Kornimate/medical-research-clean huggingface dataset:
technology-assisted language intervention (tali)

Conditions: Hearing Loss, Bilateral; Language Development

Summary: this study is testing the effectiveness of augmentative and alternative communication technology among deaf or hard of hearing children for improving language development. children will be randomized to receive either the technology intervention or treatment as usual


Eligibility criteria:
inclusion criteria: * age 3-10 years * documented permanent bilateral hearing loss with severity levels clinically defined moderate to profound). * identified with a language deficit, defined by either the ratio of language standard scores to nonverbal intelligence quotient \<.85 or a differences in nonverbal iq and language standard scores of 10 points. language scores may either be receptive or expressive. * currently receiving speech-language therapy. exclusion criteria: mild hearing loss and unilateral hearing loss * primary language other than english * significant motor impairments * nonverbal iq \<80 * children with severe communication disorders (i.e. autism spectrum disorders).

Keywords: hearing loss randomized clinical trial intervention language development
muscle treatment for management of pain & disability in tension-type headache

Conditions: Tension-type Headache

Summary: the purpose of this study is to determine the effectiveness of treatments (massage therapy or ultrasound) directed at skeletal muscle for alleviating pain associated wtih tension headache.

chronic or episodic forms of tension-type headache affect a high percentage of the population. pain from tension-type headache (tth) not only impacts personal well-being, but also poses a significant socioeconomic burden in terms of workdays lost and decreased worker productivity. although tth is the most prevalent of the headache disorders, there is a distinct lack of research with regards to specific treatments for this ailment in comparison to all other headache classifications, such as migraine. a muscular involvement is associated with tth and is reported in the research literature as elevation in skeletal muscle tenderness, increased presence of active myofascial trigger point's, and physical abnormalities in cervical and cranial muscles. thus, a treatment approach that addresses the skeletal musculature could be an important component in the management of tth. the purpose of this randomized trial is to determine the effectiveness of two muscle oriented treatments on reducing pain and disability associated with tth: massage therapy and ultrasound.

Eligibility criteria:
inclusion criteria: * 2 or more tension-type headache episodes per week * headache episodes of 2 hours or longer * experiencing tension-type headache for 6 months or longer exclusion criteria: * migraine \>1/month * presence of alternate forms of headache (e.g. cluster headache, medication-induced headache, headache caused by injury) * the diagnosis of fibromyalgia, major depression, other neurological or cardiovascular disease * pregnancy * prior massage or ultrasound treatment for headaches
isonep to treat persistent pigment epithelial detachment (ped) in subjects with exudative age-related macular degeneration (amd) or polypoidal choroidal vasculopathy (pcv)

Conditions: Pigment Epithelial Detachment

Summary: lt1009-oph-002 is a phase 1b study designed to evaluate the safety and potential efficacy of isonep following one, two or three injections of isonep, as needed, for the treatment of pigment epithelial detachment (ped) secondary to ped secondary to exudative age-related macular degeneration (amd) or polypoidal choroidal vasculopathy (pcv).

sixteen (16) subjects per dose group who have received a minimum of 3 and no more than 7 doses of an anti-vegf agent (i.e., lucentis or avastin), and whose ped has not decreased by greater than 25% in height despite therapy, will be enrolled for a total of 32 subjects. the presence of ped diagnosed by the investigator will be confirmed by sdoct, icg and fa by a digital imaging reading center prior to subject enrollment. the ability of isonep to induce regression of persistent ped in subjects with exudative amd or pcv despite previous treatment with an anti-vegf agent will be evaluated.

Eligibility criteria:
inclusion criteria: * males and females \> 50 years of age with a diagnosis of ped secondary to amd or pcv * serous and/or fibrovascular ped secondary to exudative amd or secondary to pcv (confirmed by sdoct, fa and icg) that has not demonstrated at least a 25% decrease in the height of the ped (from the onset of anti-vegf therapy) following a minimum of 3 doses of an anti-vegf agent (i.e., lucentis or avastin) * ped that has a height greater than 100 μm * presence of cnv secondary to (i) amd (based on fa) or (ii) pcv (based on icg) * etdrs bcva of 20/32 to 20/320 (letter score of 73 to 25) in the study eye * etdrs visual acuity of 20/400 or better in the fellow eye exclusion criteria: * subjects previously treated with, or are currently receiving treatment with another investigational agent or device for neovascular amd in the study eye * subjects who have received \ 7 anti-vegf treatments in the study eye * subjects with retinal angiomatous proliferation (rap lesion) * lucentis or avastin within 30 days prior to day 1 in the study eye

Keywords: pigment epithelial detachment exudative age-related macular degeneration polypoidal choroidal vasculopathy
c-reactive protein and endothelial dysfunction in women with glucose intolerance

Conditions: Glucose Intolerance

Summary: the goal of this study is to determine whether markers of vascular inflammation (such as c-reactive protein) can predict endothelial dysfunction (as measured by flow-mediated dilation) in postmenopausal women with glucose intolerance compared to normal controls.


Eligibility criteria:
inclusion criteria: * healthy postmenopausal women * ages 40-65 exclusion criteria: * smokers * diabetes requiring medication

Keywords: c-reactive protein endothelial dysfunction glucose intolerance
partial response to ppi treatment: the cost to society and the burden to the patient - a study in france

Conditions: Gastroesophageal Reflux Disease

Summary: the purpose of this study is to describe common treatment pathways, to collect health care utilization data and to assess symptom load as well as impact of symptoms on daily life in gerd patients who are partial-responders to ppi treatment.


Eligibility criteria:
inclusion criteria: * at least 6 month history of gerd symptoms * treated with unchanged optimized ppi treatment for any gerd indication during the last 4 weeks before enrollment * remaining gerd symptoms despite optimized ppi treatment * able to read and write in french, and able to comply with study requirements exclusion criteria: * patients that have not experienced any gerd symptom improvement at all during ppi treatment * involvement in the planning or conduct of the study * involvement in any other observational study or in any clinical study at the time of this study or during the last 6 months * prior surgery of the upper gi tract

Keywords: gerd ppi partial responders
reduce pain and improve quality of life in patient with knee osteoarthritis by light, sound and brain stimulation

Conditions: Knee Osteoarthritis

Summary: patients affected with osteoarthritis knee have associated with pain and inflammation of the joint capsule, impaired muscular stabilization, decrease range of motion and functional disability. laser therapy, phonophoresis, transcranial direct current stimulation (tdcs) and conventional physiotherapy exercises has innumerable benefits to the patients with knee osteoarthritis (koa).however, it is still not clear which treatment is effective among them in rehabilitating the patients with chronic knee osteoarthritis (koa). aim is to establish the benefits of high intensity laser therapy, phonophoresis, tdcs and conventional physiotherapy in the treatment of patient with chronic koa living in the hilly terrain. a total of 160 patients with chronic koa will be recruited by the simple random sampling (random number generator) to participate in randomized, double blind randomized controlled, study. recruited patients with chronic koa will be randomly divided into four groups, high intensity-laser therapy (hilt) group, ibuprofen gel phonophoresis (igp) group, transcranial direct current stimulation (tdcs) group and conventional physiotherapy (cpt) group. duration of the treatment will be 8 minutes in one session/knee joint for hilt and igp and 30 minutes in one session for tdcs each day for 3 days/week for 8 weeks. thus, each patient with chronic koa will receive 24 sessions in total. the western ontario and mc master universities osteoarthritis index (womac), digitalized pain pressure algometer (algo-ds-01) and 36-item short form health survey (sf-36) questionnaire are the outcome measures will be recorded at baseline, end of 8-week post-intervention period.


Eligibility criteria:
inclusion criteria: * patients diagnosed with clinical chronic knee oa according to the diagnostic criteria of american college of rheumatology (acr) were included in the study * age between 45-70 * both sex male and female exclusion criteria: * unwillingness to participate in the study, * recent history (within the last 3 months) of physical therapy to the same joint, * recent history (within the last 3 months) of intra-articular procedure (injection and/or lavage) to the knee, * history of knee surgery/fracture, * acute synovitis/arthritis including the infectious conditions, * presence of malignancy, * pregnancy * taking pain relief medications * any metal implants near the site of stimulation

Keywords: knee osteoarthritis uphill incline walking degeneration laser therapy ultrasound tdcs
evaluation of the lungpoint virtual bronchoscopic navigation (vbn) system

Conditions: Lung Neoplasm

Summary: to evaluate the role of the lungpoint vbn system in the bronchoscopic access to a target location. the evaluation will explore: * ability of the system to guide a user to one or more target site(s) * ease of use of the system (assessment of the user interface) * incremental value brought by the use of the system to the successful completion of a case.

multi-center, prospective, single-arm study. the study will take the form of a user evaluation. the evaluation will require the user to perform several standardized functions (e.g. peripheral lesion sampling, lymph node sampling). in addition, users will be asked about other potential techniques that fall within the intended use of the device. the evaluation will be conducted in patients who are indicated for procedures that fall within the intended use of the device. examples of such patients include: * patients who have been recommended for bronchoscopy for the purpose of obtaining a biopsy sample of a central or peripheral pulmonary lesion. * patients who have been recommended for bronchoscopy for the purpose of diagnosing mediastinal or hilar lymphadenopathy. * patients who have been recommended for bronchoscopy for the purpose of lung fiducial placement.

Eligibility criteria:
inclusion criteria: * subject has provided informed consent * subject is scheduled for bronchoscopy for the purpose of diagnosing: a central or peripheral pulmonary nodule or mass, infiltrative disease, mediastinal or hilar lymphadenopathy, or placing fiducial markers. * subject has a ct scan that is consistent with high-resolution specifications exclusion criteria: * patients less than 18 years of age. * any patient that the investigator feels is not appropriate for this study for any reason.

Keywords: navigation bronchoscopy lymphadenopathy
effect of topical cbd cream for degenerative hallux disorders

Conditions: Hallux Valgus; Hallux Rigidus

Summary: hallux rigidus and hallux valgus are chronic forefoot conditions associated with pain, inflammation and functional impairment. topical cannabidiol (cbd) cream has been shown to decrease inflammation, swelling, and pain response in arthritis models with minimal side effects, although the intervention has never been studied in hallux valgus or hallux rigidus. the purpose of this study is to determine if topical cbd cream is an effective treatment for pain secondary to hallux rigidus and hallux valgus.

hallux rigidus and hallux valgus are chronic forefoot conditions associated with pain, inflammation and functional impairment. while operative interventions exist, nonoperative modalities are the mainstay of treatment for most patients. options include shoe wear modification, manual and physical therapy, intraarticular injection of corticosteroids or sodium hyaluronate, oral nonsteroidal anti-inflammatories, and foot orthoses. oral anti-inflammatories are the most effective non-operative strategy, but unfortunately, are associated with major adverse side effects and are contraindicated in many patients. topical cannabidiol (cbd) cream has been shown to decrease inflammation, swelling, and pain response in arthritis models with minimal side effects, although the intervention has never been studied in hallux valgus or hallux rigidus. this prospective randomized trial will compare topical cbd cream vs placebo cream for the treatment of pain secondary to hallux valgus and hallux rigidus. the primary outcome of interest in the change in pre and post-treatment visual analog system (vas) pain scores. vas pain score is a measurement on a continuum of values of pain intensity. the purpose of this study is to determine if topical cbd cream is an effective treatment for pain secondary to hallux rigidus and hallux valgus.

Eligibility criteria:
inclusion criteria: * patients with a new diagnosis of hallux rigidus or hallux valgus * vas pain score of 4 or higher * age \> 18 years * the patient provides informed consent exclusion criteria: * a previous operative procedure to the first metatarsal for treatment of hallux valgus or hallux rigidus * vas pain score at presentation less than 4 * concomitant hallux valgus and hallux rigidus on the ipsilateral side * allergy to cbd, cannabidiolic acid (cbda) or any other ingredient contained in the topical cream * pregnant patients
open label trial of immunotherapy for advanced liver cancer

Conditions: HCC; Liver Cirrhosis

Summary: the purpose of this study is to evaluate daily dosing of oral immunotherapy hepcortespenlisimut-l (v5) in patients with advanced stage of hcc not amenable to surgical intervention or with recurrent tumor after surgery.

hepcortespenlisimut-l (v5) immunotherapy of hcc in an open label setting with baseline alphafetoprotein serum levels and ct scan image as primary endpoints with monthly follow-up thereafter. additional endpoints will include blood biochemistry indices and safety monitoring.

Eligibility criteria:
inclusion criteria: * subjects who are at least 18 years old and are willing and capable of providing informed consent. both men and non-pregnant women will be included. * hcc diagnosis documented prior to study entry by either cytology/histology, ct scan, and afp serum test higher or equal to 30 iu/ml. * all subjects with reproductive potential are advised to utilize effective contraception throughout the course of this study. * health score status at baseline. * agreement to participate in the study and to give at least 3 samples of blood for lab tests. * readily available home or o other address where patient can be found. exclusion criteria: * subjects who might have already taken v5 in prior trials and have no baseline data. * those who met inclusion criteria can be retrospectively enrolled. * pregnant or breast-feeding women are excluded. * subjects who have taken other immunomodulatory therapies within 2 months prior to entry: systemic corticosteroids, immune globulin (iv gamma globulin, ivig), interferons, interleukins, pentoxifylline (trental), thalidomide, filgrastim (g-csf), sargramostim (gm-csf); dinitrochlorobenzene (dncb), thymosin alpha 1 (thymosin alpha), thymopentin, inosiplex (isoprinosine), polyribonucleoside (ampligen), ditiocarb sodium (imuthiol), any locally available immune modulators, and any other therapeutic or preventive hcc vaccine. * subjects requiring concurrent participation in another experimental research treatment study, or who received an experimental agent within four weeks prior to study entry. * evidence of active or acute cardiac disease, epilepsy, or life-threatening diseases unrelated to hcc. * medical conditions such as active alcohol or substance abuse, or psychological issues that in the opinion of the local investigator would interfere with adherence to the requirements of this study.

Keywords: therapeutic vaccine
the bridge rehabilitation trial

Conditions: Musculoskeletal Disease

Summary: the main aim of this multi-centre stepped wedge randomized controlled trial is to improve the quality, professional practice and cost-effective utilization of health care resources by evaluating if a new rehabilitation program aimed at bridging gaps in rehabilitation across levels of care may increase and/or prolong the effect of rehabilitation.

the goal of rehabilitation is to help people to reach and maintain their optimal functioning and coping capabilities, and to promote independence and participation in society. according to current political documents, there are large variation in the content and quality of rehabilitation in norway, and systems to improve coordination and communication are needed. this trial is a collaborative project between eight centres across norway, investigating whether a new program aimed at bridging gaps in rehabilitation across levels of care increase and/or prolong the effect of rehabilitation for people with rheumatic and musculoskeletal diseases. additionally, we will use a newly developed set of quality indicators to monitor and compare the quality of rehabilitation across different centres, and explore relationships between adherence to structure and process indicators and the outcomes of rehabilitation. the effects will be evaluated in a multi-centre stepped wedge randomized controlled trial, where participating centres switch from control (current rehabilitation program) to intervention phase (adding the bridge program to the current program) in a randomized order. primary outcome is goal attainment after seven months, and secondary outcomes are health related quality of life and function. the results will give insight in the content and organisation of current rehabilitation programs, what follow-up people want and receive in primary care, their planned and completed efforts to implement and maintain life style changes, and predictors for improvement following rehabilitation in specialist health care. results will also have consequences on how rehabilitation is to be organized in the future regarding follow-up and coordination across levels of care. the study has been developed in close collaboration with patient research partners, clinicians and international experts, who will also contribute in the process of integrating study results in clinical practice.

Eligibility criteria:
inclusion criteria: * inflammatory rheumatic disease or osteoarthritis or fibromyalgia or low back pain or wide spread pain or osteoporosis. having a good understanding of norwegian and having a bank-id exclusion criteria: * cognitive impairment or severe psychiatric disorder
a study evaluating the presence and concentration of briumvi™ (ublituximab) in breast milk

Conditions: Relapsing Multiple Sclerosis

Summary: the primary objective of the lactation study is to characterize the presence and concentration of briumvi™ in breast milk among breastfeeding participants who receive briumvi™ therapeutically for the treatment of relapsing forms of multiple sclerosis (rms).


Eligibility criteria:
inclusion criteria: maternal criteria: * participant has independently decided to be treated with briumvi™ prior to providing consent to participate in the study * diagnosis of rms, to include clinically isolated syndrome (cis), relapsing-remitting multiple sclerosis (rrms), and active secondary progressive multiple sclerosis (spms) * willing to breastfeed or pump regularly during the study period to maintain milk supply and exclusively pump breast milk for the 24-hour period of breast milk collection day 1 post iv dose * plans to continue feeding infant breast milk at least throughout the duration of the study and is not weaning infant criteria: * gestational age at delivery ≥35 weeks * birthweight \> 10th percentile * weight \> 10th percentile as reported by the mother at the time of enrollment exclusion criteria: maternal criteria: * any active infection or other condition that would prevent the individual from breastfeeding * history of breast implants, breast augmentation, or breast reduction surgery that significantly impacts breastfeeding or collection of milk from 1 or both breasts * history of mastectomy * evidence of mastitis or any other significant active infection at day 1 (pre-dose) that would prevent collection of milk from one or both breasts * current use of drugs known to transfer to the breast milk and with established or potential deleterious effects for the infant, including but not limited to aspirin (risk of reye's syndrome), tetracyclines or fluoroquinolones infant criteria: - any abnormality noted or clinically significant medical condition, including cardiac, pulmonary, and liver disease, glucose instability, or active infection at the time of screening that, in the opinion of the investigator, may make implementation of the protocol or interpretation of the trial difficult or would put the infant at risk by participating in the study

Keywords: multiple sclerosis