cyrilzakka/clinical-trials huggingface dataset:
Automation Oxygen Flow Titration in Spontaneously Breathing Infants

The objective of this study is to assess the efficacy of the FreeO2 device in shortening the hospital length of stay during a first episode of hypoxemic bronchiolitis in infants less than 1 year of age.

FreeO2Bronchio study is a multicenter, prospective, controlled, randomized, open-label study.

This is a controlled, randomized, open-label, multicentre trial. Patients will be included after written informed consent will be obtained from the patients' parents or legally authorized representatives. Patients will be randomized either in the "FreeO2" group for automatic oxygen flow titration or in the "manual" group for Oxygen therapy with manual flow titration. The SpO2 will be recorded continuously in both groups of the study using the FreeO2 device throughout the duration of hospitalization; In the group "FreeO2 ", the device will record the data continuously and allow the automation of oxygen titration - in the group "Manual", the device will only be used to monitor SpO2 and heart rate.

Eligibility Criteria:
Inclusion Criteria:

* Infants from 1 month of age and less than 1 year of age who present a first episode of bronchiolitis and require oxygen therapy
* Informed consent of parents (written informed consent will be obtained from the patients' parents or legally authorized representatives)
* Affiliation to the French social security system

Exclusion Criteria:

* Need for oxygen flow higher than 3 L / min to maintain SpO2 greater than 92%
* Patient with severity criteria according to the 2019 French National Authority for Health (HAS) guidelines and for whom it's indicated to maintain SpO2 above 94%
* Criteria of severity justifying from the start another technique of assisted ventilation:

  * Polypnea: respiratory rate (FR)\> 80 c / min.
  * Consciousness with glasgow score (GSC) \<or = 12. Hemodynamic instability (mean arterial pressure (MAP) \<- 2 SD for age or use of vasopressors).
  * Cardiac or respiratory arrest.
  * PCO2\> 55 mm Hg and pH \<7.20 when blood gas are performed
* Need for urgent surgery
* Contraindication to the FreeO2 device as described in the user manual
* Lack of informed consent from parents
* Premature birth with a gestational age at birth under 36 weeks
* Severe co-morbidities (cystic fibrosis, immune deficiency, congenital heart disease, neuromuscular illness)
Haemostasis and Therapeutic Hypothermia

The purpose of this study is to investigate, if the haemostasis is impaired in cardiac arrest patients during therapeutic hypothermia compared with normothermia.

Treatment with mild therapeutic hypothermia, 32-34 °C for 12-24 hours, has shown to improve the neurologic outcome in comatose survivors of out-of-hospital cardiac arrest. Hypothermia is suspected to inhibit haemostasis and therefore cardiac arrest patients with a risk of bleeding are not treated with therapeutic hypothermia. However, the impact on the coagulation system during mild therapeutic hypothermia, has not yet been fully investigated.

The investigators aim to investigate if mild therapeutic hypothermia influences haemostasis. We are including survivors of cardiac arrest, who are treated with hypothermia for 24-48 hours.

Blood will be sampled during hypothermia and secondly during normothermia. 30 minutes after the blood are sampled it will be analyzed using a sensitive low-tissue-factor assay with rotational thromboelastometry (ROTEM®). All the dynamic coagulation parameters obtained on the ROTEM® at hypothermia and normothermia, respectively, will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Treatment with therapeutic hypothermia, for minimum 24 and up to 48 hours, due to cardiac arrest.

Exclusion Criteria:

* age \<18 years.
Endoscopic Papillary Large Balloon Dilatation Versus Mechanical Lithotripsy for Large Stones

Endoscopic sphincterotomy (EST) combined with large balloon dilation (LBD) has been increasingly accepted as alternative method for removal of large bile duct stones. However, there were limited studies comparing the efficacy of EST in combined with LBD to EST with mechanical lithotripsy (ML). The purpose of this study to compare the efficacy and safety of combined EST- LBD versus EST-ML in the removal of very large bile duct stones.

The large common bile duct stones (CBDS) remains a therapeutic challenge in ERCPs. Large CBDS are generally refractory to be removed by EST and stone extraction balloons and or baskets. Traditional rescue therapy was the technique of stone fragmentation using ML. The previous reports have shown that EST with ML was successful in the fragmentation of large stones yielding stone clearance rate from 68 t0 79 %. EST-LBD has been shown favorable outcome in the treatment of large bile duct stone. A meta-analysis comparing the effectiveness and complications between EST-LBD and EST in the management of CBDS showed that EST-LBD was as effective as EST for the removal of large or difficult of CBDS in terms of stone clearance in the first ERCP session of 87.87 % vs. 84.15 % and overall clearance of 97.35 % vs. 96.35 % but EST-LBD was associated with fewer complications as well as reduced need for ML compared to EST. The efficacy of EST-ML versus EST-LBD as a therapy for relatively large CBDS, a mean stone size \> 20 mm in currently not well defined. The investigators, herein, compared the efficacy and complications between EST followed by LBD or ML for the removal of CBDS \> 15 mm with a mean stone size \> 20 mm.

Eligibility Criteria:
Inclusion Criteria: -Patients with age\>/= 18 years with confirmed or suspected CBDS at our institute were enrolled in the study.

* Informed consent was obtained in every patients prior to the procedure
* Patients were randomized to LBD or ML if they had CBD stone \>/= 15 mm in shortest dimension or stone' size was disproportionate to the lower bile duct segment with a ratio of largest stone dimension/lower bile duct segment diameter \> 50 % identified by a cholangiogram at ERCP.

Exclusion Criteria:-pregnant woman

* uncorrectable coagulopathy (INR \>1.5 ), thrombocytopenia( platelet count \< 50,000)
* concomitant intrahepatic duct stones
* ongoing acute pancreatitis or acute cholecystitis
* surgically altered anatomy (i.e. Billroth II or Roux-en-Y reconstruction)
* concomitant pancreatic or biliary malignancy
Radiation Therapy in Treating Patients With Prostate Cancer

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether standard radiation therapy is more effective than high-dose radiation therapy in treating patients with prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of standard radiation therapy with that of high-dose radiation therapy in treating patients with stage II or stage III prostate cancer.

OBJECTIVES:

* Compare local tumor control in patients with stage II or III prostate cancer treated with neoadjuvant androgen deprivation therapy with standard vs high-dose conformal radiotherapy.
* Compare the incidence of biochemical failure (prostate-specific antigen (PSA) greater than 2 ng/mL at 6 or more months after initiation of radiotherapy and PSA rising from nadir level by at least 50%), development of metastases, and survival in patients treated with these regimens.
* Compare the acute and late radiation-induced side effects of these regimens in this patient population.
* Compare aspects of quality of life, health economics, models of normal tissue, and tumor control in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prostate-specific antigen, T stage, and Gleason score. Patients are randomized to one of two treatment arms.

All patients receive neoadjuvant androgen deprivation with luteinizing hormone-releasing hormone agonists every 4 weeks beginning 3-6 months before initiation of radiotherapy and continuing until completion of radiotherapy.

* Arm I: Patients undergo standard conformal radiotherapy for 6.5 weeks.
* Arm II: Patients undergo high-dose conformal radiotherapy for 7.5 weeks. Quality of life is assessed at baseline, every 6 months for 2 years, and then annually thereafter.

Patients are followed every 6 months for 2 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 800 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed prostate cancer

  * T1b-T3a, N0, M0 (stage II or III)
* Prostate-specific antigen at least 50 ng/mL

PATIENT CHARACTERISTICS:

Age:

* Not specified

Performance status:

* WHO 0-1

Life expectancy:

* Not specified

Hematopoietic:

* WBC greater than 4,000/mm\^3
* Platelet count greater than 100,000/mm\^3
* Hemoglobin greater than 11 g/dL

Hepatic:

* Not specified

Renal:

* Not specified

Other:

* No significant past medical history that would preclude radical radiotherapy
* No condition that would preclude standard radiotherapy
* No hip prosthesis

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* Not specified

Endocrine therapy:

* No prior androgen deprivation therapy

Radiotherapy:

* No prior pelvic radiotherapy

Surgery:

* No prior radical prostatectomy
A Study Comparing Obinutuzumab and BGB-3111 Versus Obinutuzumab Alone in Treating R/R Follicular Lymphoma

he purpose of the study is to evaluate the efficacy, safety, and tolerability BGB-3111 plus obinutuzumab versus obinutuzumab alone in participants with relapsed/refractory non-Hodgkin follicular lymphoma.


Eligibility Criteria:
Key Inclusion Criteria:

1. Histologically confirmed diagnosis of B-cell follicular lymphoma
2. ≥2 prior systemic treatments for follicular lymphoma.
3. Previously received an anti-CD20 antibody and an appropriate alkylator-based combination therapy.
4. Disease progression after completion of most recent therapy or refractory disease.
5. Presence of measurable disease.
6. Availability of archival tissue confirming diagnosis.
7. Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2.
8. Adequate renal and hepatic function.

Key Exclusion Criteria:

1. Prior exposure to a Bruton's tyrosine kinase (BTK) inhibitor.
2. Known central nervous system involvement by leukemia or lymphoma.
3. Evidence of transformation from follicular lymphoma to other aggressive histology.
4. Allogeneic hematopoietic stem cell transplantation within 12 months of enrollment
5. Prior malignancy within the past 2 years, except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix of breast, or localized Gleason score 6 prostate cancer.
6. Clinically significant cardiovascular disease.
7. Major surgery ≤ 4 weeks prior to start of study treatment.
8. Active fungal, bacterial or viral infection requiring systemic treatment.
9. History of severe bleeding disorder.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
The AT-REBOA Target Trial

Temporary aortic occlusion can limit haemorrhage, can help to maintain perfusion to the heart and brain, and may be associated with improved survival. Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) potentially provides a relatively quick means of achieving this temporary control.

In the past years, studies have tried to evaluate the benefit for this method with conflicting results. The previous UK-REBOA trial has not found any benefit in the intervention group and has even hinted at possible harm caused by the intervention. A major limitation of this study is the low number of interventions performed in participating trauma centres and the associated potentially insufficient experience with REBOA.

The aim of this study is to evaluate the effectiveness of REBOA in a setting with already experienced providers.


Eligibility Criteria:
Inclusion criteria:

* aged, or believed to be aged, 16 years or above
* confirmed or suspected life-threatening torso or lower body trauma
* thought to benefit from trauma resuscitation with REBOA

Exclusion criteria:

* penetrating chest trauma
* known or suspected pregnancy at presentation
* prehospital thoracotomy
* severe burns injuries.
Sotatercept on Central Cardiopulmonary Performance and Peripheral Oxygen Transport During Exercise in Pulmonary Arterial Hypertension

The purpose of this study is to see if the drug sotatercept given for 36 weeks improves the functioning of the heart and improves quality of life.


Eligibility Criteria:
Inclusion Criteria

* Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
* NYHA Class II-IV.
* LVEF ≥ 40 % within the preceding year.
* No recent initiation of pulmonary vasodilator in the last 60 days.
* Pulmonary arterial hypertension by right heart catheterization (Mean PA pressure ≥ 20 mmHg with PVR\>2 Wood units) with no evidence of heart failure with preserved ejection fraction (exercise PCWP \<25 mm Hg).
* Symptomatic PAH patients with plan to undergo exercise RHC for reassessment of exertional symptoms.

Exclusion Criteria

* Myocardial infarction, stroke, hospitalization for heart failure, unstable angina pectoris or transient ischemic attack within 30 days prior to the day of screening.
* Planned coronary, carotid, or peripheral artery revascularization.
* Any other condition judged by the investigator to be the primary cause of dyspnea (such as heart failure due to restrictive cardiomyopathy or infiltrative conditions (e.g., amyloidosis), hypertrophic obstructive cardiomyopathy, anemia, or more than moderate mitral or aortic heart valve disease).
* Wheelchair bound or orthopedic inability to exercise.
* Chronic hypoxemia with inability to exercise without oxygen supplementation.
* Skeletal muscle myopathy.
* History of rhabdomyolysis.
* Participation in any clinical trial of an approved or non-approved device for the treatment of pulmonary hypertension within 30 days before screening.
* Receipt of any investigational medicinal product within 30 days before screening.
* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method.
* Major surgery scheduled for the duration of the trial, affecting walking ability in the opinion of the investigator.
* Any disorder, including severe psychiatric disorder, suicidal behavior within 90 days before screening, and suspected drug abuse, which in the investigator´s opinion might jeopardize subject´s safety or compliance with the protocol.
Heart Failure Recorded in Primary Care, Hospital Admissions and National Mortality Registry

The main objectives of this study are i) to assess how heart failure was captured accross different linked electronic health record sources within the CALIBER program and the overlap between primary care, hospital admissions and/or the national mortality register, and ii) to assess risk factors, heart failure treatment and survival in patients, stratified by EHR source.

Heart failure (HF) is one of the leading causes of hospital admissions and mortality in modern healthcare systems. It can be viewed as a collective clinical syndrome of many signs and symptoms and is frequently the common endpoint of various heart diseases. Often, it is not diagnosed until it has reached a level whereby quality of life is significantly, and often irreversibly, impaired. Even though vast quantities of National Health Service (NHS) data concerning patients with heart failure are recorded, there are limited 'real world' longitudinal insights about the prognosis and consequences of HF. Although linked electronic health records cohorts such as the CALIBER program become increasingly available, for heart failure the overlap, risk factors and subsequent mortality have not been compared. Previous studies on heart failure using EHR sources have used ICD-9 or 10 codes for the identification of heart failure cases and the prevalence estimates of risk factors and comorbidity. Furthermore, the assessment of supporting information for heart failure present in electronic healthcare registries remains largely unknown. Currently, heart failure is typically inferred based on previous reports or the prescription of heart failure related medication. To strengthen heart failure case ascertainment in large electronic healthcare registries, linkages with primary care data such as what is done in CALIBER could allow more detailed insight in medical history, clinical diagnoses, anthropometric measures, health behaviour, laboratory tests, medical procedures and prescriptions.

In this study, the investigators assessed the distribution of recording, supportive medical information for heart failure diagnosis, risk factors and subsequent mortality of heart failure patients captured in linked EHR data from primary care, hospital admissions and/or death registry.

This study is part of the CALIBER (Cardiovascular disease research using linked bespoke studies and electronic records) programme funded over 5 years from the NIHR and Wellcome Trust. CALIBER has received both Ethics approval (ref 09/H0810/16) and ECC approval (ref ECC 2-06(b)/2009 CALIBER dataset).

Eligibility Criteria:
Inclusion Criteria:

* Patients with a coded diagnosis for heart failure in primary care or hospital admission
* Patients with a coded diagnosis for heart failure as a cause of death in the national mortality register
* Patients in CPRD practices which are deemed "up to standard" for more than 1 year by CPRD criteria.
* Patients with at least one year of follow-up in the CPRD practice CPRD.

Exclusion Criteria:

* past medical history of heart failure
Intensity-Modulated Radiation Therapy (IMRT) in the Treatment of Non-Anaplastic Non-Medullary Thyroid Cancer

The purpose of this Phase 2 study is to find out what effect, good and/or bad, external beam radiation therapy, has on the patient and their thyroid cancer where surgery is not an option or where despite surgery, the disease is still present.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed diagnosis of non-anaplastic non-medullary thyroid cancer that is either grossly recurrent after surgery or unresectable with or without metastatic disease.
* Age ≥18 years
* Karnofsky performance status ≥70%
* Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months after treatment.
* Patients must have ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Women who are pregnant or lactating
* Inability to comply with study and/or follow-up procedures
An Asian Study to Evaluate Efficacy and Safety of Oral Enzalutamide in Progressive Metastatic Prostate Cancer Participants

Purpose of the study was to assess the effect of enzalutamide on time to Prostate Specific Antigen (PSA) progression as compared to placebo in chemotherapy naïve participants with progressive metastatic prostate cancer who have failed androgen deprivation therapy.

The study was a multinational Phase 3, randomized, double-blind, placebo-controlled efficacy and safety study of oral enzalutamide (formerly MDV3100) in asymptomatic or mildly symptomatic participants with progressive metastatic prostate cancer who have disease progression despite androgen deprivation therapy. In order to join the study, participants could not have been previously treated with cytotoxic chemotherapy. Approximately 30 Chinese participants were allocated to the pharmacokinetic (PK) cohort. Participants in the PK cohort were required to be hospitalized from Day 1 before the randomization date to at least the completion of all the assessments planned on Day 3. All participants in the PK cohort underwent blood sampling for the PK analysis. Data reported in the results section was based on data cutoff dates of 20 Sept 2015 for efficacy and safety data and 20 Jan 2016 for PK outcome measures. The study completed double-blind period and is now in the open-label period.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features
* Ongoing androgen deprivation therapy with a GnRH analogue or bilateral orchiectomy
* Progressive disease despite androgen deprivation therapy as defined by rising PSA levels or progressive soft tissue or bone disease
* No prior treatment with cytotoxic chemotherapy
* Asymptomatic or mildly symptomatic from prostate cancer

Exclusion Criteria:

* Severe concurrent disease, infection, or co-morbidity that, in the judgment of the Investigator, would make the patient inappropriate for enrollment
* Known or suspected brain metastasis or active leptomeningeal disease
* History of another malignancy within the previous 5 years other than curatively treated non-melanomatous skin cancer
* History of seizure including febrile seizure or any condition that may predispose to seizure (e.g., prior stroke, brain arteriovenous malformation, head trauma with loss of consciousness requiring hospitalization).
The FuSion Program: A Prospective and Multicenter Cohort Study of Pan-Cancer Screening in Chinese Population

The integrative study by Fudan and Singlera for cancer early detection(The FuSion Program ) will evaluate sensitivity,specificity and positive/negative predictive value of the screening model jointly developed by FuDan University and Singlera in a 2-year follow-up corhort including 10,000 persons in routine annual physicals from dozens of hospitals. The multi-omics model for pan-cancer screening will be developed in a 3-year follow-up corhort including 50,000 natural persons in community containing genetic information of tumor families, assessment of epidemiological risk factors, tumor markers, proteomics, genomics and DNA methylation. After optimizing, the ability of this model will be validated in the Taizhou corhort in reality.


Eligibility Criteria:
Inclusion Criteria:

1. Take physical examinations in our research centers and have no cancer history;
2. "Population Health tracking Survey - simplified version of the questionnaire" must be filled according to the research program and an annual physical examination can be received as follow-up ;
3. Timely feed back the information related to tumor diagnosis in other hospitals to the investigator during the program;
4. Have no birth plan for the last 3 years;
5. Fully understand the study and voluntarily sign the informed consent.

Exclusion Criteria:

1. Have been diagnosed with esophageal cancer, gastric cancer, colorectal cancer, liver cancer, lung cancer, pancreatic cancer, breast cancer (including non-primary, such as recurrence, metastasis or other complications) and other malignant tumors;
2. Received blood transfusion, transplantation and other major operations within 3 months;
3. Participated in other interventional clinical researchs within 3 months;
4. Pregnant or lactating women;
5. Patients with autoimmune diseases, genetic diseases, mental diseases/disabilities and other diseases considered unsuitable for the study by the investigator;
6. Due to poor compliance, the researcher judged that the study could not be completed.