Kornimate/medical-research-clean huggingface dataset:
towards better understanding of fce performance in different societal contexts

Conditions: Musculoskeletal Diseases

Summary: purposes of this research: * to study similarities and differences in fce performances between participants from different countries, jurisdictions, and evaluators. * to study determinants of fce performance.

a considerable amount of research has been made on the safety, reliability and validity of the functional capacity evaluation (fce). evidence is accumulating on different aspects of validity of fce in healthy workers and in different patient groups, which has indicated that we are measuring a complex construct consisting of biological, psychological and social variables. however, this knowledge is still unstable as the majority of studies stem from a limited amount of countries. the present project focuses on the biopsychosocial factors that influence fce performance. participants undergoing an fce perform differently depending on biological, psychological and social variables, although the latter has been under-researched. clinicians are currently unable to predict which factors determine the differences in patient's fce results. in this project, in addition to biological and psychological variables, investigators include a variety of social variables from different countries, jurisdictions, and evaluators, which may help investigators to identify important determinants of fce performance. knowing which characteristics and behaviors are associated with better or poorer participant performances may help clinicians to deliver improved fce services.

Eligibility criteria:
inclusion criteria: * musculoskeletal pain including: back pain, neck pain (including whiplash-associated syndrome grade i or ii), upper extremity pain, lower extremity pain. * non-specific pain: without specific medical diagnosis, see also exclusion criteria) . * complaints' duration \> 6 weeks * employed or self-employed * language skills sufficient to communicate with the fce-clinician and fill out the required questionnaires exclusion criteria: * pregnancy * tumours * fractures * radicular syndromes * spondylolisthesis grade 3 or 4) * whiplash-associated syndrome grade iii or iv * other specific diagnoses related to the musculoskeletal system * unstable cardiovascular conditions and other co-morbidity affecting performance or safety during the fce (i.e. severe depression needing psychiatric referral).

Keywords: disability evaluation psychosocial factors
a new surgical strategy to protect the inferior parathyroid

Conditions: Thyroid Cancer

Summary: the incidence of temporary hypoparathyroidism after thyroid surgery is 14%-60%, and the incidence of permanent hypoparathyroidism is 4%-11%. the protection of parathyroids has always been the focus and difficulty of thyroid surgery. the anatomical position of the superior parathyroids is relatively fixed, and can be preserved in situ easily; while the anatomical position of inferior parathyroids varies greatly between patients. it is always difficult to look for, identify, and protect them. concepts such as thyro-thymic ligament and "thymus-vascular-inferior parathyroid plane" were raised to help identify the inferior parathyroids. we found that this surgical strategy can protect inferior parathyroids in situ effectively in our retrospective studies. thus, we are going to carry out a prospective study to compare the new method and the traditional method of thyroidectomy, to see if more inferior parathyroids can be protected in situ through the new surgical strategy.


Eligibility criteria:
inclusion criteria: * initial thyroid surgery; thyroidectomy with/without central lymph node dissection exclusion criteria: * coexisting parathyroid disease; need lateral neck dissection; history of radio-iodine ablation treatment
electroconvulsive therapy and neuroradiology

Conditions: Depression; Electroconvulsive Therapy

Summary: the study will apply state of the art radiology through advanced magnetic resonance imaging (mri) techniques to investigate structural and functional brain effects of ect.

as a multi-disciplinary collaboration, imaging findings will be correlated to psychiatric response parameters, neuropsychological functioning as well as neurochemical and genetic biomarkers that can elucidate the underlying mechanisms. the aim is to document both treatment effects and potential harmful effects of ect. sample: n = 40 patients in a major depressive episode (bipolar and major depressive disorder). two control groups with n = 15 in each group: age and gender matched healthy volunteers not receiving ect and patients undergoing electrical cardioversion (ecv) for atrial fibrillation (af). observation time: six months.

Eligibility criteria:
inclusion criteria: * patients (age \> 18) referred to the ect-unit and accepted for treatment because of moderate and severe depression, * fulfilling the criteria for the following icd-10 diagnoses: f31.3 and f31.4; f32.1 and f32.2 and f32.3; f33.1 and f33.2 and f33.3. * symptom intensity must be verified by a score ≥ 25 on the montgomery and åsberg depression rating scale (madrs). exclusion criteria: * ect treatment within the last 12 months. * pregnancy. * patients unable to give written informed consent (according to the responsible clinician or ect responsible). * patients who cannot participate in the mri scanning because of contraindications to mri.
broadband amplification as tinnitus treatment

Conditions: Tinnitus, Subjective

Summary: * the effect of broadband amplification was tested in a double-blinded crossover study * its effect was compared to an active placebo treatment * an improvement in tinnitus distress was found after use of broadband amplification * no effect was found on the tinnitus loudness

this study investigated the effect of broadband amplification (125 hz to 10 khz) as tinnitus treatment for participants with high-frequency hearing loss and compared these effects with an active placebo condition using band-limited amplification (125 hz to 3-4 khz). a double-blinded crossover study. 23 participants with a high-frequency (≥ 3 khz) hearing loss and chronic tinnitus were included in the study and 17 completed the full treatment protocol. two different hearing aid treatments were provided for 3 months each: broadband amplification that provided gain in the frequency range from 125 hz to 10 khz and band-limited amplification that only provided gain in the low frequency range (≤ 3-4 khz). the effect of the two treatments on tinnitus distress was evaluated with the tinnitus handicap inventory (thi) and the tinnitus functional index (tfi) questionnaires. the effect of the treatment on tinnitus loudness was evaluated with a visual analog scale (vas) for loudness and a psychoacoustic loudness measure. furthermore, the tinnitus annoyance was evaluated with a vas for annoyance. the tinnitus pitch was evaluated based on the tinnitus likeness spectrum.

Eligibility criteria:
inclusion criteria: * chronic tinnitus * hearing thresholds (\<=25 db hl) up to 2000 hz and hearing loss at frequencies above 2 khz * inexperienced hearing aid user exclusion criteria: * objective or pulsatile tinnitus * ménière's disease, otosclerosis, stapedectomy, stapedotomy or tympanoplasty
adapting project uplift for hispanic patients with epilepsy ii

Conditions: Epilepsy

Summary: the purpose of this study is to adapt project uplift for hispanic adults with epilepsy and depression. project uplift (using practice and learning to increase favorable thoughts) is a home-based intervention that teaches cognitive and mindfulness skills to people with epilepsy by phone to reduce their depression and improve quality of life (qol); it was developed at emory university with cdc funding. the purpose of this study is to adapt project uplift for hispanic adults with epilepsy and depression. project uplift (using practice and learning to increase favorable thoughts) is a home-based intervention that teaches cognitive and mindfulness skills to people with epilepsy by phone to reduce their depression and improve quality of life (qol); it was developed at emory university with cdc funding.

the goal of this study is to adapt project uplift for hispanic adults with epilepsy and depression. a 2-arm randomized control trial will be conducted to evaluate the feasibility, acceptability and effects of project uplift versus usual care (uc) in hispanic patients with epilepsy. the specific aim of this study is: to evaluate the feasibility, acceptability and short- and long-term effects of the adapted intervention on depression and other outcomes in 72 english- and spanish-speaking hispanic epilepsy patients.

Eligibility criteria:
inclusion criteria: * self-identified as hispanic * english or spanish speaking * diagnosis of epilepsy for at least one year post diagnosis * willing to participate in 8 one-hour telephone sessions every week for eight weeks. * willing to be audio-taped * elevated depressive symptoms (center for epidemiological studies depression scale (ces-d) score \>13 exclusion criteria: * severe depression (ces-d \> 37) * active suicidal ideation * significant cognitive impairment (evident during screening)
feasibility of pre transplant exercise (pre-habilitation) for multiple myeloma patients awaiting autologous stem cell transplantation

Conditions: Myeloma

Summary: the investigators propose to determine whether it is acceptable to patients with a diagnosis of multiple myeloma (a type of blood cancer that can cause bone weakness, pain and fatigue) to be offered and attend an exercise group before receiving an autologous stem cell transplantation (being given back one's own stem cells, following receipt of intensive chemotherapy, to enable bone marrow to start producing blood cells again). exercise has been shown to be effective in reducing many of the side effects of myeloma and the treatment patients receive to manage the disease. prehabilitation i.e. providing an intervention after diagnosis but before treatment begins has been effective in reducing the severity of side effects of treatment in cancer patients receiving surgery. no evidence exists for its use in patients with myeloma. patients awaiting transplantation will be provided with information regarding the study and invited to join. patients who agree to take part will attend the hospital for an assessment of their exercise capability and to complete one set of four questionnaires. they will receive an exercise booklet, advice and complete one attempt at their exercise programme under supervision of a physiotherapist. patients will be requested to attend the gym for a minimum of six further weeks to complete their exercise programme. patients will complete a repeat set of questionnaires and a repeat walking test six weeks after the first, on admission to hospital for their transplant and on the day they leave hospital. some patients will be invited to discuss their opinions of the exercise programme and how useful they felt it was to them in preparing for their transplant. if the study shows that the exercise programme is acceptable to patients and we can recruit enough patients to test it in a larger trial, the investigators will apply for further funding.


Eligibility criteria:
inclusion criteria: * all patients will have a diagnosis of multiple myeloma and assigned to the autologous transplantation waiting list for either a first or second transplant exclusion criteria: * history of unstable angina or a heart attack in the previous month to allow safe completion of the six minute walk test. * medical stability is a pre-requisite for transplantation so no patients would be excluded on this basis.
tqb3525 for advanced bone sarcomas with pi3ka mutations or pten loss

Conditions: Safety Issues; Efficacy, Self

Summary: the pi3k, protein kinase b (akt), and mtor signaling network promotes cell growth, survival, metabolism, and motility, but becomes a critical oncogenic driver under aberrant conditions that control the tumor microenvironment and angiogenesis. the pi3k-akt-mtor axis is the most frequently deregulated signaling pathway in primary osteosarcoma and other bone tumors. pi3ka has high rates of 25-50% activating mutations associated with tumor formation in osteosarcoma. other causes of pathway hyperactivation include loss of function of the tumor suppressor pten, gain-of-function mutations in akt and pdk1, or upregulation of receptor tyrosine kinases. tqb3525 is an orally bioavailable, potent, dual catalytic site inhibitor of pi3ka and pi3kd. tumor growth inhibition has been demonstrated in multiple xenograft osteosarcoma models with pi3k-mutant, pten-null cell lines. the investigators try to investigate tqb3525 in primary osteosarcoma and other bone tumors for its safety, tolerability, dose-limiting toxicities (dlt), mtd and antitumor efficacy.


Eligibility criteria:
inclusion criteria: * progression upon first-line chemotherapy; * with target lesions according to recist 1.1; * geno-profiling with pi3ka mutations or pten loss; * ecog ps status 0 or 1 with a life expectancy \>3 months; * adequate renal, hepatic, and hematopoietic function; exclusion criteria: * been previously exposed to other tkis; * had central nervous system metastasis; * had other kinds of malignant tumors at the same time; * had cardiac insufficiency or arrhythmia; * had uncontrolled complications such as diabetes mellitus, coagulation disorders, urine protein ≥ ++, and so on; * had pleural or peritoneal effusion that needed to be handled by surgical treatment; * had other infections or wounds; * pregnant or breastfeeding.

Keywords: osteosarcoma ewing sarcoma chondrosarcoma pi3ka mutation pten loss tqb3525
a comparative post-marketing study of commercially available peripheral nerve gap repair options

Conditions: Traumatic Nerve Injury

Summary: this study is a comparison of sensory recovery outcomes following the use of avance nerve graft or hollow tube conduit for peripheral nerve gap repairs in the hand.

the change study is a post-marketing study designed as a prospective, single-blind, randomized, two phase study comparing clinical outcomes of avance nerve graft to hollow tube conduits. the first phase (pilot phase) assesses projected differences expected between two treatment groups. the second phase of the study provides comparison data between the two treatment groups. avance nerve graft is current regulated in the united states as a 361 hct/p tissue for transplantation; not a drug, biologic, or medical device. hollow tube conduits are currently regulated in the united states as medical devices.

Eligibility criteria:
inclusion criteria: * require primary or secondary nerve injury repair with hollow nerve conduit or avance™ in at least 1 digital nerve; * undergo end to end nerve to nerve graft coaptation on both the proximal and distal portion of the nerve gap in the avance™ group or nerve entubulation in the hollow nerve conduit group; * be willing to comply with all aspects of the treatment and evaluation schedule over a 12 month duration; and * sign and date an irb-approved written informed consent prior to initiation of any study procedures, including screening procedures. exclusion criteria: * nerve gaps of \ 20 mm; * estimated distance of regeneration of \>125 mm (distance from injury site to sensory target) * nerve crush or avulsion injuries; * incomplete nerve transections; * injury requiring replantation of target digit; * contralateral digital injuries corresponding to the target digit; * nerve injuries in the affected limb proximal to the crease of the wrist; * end to side nerve repair; * injuries with significant vascular damage which may impair adequate perfusion of the target limb; * subjects who are undergoing treatment with chemotherapy, radiation therapy, or other know treatment which affects the growth of neural and/or vascular system; * use of bovine collagen based hollow nerve conduit in a subject with known or suspected bovine sensitivity; * subjects age ≤18 years or ≥70 years; * history neuropathy, diabetic or any other known neuropathy; * secondary nerve repair \>12 weeks post initial injury; * currently enrolled in another investigational study; * expected use of medications during the study that are known to cause peripheral neuropathy; * history or reynaud's or other disorder known to compromise circulation or sensation in the upper extremity; and * any subject who at the discretion of the investigator is not suitable for inclusion in the study.

Keywords: peripheral nerve repair conduit avance neuroma resection nerve gap repair digital nerve repair nerve graft nerve allograft
telehealth & hpv self-collection

Conditions: Gynecologic Cancer

Summary: this study aims to compare the efficacy and participant experience of telehealth-based, self-collected cervical cancer screening to mail-based, self-collected cervical cancer screening across the adult female screening lifespan. this will be done by evaluating sufficient human papillomavirus (hpv) sample collection and determining preference for self-collection verses provider collection, comparing role of telehealth in pre- and post- menopausal women's comfort with self-collection, comparing self-collection completion rates for women with and without telehealth visits.

this will be a prospective, randomized study of women ages 25 and older, stratified by menopausal status (defined as 12 months or greater without menses or time at which both ovaries have been surgically removed), who are eligible for cervical cancer screening.

Eligibility criteria:
inclusion criteria: * individuals with a cervix who are eligible for primary hpv testing (age 25 and older) according to national cervical cancer screening guidelines. * pregnant women are eligible for participation in this study as the collection process poses no threat to the woman or her fetus. exclusion criteria: * individuals without a cervix * have had prior pelvic radiation therapy or brachytherapy * active or former diagnosis of ovarian, uterine, or cervical cancer unless determined eligible by pi upon further review of history and treatment * individuals less than age 25 or no longer eligible/recommended to undergo cervical cancer screening * adults who are unable to consent or are decisionally impaired * individuals who are not english speaking

Keywords: pap smear human papillomavirus telehealth
midnor-tia - a study of 600 patients with transient ischemic attack

Conditions: Ischemic Attack, Transient; Stroke

Summary: patients with a transient ischemic attack (tia) are at high risk of stroke. rapid assessment and treatment can reduce the risk. several international guidelines recommend a test, the abcd2 score, to identify tia patients with low and high risk for stroke. the main purpose of this study is to investigate stroke risk after tia in both short (1 week) and long term (3 months/1 year), and to assess whether the abcd2 score ('age, blood pressure, clinical features, duration of tia, diabetes score) is an adequate tool for predicting stroke risk. secondary aims are to explore whether adopting imaging modalities (ultrasound, mri) and biological markers of blood into a risk score could improve the predictive value of the abcd2 score and still be feasible in a daily clinical practice. further on overall risk factors in tia patients, and the incidence of other vascular events will be studied. a substudy designed as a randomised controlled trial evaluates pharmaceutical counseling in a subset of participants. cost-benefit analysis, and a long-term follow-up (5 years) is planned.


Eligibility criteria:
inclusion criteria: * probable or possible transient ischemic attack * residing in central norway * examined within 2 weeks after the onset of symptoms * modified rankin scale 3 or less and living at home * informed consent

Keywords: risks risk factors abcd2 score predictive value of tests risk assessment severity of illness index decision support techniques
clinical trial to evaluate safety and efficacy of ultherapy™ system for lifting skin on the neck

Conditions: Wrinkles

Summary: study is a prospective clinical trial to evaluate the efficacy of the ulthera® system to improve lifting skin on the neck. changes from baseline in the face-q appraisal of neck scale score and global aesthetic improvement scale scores will be assessed at study follow-up visits.

before treatment: the subject's eligibility (inclusion/exclusion criteria) will be assessed, and all subjects will check the face-q appraisal of neck scale score treatment: the investigator will apply to the eligible subject the study device ultherapy™ system with 200\~260 lines of 3.0 and 4.5 probe respectively on the subject's neck. post-treatment: all subjects will visit the institution at 12 weeks from the day of procedure, and will take photos of the neck. efficacy evaluation will performed by the photographic evaluator.

Eligibility criteria:
inclusion criteria: * male or female, aged 30 to 65 years. * subject in good health * subjects who desire improvement in neck skin exclusion criteria: * presence of an active systemic infectious disease * general disease or skin disorder in the area to be treated * pregnant or lactating subjects * previous episode of facial or neck surgery for wrinkle correction * subjects who have aesthetic addiction, drug abuse, alcohol abuse * subjects who were treated botox or filler at the neck area * subjects who had auto-immune disease

Keywords: rhytids skin laxity
a study of onartuzumab (metmab) in combination with tarceva (erlotinib) in participants with met diagnostic-positive non-small cell lung cancer who have received chemotherapy for advanced or metastatic disease (metlung)

Conditions: Non-Squamous Non-Small Cell Lung Cancer

Summary: this randomized, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of onartuzumab (metmab) in combination with tarceva (erlotinib) in participants with incurable non-small cell lung cancer identified to be met diagnostic-positive. participants will be randomized to receive either onartuzumab (metmab) or placebo in combination with erlotinib. anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.


Eligibility criteria:
inclusion criteria: * adult participants, greater than or equal to (\>/=) 18 years of age * eastern cooperative oncology group (ecog) performance status 0-1 * histologically or cytologically confirmed incurable stage iiib/iv nsclc tumor * met diagnostic-positive status tested by immunohistochemistry (ihc) * results of endothelial growth factor receptor (egfr)-activating mutation testing * radiographic evidence of disease * prior treatment with at least one platinum-based line of treatment (for stage iiib/iv) and no more than one additional line of chemotherapy treatment; the last dose of chemotherapy must have been administered \>/= 21 days prior to day 1 * availability of tissue sample for diagnostic testing is required exclusion criteria: * more than 30 days of exposure to an investigational or marketed agent that can act by egfr inhibition, or a known egfr-related toxicity resulting in dose modifications (egfr inhibitors including but not limited to gefitinib, erlotinib and cetuximab) * brain metastases or spinal cord compression not definitively treated with surgery and/or radiation, or previously treated central nervous system (cns) metastases or spinal cord compression without evidence of stable disease for \>/= 14 days * history of another malignancy in the previous 3 years, unless cured by surgery alone and continuously disease free for at least 3 years; participants with prior history of non-invasive cancers are eligible * inadequate hematological, biochemical or organ function * significant history of cardiac disease * serious active infection at time of randomization or other serious underlying medical conditions that would impair the ability of the participant to receive protocol treatment * any inflammatory changes of the surface of the eye * clinically significant gastro-intestinal disease, including uncontrolled inflammatory gastro-intestinal diseases * pregnant or lactating women * positive for human immunodefinciency (hiv) infection