Kornimate/medical-research-clean huggingface dataset:
a multi-surgery assessment of zynrelef (htx-011), amaze. master protocol htx-011-401.

Conditions: Analgesia

Summary: this is a phase 4, randomized, blinded, active-controlled, multicohort study to evaluate htx-011 compared with bupivacaine hcl in subjects undergoing different surgical procedures. each parallel cohort will enroll subjects undergoing a unique surgical procedure: total shoulder arthroplasty (tsa) in cohort 1 and abdominoplasty in cohort 2.


Eligibility criteria:
inclusion criteria: * has american society of anesthesiologists (asa) physical status of i, ii, or iii. * is scheduled to undergo a unilateral total shoulder arthroplasty (tsa) or abdominoplasty. exclusion criteria: * is undergoing a revision surgery. * has a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to bupivacaine (or other local anesthetics), nsaids, acetaminophen, oxycodone, morphine, or hydromorphone. * history of severe allergic reaction to aspirin or other nsaids, or known history of severe gastrointestinal adverse reactions associated with nsaid use. * has taken meloxicam within 10 days prior to the scheduled surgery, or any nsaid within 24 hours prior to the scheduled surgery, with the exception of subjects on low-dose (≤100 mg) daily acetylsalicylic acid for cardioprotection. * opioid use for most days within the last 3 months prior to screening in the opinion of the investigator. * has been administered immediate-release bupivacaine hcl within 5 days prior to the scheduled surgery, or a modified-release bupivacaine product within 14 days prior to the scheduled surgery. * has initiated treatment with any of the following medications within 1 month prior to study drug administration: selective serotonin reuptake inhibitors, selective norepinephrine reuptake inhibitors, gabapentin, pregabalin, duloxetine, or cyclooxygenase-2 inhibitors. * has been administered systemic steroids within 5 half-lives or 10 days prior to the scheduled surgery (whichever is longer). * has a known or suspected history of drug abuse, a positive drug screen (except for cannabinoids) on the day of surgery, or a history of alcohol abuse within the past 5 years. * suspected or confirmed active coronavirus disease 2019 (covid-19) infection. * had a malignancy in the last year, with the exception of nonmetastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix. * has undergone 3 or more surgeries within 12 months, other than for diagnostic procedures (eg, colonoscopy). * has a body mass index (bmi) \>40 kg/m2. * had undergone prior abdominoplasty or major abdominal wall surgery.

Keywords: postoperative pain total shoulder arthroplasty abdominoplasty multimodal analgesia
optimizing cardiac rehabilitation by integrating sleep therapeutics

Conditions: Sleep Wake Disorders; Sleep Disturbance; Sleep-Related Impairment

Summary: the study aims are to: 1) optimize the transdiagnostic sleep and circadian intervention (trans-c) for delivery to veterans in cardiac rehabilitation, 2) test and refine the adapted trans-c treatment manual and protocol, and 3) conduct a pilot randomized trial to establish the feasibility, acceptability, and plausibility of the intervention protocol and study procedures.

aim 1 will involve formative work to optimize the trans-c manual and protocol for delivery in cardiac rehabilitation, with input from veterans and provider stakeholders. aim 2 will involve a preliminary test and refinement of the adapted trans-c manual and protocol with a small sample of veterans who are participating in cardiac rehabilitation and report sleep disturbance and/or sleep-related impairment. aim 3 will involve a pilot randomized trial to establish the feasibility, acceptability, and plausibility of the intervention protocol and study procedures. veterans in cardiac rehabilitation with sleep disturbance and/or sleep-related impairment will be randomized to trans-c + usual care or usual care. treatment satisfaction will be assessed at 3-months; sleep disturbance and sleep-related impairment, disability and functioning, and health-related quality of life will be assessed at baseline, 3-months, and 6-months to determine measure responsiveness and provide preliminary insight into treatment effects. of note, information provided in this entry (e.g., design, eligibility criteria, outcomes, etc.) pertains only to aim 3 which includes the pilot randomized trial. consistent with stage i of the nih stage model of behavioral intervention development research, results from aim 1 and 2 activities may lead to modifications to the pilot protocol and procedures in aim 3.

Eligibility criteria:
inclusion criteria: * veteran * age 18 years or older * referred for vaphs cardiac rehabilitation * self-reported sleep disturbance or sleep-related impairment, determined by promis sleep disturbance t-score at least 55 (raw score at least 25) or promis sleep-related impairment t-score at least 55 (raw score at least 20) * english language fluency * willing and able to voluntarily participate in a behavioral sleep intervention clinical research study * willing to permit study personnel access to va ehr * willing to permit study personnel to communicate with routine va healthcare providers * willing and able to participate in outpatient cardiac rehabilitation at vaphs exclusion criteria: * moderate to severe cognitive impairment * active suicidal ideation, plan, or intent * current moderate to severe alcohol or substance use disorder * current severe symptoms of depression, anxiety, mania/hypomania, psychosis, or ptsd * currently engaged in a non-pharmacological intervention for sleep * currently working night shifts * currently pregnant and/or breast-feeding

Keywords: veterans cardiac rehabilitation
telehealth exercise intervention to improve cardiovascular health in lymphoma survivors, techs trial

Conditions: Hodgkin Lymphoma; Non-Hodgkin Lymphoma

Summary: this clinical trial tests how well a telehealth exercise intervention works to improve cardiovascular health in lymphoma survivors. telehealth exercise is a service to help perform physical exercises at home with a care provider online. with the use of telehealth exercise lymphoma survivors may be able to participate in exercise programs safely to improve heart health and reduce the risk of cardiovascular disease.

primary objective: i. determine the feasibility of an 8-week telehealth exercise intervention, as assessed by enrollment, retention, and adherence to the telehealth exercise intervention. secondary objective: i. explore the effects of an 8-week telehealth exercise intervention on cardiovascular health, assessed by cardiopulmonary exercise test, pulmonary function test, body compositions, and blood biomarkers. outline: participants are randomized into 1 of 2 groups. group i (telehealth exercise): patients participate in telehealth exercise intervention for 30 minutes per day, 3 days a week for 8 weeks. group ii (delayed control): patients maintain current levels of physical activity for 8 weeks. patients may then participate in telehealth exercise intervention for 8 weeks. after completion of study treatment, participants are followed up after 1 week.

Eligibility criteria:
inclusion criteria: * diagnosed with hodgkin or non-hodgkin lymphoma. * \>= 18 years old. * are between 2-5 years after completing anti-cancer therapy and with no evidence of disease. * intermediate (4-5) to high ( \>= 6) risk of cardiovascular risk factors based on six key variables: age 30 to 50 years (y) \[2\]) and \>= 50y \[3\]; anthracycline dose \>250mg/m \^ 2 \[1\]; hypertension \[2\]; diabetes \[2\]; smoking \[1\]; and chest radiation \[1\]). * able to understand and sign the informed consent document. * physically able and willing to complete all study procedures. exclusion criteria: * have overt cardiovascular disease within 6 months (e.g. myocardial infarction, stroke, angina). * have contraindications to exercise. * participate in structured exercise (\>60 minutes/week). * female patients who are pregnant or planning to become pregnant.
effect of knee bracing on improving pain & disability

Conditions: Knee Osteoarthritis

Summary: the overall purpose of the proposed pilot study is to establish the feasibility of conducting a clinical trial by evaluating the preliminary effects of 8 weeks of knee bracing on physiological measures of self-reported pain and disability, physical performance, physical activity, as well as femoral cartilage deformation in individuals with medial compartment knee osteoarthritis (oa). the investigators will recruit 36 symptomatic knee oa patients for the pilot study. the investigators will evaluate a class of braces (two different models will be used) designed to correct genu varum. the purpose of the study is to evaluate changes in these novel outcomes following the use of a class of braces used to reduce medial tibiofemoral compartment compression used for 8 weeks. this pilot study will inform a larger future trial to determine the efficacy of bracing on decreasing disability and disease progression in patients with knee osteoarthritis.


Eligibility criteria:
inclusion criteria: participants must: * have a physician diagnosis of knee oa in the medial compartment and exhibit symptomatic knee oa, which the investigators will define as a normalized, person based, western ontario and mcmaster universities arthritis index (womac) function subscale score \> 31 (out of 100 points, indicating most dysfunction). * have had a knee radiograph taken within the previous 6 months. * be between the ages of 40 and 75 years old will be included. exclusion criteria: participants will be excluded if they have: * been diagnosed with a cardiovascular condition restricting exercise; * had a corticosteroid or hyaluronic acid injection in the involved knee in the previous 2 weeks; * a pacemaker; * a neurodegenerative condition; * rheumatoid arthritis; * cancer; * neural sensory dysfunction over the knee; * a bmi over 35; * history of lower extremity orthopaedic surgery in the past year; * a history of a traumatic knee injury in the past 6 months; * any history of a total knee arthroplasty in either extremity; or * a diagnosed, non-reconstructed knee ligament tear. * the need of an assistive device to walk. the investigators will also exclude pregnant women, as well as women who are trying to get pregnant or plan to get pregnant during the study.
quality of life, unmet needs and satisfaction with care after vulvar cancer

Conditions: Vulvar Cancer; Quality of Life

Summary: the aim of this prospective, longitudinal swedish multi-center study is to assess the quality of life, treatment-related morbidity, unmet needs and satisfaction with care after treatment for vulvar cancer, evaluated by a validated questionnaire.

primary objectives: information about: * general and vulvar-cancer-specific quality of life before and after any treatment for newly diagnosed vulvar cancer * treatment-related morbidity after any treatment for newly diagnosed vulvar cancer * unmet needs of patients with newly diagnosed vulvar cancer * satisfaction with care after any treatment for newly diagnosed vulvar cancer in sweden. outline: the study is planned as a prospective, longitudinal multi-centre study in sweden. since 2017, the treatment of vulvar cancer patients has been accredited to four tertiary referral university hospitals in sweden; the sahlgrenska university hospital in gothenburg, the linköping university hospital, the skåne university hospital in lund and the karolinska university hospital in stockholm. 150 patients are estimated for inclusion during a time frame of about 18 months. eligible patients will be asked to complete a validated questionnaire at different points of time (before and after treatment). calculating a response rate of about 50% - 60%, this will result in at least 80 completed questionnaires. the questionnaires consist of the following parts: * european organisation for research and treatment of cancer (eortc)-qlq-c30 * european organisation for research and treatment of cancer (eortc)-qlq-vu-34 (vulva-specific module) * hospital depression and anxiety scale (hads) * supportive care needs survey short form, excerpt (scns-sf34) * european organisation for research and treatment of cancer (eortc)-patsat (patient satisfaction), excerpt * demographic data * 25 self-constructed (and validated) questions results: results are expected to be available in 2021.

Eligibility criteria:
inclusion criteria: * primary diagnosis of vulvar cancer, all stages, all planned treatments * informed consent exclusion criteria: * disability to understand and complete the questionnaire due to language difficulties, severe psychiatric illness or dementia

Keywords: questionnaire eortc qlq c30 + vu34 hospital depression and anxiety scale eortc-patsat supportive care needs survey short form
individualised mapping in persistent af ablation

Conditions: Persistent Atrial Fibrillation

Summary: a clinical randomised trial to compare strategies for ablation in persistent and long-standing persistent atrial fibrillation comprising of two arms: pulmonary veins isolation (pvi) only and pvi + individualised mapping-guided ablation (cartofinder, biosense webster inc.)


Eligibility criteria:
inclusion criteria: 1. age \> 18 years old 2. signed informed consent. 3. scheduled to undergo a clinically indicated, first-time catheter ablation procedure for the treatment of persistent atrial fibrillation. 4. in atrial fibrillation at the time of the index procedure. exclusion criteria: 1. paroxysmal atrial fibrillation. 2. previous ablation procedure for atrial fibrillation. 3. left ventricular ejection fraction \< 45% 4. obesity with bmi \> 35 kg/m2 5. congenital heart disease. 6. previous cardiac surgery with atriotomy. 7. previous left atrial appendage closure/ligation. 8. contraindications to systemic anticoagulation, catheter ablation, and/or general anaesthesia. 9. pregnancy 10. current enrolment in a study evaluating another device or drug.

Keywords: persistent atrial fibrillation catheter ablation individualized mapping focal activity rotational activity
cohort study of patients with hepatocellular carcinoma and circulating tumor dna monitoring of chemoembolization

Conditions: Circulating Tumor DNA; Hepatocellular Carcinoma Non-resectable; Transarterial Chemoembolization

Summary: cohort study to assess the impact of ctdna detection in the follow-up and management of patients with hepatocellular carcinoma treated by tace

the incidence of hepatocellular carcinoma (hcc) has increased significantly over the past 30 years. the majority of hccs present at an intermediate stage, ineligible for a curative surgical approach and the reference treatment in this situation corresponds to a palliative locoregional treatment of transarterial chemoembolization (tace). this treatment modality can be repeated several times and the interval between each session as well as the modalities to evaluate the efficacy of this procedure remain poorly codified. this evaluation is currently based on imaging performed at one month (m1) (mri and/or ct scan) more or less associated with the study of the variation of the alphafetoprotein level measured before (baseline) and after (m1) the treatment. however, these evaluation tools have many limitations and remain imperfect in predicting response to treatment. in this context, liquid biopsy, which is experiencing significant growth in oncology, could be a promising tool. it is characterized by the detection of tumor elements in the bloodstream such as circulating tumor dna (ctdna). several studies have successfully demonstrated the diagnostic or prognostic value of ctdna in patients followed for hcc. the aim of our study is to evaluate the impact of ctdna detection in the follow-up of patients treated by tace.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * hcc diagnosed on consensus radiological criteria in cirrhotic patients (easl-eortc 2012): helical ct or mri with triple arterial, portal, and late acquisition. the diagnosis is based on the presence of hypervascularization at the early arterial time (wash-in) with wash-out (hypodensity or hypointensity compared with non-tumor liver parenchyma) at the portal phase or late phase compared with non-tumor parenchyma. * histologically diagnosed hcc in the absence of an imaging diagnosis * patient with a first tace (naive) or not, regardless of the number of previous procedures * patient naïve or on a new line of oncological treatment, regardless of the number of previous lines of treatment. * treatment decision validated by the digestive oncology staff. * patient having read and understood the information letter and signed the informed consent. * patient follow-up performed at the charles nicolle university hospital in rouen. exclusion criteria : * other active cancer or hematological malignancy, currently being treated * patient not affiliated to the social security system * pregnant woman or woman in labour or breastfeeding * person deprived of liberty by an administrative or judicial decision * person placed under court protection

Keywords: cell-free dna; circulating tumor dna; hepatocellular carcinoma;
longitudinal multimodal response assessment during neoadjuvant treatment of rectal cancer

Conditions: Locally Advanced Rectal Carcinoma; Neoadjuvant Treatment; Radiotherapy; Adaptive Treatment

Summary: this pilot study aims to trial multimodal early response assessment to enable therapy adaptions in the context of non-operative therapy strategies of locally advanced rectal cancer (larc) for development of a non-invasive response prediction model.

patients with larc, receiving neoadjuvant chemoradiotherapy (crt) are followed by at least 4 multiparametric mri-scans (diffusion weighted imaging and hypoxia-sensitive sequences) as well as repeated blood samples in order to analyse circulating tumour cells (ctcs). a standard pelvis radiotherapy (rt, 5040 cgy) will be performed in combination with a 5-fluorouracil / oxaliplatin regimen in all patients (planned: n = 50), succeeded by consolidation ctx (folfox4) if feasible. additional histologic markers, such as tumour-infiltrating lymphocytes (tils) or pd-l1 status will be analysed before and after crt. resection is standard after completion of preoperative treatment. in case of complete regression and patient's request, a non-operative management ("watch and wait") is offered alternatively. the primary endpoint is response, defined by tumor regression grading, secondary endpoints comprise longitudinal changes in mri as well as in ctcs and tils.

Eligibility criteria:
inclusion criteria: * locally advanced rectal cancer (larc): uicc stage ii/iii * no severe cardiac or lung disease * no severe hepatic disorders (liver enzymes \ 30ml/min) * no severe cytopenia (neutrocytes \>= 3 gpt/l; thrombocytes \>= 100 gpt/l; hemoglobin \>6mmol/l) * no homozygotic dpd deficiency * no other neoplasms requiring therapy * no earlier radiotherapy of the pelvis or earlier chemotherapy * no contraindications for mri

Keywords: total neoadjuvant therapy (tnt) t2* mri circulating tumor cells tumor infiltrating lymphocytes liquid biopsy dwi rectal cancer organ preservation
20070360 incident dialysis

Conditions: Chronic Kidney Disease; Secondary Hyperparathyroidism

Summary: randomized trial to evaluate the efficacy and safety of cinacalcet treatment in combination with low dose vitamin d for the treatment of subjects with secondary hyperparathyroidism (shpt) recently initiating hemodialysis


Eligibility criteria:
inclusion criteria: * adults greater than or equal to 18 years of age on hemodialysis for \> 3 and less than or equal to 12 months prior to enrollment into the study * mean of 2 pth determinations during the screening period (drawn at least 2 days apart) \> 300 pg/ml (31.8 pmol/l); or bipth \> 160 pg/ml (17.0 pmol/l) * mean of 2 corrected serum calcium determinations drawn on the same day as the pth determinations greater than or equal to 8.4 mg/dl (2.1 mmol/l) * subject will be able to complete the study, to the best of his/her knowledge * before any study-specific procedure, the appropriate written informed consent must be obtained exclusion criteria: * mean of 2 pth determinations during the screening period (drawn at least 2 days apart) \> 800 pg/ml (84.9 pmol/l); or bipth \> 430 pg/ml (45.6 pmol/l) and receiving vitamin d on entering screening * parathyroidectomy (partial or full) less than or equal to 6 months before entering screening * anticipated parathyroidectomy (partial or full) within 6 months after randomization * have a scheduled date for kidney transplant surgery * received cinacalcet since initiating hemodialysis * have received vitamin d therapy for less than 30 days before entering screening or required a change in prescribed vitamin d brand or dose within 30 days before entering screening. if subjects are not receiving vitamin d therapy, they must remain free of vitamin d therapy for the 30 days before entering screening * subject is pregnant (eg, positive hcg test) or is breast-feeding * refusal to use highly effective contraceptive measures (as determined by the investigator) throughout the study (screening and post enrollment) * current gastrointestinal disorder that may be associated with impaired absorption of orally administered medications or an inability to swallow tablets * known sensitivity, intolerance, or other adverse response to cinacalcet which would prevent on-study treatment compliance * have an unstable medical condition within 30 days before screening, or otherwise unstable in the judgment of the investigator * subject is currently enrolled in, or fewer than 30 days prior to entering screening have passed since subject received other investigational agent(s) (devices or drug).