louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01237132: East-West Hepatocellular Carcinoma Study Group
Official title: EAST-WEST HEPATOCELLULAR CARCINOMA STUDY GROUP
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Hepatocellular
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2010-11-09
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 affected by HCC

Brief summary: The current treatment guidelines of hepatocellular carcinoma (HCC) of the American and European Associations for the Study of Liver Disease are based on the Barcelona-Clinic-Liver-Cancer classification (BCLC), which does not recommend surgery in patients with large, multinodular and macrovascular invasive disease. The aim of this study was to investigate the role of hepatic resection in a large retrospective multicentric cohort of patients resected for HCC regardless of the BCLC indications.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of hepatocellular carcinoma
* candidate to liver resection as a curative treatment

Exclusion Criteria:

* uncertain diagnosis of hepatocellular carcinoma
* uncertain follow-up data

Primary outcomes:
measure: Overall survival of resected patients for HCC
Secondary outcomes:
measure: Disease-free survival of resected patients for HCC
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04704232: Study of Safety, Efficacy, and Pharmacokinetics of Topical ACD440 in Healthy Volunteers
Official title: Prospective,Double-blind,Randomized,Placebo-controlled Study of Safety,Efficacy, and Pharmacokinetics of Topical ACD440 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Lead sponsor: AlzeCure Pharma
Sponsor class: INDUSTRY
First posted: 2021-01-11
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Phase 1 b placebo-controlled study in healthy volunteers to study safety, efficacy and pharmacokinetics of Topical ACD440 on normal skin, skin optimized for penetration and skin exposed to ultraviolet radiation

Detailed description: This is an exploratory study, no primary or secondary endpoints are being defined.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteer
* Fitzpatrick skin type II or III
* Women not childbearing potential or highly effective contraception

Exclusion Criteria:

* Pregnancy, lactation
* Drug abuse
* Clinically significant illness
* Positive COVID 19 test at screening or COVID 19 infection in the past

Primary outcomes:
measure: Laser-evoked potentials as a tool for assessing the efficacy of antinociceptive drugs
timeFrame: 5 Days
Secondary outcomes:
Other outcomes:
measure: Laser-evoked potentials as a tool for assessing the efficacy of antinociceptive drugs
timeFrame: 5 days
measure: Visual analog scale rating of laser induced pain
timeFrame: 5 days
measure: Number and percentage of subjects with adverse events
timeFrame: 5 days
measure: Number and percentage of subjects with clinically significant changes in 12-lead ECGs, vital signs and laboratory findings
timeFrame: 5 days
Locations:
city: Stockholm
country: Sweden
facility: AlzeCure Pharma investigational site
Study officials:
References:
Clinical trial NCT00519532: Long-term Extension of RECOVER- Long-term Effect of the 24h Transdermal Delivery of Rotigotine in Subjects With Idiopathic Parkinson's Disease
Official title: A Multicenter, Multinational, Phase 3b, Open-label Extension Trial to Evaluate the Long-term Effect of the 24-hour Transdermal Delivery of Rotigotine on Motor Function, Sleep Quality, and Nocturnal and Non-motor Symptoms in Subjects With Idiopathic Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Parkinson's Disease
Keywords: Neupro®
Rotigotine
Parkinson's Disease
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2007-08-22
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this open-label extension is to assess the long-term effect of the 24-hour transdermal delivery of rotigotine on motor function, sleep quality, and nocturnal and non-motor symptoms of Parkinson's disease. The long-term safety and tolerability of the rotigotine transdermal patch will also be evaluated.


Eligibility criteria: Inclusion Criteria:

* Completion of trial SP889

Exclusion Criteria:

* Ongoing serious adverse event assessed as related to trial medication

Primary outcomes:
measure: Change From Baseline in UPDRS III Score at Week 13 (End of Maintenance)
timeFrame: Baseline (baseline SP915) and week 13 (End of maintenance)
measure: Change From Baseline in Parkinson Disease Sleep Scale (PDSS) at Week 13 (End of Maintenance)
timeFrame: Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance)
Secondary outcomes:
measure: Change From Baseline in Nocturnal Akinesia, Dystonia, and Cramps Score (NADCS) at Week 13 (End of Maintenance)
timeFrame: Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance)
measure: Change From Baseline in Number of Nocturias at Week 13 (End of Maintenance)
timeFrame: Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance)
Other outcomes:
Locations:
city: St. Petersburg
country: United States
state: Florida
city: Salisbury
country: United States
state: North Carolina
city: Concord
country: Australia
city: Oulu
country: Finland
city: Berlin
country: Germany
city: Dresden
country: Germany
city: Kassel
country: Germany
city: Marburg
country: Germany
city: Naumburg
country: Germany
city: Ulm
country: Germany
city: Budapest
country: Hungary
city: Nyiregyhaza
country: Hungary
city: Chieti
country: Italy
city: Milano
country: Italy
city: Christchurch
country: New Zealand
city: Olyszytn
country: Poland
city: Cape Town
country: South Africa
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Lancashire
country: United Kingdom
city: Liverpool
country: United Kingdom
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00739232: Single Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HSD-016
Official title: Single Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HSD-016 Administered Orally to Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Keywords: Safety and tolerability of HSD-016
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2008-08-21
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single ascending dose study of HSD-016 to provide the initial assessment of the safety, tolerability, how the drug is absorbed and eliminated, and its effect on the body.


Eligibility criteria: Inclusion:

1. Men or women of nonchildbearing potential aged 18 to 50 years inclusive at screening.
2. Healthy as determined by the investigator on the basis of screening evaluations.
3. Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history.

Exclusion:

1. No presence or history of any disorder that may prevent the successful completion of the study.
2. No history of drug abuse within 1 year.

Primary outcomes:
measure: Safety and Tolerability
timeFrame: 3 months
Secondary outcomes:
measure: Profiles of Drug Concentrations
timeFrame: 3 months
Other outcomes:
Locations:
city: Overland Park
country: United States
state: Kansas
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03629132: PRP Prevents Recurrence of Intrauterine Adhesions
Official title: Platelet-rich Plasma(PRP) Prevents Recurrence of Intrauterine Adhesions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intrauterine Adhesion
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2018-08-14
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Effect of platelet-rich plasma (PRP) on uterine scar fibrosis, endometrial receptivity and pregnancy outcome in patients with severe intrauterine adhesions

Detailed description: 1. Inclusion criteria: patients with intrauterine adhesions (AFS score \>9 points); age 21 to 40 years old, with fertility requirements.
2. Study design:prospective, randomized controlled cohort study, patients with intrauterine adhesions were randomized into two groups, the control group and the intervention group (intraoperative and postoperative 1 week postoperative PRP). The surgical procedures and postoperative medication regimens were the same.
3. Compare the biochemical pregnancy rate, clinical pregnancy rate, abortion rate and live birth rate after hysteroscopic resection in PRP group and control group, and explore the effect of PRP on pregnancy outcome after intrauterine adhesion.

Eligibility criteria: Inclusion Criteria:Patients with intrauterine adhesions (AFS score \>9 points); age 21 to 40 years old, with fertility requirements -

Exclusion Criteria:Endometrial tuberculosis, endometrial polyps, uterine submucosal fibroids, endometrial hyperplasia, endometrial malignant lesions, premature ovarian failure, chromosomal abnormalities

-

Primary outcomes:
measure: AFS score
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05446532: Coexistence HBsAg/HBcAC, Clinical Characterístics & Outcomes
Official title: Characteristics of Hepatitis B HBsAg & HBsAc Carriers Simultaneously
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis B
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
Collaborators: name: Hospital Mutua de Terrassa
name: Consorci Sanitari de Terrassa
name: Hospital Universitario La Fe
name: Germans Trias i Pujol Hospital
First posted: 2022-07-06
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All those patients included all patients visited asoutpatient hepatology consultations of the respective centers in the last 10 years (between 01/01/2010 and 12/31/2020) and who present positive HBsAg and HBsAc serology simultaneously.

Brief summary: HBV infection is a dynamic process with complex interactions between virus replication and the host's immune response. The appearance of anti-HBs after HBV infection generally indicates recovery and immunity to HBV1 infection. However, there are several published studies that describe the coexistence of the marker of chronic infection (HBsAg +) and the marker of functional cure (HBsAc +). There are contradictory studies on whether the coexistence of HBsAg/HBsAc implies a different clinical course.


Eligibility criteria: Inclusion Criteria:

* all those patients who have been seen in outpatient hepatology consultations and who present positive HBsAg and HBsAc serology simultaneously.

Exclusion Criteria:

* Hepatitis C or HIV Co-infection

Primary outcomes:
measure: prevalence concomitant HBsAg and HBsAc markers
timeFrame: 10 years
Secondary outcomes:
measure: differences between immunocompetent patients with respect to immunocompromised ones.
timeFrame: 10 years
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: H. Consorci Sanitari Parc Tauli
state: Barcelona
Study officials:
References:
Clinical trial NCT05629832: Transpulmonary Pressure in Right Ventricle Protection of ARDS
Official title: Transpulmonary Pressure Guided Mechanical Ventilation Strategy for Right Ventricle Protection in Acute Respiratory Distress Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Respiratory Distress Syndrome
Acute Cor Pulmonale
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2022-11-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To compare the effect between mechanical ventilation strategy guided by transpulmonary pressure and tranditional lung protective ventilation strategy in acute respiratory distress syndrome for right ventricle protection.


Eligibility criteria: Inclusion Criteria:

* duration of invasive mechanical ventilation less than 72 hours;
* meet the diagnostic criteria of Berlin definition for ARDS;
* age older than 18

Exclusion Criteria:

* esophageal surgery or damage;
* cardiac surgery;
* severe bronchopleural fistula;
* serious arrhythmia; pneumothorax;
* tricuspid stenosis;
* heparin allergy;
* chronic pulmonary heart disease

Primary outcomes:
measure: Pulmonary vascular resistance (PVR)
timeFrame: 3 days
measure: Pulmonary vascular compliance
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Chao-Yang Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT03701932: Mental Activity During (TMS) Therapy for Depression
Official title: Mental Activity During Transcranial Magnetic Stimulation (TMS) Therapy for Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Impairment
Keywords: Depression, Transcranial Magnetic Stimulation (TMS)
Lead sponsor: Augusta University
Sponsor class: OTHER
Collaborators: name: Lumos Labs, Inc.
First posted: 2018-10-10
Enrollment: 11
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 the study is to assess the effects of different types of mental activity performed while receiving transcranial magnetic stimulation (TMS) for the treatment of major depressive disorder. Our primary aim for this study is to assess the feasibility of combining TMS and computer based cognitive exercise in patients with major depressive disorder who may also have some degree of cognitive dysfunction, and to formally measure changes in mood and cognition over the course of the study.

Detailed description: Patients will receive TMS treatment daily for 6 weeks as part of their standard care. They will complete clinical assessments and participate in cognitive retraining through completion of 15 hours of Lumosity gaming cognitive exercises while simultaneously receiving active TMS stimulation. Those participants in the control group will complete 15 hours of computer gaming activity during the administration of active stimulation. Computer games in the control group exercises are elected by the patient from a library of intellectually and motivationally engaging games drawn from several gaming software compilations that includes Play 101 Games and Hoyle Puzzle and Board Games.

Eligibility criteria: Inclusion Criteria:

* • Subject has a diagnosis of depression

  * Subject has been approved and scheduled to receive TMS at Augusta University
  * Subject does not have a major neurocognitive impairment or an alcohol or substance abuse disorder, and can see images on a computer monitor.

Exclusion Criteria:

-

Primary outcomes:
measure: The University of Pennsylvania Computerized Neuropsychological Testing Battery (Penn CNP)
timeFrame: Change from baseline at six weeks
Secondary outcomes:
measure: The Lumosity® Brain Performance Test (BPT)
timeFrame: Change from baseline at six weeks
measure: Inventory of Depressive Symptoms- Self Report
timeFrame: Change from baseline at six weeks
measure: Hamilton Depression Rating Scale 17 item
timeFrame: Change from baseline at six weeks
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Augusta University
state: Georgia
Study officials:
affiliation: Augusta University
name: Peter B Rosenquist, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04293432: A Pharmacovigilance Study of Torsade de Pointes
Official title: A Pharmacovigilance Study of Torsade de Pointes in the Food and Drug Administration Adverse Event Reporting System Using Data Mining Algorithms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Torsades de Pointe Caused by Drug
Lead sponsor: University of Peshawar
Sponsor class: OTHER
First posted: 2020-03-03
Enrollment: 6670
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presented with TdP treated for any disease

Brief summary: Many cardiac and non-cardiac drugs are associated with TdP that may constitute a significant problem because of sudden cardiac death. This study aims to present a comprehensive overview and disproportionality analysis of TdP cases reported to the Food and Drug Administration Adverse Event Reporting System (FAERS) in order to identify new signals of TdP.

Detailed description: Drug-induced Torsade de Pointes (TdP) is a serious but an overlooked adverse drug reaction because a wide range of marketed drugs associated with TdP are commonly prescribed in routine practice. Owing to the heightened concern of a vast number of drug-TdP associations including newly approved drugs, the investigators, therefore, aims to investigate drug-TdP associations by performing disproportionality analysis in order to identify new signals of TdP utilizing the individual case reports of TdP in the FAERS database.

Eligibility criteria: Inclusion Criteria:

* TdP cases reported in the FAERS database till 31/03/2019
* Adverse event reported was including the MedDRA term: Torsade de Pointes

Exclusion Criteria:

* Drugs with less than 10 TdP reports

Primary outcomes:
measure: Identification of drugs associated with TdP
timeFrame: Cases reported to the FAERS database till 31/03/2019
measure: Identification of new signals of TdP
timeFrame: Cases reported to the FAERS database till 31/03/2019
Secondary outcomes:
measure: Validation of already known drug-TdP associations
timeFrame: Cases reported to the FAERS database till 31/03/2019
measure: Stratification of new signals with respect to age
timeFrame: Cases reported to the FAERS database till 31/03/2019
measure: Stratification of new signals with respect to gender
timeFrame: Cases reported to the FAERS database till 31/03/2019
measure: Trends of TdP reports in FAERS database
timeFrame: Cases reported to the FAERS database till 31/03/2019
measure: Description of the population of patients having TdP
timeFrame: Cases reported to the FAERS database till 31/03/2019
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: Department of Pharmacy, University of Peshawar
state: Khyber Pakhtunkhwa
Study officials:
References:
Clinical trial NCT05411432: Clinical Study of 68Ga Labeled HER2 Affibody Analogues
Official title: Clinical Study of 68Ga Labeled HER2 Affibody Analogues in Healthy Volunteers and Patients With Breast or Gastric Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: HER2-positive Breast Cancer and Gastric Cancer
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2022-06-09
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to assess the dosimetric properties of the positron emission tomography (PET) imaging probe 68Ga labeled HER2 Affibody analogues and preliminarily evaluate its diagnosis value in patients with breast or gastric tumors.

Detailed description: 6 healthy volunteers with whole-body PET/CT scans at 0-1.0, 2.0, 3.0 and 4.0 hours after tracer injection (mean dose, 4.93 ± 0.10 mCi) will be performed. During the imaging period, 1 mL blood samples will be obtained specifically at 1, 3, 5, 10, 30,60, 90, 120, 150, 180 and 240 minutes after the injection, for time-activity curve calculations. The estimated radiation doses will be calculated by using OLINDA/EXM software.

50 patients with breast or gastric tumors will be enrolled for the clinical study, they will be performed with both 68Ga-HER2 Affibody PET/CT and18F-FDG PET/CT scans before surgery. The preoperative images are compared and correlated with the pathologically report. Next, the expression of HER2 will be determined by immunohistochemical staining of the resected brain tumor tissues.

Eligibility criteria: Inclusion Criteria:

* patients with breast or gastric cancers: diagnosed by MR and ready for surgery

Exclusion Criteria:

* refuse or cannot endure surgery pregnant women

Primary outcomes:
measure: SUV of organs
timeFrame: 0, 0.5, 1.0, 2.0,3.0 and 4.0 hours after injection
Secondary outcomes:
measure: radioactivity of blood sample
timeFrame: 1, 3, 5, 10, 30,60, 90, 120, 150, 180 and 240 minutes
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02260232: Worksite Exercise Intervention Effects on Cardiovascular Disease Risk Factors and Physical Activity Levels Among Healthy Employees
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise Therapy
Lead sponsor: Universidad Europea de Madrid
Sponsor class: OTHER
First posted: 2014-10-09
Enrollment: 295
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Objective: To investigate the effects of a one-year worksite individual exercise intervention on lifestyle-related modifiable health risks, physical capacity and work performance.

Methods: Two hundred ninety-five employees volunteered to participate (n=191 women, n=104 men), aged 38 ± 8 years and body mass index (BMI), 24.71 ± 3.79. Measures of physical activity levels were assessed by the long self-administrated version of the International Physical Activity Questionnaire-Long Form (IPAQ-L), and all subjects performed a maximal cardiopulmonary treadmill graded exercise test. Blood samples and anthropometry measures were collected from participants at baseline survey, at 6 months and 1-year after. Components of the program included supervised moderate to high intensity cardiorespiratory exercise, resistance training, and flexibility.


Eligibility criteria: Inclusion Criteria:

Working in ASISA company, middle-age (20-60)

Exclusion Criteria:

No medical condition contraindicating exercise participation

Primary outcomes:
measure: International Physical Activity Questionnaire-Long Form (IPAQ-L)
timeFrame: 1 week
measure: Graded cardiorespiratory fitness exercise test
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: