louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03942926: The Efficacy and Safety of Sirolimus for Plastic Bronchitis
Official title: The Efficacy and Safety of Sirolimus for Plastic Bronchitis：a Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Plastic Bronchitis
Keywords: plastic bronchitis
sirolimus
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: North-China Pharmaceutical Company, China
First posted: 2019-05-08
Enrollment: 10
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Ten lymphatic bronchitis patients are planned to be recruited for the study. Sirolimus will be administered for 6 months.
Primary purpose: TREATMENT

Brief summary: There is no confirmed drug therapy for plastic bronchitis. The study wish to test the effectiveness and safety of sirolimus (rapamycin) in patients with lymphatic plastic bronchitis.

Detailed description: Plastic bronchitis is a rare respiratory disorder characterized by formation of gelatinous or rigid cast of bronchial tree. Confirmed drug therapy for plastic bronchitis is lacking. Recently, part of plastic bronchitis has been found to have dysfunction of lymphatic circulation in the lung. Pulmonary lymphatic perfusion syndrome (PLPS) is regarded as a major mechanism of lymphatic plastic bronchitis. Sirolimus (rapamycin) has not been studied in plastic bronchitis, however, it has been shown effective in several lymphatic disorders, such as lymphangioleiomyomatosis, generalized lymphatic anomaly (GLA) including lymphangiomatosis, etc. We wish to test the effectiveness of sirolimus in lymphatic plastic bronchitis.

Eligibility criteria: Inclusion Criteria:

* plastic bronchitis
* pulmonary lymphatic perfusion syndrome demonstrated on 68Ga-NEB positron emission tomography (PET)

Exclusion Criteria:

* Pregnancy and breastfeeding
* Severe cardiovascular, hepatic and renal dysfunction
* allergy to sirolimus or 68Ga-NEB

Primary outcomes:
measure: changes of pulmonary lymphatic perfusion distribution
timeFrame: 6 months
measure: changes of coughing score
timeFrame: 6 months
Secondary outcomes:
measure: changes of pulmonary function (FEV1, FVC)
timeFrame: 6 months
measure: changes of six minutes walking distance
timeFrame: 6 months
measure: change of health-related quality of life
timeFrame: 6 months
measure: changes of breathlessness score
timeFrame: 6 months
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 6 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Kai-Feng Xu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03490526: Root Canal Disinfection: a Comparison Between Techniques
Official title: Comparison Between Two Different Techniques of Root Canal Disinfection (XP-endo Finisher Versus Passive Ultrasonic Irrigation): Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endodontically Treated Teeth
Lead sponsor: Federal University of Pelotas
Sponsor class: OTHER
First posted: 2018-04-06
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Caries disease is still the leading cause of severe tooth decay. Since this can lead to tooth loss, it is important that appropriate treatment is advised to help prevent damage and maintain tooth health. Faced with major coronary destruction, several times it becomes necessary to perform the endodontic treatment, aiming to maintain the element in the buccal cavity for longer. It is known that an excellent restorative treatment with poor endodontic treatment and vice versa has a direct impact on the (in) success of the treatment. In this context, the proper cleaning of the root canals is highlighted, aiming the removal of bacteria and toxins. There are several cleaning methods described in the literature, but it is not yet known which would be the most effective in the removal of these contaminants. In this double-blind randomized clinical trial, patients who need and meet the inclusion criteria will undergo endodontic treatment in two different root canal cleansing techniques (passive ultrasonic cleaning and cleaning with the XP Endo device). Patients will be monitored annually after finish your endodontic treatment to evaluate the periradicular repair and the quality of endodontic treatment.


Eligibility criteria: Inclusion Criteria:

* 18 years old or more;
* good general healthy;
* molars or premolar requiring endodontic treatment;
* at least 20 teeth;

Exclusion Criteria:

* root fracture;
* injury involving the furcation region
* need to behave as a prosthetic abutment;
* mobility greater than degree I;

Primary outcomes:
measure: Periradicular repair
timeFrame: 2 years
Secondary outcomes:
measure: Quality of endodontic treatment
timeFrame: 2 years
Other outcomes:
Locations:
city: Pelotas
country: Brazil
facility: Federal University of Pelotas
state: Rio Grande Do Sul
Study officials:
References:
Clinical trial NCT01773226: Evaluation of Intra-articular Injection of Autologous Protein Solution ("APS(TM)") for the Treatment of Osteoarthritis (OA)
Official title: A Prospective Single-Center Clinical Study of a Single Intra-Articular Injection of Autologous Protein Solution ("APS(TM)") in Patients With Osteoarthritis (OA) of the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gonarthrosis
Knee Osteoarthritis
Osteoarthritis
Keywords: Autologous Protein Solution
APS
Osteoarthritis
Injection
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2013-01-23
Enrollment: 11
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This prospective single-center study will evaluate the safety and tolerability of a single dose of "APS(TM)" treated patients with OA of the knee who have failed conservative OA therapy. The study will also evaluate efficacy by assessing patient pain and functionality.


Eligibility criteria: Eligibility Criteria:

* Male or female ≥40 years.
* Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions.
* A standing radiograph of the knee showing a Kellgren grade of 2 or 3
* Frequency of knee pain on most days over the last month.
* Diagnosis of unilateral knee OA
* Body mass index (BMI) ≤40 kg/m2.
* Failed conservative OA therapy.
* Signed an independent ethics committee (IEC)-approved informed consent form (ICF).
* Willingness to abstain from the use of topical pain therapies, intra-articular corticosteroids, and viscosupplementation during the study.
* Willingness to abstain from systemic pain medications except rescue medication.

Primary outcomes:
measure: Number of Adverse Events
timeFrame: Up to 6 months post-injection
Secondary outcomes:
measure: Number of Patients Using Rescue Medication
timeFrame: Up to 6 months post-injection
measure: Pain Score
timeFrame: Baseline, Week 1, Week 2, and at Months 1, 3, and 6.
measure: Stiffness Score
timeFrame: Baseline, Week 1, Week 2, and at Months 1, 3, and 6.
measure: Physical Function Score
timeFrame: Baseline, Week 1, Week 2, and at Months 1, 3, and 6.
Other outcomes:
Locations:
city: Geldrop
country: Netherlands
facility: St. Anna Hospital
Study officials:
affiliation: St. Anna Hospital, Geldrop, NL
name: R.A.M. van Drumpt, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: King W, van der Weegen W, Van Drumpt R, Soons H, Toler K, Woodell-May J. White blood cell concentration correlates with increased concentrations of IL-1ra and improvement in WOMAC pain scores in an open-label safety study of autologous protein solution. J Exp Orthop. 2016 Dec;3(1):9. doi: 10.1186/s40634-016-0043-7. Epub 2016 Feb 9.
Clinical trial NCT06779526: Effect of Four-Week Wellness Program on Work Engagement Burnout and Sleep in a Healthcare Organization (WEBS)
Official title: Effect of Four-Week Wellness Program on Sleep and Work Engagement in a Healthcare Organization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Burnout
Work Engagement
Keywords: heartfulness
meditation
work enagement
sleep
burnout
Lead sponsor: WellSpan Health
Sponsor class: OTHER
First posted: 2025-01-16
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The goal of this clinical trial is to learn if having a 4-week heartfulness meditation program in a healthcare organization would

1. decrease burnout
2. improve sleep and work engagement.

Researchers will compare : intervention group : participating in 4 weeks of Heartfulness Meditation with control group: receiving no intervention

Responses to the Utrecht Work Engagement Scale (UWES), Bergen Insomnia Scale (BIS) and two burnout questions will be compared between the study groups at the beginning and end of the intervention period.

Detailed description: The study is an 8-week single-center prospective, randomized, crossover study among healthcare workers in the WellSpan Health System. All participants were asked to answer two demographic questions and responses to the Utrecht Work Engagement Scale (UWES), and Bergen Insomnia Scale (BIS), two burnout questions were requested for a baseline. Participants were randomized to two groups. One of the groups would undergo the intervention first, which comprised receiving an orientation session regarding the study, attending at least once weekly didactic sessions on Zoom, and participating in morning and evening meditation for ten to fifteen minutes daily. The duration of the intervention period was four weeks. During this time, the control group would not be undergoing any intervention. After four weeks, both groups completed the original questionnaire again followed by a 2 week washout period. This was followed by a crossover, allowing the second group to undergo the intervention for four weeks. After four weeks, the final survey was sent to all participants again.

Eligibility criteria: Inclusion Criteria:

* Age above 18 and willing to participate
* Able to understand the English language as the instructions were in English

Exclusion Criteria:

* Not able to understand English language

Primary outcomes:
measure: Sleep
timeFrame: From intervention to end of intervention at 4 weeks for each group
Secondary outcomes:
measure: Work engagement
timeFrame: From intervention to end of intervention at 4 weeks for each group
measure: Burnout
timeFrame: From intervention to end of intervention at 4 weeks for each group
Other outcomes:
Locations:
city: York
country: United States
facility: WellSpan Health
state: Pennsylvania
Study officials:
References:
Clinical trial NCT06199726: REFLECT: Reproductive Education and Fertility Links for Cancer Treatment
Official title: REFLECT: Reproductive Education and Fertility Links for Cancer Treatment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Reproductive Behavior
Keywords: Fertility
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
First posted: 2024-01-10
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults ages 18-39 who have received cancer care at Moffitt and have children or are considering having a chilid in the future.

Brief summary: The purpose of this study is to evaluate a web-based education tool geared at helping Adolescent and Young Adult (AYA) patients better understand fertility and genetic risks for cancer in future offspring.


Eligibility criteria: Inclusion Criteria:

* Adults between the ages of 18-39
* Must have received Cancer care at Moffitt Cancer Center
* Participants must consider having a child in the future or have had children at the time of diagnosis
* Participants must be able to speak and read English
* Participants must have access to a device that can connect to the internet

Exclusion Criteria:

* Any participants who do not meet all Inclusion Criteria

Primary outcomes:
measure: Ease of use of the REFLECT tool
timeFrame: One Year
measure: Confidence in use of the REFLECT tool
timeFrame: One Year
measure: Complexity of use of the REFLECT tool
timeFrame: One Year
measure: Desire to use the REFLECT tool
timeFrame: One Year
measure: Perception of inconsistencies of the REFLECT tool
timeFrame: One Year
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: Susan Vadaparampil
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02277626: Electro Flo 5000 and Vest Therapy
Official title: Comparison of the Airway Clearance Efficacy of Electro Flo 5000 and Vest Therapy in
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cystic Fibrosis
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2014-10-29
Enrollment: 15
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: It is the goal of the proposed study to compare the efficacy, as assessed primarily by sputum weight, of these two different devices (the Electroflo 500 and VEST therapy) for airway clearance (AC) in CF patients with mild to moderate lung disease, who have stable lung health and perform AC at home as part of their routine therapeutic regimen.


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of CF established by standard criteria (sweat chloride \> 60 mmol/L and/or two alleles affected by gene mutations know to be associated with CF).
2. Age older than 12 years.
3. Known to consistently produce sputum.
4. Currently on a home therapeutic regimen that includes some form of AC performed at least 2 times daily.
5. FVC and FEV1 \> 40%-predicted, and with stable lung function (no greater than a 10% variation in lung function parameters over the preceding 3 months).

Exclusion Criteria:

1. Hospitalization for CF pulmonary complications in the 2 months preceding enrollment.
2. Hemoptysis \> 60 cc in a single episode in the 4 weeks preceding enrollment.
3. Chronic chest pain.
4. Participation in another interventional clinical trial in the previous 30 days. -

Primary outcomes:
measure: Wet Sputum Weight
timeFrame: End of study visit per intervention
measure: Pulmonary Function Measured as a Percent Predicted BEFORE Therapy With Either ElectroFlo 5000 / VEST.
timeFrame: End of study visit per intervention
measure: Pulmonary Function Measured as a Percent Predicted AFTER Therapy With Either ElectroFlo 5000 / Vest.
timeFrame: End of study visit per intervention
measure: Comfort Level After Receiving Therapy With Either ElectroFlo 5000 / Vest
timeFrame: End of study visit per intervention
Secondary outcomes:
measure: Dry Sputum Weight
timeFrame: End of study visit per intervention
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04241926: Single-lumen 5Fr and Triple-lumen 6Fr PICCs Are Accurate for Hemodynamic Measurement by Transpulmonary Thermodilution.
Official title: Single-lumen 5Fr and Triple-lumen 6Fr PICCs Are Accurate for Hemodynamic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripherally Inserted Central Catheters
Centrally Inserted Central Catheter
Transpulmonary Thermodilution
Hemodynamic Monitoring
Keywords: PICC
CICC
Cardiac output
shock
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
Collaborators: name: Antonio Maria Dell Anna
name: Sofia Cacciola
name: Claudio Sandroni
name: Giulia Chiuri
name: Mauro Pittiruti
name: Cesare Colosimo
name: Maria Giuseppina Annetta
name: Massimo Antonelli
First posted: 2020-01-27
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Peripherally inserted central catheters (PICCs) are increasingly used in intensive care unit (ICU) as an alternative to centrally inserted central catheters (CICCs) for intravenous infusion. In the present study the investigators try to assess their reliability for measuring cardiac index (CI) with trans-pulmonary thermodilution (TPTD) technique.


Eligibility criteria: Inclusion Criteria:

* adult patients (≥18 years) admitted to the ICU
* Patients requiring hemodynamic monitoring using EV1000TM
* Patients having both PICC and CICC in place (these patients had their PICC replaced with a CICC, usually at the time of ICU admission, or vice versa, usually at the end of their ICU stay, and were enrolled immediately after the placement of the new device before the previous one was removed)

Exclusion Criteria:

* body weight \<40 kg
* severe aortic regurgitation or intra-cardiac shunt
* treatment with an intra-aortic balloon pump
* contraindication for placement of PICC, CICC or a femoral arterial catheter
* abdominal aneurism
* extracorporeal circulation
* pregnancy
* lack of informed consent

Primary outcomes:
measure: Cardiac Index comparison via PICC
timeFrame: one hour
Secondary outcomes:
measure: Comparison of single-lumen 5Fr PICCs to CICC
timeFrame: one hour
measure: Comparison of triple-lumen 6Fr PICCs to CICC
timeFrame: one hour
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
state: Italia
Study officials:
affiliation: Università Cattolica del sacro Cuore- Fondazione Policlinico Universitario A. Gemelli IRCSS
name: Massimo Antonelli, MD
role: STUDY_CHAIR
References:
citation: D'Arrigo S, Sandroni C, Cacciola S, Dell'Anna AM, Pittiruti M, Annetta MG, Colosimo C, Antonelli M. Are single-lumen 5Fr and triple-lumen 6Fr PICCs suitable for hemodynamic assessment by trans-pulmonary thermodilution? A pilot study. Ann Intensive Care. 2020 Dec 7;10(1):165. doi: 10.1186/s13613-020-00785-2.
Clinical trial NCT04372030: Health Care Use During the Covid19 Crisis
Official title: Utilisation de Soins Pendant la Crise Covid-19 : Recours, Report et Renoncement (US3R)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Care Utilization
Keywords: foregone care
postponed care
covid19
confinement
Lead sponsor: Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2020-05-01
Enrollment: 3164
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is an online survey completed by participants willing to take part
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The project US3R is a general population survey that will measure the magnitude of utilised, postponed and foregone medical care in relation with other health care needs than coronavirus symptoms during the confinement period in Belgium. The study aims to describe the magnitude of unsatisfied health care needs for various types of care. It will also identify the reasons for these postponed and foregone care according to gender, health and socioeconomic status.

Detailed description: Context:

Belgium has put in place confinement measures on March 13th 2020 with the aim to reduce contagion related to Covid19 in the population and manage the number of patients to be treated in the hospital.

However, some weeks after those confinement measures, health care professionals are worry about other patients than Covid19 since they have observed a significantly lower use of emergency services, cancellations of screening appointments, interrupted health care in patients with chronic conditions, disabilities, or mental health disorders.

Objectives: to collect data on used, postponed and foregone medical care related to other health care needs than Covid19 during the confinement period in Belgium; to measure the magnitude of unsatisfied health care needs for various types of care; to identify the reasons explained postponed and foregone care

Methods : the survey is made of about 50 questions collecting self-reported data on health care use and non-use for various types of care along with demographics, socioeconomics and health status characteristics during the confinement period . Data will be analysed with Stata 15 using statistical tests and regression models.

Participants are collected via social media platforms and institutionnal mailing, and Belgian newspapers.

Eligibility criteria: Inclusion Criteria:

* living in Belgium
* more than 18

Exclusion Criteria:

* living outside Belgium
* less than 18

Primary outcomes:
measure: Health care use
timeFrame: throughout the whole study, assessed up to 18 months
measure: Postponed heath care use
timeFrame: throughout the whole study, assessed up to 18 months
measure: Foregone health care use
timeFrame: throughout the whole study, assessed up to 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: UCLouvain
Study officials:
References:
Clinical trial NCT06052748: A Study to Evaluate the Efficacy and Safety of AD-223
Official title: A Multicenter, Randomized, Double-blind, Active-control, Phase III Study to Evaluate the Efficacy and Safety of AD-223A and AD-223B Combination Therapy in Patients With Essential Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension,Essential
Lead sponsor: Addpharma Inc.
Sponsor class: INDUSTRY
First posted: 2023-09-25
Enrollment: 502
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of AD-223

Detailed description: Condition or disease : hypertension

Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Other inclusions applied

Exclusion Criteria:

* Orthostatic hypotension with symptom
* Other exclusions applied

Primary outcomes:
measure: Change rate of MSSBP
timeFrame: Baseline, Week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hanyang University Hospital
Study officials:
affiliation: Hanyang University
name: Jin Ho Shin, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References: