diabetic polyneuropathy) * are involved in drug studies or other clinical trials.

Keywords: electrical stimulation, exercise, stroke , rehabilitation
a study of a non-invasive glucose measuring device in out-patient settings

Conditions: Diabetes Mellitus

Summary: this explorative clinical investigation has been launched to collect spectral raman data paired with validated glucose reference values in persons with diabetes.


Eligibility criteria:
inclusion criteria: * male and female subjects minimum 18 years of age * individuals diagnosed with any type of insulin-dependent diabetes mellitus ≥ 1 year * willing to perform up to 12 finger-pricks during each day of out-patient measurements * signed informed consent * for women of childbearing potential: willing and able to practice fda approved birth control during the duration of the investigation * subject has a 2.4 ghz wireless internet connection at home (standard in normal routers) to be used in the study exclusion criteria: * for female subjects: pregnancy or breastfeeding * skin phototype vi categorized by fitzpatrick scale measured on thenar * subjects not able to understand and read local language * cognitive impairment, or in investigator's opinion, subject is not able to follow instructions provided and as specified in the protocol * subject not able to hold hand/arm steady (including tremors and parkinson's disease) * extensive skin changes, tattoos or diseases on right thenar (measurement site) * reduced circulation in right hand evaluated by allen's test * known allergy to medical grade alcohol * hemodialysis * systemic or topical administration of glucocorticoids at the right hand for the past 7 days or during the study period expected * any disorder, which in the investigator's opinion might jeopardize subject's safety or compliance with the protocol * severe diabetes-related complications such as advanced autonomic neuropathy, kidney disease, foot ulcers, legal blindness, or symptomatic cardiovascular disease as evidenced by a history of cardiovascular episode(s) * dependency from the sponsor or the clinical investigator (e.g. co-workers of the sponsor, the study site, and/ or their families) * subjects currently participating in another study * subjects who have participated in the study idt-1904-ro/rsp-21 or rsp-19. * incapacity for consent

Keywords: non-invasive glucose monitoring raman spectroscopy
a study of mkc-442 in hiv-positive patients

Conditions: HIV Infections

Summary: the purpose of this study is to see if it is safe and effective to give mkc-442 plus at least two other anti-hiv drugs to patients who have never been treated with nonnucleoside reverse transcriptase inhibitors but who have been treated with nucleoside reverse transcriptase inhibitors and protease inhibitors. this study also determines how long a drug combination including mkc-442 is effective.


Eligibility criteria:
inclusion criteria concurrent medication: allowed: based on medical history, medical condition, prior use of antiretroviral drugs, and genotypic analysis of the predominant strain of hiv-1 isolated from plasma, administration of at least 2 available antiviral agents by prescription may be given with mkc-422. patients must have: - hiv infection with hiv-1 rna greater than or equal to 2,000 by roche amplicor method, within 30 days of entry. prior medication: allowed: * prior nucleoside reverse transcriptase and protease inhibitors. * cytotoxic chemotherapy more than 30 days prior to entry. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * malabsorption or severe chronic diarrhea within 30 days prior to entry, or inability to consume adequate oral intake because of chronic nausea, emesis, or abdominal or esophageal discomfort. * inadequately controlled seizure disorder. * acute and clinically significant medical event within 30 days of screening. * any clinical or laboratory abnormality greater than grade 3 toxicity, with the exception of the listed laboratory values. prior medication: excluded: * non-nucleoside reverse transcriptase inhibitor therapy. * any unapproved experimental antiretroviral therapy. prior treatment: excluded: * radiation therapy within 30 days of entry, except to a local lesion. * transfusion of blood or blood products within 21 days of screening. risk behavior: excluded: active substance abuse that may interfere with compliance or protocol evaluations.

Keywords: anti-hiv agents viral load mkc 442
effects of an oxymizer on endurance time in patients with chronic lung diseases

Conditions: COPD; Interstitial Lung Disease

Summary: the oxymizer pendant® is a special oxygen cannula that can be used to supply high flow long term oxygen therapy. it is compatible with a wide variety of oxygen sources. in a reservoir, the oxymizer® stores pure oxygen so that the concentration of inhaled oxygen is increased. the aim of this study is to investigate the potential benefit of the oxymizer® with regard to the blood oxygenation during exercise testing. given that the "endurance time" is very sensitive for little changes in exercise capacity, this test will be used to show the difference between the oxymizer® and a conventional nasal cannula regarding exercise duration at 70% of peak watt and oxygenation. the tests will be accompanied by blood gas analysis, partial pressure of carbon dioxide and heart rate.


Eligibility criteria:
inclusion criteria: * copd iv * interstitial lung disease * long-term oxygen therapy with oxygen flow rate \>= 2 l/min exclusion criteria: * acute cardial decompensation * usual kontraindication for exposure test (higher-grad hypertension (arterial and pulmonal), cardiac valve vitien, instabile angina pectoris, cardiac arrhythmia)

Keywords: oxymizer endurance time exercise test nasal cannula copd ild oxygenation