Kornimate/medical-research-clean huggingface dataset:
prevalidation of the first german version of the vocal fatigue index (vfi)

Conditions: Vocal Fatigue

Summary: vocal fatigue has been described as a common complaint in patients with voice disorders, however to date there is no standardized questionnaire in german language to assess specific symptoms. main aim of this study is to assess the validity of the first german version of the vocal fatigue index (vfi), and english questionnaire developed for voice patients to assess vocal fatigue. in this study patients with voice disorders will receive the patient based questionnaires "vocal fatigue index (vfi)", "voice handicap index 9 international (vhi 9i)" and "vocal tract discomfort scale (vtd)", the study information and consent letter together with the standard invitation letter to a voice assessment at the department for phoniatrics and speech pathology university hospital zurich. data of 93 consecutive volunteering patients will be collected. furthermore a retest using the vfi will be conducted after 1 week with 10 volunteers. thereafter construct validity of the vfi as compared to the established voice symptom questionnaires vhi 9i and vtd will be investigated. further test-retest reliability will be determined.


Eligibility criteria:
inclusion criteria: * age \> 18 years * voice disorder (all etiologies) exclusion criteria: * age \< 18 jahre * current voice therapy * psychological disease * botox injection in the larynx * inability to independently fill out the questionnaire
effects of convective therapies in dialysis patients

Conditions: Uremia

Summary: convective therapies have been proposed for improving chronic dialysis patient outcomes, including intradialytic symptomatic hypotension. to evaluate the frequency of sessions with intradialytic symptomatic hypotension in different types and doses of convective therapies compared with low-flux hemodialysis (hd), the investigators performed a multicentre, open-label, randomized controlled trial.


Eligibility criteria:
inclusion criteria: * dialysis patients aged 18-80 years * thrice-weekly hd or hdf for at least 6 months * body weight less or equal to 90 kg * stable clinical condition * written consent exclusion criteria: * infections * malignancies * active systemic diseases * active hepatitis or cirrhosis * unstable diabetes * diuresis higher than 200 ml/24h * dysfunction of vascular access * blood flow rate less than 300 ml/min

Keywords: blood pressure cardiovascular instability symptomatic hypotension online hemofiltration online hemodiafiltration
a randomized trial of itraconazole in acute stages of allergic bronchopulmonary aspergillosis

Conditions: Allergic Bronchopulmonary Aspergillosis

Summary: the study evaluates the addition of itraconazole to glucocorticoids in management of acute stages of allergic bronchopulmonary aspergillosis (abpa). half of the participants will receive glucocorticoids while the other half will receive itraconazole and glucocorticoids

the management of allergic bronchopulmonary aspergillosis (abpa) includes two important aspects namely institution of immunosuppressive therapy in the form of glucocorticoids to control the immunologic activity, and close monitoring for detection of relapses. another possible target is to use antifungal agents to attenuate the fungal burden secondary to the fungal colonization in the airways. oral corticosteroids are currently the treatment of choice for abpa associated with bronchial asthma. they not only suppress the immune hyperfunction but are also anti-inflammatory. itraconazole, an oral triazole with relatively low toxicity, is active against aspergillus spp. in vitro and in vivo. the activity of itraconazole against aspergillus spp. is more than that of ketoconazole. the administration of itraconazole can eliminate aspergillus in the airways and can theoretically reduce the allergic responses in abpa. we hypothesize that itraconazole when given in the acute stages of abpa will decrease the chances of relapse and progression to glucocorticoid-dependent abpa.

Eligibility criteria:
inclusion criteria: treatment naive patients of allergic bronchopulmonary aspergillosis (abpa) defined by the presence of all the following: * asthma * immediate cutaneous hyperreactivity on aspergillus skin test or a.fumigatus specific ige levels \>0.35 kua/l * elevated total ige levels \>1000 iu/ml and, two of the following features: * presence of precipitating antibodies against a.fumigatus in serum * fixed or transient radiographic pulmonary opacities * total eosinophil count \>1000/µl * bronchiectasis on hrct chest exclusion criteria: * intake of systemic glucocorticoids for more than three weeks in the preceding six months * exposure to azoles in the last six months * immunosuppressive states such as uncontrolled diabetes mellitus, chronic renal failure, chronic liver failure and others * patient on immunosuppressive drugs * pregnancy * enrollment in another trial of abpa * failure to provide informed consent
efficacy of an extract of concentrated korean red ginseng for preventing upper respiratory tract infections

Conditions: Healthy Subjects

Summary: upper respiratory tract infections are a major source of morbidity throughout the world. extracts of korean red ginseng have been found to have the potential to modulate both natural and acquired immune responses. the investigators sought to examine the efficacy of an extract of korean red ginseng in preventing colds. therefore, the efficacy and safety of korean red ginseng will be investigated in healthy subjects during the influenza season.

the extract of korean red ginseng has been found efficacious in the prevention of respiratory infections in healthy adults. the investigators will be conducted a randomized, double-blind, placebo-controlled study at the onset of the influenza season. a total of 100 subjects 30-70 years of age with a history of at least 2 colds in the previous year will be recruited from the general population in jeollabuk-do, south korea. the subjects will be instructed to take 9 capsules per day of either the korean red ginseng extract or a placebo for a period of 12weeks. the primary outcome measure will be the number of jackson-verified colds. secondary outcome measures will be included symptom severity, total number of days of symptoms and duration of all colds. cold symptoms will be scored by subjects.

Eligibility criteria:
inclusion criteria: * males and females 30-70 years old * have contracted at least 2 colds in the past year exclusion criteria: * if they had been vaccinated against influenza in the previous 6 months. * subjects with medical conditions such as multiple sclerosis, tuberculosis, diabetes, cancer, lupus, hiv/aids, cardiovascular disease, hypertension, neurologic or psychiatric disease, and renal, pulmonary and hepatic abnormalities * subjects taking medications such as immunosuppressive drugs, corticosteroids, warfarin, phenalzine, pentobarbital, haloperidol or cyclosporine * abnormal liver or kidney function tests (alt or ast\>2 times the upper limit of normal; elevated creatinine, males\>125um/l, females\>110um/l) * pregnant or lactating women and heavy smokers. * being judged by the responsible physician of the local study center as unfit to participate in the study
clinical predictors of extracorporal shockwave therapy efficacy in patients presenting with lateral hip pain

Conditions: Tendinopathy

Summary: this pragmatic clinical trial is considering the variable response to treatment outcome of individuals with greater trochanteric pain syndrome (gtps). the aim of this study is to identify predictors of focused extracorporeal shockwave therapy (feswt) efficacy in individuals with gtps. specifically, the ability of clinically applicable measurements including: patient demographics, co-morbidity, oestrogen levels, pain characteristics, hip abductor strength, time to pain during single-leg stance test, low back pain, and immediate pain reduction to local anaesthetic injection at the trochanter major insertion of gluteus medius (gmed) during walking.


Eligibility criteria:
inclusion criteria: * lateral hip pain, worst over the greater trochanter, present for a minimum of 3 months * age 35-70 years * female * pain at an average intensity of ≥3 out of 10 on most days of the last week. * tenderness on palpation of the greater trochanter * pain on one of the following: reproduction of pain on 30 sec single leg stand or positive faber test exclusion criteria: * any known advanced hip joint pathology where groin pain is the primary complaint and/or reproduction of groin pain with faber or faddir. * where range of pure hip joint flexion is \<90° * radiating pain distal to the gluteus max + positive straight leg raise (slr-test \< 30°) * known advanced knee pathology or restricted range of knee motion (must have minimum 90° flexion and full extension) * any systemic diseases affecting the muscular or nervous system, and uncontrolled diabetes * malignant tumour or systemic inflammatory disease * any factors that would preclude the participant from having an mri (e.g. pacemaker, metal implants, pregnancy, claustrophobia) * if the participant is involved in a legal/workcover or other injury claim * fear of needles (trypanophobia) * if the participant is unable to write, read or comprehend danish

Keywords: greater trochanter pain syndrome lateral hip pain
thalamic deep brain stimulation for tourette syndrome

Conditions: Tourette Syndrome

Summary: the purpose of this study is to determine whether deep brain stimulation is effective at reducing tic frequency and severity in adults with tourette syndrome.


Eligibility criteria:
inclusion criteria: * age 18 or older * diagnosis of tourette syndrome by dsm-iv * tic frequency at least one per minute at screening * prior failure of at least two dopamine receptor or presynaptic blockers * negative impact on quality of life exclusion criteria: * significant structural brain lesion (on imaging studies) * significant dementia * severe head trauma preceding onset of tics * use of dopamine receptor blockers prior to recognition of tics * prior implanted electrical device * electroconvulsive therapy (ect) within 24 months * suicide attempt within 12 months * significant sociopathic personality * current or planned pregnancy

Keywords: tourette syndrome deep brain stimulation video assessment ygtss tssl
foreign body removal with the assistance of ultrasound guidance and methylene blue staining in children

Conditions: Foreign Bodies; Ultrasound

Summary: soft-tissue foreign bodies (fb) are very commonly observed in pediatric emergency departments. some are metallic and can be diagnosed easily via x-ray radiography, whereas others are radiolucent and are hence less easily diagnosed. not all fb can be removed effectively, even via open surgery and c-arm guidance. this deficiency may potentially be addressed through the ultrasound (us) skills instrument, which is increasingly popular and is convenient for use in the operation room. in the current study, we evaluated the efficiency of fb removal with the assistance of us and methylene blue (mb) staining.


Eligibility criteria:
inclusion criteria: * diagnosed with soft-tissue foreign body * must have complete clinical data exclusion criteria: * had other injuries * presented with more than 3 pieces foreign bodies
study of sys6020 in bcma-positive multiple myeloma

Conditions: Multiple Myeloma

Summary: this is a multi-center, phase i trial that studies the efficacy and recommended dose of bcma cart cells in treating patients with bcma-positive multiple myeloma (mm) that have not respond or relapsed after chemotherapy. b-cell maturation antigen (bcma), a cell surface protein expressed on malignant plasma cell, has emerged as a very selective antigen to be targeted in novel immunotherapy for mm.


Eligibility criteria:
inclusion criteria: * 1. ≥ 18 years of age at the time of signing informed consent; * 2. cytology or tissue biopsy meets diagnostic criteria for multiple myeloma (according to imwg criteria); * 3. bone marrow specimens confirmed positive bcma expression in plasma cells and myeloma cells by immunohistochemistry or flow cytometry (\>5%); * 4. have measurable disease by international myeloma working group (imwg) criteria based on one or more of the following findings: * serum m-protein≥ 1 g/dl（≥10 g/l） * urine m-protein ≥ 200 mg/24 hour * involved serum free light chain (flcs) level≥10 mg/dl with flcs abnormal ratio (\ 1.65) * 5. eastern cooperative oncology group (ecog) performance status 0 or 1; * 6. diagnosis of mm with relapsed or refractory disease and have had at least 1 prior lines of therapy. exclusion criteria: * 1. patients with plasmacytic leukemia or waldenstrom's macroglobulinemia or poems syndrome (polyneuropathy, organ enlargement, endocrinopathy, monoclonal protein and skin lesions) or amyloidosis at screening; * 2. received any prior car-t therapy or bcma targeted therapy; * 3. patients who have received autologous hematopoietic stem cell transplantation (asct) within 12 weeks prior to monocyte collection or history of allogeneic stem cell transplantation; * 4. a history of immunodeficiency, including a positive hiv antibody test; * 5. hepatitis b surface antigen (hbsag) positive and hbv-dna above the lower limit of measurement or 1000 copies /ml (500 iu/ml), (whichever is lower), hcv antibody positive and hcv-rna above the lower limit of measurement or 1000 copies /ml (whichever is lower); * 6. patients who, in the judgment of the investigator, need but are unable to receive prophylactic treatment for pneumocystis, herpes simplex virus (hsv), or herpes zoster (vzv) prior to initiation of treatment, or syphilis confirmatory positive; * 7. history of bacillus tuberculosis (tb) treatment within 2 years prior to first medication; * 8. patients with a history of interstitial lung disease and/or severe lung function impairment; * 9. have an active bacterial, fungal, or viral infection; * 10.a history of severe cardiovascular disease.
ranibizumab for macular edema secondary to branch retinal vein occlusion in patients with fair vision

Conditions: Branch Retinal Vein Occlusion; Macular Edema

Summary: the purpose of this study is to determine the effect of ranibizumab for the treatment of macular edema (me) secondary to branch retinal vein occlusion (brvo) in patients with initial fair visual acuity.

lucentis was approved for me due to brvo based on the results from bravo study. the inclusion criteria in bravo was "best corrected visual acuity (bcva) 20/40 to 20/320". therefore, the patients with va better than 20/40 who are out of inclusion criteria of bravo study had no treatment and just wait to reach spontaneous improvement. but, there is unmet needs of these patients and, in actual clinical practice, many retina specialists treat these patients with ranibizumab. these patients have been experiencing va improvement after the injection. based on these clinical backgrounds, the investigator wants to suggest the treatment guidelines in these patients group, which is, early treatment of ranibizumab would be effective and increase patients' qol. in other words, there are many experiences in these cases among ophthalmologists, but there have been no clinical trials that can endorse the treatments. to confirm the efficacy of ranibizumab in patients with initial fair vision, the investigators started the prospective randomized clinical trial on the efficacy and safety of ranibizumab for the patients.

Eligibility criteria:
inclusion criteria: 1. foveal center-involving macular edema secondary to brvo diagnosed within 12 months before study enrollment 2. etdrs chart bcva: 63 to 77 letters (20/32 to 20/50 snellen equivalent) 3. cft \>= 300 um (mean of measurements obtained at screening and day 0) 4. signed consent informed 5. male or female, age ≥18 years old exclusion criteria: 1. prior episode of rvo: past history of rvo in the study eye diagnosed before 1 year of study enrollment. 2. bcva improvement \>10 letters between screening and day 0 3. history of other ocular diseases (e.g. diabetic retinopathy, age-related macular degeneration) 4. laser treatment within 3 months before baseline 5. intraocular corticosteroid use within 3 months before baseline 6. anti-vascular endothelial growth factor (vegf) treatment in the study or fellow eye within 3 months before baseline 7. intraocular surgery other than cataract surgery, cataract surgery within 6 months before baseline 8. stroke or myocardial infarction ≤3 months before baseline 9. pregnancy or plan to have baby in female

Keywords: branch retinal vein occlusion macular edema ranibizumab
spa therapy for upper or lower limb lymphoedema

Conditions: Lymphoedema; Breast Cancer; Malignant Disease; Gynaecological Cancer; Lymphoma; Prostate Cancer

Summary: thermoedeme is a comparative, controlled, randomized, multicenter and simple blinded (investigator) trial. the aim of this study is to evaluate effects of spa therapy in phlebology with a therapeutic education program in daily life of patients suffering lymphoedema.

lymphoedema is a chronic disease related to an insufficiency of the lymphatic system, which most often affects the limbs. secondary forms are the most common, particularly those following surgical and radiotherapy treatments for cancer, the most classic being the post-therapeutic large arm of breast cancer. the lymphoedema is a traditional phlebology indication in spa therapy. the spa therapy linked with therapeutic education could constitute a favorable environment for the treatment of lymphoedema. the primary endpoint is the comparison of the rate of patients improved from baseline to 6 months on lms27 (upper limb lymphoedema) or lymqol-leg (lower limb lymphoedema) (improvement is defined as 7 points between baseline and 6-month follow-up).

Eligibility criteria:
inclusion criteria: * 18 years old and older * available for a spa treatment (phlebology indication) during 18 days and a follow up period of 15 months * with permanent lymphoedema of the upper or lower limb (2 ou 3 stade of international society for lymphology scale) * voluntary to participate to the study, informed consent form signed after appropriate information * affiliation to the social security system or equivalent exclusion criteria: * cancer undergoing chemotherapy and radiotherapy treatment in primary phase * the baseline score of lms27 or lymqol-leg \> 79 * pain of upper limb linked with a radical plexitis * contra-indication of spa treatment (cancer in progress, psychiatrics disorders, immunodeficiency) * erysipelas case history in the last 6 months or pachyderma and lymphangiectasia * no previous spa treatment for upper limb lymphoedema during the spa year * risk of intensive treatment in the next 6 months * subject participating to an other clinical study interventional * pregnancy, parturient or breast feeding

Keywords: lymphoedema post breast cancer spa therapy education therapeutic malignant disease post gynaecological cancer post lymphoma post prostate cancer
pilot study of bcaa on sleep

Conditions: Sleep Disorder; Traumatic Brain Injury

Summary: individuals will be recruited from the va portland health care system and the community affiliated with oregon health \& science university. traumatic brain injury status will be assessed as a contributing factor. subjects will be randomized to one of 3 groups (bcaa or one of 2 placebo conditions) and instructed to consume study product twice daily for 21 days. self-report questionnaires, wrist actigraphy, pressure pain testing, and cognitive function will be assessed pre and post the experimental period.

the goal of this proposal is to explore the feasibility of, and potential for, dietary supplementation with branched chain amino acids (bcaas) to effect sleep quality and cognitive function in veterans. the bcaas (leucine, isoleucine, and valine) cannot be synthesized endogenously (i.e., they must be obtained through the diet) and are the precursors to \>50% of de novo glutamate and gaba synthesis in the brain, which are the primary excitatory and inhibitory neurotransmitters, respectively. preclinical evidence strongly suggests that dietary bcaa supplementation restores normal sleep-wake patterns and cognitive function following tbi through a restoration in the global cortical excitation:inhibition ratio. bcaa supplementation has been studied extensively in healthy humans and in a variety of disease states, including following tbi, but not yet in veterans in the chronic phase of recovery from tbi. bcaas are a commercially available dietary supplement and very well tolerated with minimal side-effects. subjects will be randomized in a double-blind fashion through the va research pharmacy to one of three groups: 1) bcaa; 60 g/day in two 30 g doses, 2) rice protein; 60 g/day in two 30 g doses, and 3) placebo; 60 g microcrystalline cellulose in two 30 g doses. bcaa and placebo will be prepared by the va research pharmacy and dispensed in a blinded fashion to veterans after demonstrating informed consent. following a \~4-week period of baseline, veterans will be instructed to consume study product after waking and \~6 hours later, on an empty stomach for a period of up to 21-days. self-report questionnaires assessing sleep quality, cognitive function, trauma-related symptom severity, and other measures of mental and physical well-being will be administered before and after the experimental period. wrist actigraphy will be continuously collected over the baseline and the experimental period. cognitive function will be assessed before and after the experimental period using an established battery of neuropsychological tests (i.e., selected tests from wais, d-kefs, hvlt, cowat, among others. pressure pain testing will be conducted before and after the experimental period.

Eligibility criteria:
inclusion criteria: * veteran * english speaking * accessible via phone * sleep problems exclusion criteria: * decisional impairment * nickel allergy * maple syrup urine disease or family history of disease * allergy to sucralose * currently taking bcaas