louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04938921: Sutureless Closure for Primary Total Anomalous Pulmonary Venous Connection
Official title: Short-term and Mid-term Outcome of Sutureless Closure for Primary Total Anomalous Pulmonary Venous Connection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Total Anomalous Pulmonary Venous Connection
Pulmonary Venous Stenosis
Sutureless Closure
Keywords: TAPVC
Sutureless
Pulmonary venous stenosis
Lead sponsor: Children's Hospital 1
Sponsor class: OTHER
First posted: 2021-06-25
Enrollment: 30
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with TAPVC operated with sutureless closure and be agreed to joint this study by parents from 01/2019 to 06/2024

Brief summary: The purpose of this study is to assess the percentage of pulmonary venous stenosis after TAPVC repair with sutureless closure.

Detailed description: Parents of patients with TAPVC after repairing by sutureless technique will be informed about the study. If parents agree to participant in the study and sign the informed consent, the investigators will collect information of patients and echocardiography results at 1 month, 6 month, 12 month and 18 month after the operation.

Eligibility criteria: Inclusion Criteria:

* All patients with TAPVC operated with sutureless closure and be agreed to join this study by parents from 01/2019 to 06/2024.

Exclusion Criteria:

* TAPVC operated with sutureless closure have single ventricle, isomerism or heterotaxy, congenital pulmonary venous stenosis.
* TAPVC enrolled to study but cannot the obtain the echocardiography at the time of 1 month, 6 month, 12 month and 18 month.

Primary outcomes:
measure: The percentage of pulmonary venous stenosis after reparing TAPVC with sutureless technique
timeFrame: The investigators assess the PVS at the time of 12 month after the operation.
measure: Early mortality (<30 days)
timeFrame: 30 days
measure: The percentage of pulmonary venous stenosis after reparing TAPVC with sutureless technique
timeFrame: The investigators assess the PVS at the time of 18 month after the operation.
Secondary outcomes:
measure: Late mortality (> 30 days)
timeFrame: The investigators assess mortality at the time of 18 month after the operation
measure: The percentage of pulmonary venous stenosis after reparing TAPVC with sutureless technique
timeFrame: The investigators assess the PVS at the time of 6 month after the operation.
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: Children's Hospital 1
Study officials:
affiliation: Children's Hospital 1
name: Thoi K Ngo, MSC
role: STUDY_DIRECTOR
affiliation: University of Medicine and Pharmacy in HCMC
name: Phuc M Vu, PhD
role: STUDY_DIRECTOR
affiliation: Children's Hospital 1
name: Tuan D Nguyen, MSC
role: STUDY_DIRECTOR
affiliation: University of Medicine and Pharmacy in HCMC
name: Linh NU Truong, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05721521: The Effects of Exercise Intensity on Mood and Wellbeing
Official title: The Effects of Exercise Intensity on Mood and Wellbeing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Exercise
Mood
Lead sponsor: University of Reading
Sponsor class: OTHER
First posted: 2023-02-10
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The study will adopt a between-within group design where participants will exercise at 1 of 4 intensities for 30 minutes at SportsPark Reading. Mood, mental health (e.g., state anxiety and immediate depressive feelings) and physiological parameters (heart rate, blood pressure and body temperature) will be assessed before and after exercise intervention to compare the acute change across time for each intensity condition (no exercise (control), low, moderate, high).


Eligibility criteria: Inclusion Criteria:

* 18-30 years old

Exclusion Criteria:

* If participants' General Practitioner (GP) has advised them against exercising at low, moderate or high intensities
* Recent injuries within the last 12 weeks
* Physical health conditions that may be affected by exercising (e.g., asthma)
* Taking blood pressure medications

Primary outcomes:
measure: Change from baseline state anxiety
timeFrame: In the immediate 10 minutes after the end of the intervention
measure: Change from baseline current mood
timeFrame: In the immediate 10 minutes after the end of the intervention
Secondary outcomes:
measure: Change from baseline depressive aspects of mood
timeFrame: In the immediate 10 minutes after the end of the intervention
Other outcomes:
measure: Change from baseline blood pressure
timeFrame: In the immediate 10 minutes after the end of the intervention
measure: Change from baseline temperature
timeFrame: In the immediate 10 minutes after the end of the intervention
measure: Change from baseline heart rate
timeFrame: approx. 1 hour in total
measure: Change from baseline stress appraisal of intervention
timeFrame: In the immediate 10 minutes after the end of the intervention
Locations:
city: Reading
country: United Kingdom
facility: University of Reading
state: Berkshire
Study officials:
References:
Clinical trial NCT04940221: Testing Informed Decision Making in Lung Cancer Screening
Official title: Testing Informed Decision Making in Lung Cancer Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Lead sponsor: Christiana Care Health Services
Sponsor class: OTHER
Collaborators: name: Thomas Jefferson University
name: University of Delaware
name: National Institute of General Medical Sciences (NIGMS)
First posted: 2021-06-25
Enrollment: 80
Sex: ALL
Minimum age (years): 55
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Lung cancer screening rates are very low despite the fact that lung cancer screening could save many lives. People need to understand the risks and benefits to screening as well as their own beliefs about screening. This study builds an intervention in real world primary care that will help people make the right decision for them as well as help people to quit smoking. Interventions like this are needed to improve the screening rate and reduce death from lung cancer, which is the leading cancer killer.

Detailed description: Lung cancer screening rates in the United States are very low- just 3.3% in 2010 and 3.9% in 2015. There is a critical need to develop and implement effective strategies to engage high-risk patients in a coordinated program of lung cancer screening, which includes shared-decision making. The investigators proposed to modify and expand a shared decision- counseling intervention previously developed in one primary care practice. The investigators measured lung cancer screening in our intervention group compared to a propensity-matched usual care cohort. The investigators compared patients recruited to patients who are not in order to identify potential sources of disparity in future work and the investigators developed a more intense smoking cessation component. Model interventions for shared-decision making in clinical practice are needed across a wide range of diseases and decisions.

Eligibility criteria: Inclusion Criteria:

* Current or former smoker
* Greater than or equal to 30 pack years smoking

Exclusion Criteria:

* Prior CT in last year
* Quit smoking greater than 15 years ago
* Current diagnosis of lung cancer

Primary outcomes:
measure: Number of Patients Who Received a Low Dose CT Scan of the Chest
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Newark
country: United States
facility: Christiana Care Health System
state: Delaware
Study officials:
affiliation: Christiana Care Health Services
name: Heather B Fagan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00286221: IVPCA in the Management of Pain Following Major Intracranial Surgery
Official title: The Safety and Efficacy of IVPCA in the Management of Adult Postoperative Craniotomy Pain: A Prospective, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Intracranial Surgery
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2006-02-03
Enrollment: 159
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: This is a prospective, randomized controlled clinical trial to evaluate the efficacy and safety of intravenous patient controlled analgesia (IVPCA) in patients following major intracranial surgery (e.g. brain tumors, vascular surgery). We will compare pain, opioid consumption, costs, sedation level, length of hospital stay, patient satisfaction, and complications in patients randomized to receive either pro re nata (PRN) or IVPCA opioids. We hypothesize that IVPCA will be more efficacious than PRN opioids in the treatment of postoperative without an increased incidence of adverse effects.


Eligibility criteria: Inclusion Criteria:

* Adults undergoing intracranial surgery

Exclusion Criteria:

* Patient refusal
* Pregnancy
* Aphasia
* Respiratory failure
* Allergy/intolerance to fentanyl
* Opioids use
* History of opioid-dependent pain,
* Patient has been in an investigational drug trial (except chemotherapy) in the month preceding the day of enrollment
* Mental or physical limitations that would prevent patient assessment or PCA use
* Chronic painful conditions unrelated to the reason for surgery,
* Clinically significant respiratory disease that required supplemental oxygen or ventilatory support such as use of mechanical ventilation or positive pressure ventilation
* Patient is unable to initiate a bolus dose of IVPCA fentanyl

Primary outcomes:
measure: Hourly Pain Scores
timeFrame: Up to 16 hours
Secondary outcomes:
measure: Fentanyl Consumption
timeFrame: Up to 16 hours
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Bradford Winters, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Morad AH, Winters BD, Yaster M, Stevens RD, White ED, Thompson RE, Weingart JD, Gottschalk A. Efficacy of intravenous patient-controlled analgesia after supratentorial intracranial surgery: a prospective randomized controlled trial. Clinical article. J Neurosurg. 2009 Aug;111(2):343-50. doi: 10.3171/2008.11.JNS08797.
citation: Morad A, Winters B, Stevens R, White E, Weingart J, Yaster M, Gottschalk A. The efficacy of intravenous patient-controlled analgesia after intracranial surgery of the posterior fossa: a prospective, randomized controlled trial. Anesth Analg. 2012 Feb;114(2):416-23. doi: 10.1213/ANE.0b013e31823f0c5a. Epub 2011 Dec 9.
Clinical trial NCT01305421: Grip Test in Ventilated ICU Patients
Official title: The Role of the Grip Test in the Evaluation of Extubation Success in ICU Patients.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mechanically Ventilated ICU Patients
Keywords: ICU
muscle strength
mechanical ventilation
weaning
Lead sponsor: Centre Hospitalier Universitaire Brugmann
Sponsor class: OTHER
First posted: 2011-02-28
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: ICU patients do experience extubation failure. Guidelines rarely include muscle strength criteria. Prior work indicates that grip strength is a reliable surrogate for muscle strength. The purpose of the study is to assess the success rate of mechanical ventilation weaning based on the grip test.


Eligibility criteria: Inclusion Criteria:

* mechanically ventilated ICU patients

Exclusion Criteria:

* tracheotomy

Primary outcomes:
measure: Extubation success
timeFrame: 48 hours without reintubation
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU Brugmann
Study officials:
References:
Clinical trial NCT02648321: Motivational Intervention for Physical Activity in Psychosis
Official title: Motivational Intervention of Exercise in Patients With Psychosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychotic Disorders
Keywords: Motivational Interviewing
Exercise
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2016-01-07
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether motivational intervention is effective in promoting exercise habit in patients with psychosis.

Detailed description: The current study aims to investigate the beneficial effect of motivational intervention in promoting exercise habit in patients with psychosis. Outpatients will be recruited and will be randomized to a 12-week motivational intervention program. They will be assessed for their clinical symptoms, cognitive function, physical fitness, and quality of life. All patients will have cognitive function assessments at baseline, 12 weeks after the completion of the program and 6 months. The primary hypothesis of the current study is that motivational intervention can help patient to develop exercise habit in patients with early psychosis.

Eligibility criteria: Inclusion Criteria:

* Diagnosed to have psychotic disorders
* Cantonese-speaking Chinese (to enable cognitive testing)
* Ability to understand the nature of the study and to give written informed consent

Exclusion Criteria:

* Severe physical illness (Myocardial Infarction, Hypertension, Fracture, Spinal problems in which exercise may be contraindicated), and seizure disorders
* Comorbid substance dependence
* Unstable psychotic symptoms
* Known pregnancy
* A history of brain trauma or organic brain disease
* Known history of intellectual disability or special school attendance

Primary outcomes:
measure: Physical Activity Level
timeFrame: 12 weeks
Secondary outcomes:
measure: Role Functioning Scale
timeFrame: 12 weeks
measure: Short Form 36
timeFrame: 12 weeks
measure: PANSS
timeFrame: 12 weeks
measure: Physical Activity Level
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: The University of Hong Kong
Study officials:
References:
Clinical trial NCT05062421: Persistence of Biological Treatment and Inhibitors of Jak Kinases in Patients With Rheumatoid Arthritis.
Official title: Persistence of Biological Treatment and Inhibitors of Jak Kinases in Habitual Clinical Practice in Patients With Rheumatoid Arthritis. Influence of the Comorbidities.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Arthritis, Rheumatoid
Lead sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sponsor class: OTHER
First posted: 2021-09-30
Enrollment: 540
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients aged \> 18 years diagnosed with rheumatoid arthritis, who have been under treatment with at least one dose of the study drugs, whose treatment is followed by the rheumatology unit.

Brief summary: One-center observational study aimed at determining the survival of patients with rheumatoid arthritis treated with targeted synthetic disease-modifying drugs (FAMEsd) and biologic disease-modifying drugs (FAMEb).

These patients will be administered a series of medications and a follow-up will be carried out to analyze their evolution.

Detailed description: One-center observational study aimed at determining the survival of patients with rheumatoid arthritis treated with targeted synthetic disease-modifying drugs (FAMEsd) and biologic disease-modifying drugs (FAMEb).

The drugs to be administered to patients are:

* JAK-type kinase inhibitors.
* Monoclonal antibodies against TNF.
* Soluble receptor against TNF.
* Biosimilar FAMEb.
* Rituximab.
* Abatacept.
* Drugs that block IL6.

A follow-up will be carried out at 12, 24, 48, 60, 72 and 84 months from the start of treatment, to analyze how the patient's health improves.

Eligibility criteria: Inclusion Criteria:

* Patients aged ≥18 years.
* With a diagnosis of Adult Rheumatoid Arthritis according to the 2010 ACR / EULAR criteria.
* Who have received at least one of the doses of the study drugs.
* In follow-up in the consultations of the UGC of Rheumatology of the HUVM.
* With at least two complete evaluations (baseline and final) of clinical variables.

Exclusion Criteria:

* Patients where the medical records lack sufficient baseline and final variables to perform the analysis.
* Patients in whom more than 50% of the variables to be collected are missing in the data collection.

Primary outcomes:
measure: Survival study
timeFrame: Up to 60 weeks
Secondary outcomes:
measure: Study of clinical characteristics.
timeFrame: Up to 60 weeks
measure: Measure of the influence of comorbidities.
timeFrame: Up to 60 weeks
measure: Number of participants who discontinued treatment due to serious adverse effects.
timeFrame: Up to 60 weeks
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen macarena
Study officials:
affiliation: Hospital Universitario Virgen Macarena
name: Blanca Estela Hernández Cruz
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02502721: A Clinical Trial to Evaluate Pharmacokinetics and Safety Between DWC20151 and DWC20152
Official title: A Randomized, Open-labeled, Oral Dose, Crossover Design Clinical Trial to Evaluate Pharmacokinetics and Safety Between DWC20151 and DWC20152 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Male
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2015-07-20
Enrollment: 58
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A randomized, open-labeled, oral dose, crossover design clinical trial to evaluate pharmacokinetics and safety between DWC20151 and DWC20152 in healthy male subjects.

Detailed description: This study is to evaluate pharmacokinetics and safety between DWC20151 and DWC20152 in healthy male subjects.

Study design is randomized, open-labeled, oral dose, crossover design. This study will conducted with 2 separated part (Part A, Part B).

Eligibility criteria: Inclusion Criteria:

* Healthy male subjects (18\~55 years)

Exclusion Criteria:

* Who has allergy to investigational product

Primary outcomes:
measure: Peak Plasma Concentration (Cmax)
timeFrame: 0~72hr
measure: Area under the plasma concentration versus time curve (AUC)
timeFrame: 0~72h
Secondary outcomes:
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Busan Paik Hospital
Study officials:
affiliation: Busan paik hospital
name: Jinah Jung
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02708121: Increasing Uptake of Behavioral Weight Loss Programs Among Primary Care Patients
Official title: Increasing Uptake of Behavioral Weight Loss Programs Among Primary Care Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Duke University
First posted: 2016-03-15
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This pilot trial will test feasibility and acceptability of a primary care-based intervention that aims to increase the portion of patients who enter evidence-based behavioral weight loss treatment.

Detailed description: This trial is a pilot, pragmatic cluster randomized trial conducted in primary care clinics to determine intervention acceptability and the feasibility of proposed study protocol.

Eligibility criteria: Primary care provider Inclusion criteria:

* Employed by Duke PCRC clinic as primary care provider at least ½ FTE.
* Has a primary adult panel
* Has worked at Duke PCRC clinic for at least one year

Patient inclusion criteria

* BMI ≥ 30 kg/m2 as measured at any clinic in previous 12 months.
* English speaking
* Self-report BMI ≥ 29 kg/m2 (to allow for under-reporting)
* Regular email usage, defined as accessing email 3 or more times per week (on home or work computer or cell phone)
* Age 18-75
* Clinical appointment (well visit or chronic care visit) with enrolled Duke provider in 2-6 weeks of record review.
* At least one prior appointment with the provider they are scheduled to see at target clinical appt.
* Has a valid email address in electronic health records.

Patient exclusion criteria:

* In weight loss treatment program in past year
* Unable to read content on websites without any assistance

Primary outcomes:
measure: Number of Participants Attending 6 Month Follow-up Appointment
timeFrame: 6 months
Secondary outcomes:
measure: Intervention Acceptability (Acceptability Outcome)
timeFrame: 1 month
Other outcomes:
measure: Number of Participants Who Initiated Treatment Based on Program-provided Data and Self-report
timeFrame: 6 months
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Megan A McVay, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McVay MA, Yancy WS, Bennett GG, Levine E, Jung SH, Jung S, Anton S, Voils CI. A web-based intervention to increase weight loss treatment initiation: results of a cluster randomized feasibility and acceptability trial. Transl Behav Med. 2021 Feb 11;11(1):226-235. doi: 10.1093/tbm/ibz143.