louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02493270: Effect of Smoking Cessation on Non-surgical Periodontal Therapy
Official title: Effect of Smoking Cessation on Non-surgical Periodontal Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Keywords: smoking cessation
tobacco
dental
periodontal
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2015-07-09
Enrollment: 177
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this prospective study is to verify the efficacy of smoking cessation on non-surgical periodontal therapy in adult subjects with chronic periodontitis.

Smokers that were willing to quit received periodontal treatment and concurrent smoking cessation therapy. Periodontal maintenance was performed every 3 months. A calibrated examiner, blinded to smoking status, assessed periodontal status, gathered demographic and behavioural information with a structured questionnaire and measured air carbon monoxide concentration measurements.


Eligibility criteria: Inclusion Criteria:

* subjects were willing to stop smoking
* \>10 teeth
* periodontitis (30% or more of their teeth with proximal CAL ≥ 5 mm

Exclusion Criteria:

* systemic conditions considered as risk factors for periodontal disease,
* periodontal therapy in the last 6 months
* continuous systemic use of anti-inflammatory or steroidal drugs

Primary outcomes:
measure: Change in Clinical Attachment Level (millimeters) after 24 months
timeFrame: baseline and 24 months
Secondary outcomes:
measure: Change in Gingival recession (millimeters) after 24 months
timeFrame: baseline and 24 months
measure: Change in Pocket depth (millimeters) after 24 months
timeFrame: baseline and 24 months
measure: Change in bleeding on probing (percentage of sites with bleeding) after 24 months
timeFrame: baseline and 24 months
measure: Change in visible plaque (percentage of sites with visible plaque) after 24 months
timeFrame: baseline and 24 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Sao Paulo
name: Claudio M Pannuti, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rosa EF, Corraini P, Inoue G, Gomes EF, Guglielmetti MR, Sanda SR, Lotufo JP, Romito GA, Pannuti CM. Effect of smoking cessation on non-surgical periodontal therapy: results after 24 months. J Clin Periodontol. 2014 Dec;41(12):1145-53. doi: 10.1111/jcpe.12313. Epub 2014 Nov 21.
citation: Rosa EF, Corraini P, de Carvalho VF, Inoue G, Gomes EF, Lotufo JP, De Micheli G, Pannuti CM. A prospective 12-month study of the effect of smoking cessation on periodontal clinical parameters. J Clin Periodontol. 2011 Jun;38(6):562-71. doi: 10.1111/j.1600-051X.2011.01723.x. Epub 2011 Apr 13.
Clinical trial NCT04825470: Liver Transplantation for Unresectable GIST Liver Metastases
Official title: Liver Transplantation in Patients With Unresectable GastroIntestinal Stromal Tumors (GIST) Liver Metastases
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Liver Diseases
Liver Cancer
Liver Metastases
Liver Neoplasms
Liver Mass
Liver Carcinoma
Liver Transplant; Complications
Liver Transplant Disorder
GIST
GIST, Malignant
Gastrointestinal Stromal Tumors
Gastrointestinal Stromal Tumor of Duodenum
Gastrointestinal Stromal Tumor of Rectum
Gastrointestinal Stromal Tumor of Other Sites
Gastrointestinal Stromal Tumor, Unspecified Site
Gastrointestinal Stromal Tumor of Stomach
Gastrointestinal Stromal Tumor of Esophagus (Disorder)
Gastrointestinal Stromal Tumor by AJCC V8 Stage
Gastrointestinal Stromal Tumor, Malignant
Gastrointestinal Stromal Tumor (GIST) of the Gastrointestinal Tract
Gastrointestinal Stromal Tumor of Small Intestine (Disorder)
Gastrointestinal Stromal Tumor of Large Intestine (Disorder)
Metastases to Liver
Metastatic Liver Cancer
Metastasis
Metastases
Liver Transplantation
Transplant Oncology
Keywords: liver transplantation
gastrointestinal stromal tumor (GIST)
Transplant Oncology
liver neoplasms
liver metastases
Lead sponsor: Hospital Universitario Virgen de la Arrixaca
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 50
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: Liver Transplantation for Unresectable GIST Liver Metastases


Eligibility criteria: Inclusion Criteria:

* GIST diagnosis (c-Kit, CD34, DOG-1)
* Imatinib-sensitive mutation
* Non-resectable liver metastases
* Abscence of extrahepatic disease
* Period greater than two years between primary tumor and metastases diagnosis

Primary outcomes:
measure: Overall Survival
timeFrame: Through study completion, an average of 2 years
measure: Graft Survival
timeFrame: Through study completion, an average of 2 years
Secondary outcomes:
measure: Relapse free survival
timeFrame: Through study completion, an average of 2 years
measure: Disease free survival
timeFrame: Through study completion, an average of 2 years
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Felipe Alconchel
Study officials:
References:
citation: Fernandez JA, Alconchel F, Gomez B, Martinez J, Ramirez P. Unresectable GIST liver metastases and liver transplantation: A review and theoretical basis for a new indication. Int J Surg. 2021 Oct;94:106126. doi: 10.1016/j.ijsu.2021.106126. Epub 2021 Sep 27.
Clinical trial NCT01333670: Efficacy of Prontosan Solution on Chronic Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pressure Ulcer
Chronic Wound Care
Wound Cleansing
Lead sponsor: Associazione Infermieristica per lo studio delle Lesioni Cutanee
Sponsor class: OTHER
Collaborators: name: B. Braun Medical SA
First posted: 2011-04-12
Enrollment: 289
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 this study is to evaluate the efficacy of Prontosan® Wound Irrigation Solution compared with standard isotonic solution on infammation reduction and wound bed cleansing of chronic pressure or vascular leg ulcers.


Eligibility criteria: Inclusion Criteria:

* Male and females aged at least 18 with Pressure ulcer stage 2-3 NPUAP (National Pressure Ulcer Advisory Panel 1989)or subcutaneous vascular ulcer with inflammation and/or biofilm and/or slough
* Braden index at baseline\>=10
* Ulcer area\<80 cm2
* Ability to give an informed consent

Exclusion Criteria:

* Braden index at baseline\<10
* Current therapy with corticosteroids or immunosuppressor or radiotherapy
* Sensitivity to any of the components of Prontosan® Solution
* Diabetic foot ulcer
* Current use of local antiseptics on the wound bed
* Previous recruitment of another ulcer in the trial

Primary outcomes:
measure: Reduction of necrotic tissue (Pressure Sore Status Tool-PSST)
timeFrame: From basaline visit to the final visit, that is between a minimum of 1 visit (10 days later) or a maximum of 4 visits (1 month later, weekly)
measure: Reduction of inflammatory tissue(Pressure Sore Status Tool-PSST)
timeFrame: From basaline visit to the final visit, that is between a minimum of 1 visit (10 days later) or a maximum of 4 visits (1 month later, weekly)
Secondary outcomes:
measure: Frequency of wound dressing (clinical score)
timeFrame: From basaline visit to the final visit, that is between a minimum of 1 visit (10 days later) or a maximum of 4 visits (1 month later, weekly)
Other outcomes:
Locations:
city: Busto Arsizio
country: Italy
facility: Azienda Ospedaliera Ospedale di Circolo di Busto Arsizio
state: Milan
city: Firenze
country: Italy
facility: Home nursing assistance
city: Pavia
country: Italy
facility: Policlinico San Matteo
city: Trieste
country: Italy
facility: Azienda Ospedaliero-Universitaria Ospedali Riuniti
city: Turin
country: Italy
facility: Azienda Ospedaliero Universitaria San Giovanni Battista
city: Varese
country: Italy
facility: Ospedale di Circolo-Fondazione Macchi
Study officials:
References:
Clinical trial NCT05149170: Radiotherapy and Anti-PD-1 in Low-risk ES-ENKTCL
Official title: Radiotherapy With Inductive and Concurrent Anti-PD-1 Antibody in Early-stage Low-risk Extranodal NK/T Cell Lymphoma, Nasal Type: A Multi-center Phase II Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Early-stage
Extranodal NK-T-Cell Lymphoma, Nasal and Nasal-Type
Keywords: NK/T-Cell Lymphoma, Nasal and Nasal-Type
radiotherapy
Anti-PD-1 Antibody
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
Collaborators: name: Peking University Cancer Hospital & Institute
name: The First Hospital of Jilin University
name: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
First posted: 2021-12-08
Enrollment: 30
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 current study is a phase II multi-center single arm trial to evaluate the efficacy and safety of adding Anti-PD-1 antibody in an inductive and concurrent way to radiotherapy in early-stage low-risk extranodal NK/T cell lymphoma, nasal type


Eligibility criteria: Inclusion Criteria:

* Biopsy proved extranodal NK/T cell lymphoma
* No previous anti-cancer treatment
* Measurable lesion on baseline PET/CT and MRI
* Stage I
* Normal serum LDH level
* Primary tumor invasion (PTI) absence
* ECOG PS 0-1
* Sufficient organ functions

Exclusion Criteria:

* Other mature T- or NK- lymphoma
* Hemophagocytic lymphohistiocytosis
* Primary CNS lymphoma or CNS-involved lymphoma
* History of malignancy except for cutaneous basal-/squamous- cell carcinoma or cervical carcinoma in situ 3 years prior to study treatment

Primary outcomes:
measure: Rate of Complete response after inductive therapy
timeFrame: 2-4 weeks after inductive anti-PD-1 antibody
Secondary outcomes:
measure: Progression-free survival rate at year 2 after enrollment, 2y-PFS
timeFrame: 2-year
measure: Overall Survival rate at year 2/5 after enrollment，2y-/5y-OS
timeFrame: 2-year, 5-year
measure: Rate of acute toxicity (any and above grade 3)
timeFrame: From enrollment to 3 months after treatment
measure: Quality of Life change, QoL
timeFrame: baseline, 1/3/6/12/24 months after treatment
measure: Quality of Life change, QoL
timeFrame: baseline, 1/3/6/12/24 months after treatment
Other outcomes:
measure: Biomarkers to predict anti-PD-1 antibody efficacy and 2y-PFS
timeFrame: baseline
Locations:
city: Beijing
country: China
facility: National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
state: Beijing
Study officials:
affiliation: CAMS
name: Ye-Xiong Li, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04087070: Blood Pressure Estimation Using Noninvasive Biosignals During Pediatric Anesthesia
Official title: Blood Pressure Estimation Using Noninvasive Biosignals During Pediatric Anesthesia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Blood Pressure
Pediatrics
Electrocardiography
Accelerometer
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2019-09-12
Enrollment: 100
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ASA class I, and II pediatric patients (\<12 years) scheduled for elective surgery under general anesthesia

Brief summary: The aim of this study is to estimate blood pressure in pediatric patients using a non-invasive electrocardiogram (ECG), photoplethysmograph (PPG), and an accelerometer on the chest.

Detailed description: Blood pressure is measured by an automated oscillometric device or arterial waveform from IntelliVue MX800 Bedside patient monitor (Philips Healthcare, Amsterdam, Netherlands).

Following parameters will be measured by non-invasive electrocardiogram (ECG), photoplethysmograph (PPG), and an accelerometer on the chest and will be used to estimate the biosignal derived blood pressure.

1. PAT(time between R peak of ECG and beginning of the pulse of PPG)
2. PEP(time between R peak of ECG and peak of accelerometer signal)
3. PTT(PAT-PEP)

The algorithm of the biosignal derived blood pressure will be made using the MATLAB 2016b(Mathworks, Natick, MA) program.

The agreement between the non-invasive blood pressure and the biosignal derived blood pressure will be analyzed using Cohen's Kappa or Bland-Altman plot.

Eligibility criteria: Inclusion Criteria:

* ASA(American Society of Anesthesiologist) Class I, II
* Scheduled for elective surgery under general anesthesia

Exclusion Criteria:

* History of cardiovascular disease
* History of thoracic cavity disease
* Unable to measure blood pressure

Primary outcomes:
measure: Systolic and diastolic Blood pressure
timeFrame: During general anesthesia, up to 12 hours
Secondary outcomes:
measure: Electrocardiogram wave
timeFrame: During general anesthesia, up to 12 hours
measure: photoplethysmograph wave
timeFrame: During general anesthesia, up to 12 hours
measure: accelerometer signal
timeFrame: During general anesthesia, up to 12 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Department of Anesthesiology and Pain Medicine, Seoul National University Hospital
name: Hee-Soo Kim, MD.PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yoon Y, Cho JH, Yoon G. Non-constrained blood pressure monitoring using ECG and PPG for personal healthcare. J Med Syst. 2009 Aug;33(4):261-6. doi: 10.1007/s10916-008-9186-0.
Clinical trial NCT04358770: Bio-equivalence Vasoconstriction Activity Study for Topically Applied Clocortolone Pivalate 0.1% Cream
Official title: Single Exposure Bioequivalence Study to Evaluate the Vasoconstriction Activity of Topically Applied Cloderm® (Clocortolone Pivalate) 0.1% Cream and Clocortolone Pivalate 0.1% Cream (Taro Pharmaceuticals) in Healthy Male and Female Volunteers With Normal Skin Under Occlusive Conditions.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bioequivalence Study
Lead sponsor: Taro Pharmaceuticals USA
Sponsor class: INDUSTRY
Collaborators: name: WAYCro
First posted: 2020-04-24
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: single-exposure, open-label, vasoconstriction response study
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To compare pharmacodynamic vasoconstriction response profile of Clocortolone Pivalate 0.1% Cream and Cloderm® (Clocortolone Pivalate) 0.1% Cream in normal skin of healthy male and female adults


Eligibility criteria: Inclusion Criteria:

* Normal or clinically insignificant dermatological history the Screening visit and Day 1dosing;

Exclusion Criteria:

* Female subjects who were pregnant, nursing, or planning to become pregnant during study participation;
* History of hypersensitivity to the study products or any topical or systemic corticosteroids;

Primary outcomes:
measure: AUEC0-24 (area under the effect curve)
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: WayCro
state: Texas
Study officials:
References:
Clinical trial NCT04716270: Ablation of Supraventricular Arrhythmias With As Low As Reasonably Achievable X-Ray Exposure
Official title: Ablation of Supraventricular Arrhythmias With As Low As Reasonably Achievable X-Ray Exposure (AALARA)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Tachycardia, Supraventricular
Keywords: Supraventricular tachycardia
Radiation exposure
Lead sponsor: Mohamed Bin Khalifa Bin Sulman Al Khalifa Cardiac Centre
Sponsor class: OTHER_GOV
First posted: 2021-01-20
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male or female patients ≥ 18 years of age, indicated for supraventricular arrhythmias ablation according to the current local applicable guidelines

Brief summary: Observational study is to demonstrate a clinically significant reduction of ionizing radiation exposure during transcatheter ablation of supraventricular tachycardias using the EnSite precision mapping system in a real-world clinical setting without compromising efficacy and safety.


Eligibility criteria: Inclusion Criteria:

* Male or female patients ≥ 18 years of age
* Patient indicated for supraventricular arrhythmias ablation according to the current guidelines
* Patient is willing to provide written informed consent.

Exclusion Criteria:

* Patient is pregnant.
* Contraindications to ionizing radiation exposure
* Patient's life expectancy is less than 1 year
* Associated complex congenital heart disease
* Cardiac implantable electric devices
* Known pathological venous access to the heart

Primary outcomes:
measure: Radiation exposure dose
timeFrame: The day of performing the procedure
measure: Incidence of procedure related cardiac Adverse Events (Safety)
timeFrame: 6 months
Secondary outcomes:
measure: Fluoroscopy time
timeFrame: The day of performing the procedure
Other outcomes:
Locations:
city: Ar Rifā'
country: Bahrain
facility: Mohamed Bin Khalifa Cardiac Center
Study officials:
affiliation: Mohamed Bin Khalifa Cardiac Center
name: Mohammad Amin, MRCP(UK)FHRS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04090970: Briagen Observational Study
Official title: Briagen™ Case Study and Observation of Skin Excision Healing in Mohs and Other Dermatological Procedures
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mohs Surgery
Lead sponsor: Gemstone Biotherapeutics
Sponsor class: INDUSTRY
First posted: 2019-09-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient seeking treatment for wound created by Mohs skin excision

Brief summary: This research study is evaluating a study product called Briagen™ as a possible treatment for wound healing after Mohs procedure.

Detailed description: Briagen, the study product being used in this study, is a natural complex carbohydrate wound dressing for skin wounds created by Mohs surgery.

Briagen was developed with the intent to improve healing time and reduce scarring of skin wounds. Briagen seeks to match the mechanical aspects of your skin (thickness, stiffness, hydration, pore size) to assist in the healing process.

The purpose of this research study is to observe healing time of Briagen applied to wounds created as a result of Mohs surgery.

Eligibility criteria: Inclusion Criteria:

1. Patient seeking treatment for wound created by Mohs or other full thickness skin excisions
2. Over 18 years of age
3. English-speaking
4. Presents for treatment within 24 hours of initial Mohs skin excision procedure.

Exclusion Criteria:

1. History of significant wound complications and non-compliance on wound maintenance instructions (infections, disturbing the wound during the healing process, etc.)
2. Known diagnosis of Diabetes
3. Active infection in the wound bed
4. Under 18 years of age

Primary outcomes:
measure: Healing Time
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Englewood
country: United States
facility: Dr. David Abramson
state: New Jersey
city: Charlotte
country: United States
facility: Dermatology, Laser & Vein Specialists of the Carolinas
state: North Carolina
Study officials:
References:
Clinical trial NCT02839070: Influence of Sleep Regularity on Circadian Rhythms, Learning, Performance, and Mood
Official title: Influence of Sleep Regularity on Circadian Rhythms, Learning, Performance, and Mood
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Physiology
Keywords: Sleep
Learning
Circadian Rhythms
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2016-07-20
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The study is a combination of outpatient and inpatient monitoring. During the 27-day inpatient portion of the study, the individual's sleep-wake schedule will be varied daily. Volunteers will be randomized to a regular or irregular inpatient schedule.


Eligibility criteria: Inclusion Criteria:

* healthy
* BMI between 18.5 and 29.5

Exclusion Criteria:

* medications
* recent night-work, shift-work, or travel across \>2 time zones
* use of medications
* pregnant or within 6 months post-partum

Primary outcomes:
measure: Circadian phase
timeFrame: 27 days
measure: Learning
timeFrame: 27 days
measure: Mood
timeFrame: 27 days
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Elizabeth B Klerman, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: