Kornimate/medical-research-clean huggingface dataset:
sentinel lymph node procedure in testicular germ cell tumour

Conditions: Testicular Germ Cell Tumor

Summary: assessment of accuracy of sentinel node biopsy, defined as the false negative rate.

current practice in patients with clinical stage i (cs i) testicular germ cell tumour is active surveillance after orchiectomy, with relapses occurring in 15-20% of patients. the majority of relapses occur in the lymph nodes as lymphogenic spread is the dominant route of dissemination. a sentinel node procedure, in which the sentinel lymph node is resected and pathologically examined, could be more reliable to identify patients who are likely to relapse. early identification of patients with micro-metastases in the sentinel node makes it possible to treat these patients at the earliest possible moment. absence of metastases could lead in the future to a less intensive follow up protocol than the present one.

Eligibility criteria:
inclusion criteria: * patients suspected of testicular germ cell tumour, based on physical examination, ultrasound imaging, and tumour markers * patients 18 years and older * no evidence of metastases on first staging (thoraco-abdominopelvic ct) * written and signed informed consent exclusion criteria: * patients with evidence of metastases at first staging * patients with a second primary tumour * patients with recent (\< 6 months before diagnosis) surgical treatment to the external genitals or recent surgical intervention in the inguinal or retroperitoneal regions * patients with previous abdominal surgery, necessitating open surgical approach for the sentinel node biopsy
intermittent theta burst stimulation of the precuneus

Conditions: Schizophrenia

Summary: the purpose of the study is to compare the effectiveness of stimulation of the left precuneus by intermittent theta burst stimulation to placebo stimulation on the severity of schizophrenia symptoms.

this is an interventional, prospective, randomized, double-blind, multicenter study, comparing itbs treatment (experimental group) of the precuneus to placebo stimulation (control group) of patients suffering from resistant schizophrenia and having been exposed to childhood trauma. the study population will be patients aged 18 to 40 years old exposed to childhood trauma, presenting with schizophrenia resistant to antipsychotic treatments. this study will be implemented in 4 investigative centers. each patient will participate for a period of 3 months.

Eligibility criteria:
inclusion criteria: * right-handed patient aged 18 to 40 years inclusive; * patient presenting schizophrenia as defined in the diagnostic and statistical manual-5; * patient under antipsychotic treatment in accordance with the recommendations of the high authority of health, at a stable dosage and without modification of psychotherapeutic treatment for at least 4 weeks; * patient on mono or dual antipsychotic therapy. * patient presenting residual symptoms, i.e. absence of remission defined by the criteria of the "remission criteria of the schizophrenia working group consensus"; * patient having been exposed to at least one type of trauma in childhood and having a score higher than the threshold values of the childhood trauma questionnaire: emotional neglect, physical abuse, emotional abuse, physical neglect, sexual abuse; * patient having signed an informed consent form to participate in the study. exclusion criteria: * patient with a contraindication to magnetic resonance imaging or intermittent theta burst stimulation (presence of a metallic body, pacemaker, implantable defibrillator or other implantable metallic device, epilepsy, stroke or recent head trauma); * patient who is not french-speaking or cannot read and write; * patient under guardianship; * patient in forced care (psychiatric care upon decision of the state representative and psychiatric care at the request of a third party); * pregnant woman or likely to be pregnant (of childbearing age) without effective contraception or breastfeeding; * patient participating in another clinical trial, or during a period of exclusion from another clinical trial; * patient who is not a beneficiary of a social security system. * patient who, according to the assessment of the investigator, risks not being compliant or diligent in the study procedures.
processed residual pump blood in cardiac surgery: the prbc trial

Conditions: Cardiopulmonary Bypass; Hemorrhage; Surgery

Summary: the study is an randomized controlled trial (rct) of 198 coronary artery bypass graft (cabg) patients, exploring whether ultrafiltration of residual blood in the cardiopulmonary bypass circuit reduces transfusion and bleeding.

blood products are a limited resource and cardiac surgery is a high consumer. processing residual cardiopulmonary bypass (cpb) volume via ultrafiltration may improve hemostasis and reduce transfusion through clearing activated complement, activated coagulation components, and proinflammatory cytokines. unlike cell saver technology, ultrafiltration has the advantage of maintaining plasma proteins, platelets, and coagulation factors. we sought to establish if the processing of residual cpb volume with ultrafiltration reduces homologous blood transfusion and bleeding.

Eligibility criteria:
inclusion criteria: * at least 18 years of age * were to undergo isolated on-pump cabg * were able to give informed consent exclusion criteria: * performed autologous blood donation * underwent off-pump cabg * emergency procedure * resternotomy * known bleeding disorder not drug related * history of heparin-induced thrombocytopenia * jehovah's witness * intra-operative catastrophe prior to randomization

Keywords: cardiopulmonary bypass hemorrhage trials surgery
safety and efficacy study to compare smoflipid and intralipid 20% in pediatric patients of 3 months to 16 years of age

Conditions: Malnutrition, Child

Summary: evaluate the safety and efficacy of smoflipid compared to standard of care lipid emulsion intralipid 20% administered via a central vein in pediatric patients 3 months to 16 years of age who require parenteral nutrition for at least 90 days and up to 1 year.


Eligibility criteria:
inclusion criteria: 1. male and female patients 3 months to 16 years of age. 2. patients who require pn for at least 5 days/week. 3. patients who receive 60% or more of their total energy requirements as pn at enrollment and who are expected to receive 60% or more of their total energy requirements as pn for at least 90 days. 4. written informed consent from parent(s) or legal representative(s). if possible, patient assent must also be obtained (according to local law). exclusion criteria: 1. known hypersensitivity to fish, egg, soybean, or peanut proteins, or to any of the active ingredients or excipients of smoflipid or intralipid 20%. 2. hyperlipidemia or disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglyceride concentration \> 250 mg/dl). 3. inborn errors of amino acid metabolism. 4. cardiopulmonary instability (including pulmonary edema, cardiac insufficiency, myocardial infarction, acidosis and hemodynamic instability requiring significant vasopressor support). 5. hemophagocytic syndrome. 6. liver enzymes (either ast, or alt, or ggt) exceeding 5 x upper limit of normal range 7. direct bilirubin ≥ 2.0 mg/dl 8. inr \> 2. 9. any known hepatic condition outside of intestinal failure-associated liver disease (ifald) that will increase direct bilirubin ≥ 2.0 mg/dl. 10. clinically significant abnormal levels of any serum electrolyte (sodium, potassium, magnesium, calcium, chloride, phosphate). 11. active bloodstream infection demonstrated by positive blood culture at screening. 12. severe renal failure including patients on renal replacement therapy. 13. abnormal blood ph, oxygen saturation, or carbon dioxide. 14. pregnancy or lactation. 15. participation in another clinical study. 16. unlikely to survive longer than 90 days.

Keywords: parenteral nutrition pediatrics malnutrition nutritional needs
a study to evaluate similarity of abp 206 compared with opdivo® (nivolumab) in subjects with resected melanoma

Conditions: Melanoma

Summary: the purpose of this study is to investigate the pharmacokinetic (pk) similarity and efficacy, safety, and immunogenicity of abp 206 compared with opdivo® (nivolumab) in subjects with resected advanced melanoma.

eligible subjects will be randomized in a 1:1:1 ratio to receive either abp 206, food and drug administration (fda)-licensed nivolumab, or european union (eu)-authorized nivolumab. the treatment period is in alignment with the maximum treatment duration for opdivo® (nivolumab, reference product) in the adjuvant setting for melanoma. all subjects will be treated until recurrence of disease, unacceptable toxicity, or subject withdrawal of consent with a maximum of 1 year of treatment. the total duration of study participation for each subject will be approximately 13 months.

Eligibility criteria:
inclusion criteria: * at least 18 years of age * completely removed melanoma by surgery performed within 12 weeks of randomization * advanced melanoma * tumor tissue from the resected site of the disease must be available for biomarker analyses in order to be randomized * subject has an eastern cooperative oncology group (ecog) performance status score of 0 or 1 exclusion criteria: * previous anti-cancer treatment * known hypersensitivity to monoclonal antibodies or to any of the excipients of the study drug * ocular or uveal melanoma or history of carcinomatosis meningitis * history of auto-immune disease * subject has medical conditions requiring systemic immunosuppression with either corticosteroids or other immunosuppressive medications within 14 days of the first dose of the investigational product other protocol-defined inclusion/exclusion criteria apply

Keywords: pharmacokinetic similarity study adjuvant melanoma treatment advanced melanoma
performance of a single-use intermittent micro-hole zone catheter

Conditions: Urinary Incontinence; Retention, Urinary

Summary: the goal of this randomized, controlled crossover study was to assess the performance of a new micro-hole zone catheter compared to a conventional 2-eyelet catheter in 42 male intermittent catheter users. the main objective of this study was to demonstrate superiority of the micro-hole zone catheter in terms of number of flow-stop episodes and residual volume at first flow-stop, with the catheterization performed by a health care professional in a hospital setting compared to a conventional two-eyelet catheter.

the investigation was a single-centre, randomized, controlled crossover study including 42 male participants comparing the performance of two intermittent catheters (ic). the study included an information visit (visit 0) and two test visits (visit 1 and 2) in which one catheterization with either the investigational device or the comparator device, according to a randomization scheme, was performed by a health care professional in a hospital setting assessing flow stop episodes, bladder emptying and hematuria. there were 4-14 days between each test visit (visit 1 and 2) and visit 0 and 1 could be held on the same day.

Eligibility criteria:
inclusion criteria: 1. is male 2. is at least 18 years of age and has full legal capacity 3. has given written informed consent 4. has signed letter of authority (only dk) 5. has used clean intermittent catheterisation ch12 or ch14 for at least one month 6. use intermittent catheterisation as the primary bladder emptying method 7. is able (assessed by investigator) and willing to follow study procedures exclusion criteria: 1. is participating in any other clinical study during this investigation 2. has previous participated in this study 3. has symptoms of urinary tract infection as judged by the investigator 4 is an individual with history, suspected or showing signs of producing urine with excessive amount of mucus or large/clustered sediments or debris 5. has any known allergies towards ingredients in the investigational device
exercise and branched chain amino acids (bcaa)requirements in older men

Conditions: Sarcopenia

Summary: likely, branched chain amino acid (bcaa) requirements are increased in older strength-trained (st) individuals. if so, supplementation in this group will maximize muscle protein synthesis (mps) and minimize loss of muscle with age (sarcopenia).

we hypothesize that the dietary requirement for the branched chain amino acids (bcaa) in an older strength-trained (st) population will be greater than the current recommendation (rda). if so, a greater intake of bcaa together with st is necessary if one aims to maximize muscle protein synthesis (mps). currently, the bcaa requirement in the st older population (55-65 y) is unknown. this is critical information especially given the value of st for overall health.

Eligibility criteria:
inclusion criteria: * recreationally active (\~2-3 h/wk of physical activity) healthy older men (55-65 y) * a minimum of 4 month weight training experience exclusion criteria: * have symptoms or take medication for respiratory disease * have symptoms or take medication for cardiovascular disease * have symptoms or take medication for metabolic disease * have symptoms or take mediation for neuromuscular disease * use heart rate or blood pressure medications * use any medications with side effects of dizziness, lack of motor control, or slowed reaction time * have an excessive alcohol intake (more than 2 drinks per day) * have any cardiovascular or neuromuscular limitations to exercise * are allergic to milk or milk products * use anabolic steroids or performance enhancing drugs

Keywords: branched chain amino acid requirement older men strength training sarcopenia
health opportunities and promoters of equitable screening for lung cancer

Conditions: Lung Cancer; Smoking Behaviors; Diagnosis

Summary: the goal of this clinical trial is to promote lung cancer screening (lcs) uptake among hispanic current and former smokers. the main questions it aims to answer are: * what barriers do current and former hispanic smokers face in the identification and documentation of their smoking status? * how can digital delivery of an educational video promote lcs uptake among current and former hispanic smokers? participants will receive an educational video about lung cancer screening and complete brief, self-reported surveys afterwards.

lung cancer remains the leading cause of cancer-specific mortality in the us, and hispanics experience worse lung cancer outcomes and die at higher rates due to advanced stage at presentation. lung cancer screening (lcs) can save many lives through early lung cancer detection among hispanic current and former smokers. still, without increasing efforts to improve smoking status disclosure and documentation and tailored interventions to promote lcs uptake among hispanic current and former smokers, this underserved population will continue to demonstrate disparities in lung cancer survival. based on prior research experience, dr. flores has adapted the nimhd research framework by incorporating elements from ford's evidence-based theoretical model to guide the following proposed study aims: 1) to elucidate barriers and facilitators to consistent identification and documentation of smoking status to promote lcs uptake among hispanic current and former smokers; 2) to assess feasibility, acceptability, and reach of the digital delivery of an educational video to promote lcs uptake among hispanic current and former smokers; 3) to explore the effect of the digital delivery of the educational video to increase interest, intent, and scheduling of lcs uptake among hispanic current and former smokers. impact: the successful completion of this research will serve as a foundation for developing novel interventions to overcome disparities and advance equity in lung cancer outcomes among hispanics and other vulnerable populations.

Eligibility criteria:
inclusion criteria: * must be 50-80 years old * are a current or former smoker (quit within 15 years, or a cumulative smoking status of \> 20 pack-years) * not currently enrolled in lung cancer screening * must speak english or spanish exclusion criteria: * has a clinical cognitive inability to provide informed consent for participation in the study or complete a brief survey * currently diagnosed with lung cancer * currently enrolled in lung cancer screening * have participated in the focus groups discussions from aim 1

Keywords: lung cancer screening hispanic outreach educational intervention digital health smoking documentation smoking history health equity
effects of neoadjuvant therapy with carboplatin, paclitaxel combined with anti-pd-1 drugs on pain, anxiety and depression in patients with resectable head and neck squamous cell carcinoma

Conditions: Head and Neck Squamous Cell Carcinoma

Summary: the goal of this observational study is to learn about the effects of neoadjuvant therapy with carboplatin, paclitaxel combined with anti-pd-1 drugs on pain, anxiety and depression in patients with operable head and neck squamous cell carcinoma: a prospective cohort study


Eligibility criteria:
inclusion criteria: - 1: clinical diagnosis of head and neck squamous cell carcinoma (stage i-iva), without prior treatment, and planning to undergo either surgical treatment alone or surgical treatment combined with chemotherapy and immunotherapy. 2: ability to speak chinese and possess basic reading and writing skills. exclusion criteria: * 1: presence of mental illnesses such as dementia or delirium. 2: active use of narcotic drugs, including consuming alcohol more than 4 times per day or more than 4 times per week. 3: patients who alter their treatment plan during the course of treatment. 4: current or prior use of antidepressants.
pharmacokinetic study of 4 mg nicotine lozenge.

Conditions: Smoking Cessation

Summary: this is a randomized, single center, open label, single dose, four way crossover study in fasted healthy male subjects to compare the pharmacokinetics of nicotine following administration of 3 prototype 4mg nicotine lozenge to an internationally marketed 4mg nicotine lozenge. blood samples will be drawn at pre-specified intervals for a total of 12 hours post dose in each treatment session and plasma samples analyzed for nicotine levels.


Eligibility criteria:
inclusion criteria: - smoked commercially-manufactured cigarettes daily for the preceding 12 months and routinely smokes first cigarette within 30mins of awakening. exclusion criteria: * inability to refrain from smoking during confinement period, smoking tobacco in any other form other than commercially manufactured cigarettes, subject has used chewing tobacco or other tobacco products other than commercially manufactured cigarettes within 7 days of dosing
a phase 3 study of amifampridine phosphate in patients with lambert eaton myasthenic syndrome (lems)

Conditions: Lambert Eaton Myasthenic Syndrome

Summary: a phase 3 study to evaluate the efficacy and safety of amifampridine phosphate in patients with lambert-eaton myasthenic syndrome (lems).

this multicenter, double-blind, placebo-controlled, randomized (1:1) discontinuation study is a 4-part study designed to evaluate the efficacy and safety of multiple dose administration of amifampridine phosphate in patients with lems. data from parts 2 and 3 (the double-blind parts of the study) are presented in this record.

Eligibility criteria:
inclusion criteria: individuals eligible to participate in this study must meet all of the following inclusion criteria: * ≥18 years of age * confirmed diagnosis of lems * normal respiratory function * normal swallowing function * if receiving peripherally acting cholinesterase inhibitors a stable dose is required for at least 7 days prior to screening. * if receiving oral immunosuppressants a stable dose is required for at least 90 days prior to screening. * negative pregnancy test for females of childbearing potential * if sexually active, willing to use 2 acceptable methods of contraception * willing to perform all study procedures as physically possible. * willing and able to provide written informed consent after the nature of the study has been explained and prior to the start of any research-related procedures. exclusion criteria: individuals who meet any of the following exclusion criteria are not eligible to participate in the study: * history of epilepsy or seizure. * known active brain metastasis. * use of fampridine (4-aminopyridine), and any form of 3,4-diaminopyridine other than the ip provided, such as amifampridine base or firdapse, during the study. * use of medications known to lower the epileptic threshold within 7 days or 5 half-lives. * use of medications which inhibit neuromuscular junction function within 7 days or 5 half-lives. * use of ivig, plasmapheresis (plasma exchange), or immunoadsorption within 90 days * use of guanidine hydrochloride within 7 days * use of rituximab within 12 months * history of drug allergy to any pyridine-containing substances or any amifampridine phosphate excipient(s). * use of any other investigational productwithin 30 days * treatment with a concomitant medication that prolongs the qt/qtc interval within 7 days or 5 half-lives. * treatment with sultopride (4-amino-n-\[(1-ethylpyrrolidin-2-yl)methyl\]-5-ethylsulfonyl-2-methoxybenzamide) within 7 days. * an abnormal electrocardiogram (ecg). * documented history of arrhythmias. * history of additional risk factors for torsade de pointes. * breastfeeding or pregnant or planning to become pregnant (self or partner) at any time during the study. * likely or expected to require treatment for cancer within 3 months (90 days) after entering. * history of severe renal impairment or evidence of severe renal impairment * any condition that places the patient at high risk of poor treatment compliance or of not completing the study. * history of uncontrolled asthma.
effect of intraperitoneal and intravenous lignocaine on pain relief following laparoscopic cholecystectomy

Conditions: Pain, Postoperative; Analgesic Requirement; Stress Response; Return of Bowel Activity; Inadequate or Impaired Respiratory Function

Summary: laparoscopic cholecystectomy is the treatment of choice for patients with symptomatic gall stones. for pain relief following laparoscopic cholecystectomy both intraperitoneal and intravenous administration of lignocaine has been used. but it is not clear from the existing literature which form of administration is more effective for pain relief. hence this study has been undertaken with the following hypothesis : intravenous lignocaine is superior to intraperitoneal lignocaine for postoperative pain relief and minimizing the stress response in laparoscopic cholecystectomy.

laparoscopic cholecystectomy is the treatment of choice for patients with symptomatic gall stones. for pain relief following laparoscopic cholecystectomy both intraperitoneal and intravenous administration of lignocaine has been used. but it is not clear from the existing literature which form of administration is more effective for pain relief. hence this study has been undertaken with the following hypothesis : intravenous lignocaine is superior to intraperitoneal lignocaine for postoperative pain relief and minimizing the stress response in laparoscopic cholecystectomy. in this study the effect of intraperitoneal and intravenous lignocaine will be assessed based on the postoperative pain scores, total analgesic requirement, stress response in the form of total leukocyte count, c-reactive protein levels,return of bowel activity.

Eligibility criteria:
inclusion criteria: * patients planned for elective laparoscopic cholecystectomy in the age group of 20 -60 years belonging to american society of anesthesiologists (asa)score i-ii exclusion criteria: * chronic pain diseases other than gall stone disease. * use of opioids, steroids, non steroidal anti inflammatory drugs or alcohol. * allergy and contraindication to lignocaine. * conversion to open cholecystectomy. * patients who do not comprehend visual analogue scale (vas) / patient controlled analgesia (pca).

Keywords: lignocaine laparoscopic cholecystectomy pain relief