cyrilzakka/clinical-trials huggingface dataset:
Prophylactic nCPAP Following Bowel Surgery (Bio-REB File 11-27)

The purpose of this study is to determine whether prophylactic nasal continuous positive airway pressure (nCPAP) in the post-anaesthesia care unit (PACU) improves post-operative pulmonary function following elective bowel surgery. The investigators hypothesize that one hour of nCPAP in the PACU will result in a higher partial pressure of arterial oxygen (PaO2) when compared to the standard treatment of low flow oxygen applied by face mask.

Post-operative pulmonary complications, such as hypoxemia, pneumonia and respiratory failure, occur in 5-10% of patients following abdominal surgery. These post-operative pulmonary complications result in increased morbidity, mortality, ICU admission, length of hospital stay and resource use.

CPAP has shown to be an effective treatment for hypoxemia following abdominal surgery. It decreases atelectasis formation the risk of pneumonia. Application of nCPAP to treat hypoxemic respiratory failure following thoraco-abdominal surgery has shown to decrease endotracheal intubation.

Nasal CPAP has shown to be effective prophylaxis following elective cardiac and thoraco-abdominal aortic surgery. It reduces the incidence of hypoxemia, pneumonia, re-intubation and re-admission to the ICU. It has also shown to decrease the length of hospital stay.

The use of nCPAP immediately post-operatively in the PACU following abdominal surgery has not been evaluated. Nasal CPAP is better tolerated than full face mask CPAP. It allows for effective clearance of respiratory secretions, improved communication and decreases claustrophobic sensation. The PACU is a transition period from general anaesthesia into the post-operative recovery phase. During this time, residual anaesthetic causes decreased level of consciousness and sub-optimal respiratory effort. Reversal agent for neuromuscular blockade has often not reached its peak effect. Inadequate pain control may further decrease respiratory effort. This transition period may be when maximal atelectasis of alveolar lung units occurs. This time period may be optimal for the application of nCPAP for prophylaxis against hypoxemia. It may improve post-operative pulmonary function which could decrease post-operative morbidity, mortality, length of hospital stay and resource use.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled to undergo elective laparotomy for bowel surgery

Exclusion Criteria:

* age \< 18 years
* postoperative admission to the intensive care unit
* a history of allergy/intolerance to Ametop
VOCs vs FIT for Colorectal Cancer Screening

Endogenous breath VOCs (Volatile Organic Compounds) are present in various excreted biological materials (urine, blood, faeces an breath) and their analysis offers a possibility for cancer screening. Some of these VOCs are reversed in the venous blood stream and reach the lung alveoli where some of them are exhaled.

Colorectal cancer (CRC) is one of the commonest tumours and is an important cause of cancer-related mortality. Colonoscopy is the gold standard for the diagnosis of CRC.

Screening with fecal immunochemical test (FIT) is associated with a 13-18% CRC-mortality reduction.

Aim of the study To compare the reliability of this breath analysis with Immunochemically-based Fecal Occult Blood Test.

Volatile organic compounds (VOCs) are low molecular weight (\<1 kDa) compounds which represent the final products of cell metabolism. Their composition can be affected by several factors including diet, hormones, environment and the presence of diseases, in particular, cancer.

Endogenous breath VOCs are present in various excreted biological materials (urine, blood, faeces an breath) and their analysis offers a possibility for cancer screening. Some of these VOCs are reversed in the venous blood stream and reach the lung alveoli where some of them are exhaled.

Colorectal cancer (CRC) is one of the commonest tumours and is an important cause of cancer-related mortality. Colonoscopy is the gold standard for the diagnosis of CRC, although its cost prevents its use for mass screening. Furthermore colonoscopy is not well accepted by patients since it is an invasive exam. Screening with fecal immunochemical test (FIT) is associated with a 13-18% CRC-mortality reduction in major randomized studies and is the most widely used non-invasive screening tool, showing fairly good specificity but a high variation in sensitivity (61-91%) and adherence to screening programmes rarely reaches 50-70% of the target population.

Recently the breath analysis has been demonstrated to be a new well accepted and non-invasive tool to detect colorectal cancer.

The purpose of this trial is to compare the reliability of this breath analysis with Immunochemically-based Fecal Occult Blood Test, which is the routinely employed tool for mass screening. A group of subjects adherent to the regional screening program for colorectal cancer prevention, who resulted positive to the FIT, will be enrolled in this study, and will have a breath sampling before undergoing colonoscopy. The predictive ability of the Breath test will be tested in a blind fashion in this selected group of high-risk subjects.

Eligibility Criteria:
Inclusion Criteria:

* Patients with and without positive FIT with a planned colonoscopy
* Patients included in the regional screening program for CRC
* Written informed consent

Exclusion Criteria:

* Pregnancy
* Inflammatory bowel disease
* Bowel prep
* Any psychiatric disease
* Previous (or still present) cancers in other organs
Study of the Safety and Efficacy of REGN1033 (SAR391786) in Patients With Sarcopenia

This is a randomized, double-blind, placebo-controlled, multicenter phase 2 study of the safety and efficacy of 3-month subcutaneous (SC) REGN1033 (SAR391786) treatment in patients with sarcopenia.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women aged 70 years and older (all women participating in the study must be postmenopausal)
2. Are capable, in the investigator's opinion, to complete the study per protocol and have no significant health issues or conditions
3. Ability to follow a walking program
4. Willing and able to comply with clinic visits and study-related procedures
5. Provide signed informed consent
6. Able to understand and complete study-related questionnaires

Exclusion Criteria:

1. Hospitalization or immobilization with a duration of \>48 hours within the month prior to screening
2. Surgical procedure requiring general anesthesia within 1 month prior to screening, or a planned surgical procedure requiring general anesthesia within the next 6 months
3. Participate in resistance training more than 3 times per week and regular exercise consisting of an average of 30 minutes per day or more of at least moderate physical activity
4. Chronic medications introduced within 2 weeks prior to screening
5. Respiratory disease that requires oxygen treatment
6. Cancer requiring treatment currently or in the past 3 years (except primary nonmelanoma skin cancer or in situ cervical cancer)
7. Neurological conditions that are causing impaired muscle function or mobility
8. Certain cardiovascular conditions
9. Uncontrolled diabetes

The information listed above is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial and not all inclusion/ exclusion criteria are listed.
Comparing the Prognosis of Patients With Cardia and Non-cardia Gastric Cancer.

To comparing the stage-for-stage prognosis of patients with cardia and non-cardia gastric cancer after operation.

The aim of this study is to compare the stage-for-stage prognosis of patients with cardia and non-cardia gastric cancer after operation.In this study, patients with cardiac and non-cardiac gastric cancer who undergo radical resection from January 2019 to December 2024 will be included. We will follow up the patient's progression, recurrence time and survival time.

Eligibility Criteria:
Inclusion Criteria:

1. Histopathology or cytopathology proven cardia or non-cardia gastric cancer;
2. Operable gastric cancer patients: primary lesions can be completely excision, no distant metastasis;
3. Life expectancy of at least 6 months;
4. ECOG（Eastern Cooperative Oncology Group ） score 0-1;
5. Age: 18\~80 years old;
6. Normal hemodynamic indices before the recruitment (including blood cell count and liver/kidney function).

   For example: WBC（White blood cell count ）\>4.0×109/L; NEU（Neutrophils）\>1.5×109/L; PLT（Platelet）\>100×109/L;
7. Roughly normal cardiopulmonary function: No coronary heart disease, myocardial infarction, pulmonary heart disease, refractory hypertension;
8. Not concomitant with other uncontrollable benign diseases before the recruitment;
9. Voluntarily signed the informed consent.

Exclusion Criteria:

1. Advanced gastric cancer patients with distant metastasis and inoperable ;
2. Pregnant or lactating women;
3. Patients who have no desire to participate in the study.
CAR-T-19 Cells for Patients With CD19+ Relapse/Refractory B-ALL

This is a single-arm, open-label phase I study to determine the safety, tolerability, and recommended dose (RD) of CAR-T-19 cells for patients with CD19+ relapse/refractory B-ALL under the age of 25.

B-cell acute lymphoblastic leukemia (B-ALL) accounting for 85% of all ALL cases, is a common hematological malignancy in children and adults. CD19 is a widely expressed antigen in both normal B cells and B cells-derived leukemia and lymphomas. This is a single-arm, open-label phase I study of CAR-T-19 (anti CD19 scFv chimeric antigen receptor T) cells for patients with CD19-positive relapse/refractory B-ALL under the age of 25.

Primary endpoint is to determine the safety, tolerability, and recommended dose (RD) of CAR-T-19. Secondary endpoints measure ORR, OS and others.

Eligibility Criteria:
Inclusion Criteria:

* Patients with relapse/refractory B-ALL.
* Tumor cells from bone marrow or peripheral blood are measured CD19+ with 3 months before enrollment.
* Karnofsky Score ≥ 70 or Lansky Score ≥ 50.
* Patients who have a life expectancy of at least 12 weeks.
* Understand and voluntarily sign informed consent and are willing to comply with laboratory tests and other research procedures.

Exclusion Criteria:

* Patients with extramedullary relapse (EMR).
* Patients with genetic diseases, Burkitt lymphoma and leukemia or other malignancies.
* Patients positive for any of the following: HbsAg, HBV-DNA, HCV-Ab, HCV-RNA, HIV-Ab, TP-Ab, EBV-DNA or CMV-DNA.
* Patients with other uncontrolled infection.
* Patients who received anti-CD19 / anti-CD3 therapy, or any other anti-CD19 therapy.
* Patients with active Grade II-IV GVHD within 3 months prior to screening.
* Tumor cells are detected in cerebrospinal fluid.
* Patients who received HSCT within 3 months prior to screening.
* Anticipated other clinical trials within 4 weeks before this trial
* Pregnant or lactating women.
* Any condition that would, in the investigator's judgment, make it unsuitable for the donors to be enrolled.
Immunocompetent Versus Immunocompromised Tuberculosis (TB) Patients

Tuberculosis (TB) is caused by Mycobacterium tuberculosis and is one of the top 10 causes of mortality worldwide. It is estimated that in 2017, 10 million people were infected with TB, and 1.6 million died from the disease, including 0.3 million people with human immunodeficiency virus (HIV) infection . TB remains the primary killer of HIV-positive individuals. TB incidence is falling at about 2% per year . Airborne transmission of M. tuberculosis typically causes TB infection in both immunocompetent and immunocompromised hosts and the disease is symptomatic and contagious .

TB and HIV infections are strictly linked together. TB is the most common opportunistic infection and causes high morbidity rate among people living with HIV. Because of the decrease in cell-mediated immunity, HIV alters the pathogenesis of TB, thereby expressively increasing the risk of TB in HIV-positive patients and eventually leading to more severe complications and forms of TB.

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic chest disease

Exclusion Criteria:

* Patients with other respiratory or infectious diseases.
Prospective Observational Study Comparing GA and WALANT in Distal Radius Fracture Plating Surgery

The wide-awake local anesthesia no tourniquet (WALANT) has been widely used in the field of hand surgery in recent years. This surgical method has progressed to open reduction and internal fixation of distal radial fracture and radial or ulnar shaft fractures. However, there are still many unclear points for clinicians, including the perioperative subjective feedback from the patient and changes in postoperative pain. In this study, participants having forearm fractures should undergo open reduction and internal fixation were randomized to general anesthesia or WALANT. The investigators will compare the differences in perioperative subjective and objective assessments of these participants during surgery, as well as the prognosis and function after surgery.

1. Written informed consent must be obtained before any study-specific procedures are undertaken.
2. The process of the experiment A. Include participants into this study, they will be randomized into general anesthesia or WALANT group B. The maximum (toxic) dose of lidocaine was 7 mg/kg. Make distal radius fracture for an example, the solution used in the WALANT technique consisted of 20 ml of 2% lidocaine with epinephrine 1:50,000, which were mixed with normal saline to give a total of 40 ml. A set of baseline parameters, including pulse oximetry, respiratory rate, heart rate, blood pressure, respiratory rate, and oxygen saturation, was obtained during the entire surgery. At the same time, preoperative intravenous antibiotics with 1 g cefazolin were given for each patient as prophylaxis. The amount of blood loss was based upon the amount in a suction container in the operation room. In addition, the investigators will measure the participant's intraoperative subjective satisfaction and pain assessment.

C. After surgery, the participant needs to stay in the in-patient department for one day. The investigators will provide routine prophylactic antibiotics and oral pain pillar. Postoperative pain, sensory, and motor function assessment.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a mature skeleton having a radial fracture

Exclusion Criteria:

* Patients having multiple trauma and need to undergo open reduction and internal fixation surgery
* Patients having a concomitant intracranial injury
* Pathological fracture
* Patients refused to be randomized into general anesthesia or WALANT group
* Patients have a history of allergy to anesthetic drugs
Real World Study of Oral Upadacitinib Tablets to Assess Adverse Events and Change in Disease Activity in Adolescent and Adult Chinese Participants With Atopic Dermatitis

Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. This study will assess how safe and effective upadacitinib is in treating AD in adolescent and adult Chinese participants.

Upadacitinib is an approved drug for treating AD. Approximately 200 adolescent and adult participants who are prescribed upadacitinib by their physician in accordance with local label will be enrolled in China.

Participants will receive upadacitinib as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed up for approximately 24 months per participant and 30 days after last treatment dose for safety data collection.

There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of moderate to severe atopic dermatitis (AD) at the time of enrollment.
* Chinese adolescents (≥12 to \<18 years of age with body weight of ≥40 kg) or adults (≥18 years of age) at the time of enrollment.
* Participants eligible for initiation of Upadacitinib treatment for AD, including any required screening tests indicated per China Label.
* The decision to prescribe Upadacitinib is made prior to and independently of study participation.

Exclusion Criteria:

* Participants who cannot be treated with Upadacitinib as per China label or by judgement of treating physician.
* Currently participating in any interventional research studies.
Genotype-Guided Abbreviated DAPT Versus Un-Guided De-escalation Therapy in Patients with ACS and HBR

The aim of this study is to assess the safety and efficacy of the CYP2C19 genotype-guided abbreviated dual antiplatelet therapy (DAPT) strategy versus the un-guided stepwise intensity de-escalation of DAPT strategy in patients with acute coronary syndrome (ACS) and high bleeding risk (HBR) undergoing percutaneous coronary intervention (PCI).

Current guidelines recommend reducing the duration of dual antiplatelet therapy (abbreviated DAPT) or de-escalating P2Y12 inhibitor intensity (de-escalation therapy) in patients at risk of major bleeding, even in patients with acute coronary syndromes. A network meta-analysis that indirectly compared these two strategies found that abbreviated dual antiplatelet therapy reduced major bleeding compared with de-escalated dual antiplatelet therapy.

Unlike prasugrel and ticagrelor, which are potent P2Y12 inhibitors, clopidogrel is activated in the liver via the cytochrome P450 2C19 (CYP2C19) metabolic pathway to exert its antiplatelet effects. Its use as monotherapy requires caution, given that CYP2C19 genotypes that may be resistant to clopidogrel are more prevalent in Asian populations than in Western populations.

Therefore, this study aimed to compare the clinical outcomes and confirm the efficacy and safety of an abbreviated dual antiplatelet therapy (Abbreviated DAPT, P2Y12 inhibitor monotherapy) strategy based on CYP2C19 genetic testing and a step-down DAPT strategy (De-escalation therapy) after 1 month of maintenance potent P2Y12 inhibitor-based dual antiplatelet therapy in patients at HBR who underwent PCI for ACS.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be at least 19 years of age
* Patients who is able to understand risks, benefits and treatment alternatives and sign informed consent voluntarily.
* Patients presenting with ACS (ST-elevation myocardial infarction \[STEMI\] or non-ST-elevation \[NSTE\] ACS).
* Patients with at least one lesion with equal or greater than 50% diameter stenosis requiring treatment with drug-eluting stents in native coronary artery or graft.
* Patients with high bleeding risk (by ARC-HBR definition or PRECISE-DAPT score 25 or more)

Exclusion Criteria:

* Patients unable to provide consent.
* Patients who need chronic anti-coagulation therapy.
* Patients suffering from cardiogenic shock or cardiac arrest
* Patients with known intolerance to aspirin, all P2Y12 inhibitors, or components of drug-eluting stents.
* Clinically significant out of range values for platelet count (\< 50,000/mm3) or hemoglobin (\<8 g/dL) at screening
* Non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
* Pregnant or lactating women.
Outcomes of MAKOplasty Patellofemoral Arthroplasty in Younger Active Patients

The primary purpose of this investigation is to report the short-term clinical outcomes (2-3 years) of patellofemoral arthroplasty implanted using the MAKOplasty knee resurfacing system.

The primary purpose of this investigation is to report the short-term clinical outcomes of patellofemoral arthroplasty implanted using the MAKOplasty knee resurfacing system.

The secondary purpose is to compare the short-term outcomes, complication rates, and survival rates of this operation to those of our historical controls of patients who underwent either osteochondral autograft transfer or autologous chondrocyte implantation for full-thickness patellofemoral articular cartilage lesions. The investigators believe these data will provide strong evidence to improve the selection criteria for patellofemoral arthroplasty.

All patients will complete validated questionnaires from the Cincinnati Knee Rating System, including the Sports Activity and Function Form, the Occupational Rating Form, and the Symptom Rating Form. Patients will also complete the SF-12 general health questionnaire. In addition to the above mentioned rating systems, patients will also complete questionnaires on post-surgical expectations and general fitness level.

Eligibility Criteria:
Inclusion Criteria:

* Arthroscopically demonstrated localized and isolated full-thickness articular cartilage lesions (Grade 2B or 3A-B as defined by Noyes \& Stabler9) on the patellofemoral joint.
* Lesion is symptomatic as defined by pain, swelling, locking, or catching that affects daily activities.
* Patient provides informed consent.
* Patient agrees to comply with postoperative rehabilitation program.

Exclusion Criteria:

* Obesity (body mass index greater than 35).
* Arthroscopically demonstrated full-thickness articular cartilage lesions (Grade 2B or 3A-B) in the other compartments of the knee.
* Uncorrected varus or valgus malalignment
* Uncorrected knee joint instability
* Knee arthrofibrosis
* Patient unwilling to comply with postoperative rehabilitation
* Significant muscular atrophy and weakness that does not respond to rehabilitation
* History of alcohol or drug abuse within 3 years of the operation.
* Disabling or widespread osteoarthritis or other joint disease in any other joint.
* Presence of a significant connective tissue disease, autoimmune disease, HIV-positive, or immune deficiency syndrome.
* Any contraindications to surgery or other medical disorder that in the opinion of the principal investigator would interfere with the conduct of the study.
Evaluation of Muscle Involvement in Systemic Sclerosis

Muscle involvement is poorly described in patients with systemic sclerosis (SSc) .

The prevalence of muscle damage is evaluated at 5-95 % of SSc patients, particularly due to variable definitions depending on the series in the scientific litterature. Muscle clinicobiological and histological presentation an response to immunosuppressive treatments are highly variable. Muscle involvement defined by creatinine kinase (CK) elevation, the presence of electromyography (EMG) abnormalities and/or muscle magnetic resonance imaging (MRI) hyperintensities and/or muscle biopsy inflammation appears to be associated with diffuse SSc, the presence of cardiac damage, and anti-PM-Scl antibodies.

The main objective is to describe muscular manifestations associated with SSc.

Secondary objectives are:

* to compare characteristics between SSc patients with and without muscle involvement
* to determine homogeneous groups of SSc patients with muscle involvement


Eligibility Criteria:
Inclusion Criteria:

* Patients with systemic sclerosis according to 2013 ACR/EULAR classification criteria