louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05779514: Effect of Mirabegron on Promoting Brown Adipose Tissue Activation
Official title: Effect of Mirabegron on Promoting Brown Adipose Tissue Activation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tumour
Keywords: brown adipose tissue
Mirabegron
Lead sponsor: Zhejiang Provincial People's Hospital
Sponsor class: OTHER
First posted: 2023-03-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In previous preclinical studies, our group found that Mirabegron, a clinical drug, could activate brown adipose tissue and inhibit tumor growth in tumour-bearing mice.Investigators look forward to further evaluating the effect of Mirabegron-mediated brown adipose tissue activation, so as to provide new drug applications for clinical cancer prevention and treatment


Eligibility criteria: Inclusion Criteria:

* Health Volunteers

  1. Sign the informed consent before the study, and fully understand the content, process and possible adverse events.
  2. Both men and women, aged 18-75 years (including the boundary value) .
  3. Body mass index (BMI) is 19.0-26.0 kg/m2 (including the boundary value).
* Tumor patients

  1. Sign the informed consent before the study, and fully understand the content, process and possible adverse events.
  2. Tumor bearing and not in the period of chemotherapy and targeted drug intervention).
  3. Both men and women, aged 18-75 years (including the boundary value) .
  4. Body mass index (BMI) is 19.0-26.0 kg/m2 (including the boundary value).
  5. Proper bone marrow and organ function, as defined below:HB≥80h/L; ANC≥1.5\*109/L; PLT≥50\*109/L; ALT≤3 upper limit of normal ( ULN ); AST≤3 ULN ; TBIL≤1.5 ULN.
  6. The expected survival is 3 months or more.

Exclusion Criteria:

* Health Volunteers and Tumor patients

  1. A history of tuberculosis infection.
  2. Patients with contraindications to Mirabegron: allergic to Mirabegron or any of its excipients; Patients with poorly controlled severe hypertension(SBP≧180mmHg or/and DBP≧110mmHg).
  3. Women who are pregnant or breastfeeding.
  4. The subject may not be able to complete the study for other reasons or may not be able to participate in the study for other reasons judged by the investigator.

Primary outcomes:
measure: The growth of brown adipose tissue by PET-CT
timeFrame: Day 0 and Day 28
Secondary outcomes:
measure: blood glucose and glucose tolerance test ( GTT ) by Hematological tests
timeFrame: Day 0 and Day 28
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
Study officials:
affiliation: Institution Affiliation
name: Minghua Ge, Doctor
role: STUDY_CHAIR
References:
Clinical trial NCT06082414: Systemic Management in Extremely Preterm and Extremely Low Birth Weight Infants
Official title: Systemic Management in Extremely Preterm and Extremely Low Birth Weight Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bronchopulmonary Dysplasia
Death
Lead sponsor: Peking University
Sponsor class: OTHER
Collaborators: name: Peking University First Hospital
name: Peking University People's Hospital
name: Peking University Third Hospital
name: Tianjin Central Hospital of Gynecology Obstetrics
name: Peking Union Medical College Hospital
name: Beijing Children's Hospital
name: Beijing Friendship Hospital
name: Shanxi Provincial Maternity and Children's Hospital
name: The Second Hospital of Hebei Medical University
name: Handan Central Hospital
name: Xingtai People's Hospital
name: Tianjin Medical University General Hospital
name: The Affiliated Hospital of Inner Mongolia Medical University
name: Children's Hospital of Hebei Province
name: Tianjin First Central Hospital
name: Chifeng Municipal Hospital
name: Tianjin Medical University Second Hospital
name: PLA Rocket Force Characteristic Medical Center
First posted: 2023-10-13
Enrollment: 1200
Sex: ALL
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: infants with a birth weight \<1000grams or a gestational age \<28 weeks;

Brief summary: to estimate incidences of major complications, such as bronchopulmonary dysplasia, death, and delivery room resuscitation among extremely preterm and extremely low birth weight infants in Northern China

Detailed description: to estimate incidences and risk factors of bronchopulmonary dysplasia, death, and delivery room resuscitation among extremely preterm and extremely low birth weight infants in Northern China

Eligibility criteria: Inclusion Criteria:

1. born between January 1, 2015, and December 31, 2018;
2. a birth weight \<1000grams or a gestational age \<28 weeks;
3. admitted within 72 hours after birth.

