louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06390293: The Effectiveness of Group-Delivered Revised Guided Written Exposure Therapy for PTSD and Subclinical PTSD Among Chinese Adolescents
Official title: The Effectiveness of Group-Delivered Revised Written Exposure Therapy for PTSD and Subclinical PTSD Among Chinese Adolescents: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: PTSD
Keywords: PTSD
written exposure therapy
randomized controlled trial
adolescents
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2024-04-30
Enrollment: 70
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to examine the effectiveness of the group-delivered revised written exposure therapy (WET-R) for post-traumatic stress disorder (PTSD) and subclinical PTSD among Chinese adolescents with a randomized controlled trial. The study will recruit 70 participants, with 35 randomized to the WET-R group and 35 randomized to the waiting list (WL) group. The WET-R intervention consists of 5-8 group sessions. The primary outcome CPSS-5-I (Child PTSD Symptom Scale-Interview Version for DSM-5) and PCL-5 ( PTSD Checklist-5) will be administered on baseline, post-treatment, 1-month follow-up, 3-month follow-up, and 6-month follow-up assessments.


Eligibility criteria: Inclusion Criteria:

1. Adolescents aged 10-18 years.
2. Meeting full or subthreshold PTSD (up to one symptom missing) diagnostic criteria according to the Child PTSD Symptom Scale-Interview Version for DSM-5 (CPSS-5-I).
3. If taking psychotropic medication, currently stabilized on psychotropic medication for at least four weeks.
4. Capable of writing and understanding written instructions.

Exclusion Criteria:

1. Presence of severe psychopathology necessitating immediate medical attention
2. Moderate to high suicide risk (e.g., intent or plan to attempt suicide in the near future
3. Evidence of a moderate or severe traumatic brain injury
4. Currently undergoing psychotherapy specifically for PTSD.

Primary outcomes:
measure: PTSD Checklist-5 (PCL-5)
timeFrame: baseline,post treatment(2 weeks), 6 weeks, 14 weeks, 26 weeks
measure: Child PTSD Symptom Scale-Interview Version for DSM-5 (CPSS-5-I)
timeFrame: baseline,post treatment(2 weeks), 6 weeks, 14 weeks，26 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Peking
country: China
facility: Peking University
state: Beijing
Study officials:
References:
Clinical trial NCT04172493: Hyperspectral Endoscopy Imaging for the Early Detection of Precancerous Lesions in Average Risk Patients
Official title: Hyperspectral Endoscopy Imaging for Early Detection of Precancerous Lesions in Average Risk Patients: Proof of Principle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Oregon Health and Science University
First posted: 2019-11-21
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This trial studies whether hyperspectral endoscopy improves visualization of abnormal tissue in average risk patients during standard-of-care colonoscopies. Hyperspectral endoscopy is an emerging technique that has the potential to enable the signals from blood to be resolved from tissue-specific signals. Image-enhanced endoscopy may improve visualization of abnormal colonic tissue when compared to the standard-of-care high-definition white light endoscopy.

Detailed description: PRIMARY OBJECTIVE:

I. To assess whether use of hyperspectral endoscopy (HySE) can improve visualization of abnormal colonic tissue.

SECONDARY OBJECTIVES:

I. To assess whether use of HySE could reduce the rate of missed flat polyps.

II. To assess whether use of HySE might in the future reduce the incomplete resection rate (IRR).

III. To examine accuracy of practitioners in predicting polyp histology.

OUTLINE:

Patients undergo standard of care white light endoscopy and hyperspectral endoscopy during routine colonoscopy procedure.

After completion of study, patients who experience a colonoscopy-related severe adverse event are followed up until resolution or stabilization of the event.

Eligibility criteria: Inclusion Criteria:

* Ability to understand and the willingness to sign a written informed consent document
* Patients scheduled for a standard of care screening or surveillance colonoscopy

Exclusion Criteria:

* Any condition that, in the opinion of the investigator, precludes the patient from completion of the study procedure

Primary outcomes:
measure: Spectral profiles corresponding to normal versus abnormal colonic tissue
timeFrame: 1 year
measure: Image quality
timeFrame: 1 year
Secondary outcomes:
measure: Imaging differences in polyp characteristics documented upon post-procedure video review
timeFrame: 1 year
Other outcomes:
Locations:
city: Portland
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
Study officials:
affiliation: OHSU Knight Cancer Institute
name: Vassiliki L Tsikitis
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05504993: Are Comorbidities Related to Frequent Severe Exacerbations of AECOPD
Official title: Are Comorbidities Related to Frequent Severe Exacerbations of AECOPD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Lung Disease
Acute Exacerbation of COPD
Comorbidities and Coexisting Conditions
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2022-08-17
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study included all patients, admitted to pulmonary diseases department, and hospitalized in ward for acute exacerbation of COPD (AECOPD) for a six-month period.

Brief summary: INTRODUCTION: Relationship between comorbidities and COPD is two-sided. While the number of comorbidities increasing, the frequency of acute exacerbations of COPD (AECOPD) is increasing, too. Comorbidity indexes can be used for recognition of comorbidities while managing COPD patients. In the present study, it is aimed to compare comorbidity indexes such as Charlson Comorbidity Index, COMCOLD and COTE in the matter of exacerbation frequency.

METHOD: Subjects hospitalized for AECOPD, admitted to the study. Exacerbation severity, frequency, further exacerbations for a 1-year period in the follow-up period and CCI, COMCOLD and COTE scores were recorded. High and low comorbidity groups were compared for AECOPD frequency, severity, and further exacerbations.


Eligibility criteria: Inclusion Criteria:

* COPD patients
* Admitted to the ward for AECOPD

Exclusion Criteria:

* Not giving informed consent
* Unable to perform PFT
* Lost to follow-up

Primary outcomes:
measure: Frequency of AECOPD
timeFrame: 1 year
Secondary outcomes:
measure: Having at least one severe AECOPD
timeFrame: 1 year
measure: Frequency of AECOPD for the next one year
timeFrame: 1 year
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University Faculty of Medicine
Study officials:
References:
Clinical trial NCT05826093: Cutaneous Sensory Block Area of the Subcostal Ultrasound-Guided Transversus Abdominis Plane Block
Official title: Cutaneous Sensory Block Area of the Subcostal Ultrasound-Guided Transversus Abdominis Plane Block
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Pain
Keywords: Transversus abdominis plane block
Lead sponsor: Nordsjaellands Hospital
Sponsor class: OTHER
First posted: 2023-04-24
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: Patients planned for elective laparoscopic cholecystectomy in a day surgery setting.

Brief summary: Patients planned for elective laparoscopic cholecystectomy received a peroperative ultrasound-guided subcostal transversus abdominis plane block (USTAP) at the beginning of the procedure. At T90 minutes after the end of anaesthesia the cutaneous sensory block area (CSBA) was measured using cold sensation and mapped with a sterile marker. The CSBA was photodocumented and the area calculated.


Eligibility criteria: Inclusion Criteria:

* Planned for elective laparoscopic cholecystectomy, age 18 or older, written and verbal consent

Exclusion Criteria:

* Non-compliant due to language or psychiatric disease, previous surgery to the upper abdomen, incisional hernia, pregnancy, sensory deficit of the abdomen or thorax.

Primary outcomes:
measure: Cutaneous Sensory Block Area
timeFrame: 90 minutes postoperatively or 150 minutes after US-TAP application
Secondary outcomes:
Other outcomes:
Locations:
city: Hillerød
country: Denmark
facility: Nordsjaellands Hospital
Study officials:
affiliation: Copenhagen University Hospital - North Zealand
name: Cluas A Bertelsen, MD PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00046111: A Bioequivalence Study of Two Oral Formulations of Topotecan in Patients With Advanced Solid Tumors
Official title: A Study to Determine the Bioequivalence of an Oral Formulation of Topotecan Containing the Drug Substance Manufactured by New Process Relative to the Current Study Formulation of Topotecan in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lung Cancer, Small Cell
Solid Tumor Cancer
Keywords: oral
Bioequivalence
Hycamtin
Topotecan
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2002-09-23
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare two capsules of topotecan made by slightly different methods. This will be done by giving the drug made by the two different methods to patients orally and testing blood levels.


Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Patients with confirmed advanced solid tumors.
* No prior chemotherapy within 5 years of the diagnosis of SCLC (small cell lung cancer).
* At least 4 weeks since last chemotherapy, radiotherapy, biologic therapy or surgery.
* Laboratory criteria: Patients must have adequate bone marrow reserve and adequate kidney and liver function.

Exclusion criteria:

* Women who are pregnant or lactating.
* Patients of child bearing potential refusing to practice adequate contraception.
* Patients with uncontrolled vomiting.
* Active infection.
* Patients with clinical evidence of any gastrointestinal (GI) conditions which would alter GI absorption or GI motility.
* Patients requiring treatment with cyclosporin A.
* Severe medical problems other than the cancer, that would limit the ability of the patient to follow study guidelines or expose the patient to extreme risk.
* Ongoing or planned chemotherapy, immunotherapy, radiotherapy, or investigational therapy for cancer treatment.
* Use of investigational drug within 30 days prior to the first dose of study medication.

Primary outcomes:
measure: To determine the bioequivalence of new formulation (test) of oral topotecan relative to the current Phase III formulation (reference) of oral topotecan by comparing AUC in patients with advanced solid tumors.
timeFrame: Four weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: Philadelphia
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Nashville
country: United States
facility: GSK Investigational Site
state: Tennessee
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: Ottawa
country: Canada
facility: GSK Investigational Site
state: Ontario
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00302211: The "VISION" Trial: Ventavis Inhalation With Sildenafil to Improve and Optimize Pulmonary Arterial Hypertension
Official title: A Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of the Addition of Inhaled Iloprost in Patients With Pulmonary Arterial Hypertension Receiving Oral Sildenafil
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Pulmonary Hypertension
Keywords: PAH
Pulmonary Arterial Hypertension
Lead sponsor: Actelion
Sponsor class: INDUSTRY
First posted: 2006-03-14
Enrollment: 67
Sex: ALL
Minimum age (years): 12
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this multi-center international trial is to evaluate the safety and effectiveness of adding iloprost or placebo (an inactive substance that contains no active study drug) to sildenafil therapy for pulmonary arterial hypertension (PAH). The study will also examine whether patients on sildenafil can reduce the number of iloprost inhalations from the approved 6 doses per day to 4 doses per day.


Eligibility criteria: Inclusion Criteria:

* Aged 12-85 years; of either gender.
* Confirmed PAH due to idiopathic pulmonary arterial hypertension (IPAH) or familial pulmonary arterial hypertension (FPAH).
* 6-minute walk distance (6-MWD) between 100-450 meters at screening.
* On a stable dose of sildenafil, with or without bosentan.

Exclusion Criteria:

* Any treatment for PAH with prostacyclins, prostacyclin analogues, endothelin-1 antagonists, or phosphodiesterase-5 (PDE-5) inhibitors other than sildenafil within the past 12 weeks.
* Pulmonary hypertension due to conditions other than those stated in inclusion criteria.
* Additional PAH medications added within the past 12 weeks.

Primary outcomes:
measure: Absolute Change From Baseline to Week 16 in 6-Minute Walk Distance (6MWD) During the Double-blind Treatment Period
timeFrame: Day 1 and Week 16
Secondary outcomes:
measure: Number of Subjects With WHO Functional Class (WHO FC) Improvement at Week 16
timeFrame: Day 1 and Week 16
measure: Time to Clinical Worsening
timeFrame: Week 16 and Week 48
Other outcomes:
measure: Number of Participants With Any Adverse Events
timeFrame: From Day 1 to Week 16 and Week 48
Locations:
Study officials:
affiliation: Istituto Malattie Apparato Cardio Univ di Bologna
name: Nazzareno Galie, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01486511: Pulmonary Embolism After Liver Resection
Official title: Pulmonary Embolism After Liver Resection: A Prospective Analysis of Risk Factors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Disease
Pulmonary Embolism
Thrombophilia
Death
Keywords: Liver disease
Pulmonary embolism
Thrombophilia
Death
Lead sponsor: Beaujon Hospital
Sponsor class: OTHER
First posted: 2011-12-06
Enrollment: 500
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: All consecutive patients that will undergo liver resection for any type of liver disease.

Brief summary: Major surgery is associated with a postoperative hypercoagulable state related to the surgical trauma that may lead to thromboembolic complications. To the investigators knowledge, only two series have reported the risk of PE after liver surgery with an incidence of up to 6.3% The purpose of this study is to identify the independent risk factors associated with the development of PE after elective liver surgery.


Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* Malignant liver diseases
* Benign liver diseases

Exclusion Criteria:

* Age \<18 years
* Previous history of thromboembolic events
* Living Donor hepatectomies

Primary outcomes:
measure: Pulmonary embolism
timeFrame: up to January 2012
Secondary outcomes:
measure: Complications
timeFrame: up to January 2012
measure: Length of hospital stay
timeFrame: up to January 2012
measure: Mortality
timeFrame: up to January 2012
Other outcomes:
Locations:
city: Paris
country: France
facility: Prof. Jacques Belghiti
state: Clichy
Study officials:
affiliation: Beaujon Hospital
name: Jacques Belghiti, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00789711: An Observational Study to Compare the Safety and Effectiveness of NovoMix® 30 and Levemir™ for the Treatment of Diabetes
Official title: A Multicentre, Open-label, Nonrandomised, Non-interventional, Observational Study to Compare Safety and Effectiveness of Biphasic Insulin Aspart 30 (NovoMix 30) and Insulin Detemir (Levemir) for the Treatment of Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-11-13
Enrollment: 3131
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any subject with diabetes mellitus who needs insulin treatment at the time of inclusion is eligible for the study, including newly diagnosed subjects who have never received insulin or an insulin analogue before

Brief summary: This study is conducted in Asia. The aim of this observational study is to compare the clinical safety profile and effectiveness of NovoMix® 30 and Levemir™ for the treatment of diabetes in the Philippines.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with type 1 or type 2 diabetes mellitus
* Patients uncontrolled on oral antidiabetic drugs
* Insulin naïve patients or patients currently on human insulin

Exclusion Criteria:

* Subjects who are unlikely to comply with protocol requirements
* Subjects who are previously enrolled in NovoMix® 30 and Levemir™ study
* Subjects on NovoMix® 30 and Levemir™ therapy
* Subjects with hypersensitivity to NovoMix® 30 or to any of the excipients
* Subjects with hypersensitivity to Levemir™ or to any of the excipients
* Females of child bearing potential who are pregnant, breast feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures are required by local law or practice
* Contraindications and warnings specified in the current prescribing information

Primary outcomes:
measure: Number of all (Major/Minor/Nocturnal) hypoglycaemic events, reported as serious adverse drug reactions.
timeFrame: during 12 months of treatment
Secondary outcomes:
measure: HbA1c
timeFrame: at the end of the study
measure: FBG (Fasting Blood Glucose)
timeFrame: at the end of the study
measure: Average (mean) fasting plasma glucose level
timeFrame: at the end of the study
measure: Number of minor (including nocturnal) hypoglycaemic events
timeFrame: during 12 months of treatment
measure: Number of major (including nocturnal) hypoglycaemic events
timeFrame: during 12 months of treatment
Other outcomes:
Locations:
city: Manilla
country: Philippines
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT03908411: The Effect of Paratracheal Pressure on the Glottic View
Official title: The Effect of Paratracheal Pressure on the Glottic View During Direct Laryngoscopy : a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Paratracheal Pressure
Sellick's Maneuver
Airway Management
Cricoid Pressure
Keywords: Paratracheal pressure
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2019-04-09
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Paratracheal pressure may have a role in the prevention of pulmonary aspiration. The effects of paratracheal pressure on glottic view, ease of facemask ventilation, or tracheal intubation are not studied yet. In this study, the subjects are divided into two groups (group I: paratracheal pressure applied during induction of anesthesia, group II: conventional Sellick's maneuver applied during induction of anesthesia). Investigators will assess the glottic view during direct laryngoscopy.

Detailed description: Primary outcome:

-Cormack-Lehane grade

Secondary outcome:

* POGO score before and after application of each intervention
* Difficulties of mask ventilation after application of each intervention
* Inspiratory pressure and tidal volume during manual mask ventilation
* Rates of worsening of the glottic view after intervention
* The difficulty of endotracheal intubation
* Intubation time

Eligibility criteria: Inclusion Criteria:

Adult patient undergoing elective surgery with general anesthesia

Exclusion Criteria:

A patient who does not agree to participate in this study A patient who has a history of cervical/esophageal operation A patient who has a risk of gastric regurgitation A patient who has atherosclerosis of the left carotid artery or history of stroke or angina in 3 months.

Primary outcomes:
measure: Cormack-Lehane grade
timeFrame: During anesthesia induction procedure
Secondary outcomes:
measure: POGO
timeFrame: During anesthesia induction procedure
measure: Difficulty of mask ventilation
timeFrame: During anesthesia induction procedure
measure: Inspiration pressure
timeFrame: During anesthesia induction procedure
measure: Tidal volume
timeFrame: During anesthesia induction procedure
measure: Intubation difficulty
timeFrame: During anesthesia induction procedure
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: SMG - SNU Boramae Medical Center
Study officials:
References:
citation: Won D, Kim H, Chang JE, Lee JM, Min SW, Ma S, Kim C, Hwang JY, Kim TK. Effect of Paratracheal Pressure on the Glottic View During Direct Laryngoscopy: A Randomized Double-Blind, Noninferiority Trial. Anesth Analg. 2021 Aug 1;133(2):491-499. doi: 10.1213/ANE.0000000000005620.