Kornimate/medical-research-clean huggingface dataset:
measurement based care in opioid treatment programs

Conditions: Opioid Use Disorder

Summary: the goal of this heal initiative study is to enhance the measurement, quality, and equity of care delivered in 20 community opioid treatment programs (otps) by creating and using measurement-based care (mbc) tools and systems. patients will use mbc tools to track their symptoms and discuss with their providers. this data will be collected over the course of the study to evaluate the effectiveness of mbc in improving patient care and treatment outcomes.

opioid use disorder (oud) remains a critical public health crisis in pennsylvania. measurement-based care (mbc) is the systematic use of client self-report data to inform treatment and is an evidence-based intervention that is uniquely well suited to complement opioid use disorder (oud) pharmacotherapy that occurs within opioid treatment programs (otps). the study aims to enhance the measurement, quality, and equity of care delivered in 20 community otps by co-designing and implementing mbc tools and systems. using a hybrid implementation effectiveness type ii trial with a stepped-wedge design, mbc implementation (e.g., fidelity) and clinical (e.g., patient retention, improved quality of life) effectiveness will be evaluated simultaneously with quantitative and qualitative data. this study aims to provide: (1) preliminary evidence regarding the role and significance of capitalizing on mbc in opioid use disorder (oud) treatments (including evidence on potential mechanisms underlying mbc's effects); (2) enhanced adoption of mbc via implementation strategies that are co-designed with stakeholders (policymaker, payer, and otp); and (3) alternative avenues to potentially enhance symptom-related outcomes and treatment retention of oud interventions with downstream societal, psychological, and public health benefits.

Eligibility criteria:
inclusion criteria otp patients will be eligible to participate if they: 1. are adults (aged 18 years or older); 2. are initiating moud at the otp, as a new patient (as defined by otp guidelines); and 3. speak primarily english or spanish. exclusion criteria otp patients will be excluded from participation if they: 1. are under the age of 18; 2. are not a new moud patient at the otp 3. do not speak primarily english or spanish.
cardiovascular prevention strategies in elderly patients with cancer (cartier clinical trial)

Conditions: Cancer (Colon Cancer, Breast Cancer, Lymphoma, Chronic Lymphoma Leukemia, Multiple Myeloma); Elderly; Antineoplastic Agents; Cardiotoxicity

Summary: the cartier study is a randomized, multicenter, open-label clinical trial comparing, in elderly patients with cancer under anti-tumoral treatment, two different cardiotoxicity prevention strategies: primary (intensive cardiovascular monitoring focused on prevention and early diagnosis and treatment of cardiotoxicity based in cardio-onco-hematology teams involved in cancer patient care) vs. secondary (current clinical practice where intensive cardiovascular monitoring is not routinely performed and cardiotoxicity patient care is based on the onco-hematologist criteria). the primary endpoint is to determine whether this primary prevention englobing cardiovascular monitoring plus intensive multidisciplinary management is superior to the current clinical practice in reducing all cause mortality. other secondary objectives of the study are to analyze the impact of this intensive cardiovascular monitoring strategy on the incidence of cardiovascular mortality, oncological mortality, hospitalization and/or urgent care due to cardiovascular complications, hospitalization and/or urgent oncological care due to cancer complications, tumor progression and cost-effectiveness analysis. a total of 514 patients ≥ 65 years old diagnosed with any of the following onco-hematological cancers, colon, breast, lymphoma, chronic lymphoma leukemia, chronic myeloid leukemia or myeloma, undergoing standardized anti-tumoral treatment, will be recruited. the incidence of primary and secondary outcomes will be measured at 2 and 5 years


Eligibility criteria:
inclusion criteria: * \> 65 years old * expected survival \>1 year * colon cancer, breast cancer, lymphoma, chronic lymphoma leukemia, chronic myeloid leukemia, myeloma * signature on the informed consent exclusion criteria: * patients included in clinical trials will be excluded if they interfere with the cartier follow-up protocol. if they do not interfere they can be included * patients who had received previous potentially cardiotoxic anticancer treatment

Keywords: cardiotoxicity elderly antineoplastic agents cardiovascular monitoring cardioprotection cardio-oncology chemically-induced disorders radiation injuries drug-related side effects and adverse reactions. primary prevention secondary prevention. mortality
influence of diet and endurance running on intramuscular lipids measured at 4.1 tesla

Conditions: Obesity

Summary: the purpose of this pilot investigation is to use 1 h magnetic resonance spectroscopy (mrs) to 1) document the change in intra-muscular lipid stores (iml) before and after a prolonged bout of endurance running and, 2) determine the pattern (time course) of iml replenishment following an extremely low-fat diet (10% of energy from fat) and a moderate-fat diet (35% of energy from fat). specifically, the study will evaluate the change in iml following a 2-hour training run and the recovery of iml in response to the post-exercise low-fat or moderate-fat diet in 10 endurance trained athletes who will consume both diets in a randomly assigned cross-over fashion. we hypothesize that iml will be depleted with prolonged endurance exercise, and that replenishment of iml will be impaired by an extremely low-fat diet compared to a moderate-fat diet. results of this pilot study will be used to apply for extramural grant support from nih or the us armed forces to investigate the effect of dietary fat on the health and performance of individuals performing heavy physical training. it is anticipated that this methodology could also be employed in obesity research to delineate, longitudinally, the reported cross-sectional relationships among iml stores, insulin resistance and obesity.