Exclusion Criteria:

No medical history in the electronic record

Primary outcomes:
measure: incidences
timeFrame: at 36 weeks' corrected age (CA) or at discharge
measure: risk factors
timeFrame: at 36 weeks' corrected age (CA) or at discharge
measure: incidences of delivery room resuscitation
timeFrame: on admission
measure: risk factors of delivery room resuscitation
timeFrame: on admission
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Qi Feng
state: Beijing
Study officials:
affiliation: Peking University First Hospital
name: Qi Feng
role: STUDY_CHAIR
References:
Clinical trial NCT03999814: Natural History of Infantile Neuroaxonal Dystrophy
Official title: A Retrospective Review of the Natural History of Infantile Neuroaxonal Dystrophy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infantile Neuroaxonal Dystrophy
INAD
Keywords: Infantile Neuroaxonal Dystrophy
INAD
PLA2G6
Lead sponsor: Biojiva LLC
Sponsor class: INDUSTRY
First posted: 2019-06-27
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Living or deceased males or females with a diagnosis of classic INAD between the ages of 18 months and 10 years of age.

Brief summary: This is a retrospective and cross-sectional review of the natural history of INAD.

Detailed description: After obtaining informed consent, the study participants' relevant medical records will be collected and reviewed. If needed, a telephone or video conference will be scheduled with the patient's family to confirm and clarify information in the medical record. Deceased patients may be eligible for inclusion the retrospective registry if medical records are sufficient and indicate eligibility. Data will be pooled and presented in aggregate, without identification of individual subjects.

Eligibility criteria: Inclusion Criteria:

* Male or female 18 months to 10 years of age
* Medical history consistent with the symptoms of classic INAD (onset of symptoms between the ages of 6 months and 3 years)
* Homozygous for PLA2G6 deficiency (variant alleles may be mixed heterozygotes)
* Signed informed consent form (ICF) prior to entry into the registry

Exclusion Criteria:

* Diagnosis of atypical NAD (ANAD)
* Unwilling or unable to allow medical record review

Primary outcomes:
measure: To describe the natural history of infantile neuroaxonal dystrophy (INAD).
timeFrame: Birth to time of enrollment.
Secondary outcomes:
measure: To look for trends in disease progression of INAD that may be helpful in planning future interventional trials in INAD.
timeFrame: Birth to time of enrollment.
measure: Evaluating and potentially validating a Assessment of Severity by Parent or Caregiver questionnaire.
timeFrame: At time of enrollment.
Other outcomes:
Locations:
city: Los Altos
country: United States
facility: Sarah Endemann
state: California
Study officials:
affiliation: Biojiva LLC
name: Peter Milner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04370314: Retrospective Study on Clinical Performance of Screw-retained Implant Crowns
Official title: Clinical Performance of One-piece Screw-retained Implant Crowns Base on CAD/CAM Hand-veneered Zirconium Dioxide Customized Abutments With a 6 Years and 7 Months Mean Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Implant Failed
Lead sponsor: University of Bern
Sponsor class: OTHER
First posted: 2020-04-30
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Survival and success rates of all-ceramic implant-supported fixed reconstructions fabricated with CAD/CAM technology after at least one year in function.

Survival and success rates (clinical, radiologic and esthetic) of all-ceramic implant-supported fixed reconstructions fabricated with CAD/CAM technology after 2 to 10 years in function.

Establishment of a database of patients with all-ceramic implant-supported fixed reconstructions fabricated with CAD/CAM technology for future longitudinal retrospective studies.


Eligibility criteria: Inclusion Criteria:

* Patients with at least one fixed all-ceramic reconstruction (single implant restoration on BL implant with individualized zirconia abutment directly screwed and directly veneered, three- to five-unit zirconia bridges directly veneered, single tooth crown made of a lithium disilicate glass-ceramic (LS2) blank)
* Written informed consent

Exclusion Criteria:

* Pregnancy at the time of the follow-up examination
* Mental handicap
* Patients that could not be contacted/located
* Patients not interested in participating
* Patients with the need of antibiotic prophylaxis prior to a clinical examination

Primary outcomes:
measure: Survival and success rates of all-ceramic implant-supported fixed reconstructions
timeFrame: 1 year
Secondary outcomes:
measure: Number of patients with biological complications assessed via clinical examination
timeFrame: 1 year
measure: Number of patients with biological complications assessed via periapical x-ray
timeFrame: 1 year
measure: Number of patients with technical complications
timeFrame: 1 year
measure: Patient satisfaction as assessed by VAS A
timeFrame: 1 year
measure: Patient satisfaction as assessed by VAS B
timeFrame: 1 year
measure: Esthetic outcome
timeFrame: 1 year
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: University of Bern
Study officials:
affiliation: University of Bern
name: Manrique Fonseca, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fonseca M, Molinero-Mourelle P, Forrer FA, Schnider N, Hicklin SP, Schimmel M, Bragger U. Clinical performance of implant crowns with customized zirconia abutments: A prospective cohort study with a 4.5- to 8.8-year follow-up. Clin Oral Implants Res. 2021 Jul;32(7):853-862. doi: 10.1111/clr.13761. Epub 2021 May 24.
Clinical trial NCT00552214: Evaluation of HIV-1, HCV and HBV Blood Screening Tests With Human Blood Donor Specimens
Official title: Evaluation of a TMA Assay for the Screening of HIV-1 RNA, HCV RNA and HBV DNA in Human Blood Donor Plasma Specimens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Screening for the Presence of HIV-1, RNA and HBV DNA in Blood Donations
Keywords: Nucleic acid test
HIV-1
hepatitis
HBV
HCV
TMA
HIV Seronegativity
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-11-01
Enrollment: 10290
Sex: ALL
Minimum age (years): 17
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to validate the performance characteristics of an assay that tests for HIV-1, HCV and HBV on an automated blood bank instrument for registration submission.


Eligibility criteria: Inclusion Criteria:

* An acceptable blood donation health history and an EIA negative donation sample result with licensed EIA procedures in routine use at each facility

Exclusion Criteria:

* A positive (reactive) HIV and/or HCV and/or HBV test

Primary outcomes:
measure: Sensitivity and Specificity
timeFrame: 01 August 2007 to 31 December 2007
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Blood Center Taiwan Blood Service Foundation (TBSF)
Study officials:
affiliation: Grifols Biologicals, LLC
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04508114: Technology-assisted Index on Improving Hand Hygiene of Registered Nurses
Official title: The Effectiveness of Technology-assisted Index on Improving Hand Hygiene of Registered Nurses - An Experimental Research
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hand Hygiene
Keywords: nurse
hand washing
ATP
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2020-08-11
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: In 2009, the World Health Organization (WHO) recommended the use of a multi-faceted, multi-modal hand hygiene strategy (Five Moments for Hand Hygiene) to improve hand hygiene compliance among healthcare staff. The outbreak of coronavirus disease 2019 (COVID-19) has rapidly spread globally. The novel coronavirus is characterized by rapid human-to-human transmission. Hand washing is a part of measures recommended by the World Health Organization (WHO) to avoid contracting COVID-19.The purpose of this study was to use adenosine triphosphate (ATP) testing and direct observation for improving hand hygiene and compliance in nurse.

Detailed description: The purpose of this study was to use adenosine triphosphate (ATP) testing and direct observation as technology-assisted index on improving hand hygiene and compliance in nurse.

Eligibility criteria: Inclusion Criteria:

* (1)Day shift nurse on cancer ward,(2)who speak in Taiwanese and Mandarin,(3)and are willing to participate in the study.

Exclusion Criteria:

* (1)There is any wound or scar on hand.

Primary outcomes:
measure: Demographics
timeFrame: Pre-test
measure: Knowledge of My 5 Moments for Hand Hygiene
timeFrame: Pre-test
measure: Knowledge of My 5 Moments for Hand Hygiene (Post-test)
timeFrame: Immediately after completing the pre-test.
measure: Frequency of performing My 5 Moments for Hand Hygiene
timeFrame: Pre-test
measure: Frequency of performing My 5 Moments for Hand Hygiene (Post-test)
timeFrame: Immediately after completing the pre-test.
measure: Attitude on hand hygiene
timeFrame: Pre-test
measure: Attitude on hand hygiene (Post-test)
timeFrame: Immediately after completing the pre-test.
measure: ATP testing
timeFrame: Pre-test
measure: ATP testing (Post-test)
timeFrame: Immediately after completing the pre-test.
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei, Taiwan, 10051
country: Taiwan
facility: NTUH
Study officials:
affiliation: National Taiwan University, College of Medicine
name: Wei-Wen Wu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03894995: Optimizing Ventilation to Improve Health
Official title: Optimizing Windows to Improve Ventilation in Dhaka Slums
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pollution; Exposure
Keywords: Ventilation
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: International Centre for Diarrhoeal Disease Research, Bangladesh
name: Johns Hopkins University
name: University at Buffalo
First posted: 2019-03-29
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Our overall goal is to optimize preferred, ventilating windows/apertures/vents in low-income neighborhoods of Dhaka, Bangladesh. We will:

I. Collect baseline data on housing types and finalize windows/vents protoypes.

II. Measure the impact of improved ventilation on air exchange rates in houses in low-income neighborhoods of Dhaka and characterize the current and potential market for windows/vents in households in low-income neighborhoods of Dhaka, Bangladesh.

III. Understand recipients' (tenants and landords) perceived benefits of installed window/vent designs and difficulties faced with adoption of each design


Eligibility criteria: Inclusion Criteria:

* 1) lack cross-ventilation at the time of enrollment
* 2) have obtained landlord permission to make adjustments to their dwelling,
* 3) have a free roof where a window can be installed

Exclusion Criteria:

* 1) Household reports receiving dust from nearby machine that pulverizes materials for making roads

Primary outcomes:
measure: Household air exchange rate - spring (Part 3)
timeFrame: 50 minutes
measure: Household air exchange rate - summer (Part 3)
timeFrame: 50 minutes
measure: Household air exchange rate - fall (Part 3)
timeFrame: 50 minutes
measure: Household air exchange rate - winter (Part 3)
timeFrame: 50 minutes
measure: Number of households that adopt the intervention (Part 3)
timeFrame: 20 minutes
measure: Revealed willingness-to-pay for ventilation (Part 3)
timeFrame: 20 minutes
measure: Concentration of radon gas in house (Part 3)
timeFrame: 7 days
measure: Concentration of indoor particulate matter 2.5 (Part 3)
timeFrame: 48 hours for normal tests; 72 hours for quality control tests.
measure: Concentration of indoor particulate matter 2.5 (Part 2)
timeFrame: up to 5 hours
measure: Concentration of outdoor particulate matter 2.5 (Part 2)
timeFrame: up to 5 hours
measure: Personal exposure to particulate matter 2.5 - mother (Part 2)
timeFrame: up to 5 hours
measure: Personal exposure to particulate matter 2.5 - child (Part 2)
timeFrame: up to 5 hours
measure: Number of non-study, neighboring households that adopt the intervention and their willingness to pay (Part 4)
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: International Centre for Diarrhoeal Disease Research, Bangladesh
Study officials:
affiliation: Stanford University
name: Stephen P Luby, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05246995: A Phase I Study of IBI325 in Patients With Advanced Solid Tumor
Official title: A Phase I, Open-label, Dose-escalation Study Evaluating the Safety, Tolerability, and Potential Efficacy of IBI325, an Anti-CD73 Antibody, Combined With Sintilimab in Patients With Advanced Solid Tumor
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Solid Tumor
Lead sponsor: Shandong Cancer Hospital and Institute
Sponsor class: OTHER
First posted: 2022-02-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this phase I study is to evaluate the safety and potential efficacy and to determine the recommended phase 2 dose (RP2D) of IBI325 combined with Sintilimab in patients with advanced solid tumors


Eligibility criteria: Inclusion

1. Histologically confirmed, locally advanced unresectable or metastatic tumors.
2. At least one measurable lesion per RECIST 1.1
3. Male or female subject at least 18 years old and no more than 75 years old.
4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) performance status 0 or 1.
5. Must have adequate organ function
6. Be able to provide archived or fresh tumor tissues Exclusion

1. Any anti-tumor treatment with 4 weeks, except anti-CD73 monoclonal antibody. 2. Subjects participating in another interventional clinical study, except for during the survival follow-up phase of the studies.

3. Unstable central nervous system netastases 4. Known active autoimmune disease or inflammatory disease 5. Known active infectious disease 6. Other uncontrolled systematic disease that may increase the risk of participating the study

Primary outcomes:
measure: Number of patients with DLT
timeFrame: 42 days post first dose
measure: Number of patients with treatment related AEs
timeFrame: Up to 90 days post last dose
Secondary outcomes:
measure: Number of patients with response
timeFrame: Every 6 weeks until progressive disease or up to 24 months after treatment, whichever came first
Other outcomes:
Locations:
city: Jinan
country: China
facility: Shandong Province Cancer Hospital
state: Shandong
Study officials:
References:
Clinical trial NCT02767895: Prehabilitation for PAD Revascularization Patients
Official title: A Pilot Trial of Prehabilitation Among Patients Undergoing PAD Revascularization
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Peripheral Vascular Disease
Peripheral Artery Disease
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2016-05-10
Enrollment: 7
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients undergoing elective revascularization of their peripheral artery disease will be randomized to a prehabilitation program or usual care prior to their scheduled procedure.

Detailed description: Patients undergoing elective revascularization for their peripheral artery disease will be randomized to a "prehabilitation" program prior to their surgery or to usual care. The prehabilitation program is self-directed program designed to improve health and quality of life prior to surgery. The program is currently offered to general surgery patients; this study will examine the feasibility and acceptability of such a program in a different patient population.

Eligibility criteria: Inclusion Criteria:

* Documented lower extremity PAD
* Ability to walk at least 1 block
* Sedentary
* Medical clearance from the surgical team
* Competent to provide consent

Exclusion Criteria:

* Life expectancy \< 6 months
* Co-morbidities which limit walking to a severe degree
* Signs of critical limb ischemia
* Recent or current enrollment in a formal exercise program
* Recent cardiovascular events including stroke, TIA, severe valve disease, etc.
* Current substance abuse
* Psychiatric disorder which limits ability to participate in study procedures
* Non-English speaking

Primary outcomes:
measure: Feasibility of Study as Indicated by Number of Participants
timeFrame: 1 day
measure: Acceptability of Study as Indicated by Percentage of Participation
timeFrame: 8 months
Secondary outcomes:
measure: Increased Physical Activity Characteristics
timeFrame: 8 months
measure: Health-related Quality of Life
timeFrame: 8 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Elizabeth Jackson, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: