louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06353178: Building Empowerment and Coping Outcomes for CaNcer Patients, Survivors and Their Caregivers
Official title: BEACON Study: Virtual Coping Skills Groups for Cancer Patients, Survivors and Their Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Caregiving Stress
Caregiver Burnout
Survivorship
Keywords: cancer
caregiving
emotional support
psychology
Lead sponsor: Color Health, Inc.
Sponsor class: INDUSTRY
First posted: 2024-04-08
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to waitlist or intervention group. Those in intervention group will receive the peer program; those on the waitlist will receive it after being on the waitlist for 3 months.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Cancer has a psychological, emotional and social impact beyond a patient's physical health. This study examines three new online peer mental-wellness support program for cancer patients, survivors or their caregivers. Each program teaches evidence-based skills, in the context of that groups lived experience, to manage the emotional impact of cancer. This study examines the impact of that program.

Detailed description: Cancer has a psychological, emotional and social impact beyond a patient's physical health. These problems often ripple beyond the individual with the diagnosis, to their broader community, and also beyond a cancer treatment course into survivorship. As a result, there are a wide range of socioemotional needs in those who have been impacted by cancer. Further, these emotional impacts have a direct impact on morbidity and mortality of cancer. A new peer mental-wellness support program, called Color Cancer Connect (CCC) supports cancer patients, survivors and their caregivers by teaching them evidence-based skills to manage the emotional impact of cancer. This study will examine all three programs (i.e., patient, survivor, caregiver) to gather data to measure the impact of the program on emotional well-being, quality of life and health behaviors.

Eligibility criteria: Inclusion Criteria:

* Lived experience as either a current cancer patient, cancer survivor or caregiver of someone with cancer
* Adult - 18+
* Has health insurance provided by employer or union (can be dependent of person on insurance)
* Read/speak English
* Have access to internet and personal email account

Exclusion Criteria:

* Severe mental illness that is disruptive to other group members

Primary outcomes:
measure: Depression
timeFrame: Multiple time points across 8 months (waitlist; baseline, 2 months post waitlist, 3 months post waitlist, 2 months post program start, 3 months post program start) or 5 months (intervention; baseline, 2 months post program start, 3 months post program)
Secondary outcomes:
Other outcomes:
Locations:
city: Burlingame
country: United States
facility: Color Health
state: California
Study officials:
References:
Clinical trial NCT03770078: Assessment of New Enhanced Ostomy Device in Real-life Settings in Subjects Having a Stoma
Official title: Assessment of New Enhanced Ostomy Device in Real-life Settings in Subjects Having a Stoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ileostomy - Stoma
Colostomy Stoma
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2018-12-10
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study investigates the performance of a new adhesive with regard to the skin condition


Eligibility criteria: Inclusion Criteria:

* Have given written informed consent
* Have an ileostomy or a colostomy with liquid\* output (as their usual output)
* Be at least 18 years of age and have full legal capacity
* Have had their stoma for at least three months
* Be able to use products with max cut size 45 mm
* Have self-reported problems with leakage\*\* (three times within 14 days)
* Handle the Clinical App, test product and comparator product themselves
* Use a flat SenSura® Mio or a flat SenSura® with standard adhesive as their current product
* Minimum change of baseplate at least once every 3rd day
* Are willing and suitable (determined by investigator/study nurse) to use the test product and comparator without using a paste/mouldable ring during the investigation
* Are willing and suitable (determined by investigator/study nurse) to use a 1-piece product during the investigation

Exclusion Criteria:

* Are currently receiving or have within the past two months received radio-and/or chemotherapy (low doses chemotherapy are allowed for other indications than cancer, e.g. below 15 mg methotrexate for rheumatoid arthritis)
* Are currently receiving or have within the past month received topical steroid treatment in the peristomal skin area (e.g. lotion or spray) or systemic treatment\* (e.g. injection or tablets).
* Get a positive result of a pregnancy test for women of childbearing age/fertile (\*\*clarified in section 6.3.2)
* Are breast feeding
* Are participating in other interventional clinical investigations or have previously participated in this investigation

Exception:

Participation in other Coloplast in-house clinical investigations is accepted under the circumstances that the subject has paused the activities in the investigation and are otherwise complying with the inclusion and exclusion criteria of this (CP300) protocol.