Eligibility criteria:
inclusion criteria: * healthy volunteers (developmental phase) * healthy endurance-trained subjects * maximum age for males is 39 * maximum age for females is 49

Keywords: exercise exertion physical fitness lipids nutrition
early goal-directed therapy utilizing transpulmonary thermodilution and severe burn injury

Conditions: Burns

Summary: this study aimed to optimize fluid resuscitation with transpulmonary thermodilution (tptd)-guided protocol and to lower the mortality rate of the severely burned.


Eligibility criteria:
inclusion criteria: * adult patients (age \> 18 years). * major burn (as total burned surface area (tbsa) \> 20% with at least second degree burn depth). * admitted to the intensive care unit (icu) of the burn center. exclusion criteria: * patients younger than 18 years old. * patients with severe cardiopulmonary diseases, or associated with other major trauma. * patient with incomplete data.
study to evaluate safety and preliminary efficacy of tafasitamab with idelalisib or venetoclax in r/r cll/sll patients pretreated with btki

Conditions: Leukemia, Lymphocytic, Chronic, B-Cell; Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma

Summary: this is a two-cohort, multicenter, open-label study of tafasitamab (mor208) combined with idelalisib or venetoclax in adult patients with r/r cll or r/r sll pretreated with a btk inhibitor (e.g., ibrutinib) as single agent or as part of combination therapy. patients completing the study treatment are invited to participate in an optional biomarker sub-study.

the purpose of this study is to evaluate the clinical safety and preliminary efficacy of tafasitamab (mor208) combined with idelalisib or venetoclax. the study will include safety run-in phase for each cohort with an evaluation of the safety data by an independent data monitoring committee. an optional sub-study has been introduced to collect biological samples for investigations on biomarkers (e.g., cd19 expression) after tafasitamab treatment.

Eligibility criteria:
major inclusion criteria diagnosis/trial population * chronic lymphocytic leukemia (cll) or small lymphocytic lymphoma (sll): * history of diagnosis of cll or sll that meets iwcll diagnostic criteria * histologically confirmed diagnosis of sll by lymph node biopsy * indication for treatment as defined by the iwcll guidelines * patients must have both of the following: * relapsed or refractory disease while receiving a btki therapy or intolerance of such therapy * single-agent or combination therapy with a btki for at least one month must be the patient's most recent prior anticancer therapy * ecog performance status of 0 to 2 * patients with a past medical history of autologous or allogeneic stem cell transplantation must exhibit full hematological recovery laboratory values • patients must meet adequate bone marrow function and adequate hepatic and renal function other inclusion criteria • females of childbearing potential must use a highly effective method of contraception major exclusion criteria diagnosis • patients who have: * non-hodgkin's lymphomas other than cll/sll * transformed cll/sll or richter's syndrome * active and uncontrolled autoimmune cytopenia previous and current treatment * patients who have received treatment with a btk inhibitor within 5 days prior to day 1 dosing * patients who have, within 14 days prior to d1 dosing: * not discontinued cd20-targeted therapy, chemotherapy, radiotherapy, investigational anticancer therapy or other lymphoma specific therapy * systemic corticosteroids in doses greater than prednisone equivalent to 20 mg/day with the exception of patients with signs of rapidly progressing disease * received live vaccines with the exception of vaccination against influenza with inactivated virus or for pneumococcal diseases

Keywords: cd19 mor208 mor00208 cll sll cosmos tafasitamab
impact of bariatric surgery on cardiorespiratory function

Conditions: Obesity; Bariatric Surgery Candidate; Physical Activity

Summary: obesity is a growing problem worldwide and its prevention has become one of the leading priorities for the world health organisation. obesity results from chronic imbalance between energy intake and energy expenditure. although early prevention of obesity is preferable, surgical treatment is often required for severely obese people. bariatric surgery has been shown to be the most effective therapy for severe obesity. weight loss following bariatric surgery results in significant improvements in coexisting comorbidities, such as diabetes and hypertension but there is controversy whether bariatric surgery also improves aerobic capacity. the purpose of this study is to investigate the effects of bariatric surgery on cardiopulmonary function and on daily physical activity. it is hypothesized that bariatric surgery will improve aerobic capacity and result in beneficial lifestyle changes from sedentary to more active.


Eligibility criteria:
inclusion criteria: * ages 18 years to 50 years * patients enrolled in the bariatric surgery program of st george's hospital with bmi \> 40 kg/m2, or 35-40 kg/m2 in the presence of other obesity-related comorbidities such as hypertension or type- 2 diabetes exclusion criteria: * locomotor difficulties which would prevent participants from completing the cardiopulmonary exercise testing * weight \> 190 kg (due to weight restrictions of equipment used to transfer patients in the event of medical emergencies) * cognitive impairment * patients unable to follow instructions in english

Keywords: obesity bariatric surgery physical activity cardiopulmonary exercise test
an open-label study of a novel jak-inhibitor, incb052793, given to patients with advanced malignancies

Conditions: Solid Tumors; Advanced Malignancies; Metastatic Cancer

Summary: this was a study of incb052793 given to patients with advanced malignancies that was to be conducted in three phases; phase 1a (monotherapy) and phase 1b (combination therapy) and phase 2 (combination therapy of incb052793 with azacitidine and itacitinib with azacitidine). phase 1 had two parts; a dose escalation (part 1) and an expansion (part 2).


Eligibility criteria:
inclusion criteria: phase 1a * aged 18 years or older * histologically or cytologically confirmed solid tumor or hematologic malignancy * life expectancy of 12 weeks or longer * must have received ≥ 1 prior treatment regimen * must not be a candidate for potentially curative or standard of care approved therapy phase 1b * aged 18 years or older * cohort a: histologically or cytologically confirmed pancreatic adenocarcinoma, triple-negative breast cancer, urothelial cancer with at least 1 measurable or evaluable target lesion * cohorts b, c, d, e and g: histologically confirmed multiple myeloma and measureable/evaluable disease * cohort f: confirmed acute myeloid leukemia or myelodysplastic syndrome * cohort h: individuals diagnosed with lymphoma * prior therapy: * cohort a: no more than 1 prior chemotherapy regimen for advanced or metastatic disease (not including neoadjuvant and/or adjuvant therapy) * cohorts b, c, d, e and g: must have relapsed from or have been refractory to ≥ 2 prior treatment regimens * cohort f: may have received any number of prior treatment regimens or be treatment-naïve * cohort h: must have relapsed from or have been refractory to available treatments phase 2 * aged 18 years or older * cohorts i and j: confirmed acute myeloid leukemia or high risk myelodysplastic syndrome * prior therapy: * cohorts i and j: must have failed prior therapy with a hypomethylating agent (hma) exclusion criteria: * prior receipt of a jak1 inhibitor (phase 1a only) * known active central nervous system metastases and/or carcinomatous meningitis * eastern cooperative oncology group (ecog) performance status \> 2 * any known contraindications to the use of gemcitabine, nab-paclitaxel, dexamethasone, carfilzomib, bortezomib, lenalidomide, azacitidine, pomalidomide or pi3kδ inhibitor (phase 1b and phase 2 only, as appropriate to treatment cohort) * known human immunodeficiency virus infection, or evidence of hepatitis b virus (hbv) or hepatitis c virus (hcv) infection or risk of reactivation
self-applied acupressure for arthralgia-fatigue-sleep disturbance in breast cancer

Conditions: Breast Neoplasms; Cancer Survivor

Summary: this study aims to evaluate the feasibility, acceptability and preliminary effects of self-applied acupressure on arthralgia-fatigue-sleep disturbance symptom cluster in breast cancer survivors receiving aromatase inhibitors. this is a preliminary randomized controlled trial, with a three-arm trial design including verum self-acupressure, sham self-acupressure, and usual care. subjects will include 52 breast cancer survivors who are receiving aromatase inhibitors and have experienced a moderate level of joint pain and at least one of the two symptoms including fatigue and sleep disturbance. subjects who are randomized to either the verum self-acupressure group (group a) or the sham self-acupressure group (group b) will receive up to 8 weeks of the intervention consisting of two components: (1) two individual/group acupressure training sessions over 2 weeks and (2) self-acupressure for 6 weeks. the method and duration of self-acupressure in the sham group will be the same to those in the verum intervention group. the control group will receive usual care. the outcome measures of this study will be related to feasibility, acceptability and preliminary effects of self-acupressure. individual in-depth interviews will be conducted with selected participants in group a and b to understand their perceptions and perceived effectiveness of the intervention.


