louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05454254: Effect of Muscle Strengthening Training in Adults with Fontan Circulation
Official title: Effect of Muscle Strengthening Training in Adults with Fontan Circulation Compared to Healthy Controls
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Heart Disease
Univentricular Heart
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2022-07-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Aim: to evaluate the effect of muscle strengthening exercise training in adults with Fontan circulation compared to healthy controls.

Hypothesis: adults with Fontan circulation have a relatively lower effect of muscle strengthening exercise training compared to healthy controls.

Detailed description: 10 adults with Fontan circulation will be recruited from the clinic specialised in adults with congenital heart disease at Norrlands Universitetssjukhus. In addition, 10 age- and sex matched controls will be recruited. The sample size is estimated according to a previous study with the same primary outcome. We estimate that 7 patients and 7 controls are needed in the study and plan to enrol 10 patients and 10 controls in case of any drop outs.

Muscle tests will be performed at baseline. Based on the results from the muscle tests, an individualised muscle training exercise protocol will be designed and the participants will be working out at a gym during 10 weeks. After 10 weeks the same tests will be performed to evaluate the effect of the muscle training exercise.

In addition to the muscle tests, muscle mass and aerobic exercise capacity will be evaluated with peripheral quantitative computed tomography and cardiopulmonary exercise test respectively. Physical activity will be mapped with a validated questionnaire (IPAQ) and an accelerometer attached to the participants thigh. Any impact on fatigue will be evaluated with a validated questionnaire (MFI-20). All tests and questionnaires will be performed at baseline and at follow-up.

Eligibility criteria: Inclusion Criteria:

* Age minimum 18 years
* Patients: Congenital heart disease (Fontan circulation, univentricle heart)
* Controls: no known congenital heart disease.

Exclusion Criteria:

* Muscle strenghtening exercise training at regular basis (2 times/week or more)
* Active disease or other condition that affect exercise training (e.g. rheumatoid arthritis)
* Cognitive or psychological affection
* Other conditions that affect independent decision-making competence

Primary outcomes:
measure: Change in muscle oxygenation kinetics evaluated with near-infrared spectroscopy (NIRS).
timeFrame: 10 weeks
Secondary outcomes:
measure: Change of isometric muscle strength
timeFrame: 10 weeks
measure: Change of muscular endurance
timeFrame: 10 weeks
measure: Change of muscle mass
timeFrame: 10 weeks
measure: Change of aerobic exercise capacity
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Umeå University Hospital
Study officials:
References:
Clinical trial NCT04929054: PCR Based CEUS in BI RADS 4A Nodules
Official title: Principal Component Regression Based Contrast Enhanced Ultrasound Evaluating System in the Management of BI-RADS 4A Breast Nodules
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: PCA
Breast Cancer
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: Beijing Friendship Hospital
First posted: 2021-06-18
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with nodules which were sonographically classified as BI-RADS 4 A breast lesion

Brief summary: The aim of this study was to investigate the added value of Principal Component Regression (PCR) based contrast-enhanced ultrasound (CEUS) for differentiating low risk patients with breast nodules categorized as 4A using the Breast Imaging Reporting and Data System (BI-RADS).

Detailed description: The aim of this study was to investigate the added value of Principal Component Regression (PCR) based contrast-enhanced ultrasound (CEUS) for differentiating low risk patients with breast nodules categorized as 4A using the Breast Imaging Reporting and Data System (BI-RADS). The study included patients with 4A nodules confirmed by core biopsy and/or surgery. The CEUS parameters were assessed and PCR scores were calculated to evaluated the added value in BI-RADS 4A nodules.

Eligibility criteria: Inclusion Criteria:

patients with BI-RADS 4A breast lesion

Exclusion Criteria:

(i) absence of a pathologic diagnosis; (ii) presence of breast nodules that were too large to compare with normal parenchyma; (iii) patients with radiotherapy and chemotherapy of breast cancer; and (iv) skin disorders.

Primary outcomes:
measure: surgery or biopsy
timeFrame: up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hanzhou
country: China
facility: SAHZJU
state: Zhejiang
Study officials:
affiliation: SAHZJU
name: pintong Huang
role: STUDY_CHAIR
References:
Clinical trial NCT05727254: Agility Training for Older Adults to Improve Fall Risk Factors
Official title: Agility Training for Older Adults: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Age-Related Loss of Skeletal Muscle Mass
Aging
Sarcopenia
Cognitive Decline
Lead sponsor: University of Basel
Sponsor class: OTHER
First posted: 2023-02-14
Enrollment: 48
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial with an intervention and a control arm.
Primary purpose: TREATMENT

Brief summary: In this randomized controlled trial the effect of 4 months of multi-component (strength, balance, cognition, endurance) exercise training intervention on measures of neuromuscular performance, cognition, and endurance as well as neural adaptations on a central and peripheral level is investigated. 40 subjects are recruited that are generally health and between 60 and 80 years of age. The interventions is based around exercises, where different tasks have to be solved simultaneously rather than serially, as has previously been done.


Eligibility criteria: Inclusion Criteria:

* willing to be randomized to either arm
* ability to travel to the sports facility twice a week
* understanding the german language

Exclusion Criteria:

* smoking, obesity
* history of cardiovascular, pulmonary or chronic inflammatory disease
* vision impairments
* orthopaedic problems preventing them from participating in an exercise program
* history of osteoporosis or recent low trauma fracture
* less than two weeks during the intervention period
* not have taken part in a structured exercise program more than once a week in the past three months

Primary outcomes:
measure: Isometric knee-extension strength
timeFrame: 16 weeks
Secondary outcomes:
measure: Isometric knee-flexion strength
timeFrame: 16 weeks
measure: Cognitive Processing Speed
timeFrame: 16 weeks
measure: Cognitive Impulsiveness
timeFrame: 16 weeks
measure: Balance Performance
timeFrame: 16 weeks
measure: Hand Grip Strength
timeFrame: 16 weeks
measure: Counter movement jump power
timeFrame: 16 weeks
measure: Blood Pressure
timeFrame: 16 weeks
measure: Pulse Wave Velocity
timeFrame: 16 weeks
measure: Retinal vessel diameter
timeFrame: 16 weeks
measure: Quality of Life Questionnaire
timeFrame: 16 weeks
measure: Fall Efficacy
timeFrame: 16 weeks
measure: Sleep Disturbances
timeFrame: 16 weeks
measure: Stress
timeFrame: 16 weeks
measure: Depression
timeFrame: 16 weeks
Other outcomes:
measure: Corticospinal Inhibition
timeFrame: 16 weeks
measure: Voluntary activation
timeFrame: 16 weeks
Locations:
city: Basel
country: Switzerland
facility: Departement für Sport, Bewegung und Gesundheit
state: Basel-Stadt
Study officials:
References:
Clinical trial NCT06226454: A Phase 1 Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics, of VX-993
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled Single- and Multiple-dose Escalation Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of Oral VX-993 in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2024-01-26
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of VX-993 at different doses in healthy participants.

Detailed description: This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Eligibility criteria: Key Inclusion Criteria:

* Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (kg/m\^2)
* A total body weight of more than (\>) 50 kg
* Nonsmoker or ex-smoker for at least 3 months before the first study drug dose

Key Exclusion Criteria:

* History of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug
* Any condition possibly affecting drug absorption, distribution, metabolism, or excretion

Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: From Day 1 up to Day 16
measure: Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: From Day 1 up to Day 43
Secondary outcomes:
measure: Part A: Maximum Observed Plasma Concentration (Cmax) of VX-993
timeFrame: Day 1 up to Day 16
measure: Part A: Area Under the Concentration Versus Time Curve (AUC) of VX-993
timeFrame: Day 1 up to Day 16
measure: Part B: Maximum Observed Plasma Concentration (Cmax) of VX-993
timeFrame: Day 1 up to Day 43
measure: Part B: Area Under the Concentration Versus Time Curve (AUC) of VX-993
timeFrame: Day 1 up to Day 43
measure: Part B: Pain Tolerance Threshold (PTT) for the Cold Pressor Test
timeFrame: Day 1 up to Day 11
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: ICON Salt Lake City
state: Utah
Study officials:
References:
Clinical trial NCT01768754: Walking Speeds in Patients With Chronic Obstructive Pulmonary Disease
Official title: Repeatability and Utility of the Usual and Fast Walking Speeds in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Exercise testing
Functional status
Pulmonary rehabilitation
Lead sponsor: West Park Healthcare Centre
Sponsor class: OTHER
First posted: 2013-01-15
Enrollment: 29
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 with stable moderate-severe COPD will be recruited from those under the care of a respirologist at West Park Health Care Centre

Brief summary: A growing body of evidence suggests that in individuals with chronic lung disease their walk speed is related to their daily function and quality of life. It is possible to assess their usual (routine) and fast walking speeds by getting them to walk in a flat hallway.

In individuals with chronic lung disease, we anticipate that their usual walk speed will be helpful in exercise prescription and use in multidimensional scoring systems. However, it is important to first determine the measurement properties of these two walk speeds.


Eligibility criteria: Inclusion Criteria:

* Clinical and spirometric diagnosis of COPD
* Able to provide written informed consent

Exclusion Criteria:

* Unstable cardiovascular disease
* Acute respiratory exacerbation within 4 weeks
* Neurologic or orthopedic limitation to walking
* Inability to comprehend instructions in English

Primary outcomes:
measure: Coefficient of repeatability for usual and fast walk speeds
timeFrame: At baseline and over 1 week period.
Secondary outcomes:
measure: Agreement in walk speeds between optical sensors and stopwatch
timeFrame: Baseline and over 1 week of testing.
measure: Agreement in the Bode Index using six minute walk distance and usual walk speed.
timeFrame: Baseline
Other outcomes:
measure: Precision of achieving a targeted endurance time using the usual and fast walking speeds.
timeFrame: Baseline
Locations:
city: Toronto
country: Canada
facility: Westpark Health Care Centre
state: Ontario
Study officials:
affiliation: Westpark Healthcare Centre
name: Roger Goldstein, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bland JM, Altman DG. Measuring agreement in method comparison studies. Stat Methods Med Res. 1999 Jun;8(2):135-60. doi: 10.1177/096228029900800204.
Clinical trial NCT04559854: Mindful After Cancer: A Mindfulness-based Therapy Intervention for Sexual Health After Cancer
Official title: Mindful After Cancer Study: Fostering Positive Body Image, Sexual Health, and Well-being
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Gynecologic Cancer
Lead sponsor: Oregon State University
Sponsor class: OTHER
Collaborators: name: OHSU Knight Cancer Institute
First posted: 2020-09-23
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objectives of this study are to: 1) adapt a mindfulness-based therapy program designed to help women manage their sexual and body image concerns after cancer (Mindful After Cancer, MAC) to a videoconference format and 2) assess the feasibility, acceptability, and preliminary effects of the program among breast and gynecologic cancer survivors.

Detailed description: The specific aims are: 1) Assess the feasibility of the MAC program when delivered via videoconference and 2) Assess preliminary effects of the the program.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of breast or gynecologic cancer at least one year prior to enrollment
* English speaking
* Have access to a computer, smart phone, or tablet with internet access
* Ability to spend 15-30 minutes per day on program activities

Exclusion Criteria:

- Stage 0 (carcinoma in situ)

Primary outcomes:
measure: Feasibility/ Enrollment
timeFrame: Baseline
measure: Feasibility/ Retention in Study
timeFrame: 1 month post-intervention
measure: Feasibility/ Retention in the Program
timeFrame: 1 month post-intervention
measure: Acceptability
timeFrame: 1 month post-intervention
Secondary outcomes:
measure: Change from baseline self-efficacy at 1 month
timeFrame: Baseline and 1 month post-intervention
measure: Change from baseline body image at 1 month
timeFrame: Baseline and 1 month post-intervention
measure: Change from baseline body appreciation at 1 month
timeFrame: Baseline and 1 month post-intervention
measure: Change from baseline anxiety at 1 month
timeFrame: Baseline and 1 month post-intervention
measure: Change from baseline depression at 1 month
timeFrame: Baseline and 1 month post-intervention
measure: Change in facets of baseline mindfulness at 1 month
timeFrame: Baseline and 1 month post-intervention
measure: Change from baseline self-compassion at 1 month
timeFrame: Baseline and 1 month post-intervention
measure: Change from baseline relationship quality at 1 month
timeFrame: Baseline and 1 month post-intervention
measure: Change from baseline interest in sexual activity at 1 month
timeFrame: Baseline and 1 month post-intervention
measure: Change from satisfaction with sex life at 1 month
timeFrame: Baseline and 1 month post-intervention
Other outcomes:
Locations:
city: Corvallis
country: United States
facility: Oregon State University
state: Oregon
Study officials:
affiliation: Oregon State University
name: Jessica R Gorman, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05945654: Functional Outcome After Anastomotic Leak After Oesophagectomies
Official title: Subjective Functional Outcome After Oesophagectomy With and Without Anastomotic Leak
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Anastomotic Leak Esophagus
Swallowing Disorder
Lead sponsor: Stadtspital Zürich
Sponsor class: OTHER
First posted: 2023-07-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients, according to the above mentioned criteria who were operated at Stadtspital Triemli between 01.06.2018 and 31.5.2022

Brief summary: The main surgical treatment for oesophageal cancer is a curative resection, mostly performed according to Ivor Lewis. However, despite careful work and refined surgical techniques, anastomotic leakage (AL) occurs in more than 1/10 of the patients. This severe complication normally requires immediate intervention, while over the last 10 years, endoscopic vacuum therapy (EVT) has become the crucial therapy for broken-down anastomosis. The hypothesis is that despite suffering a severe complication, the subjective swallow function is not impaired in patients treated by EVT after an anastomotic leak, compared to patients without AL.

Detailed description: The investigators will select patients after oesophagectomy and perform a structured interview regarding their quality of life and subjective swallow function. Results will be compared according to defined subgroups, especially patients with and without anastomotic leak.

Eligibility criteria: Inclusion Criteria:

* Patients who received an Ivor Lewis Oesophagectomy with reconstruction due to any reason
* Patients older than 18 years

Exclusion Criteria:

* Patients with achalasia
* inability to understand study procedure or to provide informed consent

Primary outcomes:
measure: Swallow function by questionnaires: Sydney Swallow Questionnaire (SSQ)
timeFrame: earliest 6 months postoperatively
measure: Swallow function by questionnaires: Eckardt Score (ES)
timeFrame: earliest 6 months postoperatively
measure: Swallow function by questionnaires: Brief Esophageal Dysphagia Questionnaire (BEDQ)
timeFrame: earliest 6 months postoperatively
Secondary outcomes:
measure: Quality of life by questionnaires EORTC-C30 (European Organisation for Research and Treatment of Cancer-Cancer 30)
timeFrame: earliest 6 months postoperatively
measure: Quality of life by questionnaires EORTC-OG25 (Oesophagogastric-25)
timeFrame: earliest 6 months postoperatively
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Stadtspital Zurich, Triemli
state: ZH
Study officials:
affiliation: Stadtspital Zurich
name: Stefan Gutknecht, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00501033: A Prospective Comparative Study of Induction of Labor With a Cervical Ripening Double Balloon vs Foley Catheter
Official title: A Prospective Comparative Study of Induction of Labor With a Cervical Ripening Double Balloon vs Foley Catheter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Induction of Labor
Cesarean
Endometritis
Keywords: Induction of labor
Cesarean
Endometritis
Foley
Infections
Lead sponsor: Western Galilee Hospital-Nahariya
Sponsor class: OTHER_GOV
First posted: 2007-07-13
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hypothesis: The induction of labor in patients with unfavorable Bishop score is a challenging obstetrical process, and may be influenced or complicated by the cervical ripening method used. We will conduct a comparative study of the foley catheter vs the cervical ripening double balloon (Cook medical, GPN: G48149). We will compare the failure rates, cesarean section rate, infections and postpartum complications, especially endometritis.

Detailed description: We will conduct a comparative study of the foley catheter vs the cervical ripening double balloon (Cook medical, GPN: G48149). We will compare the failure rates, cesarean section rate, infections and postpartum complications, especially endometritis. The study will include 200 parturients, 100 primiparous and 100 multiparous women. We will randomize each group to induction with the foley catheter or the cervical ripening double balloon. We will compare the failure rates, cesarean section rate, infectious and other postpartum complications, especially endometritis.

Eligibility criteria: Inclusion Criteria:

* Term pregnancy
* Parturients candidates for mechanical induction of labor

Exclusion Criteria:

* Suspected amnionitis
* Vaginal discharge
* Pre induction pyrexia
* Immunocompromised parturients

Primary outcomes:
measure: Success of labor induction
timeFrame: Postpartum period
Secondary outcomes:
measure: Postpartum endometritis rate
timeFrame: The postpartum period
measure: Cesarean section rate
timeFrame: Delivery
Other outcomes:
Locations:
city: Nahariya
country: Israel
facility: Western Galilee Hospital
Study officials:
affiliation: Western Galilee Hospital
name: Ido Solt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Solt I, Frank Wolf M, Ben-Haroush S, Kaminskyi S, Ophir E, Bornstein J. Foley catheter versus cervical double balloon for labor induction: a prospective randomized study. J Matern Fetal Neonatal Med. 2021 Apr;34(7):1034-1041. doi: 10.1080/14767058.2019.1623776. Epub 2019 Jun 11.