Kornimate/medical-research-clean huggingface dataset:
chemotherapy for patients with non-small cell lung cancer (nsclc)

Conditions: Non-Small Cell Lung Cancer

Summary: the purpose of this study is to compare the efficacy and toxicity of pemetrexed and docetaxel administered on a 3-weekly schedule in the treatment of patients with locally advanced or metastatic non-small cell lung cancer (nsclc) who have had prior chemotherapy.


Eligibility criteria:
inclusion criteria: * histologic or cytologic diagnosis nsclc (stage iiia, iiib, or iv), not amenable to curative surgery or radiotherapy * at least one prior chemotherapy for palliative therapy * response evaluation criteria in solid tumors (recist) criteria for disease status assessment * eastern cooperative oncology group (ecog) performance status 0 to 2 exclusion criteria: * concurrent administration of any other tumor therapy * pregnant or breast feeding * serious concomitant disorders * inability or unwillingness to take folic acid or vitamin b12 supplementation
comparison of pet/ct and ultrasound in staging of malignant melanoma

Conditions: Malignant Melanoma

Summary: this is the first study which evaluates the different staging modalities 18f-2-fluoro-2-deoxy-d-glucose pet/ct (pet/ct) and diagnostic ultrasound (us) in a single patient cohort with malignant melanoma (mm). previous analyses are ambivalent regarding the modality of choice. these analyses, however, compared separate patient cohorts for each modality. inclusion criteria were a primary staging or re-staging of suspected or confirmed mm with one or more pet/ct and/or one or more us. exclusion criteria were the non-existence of a malignancy or a malignancy other than mm, alone or in combination with an mm. the analysis includes the calculation of sensitivity, specificity, positive predictive value (ppv), negative predictive value (npv) and accuracy in a per-patient (ppa), per-examination (pea) and per-lesion analysis (pla). this was done individually for pet/ct and us, and in pla also for the combination of these two radiological modalities. furthermore, us was divided into us as a whole (wus), peripheral lymph nodes (pus) and/or abdomen (aus). the principle equivalence of the two imaging modalities is set up as a null hypothesis h0 in all three analyses. as a further null hypothesis h0, the equivalence of the combined application compared to the sole applications of the two imaging modalities is asserted. the aim is the refutation of the null hypothesis h0 by significant differences in sensitivity and specificity.


Eligibility criteria:
inclusion criteria: * the existence of malignant melanoma (mm) as primary tumour or metastases exclusion criteria: * the non-existence of a malignancy, * a malignancy other than mm, alone or in combination with an mm

Keywords: malignant melanoma staging 18f-fdg pet/ct ultrasound
the aiur trial: surgical gloves to prevent peripheral neuropathy

Conditions: Chemotherapy-induced Peripheral Neuropathy

Summary: this study aims to demonstrate the preventive effect of compression therapy using surgical gloves in chemotherapy-induced peripheral neuropathy. patient-reported outcome measures (proms) are utilized for comparing the change in neuropathic pain between intervention and control groups. among the proms, the neurotoxicity component of the functional assessment of cancer therapy-taxane (fact-tax) is used for good and poor outcomes between baseline and post-chemotherapy in paclitaxel-treated breast cancer patients.

chemotherapy-induced peripheral neuropathy (cipn) is associated with side effects of taxanes, including paclitaxel. the common side effect may adversely affect the quality of life. however, no treatment for cipn can be strongly recommended. therefore, prevention is important. cryotherapy, compression therapy, and exercise therapy can be considered for prevention, but no definitive recommendations are available. studies with wider sample sizes are needed to confirm the efficacy and the preventive methods are complex for application. the study use surgical gloves for compression therapy to reduce discomfort and increase compliance with the procedure. patients with stage ii-iii breast cancer who receive paclitaxel chemotherapy for at least 12 weeks in six academic hospitals in south korea will participate in the study. the study design is a multicenter, open-label, randomized controlled trial. the patients are randomly assigned to intervention or control groups. intervention patients will wear two-layer of normal-sized surgical gloves on both hands during chemotherapy infusion. the primary outcome is to demonstrate the preventive effect of compression therapy using surgical gloves as measured by the change in the neurotoxicity of fact-tax questionnaire.

Eligibility criteria:
inclusion criteria: * age greater or equal to 19 years, under 70 years old * stage ii-iii breast cancer * no distant metastasis * patient scheduled to be receiving adjuvant or neoadjuvant paclitaxel for at least 12 weeks * signed informed consent * eastern cooperative oncology group (ecog) performance status ≤ 2 (karnofsky ≥60%) exclusion criteria: * recurred breast cancer * patients who have previously received treatment that could cause neuropathy; taxane or platinum-based chemotherapy, antitubulins, proteasome inhibitors * known history of neuropathy * chronic kidney disease * raynaud's phenomenon * peripheral vascular disease; peripheral arterial ischemia * cold intolerance * allergy in natural rubber latex or surgical gloves * patients who have dermatitis, wound, or musculoskeletal problems in hand at enrollment * current use medications which may mitigate chemotherapy-induced peripheral neuropathy; duloxetine, gabapentin/pregabalin, baclofen-amitriptyline-ketamine (bak; topical amitriptyline, ketamine, ±baclofen), oral cannabinoids, tricyclic antidepressants, ganglioside-monosialic acid
daily sleep enhancement for hospitalized people with dementia following a nursing protocol

Conditions: Sleep; Dementia

Summary: the purpose of this study is to determine if the daily performance of a 7 step bedtime nursing protocol for hospitalized people living with dementia is feasible and if it has an effect on bedtime and daytime variables.


Eligibility criteria:
inclusion criteria: * diagnosis of dementia of any severity and type * allocation to geriatric rehabilitation treatment exclusion criteria: * sleep related respiratory or moving related disorders or parasomnia * delirium * end of life care

Keywords: geriatric nursing
incentives and reminders to improve long-term medication adherence (inmind)

Conditions: HIV/AIDS; Medication Adherence; Habits

Summary: low medication adherence when initiating antiretroviral treatment (art) is a key barrier to hiv virologic suppression, resulting in avoidable cases of drug resistance, death, and viral transmission. routinized pill-taking can lead to successful long-term art adherence, and short-term behavioral economics-based supports are a novel way to overcome the limited success of existing routinization interventions. this study proposes to test this combined approach for promoting long-term art adherence using a stage iii sequential, multiple assignment, randomized trial (smart) design in one of the largest hiv clinics in uganda to identify the most cost-effective adaptive intervention that if found effective is generalizable to other settings and other chronic diseases.

building on a previous r34 study, the investigators will adapt and deliver the inmind approach to 550 art initiators at mildmay. participants will initially be randomized to receive either usual care (control, n=275) or daily text messages (messages, n=275) to support adherence routines. at months 1 and 2, participants may revise their adherence plans. those showing \<80% adherence in month 3 will be re-randomized to receive either monthly or monthly escalated prize incentives for the next three months. adherence will be monitored for an additional 12 months (total follow-up: 18 months) to assess long-term routine maintenance and recovery after interruptions. the smart design will help identify the most cost-effective intervention sequencing. a cost-effectiveness analysis and stakeholder dissemination will support future scale-up. the investigators hypothesize that messages will be more effective than control as a first-stage treatment; that monthly escalated prizes will be more effective than monthly prizes as a second-stage treatment; and that the mechanisms of lack of salience and present bias will mediate the effect of inmind on our primary and secondary outcomes.

Eligibility criteria:
inclusion criteria: * male and female clients age 18 and older. * started art at mildmay or another clinic within the preceding 1 month * able to speak and understand either english or luganda. * have their own cell phone or have consistent access to someone else's phone. * willing to receive daily text messages for the 6 months of intervention duration. * willing and able to use the wisepill device distributed for adherence verification for the duration of the study. exclusion criteria: * not mentally fit to consent. * language other than luganda or english. * not willing to consistently use the wisepill device for adherence measurement.

Keywords: behavioral: daily text messages behavioral: incentivization based on
observational study of botox® treatment for patients with upper limb adult spasticity

Conditions: Muscle Spasticity

Summary: this is a prospective, non-interventional, observational study to collect data on the use of botulinum toxin type a in a routine setting in patients with upper limb adult spasticity.


Eligibility criteria:
inclusion criteria: * adult patients with upper limb spasticity following a stroke * eligible to receive botulinum toxin type a * no previous botulinum toxin type a therapy exclusion criteria: * none
study of nivolumab in combination with ipilimumab versus nivolumab in combination with ipilimumab placebo in patients with recurrent or metastatic squamous cell carcinoma of the head and neck

Conditions: Head and Neck Cancer

Summary: a study in patients with metastatic or recurrent squamous cell cancer of the head and neck to evaluate the effectiveness of nivolumab plus ipilumumab vs. nivolumab alone (checkmate 714)


Eligibility criteria:
inclusion criteria: * confirmed squamous cell head and neck cancer * widespread (metastatic) disease, or returned after previous treatment (recurrent) * tumor sample must be available for analysis of pdl1 (programmed death-ligand 1) and hpv \[human papilloma virus (oropharynx only)\] * performance status ecog 0-1 (eastern cooperative oncology group) exclusion criteria: * previous treatment for metastatic or recurrent disease * cancer arising from one of the following primary sites: paranasal sinus, nasopharynx, salivary gland, skin * any non-squamous subtype * active autoimmune disease * positive test for hepatitis b, c or hiv (human immunodeficiency virus) virus * previous treatment with checkpoint inhibitor drugs * active cns metastases or carcinomatous meningitis other protocol-defined inclusion/exclusion criteria apply
early experience of a new implant system for bone conduction hearing in the pediatric population

Conditions: Unilateral Mixed Conductive and Sensorineural Hearing Loss (Diagnosis); Sensorineural Hearing Loss, Unilateral With Normal Hearing on the Contralateral Side

Summary: to study the initial experience with implanting and fitting a new bone conduction system in pediatric patient population with conductive, mixed or single-sided deafness.

experimental: bone-conduction hearing device the bone-conduction hearing device osia system allows a direct bone-conduction through an osseointegrated implant. a magnet allows the external sound processor to be placed in the correct position over the implanted system including an inner magnet. device: osia system an external sound processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. the electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea

Eligibility criteria:
inclusion criteria: individuals 5 through 18 years of age will be eligible for inclusion in the investigation if all of the criteria below are met: conductive or mixed hearing loss in the ear to be implanted. bone conduction thresholds with pure-tone average (pta4; mean of 0.5, 1, 2, and 4 khz) of less than or equal to 55 db hl. subject does not benefit from or will not wear a conventional hearing aid. note: candidates may include individuals seeking new implantation unilaterally (in one ear) or bilaterally (both ears) as well as individuals already implanted with a bone-anchored device seeking a second-side implant. or single-sided sensorineural deafness who is a candidate for baha surgery. air conduction thresholds with a pure-tone average (pta4; mean of 0.5, 1, 2, and 3 khz) of less that equal to 20 db hl in the good ear. subject does not benefit from or will not wear a conventional hearing aid exclusion criteria: uncontrolled diabetes as judged by the investigator. subject who has received radiotherapy in the area of implantation, or such radiotherapy is planned during the study period. current use of ototoxic drugs. condition that could jeopardize osseointegration and/or wound healing or condition that may have an impact on the outcome of the investigation as judged by the investigator. insufficient bone quality and quantity for implantation of a bi300 implant, as determined by the surgeon. unable to follow investigational procedures. participation in another clinical investigation with pharmaceutical and/or device
b-cell chronic lymphoid malignancies markers

Conditions: Chronic Lymphocytic Leukemia; Marginal Zone Lymphoma; Lymphoplasmacytic Lymphoma/Waldenström Macroglobulinemia; Mantle Cell Lymphoma; Hairy Cell Leukemia; Follicular Lymphoma

Summary: lymphoid chronic b-cell malignancies are frequent pathologies that affect adults, with a very variable prognosis and treatment (some of them can remain untreated). the diagnosis of these malignancies relies on the study of the morphology of tumoral cells and the expression by these cells of several markers, mainly via a technical approach called flow cytometry. because the markers currently used remain imperfect, additional ones are needed for an accurate diagnosis that affect both prognosis and treatment. in addition, because numerous markers are used at the diagnosis, there is a need of tools that synthetize the multi-dimensional structure of the data obtained. the primary purpose of this study is to detect new markers that can be of help for the diagnosis of marginal zone lymphoma and other b-cell chronic lymphoid malignancies. the secondary purpose of this study is to obtain a statistical algorithm that allow a good prediction of the different sub-types of chronic b-cell malignancies mainly using the results of flow cytometry.


Eligibility criteria:
inclusion criteria: * patients over 18 years-old with of marginal zone lymphoma and other b-cell chronic lymphoid malignancies * patients that gave their informed consent for the conservation of blood or bone marrow cells (primary objective 1) * patients that gave their informed consent for the retrospective use of their clinical and biological data exclusion criteria: * patients under guardianship or curatorship * patients who did not gave their consent for the use of their cells and/or data

Keywords: chronic b-cell malignancies flow cytometry biomarkers statistical algorithms
perioperative act for preventing cpsp: a single-arm non-randomized pilot trial

Conditions: Back Pain; Spinal Stenosis; Spondylosis; Spondylolisthesis; Back Injury

Summary: the present study aims to adapt and modify a brief perioperative acceptance and commitment therapy (act) intervention aimed at preventing the transition to chronic post-surgical pain (cpsp) and reducing long-term opioid use. investigators will assess the acceptability, feasibility, and preliminary efficacy of the intervention via a non-randomized, non-controlled pilot trial.


