louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03747263: Individualized Approach vs. Fixed Approach
Official title: Individualized Approach vs. Fixed Approach Utilizing the Novel Arctic Front Advanced Pro Cryoballoon for Pulmonary Vein Isolation in Patients With Paroxysmal Atrial Fibrillation: A Randomized Observational Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation
Lead sponsor: University of Luebeck
Sponsor class: OTHER
First posted: 2018-11-20
Enrollment: 100
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 current study is to assess differences regarding the acute efficacy, safety, procedural duration, radiation exposure and long-term success of the novel AFA-Pro in combination of an individualized shortened ablation protocol containing a reduced freezing time to the standard approach of a fixed ablation protocol in patients with symptomatic PAF.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* The patient understands the nature of the study, treatment procedure and provides written informed consent
* Symptomatic paroxysmal atrial fibrillation as defined by the current guidelines
* Willing to comply with specified pre-, post- and follow-up testing, evaluations and requirements
* Expected to remain available (geographically stable) for at least 12 months after enrollment

Exclusion Criteria:

* Atrial fibrillation secondary to a reversible cause or of non-cardiac origin
* Previous AF ablation procedure
* Longstanding persistent AF
* Documented left atrial thrombus on imaging (e.g., transesophageal echocardiogram, angiogram)
* NYHA functional Class IV heart failure
* Unstable angina
* Left ventricular ejection fraction \< 30%
* Valvular disease requiring interventional treatment
* Cardiac surgery within 3 months prior to enrolment
* Left atrial size \> 55 mm as measured in the parasternal antero-posterior view
* Uncontrolled bleeding, diathesis, coagulopathy or pro-coagulant state
* Active systemic infection or sepsis
* Other co-morbid condition(s) that could limit the participant's ability to participate in the study or to comply with follow-up requirements, or impact the scientific integrity of the study.

Primary outcomes:
measure: Freedom from documented atrial tachyarrhythmia (every documented episode of atrial tachyarrhythmia lasting >/=30 seconds will be count as recurrence.
timeFrame: Month 12
Secondary outcomes:
measure: Acute procedure success
timeFrame: Day 0
measure: Procedure duration
timeFrame: Intraoperative
measure: Number of freeze-cycles to achive pulmonary vein isolation.
timeFrame: Day 0
measure: Radiation exposure of patient and operator
timeFrame: Day 0
measure: Radiation exposure duration
timeFrame: Day 0
measure: Periprocedural complications
timeFrame: Day 0
measure: Duration of freeze-cycles to achive pulmonary vein isolation
timeFrame: Day 0
Other outcomes:
Locations:
city: Luebeck
country: Germany
facility: University Heart Center Luebeck, Electrophysiology
Study officials:
References:
Clinical trial NCT04889963: Regeneration of Posterior Cruciate Ligament Injury Using Hypoxic Conditioned Allogenic Adipose Mesenchymal Stem Cell and Condition Medium
Official title: Regeneration of Posterior Cruciate Ligament Injury Using Hypoxia Conditioned Allogenic Adipose Mesenchymal Stem Cell (AdMSC) and Ligament Derived Condition Medium (Secretome)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Adypose Mesenchimal Stem Cell
Ligament Rupture
Ligament Derived Conditined Medium
Keywords: adypose mesenchimal stem cell hypoxic culture conditioned
Ligament Rupture
ligament derived conditined medium
Lead sponsor: Gadjah Mada University
Sponsor class: OTHER
First posted: 2021-05-17
Enrollment: 16
Sex: MALE
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Transplantation of Allogenic Adipose Mesenchimal Stem cell in hypoxic cultur condition with Ligament- derived conitioned medium can enhance regeneration of posterior cruciate ligament rupture

Detailed description: this study is in vivo study to prove effect of transplantation of Allogenic Adipose Mesenchimal Stem cell in hypoxic cultur condition with Ligament- derived conitioned medium in regeneration of posterior cruciate ligament rupture

Eligibility criteria: Inclusion Criteria:

* white male new zealand rabbit
* weight 2500 - 3000 gram

Exclusion Criteria:

* have no disease

Primary outcomes:
measure: tensile strength of posterior cruciate ligament
timeFrame: 6 weeks
measure: Thrombosite of Growth Factor - beta 1
timeFrame: 6 weeks
measure: basic fibroblast of growth factor
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sleman
country: Indonesia
facility: Sholahuddin Rhatomy
state: Yogyakarta
Study officials:
References:
Clinical trial NCT01210586: Tobacco Cessation in Postmenopausal Women
Official title: Tobacco Cessation in Postmenopausal Women - Part I & Part II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HRT
Non-HRT
Continued Smoking
Smoking Abstinence
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2010-09-28
Enrollment: 160
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study investigated whether being on transdermal hormone replacement therapy (HRT) influenced smoking cessation variables in postmenopausal women undergoing short-term abstinence from cigarettes. Women were recruited into two groups according to their pre-enrollment medication status - currently on HRT (n = 17) or not on HRT (n = 13). The HRT group had their prior medication replaced with a standard 0.1 mg estradiol transdermal system and 2.5 mg of Cycrin daily. Following two weeks of medication adjustment, participants continued smoking as usual for one week, at which time baseline measurements were taken. For the remaining two weeks, participants were instructed to quit smoking. They were provided with smoking cessation counseling and monitored for abstinence. Data were collected during five clinic visits on all dependent measures: Minnesota Nicotine Withdrawal Scale, Beck Depression Inventory (BDI) Scale, Profile of Mood States, Motor Speed Tasks, and Reaction Time Test.

Part II is identical to Part I, except it randomizes participants to use nicotine patch or not.


Eligibility criteria: Inclusion Criteria:

* 40-79 years old
* Clinical Menopause
* \> 15 cigarettes per day for at least one year
* Experienced nicotine withdrawal based on DSM IV

Exclusion Criteria:

* Currently obtaining nicotine from other sources
* Abnormal vaginal bleeding
* unstable health
* history of stroke or embolism
* history of abnormal thyroid function
* significant skin disorders
* active psychiatric disease

Primary outcomes:
measure: During short term smoking abstinence, do the beneficial effects of nicotine replacement therapy on acute symptomatology differ in women who use and do not use hormone replacement therapy?
timeFrame: Outcome was measured after 1 baseline week and a 2 week quit
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Minnesota
name: Sharon S Allen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04559386: Neuromusculaire Monitoring Survey - Usability
Official title: Neuromusculaire Monitoring Survey - Usability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Survey, Usability
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2020-09-22
Enrollment: 692
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants are asked to fill in a questionnaire and provide extensive information.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This survey aims to better define Anesthesiologist's perceived usability of existing anesthesia Neuromuscular Monitoring devices.

Detailed description: This study consists of a simple online survey that takes approximately 2 minutes to complete.

The study aims to assess Anesthesiologist's perceived usability of the different types of anesthesia neuromuscular monitoring devices (quantitative and qualitative). The survey is targeted to individual anesthesiologists, independetly of their degree of experience.

Eligibility criteria: Inclusion Criteria:

* Active Anesthesiology department heads of European Anesthesiology departments.

Exclusion Criteria:

* None

Primary outcomes:
measure: Usability
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: UZ Brussel
state: Brussel
Study officials:
References:
Clinical trial NCT03988686: Testing Radical Prostatectomy in Chinese Men With Prostate Cancer and oligoMetastases to the Bone
Official title: Zhongshan Hospital, Fudan University
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer Metastatic
Keywords: oligometastasis
prostate cancer
radical prostatectomy
progression-free survival
quality of life
Lead sponsor: Fudan University
Sponsor class: OTHER
Collaborators: name: University College, London
First posted: 2019-06-17
Enrollment: 120
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to examine whether radical prostatectomy can impact survival and quality-of-life in men with oligo-metastatic prostate cancer.

Detailed description: In this study, patients with oligo-metastatic prostate cancer will be randomized to radical prostatectomy plus standard care and standard care only. Standard care refers to androgen deprivation therapy (ADT) +/- other systemic therapies. Time to disease progression and post-treatment quality of life will be assessed and compared.

Eligibility criteria: Inclusion Criteria:

* Participants is willing and able to give informed consent for participation in the study
* Male aged 19-75 years.
* Diagnosed with oligo-metastatic prostate cancer (1-3 skeletal lesions on bone specific imaging, no visceral metastases).
* Locally resectable tumor (clinical/radiological stage T1-T3).
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
* Suitable for radical prostatectomy within 12 months of starting standard care.

Exclusion Criteria:

* Contraindications to radical prostatectomy.
* Visceral metastases.
* Prior radiotherapy to the abdomen/pelvis or to skeletal metastases.
* Any systemic therapy of prostate cancer (including standard care) for 12 or more months prior to enrollment.
* Current involvement in other interventional research.

Primary outcomes:
measure: the time to castrate resistance
timeFrame: 36 months after randomization
Secondary outcomes:
measure: Quality of life in patients post-randomization
timeFrame: three month post randomization
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
Study officials:
affiliation: Fudan University
name: Jian-Ming Guo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04387786: Dornase Alfa Administered to Patients With COVID-19 (DACOVID)
Official title: Nebulized In-line Endotracheal Dornase Alfa and Albuterol Administered to Mechanically Ventilated COVID-19 Patients: A Case Series
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Mechanical Ventilation
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: Cold Spring Harbor Laboratory
First posted: 2020-05-14
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: mechanically ventilated patients with COVID-19

Brief summary: Mechanically ventilated patients with coronavirus disease 2019 (COVID-19) have a mortality of 24-53%, in part due to distal mucopurulent secretions interfering with ventilation. Dornase alfa is recombinant human DNase 1 and digests DNA in mucoid sputum. Nebulized dornase alfa is FDA-approved for cystic fibrosis treatment. DNA from neutrophil extracellular traps (NETs) contributes to the viscosity of mucopurulent secretions. NETs are found in the serum of patients with severe COVID-19, and targeting NETs reduces mortality in animal models of acute respiratory distress syndrome (ARDS). Thus, dornase alfa may be beneficial to patients with severe COVID-19-acting as a mucolytic and targeting NETs.

Detailed description: Demographic, clinical data, and outcomes were collected from the electronic medical records of five mechanically ventilated patients with COVID-19-including three requiring veno-venous extracorporeal membrane oxygenation (VV-ECMO)-treated with nebulized in-line endotracheal dornase alfa co-administered with albuterol (used to increase delivery to the alveoli), between March 31 and April 24, 2020. Data on tolerability and responses, including longitudinal values capturing respiratory function and inflammatory status, were analyzed.

Eligibility criteria: Inclusion Criteria:

* mechanically ventilated patients with COVID-19

Exclusion Criteria:

* healthy, non-ventilated

Primary outcomes:
measure: Number of participants discharged from the intensive care unit (ICU)
timeFrame: 2 months
measure: Number of participants who survived COVID-19
timeFrame: 2-4 months
Secondary outcomes:
measure: Mean change in FiO2
timeFrame: 2 months
Other outcomes:
Locations:
city: Manhasset
country: United States
facility: Feinstein Insitute for Medical Research at Northwell Health
state: New York
Study officials:
affiliation: Feinstein Institute for Medical Research
name: Betsy J Barnes
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barnes BJ, Adrover JM, Baxter-Stoltzfus A, Borczuk A, Cools-Lartigue J, Crawford JM, Dassler-Plenker J, Guerci P, Huynh C, Knight JS, Loda M, Looney MR, McAllister F, Rayes R, Renaud S, Rousseau S, Salvatore S, Schwartz RE, Spicer JD, Yost CC, Weber A, Zuo Y, Egeblad M. Targeting potential drivers of COVID-19: Neutrophil extracellular traps. J Exp Med. 2020 Jun 1;217(6):e20200652. doi: 10.1084/jem.20200652.
Clinical trial NCT01005186: Changing Lifestyle in Children
Official title: Changing Lifestyle in Children: All Change: Can This Reduce Cardiovascular Risk?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cardiovascular Risk
Lead sponsor: University of Dundee
Sponsor class: OTHER
Collaborators: name: University of St Andrews
First posted: 2009-10-30
Enrollment: 92
Sex: ALL
Minimum age (years): 9
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A lifestyle intervention aimed at improving exercise levels in primary school children.


Eligibility criteria: Inclusion Criteria

* Children 9-11 yrs

Exclusion Criteria:

* Children \<9 yrs and \>12 yrs

Primary outcomes:
measure: Can an acceptable strategy, based on social cultural factors that influence adherence to the strategy and designed for altering lifestyle associated with CV risk (ALL CHANGE) be developed for school aged children?
Secondary outcomes:
measure: Is ALL CHANGE more effective in altering lifestyle than conventional health education delivered as part of the school curriculum?
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02792686: ABX464 First in Man Study
Official title: ABX464 First in Man, Open Label, Parallel Group, Single Ascending Dose Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Healthy Volunteers
Lead sponsor: Abivax S.A.
Sponsor class: INDUSTRY
First posted: 2016-06-07
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is an open label, parallel group, single ascending dose, exploratory study performed in a single site (Centre Cap, Montpellier, France).

Detailed description: This study is an open label, parallel group, single ascending dose, exploratory study performed in a single site (Centre Cap, Montpellier, France). Six subjects per dose group were enrolled into 1 of 4 groups with escalating doses of ABX464 (50, 100, 150 and 200 mg). For each dose group, a first subject was treated, if no adverse event (AE) occurred, a second subject was dosed one hour later. The four last subjects were dosed the day after if no clinically significant AE occurred. Escalation to the following dose level was decided after review of PK and safety data (laboratory results, ECG, vital signs and AEs)

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* Subject in good health on the basis of medical history, physical examination, vital signs, electrocardiogram (ECG) and routine laboratory safety tests
* Subject with a BMI of 18 27kg/m²
* Non smokers or light smokers of less than 10 cigarettes per day
* Having given their written informed consent

Exclusion Criteria:

* Subject with any on-going infection or disease

Primary outcomes:
measure: Percentage of patients experiencing at least one Adverse Event
timeFrame: Up to 45 days post dosing
Secondary outcomes:
measure: Peak Plasma Concentrations (Cmax) of ABX464 and metabolite
timeFrame: Up to 45 days post dosing
measure: Area Under the Curve (AUC) of Plasma Concentrations of ABX464 and metabolite
timeFrame: Up to 45 days post dosing
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Centre Cap
Study officials:
References:
citation: Scherrer D, Rouzier R, Noel Barrett P, Steens JM, Gineste P, Murphy RL, Tazi J, Ehrlich HJ. Pharmacokinetics and tolerability of ABX464, a novel first-in-class compound to treat HIV infection, in healthy HIV-uninfected subjects. J Antimicrob Chemother. 2017 Mar 1;72(3):820-828. doi: 10.1093/jac/dkw458.
Clinical trial NCT06714786: Observational Study of Eating Behavior in Patients With Diabetes Mellitus and Obesity Undergoing Liver Transplantation
Official title: Observational Study on Prevalence of Eating Behavior in Adult Patients With Diabetes Mellitus and/or Obesity, Listed or Already Undergoing Liver Transplantation
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Liver Transplant
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2024-12-04
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study involves the enrollment of at least 100 patients, currently followed for the treatment of severe organ failure, on the list or already undergoing liver transplantation and referred for a dietetic visit.

Brief summary: The study aims to evaluate the presence of eating disorders, which consists of having an altered relationship with food, in patients on the list or already undergoing liver transplantation.

Detailed description: The study involves the enrollment of at least 100 patients, currently followed for the treatment of severe organ failure, on the list or already undergoing liver transplantation and referred for a dietetic visit.

Eligibility criteria: Inclusion Criteria:

* signature of written informed consent to participate in the observational study, either by the participant or legal guardian

  * age \> 18 years
  * diagnosis of type 2 diabetes mellitus and/or overweight or obesity, (BMI \> 25)
  * be listed for OLT or have already been submitted to OLT

Exclusion Criteria:

* -previous diagnosis of psychiatric illness;

Primary outcomes:
measure: eating disorder
timeFrame: at the time of enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Sant'Orsola
state: BO
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Lucia Brodosi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01920386: Phase 3 Study of Tramadol Hydrochloride/Acetaminophen SR Tab. & Tramadol Hydrochloride/Acetaminophen Tab. in Acute Toothache Patients After Teeth Extraction Surgery
Official title: A Randomized, Double-blind, Active-controlled, Parallel, Multicenter Phase 3 Study of Tramadol Hydrochloride/Acetaminophen SR Tab. & Tramadol Hydrochloride/Acetaminophen Tab. in Acute Toothache Patients After Teeth Extraction Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Toothache Patients Above Moderate Pain After Teeth Extraction Surgery
Keywords: Acute Toothache
Wontran
Wontran SR Tab.
Tramadol Hydrochloride/Acetaminophen
Lead sponsor: Daewon Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-08-12
Enrollment: 240
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized, double-blind, active-controlled, parallel, multicenter Phase 3 study of Tramadol hydrochloride/Acetaminophen SR Tab. \& Tramadol hydrochloride/Acetaminophen Tab. in Acute Toothache Patients above Moderate Pain after Teeth Extraction Surgery.


Eligibility criteria: Inclusion Criteria:

1. Adult males/Females aged over 20 years
2. Patients with over 2 impacted wisdom teeth in the upper and lower jaws
3. Pain VAS Value over 50 mm evaluated as 100mm VAS
4. Subjects who voluntarily or legal guardian agreed with written consent

Exclusion Criteria:

1. Patients with severe heart disease, uncontrol hypertension, diabetes
2. Patients who had taken a long period NSAID (eg. celecoxib, rofecoxib naproxen etc) within 3 days from the screening point
3. Patients who had taken short-time anesthetic drugs and analgesics within 12 hours from the screening point (except short-time anesthetics before or during surgery)
4. Patients with aspirin asthma(asthma seizure caused by NSAIDs) or medical history
5. Patients with severe respiratory depression

Primary outcomes:
measure: SPID ; Sum of the pain intensity differences
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12 hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: