cyrilzakka/clinical-trials huggingface dataset:
Laparoscopic Gastrectomy With D2 Lymphadenectomy Combined With Hyperthermic Intraperitoneal Chemotherapy (HIPEC) or Not

The goal of this clinical trial is to learn about Hyperthermic Intraperitoneal Chemotherapy in the Treatment of Locally Advanced Gastric Cancer after Laparoscopic Gastrectomy with D2 Lymphadenectomy. The main question it aims to answer is: whether HIPEC can effectively improving the 5-year overall survival rate and decrease the peritoneal metastases rate of patients with advanced gastric cancer underwent Laparoscopic Gastrectomy with D2 Lymphadenectomy. Participants will be divided into two groups, Experimental group received laparoscopic (robotic) D2 surgery plus HIPEC2 times plus systemic chemotherapy 6\~8 cycles; and Control group received laparoscopic (robotic) D2 surgery plus systemic chemotherapy 6\~8 cycles.


Eligibility Criteria:
Inclusion Criteria:

(1) Newly treated patients who did not receive chemotherapy, radiotherapy or other antitumor therapy before the start of the clinical trial;(2) Aged 18-80 years;(3) male or non-pregnant or lactating female;(4) Gastric adenocarcinoma was pathologically confirmed, and laparoscopic (robotic) radical gastrectomy was planned;(5) Patients with T stage T3 or above, no distant metastasis, and feasible criteria for laparoscopic D2 radical resection (AJCC Eighth edition);(6) The estimated survival time is more than 6 months;(7) History of nonabdominal surgery (except laparoscopic cholecystectomy);(8) The bone marrow reserve function was good, and the blood routine met the following conditions: white blood cell count ≥3.5×109/L, neutrophil ≥1.5×109/L, platelet count ≥100×109/L, hemoglobin ≥90g/L;(9) Organ function was good, and biochemical examination met the following conditions: ALT≤2.5× upper limit of normal value (ULN), AST≤2.5×ULN, serum total bilirubin ≤1.5×ULN, serum creatinine ≤1.5×ULN;(10) Functional status: 0-1 (ECOG);(11) Preoperative ASA grade I-III;(12) Voluntarily sign the informed consent.

Exclusion Criteria:

(1) Lymph node BulkyN2 status was diagnosed by abdominal CT/MRI, that is, at least one lymph node meridian ≥3cm or three consecutive lymph nodes, each meridian ≥1.5cm;(2) pregnant or lactating women;(3) Other malignant tumors within 5 years;(4) Preoperative temperature ≥38℃ or complicated with infectious diseases requiring systematic treatment;(5) serious mental illness;(6) Severe respiratory diseases, FEV1\< 50%;(7) Severe liver and kidney dysfunction, liver enzyme elevation more than 2 times the normal value;(8) History of unstable angina pectoris or myocardial infarction within 6 months;(9) History of cerebral infarction or cerebral hemorrhage within 6 months, except old infarct;(10) Systemic glucocorticoid therapy within 1 month;(11) Patients with gastric cancer complications (bleeding, perforation, obstruction) requiring emergency surgery;(12) The patient has participated in or is currently participating in other clinical studies (within 6 months);(13) Laparoscopic exploration, biopsy and cytology confirmed intraperitoneal implantation and metastasis.
Triprilimab(JS001) and Chemotherapy Combined With Local Treatment for Multiple Metastatic NPC

This study is a randomized, phase II, prospective, multicenter clinical trial to evaluate the efficacy and tolerability of JS001 and chemotherapy combined with local treatment in patients with multiple metastatic nasopharyngeal carcinoma.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with multiple metastases at first diagnosis or multiple metastases after treatment(multiple metastases was defined as more than 5 lesions and/or more than 2 metastasis organs); Histologically or cytologically confirmed multiple metastatic NPC.
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 at trial entry, and life expectancy ≥6months as judged by the Investigator;
3. The disease must be measurable with at least 1 unidimensional measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1;
4. Adequate organ function;
5. Take adequate contraceptive measures throughout the study, and contraception continues until 12 months after treatment;
6. Able and willing to provide signed informed consent form, and able to comply with all procedures.
7. The time from the last chemotherapy and/or radiotherapy to randomization must be ≥6 months.

Exclusion Criteria:

1. Patients with a hypersensitivity to any of the drugs used in our study;
2. With any active autoimmune disease or history of autoimmune disease;
3. Clinically significant cardiovascular and cerebrovascular diseases;
4. Have or are suffering from other malignant tumors within 5 years (except non-melanoma skin cancer or pre-invasive cervical cancer);
5. Active systemic infection;
6. Drug or alcohol abuse;
7. No or limited capacity for civil conduct;
8. The patient has a physical or mental disorder, and the researcher considers that the patient is unable to fully or fully understand the possible complications of this study;
9. History of immunodeficiency including seropositive for human immunodeficiency virus (HIV), or other acquired or congenital immune-deficient disease, or any active systemic viral infection requiring therapy；
10. Use cortisol or other systematic immunosuppressive medications within 4 weeks before the study treatment, and subject requiring hormone therapy during trials.
11. Pregnancy or breast feeding.
CART-meso Long-term Follow-up

This is a non-therapeutic, long-term follow-up (LTFU) study of subjects who have received retroviral-based gene therapy products in cancer studies. All subjects in this LTFU protocol have received lentiviral modified T cells engineered to express an anti-mesothelin scFv Chimeric Antigen Receptor (CAR). This gene therapy product is called CART-meso. Lentiviruses are a subfamily of retroviruses. This protocol is designed in adherence with the November 2006 Food and Drug Administration (FDA) Guidance for Industry, "Monitoring for Delayed Adverse Events" and "Supplemental Guidance on Testing for Replication Competent Retrovirus in Retroviral Vector Based Gene Therapy Products and During Follow-up of Patients in Clinical Trials Using Retroviral Vectors " and involves up to 15 years of monitoring of subjects who have been exposed to retrovirus-mediated gene transfer. Subjects will undergo biannual visits for a blood test evaluating persistence of cells with retroviral vector sequences, chemistry, hematology and tumor markers (as applicable). On annual visits, subjects will further undergo a physical exam and medical history (including concomitant medications and adverse events) with careful attention to features possibly related to retrovirus-induced diseases


Eligibility Criteria:
Inclusion Criteria:

* Subjects will be enrolled into this destination protocol because they have received CART-meso cells that were genetically modified with a lentiviral vector. All subjects who have participated in a lentiviral vector study under IND #15882 and have received CART-meso cells will be asked to participate in this protocol.
* Subjects 18 years of age and older
* Subjects who have provided informed consent prior to their study participation.

Exclusion Criteria:

* None
Impact of Nurse-led Intervention on Asthma Control in Children

This randomized control trial design (RCT) study was conducted on children aged 6 -11 years

This randomized control trial design study was conducted on children aged 6 -11 years, visiting the pediatric outpatient department and emergency at Dr. Ruth Pfau Civil Hospital Karachi.

For the experimental group, a nursing educational intervention session was conducted with the patient and family/caregiver by the principal investigator, and a doctor provided the usual care/treatment. In contrast, the control group received only the usual care/treatment provided by the doctor.

For the control group, educational material on asthma was provided in a booklet according to Global Initiative of Asthma (GINA) guidelines. Pre Childhood-Asthma Control Test (C-ACT) score of participants was measured before the intervention, and post-C-ACT score measurement was made after one month using the same questionnaires and C-ACT tool.

Eligibility Criteria:
Inclusion Criteria:

* Children between the aged 6 to 11 years
* Have asthma diagnosed by a physician at least 6-month back
* Uncontrolled asthma based on C-ACT score 19 or less 19.

Exclusion Criteria:

* Chronic respiratory illnesses like T.B. cystitis and fibrosis.
* Sinusitis,
* Gastrointestinal reflux disease,
* Rhinitis
Development and Validation of a Large Language Model-based Myopia Assistant System

Myopia is a rapidly growing global health concern, and there is an urgent need for advanced tools that can facilitate personalized healthcare strategies. Artificial intelligence (AI)-based solutions, such as large language models, offer robust tools for ophthalmic healthcare. In this study, investigators aim to validate a patient-centered Large Language Model (LLM)-based Myopia Assistant System with the following key objectives: 1) evaluate the ability of the LLM models to generate high-level reports and help self-evaluation of myopia for patients in primary care; 2) evaluate its performance in answering evidence-based medicine-oriented questions and improving overall satisfaction within clinics for myopic patients.

Myopia is a rapidly growing global health concern particularly affecting children and adolescents. The progression of myopia can lead to severe complications such as myopic macular degeneration, significantly impacting visual acuity and quality of life. With the rising prevalence of myopia, there is an urgent need for advanced tools that can facilitate personalized healthcare strategies. Artificial intelligence (AI)-based solutions, such as large language models, offer robust tools for ophthalmic healthcare. Nevertheless, their effectiveness and safety in real clinical environments have not been fully explored.

In this study, investigators aim to validate a patient-centered Large Language Model (LLM)-based Myopia Assistant System with the following key objectives: 1) evaluate the ability of the LLM models to generate high-level reports and help self-evaluation of myopia for patients in primary care; 2) evaluate its performance in answering evidence-based medicine-oriented questions and improving overall satisfaction within clinics for myopic patients. The findings of this study will provide valuable insights for the application of the GPT model in the healthcare field, making a significant contribution to improving the accessibility and quality of medical services.

Eligibility Criteria:
Inclusion Criteria:

1. Outpatient participants aged 6 to 75.
2. Participants who undergo ophthalmic examinations for medical purposes.
3. Participants who can produce clear ophthalmic images in both eyes.
4. No prior experience in research involving digital medicine
5. Agree to participate in this study with written informed consent

Exclusion Criteria:

1. Participants who are reluctant to participate in this study
2. Participants who are unable to understand the study.
3. Participants who have recently undergone ocular surgery or those with severe ocular conditions that may affect the interpretation of imaging results related to myopia evaluation (e.g., severe vitreous hemorrhage, cataracts, corneal leukoma, etc.) will be excluded from the study.
4. Participants with poor quality of ophthalmic images, including blurriness, artifacts, underexposure, or overexposure.
5. Other unsuitable reasons determined by the evaluators.
Health-Related Quality of Life for Thyroid Patients

Background:

Thyroid diseases are frequent. They include both metabolic changes and gland enlargement (goitre). Previous research and clinical suspicion indicate that the life quality of many patients is reduced despite successful treatment. Research methods are, however, weak, and a well-tested, disease specific quality of life questionnaire is especially needed. Several treatment possibilities exist for each thyroid disease. For example, hypermetabolism can be treated with either medication, radioactive iodine or by surgery. No comparative studies of quality of life using the different treatment modalities exist.

Purpose:

To develop and evaluate a questionnaire to measure health-related quality of life in patients suffering from thyroid diseases.

Methods:

To ensure that all relevant aspects are included, the questionnaire will be developed on the basis of a systematic examination of the scientific literature and interviews with 13 physicians and 100 patients. The questionnaire will then be tested by 100 new patients. After revision, the questionnaire will be answered by 1000 patients with a view to scientifically investigate the measuring capacity of the questionnaire. This will be done using traditional psychology methods (psychometry) as well as modern statistical methods (structural equations for categorical data and "item response" models).

Relevance:

The above-mentioned questionnaire is necessary for clarifying whether these diseases reduce quality of life and, in the long-term, whether a difference in quality of life exists using the different treatment alternatives and whether treatment can be improved. It should also be included in quality protection studies, in the evaluation of new treatment modalities and possibly also in the treatment of the individual patient.


Eligibility Criteria:
Inclusion Criteria:

* All patients with benign thyroid disease.

Exclusion Criteria:

* Unable to complete questionnaire: must be able to read and write Danish
Outpatient Antibiotic Treatment for a Cystic Fibrosis Pulmonary Exacerbation

This study plans to learn more about the effect of oral antibiotics for an outpatient pulmonary exacerbation (respiratory illness) on sputum (mucus) bacterial infections, lung function, airway inflammation and quality of life. In this study subjects will perform pulmonary function tests, provide a sputum sample and complete a questionnaire at two separate clinic visits. If a subject is unable to cough up sputum in clinic he or she will be asked to breathe in a salt water solution to help cough up sputum. The first sputum sample will be obtained at the first visit (within 48 hours of starting antibiotics). Pulmonary function testing and the questionnaire will also be completed at this time. Subjects will complete a two week course of oral antibiotics at home. During these two weeks subjects will be asked to write down the times antibiotics are taken and airway clearance (vest treatment) is performed. Within one week of completing the antibiotic course subjects will return to clinic for a second visit. At that time a sputum sample will be obtained again and if subjects are unable to cough up sputum they will again be asked to breathe in salt water solution to help cough up sputum. Pulmonary function testing and the questionnaire will also be completed at this second visit. Sputum samples will be tested for infections with bacteria and viruses. Sputum samples will also be used to measure markers of airway inflammation (swelling). The investigators hypothesize that the use of two weeks of oral antibiotics for the treatment of a pulmonary exacerbation will result in a decrease in the amount of bacteria measured in sputum. Additionally the investigators hypothesize that treatment with antibiotics will lead to an improvement in lung function, a decrease in airway inflammation and an improvement in quality of life measurements.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cystic fibrosis based on sweat chloride (≥60) or two known disease causing mutations.
* Age 8 - 18 years
* Starting treatment for an outpatient pulmonary exacerbation
* Willing to participate in study after informed consent and assent has been obtained.

Exclusion Criteria:

* Forced expiratory volume in 1 second (FEV1) less than 40%
* Patients receiving chronic daily oral antibiotics. Patients receiving azithromycin therapy three times a week will not be excluded as its use in this setting is felt to be anti-inflammatory.
* Previous reaction to inhalation of hypertonic saline. This is distinctly unusual in cystic fibrosis.
* Patients who have been treated with oral antibiotics on an outpatient basis within 2 weeks of the exacerbation.
* Patients who are being started simultaneously on inhaled and oral antibiotics. Patients who are routinely receiving inhaled antibiotics as part of their chronic management and continue inhaled antibiotics as previously scheduled will not be excluded.
Safety and Efficacy of Glumetinib Combined With Docetaxel for Injection (Albumin-bound) in Patients With Advanced Gastric Cancer/Gastroesophageal Junction Adenocarcinoma and Other Solid Tumors

The trial consists of Stage 1 (including dose escalation and dose expansion) and Stage 2 (proof-of-concept study). Among them, Stage 2 adopts a randomized, controlled, open-label, and multicenter design.


Eligibility Criteria:
Inclusion Criteria:

* 1. Patients who are able to understand and voluntarily sign the written ICF;
* 2. Male or female patients aged ≥ 18 years (inclusive);
* 3. Patients with advanced solid tumors diagnosed by pathology or cytology;
* 4. Patients with a past medical history showing either negative or positive Her-2 expression can be enrolled. For those with unknown Her-2 expression, the Her-2 status needs to be determined before enrollment. For patients with positive Her-2 expression, their previous treatments should include anti-Her-2 drug therapy.
* 5. Overexpression and/or amplification of MET in tumor tissue specimens/blood samples confirmed by the central laboratory.
* 6. There are measurable lesions or non-measurable but evaluable lesions according to RECIST v1.1.
* 7. The Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score is 0 or 1.
* 8. The expected survival time is ≥ 3 months.
* 9. The functions of major organs and bone marrow meet the criteria.

Exclusion Criteria:

* 1. Patients with prior treatment with targeted MET drugs;
* 2. Previous treatments included docetaxel;
* 3. Patients with meningeal metastases, spinal cord compression, symptomatic or progressive brain metastases are not eligible for enrollment.
* 4. Known hypersensitivity or intolerable conditions to any component of the drugs in the study protocol or their excipients.
* 5. According to NCI-CTCAE 5.0, adverse events caused by previous anti-tumor treatment have not recovered to ≤ Grade 1 (excluding toxicities such as Grade 2 alopecia which are judged by the investigator to pose no safety risk).
* 6. Any severe and/or uncontrolled co-existing diseases that may prevent the patient from participating in the study.
* 7. Female patients who are lactating or pregnant; Women of childbearing potential with a positive blood pregnancy test result within 7 days before trial enrollment. Lactating women can participate in this study if they stop breastfeeding, but they must not resume breastfeeding during and after the completion of the study treatment.
* 8. Any male or female patient of childbearing potential who refuses to use a highly effective contraceptive method throughout the trial period and within 6 months after the last administration.
* 9. Those who are unwilling or unable to comply with the study procedures and requirements, or those who, in the judgment of the investigator, are not suitable for participating in this study.
Effectiveness of Bupivacaine After Laparoscopic Cholecystectomy

Evaluate the efficacy on postoperative pain of the positioning of a 0,5% bupivacaine soaked-tabotamp in gallbladder bed after videolaparoscopic cholecystectomy.


Eligibility Criteria:
Inclusion Criteria:

* Age\>18 years old, ASA 1 and 2
* Gallbladder adenomatous polyposis and cholelithiasis with no byochemical, clinical and instrumental evidence of acute cholecystitis at the moment of surgery.

Exclusion Criteria:

* Age\<18 years old
* Pregnancy
* Previous major surgery of the supramesocholic compartment
* Acute cholecystitis
* Choledocolitiasis
* Acute pancreatitis at the moment of surgery
* Laparotomic conversion during surgery
Milrinone Versus Placebo in Patients With Septic Shock

Sepsis is one of the most serious healthcare problems, worldwide, and financial burdens.

The overall mortality of severe sepsis/septic shock was 44.5-52.6%. A common cause of death is refractory shock and multi-organ failure. Myocardial dysfunction is a relatively common complication of septic shock. This causes a decrease in the amount of cardiac output, resulting in insufficient blood supply to the organ and multi-organ failure and lead to death Early goal-directed therapy began to use dobutamine in patients with septic shock Sepsis Survival Campaign Guideline 2016 recommended drug is dobutamine and an alternative drug is milrinone in septic shock patients with clinical signs of poor tissue perfusion.

According to several studies, the use of dobutamine increases the amount of cardiac output but it has also been reported to increase mortality rates too. There are few studies of milrinone in patients with septic shock.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years old
* Diagnosis Septic Shock from the definition of SEPSIS III in intensive care unit at Siriraj hospital and Hat-Yai hospital
* Receive fluid resuscitation at least 30 ml/kg and/or Vasopressor until mean arterial pressure ≥ 65 mmHg
* Persistence lactate \>2mmol/L at 6th hour after resuscitation
* Urine output \< 0.5 ml/kg at 6th hour after resuscitation
* Left ventricular ejection fraction (LVEF) \< 40 %

Exclusion Criteria:

* Chronic kidney disease stage 5 and denied renal replacement therapy
* Life-threatening tachyarrhythmia before enrolled e.g. Ventricular tachycardia, Ventricular fibrillation
* Patient sign do-not-resuscitation and terminally ill
BIOSURE™ HEALICOIL™ PK Bone In-growth Study

The study seeks to document the bone in-growth into the BIOSURE™ HEALICOIL PK screw as measured by CT scans. Patients' improvement in pain and function will also be followed through various outcome measures.

The primary objective of the current study is to assess bone in-growth in the BIOSURE™ HEALICOIL™ Interference screw in the tibial tunnel of patients undergoing ACL reconstruction with soft tissue grafts; tunnel widening and change in IKDC knee and subjective scores will also be documented.

Eligibility Criteria:
Inclusion Criteria:

* ACL tear requiring surgical reconstruction with semitendinosus/gracilis graft.
* Willing and able to give voluntary informed consent to participate in this study
* Willing and able, in the opinion of the investigator, to cooperate with study procedures and willing to return to study site for all post-operative study visits.
* Subject is between 18 and 50 years at the time of surgery
* ASA group 0-2 (limited medical illness).

Exclusion Criteria:

* Revision ACL reconstruction
* Cartilage injury (IKDC Grade IV lesion\> 2 cm2)
* Current malignant disease
* Rheumatoid arthritis
* Osteonecrosis or Avascular Necrosis
* Ankylosing spondylitis
* Subject is Obese; BMI \> 35
* Subject is pregnant or plans to become pregnant during the study
* Subject has received medical treatment within 6 weeks of enrollment with any of the following:

Glucocorticoids Growth hormone

* Participating in another investigational trial or on-going study that would interfere with the assessment of the primary and secondary outcomes