Eligibility criteria:
inclusion criteria * female adult aged 18 and older; * clinical diagnosis of early-stage (stage i, ii, or iiia), hormone-receptor-positive breast cancer; * completion of surgery, and/or chemotherapy and/or radiotherapy; * currently taking the third generation of ais (anastrozole, letrozole, or exemestane) for at least 1 month; * based on their self-reports of moderate symptoms of joint pain and fatigue or sleep disturbance; * willing to comply with the intervention protocol, and * being able to communicate in chinese . exclusion criteria: * previous receipt of acupuncture and acupressure within the past six months; * currently receiving medications (unchanged for 3 month), physical therapy and other complementary and alternative medicines for the treatment of joint pain, fatigue and sleep disturbance; * prior joint surgery or fracture during the past six months; * mentally incapable of participating in the study (hong kong version of montreal cognitive assessment score\<22);and * inability to perform self-care (karnofsky performance scale score\<70).
a behavioral intervention for depression and chronic pain in primary care

Conditions: Chronic Pain; Depression

Summary: chronic pain and depression frequently co-exist in late and mid-life and contribute to increased disability, high health care costs, psychiatric comorbidity, and suicide. the investigators will recruit 60 adults from weill cornell medical associates primary care practices; participants will be randomized to either relief (a 9 session behavioral intervention) or usual care/referral for mental health care. research assessments are conducted with both groups at study entry (baseline), 6, 9, and 12 weeks.


Eligibility criteria:
inclusion criteria: * age 50 years * phq-9 greater than or equal to 10 * non-cancer related chronic pain, defined as pain during most days over the past 3 months by patient report * capacity to consent exclusion criteria: * dsm-5 axis 1 other than depression and anxiety disorders * montreal cognitive assessment (moca) \< 24 * active suicidal ideation, i.e. madrs suicide item greater than or equal to 4 * severe or life-threatening medical illness. * patients on psychotropics, opioids or benzodiazepines will be included if they do not meet dsm-5 criteria for opioid, anxiolytics or other substance abuse disorders

Keywords: middle-aged and older adults primary care
quality of life and cancers in nursing homes

Conditions: Quality of Life; Cancer; Nurse's Role

Summary: quality of life (qol) of nursing homes residents with cancer in france is not known. high prevalence of neurodegenerative diseases makes it difficult. it was found that oncological management is suboptimal among poitevin territory residents. publications report an inadequate management of symptoms of discomfort related to cancers. the multicentric study will comparate quality of life in patients with and without cancers in nursing homes, including residents with neurodegenerative disease, using validated questionnaires. these questionnaires, as well as pain evaluation, will be carried out by a geriatric consultations' nurse.

investigators will also make a descriptive inventory of the oncological care and support care in these patients, in order to evaluate the need for a specific oncogeriatric intervention. quality of life and pain will be compared with a randomized residents control group, in each hospital.

Eligibility criteria:
inclusion criteria: * affiliated to the social security system * talking french language * cancer group: all residents with a history of cancer, * control group: residents without any history of cancer (same number of residents as in the cancer group), randomly selected in each nursing home, matched to age, sex, presence of dementia (mild or moderate), and aggir dependancy scale exclusion criteria: * severe dementia (mms \<10/30) • total disability to communicate
safety and efficacy of ain457 in patients with quiescent non-infectious uveitis

Conditions: Non-infectious Uveitis

Summary: this extension study will assess the safety and efficacy of ain457 versus placebo for maintaining uveitis suppression when reducing systemic immunosuppression


Eligibility criteria:
inclusion criteria: * patients who have completed the entire treatment period of the 24 week core study exclusion criteria: * inability or unwillingness to undergo repeated subcutaneous injections; inability to comply with study or follow-up procedures; any medical or psychiatric condition which, in the investigator's opinion wouldpreclude the participant from adhering to the protocol or completing the study per protocol. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: quiescent uveitis intermediate uveitis panuveitis posterior uveitis uveitis nvs definition: words or phrases that best describe the protocol. keywords help users find studies in the database. avoid acronyms, abbreviations and trade names. examples: heart failure, aliskiren, heart attack, cardiovascular diseases psoriasis, inflammatory skin disease, scaly patches
the development of flat foot after ankle fractures

Conditions: Pes Planus

Summary: in this study we are trying to determine the incidence of flat foot (also called pes planus) among patients who have had an ankle fracture. as compared to the general population, it is predicted that the incidence of pes planus will be higher among people who have fractured their ankle.

pes planus may develop following ankle fractures due to additional injuries that are sustained at the time of ankle fracture. if this study can demonstrate an association, further research would investigate how to effectively treat the pes planus early to prevent it from becoming a symptomatic problem.

Eligibility criteria:
inclusion criteria: patients will be considered eligible if: * they have sustained weber type b or c ankle fractures and needed open reduction * they are 18 years of age or older * they are expected to be full weight bearing for at least 4 months to allow the potential of supporting structures to stretch and pes planus to develop exclusion criteria: * patients will be excluded if they already have flat foot in their non-fractured foot. * patients with bilateral ankle fractures * patients who are not competent to sign a consent form * a second fracture to the ankle * pathological fractures * patients with underlying cancer.

Keywords: ankle fracture pes planus