Eligibility criteria:
inclusion criteria: * scheduled to undergo fusion, discectomy, vertebroplasty, kyphoplasty, or foraminotomy * age 22 and older * able to communicate fluently in english exclusion criteria: * inability to complete study procedures due to delirium, dementia, psychosis, or other cognitive impairment * have a history of severe neurologic movement disorder * are pregnant or intent to become pregnant during study * have undergone previous spinal surgery * have spinal deformity, pseudarthrosis, trauma, infection, or tumor as primary indication for surgery * have undergone acceptance and commitment therapy in last 2 years

Keywords: acceptance and commitment therapy chronic postsurgical pain act
social media indoor tanning study

Conditions: Skin Cancer

Summary: the purpose of this research is to develop a social media delivered intervention to reduce unprotected sun exposure in young adults with a history of tanning.

we will use social marketing theory and a user-centered design approach to develop a social media intervention that engages young adults with a history of tanning to practice sun safety behaviors. we will incentivize young adults who have a history of tanning to create social media posts that encourage their peers to engage in sun safety. focus groups of tanners guided the development of the intervention. investigators will conduct a pilot feasibility trial where participants will be randomized to a condition in which they are incentivized to create sun safety social media messages to be posted on a sun safety social media account or a condition in which they are incentivized to create social media messages about how to use technology to support healthy lifestyle behaviors to be posted on a health technology social media account. the intervention will last 4 weeks. feasibility outcomes include recruitment, retention, acceptability, participation, social media message engagement (likes, comments, shares), persuasive impact of messages, unprotected sun exposure, sun protection, and tanning behavior. this work will inform a fully powered randomized trial testing the efficacy of this intervention.

Eligibility criteria:
inclusion criteria: * ages 18-30 * tanned indoors or outdoors at least once in the past year * intends to tan indoors or outdoors this summer * daily user of any social media platform exclusion criteria: * no smartphone * does not use a social media platform daily * lives in a state with an average temperature \<75 degrees in may * inability to provide consent due to mental illness or a cognitive impairment * non-english speaking * prisoner
utilization of high frequency ultrasound to diagnose chronic exertional compartment syndrome

Conditions: Chronic Exertional Compartment Syndrome

Summary: the purpose of this study is to investigate high frequency ultrasound as a future modality for the diagnosis of chronic exertional compartment syndrome (cecs). the results of the ultrasound will help determine if there are any significant radiologic findings or patterns seen in patients with cecs.

the purpose of this study is to investigate high frequency ultrasound as a future modality for the diagnosis of chronic exertional compartment syndrome (cecs). the results of the ultrasound will help determine if there are any significant radiologic findings or patterns seen in patients with cecs. evaluation of ultrasonographic findings will be dependent on tissue density as measured by hypoechoic versus hyperechoic signal as well as muscle compartment thickness at its largest dimension. a specific aim for this study would be to facilitate future research in order to eliminate the need for painful and invasive diagnostic techniques for cecs.

Eligibility criteria:
inclusion criteria: * male or female ages 13 and over * patients with any combination of the following symptoms who would otherwise be evaluated for cecs: * symptoms of leg pain worsened with activity and relieved by rest * pain that is generalized in the anterior or lateral compartments of lower leg * numbness or tingling in the distribution of the superficial peroneal nerve * sensation of "slap foot" or anterior/lateral compartment weakness * able to exercise for cpt testing: patients will be asked to go through a standardized warm up on a treadmill with increasing speed and incline settings until symptoms are achieved. they will maintain exercise for a minimum of five minutes or to patient tolerance. exclusion criteria: * known vascular disease * neurogenic or radicular symptoms

Keywords: cecs
single dose tranexamic acid in reducing blood loss during cytoreductive surgery and hipec

Conditions: Cytoreductive Surgery

Summary: the tranexamic acid group will receive an intravenous bolus of (10 mg/kg) in 100 ml of normal saline over 20 minutes after induction of anesthesia and before surgical incision. in the control group, patients will receive a placebo of 100 ml 0.9% normal saline. the primary endpoint is reduction in blood loss, while the secondary endpoint was the number of patients needing transfusion and occurrence of postoperative thrombotic complications (myocardial infarction, stroke, pulmonary embolism, renal failure, or bowel infarction) within 30 days after surgery.


Eligibility criteria:
inclusion criteria * asa 1 and asa 2 patients scheduled for colorectal cancer surgery. * age above 18 years \& less than 65 years. exclusion criteria: * thrombophilia or any bleeding disorder. * previous or active thromboembolic disease. * family history of thromboembolism. * known allergy to ta. * liver dysfunction. * preexisting renal dysfunction (serum creatinine \>1.2 mg/dl). * coronary stent insertion within a year prior to operation. * cardiovascular problem (e.g., myocardial infarction, atrial fibrillation, angina, heart failure), * lifelong warfarin therapy for thromboembolism prophylaxis.