louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06973382: Effects of Pulmonary Rehabilitation on Quality of Life and Health in Pulmonary Arterial Hypertension Patients
Official title: Intervention Study of a Comprehensive Pulmonary Rehabilitation Program on Quality of Life and Prognosis in Patients With Pulmonary Arterial Hypertension
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: PAH
CTEPH
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Municipal Health Commission
First posted: 2025-05-15
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Pulmonary hypertension (PH) is a major global health concern, affecting approximately 1% of the world's population. With global aging and increased life expectancy, its incidence continues to rise. PH is a progressive and disabling disease, with studies showing its progression correlates with worsening symptoms and increased mortality. Even with targeted medications, the prognosis remains poor across PH subtypes, with PAH patients showing only a 49% 7-year survival rate. The 2022 ESC/ERS guidelines emphasize that PH management requires a comprehensive, multidisciplinary approach. Beyond pharmacological and surgical treatments, rehabilitation has demonstrated benefits in improving exercise capacity, quality of life, functional class, and peak oxygen consumption. However, research on specific and effective comprehensive pulmonary rehabilitation programs remains lacking.


Eligibility criteria: Inclusion Criteria:Confirmed PH Diagnosis:

Right heart catheterization-confirmed pulmonary hypertension

Meets 2022 ESC/ERS Guidelines diagnostic criteria for:

* Group 1 (PAH) or
* Group 4 (CTEPH/other pulmonary artery obstructions)

Stabilized Treatment Status:

Group 1 (PAH): Received ≥3 months of targeted drug therapy

Group 4 (CTEPH): Completed ≥6 sessions of BPA\* or reached therapeutic endpoint

Functional Capacity:

WHO Functional Class I-III

Age: ≥18 years

Consent: Willing to provide written informed consent -

Exclusion Criteria:Physical Limitations:

Unable to perform pulmonary rehabilitation exercises due to disability or congenital malformations

Cardiopulmonary Testing Contraindications:

Medically unfit to complete CPET (cardiopulmonary exercise testing) after evaluation

Poor Compliance:

History of non-adherence making protocol completion unlikely

Life Expectancy:

Prognosis ≤1 year

-

Primary outcomes:
measure: 6MWD
timeFrame: 12week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02280382: An Intervention to Improve Prolapse Using Femmeze® (v1)
Official title: An Intervention to Improve the Management of Posterior Vaginal Compartment Prolapse Using Femmeze®: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rectocele
Pelvic Organ Prolapse
Keywords: splinting
Lead sponsor: Royal Cornwall Hospitals Trust
Sponsor class: OTHER
Collaborators: name: Peninsula Health
First posted: 2014-10-31
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The main purpose of the feasibility study is to identify the patient experience of Femmeze® which is a device aimed at improving posterior vaginal compartment prolapse (rectocele) for women with obstructive defaecation. The investigators want to investigate implementation and preliminary effectiveness of the device. The method of investigation will be a pre-post intervention design, which involves asking 30 women to use Femmeze® over a period of 8 weeks. This is an academic study on a labelled indication (http://www.nres.nhs.uk/search/?q=medical+devices).

Detailed description: Aim Evaluate the feasibility of the Femmeze® device to improve management of posterior vaginal compartment prolapse addressing implementation of the intervention and preliminary effectiveness.

Objectives

* demonstrate effectiveness of the device (comfort, ease of use, empty the rectum of stool more easily than their current approach and quality of life)
* identify which stage of prolapse the device would be most suitable
* identify any changes to the device or instructions for use (needs adjustment to its design in terms of length/width)

The study will use a pre-post intervention design with the aim of evaluating the feasibility of the intervention (using the device); and identifying any implementation issues and preliminary effectiveness. The participants will be followed prospectively to compare the device against their own usual care. Usual care in this context will be using their fingers to help empty their rectum of stool.

Participants will be invited to complete a semi-structured interview to understand their lived experience. A Patient and Public Involvement Group has contributed to improving the study methods.

Eligibility criteria: Inclusion Criteria:

* Adult women (over 18 years of age) with symptoms of obstructive defaecation
* Not undergone posterior vaginal compartment prolapse surgery

Exclusion Criteria:

* Cognitive impairment
* Hand disability
* Refuse to give informed consent
* Pregnancy
* Less than 12 weeks post-partum
* Neurological disease

Primary outcomes:
measure: Quality of life instrument (ICIQ-Vaginal Symptoms)
timeFrame: 12 months
Secondary outcomes:
measure: Device feedback questionnaire
timeFrame: 12 months
Other outcomes:
Locations:
city: Truro
country: United Kingdom
facility: RoyalCornwallHT
Study officials:
affiliation: RCHT
name: Sharon Eustice, BSc; MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01284582: Safety, Immunogenicity and Dose Response of ATH03, a New Vaccine Against the Cholesterol Ester Transfer Protein (CETP)
Official title: Safety, Immunogenicity and Dose Response of ATH03, a New Vaccine Against the Cholesterol Ester Transfer Protein (CETP), in Healthy Male Subjects With High Density Lipoprotein Cholesterol (HDLc) Blood Concentrations Equal or Below 80 mg/dl
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HDL
Drug Safety
Keywords: CETP
Vaccine
Cholesterol
Inhibition
Lead sponsor: Affiris AG
Sponsor class: INDUSTRY
First posted: 2011-01-27
Enrollment: 36
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Phase 1 Study :Safety, Immunogenicity and Dose response of ATH03, a new vaccine against the cholesterol ester transfer protein (CETP), in healthy male subjects with high density lipoprotein cholesterol (HDLc) blood concentrations equal or below 80 mg/dl.

Detailed description: This open-label Phase 1 study will be conducted in three groups of 12 subjects with HDLc blood concentrations equal or below 80 mg/dl at a single study center. 36 subjects will be enrolled.

Eligibility criteria: Inclusion Criteria:

* Healthy males
* High density lipoprotein cholesterol (HDLc) blood concentrations equal or below 80 mg/dl

Exclusion Criteria:

* Clinically relevant pathological findings

Primary outcomes:
measure: Number of adverse events
timeFrame: 264 days
Secondary outcomes:
measure: Immunogenicity
timeFrame: 264 days
measure: Response to the various applied doses of ATH03
timeFrame: 264 days
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department for Clinical Pharmacology Medical University Vienna
Study officials:
affiliation: Affiris AG
name: Achim Schneeberger, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03060382: The Treatment of Knee Osteoarthritis With Balanced Buttress Absorbable Spacer
Official title: The Treatment of Knee Osteoarthritis With Balanced Buttress Absorbable Spacer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Osteoarthritis, Knee
Lead sponsor: Hebei Medical University Third Hospital
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 150
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators randomly divided the knee osteoarthritis patients met the inclusive criteria into two groups (study group and control group). Placement of balanced buttress absorbable spacer and total knee arthroplasty were conducted. The clinical outcome of two groups were compared in this study.

Detailed description: Knee osteoarthritis, caused by non-uniform settlement of medial and lateral tibial plateau, was not uncommon in clinic. Medial stenosis was the most type of the disease. The symptoms included knee pain during walking and varus deformity of lower limbs. Total knee arthroplasty and tibial osteotomy were two common conventional treatment of the knee osteoarthritis, which were not minimally invasive and bring great financial burden to patients' family. The investigators planned to recruit 150 patients of knee osteoarthritis into this study, which were randomly divided into two groups (study group and control group). For the patients of study group, a balanced buttress absorbable spacer was placed into the gap after the osteotomy of tibia and fibula to modify the lower limb line. However, total knee arthroplasty was conducted for the patients of control group. The patients were followed up and the clinical outcomes were compared in this study.

Eligibility criteria: Inclusion Criteria:

* 40-80 years old
* Medial stenosis of the knee
* Varus deformity less than 20 degrees

Exclusion Criteria:

* Lateral stenosis of the knee
* Hepatic renal dysfunction
* Refuse to participate the study

Primary outcomes:
measure: functional outcome
timeFrame: 12 months
Secondary outcomes:
measure: complication
timeFrame: 1 week
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: Hebei Medical University Third Hospital
state: Hebei
city: Shijiazhuang
country: China
facility: Zhiyong Hou
state: Hebei
Study officials:
affiliation: Third Hospital of Hebei Medical University Department of Orthopaedic Surgery
name: Yingze Zhang, M.D
role: STUDY_CHAIR
affiliation: Third Hospital of Hebei Medical University Department of Orthopaedic Surgery
name: Zhiyong Hou, M.D
role: STUDY_DIRECTOR
affiliation: Third Hospital of Hebei Medical University Department of Orthopaedic Surgery
name: Ruipeng Zhang, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01385982: Improving Management of Outpatient Actionable Test Results
Official title: Improving Management of Outpatient Actionable Test Results
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Management of Actionable Test Results (ATRs)
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2011-06-30
Enrollment: 6000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Clinically significant test results require timely clinician follow-up including the non-urgent clinically significant, or actionable, test results that have received less standardized management and attention. Unfortunately, failure to correctly manage actionable test results is not infrequent and may be associated with important delays in diagnosis and treatment and patient harm. The investigators have designed a safe practice intervention to improve the management of actionable test results for ambulatory patients in a large healthcare system.


Eligibility criteria: Inclusion Criteria:

Primary care physicians will be enrolled in the study by virtue of being an actively practicing clinician in an PHS ambulatory practice, and having at least one patient with a diagnostic test included in the PHS CCSTR intervention. The patient population will consist of adult patients \>17 years of age with diagnostic tests in the affiliated ambulatory practices of PHS. Patients will be recruited into the study by a review of electronic medical record data to identify patients with a diagnostic test specified in the PHS CCSTR intervention.

Exclusion Criteria:

Participants who do not meet the inclusion/eligibility requirements will be excluded.

Primary outcomes:
measure: Acknowledged Sub-Critical/Abnormal ATRs
timeFrame: Acknowledgement within 15 business days from the Level 3 Laboratory ATR alert and acknowledgement within 8 business hours of the cardiology Level 2 ATR alert
Secondary outcomes:
measure: Diagnosis and/or Treatment Delays
timeFrame: Minumum of 3 months post ATR
measure: Undiagnosed/Untreated Condition Frequency and Severity
timeFrame: Minumum of 3 months post ATR
Other outcomes:
Locations:
city: Boston
country: United States
facility: Partners Healthcare
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Jeffrey Rothschild, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03394482: Bioequivalence Study of Lu AF35700
Official title: Interventional, Randomized, Open-label, Three-group, Two-sequence Crossover, Single-dose, Bioequivalence Study of Lu AF35700 in Healthy Subjects Comparing the 5, 10 and 20 mg Commercial Tablet (Test) to the 5, 10 and 20 mg Clinical Tablet (Reference)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2018-01-09
Enrollment: 87
Sex: ALL
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: The purpose of this study is to establish bioequivalence of Lu AF35700 between the clinical formulation and the commercial formulation for three tablet strengths; 5, 10 and 20 mg


Eligibility criteria: Inclusion Criteria:

* Healthy men and women aged ≥18 and ≤55 years
* Body Mass Index (BMI) of ≥18.5 and ≤32 kg/m2
* Subject must be in good general health as assessed using medical history, clinical laboratory tests, and physical examination

Exclusion Criteria:

* The subject must not be of childbearing potential (if a woman) or should use contraception, be surgically sterilized or not be sexually active (both sexes). Women must not be pregnant or lactating
* The subject must not be a CYP2D6 or a CYP2C19 poor metaboliser
* The subject has previously been dosed with Lu AF35700

Other protocol defined inclusion and exclusion criteria may apply

Primary outcomes:
measure: AUC0-72h of Lu AF35700
timeFrame: zero to 72 hours
measure: Cmax of Lu AF35700
timeFrame: zero to 72 hours
Secondary outcomes:
measure: Tmax of Lu AF35700
timeFrame: zero to 72 hours
measure: AUC0-t of Lu AF35700
timeFrame: zero to time of the last quantifiable plasma concentration
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Covance
Study officials:
affiliation: LundbeckClinicalTrials@Lundbeck.com
name: Email contact via H.Lundbeck A/S
role: STUDY_DIRECTOR
References:
Clinical trial NCT03341182: The Effects of Use of Mirror Image on Radiation Exposure During Fluoroscopically Guided Transforaminal Epidural Injection
Official title: The Effects of Use of Mirror Image on Radiation Exposure During Fluoroscopically Guided Transforaminal Epidural Injection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Radiculopathy Due to Spinal Nerve Compression
Keywords: epidural steroid injection
radiation exposure
mirror
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2017-11-14
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: normal method group (group A) mirror use group (group B)
Primary purpose: SUPPORTIVE_CARE

Brief summary: Lumbar Transforaminal Epidural Injection is helpful for the treatment of lumbosacral radicular pain.

Tunnel view technique is the basis of X-ray assisted intervention. In this technique, it is necessary to handle the block needle in order to adjust the direction of needle to the tunnel view toward target. If a mirror is used during needle handling, overall procedure time and radiation exposure can be reduced.

Detailed description: 1. A planned Fluoroscopically Guided Lumbar Transforaminal Epidural Injection should be performed after receiving the informed consent of the patient.
2. This study is single-blind because it is not possible to blind the practitioner performing the injection.
3. Subjects were randomly assigned to the normal method group (group A) and the mirror use group (group B) by a random random number table, and the possibilities for belonging to any group were all the same and can not be artificially controlled by researchers.
4. After the procedure, a resident who does not know of this study records the radiation exposure time displayed on the monitor and the overall procedure time

Eligibility criteria: Inclusion Criteria:

1. Magnetic resonance imaging (MRI) and clinical manifestations of adult men and women over 20 years of age are eligible for radiculopathy due to back nerve root compression and subject to fluoroscopically guided lumbar transforaminal epidural Injection at the suspected spinal nerveroots level.

Exclusion Criteria:

1. Blood clotting disorder
2. Infection around the site
3. Contrast agent allergy
4. Uncontrolled cardiovascular, cerebrovascular, kidney disease
5. Past history of spinal surgery (ex, spinal fusion)
6. If can not block due to Non-cooperation with subjects (ex, if you can not take the stomach)
7. Patients taking narcotic analgesics

Primary outcomes:
measure: radiation exposure time(second)
timeFrame: Immediately after the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Dept. of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT01621282: Running Successful Journal Club
Official title: Effect of Education on Running Successful Journal Club
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Educational Course
Keywords: journal club
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
First posted: 2012-06-18
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: Running successful journal club is of the important goals for postgraduate education.In this study, the effect of a 6-month interactive educational course on journal clubs of Mashhad Dental school was observed using a valid and reliable checklist(r=0.74). Data will be evaluated and compared using spss software by t-test.


Eligibility criteria: Inclusion Criteria:

* Faculty members of Dental School,Postgraduate departments

Exclusion Criteria:

* Faculty members of other schools,Undergraduate departments

Primary outcomes:
measure: checklist mean score
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04346082: Feasibility of Online Based Mindfulness Interventions During COVID-19 Outbreak
Official title: Feasibility and Acceptability of Online Based Mindfulness Interventions to Relieve Distress During COVID-19 Outbreak in a Chinese Population: a Proof-of-concept Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Stress
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2020-04-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: participants receiving online mindfulness session(s)
Primary purpose: TREATMENT

Brief summary: The investigators had designed weekly mindfulness sessions (details see intervention below), which is free-of-charge and will be made available to general public who feel distressed during the outbreak of COVID-19. Face-to-face delivery of mindfulness interventions was not possible due to mandatory quarantine. The investigators hypothesize that this intervention is feasible and acceptable by the participants. As secondary outcomes, the investigators also hypothesize that the intervention can reduce stress, depressive and anxiety symptoms and enhance participants' sense of coherence

This will be a quasi-experimental study. Participants will be invited to fill in an online informed consent and questionnaire around 2 days before each mindfulness online session and another set of questionnaire immediately after each session (see outcome measures). Participants will be identified by their e-mail and therefore serial data could be obtained.


Eligibility criteria: Inclusion Criteria:

* at least 18 years of old,
* able to speak and communicate in Cantonese
* can read Chinese or English (because they will be asked to fill in an online questionnaire).

Exclusion Criteria:

* actively suicidal,
* currently abusing restricted psychoactive substances
* diagnosed to have an active psychotic disorder and self-reported active psychotic symptoms (including schizophrenia, bipolar disorder and dementia).

Primary outcomes:
measure: rate of recruitment
timeFrame: from recruitment to end of study, up to 1 year
measure: rate of attendence
timeFrame: from recruitment to end of study, up to 1 year
Secondary outcomes:
measure: Depression, Anxiety and Stress Scale (DASS-21)
timeFrame: on recruitment, after each online mindfulness sessions (weekly) until end of study, up to 1 year
measure: Sense of Coherence Scale
timeFrame: on recruitment, after each online mindfulness sessions (weekly) until end of study, up to 1 year
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: School of public health and primary care
Study officials:
References: