cyrilzakka/clinical-trials huggingface dataset:
CPET in Evaluation of PH in COPD Patients

* To evaluate the entire course of exercise during CPET in COPD patients.
* To study whether CPET, PFTs and arterial blood gases could discriminate between COPD patients with and without PH.
* To study whether the existence of pulmonary hypertension in COPD is related to characteristic findings in gas exchange and circulatory parameters during cardiopulmonary exercise testing (CPET).

(COPD) is a common cause of pre-capillary pulmonary hypertension (PH). Pulmonary hypertension (PHT) is a common complication of COPD and is determinant for the prognosis of COPD.

PHT is defined as A mean PAP of ≥ 25 mmHg measured by right heart catheterization at rest.

Exercise tolerance in patients with COPD is reduced due to ventilatory limitation, gas exchange abnormalities, and deconditioning as the disease progresses, and this may impair functional capacity and the quality of life.

COPD patients usually terminate physical activity when the ventilatory requirement exceeds their maximal ventilatory capacity.

If they have PH, the altered hemodynamic response may reduce their exercise capacity further.

Nowadays, despite the fact that LTOT improves the survival of hypoxaemic patients, PH is still associated with lower survival rates . Importantly, an elevated Ppa was also associated with an increased risk of severe acute exacerbation in COPD patients with moderate-to-severe airflow limitation .

Impaired exercise tolerance in COPD patients would suggest that cardiopulmonary exercise test (CPET) is a valuable tool to reveal whether they have PH or not.

Transthoracic echocardiography (TTE) is one such tool and is widely available and safe. In addition to its role in diagnosis, it can be used to screen for high-risk patient populations, to assess prognosis and to monitor disease stability and response to treatment.

Eligibility Criteria:
Inclusion Criteria:

* Stable COPD patients
* with age ≥ 40 years.
* Prior to inclusion, the COPD diagnosis was verified by spirometry before and after bronchodilation.
* treatment was optimized and Patients on regular medication.

Exclusion Criteria:

* Patients who refuse to participate in the study.
* Patients underwent thorough pulmonary and cardiologic preinclusion screening, and those with pulmonary disease other than COPD and emphysema.
* arrhythmia
* valvular or coronary heart disease
* left ventricle dysfunction
* obstructive sleep apnea syndrome
* pulmonary embolism
* systemic hypertension ≥160/90 mmHg
* inflammatory disease
* hyperthyroidism
* renal failure
* inability to exercise (due to orthopedic, neurologic or musculoskeletal problem).
Transarterial Radioembolization (TARE) in COlorectal MEtastasis of Liver

Radioembolization is an established treatment option for patients with unresectable primary and secondary liver tumors. Microspheres containing 90Y are injected intraarterially to deliver a high radiation dose to the tumors. Despite of our knowledge on the effectiveness of 90Y glass microspheres in the treatment of HCC, literature data on the treatment of metastatic colorectal cancer (mCRC) patients with 90Y glass microspheres is limited. In the recent EANM guideline variable healthy liver doses are recommended for patients with mCRC with an effective tumor dose recommendation based on a study with limited number of patients.

Primary objectives; Investigate effective tumor dose and safe healthy liver dose in radioembolization for colorectal cancer liver metastasis using multicompartment dosimetry Secondary objectives; Investigate dose-response and dose-toxicity relationships, time to progress, concordance between pretreatment and posttreatment dose calculations.


Eligibility Criteria:
Inclusion Criteria:

* over 18 years old
* histopathologically proven colorectal cancer diagnosis
* treated with radioembolization for liver metastases with Y90 glass microspheres in lobar or segmental fashion
* have follow-up data at least 6 months after radioembolization

Exclusion Criteria:

* no PET-CT, CT or MR of the liver within last 6 weeks prior to radioembolization.

No PET-CT, CT or MR of the liver 2-4 months after radioembolization Poor image quality Previous local treatment or surgery for the liver
A Study to Investigate the Safety and Efficacy of TEG002 in Relapsed/Refractory Multiple Myeloma Patients

This is a single arm, open-label, multicenter phase I study to assess the safety, tolerability and preliminary efficacy of autologous T cells transduced with a specific γδTCR, i.e. TEG002, in a dose escalation and expansion study in relapsed/refractory Multiple Myeloma patients.

The study will comprise of a Dose Escalation Segment and an Expansion Segment. The study consists of a screening period, leukapheresis of mononuclear cells, and conditioning chemotherapy, followed by TEG002. All subjects continue to be followed regularly for safety and efficacy assessments until 1 year after TEG002 administration.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Adult
* Relapsed or refractory Multiple Myeloma as defined by the IMWG
* Life expectancy ≥3 months
* ECOG performance status 0 or 1
* Adequate vital organ function
* Adequate bone marrow function
* Toxicities from prior/ongoing therapies recovered to ≤ Grade 2 or subject's baseline
* WCBP and men who can father children must be willing and able to use adequate contraception

Exclusion Criteria:

* Any uncontrolled medical or psychiatric disorder that would preclude participation as outlined
* Pregnant or lactating women
* Amyloidosis
* Uncontrolled infection(s)
* Active CNS disease
* Previous allogeneic-HSCT
* History of another primary malignancy that requires intervention beyond surveillance or that has not been in remission for at least 1 year.
* Subjects that received experimental or systemic therapy \< 14 days before TEG002 infusion
* NYHA Class ≥ II
* Patients depending on dialysis
* Patients with a history of pulmonary embolism or deep vein thrombosis
* T cell mediated active autoimmune disease OR any active autoimmune disease requiring immunosuppressive therapy
First-line FOLFOXIRI Plus Bevacizumab in BRAF Mutant Metastatic Colorectal Cancer

The purpose of this study is to prospectively verify if FOLFOXIRI plus bevacizumab as first-line treatment could be considered a promising approach to improve the outcome of BRAF mutant metastatic colorectal cancer patients


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed colorectal adenocarcinoma;
* Availability of formalin-fixed paraffin embedded tumor block from primary and/or metastasis;
* BRAF V600E mutant status of primary colorectal cancer and/or related metastasis;
* Unresectable and measurable metastatic disease according to RECIST criteria;
* Male or female, aged \> 18 years and \< 75 years;
* ECOG PS \< 2 if aged \< 71 years;
* ECOG PS = 0 if aged 71-75 years;
* Life expectancy of more than 3 months;
* Adequate haematological function: ANC ≥ 1.5 x 10\^9/L; platelets ≥ 100 x 10\^9/L, Hb ≥ 9 g/dL;
* Adequate liver function: serum bilirubin ≤ 1.5 x ULN; alkaline phosphatase and transaminases ≤ 2.5 x ULN (in case of liver metastases ≤ 5 x ULN);
* Serum creatinine ≤ 1.5 x ULN;
* Previous adjuvant chemotherapy is allowed if more than 12 months have elapsed between the end of adjuvant therapy and first relapse;
* At least 6 weeks from prior extended radiotherapy and 4 weeks from surgery;
* Written informed consent to experimental treatment and molecular analyses.

Exclusion Criteria:

* Presence or history of CNS metastasis;
* Serious, non-healing wound, ulcer, or bone fracture;
* Evidence of bleeding diathesis or coagulopathy;
* Uncontrolled hypertension;
* Clinically significant (i.e. active) cardiovascular disease for example cerebrovascular accidents (CVA) (≤6 months before treatment start), myocardial infarction (≤ 6 months before treatment start), unstable angina, NYHA ≥ grade 2 chronic heart failure (CHF), uncontrolled arrhythmia;
* Current or recent (within 10 days prior to study treatment start) ongoing treatment with anticoagulants for therapeutic purposes;
* Chronic, daily treatment with high-dose aspirin (\>325 mg/day);
* Symptomatic peripheral neuropathy ≥ 2 grade NCIC-CTG criteria;
* Active uncontrolled infections;
* Treatment with any investigational drug within 30 days prior to enrolment;
* Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of curatively treated basal and squamous cell carcinoma of the skin or in situ cancer of the cervix;
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start;
* Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome;
* Fertile women (\< 2 years after last menstruation) and men of childbearing potential not willing to use effective means of contraception.
Efficacy of Idarubicin, Cytarabine and Cyclophosphamide (IAC) Regimen in Relapsed/Refractory AML

In this multi-center, randomized, open-label, prospective clinical trial, a total of 60 relapsed/refractory AML patients will be randomized into 2 groups. In the experimental arm, patients receive IAC regimen. In the control arm, patients receive other physician-directed regimen. The primary end point is complete remission rate.

In this multi-center, randomized, open-label, prospective clinical trial, a total of 60 relapsed/refractory AML patients will be randomized into 2 groups. Patients in the IAC arm receive the therapy consisting of idarubicin 10 mg/㎡/d on days 1-3, cytarabine 100mg/㎡/d on days 1-7 and cyclophosphamide at a dose of 350mg/㎡/d on the second day and the fifth day. In the control arm, patients received other physician-directed regimen including fludarabine, cytarabine with/without granulocyte stimulating factor(FLA±G) regimen,cytarabine plus daunorubicin(DA）regimen , decitabine,aclacinomycin and cytarabine(decitabine plus AA) regimen or AA regimen plus granulocyte stimulating factor. All the regimen in the control arm can not contain cyclophosphamide. The primary end point is complete remission. The second end points include overall survival, relapse-free survival and time to treatment failure.

Eligibility Criteria:
Inclusion Criteria:

1. Age of less than 60 years old;
2. Patients that meet the diagnostic criteria(WHO 2008 criteria) of AML (except APL subtypes).
3. Patients with a confirmed pathologic diagnosis of AML which had relapsed or refractory.
4. Patients with ECOG score of ≤ 2;
5. Adult patients are willing to participate in the study and sign the informed consent by themselves or by their immediate family. Patients under 18 years old willing to participate should have their legal guardians sign the informed consent.

Exclusion Criteria:

1. Patients who had received reinduction therapy including cyclophosphamide are excluded. However, patients who had received regimens including cyclophosphamide before relapse are eligible.
2. Patients with other blood diseases(for example, haemophiliacs) are excluded.
3. Relapsed patients with only extramedullary leukemia;
4. After allogeneic hematopoietic stem cell transplantation;
5. With mutation of breakpoint cluster region-Abelson(BCR-ABL) fusion gene and in need of tyrosine kinase inhibitors therapy;
6. Acute panmyelosis with myelofibrosis and myeloid sarcoma patients;
7. Had other malignant tumor in need of treatment;
8. Had active cardiovascular disease;
9. Patients with other factors which were considered unsuitable to participate in the study by the investigators.
Zenith® LP Abdominal Aortic Aneurysm (AAA) Post-Market Registry

A registry to collect additional prospective intra-operative and follow-up information on physician use of the CE-marked Zenith® Low Profile Abdominal Aortic Aneurysm (AAA) Endovascular Graft under routine clinical care.


Eligibility Criteria:
Inclusion Criteria:

* Patient is implanted with Zenith® Low Profile AAA Endovascular Graft

Exclusion Criteria:

* Patients for whom this device would not normally be considered standard of care.
Long-Term Study on Safety and Immunogenicity of HEPLISAV™ and Engerix-B® in Adults With Chronic Kidney Disease

The purpose of this study is to determine the durability of seroprotection of HEPLISAV™ and Engerix-B® and the number of injections of each vaccine needed to maintain seroprotection in a cohort of chronic kidney disease (CKD) patients over time.

An Observational Study Evaluating the Long-Term Safety and Immunogenicity of HEPLISAV™ compared with Engerix-B® in Adults with Chronic Kidney Disease who Have Previously Received At Least One Hepatitis B Vaccine Series

Eligibility Criteria:
Inclusion Criteria:

A subject must meet all of the following inclusion criteria to participate in the study:

* enrolled and completed HEPLISAV or Engerix-B treatment in: DV2-HBV-17 or DV2-HBV-18 and had anti-HBsAg ≥ 10 mIU/mL prior to or during DV2-HBV-18
* previously received a complete primary hepatitis B vaccine series in DV2-HBV-17 or prior to enrollment in DV2-HBV-18
* be otherwise clinically stable in the opinion of the investigator
* be able and willing to provide informed consent

Exclusion Criteria:

A subject who meets any ONE of the following exclusion criteria is not permitted to participate in the study:

* previously enrolled in DV2-HBV-18 and never obtained anti-HBsAg ≥ 10 mIU/mL
* received hepatitis B vaccine off-study after enrolling in DV2-HBV-17 or DV2-HBV-18
* has known history of autoimmune disease
* is unwilling or unable to comply with all the requirements of the protocol
The Perioperative Management of Anti-thrombotic Drug Registry

The purpose of the study is to investigate contemporary antiplatelet therapy management of patients referred for non-cardiac and cardiac surgical procedures while on chronic therapy with antiplatelet and/or anticoagulant drugs. These medications are routinely prescribed to patients following percutaneous coronary interventions (PCI), known diagnosis of atrial fibrillation, prosthetic heart valves, transcatheter aortic valve procedures, pulmonary embolism, deep vein thrombosis, peripheral artery revascularization procedures etc. This is a highly relevant and understudied clinical area with no randomized clinical trials or large-scale prospective evidence, except for bridging data with unfractionated heparin (UFH). Most recommendations and guidelines are based on consensus expert opinion. While post-PCI patients, especially those treated with coronary stents are placed on dual antiplatelet agents such as aspirin and P2Y12 blocking agents, performing surgery while on these agents increase the risk of hemorrhagic complications, discontinuation or interruption of dual antiplatelet therapy (DAPT) has been associated with adverse ischemic outcomes secondary to myocardial infarction (MI) and stent thrombosis (ST). Moreover, there is only no clear consensus regarding continuation of aspirin perioperatively in these patients. As in the case of PCI, similar arguments for juxtaposed risks (thrombosis vs. bleeding) can be made for a myriad of clinical situations where chronic (≥45 days) use antiplatelet and anticoagulant medication (together referred to as antithrombotic drugs) are indicated. In addition, there are many procedures and surgeries with different bleeding and ischemic risks that cannot be studies through dedicated randomized studies and a registry collection of such information could provide valuable guidance to providers and patients worldwide.


Eligibility Criteria:
Inclusion Criteria:

* Treatment with antiplatelet and/or anticoagulant medications for ≥45 days prior to the date of NCS.
* Patients with planned, urgent or emergent cardiac or non-cardiac surgery or procedure (CNCS)

Exclusion Criteria:

* None
TPF Induction With Concomitant Chemoradiation to Treat Patients With Head and Neck Cancer

The purpose of this trial is to compare two different treatments for fit patients with head and neck cancer:

All patients are given induction-chemotherapy (docetaxel, cisplatin, 5-FU).

Subsequently patients are being randomised into two groups:

* The first group receives neo-adjuvant chemotherapy ('high' dose cisplatin) and conventional radiotherapy
* The second group receives neo-adjuvant chemotherapy ('low' dose cisplatin) and accelerated radiotherapy.

Induction Chemotherapy TPF(arm A and B)

: Docetaxel 75 mg/m2 iv on day 1, Cisplatin 75 mg/ m2 iv on day 1, 5-FU 750 mg/ m2/day iv continuous infusion (in Hickman or port a cath) on days 1-5; prophylactic G-CSF

This cycle will be repeated every 21 days for a maximum of 4 cycles. Clinical evaluation after each cycle and radiological evaluation after 2 cycles will take place. In case of PD or SD (after 2 cycles) with no minor response (no decrease in measurable disease from baseline) concomitant chemoradiotherapy will started per protocol.

Surgery The investigators in each centre can decide neck surgery for residual tumor

Eligibility Criteria:
Inclusion Criteria:

Histology and staging disease

* Histologically or cytologically proven non-metastatic locally advanced HNSCC, stage III or IV, for which concomitant chemo-radiotherapy would be the standard therapy
* Patients can be included either with irresectable disease or for which the concomitant chemoradiotherapy was chosen for organ preservation
* Measurable disease
* Primary site: oral cavity, oropharynx, hypopharynx and larynx

General conditions

* Written informed consent
* Age \>18 years and ≤ 65 years
* WHO performance status 0-1
* Adequate bone marrow function (WBC \> 3.0 x 109/L, platelets \> 100 x 109/L, Hb \> 6 mmol/L)
* Adequate hepatic function: total bilirubin \< 1. 5 x upper normal limit, ASAT and ALAT \< 2.5 x upper normal limits
* Adequate renal function: calculated creatinin clearance \> 60ml/min. (Cockcroft-Gault formula) Other
* Expected adequacy of follow-up.

Exclusion Criteria:

General conditions

* Active alcohol addiction
* Admission for COPD in the last 12 months
* Weight loss \> 10% in 3 months before entry
* Pregnancy or lactation
* Patients (M/F) with reproductive potential not implementing adequate contraceptives measures

Prior or current history

* Prior surgery, radiotherapy or chemotherapy for this tumor
* Serious concomitant diseases preventing the safe administration of chemotherapy and/or radiotherapy or likely to interfere with the study assessments
* Serious active infections
* Other malignancies in the past 5 years with the exception of adequately treated carcinoma in situ of the cervix, or squamous or basal cell carcinoma of the skin

Concomitant treatments

* Concomitant (or within 4 weeks before randomisation) administration of any other experimental drug under investigation
* Concurrent treatment with any other anti-cancer therapy
A Study to Detect V-Raf Murine Sarcoma Viral Oncogene Homolog B1 (BRAF) V600 Mutation on Cell-Free Deoxyribonucleic Acid (cfDNA) From Plasma in Participants With Advanced Melanoma

This is a single arm, multicenter, open label, and non-randomized clinical study on adult participants with unresectable or metastatic melanoma. The study will be conducted in two phases. Pre-screening phase will assess the BRAF V600 mutation in a new mutation analysis triggered by a mutant plasma cfDNA test result. Treatment phase will assess the clinical outcome for the participants treated with vemurafenib plus cobimetinib. The length of the study will be approximately 38 months.


Eligibility Criteria:
Inclusion Criteria:

Pre-screening phase:

* Participants with histologically confirmed cutaneous melanoma, either unresectable Stage IIIc or Stage IV metastatic melanoma, as defined by American Joint Committee on Cancer 7th edition
* Documentation of BRAF V600 test result mutation-positive status on melanoma tumor tissue using a validated tissue test

Treatment Phase:

* Eastern Cooperative Oncology Group performance status of 0-2
* Adequate hematologic and end organ function obtained within 14 days prior to first dose of study drug treatment
* Negative serum pregnancy test prior to commencement of dosing in women of childbearing potential
* Absence of any psychological, familial, sociological, or geographical condition that potentially hampers compliance with the study protocol and treatment regimen and follow-up after treatment discontinuation schedule
* Female participants of childbearing potential and male participants with partners of childbearing potential must agree to always use two effective forms of contraception during the course of this study and for at least 6 months after completion of study therapy
* Participants should be able to swallow tablets
* Documentation of BRAF mutation positive status in melanoma tissue

Exclusion Criteria:

Treatment Phase:

* History of prior rapidly accelerated fibrosarcoma or mitogen-activated protein kinase pathway inhibitor treatment
* Use of prior chemotherapy or immunotherapy (including treatment with an anti-programmed death 1, or anti- programmed death ligand 1 or anti-cytotoxic T-lymphocyte-associated protein 4 monoclonal antibody) within 4 weeks before first study drug administration
* Palliative radiotherapy within 14 days prior to the first dose of study treatment
* Evidence of retinal pathology on ophthalmologic examination
* Systemic risk factors for retinal vein occlusion
* History of clinically significant cardiac dysfunction
* Current severe, uncontrolled systemic disease
* Pregnancy, lactating or breast feeding
* Intake of St. John's wort or hyperforin (a potent cytochrome P450 3A4 \[CYP3A4 enzyme inducer\] and grapefruit juice (a potent CYP3A4 enzyme inhibitor) at least 7 days prior to initiation of and during the study treatment