louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01995721: 4-valent HPV Vaccine to Treat Recurrent Respiratory Papillomatosis in Children
Official title: Phase III, Single-center Clinical Trial to Evaluate the 4-valent HPV Vaccine for the Treatment and Prevention of Recurrent Respiratory Papillomatosis in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Recurrent Respiratory Papillomatosis
Keywords: recurrent respiratory papillomatosis
human papillomavirus
vaccine
treatment
immunology
relapse
Lead sponsor: National Institute of Child Health, Hungary
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2013-11-27
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Recurrent respiratory papillomatosis in children caused by HPV 6,11 can be a life threatening condition resulting in surgical interventions. The maturing and disintegrating papillomas are the sources for the subsequent HPV relapses and immunization might slow down or even prevent this ongoing process.

After an initial immunological and ear-nose-throat (ENT) assessment children with at least 3 relapses in their patient history will be vaccinated with 4-valent HPV vaccine according to the following schedule: 0., 2., 6. months. It will be followed by an immunological and 3 ENT examinations to assess response to vaccination.

Detailed description: 1. Enrollment

   * ear-nose-throat (ENT) examination + oesophagoscopy
   * immunological assessment

     * assessment of selected humoral (antibodies) and
     * cellular immune response parameters(INF gamma and granzyme B testing)
     * in vitro and in vivo stimulation of PMBCs with the HPV-4 vaccine
2. Immunization with 4-valent HPV vaccine at 0,2,6 months
3. Follow up

   * 1 month after 3rd vaccine dose - immunological assessment (same tests as in the enrollment phase)
   * 6, 12 and 18 months after the 3rd vaccine dose - ENT + oesophagoscopy

Eligibility criteria: Inclusion Criteria:

* respiratory papillomatosis
* at least 3 relapses in patient history
* HPV 6 and/or 11 positive papillomas
* able to mount neutralizing antibodies

Exclusion Criteria:

* other chronic underlying condition
* other HPV type
* no antibody response

Primary outcomes:
measure: Papilloma relapses
timeFrame: 18 months after the 3rd vaccine
Secondary outcomes:
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: National Institute of Child Health
Study officials:
affiliation: National Institute of Child Health
name: Zsofia Meszner, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02267421: Effects of Home Based Exercise Therapy in Early Cirrhosis
Official title: An 8 Week Randomized Controlled Trial Assessing Home Exercise Therapy in Early Cirrhosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cirrhosis
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2014-10-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Individuals with Cirrhosis have been shown to have a low aerobic capacity. While supervised exercise training has been shown to be an effective intervention to remedy this, there is currently no data on home based exercise interventions in this population. This study will evaluate the effects of a home based exercise program on the aerobic capacity of enrolled early stage liver cirrhosis patients, as well as changes in quality of life, thigh muscle thickness, and thigh muscle oxygen consumption.


Eligibility criteria: Inclusion Criteria:

- Age \>18 and less than or equal to 70 years Liver Cirrhosis Child Pugh Class A or B If required, primary or secondary Variceal prophylaxis in place

Exclusion Criteria:

- Post-liver transplantation Hepatocellular carcinoma beyond transplant criteria Active non-hepatocellular carcinoma malignancy Significant cardiac disease Hemoglobin (\<80 g/L) Oxygen saturation at rest \<95% Known myopathy Chronic renal failure on dialysis Physical impairment making it impossible to ride an exercise bike or treadmill Orthopedic abnormality preventing exercise training HIV infection Patient unwilling to consent to study Child Pugh class C

Primary outcomes:
measure: Change in peak exercise pulmonary oxygen uptake (VO2peak).
timeFrame: Baseline (day 1) and Study End (8 weeks)
Secondary outcomes:
measure: Change in muscle mass as measured by thigh ultrasound
timeFrame: Baseline (day 1) and Study end (8 weeks)
measure: Change in quality of life - Chronic Liver Disease Questionnaire
timeFrame: Baseline (Day 1) and Study completion (8 weeks)
measure: Change in muscle oxygen extraction and consumption as measured by MRI
timeFrame: Baseline (day 1) and study completion (8 weeks)
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta, Mazankowski Heart Institute
state: Alberta
Study officials:
References:
Clinical trial NCT02680821: Reconstruction of the Anterolateral Ligament (ALL) With Revision Anterior Cruciate Ligament (ACL) Surgery
Official title: Effect of Reconstruction of the Anterolateral Ligament (ALL) in Combination With Revision Anterior Cruciate Ligament (ACL) Surgery. A Clinical Randomized Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Rupture of Anterior Cruciate Ligament
Anterolateral Ligament Reconstruction
Keywords: Laxity
Knee
Rupture
ALL
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
First posted: 2016-02-12
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Patients with combined Anterolateral ligament (ALL) reconstruction- Anterior cruciate ligament (ACL) revision will have a better rotational knee stability and therefore better patient reported outcome measure (PROM) scores compared to patients, who have ACL revision surgery without ALL reconstruction.


Eligibility criteria: Inclusion Criteria:

* Patients with ACL revision surgery indication

Exclusion Criteria:

* Patients with difficulties of understanding danish

Primary outcomes:
measure: Difference in The Knee Numeric-Entity Evaluation Score (KNEES)
timeFrame: 12 months
Secondary outcomes:
measure: Difference in Knee injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: 12 Months
measure: Difference in KT-1000
timeFrame: 12 Months
measure: Difference in TEGNER functional score
timeFrame: 12 Months
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Division of Sports Trauma, Tage-Hansens Gade 2b
Study officials:
References:
Clinical trial NCT06779721: Sestrin-2 Levels and Insulin Resistance
Official title: Sestrin-2 Levels and Insulin Resistance in Childhood Obesity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obese Adolescents
Keywords: Antioxidant
childhood obesity
insulin resistance
sestrin-2
oxidative stress
Lead sponsor: Kayseri City Hospital
Sponsor class: OTHER_GOV
First posted: 2025-01-16
Enrollment: 89
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Obese and healthy adolescents who admitted to Kayseri City Hospital

Brief summary: The aim of this study is to evaluate sestrin-2 levels in children with obesity


Eligibility criteria: Inclusion Criteria:

Obese adolescents Body mass index above the 95th percentile BMI Z-score above 2

Exclusion Criteria:

Primary hyperlipidemia Primary liver disease Hypothyroidism Diabetes

Primary outcomes:
measure: Evaluation of sestrin-2 levels in obese and healthy participants
timeFrame: From enrollment to the end of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Kayseri City Hospital
Study officials:
References:
Clinical trial NCT06144164: A Study of a Comprehensive Prevention Program to Reduce Lymphedema After Axillary Lymph Node Dissection in People With Breast Cancer
Official title: A Prospective Cohort Study of Patients Undergoing ALND for Treatment of Breast Cancer: The Efficacy of a Comprehensive Prevention Program in Decreasing the Incidence of Lymphedema and Improving Quality of Life
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Lymphedema
Lymphedema Arm
Lymphedema of Upper Arm
Breast Cancer
Breast Carcinoma
Female Breast Cancer
Keywords: immediate lymphatic reconstruction
axillary lymph node dissection
Lymphedema
Lymphedema Arm
Lymphedema of Upper Arm
Breast cancer
breast carcinoma
female breast cancer
Memorial Sloan Kettering Cancer Center
23-303
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2023-11-22
Enrollment: 285
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study to test whether a comprehensive program may help the lymph fluid to drain out of the arm and prevent lymphedema in participants with breast cancer.


Eligibility criteria: Inclusion Criteria:

* Female sex
* Diagnosis of breast cancer
* Ages 18 to 75 years
* Consented for unilateral ALND or for unilateral SLNB with possible ALND

Exclusion Criteria:

* Male sex
* Does not speak English
* Does not fit into study garment
* Axillary recurrence
* History of ALND
* Requirement of bilateral ALND for the treatment of breast cancer
* Treatment with SLNB only
* Known anaphylactic allergy to ICG dye used in ILR
* Impaired decision-making capacity

Primary outcomes:
measure: The difference between the baseline and postoperative arm volume measurement
timeFrame: Up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Limited Protocol Activities)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack (Limited Protocol Activities)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Limited Protocol Activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (Limited Protocol Activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Michelle Coriddi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00079664: Comparing Tai Chi Training to a Low-Stress Physical Activity to Enhance Sleep in Older Adults
Official title: Tai Chi Training and Sleep Enhancement in the Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Sleep Deprivation
Sleep Initiation and Maintenance Disorders
Keywords: Tai Ji
Lead sponsor: Oregon Research Institute
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2004-03-12
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the effects of Tai Chi, in comparison to conventional exercise, on the quality of sleep among sedentary older adults.

Detailed description: Elderly individuals often suffer from sleep disturbances. Chronic sleep problems can cause significant medical, psychological, and social disruptions. Although many sleep-related studies exist, few studies have focused on improving quality of sleep. Tai Chi, an exercise that incorporates meditation and breathing with whole body movements, may improve the quality of sleep and health status of elderly individuals.

Participants will be randomly assigned to either a Tai Chi group or a conventional exercise control group. Participants in each group will exercise for 60 minutes, 3 times per week, for 6 months. Assessment of sleep quality and health status will be done at study start, 3 months, 6 months, at the end of the study, and at a 3-month follow-up visit.

Eligibility criteria: Inclusion Criteria:

* Sedentary, as defined by a lack of regular exercise during the previous 6 months
* Healthy to the degree that participation in exercise testing and an exercise program would not exacerbate any existing disease condition
* Physician's clearance for participation
* Willingness to adhere to the conditions of the study

Exclusion Criteria:

* Sleep medication or other psychotropic medication during the study
* Current sleep disorder treatment
* Significant cognitive impairment as indicated by a score of 3 on the Pfeiffer Mental Status Questionnaire
* More than 7 alcoholic beverages per week or use of alcohol close to bedtime
* Smoking more than 10 cigarettes per day
* Score of 5 or higher in the Pittsburgh Sleep Quality Index questionnaire
* Score of 3 or higher on 2 out of 3 sleep items drawn from the Sleep Questionnaire and Assessment of Wakefulness

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Eugene
country: United States
facility: Oregon Research Institute
state: Oregon
Study officials:
References:
Clinical trial NCT04312464: Myocardial Damage in COVID-19
Official title: Retrospective Study of Myocardial Damage in COVID-19
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Cardiovascular Diseases
Keywords: COVID-19
myocardial injury
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2020-03-18
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The laboratory-confirmed patients with confirmed COVID-19 admitted to headquarters, west campus and cancer center of Union Hospital, Tongji Medical College, Huazhong University of science and technology, from January 1st to March 15th, 2020

Brief summary: This study aims to investigate the clinical characteristics, the incidence of myocardial injury, and the influence of myocardial injury on the prognosis in COVID-19 patients. There is no additional examination and treatment for this project.

Detailed description: The epidemic of the COVID-19 has expanded from Wuhan through out China, and is being exported to a growing number of countries. Recently, investigators have revealed that acute myocardial injury is existed in 7.2% patients with COVID-19, and this proportion in patients admitted to the ICU (22.2%) is higher than patients not treated in the ICU (2.0%). Thus, cardiac troponin I (cTNI), the biomarker of cardiac injury, might be a clinical predictor of COVID-19 patient outcomes. This study aims to investigate the clinical characteristics, the incidence of myocardial injury, and the influence of myocardial injury on the prognosis in COVID-19 patients.

Eligibility criteria: Inclusion Criteria:

* (1) Age ≥18 years. (2) Laboratory (RT-PCR) confirmed infection with SARS-CoV-2. (3) Lung involvement confirmed with chest imaging.

Exclusion Criteria:

* No cTnI test on admission

Primary outcomes:
measure: The myocardial injury incidence
timeFrame: 75 days
measure: The risk factors analysis for the death
timeFrame: 75 days
Secondary outcomes:
measure: Clinical characteristics
timeFrame: 75 days
measure: Clinical course
timeFrame: 75 days
measure: Cardiovascular comorbidity
timeFrame: 75 days
measure: Analysis of causes of death
timeFrame: 75 days
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
References:
Clinical trial NCT03310164: Lung and Gut Microbiome in Chronic Obstructive Pulmonary Disease
Official title: The Relationship Between Lung and Gut Microbiome in Chronic Obstructive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2017-10-16
Enrollment: 120
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinically stable patients with COPD and controls without COPD are enrolled.

Brief summary: Increasing evidence have implied that microbiota from airway and gut might be involved in the pathogenesis of chronic obstructive pulmonary disease (COPD). However, the cross-talk between respiratory and gastrointestinal microbiome in COPD is still undetermined. The study is aimed to investigate the interaction between lung and gut flora, and their role in the process of COPD.

Detailed description: Despite the high prevalence of chronic obstructive pulmonary disease (COPD), there continues to be a large gap in our understanding of disease pathogenesis and mechanisms accounting for large variability in disease phenotype. Cigarette smoking is the principal cause of COPD, but only approximately 15% of adults with substantial tobacco exposure develop clinical COPD. Besides, bacterial colonization or infection is also considered as an important factor in COPD. There are very limited data from microbiome studies that suggest that respiratory and gastrointestinal microbiota may be involved in the pathogenesis of COPD. However, the cross-talk between between lung and gut microbiome, and their relationship with various clinical phenotypes of COPD. Here, we conducted 16S rRNA-based pyrosequencing to evaluate the link between the lung-gut axis and the clinical phenotypes of COPD, such as lung function, emphysema, symptoms, exacerbations, inflammation levels and metabolic features.

Eligibility criteria: Inclusion Criteria:

1. males aged 40-80;
2. diagnosed with COPD according to the GOLD guidelines;
3. clinically stable patients without medication changes or exacerbation in two months;
4. smoking history of more than 10 pack years

Exclusion Criteria:

1. diagnosed with unstable cardiovascular diseases, significant renal or hepatic dysfunction or mental incompetence;
2. diagnosed with asthma, active pulmonary tuberculosis, diffuse panbronchiolitis, cystic fibrosis, clinically significant bronchiectasis, exacerbation of COPD or pneumonia in two months;
3. prescribed immunosuppressive medications.

Primary outcomes:
measure: Microbiota that can predict the progress of lung function
timeFrame: 6 months
Secondary outcomes:
measure: Bacteria related to inflammatory factors
timeFrame: 6 months
measure: Bacteria related to metabolomics
timeFrame: 6 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT03016364: Application Software in Dosage Adjustment for Advanced Cancer Patients With Pain
Official title: Application Software in Dosage Adjustment for Advanced Cancer Patients With Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Pain
Physicians
Oxycodone
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2017-01-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to determine whether Application (APP) would help clinical doctors to adjust the dose of Oxycodone Hydrochloride Prolonged-release Tablets in advanced patients with cancer pain.


Eligibility criteria: Inclusion Criteria:

* a histologically confirmed diagnosis of Cancer or Sarcoma
* advanced patients with severe cancer pain(score \>3)
* having used or expected to use the Oxycodone Hydrochloride Prolonged-release Tablets

Exclusion Criteria:

* allergic to Oxycodone Hydrochloride Prolonged-release Tablets, or other reasons (determined by clinical doctors) unable to use the Opioids

Primary outcomes:
measure: Numerical Pain Rating Scale
timeFrame: upto 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital, Chinese Academy of Medical Sciences
state: Beijing
Study officials:
References:
Clinical trial NCT06189664: Evaluation of the Effectiveness of Intraoperative Frozen Section on the Treatment of Suspected Gallbladder Cancer
Official title: Evaluation of the Effectiveness of Intraoperative Frozen Section on the Treatment of Suspected Gallbladder Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gallbladder Cancer
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2024-01-03
Enrollment: 37
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with suspected GB Cancer

Brief summary: Evaluate the effectiveness of intra-operative frozen section in the treatment of gallbladder cancer.

The study will be looking in to identify if intraoperative frozen section is a viable method to intraoperatively evaluate the presence of adenocarcinoma and the depth of its invasion and if the information given by frozen section is enough to modify the operative strategy.


Eligibility criteria: Inclusion Criteria:

- Patients with suspected GB cancer

Exclusion Criteria:

-

Primary outcomes:
measure: Detection of adenocarcinoma
timeFrame: immediately during frozen section
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: