Kornimate/medical-research-clean huggingface dataset:
study evaluating the effects of dvs sr and duloxetine on the pharmacokinetics of desipramine in healthy subjects

Conditions: Depression; Depressive Disorder; Depressive Disorder, Major

Summary: the purpose of this study is to evaluate the effects of multiple doses of dvs sr and duloxetine on the pharmacokinetics of a single dose of desipramine in healthy subjects.


Eligibility criteria:
1. healthy men and women between 18 to 55 years of age. 2. healthy as determined by the investigator on the basis of medical history and physical examination, laboratory test results, vital signs and a 12-lead electrocardiogram. 3. history of being a nonsmoker for a least 1 year.

Keywords: healthy
physical therapy components for maximum tkr outcome

Conditions: Knee Osteoarthritis; Knee Replacement

Summary: the overall goal of this study is to identify what physical therapy care components are associated with the best patient-reported functional outcome after total knee replacement (tkr) surgery. the investigators are specifically looking at outcomes at 6 and 12 months after surgery.


Eligibility criteria:
inclusion criteria: * are scheduled to undergo an elective, unilateral primary total knee replacement due to knee osteoarthritis * will receive outpatient pt from a participating physical therapist. * agree to record their exercise and activity for specific time points in the study. exclusion criteria: * total knee replacement scheduled for indications other than oa (e.g., fracture, malignancy, infection, or revision or prior implant) * the inability to obtain informed consent due to cognitive conditions. * non-english speakers as the materials used in this project have not yet been tested with non-english speakers * individuals who are not yet adults (infants, children, teenagers) * pregnant women * prisoners
edessy stem cell score (ess), endometrium, endometrioma

Conditions: Endometriosis, Ovarian

Summary: purpose of this study is to evaluate stem cell expression (sce) in endometriotic (e) and non endometriotic ovarian and endometrial tissues.

this study was conducted on 40 women at al-azhar university hospitals. they are divided into two equal groups, group 1 with ovarian endometrioma and group 2 with normal ovary. ovarian and endometrial samples were evaluated by hematoxlin \& eosin for histopathology (hp) and of oct-4 for immunohistochemistry (ih) for sce. evaluation of ih parameters revealed that the most important factors for evaluating sc were arranged as score ( edessy stem cell score=ess).

Eligibility criteria:
inclusion criteria: * 20 to 40 years and did not receive hormonal treatment for three month exclusion criteria: * diabetes mellitus, cardiovascular and kidney diseases, adenomyosis, uterine fibroid endometrial carcinoma and poly cystic ovary
laser speckle imaging during breast reconstruction

Conditions: Breast Cancer

Summary: around 3500 women a year have surgery to reconstruct a breast/s after cancer. breast reconstruction can have a positive impact on their lives, but unfortunately 3 or 4 in 10 women have problems with healing after their operation. this is distressing and often leads to more medical care or surgery. these problems are often caused by poor blood flow to the skin and deeper tissues used to reconstruct the breast. the investigators have developed a new device that does not touch the skin and provides immediate, continuous images of skin blood flow (the flow that surgeons cannot see). to test this device the investigators took images of blood flow during breast reconstruction surgery. the investigators found that imaging was good at showing where skin blood flow was poor and led to problems with healing and where flow was good and there were fewer problems after surgery (from minor problems, e.g. delayed healing; to major problems, e.g. loss of new breast). the investigators think this device can help surgeons choose healthy skin during breast reconstruction and so help more patients to heal without surgical problems. the investigators need to test the new imaging device in a large clinical trial to find out how effective it is at improving healing for women after breast reconstruction. before this, the investigators need to find out if such a trial is possible and acceptable to patients, theatre staff and surgeons. the investigators will recruit 60 women who are having breast surgery and will randomly choose 30 to have surgery without blood flow imaging and 30 to have surgery with blood flow imaging. the investigators will follow up the women whilst in hospital and for the following 6 months to record any problems. in particular the investigators need to find out how many patients will volunteer for the study and the study can collect all the information needed during the 6 months after surgery. the results from this study will be used to plan a much larger clinical trial that will test whether blood flow imaging is effective, improves patient recovery after surgery and provides good value for money for the nhs.


Eligibility criteria:
inclusion criteria: * female, aged 18 or over; * able and willing to provide informed consent; * scheduled for breast reconstruction by autologous free flap surgery (either immediately post-mastectomy or delayed). exclusion criteria: * unable to give written informed consent.
reliability and validity of outcome measures for pain in multiple sclerosis

Conditions: Pain

Summary: this project aims to provide values of test-retest reliability and insights from concurrent validity of outcome measures for pain in multiple sclerosis.

pain is one of the most annoying symptoms in multiple sclerosis (ms). however, it is underestimated albeit its high prevalence rate with 63%. it negatively affects health related quality of life, activity of daily living, mental health, social functioning, employment, sleep and life enjoyment. in literature, the prevalence of pain varies in the ms literature from 29% to 86%. this wide-range prevalence is the result of methodological differences and non-uniformity of the studied populations which makes pain unclear and underdiagnosed in multiple sclerosis.it is hypothesized that the consistency, severity and interference of pain have varying relationships between other factors such as depression, anxiety, sleep or fatigue. evaluating pain was done with various outcome measures resulting in inconclusive results. however, very few of the pain outcome measures are validated for ms population. thus, it cannot be advised yet whether they contain similar or complementary information. finally, the interference of pain on activities and participation level of the international classification of functioning, disability and health (icf) is poorly documented. this project aims to put the foundations for future interventional research by providing values of test-retest reliability and insights from concurrent validity. as well, the perceived interference from pain on activities and participation level will be documented.

Eligibility criteria:
inclusion criteria: * age 18 and above, * ambulatory pwms with definite diagnosis based on mcdonald criteria * expanded disability status scale of 6.0 or below, * having pain in last month * able to understand and answer the questions in the questionnaires. exclusion criteria: * diagnosed with major musculoskeletal disorder and any neurological disorder other than ms, * a relapse in the last month before enrolment, * cognitive decline that renders the patient incapable of performing tests and questionnaires, * patients with only headache

Keywords: pain, outcome measure, assessment, multiple sclerosis, reliability, validity
pain relief in laparoscopic surgery

Conditions: Pain, Postoperative; Surgery

Summary: pain relief after laparoscopic surgery with the use of an altered gas.

pain after laparoscopic surgery remains an important concern in the treatment of endometriosis or other gynaecologic laparoscopic surgery. several trials have demonstrated that the use of an altered insufflation gas (10 % nitrous oxide + 4% oxygen + 86% carbon dioxide) reduces pain. it also decreases inflammation and adhesion formation as a surplus. with this mono-center, investigator initiated, double-blinded, randomized controlled superiority trial, the investigators want to demonstrate a reduced postoperative pain and peritoneal inflammatory reaction following peritoneal conditioning with an altered insufflation gas compared to the standard carbon dioxide (100% co2) insufflation gas. therefore, women undergoing laparoscopic (gynaecological) surgery with an estimated surgical time of \>60 minutes will be asked to participate in this trial. baseline characteristics will be assessed, including the patients' age, body mass index, medial history, american society of anesthesiologist classification (asa classification), work status, highest level of education, fear for the surgical procedure (using an 8-item surgical fear questionnaire), pre-operative pain (using a numerical rating scale (nrs) were 0= no pain and 10= worst pain imaginable) both in resting position and in an active position), expected pain (nrs), baseline quality of recovery (qor) (using the 1-item global surgical recovery (gsr) index (3) and the functional recovery index (fri) (4)) as well as baseline quality of life (qol), using the 5-dimensional european quality of life (eq-5d) questionnaire.

Eligibility criteria:
inclusion criteria: * woman ≥ 18 years old * undergoing laparoscopic surgery for endometriosis, uterine myoma's, hysterectomy or colpopexy. exclusion criteria: * women \< 18 years old * males * pregnancy * conditions associated with chronic pain, such as peripheral neuropathy, pathology of the vertebral column and osteo-articular disease. * conditions causing acute pain e.g. abdominal trauma

Keywords: post-operative pain recovery laparoscopy nitrous oxide
a ddi study to assess the effect of inc280 on the pk of midazolam and caffeine in patients with cmet-dysregulated advanced solid tumors

Conditions: cMET-dysregulated Advanced Solid Tumors

Summary: drg-drug interaction (ddi) study to assess the effect of inc280 on the pharmacokinetics of midazolam and caffeine in patients with cmet-dysregulated advanced solid tumors


Eligibility criteria:
inclusion criteria: patients must have: * advanced solid tumors and have confirmed cmet dysregulation * at least one measurable lesion as defined by recist 1.1. * recovered from all toxicities related to prior anti-cancer therapies * adequate organ function * ecog performance status (ps) of 0 or 1 exclusion criteria: patients must not have: * known hypersensitivity to any of the excipients of inc280 or to benzodiazepines or known intolerance and hypersensitivity to caffeine * symptomatic central nervous system (cns) metastases who are neurologically unstable * presence or history of carcinomatous meningitis * history of another primary malignancy that is currently clinically significant or currently requires active intervention * clinically significant, uncontrolled heart diseases, including qtcf ≥ 450 ms (male patients), ≥ 460 ms (female patients) on the screening ecg * thoracic radiotherapy to lung fields ≤ 4 weeks prior to starting inc280 * major surgery within 4 weeks prior to starting inc280 * patients receiving unstable or increasing doses of corticosteroids. * impairment of gi function or gi disease that may significantly alter the absorption of inc280 * patients who have received or consumed, or are expected to receive or consume midazolam or caffeine-containing products (e.g., tea, coffee, cola), within 2 days prior to day 1 and during the whole duration of the ddi phase (i.e., from day -2 to day 12) other protocol-defined inclusion/exclusion criteria may apply

Keywords: cmet, inc280, caffeine, midazolam
a study to evaluate the efficacy and safety of asp5094 in patients with rheumatoid arthritis on methotrexate

Conditions: Rheumatoid Arthritis (RA)

Summary: the objective of this study is to evaluate the efficacy, safety and pharmacokinetics of asp5094 in patients with rheumatoid arthritis (ra) treated with background methotrexate (mtx).

the study drug will be intravenously administered.

Eligibility criteria:
inclusion criteria: * subject has ra diagnosed according to the 1987 american college of rheumatology (acr) criteria or the 2010 acr/european league against rheumatism (eular) criteria at least 6 months prior to screening. * subject meets the 1991 acr revised criteria for the classification of global functional status in ra class i, ii, or iii at screening. * at screening and baseline, subject has active ra as evidenced by both of the following: * ≥ 6 tender/painful joints (using 68-joint assessment) * ≥ 6 swollen joints (using 66-joint assessment) * subject meets the criterion for a crp level (latex agglutination method) at screening. * subject who has continuously received methotrexate for at least 90 days prior to screening and who is able to continue a stable dose of methotrexate from at least 28 days prior to screening throughout the study period. exclusion criteria: * subject has deviated from the criteria for previous and concomitant treatment before baseline. * subject has an ongoing infection requiring antibiotics. * subject is determined to be an inadequate responder to a prior biologic disease modifying antirheumatic drugs (dmards) or janus kinase (jak) inhibitors. * subject has participated in previous asp5094 clinical trial. * subject has participated in a clinical trial or post-marketing clinical study of another ethical drug or medical device within 12 weeks (84 days). * subject has another inflammatory arthritis than ra, or any other articular symptom which may affect on joint assessment. * subject meets any of the criteria for laboratory values at screening. * subject has a positive t-spot or quantiferon gold test within 90 days prior to screening or at screening. * subject has a history of or concurrent malignant tumor. * subject has autoimmune disease except for ra or any severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, neurological, or mental illness. * subject has a history of clinically significant allergy. * subject has clinically significant abnormalities on 12-lead electrocardiogram (ecg) at screening. * subject has a history of human immunodeficiency virus (hiv) infection. * subject had surgery within 30 days prior to screening or has a planned elective surgery. * subject has a wound that is currently healing at baseline.

Keywords: methotrexate arthritis, rheumatoid asp5094
non-interventional study of copd patients with asthma overlap syndrome in viet nam and taiwan

Conditions: Patients With Asthma-COPD Overlap Syndrome (ACOS)

Summary: the purpose of this study to determine the proportion and clinical characteristics of copd patients with asthma symptoms (acos) and describe current practices in diagnosis and management in viet nam and taiwan.

chronic obstructive pulmonary disease (copd) is a major cause of chronic morbidity and mortality. around 15% to 20% of copd patients would present with features of asthma and are considered to have the overlap syndrome of copd and asthma, commonly called asthma-copd overlap syndrome (acos). in asia, specifically taiwan, the overall prevalence of acos in patients with copd is approximately 17.4%. copd patients with asthma symptoms represent a relevant clinical population because they have worse health-related quality of life. given the increased morbidity among copd patients with asthma overlap, it is critical that these patients are properly characterized to aid the appropriate diagnosis and treatment. the global initiative for asthma (gina) and global initiative for chronic obstructive lung disease (gold) guidelines have given joint recommendations on the identification, diagnosis and treatment of these patients. these recommendations have been adapted for use in the asia area countries. the primary objective of this study is to determine the proportion and clinical characteristics of patients with acos as defined by the joint gina and gold recommendation amongst diagnosed copd patients seen at the out-patient clinics. this study is planned to determine the proportion of patients with acos as defined by the joint gina and gold recommendation amongst diagnosed copd patients seen at the out-patient clinics

Eligibility criteria:
inclusion criteria: * all patients with confirmed diagnosis of copd {post-bronchodilator fev1/fvc\<0.7 (fev1 - forced expiratory volume at one second, fvc - forced vital capacity) based on the medical records} * aged \>40 years old at time of diagnosis * seen at out-patient clinic exclusion criteria: * patients currently with acute exacerbation of copd by gold definition (any worsening of a patient's respiratory symptoms that is beyond normal day-to-day variations and requires a change in medication) * patients with respiratory diseases that can show similar symptoms to chronic airway diseases such as bronchiectasis, tuberculosis (tb)-destroyed lung parenchyma, endobronchial tb, and lung cancer, or those who have history of these diseases based on physician's judgment * patients currently diagnosed with pneumonia and acute bronchitis * patients currently randomized in other clinical studies

Keywords: copd, asthma, acos
a phase i study to evaluate the safety,tolerability, pharmacokinetics, and efficacy of yl211 in patients with advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: this is a multicenter, open-label, phase 1 study. the study will enroll subjects with advanced solid tumors. it consists of three parts. part 1 is dose-escalation part. in part 1, the safety and tolerability of yl211 in patients with selected advanced solid tumors will be evaluated and the mtd and red will be determined. part 2 is backfill enrollment part. we will further estimate the safety and efficacy of yl211 in patients with selected adcance tumor to select the red(s) of yl211. part 3 is dose-expansion part. in this part, we will further evaluate the safety and efficacy of yl211 at the mtd/red(s) in patients with selected advanced solid tumors yl211 will be administered intravenously (iv) until criteria of treatment discontinuation are met.


Eligibility criteria:
inclusion criteria: 1. informed of the trial before the start of the trial and voluntarily sign their name and date on the icf. 2. aged ≥18 years. 3. be able and willing to comply with protocol visits and procedures. 4. history of an advanced solid tumors who failed currently available standard therapies and are not amenable to surgical resection, or for whom no available standard therapy or no other approved therapeutic options that have demonstrated clinical benefit. 5. eastern cooperative oncology group performance status (ecog ps) of 0 or 1. 6. adequate organ and bone marrow function. 7. have at least 1 extracranial measurable tumor lesion according to response evaluation criteria in solid tumors (recist) version 1.1. exclusion criteria: 1. inadequate washout period for prior anticancer treatment before the first dose of study drug. 2. uncontrolled or clinically significant cardiovascular and cerebrovascular diseases. 3. clinically significant concomitant pulmonary disease. 4. uncontrolled infection that requires systemic therapy within 2 weeks before the first dose. 5. unresolved toxicities from previous anticancer therapy. 6. a history of severe hypersensitivity reactions to the drug substances, inactive ingredients in the drug product, or other monoclonal antibodies.
mobile chat messaging for smoking relapse prevention

Conditions: Smoking Cessation

Summary: most smokers return to smoking (relapse) after making a quit attempt, but evidence of effective intervention to prevent relapse is scarce. taking advantage of recent advances in mobile technologies, this study aims to evaluate the effectiveness of a mobile chat messaging-based relapse prevention intervention in promoting successful quitting in people who recently quit smoking (recent abstainers) using a randomised controlled trial design.

most smokers who made quit attempts and achieved short-term abstinence return to smoking (relapse) over time, even when aided by effective smoking cessation treatment. since relapse mostly occurred in the first 4 weeks of abstinence, relapse prevention in the early phase of abstinence could potentially boost long-term abstinence. several behavioural interventions for smoking relapse prevention have been proposed and tested in rcts. yet, a 2019 cochrane review did not find traditional approaches, including self-help materials, telephone counselling and group therapy, effective in increasing long-term abstinence at 6 months or longer. the widespread use of mobile devices has provided a highly accessible and scalable means for novel behavioural interventions for smoking cessation. a formative qualitative study in current smokers conducted by the investigators showed that mobile chat messaging is a feasible and acceptable platform for delivering smoking cessation support. a subsequent cluster randomised controlled trial on 1148 smokers found that mobile chat messaging combined with brief intervention was effective in increasing biochemically validated abstinence at 6 months. nonetheless, whether mobile chat messaging could prevent relapse in recent abstainers has remained untested. the investigators did a pilot trial to confirm the feasibility and acceptability of mobile chat messaging for relapse prevention in recent abstainers. this study aims to evaluate the effectiveness of mobile chat messaging relapse prevention intervention in promoting abstinence in recent abstainers.

Eligibility criteria:
inclusion criteria: * hong kong residents aged 18 years or above * own a smartphone with whatsapp installed * enrolled in a smoking cessation program under tung wah group of hospitals integrated centre on smoking cessation * smoked daily before the present quit attempt * abstained from smoking for 3 to 30 days exclusion criteria: * diagnosed with a mental disease or on regular psychotropic drugs * participating in other ongoing smoking cessation studies

Keywords: relapse prevention recurrence mhealth instant messaging whatsapp chatbot conversational agent chinese
outcomes and prognostic factors in hepatopancreatoduodenectomy

Conditions: Hepatopancreaticobiliary (HPB) Malignancy; Gall Bladder Cancer; Bile Duct Cancer; Pancreatoduodenectomy; Hepatectomy

Summary: 1. in biliary tract malignancies, achieving a microscopically clear resection margin (r0) is considered the only treatment for a cure. 2. hepatopancreatoduodenectomy(hpd) has been considered a surgical option for patients with extensive bile duct or gallbladder cancer to achieve an r0 resection. 3. the associated high morbidity and mortality rates have prevented hpd from becoming a standard surgical procedure worldwide. 4. over the past few decades, the understanding of the bile duct anatomy has significantly improved, and many methods have been developed to assess liver function and future remnant liver volume. 5. we aimed to evaluate the short- and long-term outcomes of hpd and to assess risk factors associated with survival, early recurrence, and major complications to better evaluate the potential of the procedure as a standard treatment.


Eligibility criteria:
inclusion criteria: * patients who received hepatopancreatoduodenectomy between january 2000 and december 2023. exclusion criteria: * patients who had r2 resection

Keywords: hepatopancreatoduodenectomy