- Have known hypersensitivity towards any of the products used in the investigation

Primary outcomes:
measure: Trans Epidermal Water Loss
timeFrame: Four weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: CCBR Aalborg
city: Humlebæk
country: Denmark
facility: Coloplast
city: Vejle
country: Denmark
facility: CCBR Vejle
city: Stockholm
country: Sweden
facility: KTA Prim Stockholm
Study officials:
affiliation: Consultant
name: Birte P Jakobsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03634878: Evaluation of the Position of Promontofixation Prostheses in Perineal Ultrasound
Official title: Evaluation of the Position of Promontofixation Prostheses in Perineal Ultrasound
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prolapse of the Uterus
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2018-08-17
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Indirect promontofixation with prostheses is the standard surgical technique for the reference of uterine prolapse. There is no validated examination to control the position of the prostheses postoperatively.

These prostheses are echogenic and perineal ultrasound could be a means of postoperative monitoring. There is no data in the literature on the relationship between prosthesis position and postoperative symptoms


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years of female sex
* Patient with double laparoscopic promontofixation without associated hysterectomy

Exclusion Criteria:

* History of hysterectomy
* Anterior cure (before index intervention) of prolapse with placement of prosthetic material.

Primary outcomes:
measure: Evaluate the reproducibility study of intra and interobserver measurements of the size of promontofixation prostheses
timeFrame: 10 minutes
measure: Evaluate the reproducibility study of intra and interobserver measurements position of promontofixation prostheses
timeFrame: 20 minutes
Secondary outcomes:
measure: Collect the position of the strips
timeFrame: 20 minutes
measure: Collect the symptoms of the patients
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Poitiers
country: France
facility: Chu de Poitiers
Study officials:
affiliation: Poitiers University Hospital
name: Xaviar FRITEL
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04386278: OrthoPulse Gen 2 Initial Device Evaluation and Assessment of Clinical Effectiveness (CA)
Official title: RI.2 OrthoPulse Gen 2 Initial Device Evaluation and Assessment of Clinical
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Orthodontic Tooth Movement
Lead sponsor: Biolux Research Holdings, Inc.
Sponsor class: INDUSTRY
First posted: 2020-05-13
Enrollment: 56
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Each group in this study includes a different device iteration that is being investigated in parallel.
Primary purpose: TREATMENT

Brief summary: This is a prospective, interventional, non-randomized, control, split-mouth, open-label, single centre, private practice study aimed to evaluate the effect of tooth movement during orthodontic treatment using a removeable thermoplastic orthodontic appliance. Intrusion and extrusion will be conducted using bilaterally equivalent elastomeric forces of 50 grams.

A comparison of the rate of bilateral orthodontic tooth movement will be conducted using six (6) varied photobiomodulation interventions on the maxillary (upper) and mandibular (lower) arches. The OrthoPulse Gen 2 and OrthoPulse (commercially approved) devices are being used in this clinical investigation. Each subject enrolled will go through intrusion and extrusion.

All subjects will be allocated to an OrthoPulse split-mouth intervention by the investigator.


Eligibility criteria: Inclusion Criteria:

* Patient must be 19 years of age or older
* Likely to be compliant to OrthoPulse use, aligner wear, and Dental Monitoring scanning
* Have a compatible iOS or Android device and are willing to download the OrthoPulse and Dental Monitoring apps for frequent automatic syncing of data

Exclusion Criteria:

* Patient is currently enrolled in another clinical study
* Crowding or rotations of bilateral bicuspids that would prevent or interfere with intrusion
* Periodontally involved teeth, acute oral infection or periodontal disease
* Patient has active/untreated caries
* Use of bisphosphonates at any time
* Use of drugs that may cause photosensitivity
* History of photosensitivity
* Epilepsy
* Pregnant or planning pregnancy during the study.
* Patient plans to relocate over the treatment period

Primary outcomes:
measure: The rate of orthodontic tooth movement
timeFrame: 36 days (±12 days) from T0 visit
Secondary outcomes:
measure: Peak Pain: Questionnaire
timeFrame: 7 Days
measure: Root Resorption
timeFrame: 36 days (±12 days) from T0 visit
measure: Initial Safety of Device
timeFrame: From enrolment to study completion, anticipated six (6) months
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Dr. Peter Brawn
state: B.C
Study officials:
References:
Clinical trial NCT05239078: Comparative Evaluation of Pulpal Anaesthetic Efficacy of Different Anaesthetic Solutions for Inferior Alveolar Nerve Block in Patients With Symptomatic Irreversible Pulpitis
Official title: Comparative Evaluation of Pulpal Anaesthetic Efficacy of Different Anaesthetic Solutions for Inferior Alveolar Nerve Block in Patients With Symptomatic Irreversible Pulpitis: a Randomized Double-blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulpitis
Lead sponsor: Jamia Millia Islamia
Sponsor class: OTHER
Collaborators: name: SGT DENTAL COLLEGE
First posted: 2022-02-14
Enrollment: 120
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: Pulpal and periapical inflammation and infection can cause tissue pH in the affected region to be lowered which results in less penetration of anesthetic solution in the nerve membrane and hence delays the onset of anesthesia. So, the purpose of this study was to compare the pulpal anesthetic efficacy of lidocaine, articaine, mepivacaine for inferior alveolar nerve block (IANB) in patients with irreversible pulpitis (IP). One hundred and twenty adult patients with IP concerning mandibular molars randomly received IANB with either of the three solutions: 2% lidocaine with epinephrine; 4% articaine with epinephrine; 3% plain mepivacaine. Pain during the endodontic treatment was assessed using a visual analog scale (Heft-Parker VAS). Endodontic treatment was initiated. Success was defined as no or mild pain (pain score≤54mm on Hp VAS) during access preparation and root canal instrumentation. The anesthetic success rates were analyzed with the chi-square test.


Eligibility criteria: Inclusion Criteria:

* active pain in a mandibular molar
* prolonged response to cold testing with an ice stick and an electric pulp tester
* absence of any periapical radiolucency on radiographs, except for a widened periodontal ligament
* vital coronal pulp on access opening and ability to understand the use of pain scales

Exclusion Criteria:

* known allergy, sensitivity, or contraindications to any opioid or nonopioid analgesic including aspirin or NSAIDs
* history of active peptic ulcer within the preceding 12 months
* history of bleeding problems or anticoagulant use within the last month
* patients who were pregnant or breast-feeding
* a history of known or suspected drug abuse
* patients who had taken NSAIDs within 12 h before administration of the study drugs

Primary outcomes:
measure: Anesthetic Success
timeFrame: 15 minutes after the inferior alveolar nerve block
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03809078: 68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for Biopsy Guidance in Patients With Suspected Prostate Cancer
Official title: A Pilot Study of 68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for Biopsy Guidance in Patients With Suspected Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: General Electric
First posted: 2019-01-18
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

Brief summary: The objective of the study is to evaluate 68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for biopsy guidance in patients with suspected prostate cancer.

Detailed description: Primary Objective: To evaluate 68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for biopsy guidance in patients with suspected prostate cancer.

Exploratory Objective:

* Correlation of 68Ga PSMA 11 uptake and Gleason score at biopsy
* Correlation of 68Ga RM2 and Gleason score at biopsy

Eligibility criteria: Inclusion Criteria:

* Suspected prostate cancer
* Planned prostate biopsy
* Able to provide written consent
* Karnofsky performance status of 50 (or ECOG/WHO equivalent)

Exclusion Criteria:

* Patients not capable of getting PET study due to weight, claustrophobia, or inability to lay still for the duration of the exam
* Metallic implants (contraindicated for MRI)

Primary outcomes:
measure: Number of Participants With Biopsy Results Correlated With PET Based Imaging Findings
timeFrame: Up to approximately 2 hours to complete each scan
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Andrei H Iagaru, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Duan H, Ghanouni P, Daniel B, Rosenberg J, Thong A, Kunder C, Aparici CM, Davidzon GA, Moradi F, Sonn GA, Iagaru A. A Pilot Study of 68Ga-PSMA11 and 68Ga-RM2 PET/MRI for Biopsy Guidance in Patients with Suspected Prostate Cancer. J Nucl Med. 2023 May;64(5):744-750. doi: 10.2967/jnumed.122.264448. Epub 2022 Nov 17.
Clinical trial NCT05536778: Shoulder Endurance Assessment in Upper Limb Athletes
Official title: Relation Between Different Tests Aimed to Assess Shoulder Endurance in Upper Limb Athletes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Strength and Endurance
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2022-09-13
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 28
Standard ages: ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: About 60 people, practicing an overhead sports at least 5 hours a week will be recruited for the study among the sportsclub of the Province of Liège (Belgium)

Brief summary: The objective of this study is to explore the relationship between two different "fatigue tests" (Xco Endurance Test and Shoulder Endurance Test) and strength/endurance of shoulder rotators muscles, measured with an isokinetic device.

The tests will be organized during two different sessions, in a randomized order. One session will be dedicated to isokinetic evaluation. The other one will include the performance of the two functional tests.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 28 years
* To practice an overhead sports, at least 5 hours a week

Exclusion Criteria:

* Any shoulder surgery history
* Any shoulder pain
* Any shoulder injury during the last 6 months

Primary outcomes:
measure: Shoulder rotators strength
timeFrame: through study completion, 6 months
measure: Shoulder rotators work
timeFrame: through study completion, 6 months
measure: Shoulder Endurance Test
timeFrame: through study completion, 6 months
measure: Xco Endurance Test
timeFrame: through study completion, 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Liege
country: Belgium
facility: University of Liege
state: Liège
Study officials:
References:
Clinical trial NCT01071278: Lipid Management in Clinical Practice (MK-0524A-115)
Official title: Lipid Management in Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lipid Metabolism Disorder
Keywords: Lipid metabolism disorder
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2010-02-19
Enrollment: 2390
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients in routine medical care either statutorily health insured or privately insured

Brief summary: The aim of this observational program is to generate data on the use of Tredaptive (nicotinic acid/laropiprant) for lipid management under routine medical practice conditions.


Eligibility criteria: Inclusion Criteria:

* Patients are 18 years of age or older with lipid disorder treated with nicotinic acid/laropiprant

Exclusion Criteria:

* Patient is currently participating in a clinical trial

Primary outcomes:
measure: Number of Participants With Lipid Panel Control
timeFrame: From Visit 1 entrance evaluation (Week 0) to Visit 2 (between Weeks 8-22)
Secondary outcomes:
measure: Number of Participants Who Reported Adverse Events
timeFrame: Up to 22 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02510378: Short Course Radiotherapy Combined With Chemotherapy in Stage IV Rectal Cancer With Resectable Liver Metastases
Official title: Short Course Radiotherapy Combined With Chemotherapy in Stage IV Rectal Cancer With Resectable Liver Metastases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Stage IV Rectal Cancer, Liver Metastasis, Resectable
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2015-07-29
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with rectal cancer and resectable liver metastases receive short course radiotherapy(5Gy/f x 5f) to the pelvis and XELOX consolidating chemotherapy al least 4 cycles after 2 weeks.

Detailed description: Patients with rectal cancer and resectable liver metastases receive 25 Gy in 5 fractions of 5 Gy over 5 days to the pelvis and XELOX consolidating chemotherapy (with or without target therapy) al least 4 cycles after 2 weeks.

After evaluation, patients with resectable rectal cancer and liver metastasis will undergo surgery. Those patients with unresectable lesions will receive chemotherapy.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed primary carcinoma of the rectum (Lower border of tumour ≤ 10 cm from anal verge) locally advanced stage in primary site of rectum resectable synchronous liver metastases. The decision of resectable liver metastases will be made at multidisciplinary clinical meetings.

Exclusion Criteria:

* Obstruction of the gastrointestinal tract Previously constructed stoma prior radiotherapy of the pelvis

Primary outcomes:
measure: percentage of patients undergo R0 surgery during the follow-up
timeFrame: 3 months
Secondary outcomes:
measure: The rate of early toxicity of radiotherapy according to the NCI Common Toxicity Criteria for Adverse Effects (version 3.0)
timeFrame: 3 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Dept of Radiation oncology, Cancer Hospital , Chinese Academy of Medical Science
state: Beijing
city: Beijing
country: China
facility: Cancer Hospital, CAMS
Study officials:
References:
Clinical trial NCT04908878: Combined PECS II and Transeversus Thoracic Plane Blocks Vs Serratus Anterior Plane Block in Modified Radical Mastectomy
Official title: Analgesic Efficacy of Combined Ultrasound-Guided PECS II and Transeversus Thoracic Plane Blocks Versus Ultrasound-Guided Serratus Anterior Plane Block in Modified Radical Mastectomy: A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ultrasound-Guided
Transeversus Thoracic Plane Blocks
Pectoral Nerve (PECS) Block
Serratus Anterior Plane Block
Modified Radical Mastectomy
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2021-06-01
Enrollment: 70
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the analgesic efficacy of combined ultrasound (US)-guided pectoral nerve (PECS) block II and transversus thoracic plane (TTP) block versus US-guided serratus anterior plane (SAP) block in female patients undergoing modified radical mastectomy.


Eligibility criteria: Inclusion Criteria:

* Female patients
* Aged 21-60 years
* ASA physical status I, II
* Scheduled for unilateral modified radical mastectomy

Exclusion Criteria:

1. Patient refusal.
2. Known hypersensitivity to local anesthetics.
3. Body mass index \> 35 kg /m2.
4. Uncooperative or psychiatric patients.
5. Infection at the injection site.
6. Coagulation disorder.

Primary outcomes:
measure: The total amount rescue analgesic consumption (morphine) in the first 24 hours postoperatively.
timeFrame: First 24 hours postoperatively.
Secondary outcomes:
measure: The degree of postoperative pain
timeFrame: First 24 hours postoperatively.
measure: Time to first rescue analgesia request.
timeFrame: First 24 hours postoperatively.
measure: Intraoperative fentanyl consumption.
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Faculty of Medicine Tanta University
state: Elgharbia
Study officials:
References: