cyrilzakka/clinical-trials huggingface dataset:
3D Imaging: Prognostic Role in Pulmonary Arterial Hypertension

Pulmonary hypertension is a rare and severe disease, affecting a young population. Survival is very poor and has been closely related to right ventricular dysfunction. Current prognostic equations rely mostly on right heart catheterization data. The identification of simple echocardiographic prognostic factor is urgently needed. It could help identifying with a non invasive method, high risk patients who could benefit from an intensive specific therapy. 3D right ventricular imaging is a new echocardiographic tool which provides RV volumic analysis, RV ejection fraction, overcoming the classical limits of 2D ultrasound.

The aim of this study is to validate a new software for 3D analysis of the right ventricle and assess its prognostic role in pulmonary hypertension.

To do so, the investigators will realize a prospective monocentric longitudinal cohort study, including 100 pulmonary hypertension patients. Echocardiographic data will be collected at baseline and after 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years old
* Pulmonary hypertension diagnosed by right heart catheterization
* Informed consent obtained
* Affiliation to the French national health insurance

Exclusion Criteria:

* Associated significant left heart disease
* Sub-optimal acoustic windows
* Patient unable to attend follow-up visits
Drug Eluting Balloon for Prevention of Constrictive Remodeling

Earlier studies indicated that Percutaneous coronary intervention (PCI) may be problematic in diffuse small vessel disease especially of diabetic patients. High restenosis rates after balloon only procedures in small vessels occur due to negative constrictive vessel remodeling if DES (drug eluting stents) are not used and prolonged anti-platelet therapy is not indicated. The main hypothesis of the trial is that in analogy to DCB success in peripheral arterial disease (PAD), cellular toxicity of the drug paclitaxel eluting from a IN.PACT FalconTM DCB will prevent constrictive remodelling of small coronary vessel segments after dilatation. The IN.PACT FalconTM DCB is compared with plain old balloon angioplasty (POBA) using a Sprinter LegendTM balloon in small vessel coronary artery disease. A constrictive remodelling process will be measured by optical coherence tomography (OCT) at 9 months median F/U. This pilot trial is planned to be randomized 1:1 for DCB against POBA therapy.


Eligibility Criteria:
Inclusion Criteria:

* at least one target lesion with a stenosis severity ≥ 50% in one coronary segment with a diameter ≤ 2.5 mm
* age \> 18 years
* weight \> 45 kg
* patient suitable for balloon dilatation and not suitable for elective implantation of a drug eluting stent
* insulin-dependent or non-insulin-dependent diabetes mellitus
* length of lesion ≥ 15 mm

Exclusion Criteria:

* Life expectancy \< 12 months
* In-Stent restenosis
* planned coronary bypass or heart valve OP
* ST elevation myocardial infarction within the last 72 hours
* cardiogenic shock
* renal impairment or liver dysfunction (creatinine \> 2.0 mg/dl, AST/ALT \> 3x of normal value
* incompliance
* pregnant or breastfeeding women or women who like to be pregnant
11C-acetate for Treatment Response After Radiotherapy for HCC

It is thought that PET of the abdomen with 11C Acetate will provide new information regarding whether or not patient's have benefited from radiotherapy. To test this theory, the project will evaluate the potential of 11C acetate to serve as an earlier and/or better signal of treatment success.


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years of age
* Subject is willing to participate in the study and has signed the study informed consent
* Subject is available and willing to comply with the protocol evaluations
* Diagnosed hepatocellular carcinoma confined to a single lobe of the liver if undergoing 90Y radioembolization
* Diagnosed hepatocellular carcinoma confined to the liver if undergoing Stereotactic Body Radiation Therapy (SBRT)
* Under consideration for 90Y radioembolization or Stereotactic Body Radiation Therapy (SBRT)

Exclusion Criteria:

* Pregnant or planning to become pregnant within the next 12 months or breast-feeding
* GFR \< 45
* Life expectancy \< 6 months
* Claustrophobic and cannot tolerate imaging procedures
* Weigh \> 350 lb (upper weight limit of scanner beds)
* Special vulnerabilities (e.g. fetuses, neonatales, pregnant women, children, prisoners, institutionalized individuals).
Stress Reduction in Ovarian Cancer

The purpose of this study is to investigate the effects of a stress reduction program on the quality of life of ovarian cancer patients during primary adjuvant chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have an initial diagnosis of ovarian, fallopian tube or primary peritoneal cancer who completed primary ovarian cancer surgery or 3 cycles of neoadjuvant chemotherapy with interval cytoreductive surgery (ICS).
* Final pathology diagnosis of stage I-IV ovarian, fallopian tube or primary peritoneal cancer with plan to receive primary adjuvant chemotherapy or completion of chemotherapy after ICS.
* Receive chemotherapy at the University of Wisconsin-Madison.
* Subjects must be at least 18 years of age.
* English-speaking
* Subjects must be able to use audio media, and read and understand the study manual.
* ECOG performance status 0-2.
* Subjects must have a phone.

Exclusion Criteria:

* Subjects participating in a meditation practice more than 1 hour per week prior to surgery and/or chemotherapy administration.
* Subjects with recurrent ovarian, fallopian tube or primary peritoneal cancer.
* Subjects with diagnosis of Chronic Fatigue Syndrome (CFS).
* Subjects unable to use audio media due to auditory dysfunction.
* Subjects unable to read written English.
* Subjects who are prisoners or incarcerated.
Nature-based Mindfulness Intervention Program for Family Carers

The program integrates ordinary mindfulness exercise with nature environment. Participants will be able to practice mindfulness in a natural environment in some of the program sessions. The study will study the effects of nature-based mindfulness program in reducing caregiving stress. The program will last for 4 session, 8 hours in total.


Eligibility Criteria:
Inclusion Criteria:

* parents with children experiencing divorce or separation
* parents of children with special needs
* family caregivers who are the primary caregivers of an older adult with dementia

Exclusion Criteria:

* parents or caregivers who cannot understand Cantonese version of Chinese
* parents or caregivers who have psychosis or developmental disabilities who are not able to comprehend the program
Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Ischemic Cardiomyopathy

The aim of the present study is to investigate safety and efficacy of intramyocardial implantation of allogeneic mesenchymal stem cells in patients with ischemic cardiomyopathy .

Coronary artery disease (CAD) is a common disorder that can lead to heart failure. Not all people with CAD are eligible for today's standard treatments. One new treatment approach uses umbilical cord blood derived mesenchymal stem cells-specialized cells capable of developing into other types of cells-to stimulate growth of new blood vessels for the heart. The aim of the present study is to investigate safety and efficacy of intramyocardial implantation of allogeneic mesenchymal stem cells in patients with ischemic cardiomyopathy .

Eligibility Criteria:
Inclusion Criteria:

1. Age from 30 to 80 years
2. ischemic cardiomyopathy
3. Left ventricular infarction area seriously low movement to no movement
4. The low whole left ventricular systolic function (LVEF 45% or less)
5. Have line or quasi coronary interventional treatment
6. Willing to accept patients with follow-up evaluation
7. Have signed informed consent form approved by the ethics committee

Exclusion Criteria:

1. Non elevation between S-wave and T-wave in patients with acute myocardial infarction
2. No function damage in patients with acute myocardial infarction
3. Acute myocardial infarction complicated with left ventricular aneurysm intends to do surgery
4. Complications of acute myocardial infarction with other machines (including: ventricular septal perforation, papillary muscle rupture, etc.)
5. Acute infectious diseases
6. Blood system diseases, such as thrombocytopenia, severe anemia, leukemia, etc
7. Severe renal disease, creatinine clearance \< 36 ml/min, serum creatinine \> 265 umol/L
8. Laboratory tests suggest abnormal liver function, glutamate-pyruvate transaminase (ALT) \> 4 times the upper limit of normal
9. Unstable cerebral lesions
10. malignant tumor
11. Cognitive dysfunction and dementia patients, patients with severe mental illness
12. Patients with severe physical disabilities can't regular follow-up
13. Other serious uncontrolled system disease
14. To prepare or have the pregnancy women patients
15. Have a percutaneous coronary intervention contraindications: high-risk patients, such as the digestive tract, and intracranial hemorrhage or contrast allergy
16. Cannot use the test dose atorvastatin
17. Is not completed in accordance with the requirements for test the timing of the magnetic resonance imaging (MRI), PET, SPECT, follow-up testing (e.g., patients with implanted pacemakers or artificial joint)
18. Patients unable or unwilling to sign a consent form
Safety and Efficacy of BGS649 in Obese, Hypogonadotropic Hypogonadal Men

This study is designed as a 2-part study, with Part 1 being open-label to best determine the appropriate dose levels to use in Part 2, which has a randomized, double-blind, placebo controlled design. The study aims to assess the safety and tolerability of BGS649, and determine whether or not BGS649 is able to normalize testosterone levels and improve insulin sensitivity in obese, hypogonadotropic hypogonadal (OHH) men


Eligibility Criteria:
Inclusion Criteria:

* Males who meet the criteria of obese, hypogonadotropic hypogonadism defined as:

  * Patients with a Body Mass Index (BMI) ≥ 30 kg/m2
  * Patients with a morning serum total testosterone level \< 300 ng/dL on at least two separate occasions during the Screening and/or Baseline periods.
  * Patients with inappropriately low gonadotropins at screening given the low testosterone:
* Luteinizing hormone (LH) ≤ ULN
* Follicle stimulating hormone (FSH) ≤ ULN
* Estradiol within or above the normal range (defined as ≥ LLN of the approved assay)

  * Normal hypothalamic/pituitary function, including:
* Prolactin: within the normal range
* Thyroid stimulating hormone (TSH): within the normal range
* Ferritin: within the normal range
* Patients agree to use a barrier method of contraception (e.g., condom), for the duration of the study and for at least 3 months following their Study Completion visit to prevent BGS649 exposure to their partners.

Exclusion Criteria:

* Patients with hypogonadism, not related to obesity or as a result of other underlying issues
* Patients with significant major organ class illness (e.g. kidney or liver disease).
* Other protocol-defined inclusion/exclusion criteria may apply
A Study of ICP-189 and ICP-189 in Combination With Anti-PD-1 Monoclonal Antibody in Patients With Advanced Solid Tumors

A Dose finding Study to Evaluate the Safety, Tolerability and Pharmacokinetics and Preliminary Anti-Tumor Activity of ICP-189 Tablets and ICP-189 Tablets in Combination with Anti-PD-1 Monoclonal Antibody in Patients with Advanced Solid Tumors.


Eligibility Criteria:
Inclusion Criteria:

1. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
2. Patients with histologically confirmed locally advanced unresectable or metastatic solid tumors;
3. At least one measurable lesion according to RECIST 1.1.

Exclusion Criteria:

1. Patients who have had other cancer(s) within 5 years prior to the first dose, except for locally curable cancers that have been apparently cured;
2. Patients with unstable primary central nervous system (CNS) tumors or CNS metastases;
3. Patients who have an active autoimmune disease or have had an autoimmune disease with risk of recurrence;
4. Patients who have active or history of interstitial lung disease or non-infectious pneumonia;
5. Patients who have a history of severe allergic reaction to any component of ICP-189 tablets or anti-PD-1 antibody (\> grade 3 assessed by CTCAE 5.0).

Other protocol-defined inclusion/exclusion criteria apply.
c-Met Second-Line Hepatocellular Carcinoma

This is a Phase 1b/2, multicenter, single arm trial to assess the efficacy, safety, and pharmacokinetics (PK) of MSC2156119J as monotherapy in subjects with MET+ advanced hepatocellular carcinoma (HCC) with child Pugh Class A liver function who have failed sorafenib treatment.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed HCC
* Child Pugh Class A liver function score
* For Phase 2 only: MET+ status
* Male or female, 18 years of age or older
* Measurable disease in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 (inclusive)
* Availability of a pretreatment tumor biopsy (excluding fine needle aspiration and cytology samples) taken after the subject has discontinued sorafenib and within 28 days before the day of first dosing with MSC2156119J. From the pretreatment biopsy either a formalin-fixed (formalin fixation is mandatory) paraffin-embedded block with tumor tissue (preferred) or at least 15 unstained slides must be sent to the central laboratory prior to enrollment. An associated pathology report must also be sent with the sample
* Previously treated with sorafenib for greater than or equal to 4 weeks and discontinued sorafenib treatment at least 14 days prior to Day 1 due to either intolerance or radiographic progression
* Signed and dated informed consent indicating that the subject (or legally acceptable representative if applicable by local laws) has been informed of all the pertinent aspects of the trial prior to enrollment
* Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other trial procedures
* Life expectancy of at least 3 months as judged by the investigator

Exclusion Criteria:

* Prior systemic anticancer treatment for advanced HCC (except for sorafenib as described in the inclusion criteria)
* Prior treatment with any agent targeting the hepatocyte growth factor (HGF)/c-Met pathway
* Local-regional therapy within 4 weeks before Day 1
* Impaired cardiac function
* Other protocol defined exclusion criteria could apply
Peginterferon Alfa-2a, Ribavirin and Epoetin β in Coinfected Patients HCV/HIV Not Responding to Previous Treatment Regimens

This trial will assess the sustained virologic response to treatment with peginterferon alfa-2a combined with high-dose ribavirin in human immunodeficiency virus (HIV)-infected patients with hepatitis C virus (HCV) genotype 1 or 4 coinfection and persistent transaminase elevations. These patients will have been nonresponders to previous regimens with peginterferon alfa and ribavirin therapy at a dosage of 800-1200 mg/d.

The purpose in treating chronic HCV infection in HIV-coinfected individuals is to clear HCV-RNA antibodies and cure the infection. Studies have shown that high doses of ribavirin are associated with higher response rates than those achieved with ribavirin at dosages of 800-1200 mg/d.

The main aim of this trial is to assess the sustained virologic response to treatment with peginterferon alfa-2a plus high-dose ribavirin in HIV-infected patients coinfected with HCV genotypes 1 or 4 who have had persistent transaminase elevations and lack of response to previous treatment with peginterferon alfa and ribavirin at dosages of 800-1200 mg/d.

The second aim will be to measure changes in serum HCV-RNA titers and the percentage of patients achieving serum viral loads of \< 50 IU/mL during treatment. Finally, we also intend to evaluate the safety of this treatment regimen.

Eligibility Criteria:
Inclusion Criteria:

* HIV-infected patients coinfected with HCV genotypes 1 or 4
* Persistent transaminase elevation
* Nonresponders to previous treatment with peginterferon alfa plus ribavirin at a dosage of 800-1200 mg/d.

Exclusion Criteria:

* Patients who abandoned treatment with peginterferon plus ribavirin before 12 weeks
* Patients with Child-Pugh B or C cirrhosis
Detailed Assessment of Augmented Renal Clearance in a Large Mixed Intensive Care Unit Population

This multi-center retrospective cohort study presents a detailed assessment of augmented renal clearance (ARC) in a mixed population of adult critically ill patients. Epidemiology of ARC will be studied in detail in a very heterogeneous population. Risk factors for ARC will be identified and a predictive scoring system for ARC ready to use in clinical practice will be constructed and validated. Performance of estimators of kidney function will be measured and a cutoff for ARC will be determined for the best estimator. Finally clinical impact of ARC will be explored using vancomycine and aminoglycosides levels as surrogate marker.

Augmented renal clearance will be assessed in detail in a very large and heterogeneous adult critically ill population. Analysis will be conducted retrospectively on a multi-center database collected by the M@tric research group. M@tric collects data from all intensive care units (surgical, medical, cardiac) in 3 Belgian University Hospitals (Leuven, Ghent, Antwerp).

Anonymised admission, demographic, clinical and laboratory data collected from 2013 until the present will be retrieved from the M@tric database. These data will then be coded and analysed in R statistical software. ARC will be defined based on a 24h creatinine clearance (CrCl24h) \>=130ml/min/1.73m².

Epidemiology and risk factors for ARC will be studied in order to confirm and clarify past studies which have mostly been done in rather small and specific subsets of patients. A predictive algorithm for ARC will be trained and subsequently validated for use in clinical practice. Moreover this algorithm will be compared to existing scoring systems, which have not yet found their way into clinical practice. This algorithm will provide the ability to anticipate ARC on the intensive care unit. Also use of formulae estimating renal function will be evaluated in this population. These estimators will be compared to the CrCl24h, which is considered the golden standard in clinical practice. A cutoff for the best estimating formula in order to detect ARC will be calculated. Finally the impact of ARC on serum levels of hydrophilic molecules likes vancomycine and aminoglycosides will be studied. As this research follows a retrospective design these levels will be used a surrogate marker for clinical impact. This will potentially point out some opportunities for future research on the clinical impact of ARC.

Eligibility Criteria:
Inclusion Criteria:

* Having at least one 24h creatinine clearance measurement available

Exclusion Criteria:

* Any form of renal replacement therapy
Effects of Fructan Prebiotics on the Intestinal Microbiota

Prebiotics are carbohydrate polymers believed to improve health by stimulating beneficial gastrointestinal microbial populations. Prebiotic health claims are currently not permitted in Canada due to a lack of validating scientific data. Currently, Health Canada considers 'prebiotic' to imply a health benefit that must be substantiated. Our goal is to conduct a human clinical trial to define the impacts of fructans on the colonic microbiome as well as the physiological, psychological and immunological effects on the host.

Current health claims for the fructan prebiotics focus on the bifidogenic properties of these substrates. While these claims appear to be widely accepted among nutritionists, the gut-microbiology community considers this an archaic view on these complex communities which contain in excess of 400 species of which the majority have yet to be cultivated or characterized. The bifidogenic effect associated with fructans also forms the basis of current prebiotic health claims in Canada, claims which up until now have not stood up to regulatory scrutiny The primary objective of this study is to assess the impact of frucans on the human microbiome, as well as the physiological, immunological health of the host. Information generated from this study will address both aspects of the current FOA definition of what constitutes a "prebiotic". New data generated from this study will be applicable for a new health claim for prebiotics and will provide a guide for industry demonstrating the requirements for a scientifically valid study for other submissions involving prebiotics.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18 - 50 years
* General good health
* Participant understands the study procedures and provides informed consent (signed) to participate and authorizes the release of relevant protected health information to the study investigators

Exclusion Criteria:

* History or presence of GI disorders (Irritable bowel syndrome, colitis, Crohn's disease, colon cancer or polyps)
* Recent use of antibiotics
* Regular use of high inulin containing food products.
* Known intolerance or sensitivity to any ingredients in the study product.
* BMI \>30
TACE Combined With Synchronous Radiofrequency /Microwave Ablation to Treat Large and Huge Hepatocellular Carcinoma

It is a prospective and multi-center clinical research in China to compare the efficacy, safety and related impact factors between TACE alone and TACE combined with synchronous multi-point MWA/RFA for large and huge liver cancer.

It is an open random prospective phase III clinical trial conducted by Principal Investigator Professor Jian-Hua Wang. Investigators in twenty-five hospitals in China participate in. Patients with unresectable large HCC (\>5cm in diameter) and huge HCC (\>=10cm in diameter) are enrolled. The investigators propose to recruitment 280 patients who are randomly assigned into the combined group (treated with TACE and synchronous ablation) and the control group (treated with TACE alone) according to the proportion of 1:1, which means 140 patients in each group. The criteria of inclusion and exclusion, and the methods of lab tests, imaging modality and treatment procedures are the same.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with primary liver cancer aged from 18-80 years, and life expectancy longer than three months;
2. Patients with large HCC (\>5cm in diameter) and huge HCC (≥10cm in diameter), including HCC and mixed type of liver cancer (HCC-ICC);
3. Patients with no thrombus in main portal vein (PV)
4. Patients' liver function classified as Child-Pugh A or B, ECOG PS ≤ 2;
5. Patients without bleeding tendency or coagulation disorder, or with reversible coagulopathy after therapy;
6. White blood cell count ≥ 3.0×10\^9/L;
7. Hemoglobin ≥ 8.5g/dl;
8. Platelet ≥ 50×10\^9/L;
9. INR ≤ 2.3 or PT not exceeding the upper limit of reference 3 seconds;
10. Blood creatinine less than 1.5 times of upper limit of reference;
11. Patients and/or their relatives willing to join in the clinical trial and signing the informed consent.

Exclusion Criteria:

1. Patients with diffuse type of liver cancer;
2. Cholangiocellular carcinoma
3. Patients with main PV thrombus;
4. Patients with hepatic vein thrombus;
5. Patients with lymph node or distant metastasis outside of liver;
6. Patients' liver function classified as Child-Pugh C and no improvement after treatment of liver protection;
7. Patients with irreversible coagulation disorder and abnormality in blood routine test, or having obvious bleeding tendency;
8. Patients with intractable massive ascites;
9. Patients' ECOG PS \>2;
10. Patients complicated with active infection, especially cholangitis;
11. Patients with severe disorders of heart, lungs, kidneys, or brain;
12. Patients and/or their relatives refuse to anticipate this study.