cyrilzakka/clinical-trials huggingface dataset:
Transbronchial Mediastinal Cryobiopsy Combined With EBUS-TBNA in the Diagnosis of Mediastinal Lesions

The clinical study is aimed to prospectively evaluate the diagnostic accuracy and the safety of adding transbronchial mediastinal cryobiopsy to standard sampling in mediastinal diseases.

A traditional method, endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) was used to be compared. The patients involved were randomly divided into two groups. In the experimental group, EBUS-TBMCB was performed following EBUS-TBNA while in the other group, EBUS-TBNA was performed respectively. The samples obtained in the two groups were analyzed by the pathologists. Patients were followed up for confirming the diagnosis and complications. The diagnostic accuracy and prevalence of procedure-related adverse events were compared between the 2 groups.

Eligibility Criteria:
Inclusion Criteria:

* Age \>=15 years;
* More than one mediastinal lesions with diameter \>= 1cm was detected by thoracic CT;
* Indication of biopsy to identify the etiology, including recently discovered mediastinal lesions or combination of clinical respiratory symptoms and complicated lung lesions implicated by thoracic image ;
* Completion of necessary preoperative laboratory examination and other examinations such as cardiac ultrasound or CTA when necessary, in order to exclude potential contradictions;
* Informed consent form achievement.

Exclusion Criteria:

* Contradictions to bronchoscopy examination such as severe cardiopulmonary diseases, coagulation disorders, intolerance to anesthesia or endoscopic operation and so on;
* Failure to detect the mediastinal lesions in ultrasonic landscape;
* Cysts or abscess;
* Requirements for additional procedures other than EBUS examination (such as endobronchial biopsy);
* Psychiatric disorders or severe neurosis.
* Participation in other clinical experiments in recent 3 months;
* Any other conditions considered to be inappropriate to be involved in this study.
Sympathovagal Balance in Smoking Cessation

This study has the following primary aim:

- the main objective of this study is to investigate the effects of smoking cessation during quit attempts on sympathovagal balance. These effects will be observed in smokers quitting smoking with pharmacological support or without.

Secondary aims of this study are also:

* the definition of MSNA in smokers and non-smokers
* the investigation of other parameters concerning the autonomic nervous system, like baroreflex-sensitivity, heart rate-variability before and during the quit attempt.
* the definition of withdrawal symptoms and craving before, during and after the quit attempt.
* the investigation of effects of smoking cues on craving and sympathovagal balance
* the investigation of relapse rates after smoking cessation in correlation with the parameters mentioned above.


Eligibility Criteria:
Inclusion Criteria:

* Men and Women at the age of 25 to 60 years.
* Group A-D: Smokers willing to quit smoking and a FTNA-result \>5.
* Group E: Never-smokers.
* Signed consent after information.

Exclusion Criteria:

* formerly known hypersensitivity against one of the used pharmacological interventions or structurally similar drugs or against one of the ingredients.
* participation in another study during this study or within 4 weeks prior to this study.
* Addiction or other circumstances that prevent the patient from estimating the study and the consequences.
* Pregnancy and breast-feeding
* women with childbearing potential, except women that fulfill the following criteria:

  * post menopause
  * postoperative (6 weeks after both-sides ovariectomy with or without hysterectomy)
  * regular and correct use of prevention methods (error-rate \<1% a year), e.g. implants, depot injections, oral contraceptives, IUP)
  * sexual abstinence
* signs that predict a possible non-compliance of the patient
* exclusion because of nicorette tx:

  * psoriasis, dermatitis, urticaria
* exclusion because of varenicline

  * creatinine-clearance \< 30ml/min
  * epilepsy
  * psychiatric diseases (schizophrenia, bipolar disorders, depression).
* Exclusion because of methods

  * Diseases that increase the sympathetic level (Heart insufficiency, high blood pressure (arteria /pulmonary), obstructive sleeping apnoea, COPD)
* cardiac rhythm disturbances
* myocardial infarction within the last 8 weeks
* polyneuropathy
* diseases that come along with damages of peripheral nerves
* severe or life-threatening diseases (e.g. cancer with life-expectancy \< 5 years, terminal kidney-insufficiency)
* treatment with antihypertensive drugs or sympathomimetic substances (e.g.theophyllin) or smoking cessation medication (NRT, Varenicline)
* Other reasons, that make a patient not suitable for the study (estimation of primary investigator)
Design and Development of Multi-modal Intelligent Anesthesia Monitoring System

This project integrates the characteristics of electroencephalo-graph（EEG）, cerebral oxygen, blood pressure, heart rate, etc., based on nonlinear theory and neural oscillation, large sample data and machine learning theory, to develop a multi-modal monitoring system suitable for domestic patients, taking into account changes in sedation, analgesia, cerebral hemodynamics and other factors, regardless of patient age and type of general anesthesia drugs.


Eligibility Criteria:
Inclusion Criteria:

1. Age: 0-65 years old
2. ASA: Level I-III
3. Patients undergoing non cardiac surgery under general anesthesia
4. Informed consent of the patient or legal representative

Exclusion Criteria:

1. Previous history of severe neurological disorders
2. History of mental illness and related medication use
3. Individuals who are unable to cooperate in completing cognitive function tests
4. Severe hearing or visual impairment
5. Preoperative delirium in patients
6. Individuals who have experienced severe adverse reactions such as cardiac arrest and cardiopulmonary resuscitation during surgery
7. Those who require neurosurgery, head and facial surgery
8. Individuals who are allergic to EEG and fNIRS electrodes
Study of the Acute Metabolic Effect of Exenatide in Type 1 Diabetes

The study is designed as an open labeled pilot trial to analyze the acute responses of glucose, GLP-1, GIP, insulin secretory,and glucagon to a mixed meal tolerance test (MMTT) or intravenous glucose tolerance tests (IVGTT) with and without pretreatment with Exenatide (Byetta) 5 mcg sc.

The investigators will also test the effects of Exenatide on gastric emptying during the MMTT.


Eligibility Criteria:
Inclusion Criteria:

* T1D of at least 3 yrs duration.
* Male or female aged 18-56 years who meets the American Diabetes Association standard T1DM criteria.
* HgbA1c\<9%
* Insulin requirement of \< 0.8 U/kg/d
* Absence of severe hypoglycemia in the past 6 months
* Absence of ketoacidosis in the past 6 months
* Menstruating women must have a negative pregnancy test and be willing to avoid pregnancy during the study period.
* Signed informed consent..

Exclusion Criteria:

* Inability or unwillingness to give informed consent.
* Prior Exenatide or Liraglutide treatment or use of any medication that could potentially affect diabetes or immunologic status
* Known hypersensitivity to Exenatide or any product components
* Participation in an investigational treatment trial within the last 6 weeks before enrollment.
* Any medical condition that in the opinion of the investigator would interfere with safe completion of the trial such as: epilepsy, atopic disease, active Grave's disease, cystic fibrosis, sickle cell anemia, neuropathy, peripheral vascular disease, cerebrovascular disease,liver disease, HIV, or any concurrent autoimmune disease except treated and stable thyroid disease
* Known severe renal impairment, end-stage renal disease or renal transplantation.
* Any history of gastroparesis or other severe gastrointestinal disease, pancreatitis, thyroid nodules or malignancy with the exclusion of a history of localized basal cell carcinoma.
* Uncompensated heart failure, fluid overload, myocardial infarction or liver disease within the last 6 weeks before enrollment.
* Active clinically serious infections.
* Positive pregnancy test in menstruating women or lactating females
A Study to Evaluate the Efficacy and Safety of Tocilizumab in Hospitalized Participants With COVID-19 Pneumonia

This study (EMPACTA) will a) evaluate the efficacy and safety of tocilizumab (TCZ) compared with a placebo in combination with standard of care (SOC) in hospitalized participants with COVID-19 pneumonia, and b) include an optional long-term extension for eligible participants to explore the long-term sequelae of resolved COVID-19 pneumonia.


Eligibility Criteria:
Inclusion Criteria

* Hospitalized
* COVID-19 pneumonia confirmed by a positive polymerase chain reaction (PCR) of any specimen and radiographic imaging
* SpO2 \< 94% while on ambient air

Inclusion Criteria Specific to Long-Term Extension

* Participated in Study ML42528 (EMPACTA) (includes participants who completed or discontinued early from the main study)

Exclusion Criteria

* Known severe allergic reactions to TCZ or other monoclonal antibodies
* Require continuous positive airway pressure (CPAP), bilevel positive airway pressure (BIPAP), or invasive mechanical ventilation
* Suspected active bacterial, fungal, viral, or other infection (besides COVID-19)
* In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments
* Immunocompromised (besides well-controlled HIV) or on immunosuppressive therapy (except for steroids for COVID), advanced cancer
* Have received oral anti-rejection or immunomodulatory drugs (including TCZ) within the past 3 months
* Participating in another interleukin (IL)-6 antagonist clinical trial or other drug clinical trials (participation in COVID-19 anti-viral trials may be permitted if approved by Medical Monitor)
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 10 x upper limit of normal (ULN) detected within 24 hours at screening (according to local laboratory reference ranges)
* Absolute neutrophil count (ANC) \< 1000/uL at screening (according to local laboratory reference ranges)
* Platelet count \< 50,000/uL at screening (according to local laboratory reference ranges)
* Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination
* Treatment with an investigational drug within 5 half lives or 30 days (whichever is longer) of randomization (investigational COVID-19 antivirals may be permitted if approved by Medical Monitor)
* Any serious medical condition or abnormality of clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study
* Any history of Diverticulitis or GI perforation
* Use of systemic corticosteroids unless on a stable chronic dose
Diagnostic Endoscopic Exploration for Pancreatic Head Mass

This study is being done to find out if an endoscope passed down the throat, through the stomach, and into the abdomen can quickly and accurately examine the organs and tissue of the abdomen and take biopsies if needed.

This study is being done to find out if an endoscope (a small, flexible tube with a camera mounted on the end) passed down the throat, through the stomach, and into the abdomen can quickly and accurately examine the organs and tissue of the abdomen and take biopsies if needed. We wish to determine if this endoscopic route is as fast and efficient as the laparoscopic route, which is the current standard of care.

Eligibility Criteria:
Inclusion Criteria:

* Age range 18-80
* Radiographic diagnosis of resectable pancreatic head mass presumed to be pancreatic adenocarcinoma

Exclusion Criteria:

* Inability to obtain informed consent
* Pregnancy
* Intra-abdominal adhesions that preclude endoscopy
* Contraindication to upper endoscopy such as stricture, stenosis of the foregut
* Previous gastric surgery
* Diagnosis of pancreatic body or tail tumor
* History or current diagnosis of gastric ulcer
* Metastatic disease diagnosed by CT, EUS, MRI, or nuclear imaging
* Patient is not a candidate for resection based upon CT, EUS, MRI, or nuclear imaging
* Antiplatelet medication not stopped at least 7 days prior to procedure
* Anticoagulant medication not stopped at least 5 days prior to procedure
Percutaneous Endoscopic Decompression for Lumbar Canal Stenosis

Lumbar spinal stenosis (LSS) is the most common spinal degenerative disease. For conservative treatment failure, open lumbar decompression and fusion surgery is the main surgical treatment. After decades of development, open lumbar decompression and fusion surgery has been the standard treatment. However, there are still people and conditions that cannot be covered, such as elderly people who intolerable surgery, severe osteoporosis, and re-stenosis at adjacent segments after fusion. Percutaneous spinal endoscopic lumbar spinal decompression technique could be performed under local anesthesia, soft tissue damage is minimized, and effective spinal decompression can be achieved. There are still some controversial points of LSS decompression under percutaneous endoscope surgery, such as the range of decompression, choice of approach, postoperative spinal stability, learning curve, surgical safety, long-term effects of endoscopic treatment of restenosis at adjacent segments after fusion surgery. The purpose of this study was to solve these controversial points. A multi-center, prospective registration study based on the real world is planned. The total sample size is about 600 cases (300 cases in endoscopic surgery group, 300 cases in open decompression and fusion group). The mid- to long-term clinical efficacy and safety were evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Patients with symptomatic lumbar canal stenosis(including central canal, lateral recess, foraminal and extraforaminal) despite more than 6 weeks of conservative treatment; Pathology was confirmed by both computed tomography and magnetic resonance imaging The operative level≤2

Exclusion Criteria:

* Segmental instability Simple disc herniation Coexisting pathological conditions, such as tumor and infection
Evaluation of the Effectiveness of the Complex of Carnitine Orotate and Biphenyl Dimethyl Dicarboxylate in the Adjuvant Therapy of Chronic Hepatitis D in Real Clinical Practice: a Prospective Cohort Study

The goal of this observational study is to evaluate the effectiveness of the carnitine-orotate complex and biphenyl dimethyl dicarboxylate in the adjuvant therapy of chronic hepatitis D in real clinical practice: a prospective cohort study


Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes aged 18 to 75 years who are citizens of the Republic of Kazakhstan;
* An established diagnosis of CGD (chronic viral hepatitis B with the delta agent);
* Patients who have contraindications to taking peg-INF-alpha2a and/or have failed treatment with peg-INF-alpha2a;
* Compensated liver disease ≤ CPT A (6 points);
* Patients without severe concomitant diseases;
* Patients who do not receive other adjuvant therapy (metabolic therapy drugs, essential phospholipids, ursodeoxycholic acid, glycyrrhizic acid, ademetionine and others);
* Patients who voluntarily signed the informed consent form.

Exclusion Criteria:

* Patients taking COC for more than 4 weeks before inclusion in the study;
* Patients with contraindications to the COC;
* Decompensated liver disease severity class \> CPT A6;
* Patients taking peg-IFN-alpha 2a;
* Alcohol abuse according to the AUDIT-c questionnaire;
* Pregnancy and lactation;
* Patients with coinfection with HIV, HCV;
* GFR ≤ 15 ml/min/1.73 m2;
* Exclude patients with significant biochemical activity (ALT, AST more than 10 ULN) and total bilirubin more than 2 norms;
* Patients with other causes of liver damage;
* Drug addict people;
* Malignant formations of the liver and other organs (in history and currently) or a clinically significant increase in alpha-fetoprotein more than 5 times or more;
* Patient takes part in an interventional clinical trial.
Treatment of Congenital Stationary Night Blindness With an Alga Containing High Dose of Beta Carotene

To assess the effect of oral administration of the alga Dunaliella bardawil containing approximately 50% all-trans beta-carotene and 50% 9-cis beta-carotene isomers on visual functions patients with Congenital Stationary Night Blindness {Fundus albipunctatus).


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent to participate in the study.
* Men or women aged 18 years or older
* Diagnosed with Fundus albipunctatus

  1. Isolated rod response markedly reduced (less than 20% of normal)after 20 minutes dark adaptation and improved by 50% after 2 hours
  2. Negative maximal response (a wave to b wave ratio less than 2)
  3. Retinal midperipheral white dots (More than 3000 dots)

Exclusion Criteria:

* Current smokers.
* Current use of Vitamin A/ beta carotene supplements.
* Active arterial disease within 3 months of study entry such as unstable angina, myocardial infarction, transient ischemic attack (TIA), stroke, and coronary artery bypass graft (CABG) surgery.
* History of malignancy, except basal or squamous cell skin carcinoma.
* Pregnant women, women who are breast feeding, and women of childbearing potential who are not using chemical or mechanical contraception.
* Uncontrolled hypertension defined as either resting diastolic blood pressure of \>95mmHg (taken from the mean of 3 readings) or resting systolic blood Pressure of \> 180 mmHg.
* History of alcohol abuse or drug abuse, or both.
* Active liver disease or hepatic dysfunction as defined by elevations of 2.0 times the ULN in any of the following liver function tests: ALT, AST or bilirubin.
* Serum CPK \> 2.0 times ULN in visit 0
* TSH above the normal range.
* Newly diagnosed diabetes within 3 months.
* Patient plans to engage in vigorous exercise or an aggressive diet regimen.
* Uncontrolled endocrine or metabolic disease.
* Participation in another investigational drug study within 4 weeks of entry into this study.
* Serious or unstable medical or psychological condition that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.
* Serum creatinine \> 2.0 mg/dl before the treatment phase, +3 proteinuria in urine dipstick, or a history of renal transplantation before the treatment period.
* Subject whose hormone replacement therapy (HRT) or oral contraceptive therapy (OCT) was initiated within the 3 month prior to enrollment.
* Forbidden medications: the combination of PPAR alpha agonists-fibric acid derivatives, PPAR gamma agonists.
IBI310 in Combination With Sintilimab in Patients With Advanced Biliary Tract Cancer

This research study is designed to establish whether the combination of IBI310 \& Sintilimab has efficacy in patients with advanced BTC


Eligibility Criteria:
Inclusion Criteria:

1. The subject must sign the written informed consent form, and can comply with the visits and related procedures specified in the protocol.
2. Aged ≥18 years.
3. Patients with unresectable or relapsed or metastatic advanced Biliary tract cancer,and diagnosed by histology/cytology (except carcinoma of ampulla).
4. Had progressed after receiving at least first-line systemic treatment (if a patient has progressed within 6 months after receiving systemic treatment during adjuvant chemotherapy or concurrent radiochemotherapy, she will be deemed to have received first-line treatment).
5. Patients who have never received any anti-PD-1, anti-PD-L1/L2 antibody, anti-CTLA-4 antibody, or other immunotherapy.
6. The subject must have at least one measurable lesion as the target lesion (according to RECIST V1.1). A measurable lesion in the radiation field from previous radiotherapy or local treatment, can also be chosen as the target lesion if confirmed progression.

Exclusion Criteria:

1. Diagnosis of other malignant tumors within 5 years before the first administration, excluding radically cured skin basal cell carcinoma, skin squamous cell carcinoma, radically resected carcinoma in situ and/or thyroid papillary carcinoma.
2. Patients who have previously received organ or bone marrow transplantation.
3. Patients with acute or chronic active hepatitis B or C infection, hepatitis B virus (HBV) DNA\> 2000 IU/ml or 104 copies/ml; hepatitis C virus (HCV) antibody positive and HCV-RNA \>103 copies/ml;. Patients with acute or chronic active hepatitis B or C infection who have received nucleotide antiviral therapy and are below the above standards can be selected.
4. Uncontrollable hypertension, systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg after best medical treatment, history of hypertensive crisis or hypertensive encephalopathy.
5. Pleural effusion, ascites, and pericardial effusion with clinical symptoms or requiring drainage , patients who only shows with a few pleural effusion, ascites, and pericardial effusion by imaging and with no clinical symptoms can be selected.
Anti-CEACAM5 ADC M9140 in Advanced Solid Tumors (PROCEADE-CRC-01)

The purpose of this first-in-human study is to evaluate the safety, tolerability, pharmacokinetics, and preliminary clinical activity of M9140 in advanced solid tumors. This study contains 2 parts: Dose escalation (Part 1) and dose expansion (Part 2).

Study details include:

* Study Duration per participant: Approximately 4 months for Part 1 and 8 months for Part 2
* M9140 is not available through an expanded access program


Eligibility Criteria:
Inclusion Criteria:

* Participants with documented histopathological diagnosis of locally advanced or metastatic colorectal cancer (CRC), who were intolerant/refractory to or progressed after standard systemic therapies for the advanced/metastatic stage, if locally indicated and available to the participant. Participants with a known microsatellite instability high (MSI-H) status must have received treatment with an immune checkpoint inhibitor (if locally indicated and available) unless contraindicated.
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) below or equal to 1
* Participants with adequate hematologic, hepatic and renal function as defined in protocol
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* Participant has a history of malignancy within 3 years before the date of enrollment (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, benign prostate neoplasm/hypertropia, or malignancy that in the opinion of the Investigator, with concurrence with the Sponsor's Medical Monitor, is considered cured with minimal risk of recurrence within 3 years)
* Participants with known brain metastases, except those meeting the following criteria: Brain metastases that have been treated locally and are clinically stable for at least 4 weeks prior to the start of treatment; No ongoing neurological symptoms that are related to the brain localization of the disease (sequelae that are a consequence of the treatment of the brain metastases are acceptable)
* Participants with diarrhea (liquid stool) or ileus Grade \> 1
* Participants with active chronic inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease, intestinal perforation) and/or bowel obstruction
* Unstable angina, myocardial infarction, congestive heart failure (New York Heart Association \[NYHA\] \>= II) or a coronary revascularization procedure within 180 days of study entry. Calculated QTc average (using the Fridericia correction calculation) of \> 470 milliseconds (ms)
* Cerebrovascular accident/stroke (\< 6 months prior to enrollment)
* Other protocol defined exclusion criteria could apply