louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06327945: Transplanting Lungs From Uncontrolled Donation After Circulatory Death
Official title: Transplanting Lungs From Uncontrolled Donation After Circulatory Death: An Early Phase Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Transplantation
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2024-03-25
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The study team developed an uncontrolled donation after circulatory death (uDCD) protocol that preserves lungs for just over 3 hours after death using positive end expiratory pressure (PEEP) and supplemental oxygen. The study will assess lung uDCD program safety by continuous review of operations/clinical records from each case activation and transplantation. Attrition outcomes include rates of initial and continued lung preservation, donation authorization, lung recovery, passing ex-vivo lung perfusion (EVLP) performance testing, and lung transplantation. Planned viability assessments also include macroscopic determination, radiology (X-ray), and fiber optic bronchoscopy before initiating EVLP. We expect \~50% of lungs assessed with EVLP will be transplanted to meet sustainability targets. Safety outcomes include the primary outcome, primary graft dysfunction (PGD) grade III at 72 hours, and secondarily survival one year after transplantation.


Eligibility criteria: Inclusion Criteria:

* Patients waiting for lung transplants
* Willing to participate in the research study

Exclusion Criteria:

* Unable to be followed for 1 year after transplantation
* Unable to provide written informed consent to participate in the research (or designate a surrogate)

Primary outcomes:
measure: Incidence of Primary Graft Dysfunction (PDG) Grade III
timeFrame: 72 Hours Post-Transplant
Secondary outcomes:
measure: Number of Participants who Required Normothermic Extracorporeal Membrane Oxygenation (nECMO)
timeFrame: 72 Hours Post-Transplant
measure: Number of Participants who Required Normothermic Extracorporeal Membrane Oxygenation (nECMO)
timeFrame: 1 Year Post-Transplant
measure: Incidence of Re-Transplantation
timeFrame: 1 Year Post-Transplant
measure: Overall Survival
timeFrame: 72 Hours Post-Transplant
measure: Overall Survival
timeFrame: 1 Year Post-Transplant
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Stephen Wall, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00636545: Genasense as a 2-hour Intravenous Infusion in Subjects With Solid Tumors
Official title: A Safety, Pharmacokinetic, and Pharmacodynamic Assessment of Genasense Administered as a 2-hour Intravenous Infusion to Subjects With Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumors
Keywords: Genasense
oblimersen
antisense
Bcl-2 antisense
Solid Tumors
Lead sponsor: Genta Incorporated
Sponsor class: INDUSTRY
First posted: 2008-03-14
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective is to determine the safety and maximum tolerated dose (MTD) of Genasense administered as a 2-hour intravenous infusion once weekly (Part 1) and twice weekly (Part 2) to patients with solid tumors.


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of a solid tumor malignancy, not to include lymphoma, that has failed standard therapy or for which no standard therapy is available
* Adequate organ function as determined ≤ 7 days prior to starting study medication
* Eastern Cooperative Oncology Group performance status 0 to 2
* At least 3 weeks and recovery from effects of major prior surgery or other therapy, including chemotherapy, radiation therapy, immunotherapy, or cytokine, biologic, or vaccine therapy

Exclusion criteria

* Other significant medical disease
* History or presence of leptomeningeal disease
* Coexisting condition that would require the subject to continue therapy during the treatment phase of the study with a drug known to alter renal function
* Pregnant or lactating

Primary outcomes:
measure: Maximum tolerated dose (MTD) of Genasense administered as a 2-hour IV infusion once a week (Part 1) and twice a week (Part 2) to patients with solid tumors
timeFrame: One year
Secondary outcomes:
measure: Pharmacokinetics (Part 1 and Part 2); pharmacodynamics (Part 2)
timeFrame: During treatment phase
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: South Texas Accelerated Research Therapeutics
state: Texas
Study officials:
References:
Clinical trial NCT05289245: A National Registry on Chinese Patients With Cystic Fibrosis
Official title: A National Registry on Clinical Manifestations, Genetics, Interventions, and Outcomes in Chinese Patients With Cystic Fibrosis (CF-CHINA)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Function
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2022-03-21
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study Population is from across the country of China.

Brief summary: Cystic fibrosis (CF) is a rare autosomal recessive disease involving multiple organs, especially the lungs and digestive organs. It is most commonly seen in Caucasians. Only a few Chinese CF patients have been described in literature, taking into account the large population of China. The main objectives of this study are to accurately evaluate the prevalence of CF, the status of disease, the diagnosis and treatment, the quality of care, and the health related outcomes in China.


Eligibility criteria: Inclusion Criteria:

Fulfilled WHO clinical diagnostic criteria for CF; Was in a stable phase with no respiratory infections for nearly 4 weeks; Subjects (or their guardians) signed informed consent.

Exclusion Criteria:

Patients with other bronchiectasis who did not meet the inclusion criteria; Those with severe cardiac or renal disease

Primary outcomes:
measure: Change in spirometry (FEV1 and FVC) of lymphangioleiomyomatosis patients.
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT02408445: Body Composition in Infants With Klinefelter Syndrome and Effects of Testosterone Treatment
Official title: Body Composition in Infants With Klinefelter Syndrome and Effects of Testosterone Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Klinefelter Syndrome
Keywords: body composition
Klinefelter syndrome
XXY
sex chromosome variation
sex chromsome aneuploidy
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2015-04-03
Enrollment: 20
Sex: MALE
Minimum age (years): 42
Maximum age (years): 108
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research study in infant males with Klinefelter syndrome (47,XXY) will learn more about body composition (muscle and fat) and male hormones and look at the effect of testosterone shots on body composition. The Investigators know that older boys and men with Klinefelter syndrome often have more fat compared to muscle than adults without Klinefelter syndrome, but we do not know if this difference is present at birth or develops over time. The Investigators will learn if body composition and motor skills are improved with testosterone treatment in infants with Klinefelter syndrome.


Eligibility criteria: Inclusion Criteria:

* Male infants with 47,XXY karyotype

Exclusion Criteria:

* Gestational age at birth \<36 weeks
* Birth weight \<5%ile or \>95% for gestational age
* History of thrombosis in a first degree relative
* Exposure to androgen therapy outside of the study protocol.

Primary outcomes:
measure: Change in Body Fat Percent Z-score
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: Serum Luteinizing Hormone (LH)
timeFrame: baseline only
measure: Serum Follicle Stimulating Hormone (FSH)
timeFrame: baseline only
measure: Serum Total Testosterone
timeFrame: baseline only
measure: Serum Inhibin B (INHB)
timeFrame: baseline only
measure: Serum Anti-Mullerian Hormone (AMH)
timeFrame: baseline only
measure: Leptin
timeFrame: baseline only
measure: Change in Raw Score on the Alberta Infant Motor Scale
timeFrame: 3 months
measure: Change in Score on the Movement Assessment of Infants (MAI)
timeFrame: 3 months
measure: Change in Total Motor Standard Score on the Peabody Developmental Motor Scales 2
timeFrame: 3 months
measure: Change in Penile Length
timeFrame: Baseline and 3 months
measure: Change in Fat Free Mass
timeFrame: Baseline and 3 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Shanlee M Davis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02957045: Alternative Measurements of Cough Pressure and Effects of Epidural Anaesthesia on Cough Pressure
Official title: Alternative Measurements of Cough Pressure and Effects of Epidural Anaesthesia on Cough Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Physiology
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
First posted: 2016-11-06
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Pressure generated by cough is an expression of expiratory muscle strength. Cough pressure (Pcough) is usually measured with gastric and/or esophageal catheters, but these are often either inconvenient or uncomfortable for the patient. The aim of this study was to evaluate whether central venous, vesical or rectal catheters could be useful to measure cough pressures as alternative sites to standard esophageal and gastric balloons.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18 to 75 years and scheduled for colon cancer surgery were recruited.
* Informed consent signed.

Exclusion Criteria:

Rectal surgery, advanced cancer, abdominal wall disorders, respiratory or neuromuscular illness, body mass index \> 30, chronic pain, pregnancy and inability to cough adequately.

Primary outcomes:
measure: Cough pressure
timeFrame: From baseline until 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital del Mar
Study officials:
References:
citation: Aguilera LG, Gallart L, Alvarez JC, Valles J, Gea J. Rectal, central venous, gastric and bladder pressures versus esophageal pressure for the measurement of cough strength: a prospective clinical comparison. Respir Res. 2018 Oct 1;19(1):191. doi: 10.1186/s12931-018-0897-6.
Clinical trial NCT05164445: The Role of Interventional Pulmonology, Microbiota and Immune Response in the Patient With Lung Cancer
Official title: Observational Participants Not Assigned to Intervention(s) Based on a Protocol; Typically in Context of Routine Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: cryobiopsy
lung cancer
gut-lung microbiota
immune system
Lead sponsor: Lithuanian University of Health Sciences
Sponsor class: OTHER
First posted: 2021-12-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study is designed to evaluate complications, specificity, diagnostic yield of radial endobronchial ultrasound guided transbronchial cryobiopsy and transbronchial forceps biopsy with fluoroscopy in the diagnosis of peripheral pulmonary lesion; the interplay between non-small-cell lung cancer associated-bacteria along the gut-lung axis and immune response in the cancer microenvironment.


Eligibility criteria: Inclusion Criteria:

* patients with peripheral lung lesion suspected of lung cancer detected on the chest computed tomography (CT) and RP-EBUS scans
* Control group - patients without non-small cell lung cancer
* Written (signed) Informed Consent to participate in the study

Exclusion Criteria:

* severe hypoxemia (partial pressure of oxygen (pO2)\< 60 mmHg) or hypercapnia (carbon dioxide partial pressure (pCO2)\> 50 mmHg),
* bleeding disorders
* The diffusing capacity for carbon monoxide (DLCOc)\< 35 %,
* forced expiratory volume in one second (FEV1) \< 800 ml or FEV 1 \< 30 %,
* peripheral lung tumor was not visualised by RP-EBUS longer than 30 minutes
* large vessels (more than 3 mm) near the tumor on the CT scan,
* technically difficult to introduce cryoprobe and/or endobronchial blocker to current bronchi segment or subsegment,
* excessive bleeding after transbronchial forceps biopsy, which was needed extra intervention to stop bleeding.

Primary outcomes:
measure: progression-free survival
timeFrame: one year after enrolment to the study
Secondary outcomes:
measure: overall survival
timeFrame: 3 years after enrolment to the study
Other outcomes:
Locations:
city: Kaunas
country: Lithuania
facility: Lithuanian University of Health Sciences
Study officials:
References:
Clinical trial NCT00682045: Latent Tuberculosis Infection in Renal Transplant Recipients
Official title: A Prospective Observational Study of Usefulness of a T Cell-based Assay for Latent Tuberculosis Infection in Renal Transplant Recipients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Transplant
Keywords: tuberculosis
transplantation
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2008-05-21
Enrollment: 240
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: renal transplant recipients

Brief summary: The aim of this study is to estimate the usefulness of a T cell-based assay (i.e. T-SPOT.TB assay) for diagnosis of latent tuberculosis infection (LTBI) in renal transplant recipients. For this purpose, the investigators enrolled renal transplant recipients and observed the developement of tuberculosis within 1 to 2 years after the transplantation.

Detailed description: We evaluate the usefulness of a newly-developed T cell-based assay prior to undergoing immunosuppression in renal transplant recipients. Among all renal transplant recipients, patients with negative tuberculin skin test and no other indications for latent tuberculosis infection will be enrolled in this study. We will exam T-SPOT.TB test in these patients, and observe the developement of tuberculosis within 1 to 2 years after the transplantation. The results of T-SPOT.TB will be blinded to the investigators.

Eligibility criteria: Inclusion Criteria:

* Age 16 or more
* Negative tuberculin skin test (induration less than 10 mm)

Exclusion Criteria:

* Recent contact of patients with active pulmonary tuberculosis
* Suspected active tuberculosis

Primary outcomes:
measure: development of tuberculosis
timeFrame: within 2 years after transplantation
Secondary outcomes:
measure: all cause mortality
timeFrame: within 2 years after transplantation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Sung-Han Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim SH, Lee SO, Park JB, Park IA, Park SJ, Yun SC, Jung JH, Kim YH, Kim SC, Choi SH, Jeong JY, Kim YS, Woo JH, Park SK, Park JS, Han DJ. A prospective longitudinal study evaluating the usefulness of a T-cell-based assay for latent tuberculosis infection in kidney transplant recipients. Am J Transplant. 2011 Sep;11(9):1927-35. doi: 10.1111/j.1600-6143.2011.03625.x. Epub 2011 Jul 12.
citation: Kim SH, Lee SO, Park IA, Park SJ, Choi SH, Kim YS, Woo JH, Park SK, Park JS, Kim SC, Han DJ. Diagnostic usefulness of a T cell-based assay for latent tuberculosis infection in kidney transplant candidates before transplantation. Transpl Infect Dis. 2010 Apr;12(2):113-9. doi: 10.1111/j.1399-3062.2010.00495.x. Epub 2010 Jan 25.
Clinical trial NCT05122845: Constitutive Study of a Serum Bank and Plasma Bank of Healthy Subjects Comparators to Dialysis Subjects (SPSSCD)
Official title: Constitutive Study of a Serum Bank and Plasma Bank of Healthy Subjects Comparators to Dialysis Subjects (SPSSCD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Serum Bank
Plasma Bank
Dialysis
Lead sponsor: Ramsay Générale de Santé
Sponsor class: OTHER
Collaborators: name: European Clinical Trial Experts Network
First posted: 2021-11-17
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To be able to evaluate the predictive value of glycosylated ferritin as a predictive marker of hepatic iron stock in dialysis patients, we need to validate these results with a cohort of healthy volunteers.

Detailed description: This biological collection will include a sample of 2 dry tubes and 2 EDTA tubes. A haematological assessment (CBC, platelets, reticulocytes, Chr (hemoglobin content of reticulocytes), TP-INR, AST, ALT, GGT), measurement of biological markers of iron metabolism (ferritin, serum iron, CRP, transferrin, soluble receptors transferrin, transferrin saturation coefficient) as well as a creatinine assay to validate the normality of renal function in healthy volunteers (GFR established from the MDRD formula), a complete ionogram and a phosphocalcic balance being given the interactions in the dialysis patient (but also in normal subjects) between iron metabolism and phosphocalcic metabolism (calcemia, phosphoremia, PTH, 25OHD3, 1,25OH2D3) will be performed.

We will also study the links between iron overload in dialysis patients and the modulation of the synthesis of parathyroid hormone (intact PTH), FGF23, alpha Klotho and sclerostin.

Eligibility criteria: Inclusion Criteria:

* Informed consent
* Age over 18 years old
* Healthy volunteers
* Having given their informed consent in writing
* Absence of current pathology
* No current treatment (except contraception)

Exclusion Criteria:

* Refusal of consent or absence of signature
* Minor, subject protected by law, (guardianship or curatorship, administrative protection measure)
* Pregnant woman, parturient
* Subject suffering from a condition liable to modify his blood parameters

Primary outcomes:
measure: Number of participant with a serum and plasma bank creation
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Quincy-sous-Sénart
country: France
facility: Hôpital Privé Claude Galien
Study officials:
References:
Clinical trial NCT00578045: UARK 2006-28 Human Cord Blood Transplantation in Advanced Hematological Malignancies
Official title: UARK 2006-28 Human Cord Blood Transplantation in Advanced Hematological Malignancies
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Multiple Myeloma
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2007-12-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The researchers want to find out if subjects treated on this study will achieve long term bone marrow recovery (engraftment) and if their tumors will respond to this treatment.


Eligibility criteria: Inclusion Criteria:

* Patients with advanced hematological malignancies who have failed at least two lines of therapy.
* Karnofsky performance score \> 60, unless due to disease and then \> 50.
* Age \> 18 years.
* An expected survival of \> 3 months.
* Subjects must have signed an IRB-approved consent and been informed about the investigational nature of the study.
* Cord blood must have negative serology for HIV.
* Release of cord blood.
* The nucleated cell count of the CBU shall equal or exceed 1 x 107 per kg of recipient body weight.

Exclusion Criteria:

* Liver function: total bilirubin \> 2x ULN or AST/ALT \> 3x ULN.
* Creatinine \> 3.0 mg/dL.

Primary outcomes:
measure: The researchers on this study want to find out if subjects treated on this study will achieve long term bone marrow recovery (engraftment) and if their tumors will respond to this treatment.
timeFrame: 12 months
Secondary outcomes:
measure: The researchers also want to find out what types of side effects, if any, subjects will experience with this treatment.
timeFrame: 12 months
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Frits van Rhee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: