Kornimate/medical-research-clean huggingface dataset:
lay health worker engage, educate, and encourage patients to share

Conditions: End of Life; Cancer

Summary: the purpose of the leaps program is to understand how a trained lay health worker who engages with newly diagnosed patients after a diagnosis of an advanced stage of cancer can help to engage patients in advance care planning, improve patient satisfaction with their decision-making, activation, quality of life, and healthcare resource utilization.

unite here health proposes to implement and evaluate several critical elements to be in alignment with the mission of the organization to provide high value care to their members. the lay health worker engages, educates, and encourages patients to share intervention is an innovative program that will strengthen provider-patient relationship and facilitate whole person care about matters important to unite here health members who are diagnosed with cancer and important to support network and family. the project is intended to help establish goals of care plan with appropriate documentation, develop, deploy, and evaluate a model of care for persons with cancer that is intended to improve clinical outcomes and experience of care for individuals. the intervention provides patients with lay health coaches who assist patients and their families in discussing goals of care and engage in shared-decision making. the goal of the project is to demonstrate that there is improved documentation of goals of care, patient experiences, patient activation and quality of life outcomes, and that the program helps to reduce utilization of health care resources at the end of life.

Eligibility criteria:
inclusion criteria: 1. newly diagnosed patients with a cancer diagnosis. 2. patients with any relapse or progressive disease (any cancer diagnosis) as identified by imaging or biopsy and confirmed by physician. 3. the patients must be 18 years or older. 4. patients must have the capacity to verbally consent. exclusion criteria: 1. inability to consent to the study due to lack of capacity as documented by the referring physician. 2. patients without a newly diagnosed malignancy or patients without relapse of disease. 3. patients not eligible for fund benefits. patients without a newly diagnosed malignancy or patients without relapse of disease.

Keywords: cancer end of life patient-centered
effect of triptorelin (decapeptyl®) 22.5 mg on two biomarkers in patients with advanced prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this study is to evaluate the effect of an initial hormonal treatment gonadotrophin-releasing hormone (gnrh agonist) on 2 biomarkers (pca3 and tmprss2-erg), in patients with histologically confirmed and advanced stages of prostate cancer. their characteristics, according to risk factors such as psa and gleason score will be determined at baseline and 1, 3 and 6 month post-treatment.


Eligibility criteria:
inclusion criteria: * a histologically confirmed, locally advanced or metastatic prostate cancer, and naïve to androgen deprivation therapy, and a candidate for hormonal treatment. * an estimated survival time of at least twelve months according to the investigator's assessment. * a performance status score ≤ 2 according to the world health organisation (who) criteria. exclusion criteria: * previous surgical castration. * previous or has planned curative prostate cancer therapy (radiation/surgery) * previous hormone therapy (gnrh analogues, estrogens or anti-androgens) * patients with risk of a serious complication in the case of tumour flare (vertebral metastases threatening spinal cord compression or significant obstructive uropathy)

Keywords: locally advanced or metastatic prostate cancer
anti-ceacam5 adc m9140 in advanced solid tumors (proceade-crc-01)

Conditions: Colorectal Cancer

Summary: the purpose of this first-in-human study is to evaluate the safety, tolerability, pharmacokinetics, and preliminary clinical activity of m9140 in advanced solid tumors. this study contains 2 parts: dose escalation (part 1) and dose expansion (part 2). study details include: * study duration per participant: approximately 4 months for part 1 and 8 months for part 2 * m9140 is not available through an expanded access program


Eligibility criteria:
inclusion criteria: * participants with documented histopathological diagnosis of locally advanced or metastatic colorectal cancer (crc), who were intolerant/refractory to or progressed after standard systemic therapies for the advanced/metastatic stage, if locally indicated and available to the participant. participants with a known microsatellite instability high (msi-h) status must have received treatment with an immune checkpoint inhibitor (if locally indicated and available) unless contraindicated. * eastern cooperative oncology group performance status (ecog ps) below or equal to 1 * participants with adequate hematologic, hepatic and renal function as defined in protocol * other protocol defined inclusion criteria could apply exclusion criteria: * participant has a history of malignancy within 3 years before the date of enrollment (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, benign prostate neoplasm/hypertropia, or malignancy that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years) * participants with known brain metastases, except those meeting the following criteria: brain metastases that have been treated locally and are clinically stable for at least 4 weeks prior to the start of treatment; no ongoing neurological symptoms that are related to the brain localization of the disease (sequelae that are a consequence of the treatment of the brain metastases are acceptable) * participants with diarrhea (liquid stool) or ileus grade \> 1 * participants with active chronic inflammatory bowel disease (e.g., ulcerative colitis, crohn's disease, intestinal perforation) and/or bowel obstruction * unstable angina, myocardial infarction, congestive heart failure (new york heart association \[nyha\] \>= ii) or a coronary revascularization procedure within 180 days of study entry. calculated qtc average (using the fridericia correction calculation) of \> 470 milliseconds (ms) * cerebrovascular accident/stroke (\< 6 months prior to enrollment) * other protocol defined exclusion criteria could apply
a retrospective chart review of three medifast weight control centers

Conditions: Obesity

Summary: the primary aim of this study is to to retrospectively evaluate the efficacy of the mwcc jump start (medifast's 5 \& 1) plan on the following indices: weight loss, anthropometric changes, and reduction in common markers of coronary heart disease.

portion-controlled meal replacements by themselves have been shown to be an effective weight control strategy in overweight and obese individuals. the addition of medical supervision has been shown to result in greater weight loss than meal replacements alone. mwcc provides this added support through individual weekly counseling sessions. thus, the investigators plan to retrospectively evaluate the efficacy of the mwcc jump start (medifast's 5 \& 1) plan on the following indices: weight loss, anthropometric changes, and reduction in common markers of coronary heart disease.

Eligibility criteria:
inclusion criteria: * adult males and females aged 18-70 * followed the jump start (5 \& 1) plan * bmi ≥ 25 * purchased a weight management program at the mwcc location in the last 3 years * signed patient health information consent form exclusion criteria: * on a plan other than the 5\&1 (jump start) * completed initial consultation but did not participate further * program stopped due to client not getting baseline labs * program stopped due for medical reasons unrelated to the 5 \& 1 (jump start) plan * currently an active participant at the mwcc * no signed patient health information consent form or written request to revoke consent

Keywords: obesity meal replacements
intravenous dexamethasone on supraclavicular brachial plexus block for shoulder arthroscopy

Conditions: Shoulder Arthroscopy; Pain

Summary: previous studies have confirmed that iv dexamethasone prolongs brachial plexus blocks. however, these studies only used fixed doses of iv dexamethasone at relatively high doses, which could potentially lead to increased glucose levels, delayed wound healing, and unintended side effects. there remains a paucity of research on the effective dose range of iv dexamethasone for the prolongation of supraclavicular blocks. the optimal dosage of iv dexamethasone for prolongation of analgesia vs. motor block prolongation from supraclavicular blocks in shoulder surgery has yet to be delineated.

numerous studies have confirmed that perineural dexamethasone prolongs bupivacaine and ropivacaine brachial plexus blocks by approximately 10 hours (from approx. 12 to 22 hours) without clinical evidence of toxicity. however, perineural toxicity in an animal model has raised concern about its use as a peripheral nerve block adjuvant. moreover, recent studies suggest that high dose iv dexamethasone (810mg) prolongs analgesia to a similar degree as perineural dexamethasone for interscalene, supraclavicular and sciatic nerve blocks performed with ropivacaine and bupivacaine. however these studies only utilized fixed, high level doses of iv dexamethasone. moreover, there remains a concern that high dose iv dexamethasone may lead to postoperative hyperglycemia and could possibly increase the risk of postoperative wound infection. open surgery under general anesthesia has been shown to increase blood glucose levels with a peak at approximately 2 hours post-induction and results have been conflicting regarding whether or not iv dexamethasone causes greater increase. to the investigators' knowledge, it is not yet known if arthroscopic surgery under regional anesthesia triggers a similar increase in blood glucose levels and if this is impacted by administration of iv dexamethasone. the investigators aim to identify the duration of supraclavicular block prolongation that can be expected over a range of doses of iv dexamethasone. the investigators also seek to identify what association, if any, is noted between iv dexamethasone and changes in blood glucose levels after shoulder surgery with regional anesthesia and sedation. finally, the investigators will collect data on side effects and postoperative complications, if any, in patients receiving a range of doses of iv dexamethasone.

Eligibility criteria:
inclusion criteria: - patients undergoing shoulder arthroscopy under regional anesthesia exclusion criteria: * general anesthesia * contraindication to regional anesthesia * pre-existing neuropathy in the surgical limb * diabetes mellitus * history of postoperative nausea and vomiting \&/ or motion sickness * procedures involving biceps tenotomy * peri-articular cocktail injections given intraoperatively to augment pain relief * chronic pain (daily opioid and/or gabapentinoid use for 6 weeks) * open surgical procedures * corticosteroid injection within 1 month * patients on systemic oral or iv steroid therapy within 6 months
effect of combined intra-articular injection of lidocaine plus physiotherapy in treatment of frozen shoulder

Conditions: Frozen Shoulder; Adhesive Capsulitis

Summary: 1. therapeutic exercise, especially stretch exercise and joint mobilization, remain the mainstay of conservative treatment of frozen shoulder. 1. nevertheless, shoulder pain during the physiotherapy reduces the treatment effect. 2. manipulation or arthroscopic release under general anesthesia may avoid pain during the intervention; however, increased risk of humeral shaft fracture and failure of release of pathological tissue were reported. 2. we consider intra-articular injection is a compromized way, from a practical point of veiw, to reduce the pain during physiotherapy. 3. we hypothesize that, intra-articular injection with lidocaine before joint mobilization and stretch exercise, can make the patient pain-free during physiotherapy, and the effect of combined therapy is superior to physiotherapy alone in the treatment of frozen shoulder.

a randomized controlled trial to compare the effect in treatment of frozen shoulder between combined intra-articular injection with lidocaine plus physiotherapy and physiotherapy alone.

Eligibility criteria:
inclusion criteria: * clinically diagnosed as unilateral frozen shoulder, with the definition as more than 50% loss of passive movement of the shoulder joint relative to the non-affected side, in one or more of the three movement direction (ie. abduction in the frontal plane, forward flexion in sagittal plane, or external rotation in 0 degree of abduction) * duration of complaints of more than three months * ability to complete questionnaires in chinese exclusion criteria: * history of shoulder fracture, dislocation, or trauma * history of rheumatic arthritis, tumor, or other diseases in the shoulder joints * receive intra-articular corticosteroid injection or manipulation therapy in shoulder joint in recent four weeks * pregnancy or breast feeding * allergic to lidocaine

Keywords: adhesive capsulitis frozen shoulder shoulder pain intra-articular injection lidocaine injection physiotherapy manipulation stretch exercise
the effects of fish oil supplements during supervised exercise therapy in patients with intermittent claudication

Conditions: Intermittent Claudication

Summary: intermittent claudication (ic) is caused by peripheral arterial disease and has a high morbidity and mortality. etiologic factors are similar to those of cardiovascular disease. primary treatment consists of cardiovascular risk management and improvement of functional capacity with supervised exercise therapy (set). a potential additional therapy is the administration of fish oil supplements containing high amounts of omega-3 poly unsaturated fatty acids (pufas). in earlier clinical and experimental trials omega-3 pufa's improved hemorheological parameters such as erythrocyte deformability and aggregation, and a number of cardiovascular risk factors. hemorheological parameters determine the blood flow in the microcirculation, which is of main importance in patients with ic since the macrocirculation is compromised. inflammation is considered an important etiologic factor in the pathogenesis of atherosclerosis and contributes to peripheral arterial disease since omega-3 pufas also have a strong anti-inflammatory effect, they might be effective in patients with ic by lowering the inflammatory response. in addition, visceral fat rather than obesity in general has been recognised as an etiologic and prognostic factor in atherosclerosis. we hypothesise that the administration of omega-3 pufa's in patients with ic has a synergistic effect with set and improves walking distance after set, by improving hemorheological parameters resulting in a better microcirculation. second, we hypothesise that omega-3 pufa's result in a less proinflammatory of whole blood in response to ex vivo stimulation with endotoxin. third, we hypothesise that omega-3 pufa's and set result in a decrease in visceral fat mass.


Eligibility criteria:
inclusion criteria: * age ≥ 18 * newly diagnosed intermittent claudication * ankle brachial index \ 0.15 decrease after exercise * able to perform standardised treadmill walking test for 2 min * written informed consent exclusion criteria: * unable to fill out a questionnaire (cognitive impairment or insufficient knowledge of the dutch language) * heart failure or unstable cardiac status (angina pectoris class iii or iv or recent myocardial infarction \< 3 months) * any illness with rapid evolution or a life expectancy \< 3 months * recent cerebrovascular accident (\< 3 months) * current use of fish oil supplements or \> 2 times a week dietary fish * pregnancy * fish, soybean or peanut allergy * contra indications for the use of omega-3 fatty acids * use of oral anticoagulants (coumarin derivatives)

Keywords: fish oil supplements supervised exercise training walking distance hemorheological factors cardiovascular risk
actigraphic measurement of a neurosurgical procedure

Conditions: Sleep Disorders; Circadian Rhythm; Pain; Rehabilitation; Mood Lability

Summary: the study examines and illustrates the utility of utilizing actigraphic measurements to assess treatment response.

actigraphic measurements, repeated verbal fluency and multi-symptom operationally defined observations will be recorded for an 11 to 12 day baseline period and continued following neurosurgical tumor resection until a repeat mri is completed three months after the procedure.

Eligibility criteria:
inclusion criteria: * diagnosis of incidental meningioma * single subject preparing to receive neurosurgical intervention exclusion criteria: * inability to wear actigraphy device

Keywords: neurosurgical outcome actigraphy treatment response measurement
a study to assess safety of imbruvicatm in indian participants with chronic lymphocytic leukemia or mantle cell lymphoma who have received at least one prior therapy or chronic lymphocytic leukemia with 17p deletion

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

Summary: the primary purpose of this study is to evaluate the post-marketing safety of imbruvicatm (ibrutinib capsule 140 milligram \[mg\]) under actual conditions of use, and to understand the incidence of adverse events (aes) (serious and non-serious aes).


Eligibility criteria:
inclusion criteria: * chronic lymphocytic leukemia (cll) or mantle cell lymphoma (mcl) participants being newly initiated on imbruvica treatment (ibrutinib capsule 140 milligram \[mg\]) based on independent clinical judgment of treating physicians as per locally approved prescribing information * must give a written informed consent indicating that they understand the purpose and are willing to participate in the study and allowing data collection and source data verification in accordance with regulatory requirements exclusion criteria: * participants who are not eligible to receive imbruvica as per the locally approved prescribing information * participants participating or planning to participate in any interventional drug trial during the course of this study
subcutaneous closed-suction drainage affects surgical wounds healing in lower gastrointestinal open surgery: a randomized controlled study

Conditions: All Diseases That Require Gastrointestinal Open Surgery

Summary: this is a single-center, randomized controlled trial to evaluate whether subcutaneous closed-suction drainage would decrease the incidence of poor surgical site healing in lower gastrointestinal open surgery. the independent risk factors of the incidence of poor surgical wounds healing in lower gastrointestinal open surgery will be analyzed.


Eligibility criteria:
inclusion criteria: * aged 18-85 years old, male or female * all patients underwent lower gastrointestinal surgery: the digestive tract below treitz ligament was called lower gastrointestinal tract, including jejunum, ileum, ileocecal part and colorectal * open surgery (instead of laparoscopic) required * willing participated in clinical verification and signed informed consent. exclusion criteria: * laparoscopic surgery * upper gastrointestinal surgery (esophagus, stomach, duodenum and hepatobiliary pancreas) * simple appendectomy / total appendectomy * hernia surgery and intestinal obstruction surgery without intestinal resection * infection of incision site before operation * pregnant women * expected death within 1 month after operation.
validity of an actigraph accelerometer following critical illness

Conditions: Critical Care; Walking; Posture

Summary: this study will determine whether an actigraph gt3x accelerometer can identify body position and quantify step count in a ward based population recovering from critical illness.

ward based patients recovering from critical illness who satisfy the inclusion criteria will have an actigraph gt3x accelerometer positioned on the thigh and ankle of the non dominant leg. these will be used as an objective method of identifying adoption of lying, sitting and standing postures and quantification of step count. both placement sites will be investigated in isolation. a further analysis will be undertaken to determine whether combining data from both placement sites (ankle and thigh) is superior in identification of lying, sitting and standing postures compared to an isolated single site. accelerometer data will be compared against direct observation as the criterion measure. patients will undertake a semi-structured movement protocol consisting of typical activities undertaken by this population. these include lying in bed, transferring over the side of the bed, sit to stand postural transfers (and the reverse), sitting in a chair and walking. observation periods will not exceed 3 hours. during this time all aspects of the movement protocol will be completed. the data from this study will be analysed to determine the validity of the actigraph gt3x in identification of body position and quantification of step count using the placement sites described above.

Eligibility criteria:
inclusion criteria: 1 18 years of age or above. 2. ventilated in excess of 48 hours during admission in the intensive care unit (icu). 3. currently resident on a hospital ward (secondary care) following step down from icu 4. able to undertake all postural transfers independently or with minimal assistance (one person only). 5. able to mobilise short distances, either independently or with assistance from a walking aid or one person. 6. willing to permit application of two actigraph gt3x accelerometers each device weighs 27g with dimensions of 3.8cm x 3.7cm x 1.8cm. 7. willing to consent to a period of direct observation for a length of time not exceeding three hours. exclusion criteria: 1. unable to provide informed written consent themselves 2. unwilling to consent to a period of observation not exceeding three hours. 3. unable to make an informed decision about participation or demonstrating an inability to interpret information or follow study instructions 4. significant neurological or coordination impairment 5. unable to speak or understand english. 6. clostridium difficile/ similar infection or unmanaged urinary incontinence. 7. evidence/ diagnosis of peripheral vascular disease. 8. lower limb amputation 9. polytrauma which prevents the adoption or normal lying, sitting or standing postures, or placement of the accelerometers

Keywords: accelerometry validity
outcome of patients treated with rrt

Conditions: Acute Kidney Injury; Cardiac Surgery

Summary: acute kidney injury (aki) is a common serious complication after cardiac surgery. aki not only prolongs the hospitalization time of patients undergoing cardiac surgery and increases the cost of treatment, but also is an independent risk factor for postoperative death. the aim of this study is to investigate the outcome of patients treated with renal replacement therapy (rrt), and to evaluate the short-term and long-term outcomes of patients with rrt.


Eligibility criteria:
inclusion criteria: * critically ill patients undergoing cardiovascular surgery admitted to intensive care units. * patients receiving rrt for renal support * patients over 18 years of age exclusion criteria: * patients \<18 years * refusal of consent