louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02651857: Exploratory Study of Upper and Lower Endoscopic Fuse System
Official title: Exploratory Study of Upper and Lower Endoscopic Fuse System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Diseases
Lead sponsor: EndoChoice Inc.
Sponsor class: INDUSTRY
First posted: 2016-01-11
Enrollment: 1000
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: OTHER

Brief summary: Single-Center, Exploratory Study of EndoChoice's Upper and Lower Gastrointestinal Endoscopic Systems Utilizing EndoChoice's Full Spectrum Optical Technology

Detailed description: The investigational devices are EndoChoice gastrointestinal endoscopic systems that are similar in their fit, form, and functions to the corresponding commercially available models with the exception of the EndoChoice's proprietary Optical system that enhances their field of view.

Eligibility criteria: Inclusion Criteria:

* Male and Female patients ages of 18-75
* The patient has been scheduled for routine screening upper or lower endoscopy, diagnostic endoscopic work up, or endoscopic surveillance.
* Signed informed consent form

Exclusion Criteria:

* Patients who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the patient's participation in this study.
* Patients who are unable to consent
* Pregnant female patients of any age.

Primary outcomes:
measure: Performance, usability and ease of use (performance questionnaire)
timeFrame: Through study completion, estimate average of 1 year
Secondary outcomes:
measure: Safety (adverse and severe adverse events)
timeFrame: Through study completion, estimate average of 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02670057: Sphenopalatine Ganglion Block to Treat Shoulder Pain During and/or After Cesarean
Official title: Sphenopalatine Ganglion Block to Treat Shoulder Pain During and/or After Cesarean
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ipsilateral Shoulder Pain
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-02-01
Enrollment: 117
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this open label pilot study is to evaluate the utility of sphenopalatine ganglion (SPG) block to manage ipsilateral shoulder pain (ISP) during and/or after cesarean.

Detailed description: Shoulder pain thought to be caused by blood and amniotic fluid irritation of the diaphragm and nerves that supply the shoulder, can occur during and/or after a cesarean. Investigators will consent 100 patients, and will enroll 10 patients who develop ISP and have a score of is \>5/10 on the Verbal Analog pain Scale (VAS). Patients will be their own controls. Transnasal SPG block will be performed after childbirth, and and beginning at 20 minutes post treatment, the patient will be asked to rate their shoulder pain using the VAS a number of times.

Eligibility criteria: Inclusion Criteria:

* Cesarean
* Presence of post-operative ISP, VAS \>5/10
* American Society of Anesthesiologists Class 1 - 3.
* No allergy to lidocaine

Exclusion Criteria:

* American Society of Anesthesiologists Class 4 or 5.
* Allergy to lidocaine
* Nasal pathology (e.g., deviated septum)
* Patients who receive sedatives during cesarean
* Bleeding diathesis
* Any patient who the PI feels will be unable to comply with all protocol related procedures
* Shoulder pain prior to cesarean

Primary outcomes:
measure: Reduction of shoulder pain measured using Verbal Analog pain Scale (VAS)
timeFrame: 90 Minutes
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York University Medical School
name: Gilbert Grant
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06155357: A Study of a Lifestyle Program on Recurrent Atrial Fibrillation
Official title: Pre-habilitation Multicomponent Lifestyle Program for Patients Undergoing Ablation for Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-12-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to examine the impact of a comprehensive lifestyle intervention, including cardiac rehabilitation, prior to catheter ablation (a procedure to stop abnormal electrical signals in the heart), on Atrial Fibrillation (AF)-related symptoms.


Eligibility criteria: Inclusion Criteria:

* Paroxysmal or persistent atrial fibrillation.
* Planned elective catheter ablation of AF.

Exclusion Criteria:

* Prior catheter ablation.
* Presence of pacemaker/ICD.
* Longstanding persistent AF.
* Uncontrolled AF (including poor rate control or tachycardia-mediated cardiomyopathy requiring urgent cardioversion/ablation at the clinician's assessment).

Primary outcomes:
measure: Number of Cardiac Rehab Sessions Attended
timeFrame: 12 weeks
Secondary outcomes:
measure: Number of subjects with Atrial Fibrillation (AF) recurrence
timeFrame: 1 year
measure: Change in weight loss
timeFrame: Baseline, 12 weeks
measure: Change in exercise capacity
timeFrame: Baseline, 12 weeks
measure: Change in Atrial Fibrillation (AF) Symptom severity
timeFrame: Baseline, 12 weeks, 6 months, 1 year
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Amanda Bonikowske
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05540457: Evaluation of Non-Invasive Continuous vs Intermittent BloodPressure Monitors in Maintenance Dialysis (BP Dialysis)
Official title: Evaluation of Non-Invasive Continuous vs Intermittent BloodPressure Monitors in Maintenance Dialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease
End Stage Renal Disease on Dialysis
Dialysis Hypotension
Dialysis Induced Hypertension
Keywords: Tablo
Outset Medical, Inc.
Caretaker Medical, LLC
VitalStream
ESKD
Lead sponsor: The Rogosin Institute
Sponsor class: OTHER
Collaborators: name: Outset Medical
name: CareTaker Medical LLC
First posted: 2022-09-14
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Prospective, single center, open label, non-randomized, post-market study of the Tablo Hemodialysis System and VitalStream Monitor in participants with End-Stage KidneyDisease undergoing In-Center Hemodialysis.


Eligibility criteria: Inclusion Criteria:

* Participant is at least 18 years of age and has provided informed consent and has signed a Health Insurance Portability and Accountability Act of 1996 (HIPAA) compliant authorization statement.
* Participant weighs ≥ 34kg.
* Participant has end stage kidney disease (ESKD) adequately treated by maintenance dialysis.

Exclusion Criteria:

* Participant has lack of perfusion of the digitalarteries and arterioles in the lower arm and hand.
* The Non-Invasive Blood Pressure (NIPB) monitorcuffs (finger and/or brachial) are unable to becorrectly sized to the participant.

Primary outcomes:
measure: Non-invasive Blood Pressure Monitor (NIPB) Measurements
timeFrame: 7 days from start of participation
Secondary outcomes:
measure: Intradialytic Blood Pressure Events
timeFrame: 7 days from start of participation
measure: Participant Preference for the Non-invasive Blood Pressure Monitor (NIPB)
timeFrame: 7 days from start of participation
Other outcomes:
Locations:
city: New York
country: United States
facility: The Rogosin Institute
state: New York
Study officials:
affiliation: The Rogosin Institute, Inc.
name: Frank Liu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05073757: Prospective Study to Evaluate the Performance and Safety of Personalized Implants in Cranio-Maxillofacial (CMF) Surgery Indicated for Orthognathic Surgery
Official title: Prospective Study to Evaluate the Performance and Safety of Personalized Implants in Cranio-Maxillofacial (CMF) Surgery Indicated for Orthognathic Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Surgery
Orthognathic Surgery
Orthognathic Surgical Procedures
Keywords: orthognatic surgery
guided surgery
3D printing
plate
screw
personnalized
Lead sponsor: Global D
Sponsor class: INDUSTRY
First posted: 2021-10-11
Enrollment: 56
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Orthognatic surgery male or female patients, adults or minors whose bone maturity is sufficient according to the judgment of the investigator.

Brief summary: With the digital age, guided surgery and cases of fully computer-assisted surgeries via 3D printing guides and preformed plates are booming.

Our project aims to study the performance and safety of personalized implants (personalized guides and plates) in orthognathic surgery in order to obtain specific clinical data on SLS France devices.


Eligibility criteria: Inclusion Criteria:

* Male or female patient, adult or minor having reached bone maturity according to the judgment of the investigator,
* Patient having first orthognathic surgery with SLS France personalized guides and plates,
* Patient who received orthodontic treatment prior to orthognathic surgery,
* Patient able to read, understand and answer the study quality of life questionnaire,
* Patient (and legal representative if a minor) who is not opposed to his participation in the study or to the processing of his data.
* Patient affiliated to a social insurance

Exclusion Criteria:

* Patient allergic to one of the compounds of the plates and / or guides,
* Patient with physical or mental disability making it impossible to follow up in the study,
* Patient with significant expansion
* Patient with a congenital craniofacial malformation
* Patient with acute or chronic local or systemic infection,
* Person placed under legal protection,
* Pregnant or breastfeeding women.

Primary outcomes:
measure: Orthognatic quality of life questionnaire
timeFrame: 12 months post-operatively
Secondary outcomes:
Other outcomes:
Locations:
city: Tournai
country: Belgium
facility: Cabinet chirurgie Maxillo-faciale
city: Lyon
country: France
facility: Cabinet Orhognatic
city: Villefranche sur Saône
country: France
facility: Hôpital Villefranche sur Sâone
Study officials:
References:
Clinical trial NCT06020157: Comparison of Simple and Continuous Suture Techniques in Oral Surgery
Official title: Comparison of Simple and Continuous Suture Techniques in Oral Surgery Regarding Wound Healing, a Split-Mouth Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound Heal
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2023-08-31
Enrollment: 34
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to compare two different suture techniques regarding wound healing. In this research, which is designed as a prospective study, a comparison of simple and locked continuous suture techniques will be done. For this purpose, Selçuk University Faculty of Dentistry, Department of Oral and Maxillofacial Surgery, being treated at the full arch flap opened (for alveoplasty). Half of the arch will be closed by a simple suture. The other half will be closed by continuous suture technique.

It is planned to evaluate wound healing with the Landry Healing Index and Early Wound Healing Score. It is planned to measure the amount of knot looseness in millimeters on the 7th day when the sutures will be removed. On the 7th day, it is planned to evaluate the suture removal pain for the patient and the ease of suture removal for the operator with the VAS scale. Data collected from these assessments will be statistically compared for simple and continuous sutures.


Eligibility criteria: Inclusion Criteria:

* Needing full arch alveoplasty
* No smoking

Exclusion Criteria:

* Uncontrolled systemic condition
* Not participating in control appointments
* Complications about wound healing

Primary outcomes:
measure: Early Wound Healing Score-1
timeFrame: Day 1
measure: Early Wound Healing Score-3
timeFrame: Day 3
measure: Early Wound Healing Score-7
timeFrame: Day 7
measure: Suturing Time
timeFrame: 1 minutes after ending suture
measure: Pain at Suture Removal
timeFrame: Day 7
measure: Suture Removal Difficulty
timeFrame: Day 7
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selcuk University, Dentistry Faculty
state: Selçuklu
Study officials:
affiliation: Selcuk University, Faculty of Dentistry
name: Şeyma Koyuncu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02116257: The Opioid-sparing Effect and Reduced PONV Using Propacetamol in PCA Among Patients With High Risk of PONV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PONV
Propacetamol
Keywords: Nausea
Vomiting
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-04-16
Enrollment: 108
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: While Patient-controlled analgesia (PCA) has the advantage of effectively reducing the degree of postoperative pain, it can also affect the patient's outcome by several adverse effects such as postoperative nausea and vomiting (PONV). Especially for high risk group of patients for PONV, the ideal regimen for sufficient analgesia with minimal adverse effect needs to be sought. Propacetamol is known for its effective, rapid analgesia, opioid-sparing effect, and is used widely for post operative pain management. This study aims to see the opioid-sparing effect and the degree of PONV when propacetamol is added to PCA for high risk PONV patients.


Eligibility criteria: Inclusion Criteria:

1. Patients scheduled for either 1-2 level spine fusion or laminectomy
2. ASA (American Society of Anesthesiology) physical status 1 or 2
3. Non-smoking female patients, between the age 20 and 65

Exclusion Criteria:

1. Administration of any anti-emetic agents within 24 hours prior to surgery
2. Administration of any opioid agents within 7 days prior to surgery
3. Regular administration of any steroid agents
4. Drug or alcohol-abuser
5. Patients with bowel movement disorder, liver or renal impairment, insulin-dependent diabetes. Patients who are pregnant, illiterate, or foreign.
6. Patients administered to Intensive Care Unit after surgery

Primary outcomes:
measure: Incidence of PONV
timeFrame: from immediate postop to 24 hours after the surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
Clinical trial NCT02668757: HeartHab, Can a Patient-tailored Application Support Coronary Artery Disease Patients During Rehabilitation?
Official title: Pilot Study, How the HeartHab Application Can Support Coronary Artery Disease Patients in Their Rehabilitation Program?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Hasselt University
Sponsor class: OTHER
First posted: 2016-01-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The HeartHab study is a pilot trial in which coronary artery disease patients (n = 15-30) are given the HeartHab application. The HeartHab application is a smarthphone based mobile application that serves as a secondary prevention tool, to support cardiac patients after their phase II cardiac rehabilitation program. During study period (4-6 weeks), participating patients will be asked to use the application. HeartHab includes a module devoted to therapy compliance, one to exercise training prescription and one to risk factor control. HeartHab aims to motivate the patient to improve his/her self-management skills and hence decrease cardiovascular morbidity (and mortality).

Motivational aspects and usability data will be collected during study period by means of app logs and/or questionnaires/interviews.


Eligibility criteria: Inclusion Criteria:

* Patients with coronary artery disease for which they received a percutaneous coronary intervention, coronary artery bypass grafting or drugs only.
* Patients that have completed the standard cardiac rehabilitation program
* Patients who have access to a computer and a WiFi internet connection
* Patients that are able to go to the rehabilitation centre ReGo of Jessa Hospital
* Patients who signed the informed consent document

Exclusion Criteria:

* Patients with a history of VF, sustained VT and/or supraventricular tachycardia during the last 6 months before enrollment.
* Patients who due to cognitive, neurological and/or musculoskeletal constraints are unable to ride a bicycle.
* Patients with a pacemaker or defibrillator.
* Non-Dutch speaking patients
* Patients who simultaneously participate in another study

Primary outcomes:
measure: Impact on motivation
timeFrame: week 6
Secondary outcomes:
measure: Usability of the HeartHab application
timeFrame: week 6
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
Study officials:
affiliation: paul.dendale@jessazh.be
name: Paul Dendale, Prof. dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01233557: Biomarkers of Bone Resorption in Metastatic Prostate Cancer
Official title: Measurement of Biomarkers of Bone Resorption in Patients With Hormone Sensitive Bone Metastases From Prostate Cancer Treated With Antiandrogen Therapy and Bisphosphonates
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Prostate Cancer
Lead sponsor: University of Aberdeen
Sponsor class: OTHER
First posted: 2010-11-03
Enrollment: 40
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: men with hormone sensitive prostate cancer with bone metastases

Brief summary: Biomarkers of bone resorption will be measured in the blood of patients with bone metastases from prostate cancer during the course of their illness. Changes in these biomarkers will be correlated with the patient's treatment with antiandrogen therapy and bisphosphonates and the response and/or progression of their cancer. It is hoped that serial measurement of these biomarkers may allow therapeutic monitoring in the future with successful individualisation of bisphosphonate therapy for metastatic prostate cancer.


Eligibility criteria: Inclusion Criteria:

* prostate cancer with bone metastases
* hormone sensitive

Exclusion Criteria:

* inadequate renal function
* ongoing dental problems
* previous bisphosphonate therapy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
Study officials:
affiliation: NHS Grampian
name: Donald Bissett, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06182657: The Prognostic Value of the Degree of Pathological Response of Induction Chemotherapy for NPC
Official title: The Prognostic Value of the Degree of Pathological Response at One Cycle of Induction Chemotherapy for Locally Advanced Nasopharyngeal Carcinon-a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Nasopharyngeal Carcinoma
Pathologic Complete Response
Tumor Microenvironment
Lead sponsor: Jiangxi Provincial Cancer Hospital
Sponsor class: OTHER
First posted: 2023-12-27
Enrollment: 300
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 biopsy proven stage III-IVA NPC (according to the 8th edition of Union for International Cancer Control stage classification).

Brief summary: This study aims to explore the prognostic value of pathological remission after one cycle of induction chemotherapy in locally advanced nasopharyngeal carcinoma, and the change of immune micro-environment after one cycle induction chemotherapy, including the density of immune cells infiltration and tertiary lymphoid structures.


Eligibility criteria: Inclusion Criteria:

1. Ability to sign informed consent
2. Age \> 18 years at time of study entry
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (amend based on specific study)
4. Histological confirmation of NPC (regardless if EBER positive or negative)
5. Locally advanced NPC, UICC stage III-IVa
6. Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.

Exclusion Criteria:

1. Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study
2. Distant metastases
3. Prior systemic anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, radiotherapy, biologic therapy, tumour embolization, monoclonal antibodies) of the locally advanced NPC.
4. History of another primary malignancy
5. Female patients who are pregnant
6. Known allergy or hypersensitivity to any drugs
7. Judgment by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements.

Primary outcomes:
measure: Progress-free survival (PFS)
timeFrame: 3 years
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: 3 years
measure: Distant metastasis-free survival (DMFS)
timeFrame: 3 years
measure: Pathological complete response (pCR) rate
timeFrame: At the end of Cycle 1 (each cycle is 21 days).
measure: Infiltrating Immune cell density
timeFrame: At the end of Cycle 1 (each cycle is 21 days).
Other outcomes:
Locations:
city: Nanchang
country: China
facility: Jingao Li
state: Jiangxi
Study officials:
affiliation: Jiangxi Provincial Cancer Hospital
name: Jingao Li, PhD
role: PRINCIPAL_INVESTIGATOR
References: