louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01486836: Lumax DX / Linox DX Evaluation
Official title: Evaluation of the Lumax DX ICD and the Linox DX Lead (ICD=Implantable Cardioverter Defibrillator, DX=Extended Diagnostics)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Disease
Keywords: Cardiac disease (ICD indication)
Lead sponsor: Biotronik SE & Co. KG
Sponsor class: INDUSTRY
First posted: 2011-12-07
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with standard ICD indication who are referred to the hospital.

Brief summary: The objective of this study is to investigate the safety and efficacy of the Lumax DX / Linox DX system.

No hypothesis has been defined.


Eligibility criteria: Inclusion Criteria:

* Patient meets the indication for ICD therapy
* LVEF ≥ 30%
* Patient's compliance with protocol
* Signed patient informed consent form

Exclusion Criteria:

* Patient meets one contraindication for ICD therapy
* Permanent atrial tachyarrhythmia
* Age \< 18 years
* Cardiac surgery planned within the next 6 months
* Life expectancy of less than 6 months
* Limited contractual capability
* Participating in another clinical study of an investigational cardiac drug or device

Primary outcomes:
measure: Rate of appropriate atrial sensing
timeFrame: 3 months
measure: Rate of successfully terminated tachyarrhythmia episodes
timeFrame: 3 months
measure: Serious adverse device effect rate
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Uniklinikum Benjamin Franklin
Study officials:
References:
Clinical trial NCT00205036: Calcium DXA: Impact of Calcium Supplements on Lumbar Spine Bone Mineral Density
Official title: Impact of Calcium Supplements on Lumbar Spine Bone Mineral Density
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2005-09-20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: We, the investigators at the University of Wisconsin, hypothesized that ingesting calcium tablets prior to a spine bone density scan will not affect the bone mineral density as measured by dual energy x-ray absorptiometry (DXA).

Detailed description: We hypothesized that ingesting calcium tablets prior to a spine bone density scan will not affect the bone mineral density as measured by DXA. To test this, 36 subjects ingested various calcium supplements after a spine DXA scan and were then scanned again 15, 30 and 45 minutes after ingestion. Subsequently a subset of 15 subjects had three spine scans performed for instrument precision and subsequently ingested a calcium tablet with scans 15 and 30 minute intervals after ingestion.

Eligibility criteria: Inclusion Criteria:

* Men or women 18 years or older

Exclusion Criteria:

* Internal spinal hardware

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Neil C Binkley, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02104336: Phase 2 Study of EPI-743 in Children With Pearson Syndrome
Official title: An Open-Label Phase 2 Safety and Efficacy Study of EPI-743 (VincerinoneTM) in Children With Pearson Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pearson Syndrome
Keywords: Pearson
EPI743
EPI-743
Vincerinone
Mitochondrial disorder
Mitochondrial disease
Lead sponsor: Edison Pharmaceuticals Inc
Sponsor class: INDUSTRY
First posted: 2014-04-04
Enrollment: 2
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Treatment of Pediatric Subjects with Pearson syndrome

Detailed description: If effective, treatment with EPI-743 should result in a significant reduction in occurrence of sepsis, metabolic crisis, hepatic failure and transfusion dependence.

Eligibility criteria: Inclusion Criteria:

* Genetically confirmed diagnosis of Pearson syndrome
* Age less than 18
* Availability of medical history for 12 months prior to enrollment
* Abstention from use of CoQ10, vitamin E, lipoic acid and Idebenone 14 days prior to treatment with EPI-743

Exclusion Criteria:

* Allergy to EPI-743, sesame oil or vitamin E
* Clinical history of bleeding/ abnormal PT/PTT
* Concurrent inborn errors of metabolism
* Use of anticoagulant medications
* Participation in any interventional study within 30 days of treatment
* Use of erythropoietin 30 days prior to trial enrollment

Primary outcomes:
measure: Occurence of episodes of sepsis, metabolic crisis or hepatic faillure
timeFrame: 1 year
Secondary outcomes:
measure: Transfusion avoidance
timeFrame: 1 year
measure: Hematologic function
timeFrame: 1 year
measure: Neuromuscular function
timeFrame: 1 year
measure: Disease severity
timeFrame: 1 year
measure: Renal function
timeFrame: 1 year
measure: Hepatic function
timeFrame: 1 year
measure: Weight gain
timeFrame: 1 year
measure: Hospitalizations
timeFrame: 1 year
measure: Pancreatic function
timeFrame: 1 year
measure: Mortality
timeFrame: 1 year
Other outcomes:
measure: Number of Dose Limiting SAEs
timeFrame: 1 year
Locations:
city: Orange
country: United States
facility: Children's Hospital of Orange County
state: California
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh
state: Pennsylvania
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: Edison Pharmaceuticals
name: Matthew Klein, MD, FACS
role: STUDY_CHAIR
References:
Clinical trial NCT03453736: Staff Experiences in Robotic Theatres
Official title: A Qualitative Study of Staff Experiences and Practices Within the Robotic Theatre Setup
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Robotic Staff Experiences
Keywords: Robotic surgery
theatre staff
teamwork
patient safety
Lead sponsor: University of Leicester
Sponsor class: OTHER
First posted: 2018-03-05
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be theatre staff, from any surgical discipline, who are involved in robotic surgery practice at University Hospitals of Leicester and Cambridge University Hospital. This includes, but not limited to surgeons (primary and assistants), nurses (scrub, circulating, or student), anaesthetists (including trainees) and operating department practitioners (ODP).

Brief summary: Studies have shown that team work impacts patients safety. This is particularly the case in surgical theatres where individuals from different backgrounds (surgeon, anaesthetists, nurses, ..etc) work together to achieve a common goal which is looking after the patient. The robotic theatre set up is different due to the physical separation of the surgeon from the patient and the rest of the team. This may represent a communication challenge. The Study investigators aim to study theatre staff experiences and practices of communication and teamwork in this special setup, investigating any challenges participants may be facing and possible ways of adapting to them. Staff opinions and suggestions for improvement will be explored for utmost surgical performance and patient safety.

The study will involve two parts:1) individual staff interviews and 2) teamwork observations during real life surgery. The two parts should complement each other giving an overall picture of the teamwork in the robotic theatre setup.


Eligibility criteria: Inclusion Criteria:

1. Robotic theatre staff as above.
2. Willing and able to participate.
3. Good command of the English language.

Exclusion Criteria:

1. Theatre staff not involved in robotic surgery.
2. Participants not willing / unable to participate.
3. Staff that have not worked in a conventional theatre setup before.
4. Inability to read/speak/understand English.
5. Lack of capacity for consent.

Primary outcomes:
measure: Robotic staff experiences.
timeFrame: 1 year
measure: Robotic staff practices
timeFrame: 1 year
Secondary outcomes:
measure: Staff communication in robotic theatres.
timeFrame: 1 year
measure: Staff teamwork
timeFrame: 1 year
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester NHS Trust
Study officials:
References:
Clinical trial NCT04514536: Evaluation of a Health Monitoring Platform for Elderly in Home Care Context
Official title: Combinatorial Approach of Connected Functions for Multimodal Health Data Collection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aging
Frailty
Keywords: Health monitoring
Frailty
Home care
Home support
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
Collaborators: name: AZNetwork
name: RF-Track
name: LTSI Rennes
First posted: 2020-08-17
Enrollment: 30
Sex: ALL
Minimum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study aims at, as a primary objective, studying acceptability of elderly about a health monitoring platform for home support and home care. The secondary objective consists in studying the correlation of different health data evolution and the frailty trajectory of the subject.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 80 years old
* Living at home or in senior residence
* Evaluated as being robust according to the Fried's frailty test (0 met criteria)
* Affiliated or beneficiary of a social protection scheme
* Having given written consent

Exclusion Criteria:

* Hospitalization during the month preceding the first visit
* Subject suffering from cognitive disorders preventing proper use of the device
* Subject being unable to give by himself / herself his / her consent to participate in the trial
* Person subject to legal protection (safeguard of justice, trusteeship, guardianship, persons deprived of liberty)

Primary outcomes:
measure: Beliefs modified questionnaire
timeFrame: 1 month
measure: UTAUT modified questionnaire
timeFrame: 1 month
measure: Usability SUS questionnaire
timeFrame: 1 month
measure: Comfort modified questionnaire
timeFrame: 1 month
Secondary outcomes:
measure: Motivation modified questionnaire
timeFrame: inclusion
measure: Beliefs modified questionnaire
timeFrame: inclusion
measure: Beliefs modified questionnaire
timeFrame: 12 months
measure: Beliefs modified questionnaire
timeFrame: 24 months
measure: UTAUT modified questionnaire
timeFrame: inclusion
measure: UTAUT modified questionnaire
timeFrame: 12 months
measure: UTAUT modified questionnaire
timeFrame: 24 months
measure: Comfort modified questionnaire
timeFrame: inclusion
measure: Comfort modified questionnaire
timeFrame: 12 months
measure: Comfort modified questionnaire
timeFrame: 24 months
measure: Usability SUS questionnaire
timeFrame: inclusion
measure: Usability SUS questionnaire
timeFrame: 12 months
measure: Usability SUS questionnaire
timeFrame: 24 months
Other outcomes:
Locations:
Study officials:
affiliation: Rennes University Hospital
name: Dominique SOMME, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04827836: Pain Control and Subconjunctival Hemorrhage Size After Intravitreal Injection
Official title: Pain Control and Subconjunctival Hemorrhage Size After Intravitreal Injection Using Cooled Anesthetic Eye Drops and Antiseptics: A Double-Blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intravitreal Injection
Pain
Subconjunctival Hemorrhage
Keywords: Intravitreal injection
Pain
Subconjunctival Hemorrhage
Bevacizumab
Eye drops
Lead sponsor: Wolfson Medical Center
Sponsor class: OTHER_GOV
First posted: 2021-04-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Intravitreal injections (IVI) are the mainstay of treatment modality in many ophthalmologic diseases including neovascular age-related macular degeneration (AMD), diabetic retinopathy and retinal vascular occlusions. Patients endure monthly IVI for several years. Although standardized topical anesthesia protocols are being carried out, many still suffer from pain during and after the procedure. Previous studies at the investigators clinic have demonstrated that alpha-agonist eye drops and cool eye compresses can be successfully used in order to reduce pain levels when administered prior to IVI. In the current research, the investigators wish to study whether cooled anesthetic eye drops and antiseptics can be utilized as well to reduce the pain and subconjunctival hemorrhage caused by bevacizumab IVI.


Eligibility criteria: Inclusion Criteria:

* Participants over the age of 18 years, receiving Bevacizumab IVI who are capable of signing a written informed consent form obtained under the Declaration of Helsinki.

Exclusion Criteria:

* No consent to participate in the study.
* Incapability of signing a written informed consent form.

Primary outcomes:
measure: Participant's discomfort after intravitreal injection (IVI) as assessed by the visual analog scale (VAS) and pain sensitivity questionnaire (PSQ).
timeFrame: Minute 1
measure: Participant's discomfort after intravitreal injection (IVI) as assessed by the visual analog scale (VAS) and pain sensitivity questionnaire (PSQ).
timeFrame: Minute 10
measure: Participant's discomfort after intravitreal injection (IVI) as assessed by the visual analog scale (VAS) and pain sensitivity questionnaire (PSQ).
timeFrame: Hour 2
measure: Participant's discomfort after intravitreal injection (IVI) as assessed by the visual analog scale (VAS) and pain sensitivity questionnaire (PSQ).
timeFrame: Hour 24
Secondary outcomes:
measure: Participant's subconjunctival hemorrhage (SCH) size after intravitreal injection (IVI) as evaluated by a slit lamp examination.
timeFrame: Minute 10
Other outcomes:
Locations:
city: Holon
country: Israel
facility: Wolfson Medical Center
state: Hamerkaz
Study officials:
affiliation: Wolfson Medical Center
name: Oriel Spierer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04002336: Testing a Smart Phone App to Enhance Voice Therapy Adherence
Official title: Testing a Smart Phone App to Enhance Voice Therapy Adherence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Voice Disorders
Keywords: adherence
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2019-06-28
Enrollment: 33
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 current project is designed as phase 1 study conducted to improve/enhance normal voice. Fifteen Thirty non-treatment seeking individuals, with no identifiable vocal pathology on laryngeal examination, will be randomized to one of two groups; 1) Voice therapy delivery without App (control/standard of care), 2) Voice therapy delivery with app (experimental). Participants in both groups will attend weekly voice therapy sessions (for 6 weeks) with the PI and Co- I (Joseph Stemple). Control group participants will be provided with an audio file of the exercises, and an exercise log sheet to track progress. Experimental group participants will use the smartphone app, which allows participants to record home practice sessions in real time and upload sessions to the app server for the clinician to access and track. Three-wave surveys will be conducted at the baseline, four weeks and 6 weeks after the intervention. Other data sources include study administration, exercise logs, app data, and clinical assessment.


Eligibility criteria: Inclusion Criteria:

1. Adults \> 18 years
2. Non-smokers
3. Hearing level within normal limits
4. Absence of vocal fold pathology as confirmed by MD on laryngeal examination
5. Agree to avoid vocally abusive behaviors for the entirety of the study

Exclusion Criteria:

1. Apple phone (iOS)
2. Impaired hearing
3. Uncontrolled asthma
4. Smoking
5. H/o vocal fold surgery
6. Presence of vocal fold pathology
7. Previous history of experience with VFE performance
8. Non-English speaking participants

Primary outcomes:
measure: Adherence
timeFrame: 6 weeks
Secondary outcomes:
measure: MPT (maximum phonation time)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Vrushali Angadi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02542436: Avastin (Bevacizumab) in the Treatment of Metastatic Colorectal Cancer in Normal Clinical Use in the UK Population
Official title: An Observational Study to Investigate the Real World Effectiveness of Avastin (Bevacizumab) in the Treatment of Metastatic Colorectal Cancer in the UK
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Metastatic Colorectal Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-09-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with metastatic colorectal cancer

Brief summary: This study will focus on participants in the United Kingdom (UK) to collect local data on the effectiveness and safety of bevacizumab (Avastin) in the treatment of metastatic colorectal cancer in normal clinical use.


Eligibility criteria: Inclusion Criteria:

* Have been diagnosed with metastatic colorectal cancer (mCRC)
* Have a Performance Status (PS) of 0-2, according to the Eastern Cooperative Oncology Group (ECOG) criteria at initiation of bevacizumab treatment
* Be chemotherapy-naive at diagnosis of mCRC or have relapsed more than 12 months after receiving adjuvant chemotherapy for early stage colorectal cancer
* Have received standard fluoropyrimidine-based chemotherapy for first-line treatment of mCRC with or without bevacizumab
* Have sufficient medical records available for assessment of eligibility at the Christie Hospital National Health Service (NHS) Trust, Manchester, United Kingdom
* For Cohort 1 (post CDF funding availability): patients between 2010-2013 who received bevacizumab with first-line chemotherapy
* For Cohort 2 (pre Cancer Drugs Fund \[CDF\] funding availability): patients propensity matched to cohort 1 between 2005-2008 who did not receive bevacizumab with first-line chemotherapy

Exclusion Criteria:

* Subjects with metastatic colorectal cancer, who have received bevacizumab via a clinical trial
* Subjects with metastatic colorectal cancer, whose medical records are not complete enough to confirm eligibility for the study

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: From date of metastatic colorectal cancer diagnosis to date of death up to 3 years
Secondary outcomes:
measure: Response Rate (RR)
timeFrame: From date of metastatic colorectal cancer diagnosis to end of study up to 3 years
measure: Progression Free Survival (PFS)
timeFrame: From date of metastatic colorectal cancer diagnosis to end of study up to 3 years
measure: Percentage of Participants with Adverse Events of Special Interest
timeFrame: From date of metastatic colorectal cancer diagnosis to end of study up to 3 years
Other outcomes:
Locations:
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01684436: Safety and Efficacy of Punctal Plug Insertion in Patients With Dry Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dry Eye
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2012-09-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will access changes in tear protein levels and symptoms of dry eye following insertion of a punctal plug.


Eligibility criteria: Inclusion Criteria:

* Patients with moderate to severe dry eye

Exclusion Criteria:

* Previous punctal plug insertion in the last 3 months or presence of plugs at the time of study
* Contact lens wear in the 7 days prior to study start or during the study
* LASIK procedure in the last year
* Cataract or other eye surgery in the last 3 months
* Corneal grafts

Primary outcomes:
measure: Concentration of Tear Cytokine Levels Before Punctal Plug Insertion in the Study Eye
timeFrame: Week 0 (Baseline)
measure: Concentration of Tear Cytokine Levels Following Punctal Plug Insertion in the Study Eye
timeFrame: Week 3
Secondary outcomes:
measure: Corneal Fluorescein Staining Score in the Study Eye
timeFrame: Week 0 (Baseline), Week 3
measure: Tear Film Break-up Time (TBUT)
timeFrame: Week 0 (Baseline), Week 3
measure: Schirmer's Test Score
timeFrame: Week 0 (Baseline), Week 3
measure: Dry Eye Questionnaire Irritation Score
timeFrame: Week 0 (Baseline), Week 3
Other outcomes:
Locations:
city: Singapore
country: Singapore
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Tong L, Beuerman R, Simonyi S, Hollander DA, Stern ME. Effects of Punctal Occlusion on Clinical Signs and Symptoms and on Tear Cytokine Levels in Patients with Dry Eye. Ocul Surf. 2016 Apr;14(2):233-41. doi: 10.1016/j.jtos.2015.12.004. Epub 2016 Jan 13.