louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05616104: FLEX FIRST Registry Research Protocol
Official title: FLEX FIRST Registry Research Protocol
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Arteriovenous Fistula
Arteriovenous Graft
Fistula
Arterial Occlusive Diseases
Lead sponsor: VentureMed Group Inc.
Sponsor class: INDUSTRY
First posted: 2022-11-15
Enrollment: 400
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: Subjects with AVF/AVG stenosis who are eligible for FLEX/Angioplasty treatment

Brief summary: Prospective, observational study evaluating the clinical use and outcomes of the FLEX Vessel Prep (VP) system in arteriovenous fistulae or grafts presenting with clinical or hemodynamic abnormalities following 12 months post treatment.

Detailed description: Prospective, observational study evaluating the clinical use and outcomes of the FLEX Vessel Prep (VP) system in arteriovenous fistulae or grafts presenting with clinical or hemodynamic abnormalities in real-world subjects per the Institution's standard practice and at 1-, 6-, and 12-months following treatment.

Eligibility criteria: Inclusion Criteria:

1. Subject is ≥18 years of age.
2. Subject is currently scheduled to undergo an endovascular intervention of arteriovenous fistula or graft due to clinical and hemodynamic abnormalities meeting the KDOQI Guidelines for AV access dysfunction:

   * Elevated venous pressure during hemodialysis,
   * Abnormal physical findings, and
   * Unexplained decrease in delivered dialysis dose.
3. Subject has a reasonable expectation of remaining on hemodialysis for ≥12 months.
4. Subject is legally competent, informed of the study, voluntarily agrees to participate, and signs the informed consent form.
5. Subject understands the study and is willing and able to comply with the follow-up requirements.

Exclusion Criteria:

1. Subject has a known or suspected systemic infection.
2. Subject has a known or suspected infection of the hemodialysis graft.
3. Subject has an untreatable allergy to radiographic contrast material.
4. In the opinion of the operating physician, the subject's hemodialysis access is unsuitable for endovascular treatment.

Primary outcomes:
measure: Target Lesion Primary Patency Rate
timeFrame: 6 months post procedure
measure: Serious Adverse Event Rate
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Open Access Vascular Access
state: Florida
city: New Brighton
country: United States
facility: Minneapolis Vascular Surgery Center
state: Minnesota
city: Orangeburg
country: United States
facility: Dialysis Access Institute
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Regional Health
state: South Carolina
Study officials:
References:
Clinical trial NCT01517204: The Efficacy of Trachway (R) Intubating Stylet in the Insertion of the Double Lumen Endobronchial Tube
Official title: The Comparison of Direct Laryngoscope and Trachway (R) Intubating Stylet in the Insertion of the Double Lumen Endobronchial Tube
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia Intubation Complications
Keywords: Trachway(R) intubating stylet
Left sided double lumen endobronchial tube
Efficacy
Intubation complication
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2012-01-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effects of Trachway(R) compared with direct laryngoscope in tracheal intubation of double-lumen endobronchial tube.

Detailed description: Intubation with the double-lumen endobronchial tube (DLT) remains a great challenge for anesthesiologists. Although new upper airway devices, such as Trachway (R), a video-assisted intubating stylet, had been developed for facilitating airway management.

The larger size and the complexity of DLT than single-lumen tube (SLT) makes the difficulties for DLT intubation. Therefore, the investigators designed this study to investigate the effects of Trachway(R)compared with direct laryngoscope in DLT intubation.

Eligibility criteria: Inclusion Criteria:

1. patients with American Society of Anesthesiologists physical status I-III
2. More than 18 years of age
3. Requiring DLT for thoracic surgery

Exclusion Criteria:

1. risk of regurgitation and pulmonary aspiration
2. history of gastroesophageal reflux, pregnancy
3. scheduled tracheostomy and postoperative prolonged ventilation in ICU
4. patients with limited neck extension (\< 35°)
5. a distance between the tip of the patient's mandible and hyoid bone of less than 7 cm
6. a sternomental distance of less than 12.5 cm with the head fully extended
7. mouth can not open

Primary outcomes:
measure: Main outcome measure is the successful rate of the first intubation
timeFrame: 12 month
Secondary outcomes:
measure: The outcome measure is the time needed to insert the DLT
timeFrame: 12 months
measure: The outcome measure is mean blood pressure (MAP) during intubation period
timeFrame: 12 months
measure: The outcome measure is the heart rate (HR) during intubation period
timeFrame: 12 months
measure: The outcome measure is the incidence of hypoxemia.
timeFrame: 12 months
measure: The outcome measure is the incidence of sore throat.
timeFrame: 12 months
measure: The outcome measure is the incidence of hoarseness.
timeFrame: 12 months
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: department of anesthesia, Kaohsiung medical university memorial hospital
Study officials:
affiliation: Department of anesthesia, Kaoshiung medical university hospital
name: Hung-Te Hsu, VS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06264804: Risk Factors for Progressive Suction Loss in Corneal Refractive Surgery
Official title: Analysis of Factors Associated With Threatened Aspiration in Patients Undergoing Small-incision Lenticule Extraction (SMILE) : Prospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Refractive Surgery
Lead sponsor: Second Affiliated Hospital of Nanchang University
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all

Brief summary: The goal of this Prospective observational studiesis to Characteristics of progressive suction loss.

Detailed description: The goal of this Prospective observational studiesis to Characteristics of progressive suction loss. The main question\[s\] it aims to answer are: • Characteristics of people who do not develop progressive aspiration Characteristics of people with progressive aspiration Participants will The differences between the two groups were compared

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years;
2. Stable refractive state in the last 2 years, with yearly change in refractive power ≤ 0.50 D;
3. Spherical power ≤ -10.00D, cylindrical power ≤ -3.00 D;
4. Best Corrected Visual Acuity (BCVA) ≥ 16/20;
5. No use of corneal contact lenses two weeks before surgery.

Exclusion Criteria:

1. Eye diseases or histories beyond myopia and astigmatism, such as keratoconus;
2. Previous eye surgeries or histories of systemic illnesses;
3. Severe mental disorders like generalized anxiety disorder, panic disorder, depression, psychosis, and bipolar disorder, impeding cooperation with the doctor.

Primary outcomes:
measure: Identify risk factors for progressive suction loss
timeFrame: 2024-12-01
Secondary outcomes:
Other outcomes:
Locations:
city: Nanchang
country: China
facility: Yuyifeng
state: Jiangxi
Study officials:
affiliation: Second Affiliated Hospital of Nanchang University
name: yifeng yu
role: STUDY_DIRECTOR
References:
Clinical trial NCT02039804: Sodium Hyaluronate Injection and Corticosteroids in Trochanteric Bursitis: a Randomized Controlled Study.
Official title: Sodium Hyaluronate Injection and Corticosteroids in Trochanteric Bursitis: a Randomized Controlled Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Osteoarthritis
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2014-01-20
Enrollment: 30
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: TREATMENT

Brief summary: Trochanteric pain can be caused by osteoarthritis of the hip, fracture, tendinitis, nerve pathology and trochanteric bursitis. Trochanteric bursitis is often seen at the outpatient clinic and is characterized by chronic lateral hip pain in the vicinity of the trochanter major, overlying the lateral aspect of the hip. When pain is persistent after conventional therapies, anesthetic and corticosteroid (CS) injections can provide short term to intermediate relief of pain, but relapse is common. Only one retrospective study showed the efficacy of intra-bursal trochanteric injections with HA and CS. They concluded that the pain release is significant with large effect sizes for both treatment. However, the efficacy of CS appeared to be short lived and it was shown that the efficacy of HA at 6 and 12 months is significant compared to CS (p\<0.05).

In this study we want to compare the efficacy of corticosteroids and hyaluronic acid in the treatment of trochanteric bursitis.

Detailed description: See brief summary

Eligibility criteria: Inclusion Criteria:

* Male or female, 18 years and older, but \<75 years;
* VAS for pain \> 30mm;
* Diagnosis of trochanteric bursitis as suggested by Brinks et al with symptoms for more than 3 months (3);
* Failure of conservative therapy of more than one month;
* Written informed consent;
* Available for the duration of the investigation.

Exclusion Criteria:

* Previous surgery in the same region;
* Current other problem(s) in the affected extremity;
* Diabetes mellitus;
* Patient who received a local (CS) injection within 3 months from the baseline visit;
* Allergic or hypersensitive to CS or HA;
* Patients suffering (chronic) low back pain with or without sciatic pain;
* Patients with radiographic signs of moderate or severe hip osteoarthritis (Kellgren and Lawrence \>1);
* Pregnant or lactating, or woman of childbearing potential not willing to use an acceptable method of contraception during the study.

Primary outcomes:
measure: VAS for pain
timeFrame: 26 weeks after administration
Secondary outcomes:
measure: Harris Hip Score
timeFrame: 6, 12, 26 weeks
measure: VAS for pain
timeFrame: 6 and 12 weeks after administration
Other outcomes:
measure: Patient's Global Assessment of Normal Function/Activity
timeFrame: 6, 12, 26 weeks
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Sascha Colen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00472004: Study Comparing 17B Estradiol/TMG CC 1mg Vs. Tibolone In Postmenopausal Women
Official title: A Prospective, Randomized, Open Label Study To Compare The Efficacy, Safety And Tolerability Of 17-B Estradiol/Trimegestone CC 1 Mg (Totelle) And Tibolone (Livial) In Postmenopausal Women.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vasomotor Symptoms
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-05-10
Enrollment: 204
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase IV prospective, randomized, open label, comparative, multicenter study in generally healthy postmenopausal women receiving Totelle (17B Estradiol/TMG CC (1mg)) and Livial (Tibolone).


Eligibility criteria: Inclusion Criteria:

* Generally healthy postmenopausal women
* Last natural (without exogenous hormone therapy) menstrual cycle completed at least 12 consecutive months prior to screening and without any other kind of gynecological bleeding during this same period
* At least 1 year of natural occurring amenorrhea

Exclusion Criteria:

* Known or suspected estrogen-dependent neoplasia
* Endometrial hyperplasia
* Any malignancy with the exception of a history of basal cell carcinoma of the skin

Primary outcomes:
measure: Decreased of Vasomotor Symptoms [from baseline to six and twelve months]
timeFrame: 1 year
Secondary outcomes:
measure: Changes in Body Weight (from baseline to six and twelve months)
timeFrame: 1 year
measure: Quality of Life (from baseline to six and twelve months)
timeFrame: 1 year
measure: Treatment Adherence (from baseline to six and twelve months)
timeFrame: 1 year
measure: Breast Tenderness (from baseline to six and twelve months)
timeFrame: 1 year
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Pfizer Investigational Site
state: Nuevo Leon
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05233904: DART: Diagnostic-CT-Enabled Planning: A Randomized Trial in Palliative Radiation Therapy
Official title: DART: Diagnostic-CT-Enabled Planning: A Randomized Trial in Palliative Radiation Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Advanced Cancer Requiring Palliative Radiation
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2022-02-10
Enrollment: 33
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 objective of this trial is to assess the efficacy, acceptability, and scalability of diagnostic-CT-enabled planning, compared to conventional CT simulation planning.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Able to provide informed consent
* Patient has consented to PRT to bone/soft tissue metastases or primary targets in the thorax, abdomen, or pelvis and RO will use simple planning techniques (i.e. parallel-opposed pair or direct field beam arrangement)
* Patient will be scheduled for same-day simulation and treatment (if randomized to Arm 1)
* Patient has a pre-existing and recent (i.e. within 4 weeks of time of enrollment) diagnostic CT or CT-fused scan with full visualization of the region-of-interest which has been acquired from an approved diagnostic scanner
* Patient positioning scan is deemed acceptable and reproducible (e.g., patient is lying supine and relatively flat, there is no/minimal motion blur, ect.)
* Intravenous (IV)/oral contrast in the region-of-interest is permitted as long as it does not create artifact which obscured the target volume (density override calculations may be required)

Exclusion Criteria:

* Any contraindication to receiving radiation
* Oncologic emergencies and/or on-call cases
* Pregnant or lactating women
* Cases requiring composite dosimetric planning to account for previous radiotherapy or extended distance set-up

Primary outcomes:
measure: Time in Centre (TIC) on Treatment Day
timeFrame: 1 Treatment Day
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: London Health Sciences Centre, Lawson Health Research Institute
name: David Palma, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06358404: Developing a Peer Support Intervention for Depression in SCD
Official title: Developing a Peer Support Intervention for Depression in SCD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Subjective Cognitive Decline
Depression in Old Age
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2024-04-10
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to assess the feasibility, acceptability, and fidelity of an 8-week intervention where peer coaches will deliver depression care to adults 60 years of age or older who have depression and subjective cognitive decline.

Detailed description: With support from the MADRC ORE Core, we will recruit 30 community-dwelling older adults to conduct an open pilot study of PeersCOG. Trained and supervised peer coaches will deliver depression care to adults 60 years of age and older with depression and subjective cognitive decline in an 8-week intervention using video chats and texts. We will use mixed methods to assess feasibility, acceptability, and fidelity. We will use validated instruments to assess the preliminary outcomes, including depression, SCD, functioning, and social factors at baseline, 8 weeks, and 3 months, and we will conduct post-intervention interviews with stakeholders at 8 weeks. Older adult participants will be asked to name a study partner who will support the older adult throughout the study in terms of study enrollment. They may also have additional perspectives on the impact of impaired cognition and depression on daily living and related needs. The older adult will not be excluded if the study partner is not available.

Eligibility criteria: Inclusion Criteria:

* Older adults aged 60+
* Endorse subjective cognitive decline
* Endorse depressive symptoms
* not currently experiencing suicidal ideation nor active, untreated manic, psychotic, or substance use disorder
* fluent in English and able to give informed consent

Exclusion Criteria:

* Meets diagnostic criteria for mild cognitive impairment or Alzheimer's dementia
* Meets diagnostic criteria for a current major depressive disorder
* have a history of neurological and psychiatric comorbidities such as major depressive disorder in the past 12 months

Primary outcomes:
measure: Feasibility of Intervention
timeFrame: Measured at baseline enrollment
measure: Acceptability of Intervention
timeFrame: Measured during intervention (8 weeks)
measure: Fidelity of Intervention
timeFrame: Measured during intervention (8 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT04593004: Teledermatology vs. Face-to-Face Visits in the Follow-Up of Patients With Acne
Official title: Randomized Open-Label Trial Comparing Teledermatology vs. Face-to-Face Consultation in the Follow-Up of Patients With Mild-to-Moderate Acne
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acne Vulgaris
Keywords: acne
telemedicine
teledermatology
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 stratified random allocation
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Acne vulgaris is a common cutaneous inflammatory condition of sebaceous follicles that can profoundly affect patients' quality of life, especially at a young age. In this context the use of teledermatology can potentially reduce the healthcare costs associated to traditional consultations as well as the costs related to travel and loss of school/working time for the patient, with a clear benefit for the whole community. Since 2016, the Department of Dermatology at Inselspital Hospital in Bern has a portal and a smartphone app for online advice service.

Hereby the investigators propose to explicitly investigate the efficacy of this system in reducing healthcare costs as compared to traditional face-to-face consultations, in a cohort of patients with mild-to-moderate acne vulgaris.


Eligibility criteria: Inclusion Criteria:

* Given written informed consent
* Mild-to-moderate acne as assessed by IGA scale
* Willingness and ability to adhere the study protocol

Exclusion Criteria:

* Need for systemic therapy for acne with Isotretinoin
* Inability to use the teledermatology system

Primary outcomes:
measure: Total time spent by dermatologist after baseline
timeFrame: 4 months
Secondary outcomes:
measure: Total time spent by patient after baseline
timeFrame: 4 months
measure: Acne severity improvement
timeFrame: 2, 4 and 6 months
measure: Number of therapies prescribed for acne
timeFrame: 2, 4 and 6 months
measure: Patient study satisfaction
timeFrame: 6 months
measure: Patient quality of life improvement
timeFrame: 6 months
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department of dermatology, University Hospital Inselspital, Bern
Study officials:
affiliation: Insel Gruppe AG, University Hospital Bern
name: Robert Hunger, MD
role: PRINCIPAL_INVESTIGATOR
References: