louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04650633: SHR-1701 in Patients With Recurrent/Metastatic Scchn
Official title: A Phase II,Open-label Trial to Investigate the Efficacy and Safety of SHR-1701 in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Squamous Cell Carcinoma of Head and Neck
Keywords: SHR-1701
Phase II
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-12-02
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 2 cohorts
Primary purpose: TREATMENT

Brief summary: This is an open label, single-arm, multi-center, phase II study of SHR-1701 in patients with recurrent/metastatic SCCHN


Eligibility criteria: Inclusion Criteria:

1. Histologically confirmed Recurrent/Metastatic SCCHN,not include NPC
2. Subjects failure after 1 lines of platinum based chemotherapy or failure from anti-PD-1/PD-L1 antibody therapy.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at trial entry.
4. Disease must be measurable with at least 1 uni dimensional measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
5. Adequate hematological, hepatic and renal function as defined in the protocol Other protocol-defined inclusion criteria could apply.

Exclusion Criteria:

1. Prior therapy with an anti-PD1, anti-PD-L1, anti-CTLA-4 or a TGFb inhibitor.
2. Anticancer treatment within 28 days before the first dose of study drug.
3. Major surgery within 28 days before start of trial treatment.
4. Systemic therapy with immunosuppressive agents within 7 days prior to the first dose of study drug; or use any investigational drug within 28 days before the start of trial treatment.
5. With any active autoimmune disease or history of autoimmune disease.
6. History of immunodeficiency including seropositive for human immunodeficiency virus (HIV), or other acquired or congenital immunedeficient disease, or any active systemic viral infection requiring therapy.

Primary outcomes:
measure: Objective Response Rate (ORR) per RECIST 1.1
timeFrame: up to 2 years
Secondary outcomes:
measure: DOR
timeFrame: 24 months
measure: DCR
timeFrame: 24 months
measure: PFS
timeFrame: 24 months
measure: OS
timeFrame: 24 months
measure: AEs
timeFrame: 24 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Tumor Hospital of the Chinese Academy of Medical Sciences
Study officials:
References:
Clinical trial NCT00358033: Strategies to Maintain Cardiac Risk Control After Discharge From Cardiovascular Risk Reduction Clinic
Official title: Effectiveness of Different Strategies in Maintaining Target Goals of Cardiovascular Risk Factors in Patients Discharged From Cardiovascular Risk Reduction Clinic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Dyslipidemia
Hypertension
Coronary Atherosclerosis
Lead sponsor: Providence VA Medical Center
Sponsor class: FED
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2006-07-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether a combined behavioral and pharmacological intervention provided by a multidisciplinary team will further reduce LDL-C, smoking, BP and Hb-A1C in diabetic patients with A1c between 7% and 9% when compared to usual care.


Eligibility criteria: Inclusion Criteria:

* Previous enrollment in Cardiovascular Risk Reduction Clinic (CRRC)
* Eligible for CRRC discharge:

  1. For DM patients:

     * HbA1c \< 7.0 %,
     * BP \< 130/85 mm Hg , and
     * LDL \< 100 mg/dl;
  2. For Non-DM patients:

     * BP \< 140/90 mm Hg, and
     * LDL \< 100 mg/dl;
* Able and willing to sign informed consent.

Exclusion Criteria:

* Presence of conditions that might limit long-term compliance (eg, dementia, acute psychiatric decompensation within the previous 6 months, unstable psychiatric disorder);
* Metastatic disease or terminal illness

Primary outcomes:
measure: The number of patients who had non-compliance to ADA target goals in smoking, LDL cholesterol, blood pressure or Hb A1c.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Providence VAMC
state: Rhode Island
Study officials:
affiliation: Providence VAMC
name: Wen-Chih Wu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05589233: COVID-19 Vaccination AZV 2021-2023
Official title: Clinical Phenotype of Persons Vaccinated Against Sars-CoV-2 Hospitalized for COVID-19 Disease as a Basis for Optimalization of National Vaccination Strategy and Post-exposure Prophylaxis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Vaccination
Immunity
Respiratory Failure
Lead sponsor: University Hospital Hradec Kralove
Sponsor class: OTHER
First posted: 2022-10-21
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients admitted to the standard ward or intensive care unit with COVID-19 positive test and any number of vaccination doses against SARS-CoV-2.

Brief summary: The study is aimed at the clinical and laboratory characteristics of patients with completed vaccination against SARS-CoV-2 admitted to the hospital in the standard ward and intensive care unit due to the severe course of COVID-19.

Detailed description: The high number of patients hospitalized for COVID-19 significantly affects the entire healthcare system, where 70-80% of the total number of patients are unvaccinated, however, approximately 20-30% of patients hospitalized for the disease COVID-19 have undergone vaccination. The investigators assume the existence of several phenotypes of infection even in vaccinated patients, which may differ both in the rate of antibody formation, the dynamics of indicators of persistent virus replication, and the intensity of a potentially self-destructive inflammatory reaction and activation of coagulation. Early identification of patients with completed vaccination who have a higher risk of a severe course of COVID or a demonstrable inadequate immune response will allow individualization of treatment. Finding out the risk characteristics of the patients is a question and the difference in the type of vaccine on the severity of the course of hospitalization and the clinical outcome of the patients can contribute to the optimization of the vaccination strategy of the population and to the early identification of risk groups of vaccinated persons from the point of view of the timely deployment of available post-exposure prophylaxis/treatment procedures.

Eligibility criteria: Inclusion Criteria:

* adult patients
* COVID-19 positiveness
* vaccination against SARS-CoV-2 (any number of doses)

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Patient phenotype
timeFrame: 1.1.2021 - 30.6.2023
Secondary outcomes:
measure: Vaccination status
timeFrame: 1.1.2021 - 30.6.2023
measure: Vaccine efectiveness
timeFrame: 1.1.2021 - 30.6.2023
Other outcomes:
Locations:
city: Hradec Kralove
country: Czechia
facility: University Hospital Hradec Kralove
Study officials:
References:
Clinical trial NCT04558333: CLAD: Finding Biomarkers to Predict Rejection and/ or Outcome After Lung Transplantation
Official title: CLAD: Finding Biomarkers to Predict Rejection and/ or Outcome After Lung Transplantation
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Lung Transplant Failure and Rejection
Primary Graft Dysfunction
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2020-09-22
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all lung transplant recipients

Brief summary: Lung transplantation is the ultimate treatment for end stage lung diseases. Survival after lung transplantation is limited mainly due to the development of chronic allograft dysfunction (CLAD). Both acute cellular rejection and primary grade dysfunction (PGD) have been associated with the development of CLAD. In this study we will investigate multiple prognostic factors that influence long term survival after lung transplantation with a specific interest in PGD, acute rejection and the development of CLAD.

Detailed description: At specific time points (according to protocol) exhaled breath, blood specimens, bronchoalveolar lavage and biopsies will be collected. These will be analyzed in an attempt to identify possible biomarkers that will predict the development of PGD and/or CLAD.

Eligibility criteria: Inclusion Criteria:

* all lung transplant recipients \> 18 years signed ICF (informed consent form)

Exclusion Criteria:

* none

Primary outcomes:
measure: identify prognostic biomarkers in blood, bronchoalveolar lavage and exhaled breath that will determine long term survival after human lung transplantation.
timeFrame: up to 520 weeks
Secondary outcomes:
measure: Secondary objectives are obtaining information on the development of (Primary graft development) PGD in relationship to respiratory viruses, genetic profile and exhaled breath in patients and (if possible donors) after human lung transplantation.
timeFrame: from transplantation till 72 hours after surgery
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: University Hospital Antwerp
state: Antwerp
Study officials:
affiliation: University Hospital, Antwerp
name: Thérèse Lapperre, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01080833: Effect of ERCP Mechanical Simulator (EMS) Practice on Endoscopic Retrograde Cholangiopancreatography (ERCP) Training
Official title: Effect of Simulator Practice on Trainees' ERCP (Endoscopic Retrograde Cholangiopancreatography) Performance in the Early Learning Period: a Multi-center Randomized Controlled Observational Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Training
Keywords: EMS
ERCP
Training
Trainees
Lead sponsor: East Bay Institute for Research and Education
Sponsor class: OTHER
Collaborators: name: University of California, Davis
name: University of California, Irvine
name: University of Arizona
name: Phoenix VA Health Care System
name: University of New Mexico
name: United States Naval Medical Center, San Diego
name: Kaiser Permanente
First posted: 2010-03-04
Enrollment: 16
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Trainees who are offered ERCP Mechanical Simulator (EMS) training in addition to routine training (study group) will demonstrate improved clinical outcomes compared to those undergoing routine ERCP training only (control group).

Detailed description: Hypothesis #1: Trainees who are offered simulator training in addition to routine training (study group) will demonstrate improved clinical outcomes compared to those undergoing routine ERCP training only (control group).

Hypothesis #2: Trainees who are initially in the control arm, but receive the simulator training after the initial 30 procedures (delayed intervention) will have significantly greater improvement of clinical outcomes in the second phase of the study (steeper learning curve) compared to the initial period.

STUDY DESIGN \& OUTCOMES

* Controlled randomized observational study.
* Immediate intervention (simulator training in the beginning of or just prior to the trainees' ERCP rotation) and delayed intervention (simulator training after 30 clinical procedures) will be studied
* Primary outcome: diagnostic biliary cannulation and deep biliary cannulation success rates Secondary outcomes: cannulation time, subjective competency score (5-point scale) graded by supervising physicians.

Eligibility criteria: Inclusion Criteria:

* Gastrointestinal fellows receiving ERCP training

Exclusion Criteria:

* Gastrointestinal fellows who are not receiving ERCP training

Primary outcomes:
measure: Diagnostic biliary cannulation and deep biliary cannulation success rates
timeFrame: 12 months
Secondary outcomes:
measure: Trainer assessment
timeFrame: 12 months
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
Study officials:
affiliation: Sacramento VA Medical Center
name: Joseph W Leung, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leung JW, Lee JG, Rojany M, Wilson R, Leung FW. Development of a novel ERCP mechanical simulator. Gastrointest Endosc. 2007 Jun;65(7):1056-62. doi: 10.1016/j.gie.2006.11.018.
Clinical trial NCT00854633: Study of Talactoferrin Oral Solution for Nosocomial Infection in Preterm Infants
Official title: Phase 1/2 Study of Talactoferrin Oral Solution for Nosocomial Infection in Preterm Infants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Nosocomial Infections
Keywords: Pre-term infants
Pre-term infants 750 to 1500 grams
Lead sponsor: Agennix
Sponsor class: INDUSTRY
Collaborators: name: National Institutes of Health (NIH)
First posted: 2009-03-03
Enrollment: 120
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will evaluate the safety, toxicity and efficacy of talactoferrin in reducing the incidence of all nosocomial infections in prematurely-born infants.


Eligibility criteria: Inclusion Criteria:

* Birth weights ranging from 750 to 1500 grams
* Entry before 24 hours of age
* Informed-consent form signed by parent(s) or legal guardian
* Able to take liquid medication by mouth or feeding tube

Exclusion Criteria

* A major birth defect or malformation syndrome
* Chromosomal or inherited disorder
* Proven presence of an immunodeficiency
* Antenatal exposure to illicit substances
* Birth asphyxia
* HIV or other congenital viral, bacterial, or fungal infection
* Lack of parental consent or refusal of attending neonatologist to allow participation
* Discretion of the investigator
* The legal representative of the infant or the patient's primary physician are not committed to providing full, aggressive life support

Primary outcomes:
measure: Reduction in incidence of Late-Onset Infection defined by positive cultures and elevated C-reactive protein (CRP)
timeFrame: 1-3 months
Secondary outcomes:
measure: "NEC Scares", the "Neonatal Sepsis Syndrome"
timeFrame: 1-3 months
measure: Length of stay: The number of days of hospitalization from the date of birth until the day of discharge from the NICU
timeFrame: 1-3 months
measure: Mortality during hospitalization
timeFrame: 1-3 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Childrens Hospital of Los Angeles
state: California
city: Louisville
country: United States
facility: Kosair Children's Hospital
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville Hospital
state: Kentucky
city: Columbia
country: United States
facility: University of Missouri Health Care, Columbia Regional Hospital
state: Missouri
Study officials:
References:
citation: Sherman MP, Adamkin DH, Niklas V, Radmacher P, Sherman J, Wertheimer F, Petrak K. Randomized Controlled Trial of Talactoferrin Oral Solution in Preterm Infants. J Pediatr. 2016 Aug;175:68-73.e3. doi: 10.1016/j.jpeds.2016.04.084. Epub 2016 May 31.
citation: Sherman MP, Sherman J, Arcinue R, Niklas V. Randomized Control Trial of Human Recombinant Lactoferrin: A Substudy Reveals Effects on the Fecal Microbiome of Very Low Birth Weight Infants. J Pediatr. 2016 Jun;173 Suppl:S37-42. doi: 10.1016/j.jpeds.2016.02.074.
Clinical trial NCT03297333: Effects of Exercise Mode on Cardiac Fat and Function
Official title: Effects of Exercise Mode on Cardiac Fat and Function
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obesity
Keywords: Obesity
Exercise
Cardiac Fat
Cardiac Magnetic Resonance
Vascular Health
Lead sponsor: Southern Illinois University Edwardsville
Sponsor class: OTHER
First posted: 2017-09-29
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The overall goal of this project is to study the effects of exercise energy expenditure matched vigorous dynamic resistance training and aerobic training on cardiac fat, and its relationship to cardiac function and geometry using cardiac Magnetic Resonance Imaging.

Detailed description: Exercise-induced weight-loss is one of the most common strategies for reducing excess fat in overweight and obese individuals. Although vigorous intensity may be more favorable promoting positive cardiac adaptations compared to low-moderate intensity, evidence of the positive effects of different exercise modes needs to be explored to allow for realistic comparisons with other strategies. Research using cardiac Magnetic Resonance Imaging that compares the effects of different modes of exercise - matched by exercise energy expenditure - on epicardial adipose tissue and paracardial adipose tissue, and how these interventions modify cardiac function and geometry have not been previously explored in obesity.

Eligibility criteria: Inclusion Criteria:

* Sedentary
* Caucasian
* BMI \>30 kg/m2 and \< 39.9 kg/m2

Exclusion Criteria:

* Known cardiovascular, metabolic, pulmonary disease or conditions
* Muscular-skeletal injuries
* Taking medications that affect endocrine or cardiovascular function
* Hypertension
* Being engaged in low intensity strength training more than two times per week or moderate-high intensity of any type of frequency
* Being pregnant
* Cigarette smoking
* Having non-removable pieces or devices incompatible with DXA and CMR assessment.

Primary outcomes:
measure: Changes in Epicardial adipose tissue (EAT)
timeFrame: 2 assessment points: at baseline and week 4
measure: Changes in Vascular Health
timeFrame: 2 assessment points: at baseline and week 4
Secondary outcomes:
measure: Changes in Paracardial adipose tissue (PAT)
timeFrame: 2 assessment points: at baseline and week 4
measure: Changes in Body Composition
timeFrame: 2 assessment points: at baseline and week 4
measure: Changes in Cardiorespiratory Function
timeFrame: 2 assessment points: at baseline and week 4
measure: Changes in Muscular Strength
timeFrame: 2 assessment points: at baseline and week 4
Other outcomes:
Locations:
city: Edwardsville
country: United States
facility: Southern Illinois University of Edwardsville
state: Illinois
Study officials:
affiliation: Southern Illinois University of Edwardsville
name: Maria Fernandez del Valle, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01759433: Reference Intervals for Sonoclot Analysis in Chinese
Official title: Reference Ranges for Sonoclot Analysis in Chinese
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Lead sponsor: Wuhan Asia Heart Hospital
Sponsor class: OTHER
First posted: 2013-01-03
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chinese healthy adults aged 18 and older

Brief summary: The reference intervals for Sonoclot Analysis may be different between Chinese and American. So far, no reference interval has been established in Chinese for Sonoclot Analysis. This study is going to establish the first Chinese reference intervals for Sonoclot Analysis and test whether they are different from American reference intervals.


Eligibility criteria: Inclusion Criteria:

* Aged 18 and older
* Han ethnic

Exclusion Criteria:

* Renal dysfunction
* Liver disorders
* Known coagulation disorders
* Patients taking medications in the last month

Primary outcomes:
measure: The reference intervals for sonoclot analysis in Chinese
timeFrame: 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Wuhan Asia Heart hospital
state: Hubei
Study officials:
References:
Clinical trial NCT00002433: The Effects of r-metHuIFN-Gamma on the Lungs of Patients With AIDS
Official title: Activation of Alveolar Macrophages by Aerosolized r-metHuIFN-Gamma (IFN-Gamma) in Patients With AIDS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: Pulmonary Alveoli
Macrophage Activation
Interferon-gamma, Recombinant
Injections, Subcutaneous
Aerosols
Acquired Immunodeficiency Syndrome
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To determine safety and tolerance of administering aerosolized recombinant interferon gamma (IFN-gamma) for 4 weeks in patients with AIDS. To examine activation of alveolar macrophages by aerosolized IFN-gamma administration. To determine if subcutaneous (SC) injection of IFN-gamma can activate alveolar macrophages in AIDS patients.


Eligibility criteria: Inclusion Criteria

Patients must have:

* Diagnosis of AIDS with one or more opportunistic infections.
* Kaposi's sarcoma with prior history of opportunistic infection.
* Stable dose of zidovudine (AZT) therapy.
* Preserved pulmonary, renal and hepatic function.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* Presence of active infection.
* Active opportunistic infections.
* Cardiac disease.
* Central nervous system disorders.
* History of seizures.
* Irreversible airway disease.

Patients with the following are excluded:

* Co-existing conditions and symptoms listed in Patient Exclusion Co-existing Conditions.

Prior Medication:

Excluded within 4 weeks of study entry:

* Immunosuppressive therapy.
* Cytotoxic therapy.
* Excluded:
* Interferon gamma therapy.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Hosp - Cornell Med Ctr
state: New York
Study officials:
References: