Kornimate/medical-research-clean huggingface dataset:
a multicenter study to assess the effect of plasma exchange in accelerating the clearance of natalizumab in subjects with multiple sclerosis (ms)

Conditions: Relapsing Forms of Multiple Sclerosis

Summary: natalizumab (tysabri) is a protein-based drug that is manufactured by biogen idec in partnership with elan pharmaceuticals. natalizumab is approved in the us and europe for the treatment of multiple sclerosis (ms). the purpose of this study is to determine whether the amount of natalizumab (tysabri) that is present in your blood (plasma) can be reduced or eliminated by separating and removing the plasma and replacing it with other fluids, a process called plasma exchange.


Eligibility criteria:
inclusion criteria: * considered by the investigator to be free of signs and symptoms suggestive of any serious opportunistic infection * willing to discontinue and remain free from concomitant immunosuppressive or immunomodulatory treatment (including interferon beta and glatiramer acetate) for the duration of the study * willing and able to comply with the site's plasma exchange protocol which may require hospitalization or daily visits exclusion criteria: * considered by the investigator to be immunocompromised * history of, or available abnormal laboratory results indicative of any major disease that would preclude the administration of a recombinant humanized antibody immunomodulating agent for the duration of the study. * condition(s) considered to be contraindication(s) for plasma exchange, including but not limited to bleeding diathesis, hypotension, or vascular access limitations

Keywords: multiple sclerosis (ms)
"re-instrumentation vs flap surgery"

Conditions: Periodontal Pocket; Periodontitis

Summary: there are no studies comparing reinstrumentation and flap surgery for the treatment of residual periodontal pockets. the aim of this rct is to compare the re-instrumentation vs the flap surgery in terms of pd reduction, cal gain, gingival recession, need of an additional surgery and pocket closure. moreover, proms will be evaluated


Eligibility criteria:
inclusion criteria: * age ≥18aa * patients with periodontal disease * less than 20 cigarettes/day * no systemic antibiotic therapy in the last 3 months * at least one interdental site showing pd≥5mm after the non surgical periodontal initial therapy. infrabony component of the defect ≤3mm at x-ray * full-mouth plaque score and full-mouth bleeding score \<15% at baseline (re-evaluation) measured at six sites per tooth * no previous periodontal surgery at the experimental tooth exclusion criteria: * connective tissue diseases * diabetes * pregnancy or lactating * furcation involvement * crowned tooth * severe tooth mobility (class iii) * radiographical horizontal bone resorption exceeding the 50% of the root

Keywords: non-surgical periodontal therapy re-instrumentation
the physical fitness cohort study in the community-dwelling elderly in the wanhwa area.

Conditions: Sarcopenia

Summary: the aims of this study are to establish the cohort of elder population based on parameters of health-related fitness, body compositions, blood biochemistry, blood biomarker, balance, quality of life, and musculoskeletal ultrasonography; and to evaluate the association between fitness parameters and disease incidence with those data.

the aims of this study are to establish the cohort of elder population based on parameters of health-related fitness, body compositions, blood biochemistry, blood biomarker, balance, quality of life, and musculoskeletal ultrasonography and to evaluate the association between fitness parameters and disease incidence with these data. we expect to recruit 1200 adults who attend the annual health check-up in national taiwan university, beihu branch in 2016 and 2017 and to train 60 individuals having sarcopenia with strengthening exercise. this study will establish the urban elderly cohort, measure both physical and functional parameters, find the risk factors for aging, and validate the role of strength training for those sarcopenia patients. we hope this study will be widely cited in related fields in the future.

Eligibility criteria:
inclusion criteria: the investigators are ready to find out the individuals aged above 65 years and having sarcopenia. the 60 individuals must be evaluated their physical fitness in advance. the investigators plan to perform exercise and nutrition intervention for the individuals. exclusion criteria: 1. patients with heart rhythm, atrial fibrillation, ventricular bigeminy, infections, tumors, and blood disease,etc. 2. individuals has lived in nursing home or long-term care institutions. 3. individuals cannot stand steadily. 4 individuals cannot fill the questionnaires by his own.

Keywords: physical fitness,body composition,sarcopenia
2-week study in people with nonalcoholic fatty liver disease

Conditions: Non-alcoholic Steatohepatitis; Non-alcoholic Fatty Liver Disease

Summary: 2-week study in people with nonalcoholic fatty liver disease. study drug at 1 of 2 doses, or placebo, will be given for 14 days. blood samples, heart monitoring, vital signs, and imaging procedures will be performed.


Eligibility criteria:
inclusion criteria: * controlled attenuation parameter greater than or equal to 260 db/m via fibroscan * liver fat greater than or equal to 6% via mri exclusion criteria: * chronic liver disease * type 2 diabetes requiring drug treatment * unable to undergo mri * history of heart attack or stroke
continuously infused intracerebral (ic) recombinant-methionyl human glial cell line-derived neurotrophic factor (r-methugdnf) for the treatment of idiopathic parkinson's disease

Conditions: Parkinson Disease

Summary: parkinson's disease is characterized by loss of neurons that produce dopamine in a region of the brain called the substantia nigra. in the early stages of the disease, the disease responds to agents that replace dopamine such as levodopa. patients with more advanced disease have wide fluctuations in their response to levodopa, exhibiting on and off periods. this is due to continued degeneration of neurons. recombinant-methionyl human glial cell line-derived neurotrophic factor (r-methugdnf or gdnf) is a neurotrophic factor that promotes survival of dopaminergic neurons. this is a protein produced by recombinant technology that is almost identical to the naturally produced factor. results of animal studies indicate that gdnf has the potential to benefit patients with advanced parkinson's disease. the purpose of this clinical trial is to determine whether gdnf works to relieve symptoms of advanced parkinson's disease. the study will also test the delivery of gdnf using a catheter implanted into the putamen, the area of the brain associated with parkinson's disease, and an infusion pump that is implanted under the skin in the abdomen or chest. gdnf will be placed into the pump and delivered through the catheter to the brain. the purposes of this study are to determine the potential benefits and side effects of gdnf. the performance and safety of the catheter/infusion pump system will also be assessed. the study will last for 6 months. subjects will undergo neurological testing, computerized gait assessment and neurological imaging.


Eligibility criteria:
inclusion criteria: * patients with advanced idiopathic parkinson's disease treated with optimal doses of levodopa, dopamine agonist, catechol-o-methyl transferase (comt) inhibitors, or selegiline for 2 months prior to implantation of the intracerebral catheter and pump. * must be able to undergo surgery required to implant the pump and catheter. * must be capable of informed consent.
the effect of amiloride and spironolactone in patients with hypertension

Conditions: Hypertension

Summary: the investigators wish to investigate the potential effects of potassium. in this study we will examine patients with hypertension and increase their potassium-levels using amiloride and spironolactone. the investigators will examine the changes in the cardiovascular system using a sphygmocor-scanner.

purpose of the study is to examine the effect of amilorid and spironolacton on 1. renal function (gfr, u-aqp2, u-enacβ, u-camp, u-pge2, ch20, fena, fek), 2. pulsewavevelocity, augmentation index and centralt bloodpressure, 3. vasoactive hormones (prc, angii, aldo, avp, anp, bnp and endot), and 4. ambulatory blood pressure

Eligibility criteria:
inclusion criteria: * hypertension * age 45-70 * bmi: 18,5-30 exclusion criteria: * other diseases * drug or alcohol abuse * abnormal findings in the screening procedure

Keywords: hypertension potassium blood-pressure
contribution of skin color in stabilization of active cases of vitiligo by narrow band uvb

Conditions: Vitiligo

Summary: vitiligo is a disease in which autoimmunity plays a major role. multiple treatment options are available, of which narrow-band uvb is a cornerstone, acting through immunosuppression and repigmentation by stimulating reservoir melanocytes. it's expected that this immunsupression is lower in darker skin types, where increased basal melanin might act as a barrier.

vitiligo is acquired depigmentation disorder. several theories were hypothesized for causing vitiligo, of which the autoimmune theory is the most accepted. the main targets of therapy are stabilization of the disease activity through immunosuppression, and repigmentation through stimulation of reservoir melanocytes proliferation and migration. narrow band ultraviolet phototherapy (nb-uvb) remains the cornerstone treatment of vitiligo. nb-uvb can induce both immunosuppression and repigmentation. several factors can modulate the efficacy of nb-uvb therapy in treatment of vitiligo cases, including patient's age, lesion site, duration of the disease, and duration of the therapy. the immunosuppressive function of nb-uvb was first detected in 1963 by hanisko and suskind, who observed that the contact hypersensitivity response in skin sensitized to dinitrochlorobenzene (dncb) was reduced if skin was previously exposed to suberythemal doses of uvb. present evidence suggests that uvb suppress immune system through generation of t-suppressor cells, which inhibit the effector cells of th1 type. it appears that uv-induced immunosuppression depresses the function of th1 cells and enhances the activity of th2 cells via cytokines such as interleukin 10. it's expected that this immunsupression is lower in darker skin types, where increased basal melanin might act as a barrier. however, skin was previously divided to uvb-resistant and uvb-sensitive (uvb-r and uvb-s) based on the contact hypersensitivity testing, regardless of the skin type. moreover, a study on nb-uvb phototherapy for psoriasis revealed that photoadaptation during nb-uvb therapy is independent of skin type.

Eligibility criteria:
inclusion criteria: * active cases of non-segmental vitiligo, vida +2 or more. * all skin types * age above 6 years, both sexes. exclusion criteria: * contraindications to nb-uvb ( photosensitive skin disorders, skin malignancy, patients on photosensitizing medications) * contraindications to mini-pulse steroid therapy (uncontrolled diabetes or hypertension, peptic ulcer) * stable disease (vida 0 \& -1) and activity more than 6 months ago (vida +1). * the use of other treatment for vitiligo during the 3 months previous to enrollment.

Keywords: vitiligo narrow-band uvb skin color minipulse
effect of cervical manipulation on mouth opening

Conditions: Bruxism; Face Pain

Summary: objectives: to compare the effects of cervical manipulation on the ranges of motion of mouth opening and painful pressure points in the masseter and temporal muscles after of cervical manipulation compared to the control group. material and methods: single-blind randomized clinical trial with two arms, one group intervention and a control group. hypothesis: there is a significant difference in mouth opening and painful pressure points between the intervention group and the control group. expected results: the intervention group would significantly increase their mouth opening maximal and decrease pressure pain in the masseter and temporalis muscles.


Eligibility criteria:
inclusion criteria: * subjects over 18 years of age, men and women * students with neck and/or facial pain minimum 3/10 vas scale * kinesiology students who regularly attend face-to-face classes who have a mobility pass and a health declaration. · students who read and sign the informed consent. exclusion criteria: * orthognathic surgery * head and neck fracture or injury * contraindication (red flag) to perform high-speed, low-amplitude cervical manipulation (bone cancer, osteoporosis, vertebral artery injury, etc.) * positive cervical safety tests (example: klein test positive)
galantamine executive function in parkinson's disease

Conditions: Parkinson's Disease

Summary: the aim of the study is to determine whether galantamine stabilizes or improves thinking abilities in individuals with parkinson's disease. individuals included in the study have minor complaints about thinking such as problems with concentration or memory but do not have dementia. this medication has been shown to have a positive effect on stabilizing memory in individuals with alzheimer's disease. it is fda approved for use in elderly individuals with alzheimer's disease. it is hypothesized that galantamine will stabilize or improve executive and attentional functions in individuals with parkinson's.

while several cholinesterase inhibitors have effectiveness in alzheimer's disease (ad), galantamine is unique since it has a dual mode of action: inhibition of acetylcholinesterase and modulation of nicotinic acetylcholine receptors.as parkinson's disease (pd) impacts frontal systems, executive cognition rather than memory function (mediated by medial temporal) would be the targeted area for potential improvement. this single center, double blind, placebo controlled study compares a group of pd patients treated with galantamine to a group of pd patients who are not treated with this medication on a series of cognitive tasks that examine attention and executive control.

Eligibility criteria:
inclusion criteria: * idiopathic parkinson's disease exclusion criteria: * dementia, depression, cardiac disease, gastrointestinal disease

Keywords: cognition
a 12-month, randomized, efficacy and safety study of 0.5 mg ranibizumab vs laser in chinese diabetic macular edema (dme) patients

Conditions: Diabetic Macular Edema; Visual Impairment

Summary: study of efficacy and safety of 0.5 mg ranibizumab in chinese patients with diabetic macular edema (dme)

the purpose of this study was to provide efficacy and safety data on 0.5 mg ranibizumab intravitreal injections compared to laser photocoagulation in chinese patients with visual impairment due to dme. treatment was driven by achieving vision stabilization.

Eligibility criteria:
key inclusion criteria: * male or female chinese patients ≥ 18 years of age with diabetes mellitus and with hba1c ≤10.0% * stable medication for diabetes within 3 months prior to visit 1 * visual impairment due to dme with bcva score between 78 and 39 letters as measured by etdrs-like charts at 4 meters key exclusion criteria: * stroke or myocardial infarction less than 3 months prior to screening visit * uncontrolled hypertension * active ocular infection or intraocular inflammation in any eye * treatment with any anti-angiogenic drugs within 3 months prior to baseline visit in any eye * active proliferative diabetic retinopathy in study eye * use of other investigational drugs within 30 days and systemic anti-vegf drugs within 6 months prior to baseline visit * prior laser photocoagulation or intraocular procedure within 3 months prior to baseline in study eye * history of intravitreal corticosteroid treatment in phakic study eye, and in aphakic or pseudophakic within 3 months prior to screening

Keywords: dme macular edema vision impairment chinese diabetes
ofatumumab in patients with relapsed/progressive diffused large b-cell lymphoma (dlbcl) ineligible for or relapse/progression after transplant

Conditions: Lymphoma, Large-Cell, Diffuse

Summary: the purpose of this trial is to determine the effect of ofatumumab in patients with diffused large b-cell lymphoma (dlbcl) ineligible for transplant or relapsed after autologous transplant


Eligibility criteria:
inclusion criteria: patients with dlbcl * and relapse after complete remission or disease progression after partial remission who are ineligible for autologous stem cell transplantation * and relapse after complete remission or disease progression after partial remission following autologous stem cell transplantation.
dietary strategies to promote muscle protein anabolism in the elderly

Conditions: Sarcopenia

Summary: aging is associated with the loss of lean muscle mass, termed sarcopenia. food intake and in particular the ingestion of protein or amino acids has been shown to be a powerful stimulus to promote net muscle protein anabolism. however this anabolic response following a meal-like protein bolus seems to be blunted in the elderly as compared to young adults. the first aim of this proposal is to investigate the post-prandial muscle protein synthesis rates in young and elderly men in response to a meal-like protein bolus after a period of rest or physical activity (study a). the rest trial (rest) will act as a proof-of-principle study to examine the blunted protein synthetic response in the elderly, and as a control trial in comparison with the exercise trial (exc) to establish the surplus value of physical activity prior to protein intake on muscle protein synthesis. the second aim of this proposal is to determine the surplus value of an increased quantity of the ingested protein bolus (study b). large amounts of protein (40 and 60 g) will be compared to a meal-like amount of protein (20 g) as a means to maximize plasma amino acid availability and/or to stimulate muscle protein anabolism. the third aim of this proposal is to study the differences in quality of the ingested protein bolus (study c). instead of significantly increasing the quantity of the protein bolus, we will also apply a more practical approach to augment skeletal muscle protein synthesis rates; modifying the digestibility or amino acid composition of a meal-like protein bolus.


Eligibility criteria:
inclusion criteria: * in study a, non-obese male subjects (bmi \<27) between the age of 18-30 yrs and 70-85 yrs will be selected. * in studies b and c, non-obese male subjects (bmi \<27) between the age of 70-85 yrs will be selected. exclusion criteria: * type ii diabetes or other known diseases * use of medication * female * other ages or bmi than indicated above * participation in any regular exercise program.

Keywords: muscle loss aging protein amino acids exercise protein synthesis
somatuline autogel: acromegaly self/partner injection study

Conditions: Acromegaly

Summary: the purpose of this study is to allow patients with acromegaly, or their partners, to learn how to successfully inject somatuline autogel at home. ability to perform unsupervised injections whilst maintaining adequate disease control will be assessed.


Eligibility criteria:
inclusion criteria: * the patient must have a clinical diagnosis of acromegaly * the patient must have been tested and shown to have a gh level less than or equal to 10 micrograms/l within 28 days prior to the baseline visit * the patient must be currently treated with somatuline autogel and have been stable on their current dose for at least 6 months immediately prior to screening * the patient must be able to store study medication in a refrigerator in their own home exclusion criteria: * the patient has had pituitary surgery (adenomectomy) within 6 months prior to screening * the patient has received pituitary radiotherapy within one year prior to screening * the patient is likely to require pituitary surgery (adenomectomy) or to receive radiotherapy during the study period * the patient is currently receiving a gh antagonist or a somatostatin analogue other than somatuline autogel

Keywords: growth hormone
effects of dexmedetomidine on the liver injury after hepatectomy

Conditions: Ischemia-reperfusion Injury

Summary: to investigate whether dexmedetomidine reduce liver injury after hepatectomy. during hepatectomy, surgeons always took inflow occlusion to reduce blood loss with pringle maneuver. a few clinical studies had shown dexmedetomidine could reduce ischaemia/reperfusion (ir) injury caused by the secretion of reactive oxygen species and inflammatory cytokines. glutathione-s-transferase (gst) was a sensitive and specific marker for hepatic injury in several studies before. so the investigator decided to use it as the primary endpoint. besides, in our center, there are some liver resection surgeries that didn't need occlusion. so it can serve the best placebo for determine the the actual effect of dexmedetomidine on the ir injury in further subgroup analysis.

the purpose of our study is to compare liver injury with dexmedetomidine. the enrolled patients were randomized into two group. in the study group, dexmedetomidine, diluted in 0.9% sodium chloride with the concentration of 4 ug ml-1 is administered with an loading dose of 0.5ug kg-1 of 10 min, and maintained with infusion rate of 0.5 ug kg-1 h-1. while, 0.9% sodium chloride serves as the placebo with the same loading dose and infusion rate in the control group. the infusion is ceased after the resection of the hepatic issues. gst is a sensitive and specific marker for hepatic injury in several studies before and is taken as the primary endpoint. and the investigator use other inflammatory cytokines reflecting the systemic inflammatory response in serum. besides these, the investigator observe the hemodynamic changes during the operation time and complications related with anesthesia and surgery.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) i\~iii * selected to have hepatectomy in our hospital, child-pugh a * patient's consent exclusion criteria: * refusing to attend or attending in other clinical study * having severe cardio-pulmonary disease, ejection fraction (ef)\<40%, having cardiac infarction in recent three months, chronic obstructive pulmonary disease (copd) (pao2\<60mmhg) * pregnant or lactating women * having neuropsychiatric disorders * emergent surgeries，hemorrhage shock， * rupture and hemorrhage of liver tumor
clindamycin-trimethoprim/sulfamethoxazole for pcp after solid organ transplantation population.

Conditions: Pneumocystis Jirovecii Pneumonia; Solid Organ Transplantation

Summary: pcp is one of the common opportunistic infections in patients with hiv and non-hiv-associated immunodeficiency.with the increasing number of solid organ transplantation, how to effectively treat severe pcp after solid organ transplantation has become an urgent problem to be solved.in general, atovaquone, dapsone, and clindamycin-primaquine can be used as second-line alternatives when tmp-smx fails to treat hiv-pcp. therefore, the objective of this study is to preliminarily investigate the safety and efficacy of low-dose tmp-smx combined with clindamycin (ct regimen) for the treatment of severe pcp after solid organ transplantation.

pcp is one of the common opportunistic infections in patients with hiv and non-hiv-associated immunodeficiency.with the increasing number of solid organ transplantation, how to effectively treat severe pcp after solid organ transplantation has become an urgent problem to be solved.in general, atovaquone, dapsone, and clindamycin-primaquine can be used as second-line alternatives when tmp-smx fails to treat hiv-pcp. more and more studies suggest that clindamycin-based alternatives play an increasingly important role in treating of pcp. therefore, the objective of this study is to preliminarily investigate the safety and efficacy of low-dose tmp-smx combined with clindamycin (ct regimen) for the treatment of severe pcp after solid organ transplantation.

Eligibility criteria:
inclusion criteria: * pjp after solid organ transplantation. exclusion criteria: * renal failure,heart failure,tumor recurrence

Keywords: tmp-smx clindamycin oxygenation index adverse reactions