cyrilzakka/clinical-trials huggingface dataset:
Phase I/II Study of the Combination of Irinotecan and POF (POFI) and Tislelizumab

The purpose of the phase I/II study is to establish the safety of Combination of Irinotecan and paclitaxel with 5-FU, leucovorin, oxaliplatin and Tislelizumab.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with advanced unresectable, histologically confirmed adenocarcinoma of the gastric or gastroesophageal junction.
2. With or without measurable lesions.
3. Patients must have a performance status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale.
4. Without serious system dysfunction and could tolerate chemotherapy. With normal marrow, liver and renal function: a hemoglobin (HGB) of ≥100g/L (without blood transfusion during 14 days); a leucopenia count of ≥4.0×109/L; a platelet count of ≥100×109/L; a total bilirubin (TBil) of ≤1.5 upper normal limitation (UNL); a creatinine (Cr) of ≤ 1.5 UNL; a creatinine clearance rate ≥ 50ml/min (Cockcroft-Gault); a alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) of ≤2.5 UNL or ≤5 UNL in case of liver metastasis.
5. Life expectancy ≥3 months.
6. With normal electrocardiogram results and no history of congestive heart failure.
7. With normal coagulation function: activated partial thromboplastin time (APTT), prothrombin time (PT) and INR, each ≤ 1.5 x ULN.
8. Female subjects of child-bearing potential must agree to use contraceptive measures starting 1 week before the administration of the first dose of Tislelizumab until 8 weeks after discontinuing study drug. Male subjects must agree to use contraceptive measures during the study and 8 weeks after last dose of study drug
9. With written informed consent signed voluntarily by patients themselves or their supervisors witted by doctors.
10. With good compliance and agree to accept follow-up of disease progression and adverse events.

Exclusion Criteria:

1. Patients with a history of another neoplastic disease within the past three years, excluding basal cell carcinoma of the skin, cervical carcinoma in situ, or nonmetastatic prostate cancer.
2. Patients with brain or central nervous system metastases, including leptomeningeal disease.
3. Pregnant (positive pregnancy test) or breast feeding.
4. Serious, non-healing wound, ulcer, or bone fracture.
5. Significant cardiac disease as defined as: unstable angina, New York Heart Association (NYHA) grade II or greater, congestive heart failure, history of myocardial infarction within 6 months Evidence of bleeding diathesis or coagulopathy.
6. History of a stroke or CVA within 6 months.
7. Clinically significant peripheral vascular disease.
8. Inability to comply with study and/or follow-up procedures.
9. Patients with any other medical condition or reason, in that investigator's opinion, makes the patient unstable to participate in a clinical trial.
Myofunctional Training for Obstructive Sleep Apnea Patients After Transoral Robotic Surgery

Background: Obstructive Sleep Apnea Syndrome (OSA) is a kind of sleep disorder. The symptoms are intermittent, partial or complete upper airway collapse, seriously impacting oxygen saturation and oxidative stress. Some patients choose to do upper airway surgeries, but the success rate is only 60-70%. The symptoms might relapse because of aging and gaining weights. The purpose of our study is to compare the effect of transoral robotic surgery (TORS) and oropharyngeal rehabilitation (OPR) on patients after TORS. Methods: Participants above 20 years old who are newly diagnosed with mild to severe OSA (Apnea-hypopnea Index \>5/h), and the physician will explain the treatment programs to every subject in clinic. Expected results: The hypothesis of this study is the success rate of surgery will be enhance by increasing tongue and jaw-opening muscle strength after OPR. The biomarkers of cardiovascular disease may decrease and both the collapse of upper airway and sleep quality may be improved after TORS and OPR.

The participants above 20 years old who are newly diagnosed with mild to severe OSA (Apnea-hypopnea Index \>5/h), and the physician will explain the treatment programs to every subject. By their willingness to choose the therapeutic method, the participants who select the surgery interventions will be assign to TORS or TORS+OPR group. The matched controls as well as age-, sex-, and body mass index-matched OSA participants will be selected from the patients who are waiting for oral appliance, losing weight and using continuous positive airway pressure. Before surgery, 6 week and 18 week after surgery, the investiagters will compare the polysomnography data, questionnaires of sleep quality, drug-induced sleep endoscopy and computed tomography as primary outcomes. The investigators will also compare the tongue and jaw-opening muscle strength and biomarkers of oxidative stress, anti-oxidative stress, inflammatory cytokines and matrix metalloproteinases 9 as secondary outcomes. The OPR would begin at 6 week after surgery, and participants will undergo three months of the home-based oropharyngeal myofunctional therapeutic training. During the training intervention period, participants will be interviewed one time per week for adjusting the treatment intensity.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of mild to severe OSA in the past year
* Age between 20-65 years old.

Exclusion Criteria:

* A history of malignancy or infection of the head and neck region and laryngeal trauma
* Craniofacial malformation
* Stroke
* Neuromuscular disease
* Heart failure
* Coronary artery disease.
A Molecule Basic Study of Early Warning for New Pathogenic Risk of Ankylosing Spondylitis

The investigators will recruit active ankylosing spondylitis patients for injection treatment of Human Mesenchymal Stem Cells (a prospective, open-label, masculine medicine controlled(NSAIDs), clinical trial), and collect their Peripheral Blood Lymphocyte (PBMCs) and sera before and after the treatment of 24 weeks to test the gene expression profiles and study related pathogenesis of AS


Eligibility Criteria:
Inclusion Criteria:

1. Aged from 16-65 years, sign the Informed Consent
2. Fulfill 1984 modified NewYork classification criteria for AS
3. Have an active refractory disease defined by a score ≥40 on the Bath AS Disease Activity Index (BASDAI) (0-100) despite optimal non-steroidal anti-inflammatory drug (NSAID) treatment.
4. Commitment to contraceptive for woman

Exclusion Criteria:

1. Completely stiff spine
2. Received spinal or joint surgery within 2 months
3. Received anti-TNF therapy within 3 months
4. History of the listed diseases: heart failure, Multiple sclerosis, severe chronic obstructive pulmonary disease, frequent infections, lymphoma or other cancers, tuberculosis
5. Female of pregnancy or breast feeding
6. Hb≤ 9g/dl for male or Hb ≤ 8.5 g/dl for male, ALT/AST≥2folds of upper level normal range, Creatine≥120mol/L(≤1.4mg/dl)
Tobacco Dependence in Alcoholism Treatment (Nicotine Patch/Naltrexone)

The purpose of this study is to determine the effectiveness of naltrexone (Revia) or matched placebo combined with nicotine patch (Nicotrol) or placebo patch using a 2x2 design in reducing drinking and smoking in patients with both nicotine and alcohol dependence.

Eligible individuals will be randomly assigned to a 12-week trial of a fixed daily dose of either naltrexone (Revia) and nicotine replacement patch or placebos. All individuals will receive weekly coping skills and smoking-cessation behavioral therapy. Followup interviews will be conducted 3 and 6 months after treatment to determine smoking and drinking status and persistence of any dependence symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Meets criteria for alcohol dependence and nicotine dependence.
* Expresses a desire to cut down or stop drinking and smoking.

Exclusion Criteria:

* Currently meets criteria for dependence on substances other than alcohol and nicotine.
* Any history of opiate dependence or evidence of current opiate use.
* Significant medical disorders that will increase potential risk or interfere with study participation.
* Liver function tests more than 3 times normal or elevated bilirubin.
* Females who are pregnant, nursing, or not using a reliable method of birth control.
* Meets criteria for a major psychiatric disorder and is in need of or currently undergoing drug therapy.
* Inability to understand and/or comply with the provisions of the protocol and consent form.
* Treatment with an investigational drug during the previous month.
* Chronic treatment with any narcotic-containing medications during the previous month.
* Sensitivity to drug as evidenced by adverse drug experiences especially with narcotic- containing analgesics or opioid antagonists.
* Current treatment with disulfiram (Antabuse) or nicotine replacement therapy.
* More than 6 weeks of abstinence.
Antibody Response of a Boosted Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in Children

This study has aim to describe the immune response to the second dose of Japanese encephalitis chimeric vaccine (JECV) in children previously vaccinated with one dose of JECV 5 years ago.

This is a prospective study to demonstrate the boosting antibody response in children previously vaccinated with one dose of JECV 5 years ago.

Eligibility Criteria:
Inclusion Criteria:

1. Subject who was vaccinated with 1 dose JE-CV in JEC02 and participated in 5 year follow-up in JEC05 trial and finished year 5 of follow-up.
2. Provision of Informed Consent Form signed by at least one parent or other legally acceptable representative.
3. Subject and parent/legally acceptable representative or guardian able to attend all scheduled visits and to comply with all trial procedures
4. In good general health, based on medical history and physical examination

Exclusion Criteria:

1. Participation in another clinical trial investigating a vaccine which need to have vaccination or blood draw within the 4 weeks preceding the trial vaccination except JEC05
2. Planned participation in another clinical trial during the Day0-Day28 period
3. Receipt of live vaccine within 4 weeks preceding the trial vaccination
4. Planned receipt of any vaccine in the 4 weeks following the trial vaccination
5. Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response
6. Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances
7. Chronic illness or any underlying illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
Salivary Oxytocin as a Biomarker in Psychedelic Assisted Psychotherapy

The main objective of this pilot study is to obtain preliminary data on the reactivity of salivary oxytocin during a single LSD intake as part of PAP treatment for anxiety disorders or depression (treatment authorisations granted in advance by the Federal Officie of Public Health for compassionate use of the substance).

There will be no interference with the usual clinical routine in our Service. The protocol is only for taking additional saliva measurements to measure oxytocin levels on the day of treatment.

Participants will be asked to give 4 saliva samples the day of their LSD treatment .In addition they will fill-in self-report questionnaires which are part of the clinical routine


Eligibility Criteria:
Inclusion Criteria:

* ongoing psychotherapy with a certified psychotherapist, anxiety disorder or depression resistant to usual treatments, agreement to stop necessary medication

Exclusion Criteria:

* Exclusion: psychotic or bipolar disorder, high suicidal risk, severe cardiovascular disease, severe liver disease, neurological disease of the central nervous system, pregnancy and breastfeeding
Impact of Anesthesiology Interventions on Postoperative Outcomes in Adult Patients Undergoing Shoulder Surgery

This retrospective, population-based cohort study will evaluate the comparative effectiveness of peripheral nerve blocks on patient outcomes after ambulatory shoulder surgery in adults patients undergoing surgery in Ontario.

First, investigators will validate health administrative data codes to demonstrate the accuracy of Ontario-wide anesthesia type and regional anesthesia interventions using a reference standard (Ottawa Hospital Data Warehouse data). Then, these validated exposures, in combination with validated outcome measures, will be used to examine the impact of anesthesia interventions on patient and health system outcomes for ambulatory shoulder surgery.

Eligibility Criteria:
Inclusion Criteria:

* Ontario residents
* Aged 18 years and older
* Elective ambulatory shoulder surgery performed in Ontario between April 2009 and December 2016.

Exclusion Criteria:

* Emergency Surgery
* If a patient undergoes multiple elective shoulder surgeries within the time period, only the first surgery will be included for any participant in the study period.
The Perioperative Value of Platelet Counts in Predicting Outcome After Liver Transplantation

Recent experimental and clinical studies have shown that platelets play a critical role in liver ischemia and regeneration. Thrombocytopenia, a frequent and potentially serious condition in liver transplantation (LT) recipients, was shown to be associated with postoperative morbidity and mortality after partial hepatectomy.

The investigators aim at evaluating whether postoperative low platelet counts are indicators of short- and long-term outcomes after liver transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years old
* End stage liver disease
* Cadaveric-donor liver transplantation

Exclusion Criteria:

* Age \<18 years old
* Pregnancy
* Living-related liver transplantation
New Prospective Expanded German Registry of Incidental Gallbladder Carcinoma (PERSUASION)- a Permanent Platform Including All Kind of Biliary Tract Cancers (BTC)

Permanent, prospective, multicenter registry including all kind of oncological therapy lines and procedures, clinical outcome, translational research (biobanking) and QoL for all types of biliary tract cancers.

Permanent, prospective, multicenter registry including all kind of oncological therapy lines and procedures, clinical outcome, translational research (biobanking) and QoL for all types of biliary tract cancers. The registry does not define any medical intervention and does not evaluate the efficacy or safety of the treatment decision made by the investigator. Every adverse event whether related to a treatment or not, will neither be documented in the trial´s eCRF nor be reported to the leading investigators of this study.

Objectives: • To establish a registry with a representative BTC-patient population in German-speaking Europe (mainly DACH region) for current and future research. The study registry is not based on a primary endpoint. The data collection includes (among basic patient-/tumor-/treatment- characteristics) the survey of quality of life (EORTC-C30), a so-called patient-reported outcome (PRO) and - if available - the collection of tissue samples for translational accompanying projects.

* Clinical data:

  * To analyse potential risk factors associated with BTC-cancer addressing clinical and biological predictors of treatment success and survival
  * To determine the course of disease and QoL throughout all applied therapy lines for patients with BTC
  * To measure progression-free, disease-free and overall survival in different BTC sub-groups, mortality and morbidity for perioperative and palliative therapy procedures
  * Recording of the therapy regimens and therapy sequences used across all treatment lines
* Molecular data (Data- and Biobanking):

  * To establish a sample collection for future molecular/genetic biomarker characterization to enable for e.g. assessment of the frequency of targetable mutations and associated therapy decisions or progression analysis in baseline and follow-up investigations

Eligibility Criteria:
Inclusion Criteria:

* Known biliary-tract cancer including intrahepatic-, extrahepatic- and gallbladder carcinomas
* age ≥18 years
* signed informed consent form
* planned for (or recently started - i.e. within the last 21 days)) neoadjuvant, adjuvant or 1st line therapy

Exclusion Criteria:

* Patients who are unable to consent because they do not understand the nature, significance and implications of the registry and therefore cannot form a rational intention
* Patient under 18 years of age
* Patient's inability to complete QoL questionnaire or answer the questions.
* Second-line or further palliative therapies if the patient's first-line therapy was not documented within the study.
Efficacy and Safety of Qizhitongluo Capsule in the Recovery Phase of Ischemic Stroke

This is a 20-week study consisting of a 12-week multicenter, randomized,double-blind adaptive study to compare efficacy and safety of Qizhitongluo Capsule,Naoxintong Capsule and placebo in the recovery phase of ischemic stroke with qi deficiency and blood stasis syndrome, and a 8-week post-treatment safety follow-up.After 312 patients complete 12 weeks of treatment there will be an interim analysis.


Eligibility Criteria:
Inclusion Criteria:

* Age≥35 years and \<80 years;
* Diagnosis of ischemic stroke in recovery phase, according to the Chinese guidelines for the diagnosis and treatment of acute ischemic stroke 2010;
* Diagnosis of ischemic stroke with qi deficiency and blood stasis syndrome;
* The interval from the onset to recruitment was 15-28 days;
* FM score \<90 or AQ\<93.8 and diagnosis of aphasia;
* Diagnosis of cerebral anterior circulation obstruction;
* 4≤ NIHSS score\<20;
* Patient is willing to participate voluntarily and to sign a written patient informed consent.

Exclusion Criteria:

* Evidence of intracranial hemorrhage (ICH) or other cerebral diseases (eg.vascular malformation, tumor, abscess or multiple sclerosis etc.) on CT or MRI.
* Known history of allergy or suspected allergic to the study drugs.
* Liver function impairment with the value of ALT or AST over 1.5-fold of normal value.
* Renal dysfunction with the value of serum creatinine over 1.5-fold of normal value.
* Cerebral embolism caused by cerebral tumor, cerebral trauma, cerebral parasitosis, rheumatic heart disease, coronary heart disease or other cardiac diseases complicated with atrial fibrillation.
* Prestroke score on the mRS ≥2.
* Space-occupying lesions, CT or MRI revealed midline structure shift; CT revealed that massive cerebral infarction including more than one lobe of brain or over 1/3 of blood-supply area of middle cerebral artery.
* Disable patients prescribed by law（blind, deaf, dumb, mental retardation, mental disorders and physical disabilities which due to other causes affect neural function deficient scale).
* Hemorrhagic tendency or recent severe or dangerous bleeding in 3 months.
* Suspected addicted into alcohol or drug abuse; with severe complications that would make the condition more complicated assessed by the investigator.
* Woman with pregnancy, lactation or positive result of pregnancy test, or women who want to be pregnant in recent.
* Patient who is participating in other trials or has been participated in other trials in recent 3 months.
Concordance of Hypoglycemia Measurement With Simultaneous Use of Two Devices for Continuous Glucose Measurement.

The aim of this study is to compare two frequently used sensors for continuous glucose monitoring (CGM); Freestyle Libre and Dexcom G 7. More precisely, the investigators want to investigate if there is any difference in the hypoglycemic range for these two devices.

The investigators are including adults with type 1 diabetes who already are using a Dexcom G 7, in their diabetes treatment. Simultaneously with their Dexcom G7, the participants will get the Libre 2 sensor attached, and are to wear this for a period of 14 days. The Libre sensor is a Freetsyle Libre 2. Glucose data are compared for paired values within a time interval of 5 min or less. In this way the investigators have access to nearly simultaneous glucose values from two different CGM's. In addition, the participants are given a Contour Next One, and are asked to measure their blood glukose with fingerprick if their Dexcom registers a glucose value \< 5 mmol/l.

By this project, we hope to gain more precise information about the two most widely distributed CGMs, and their function in the hypoglycemic area. This, can have impact on healthcare professionals' future therapeutic instructions, regarding the use of insulin adjustment and carbohydrate compensation.

Eligibility Criteria:
Inclusion Criteria:

Type 1 diabetes Using Dexcom G 7 -

Exclusion Criteria:

Do not want to participate

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Liver Ischemia-reperfusion Injury and Clinical Data Analysis

Searching for new targets for the diagnosis and treatment of liver ischemia-reperfusion injury.

Through the analysis of serological data during liver resection elective surgery with hepatic pedicle occlusion and reperfusion, as well as the analysis of patient-related data, we aim to identify key target points that affect reperfusion injury and explore their underlying mechanisms.

Eligibility Criteria:
Inclusion Criteria:

1. Willingness to participate in the study and has signed an informed consent form. 2) Age ≥ 18 years and ≤ 70 years. 3) ASA classification ≤ III. 4) Criteria for liver ischemia-reperfusion injury patients: patients undergoing elective liver resection surgery with hepatic pedicle occlusion and reperfusion during the procedure.

Exclusion Criteria:

1) Patients with adverse events during surgery. 2) Patients in the end stage of disease with liver failure. 3) Liver tumor metastasis with concomitant severe heart failure or chronic renal insufficiency, etc. 4) Deemed unsuitable for participation in the study based on the judgment of the researchers.

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Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implant

This is a multi-center, randomized, double-masked, controlled study to evaluate the safety and efficacy of fluocinolone acetonide intravitreal implants for the management of subjects with non-infectious uveitis affecting the posterior segment of the eye. An additional objective is to compare the safety and efficacy of two doses of fluocinolone acetonide.


Eligibility Criteria:
Inclusion Criteria:

* Males or non-pregnant females at least 6 years of age who had been diagnosed and treated for recurrent,
* Non-infectious uveitis affecting the posterior segment of one or both eyes for at least 1 year prior to the start of the study,
* Had clinically 'quiet' eyes at surgery.

Exclusion Criteria:

* Coexistent medical or ocular conditions that would interfere with obtaining or interpreting data for this study.