louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04914520: Study of VN-0200 in Japanese Healthy Adults and Elderly Subjects
Official title: A Phase 1 Study to Assess the Safety, Tolerability, and Immunogenicity of VN-0200 After Intramuscular Injections in Japanese Healthy Adults and Elderly Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Respiratory Syncytial Virus Infections
Keywords: Respiratory Syncytial Virus Infections
VN0200
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2021-06-04
Enrollment: 48
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will assess the safety, tolerability, and immunogenicity of VN-0200 after intramuscular injections in Japanese healthy adults and elderly subjects.


Eligibility criteria: Inclusion Criteria:

* Japanese
* Healthy adults aged ≥20 and ≤50 years (Step 1) or healthy elderly aged ≥65 and ≤80 years (at the time of informed consent)
* Body mass index (BMI) is ≥18.0 and \<30.0 kg/m\^2 (at screening)

Exclusion Criteria:

* Participants with a history of anaphylaxis or severe allergies due to food, medicine, insect bites, cosmetics, or vaccination
* Having alcohol or drug dependence, etc.

Primary outcomes:
measure: Number of Participants Reporting Treatment-emergent Adverse Events
timeFrame: From first administration through 28 days post second administration
measure: Number of Participants Reporting Local and Systemic Adverse Events
timeFrame: From first administration up to 14 days after second administration
measure: Number of Participants Reporting Serious Adverse Events
timeFrame: From date of informed consent up to approximately 3 months
Secondary outcomes:
measure: Geometric Mean Fold Rise (GMFR) of Anti-RSV Specific Neutralizing Activity
timeFrame: Day 29 and Day 57 post-dose and at the time of discontinuation (whichever occurs first), up to approximately 2 months
measure: Geometric Mean Titer (GMT) of Anti-VAGA-9001a IgG
timeFrame: Day 1 (pre-dose), Day 29 and Day 57 post-dose, and at the time of discontinuation (whichever occurs first), up to approximately 2 months
measure: Geometric Mean Titer (GMT) of Anti-RSV IgG
timeFrame: Day 1 (pre-dose), Day 29 and Day 57 post-dose, and at the time of discontinuation (whichever occurs first), up to approximately 2 months
measure: Number of IFN-γ spot-forming cells in PBMC Detected by ELISPOT
timeFrame: Day 1 (pre-dose), Day 29 and Day 57 post-dose, and at the time of discontinuation (whichever occurs first), up to approximately 2 months
Other outcomes:
Locations:
city: Shinjuku-Ku
country: Japan
facility: Medical Corporation Association Shinanokai Shinanozaka Clinic
state: Tokyo
Study officials:
affiliation: Daiichi Sankyo
name: Clinical Study Leader
role: STUDY_DIRECTOR
References:
Clinical trial NCT02535520: Evaluation of RTVue XR With SSADA
Official title: Clinical Evaluation of RTVue XR With SSADA in Retinal Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retina Vascular Pathology
Lead sponsor: Optovue
Sponsor class: INDUSTRY
First posted: 2015-08-28
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Seeing eye doctor for routine or follow-up care

Brief summary: Optovue has implemented a motion contrast imaging software in RTVue XR, a split spectrum amplitude decorrelation algorithm (SSADA), for non-invasive imaging of ocular vasculature. Consented subjects will undergo a series of images of the back of the eye using an Optical Coherence Tomograpy (OCT) device, RTVue XR, in addition to the conventional images as part of clinical routine. SSADA images will be compared with conventional methods.


Eligibility criteria: Inclusion Criteria:

* Age \>18
* Able and willing to complete exams
* Patients in retina clinic that need angiography

Exclusion Criteria:

* Unable to complete the required examinations and visits
* Large amount of subretinal hemorrhage
* Media opacity leading to poor quality images
* Extreme refractive error leading to poor quality images
* Pathologies in the anterior segment leading to poor quality images

Primary outcomes:
measure: Agreement of SSADA to conventional angiography
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02939820: Expanded Access Protocol of Patisiran for Patients With Hereditary ATTR Amyloidosis (hATTR)
Official title: Expanded Access Protocol of Patisiran for Patients With Hereditary Transthyretin-Mediated Amyloidosis (hATTR Amyloidosis) With Polyneuropathy
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: TTR-mediated Amyloidosis
Amyloidosis, Hereditary
Amyloid Neuropathies, Familial
Familial Amyloid Polyneuropathies
Amyloid Neuropathies
Amyloidosis, Hereditary, Transthyretin-Related
Keywords: RNAi therapeutic
FAP
Familial Amyloid Polyneuropathies
TTR
Transthyretin
Amyloidosis
Lead sponsor: Alnylam Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2016-10-20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: The purpose of this study is to provide expanded access of patisiran to patients with hereditary transthyretin-mediated amyloidosis (hATTR).

Detailed description: Choosing to participate in an expanded access program is an important personal decision. Talk with your doctor and family members or friends about deciding to join a research study. To learn more about this study, please have your doctor contact the study research staff using the Contacts provided. For general information, see the links provided in More Information.

Eligibility criteria: Inclusion Criteria:

* Male or female greater than or equal to 18 years of age
* Have a diagnosis of hATTR
* Meet Karnofsky performance status and Polyneuropathy Disability (PND) score requirements
* Have adequate complete blood counts, liver function tests and coagulation tests

Exclusion Criteria:

* Participated in an interventional hATTR amyloidosis clinical trial involving RNA interference (RNAi) therapeutics within the last 12 months
* Are currently eligible to participate in or currently enrolled in an ongoing interventional hATTR amyloidosis clinical trial
* Have inadequate cardiac function
* Known primary amyloidosis (AL amyloidosis) or leptomeningeal amyloidosis
* Have known serious comorbidities or considered unfit for the program by the investigator
* Prior or planned liver or heart transplantation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Alnylam Pharmaceuticals
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Miah KM, Hyde SC, Gill DR. Emerging gene therapies for cystic fibrosis. Expert Rev Respir Med. 2019 Aug;13(8):709-725. doi: 10.1080/17476348.2019.1634547. Epub 2019 Jun 27.
Clinical trial NCT03374020: Retinal Imaging Using NOTAL-OCT
Official title: Retinal Imaging Using NOTAL-OCT
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Age-Related Macular Degeneration
Diabetic Retinopathy
Lead sponsor: Notal Vision Inc.
Sponsor class: INDUSTRY
First posted: 2017-12-14
Enrollment: 33
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: 1. AMD population - intermediate and advanced AMD (with active and non-active CNV)
2. DR population. Patient with and without DME

Brief summary: Comparison between retinal measurements, done by the Notal-OCT imaging and a commercial OCT (Optical Coherence Tomography)


Eligibility criteria: Inclusion Criteria:

1. Ability and agreement to give informed consent (IC)
2. Diagnosis of AMD or DR in SE by OCT
3. Ability to undergo OCT scans
4. VA of 20/160 or better in SE

Exclusion Criteria:

1. AMD and DR in the same SE
2. Evidence of macular disease other than AMD or DME in SE

Primary outcomes:
measure: The level of agreement between NOTAL-OCT and commercial OCT in detecting fluid in the 10 central degrees of the macula.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00841620: Symptom Control 1-year After Circular Stapler Anopexy or Diathermy Excision for Prolapsed Haemorhoids
Official title: Symptom Control 1-year After Circular Stapler Anopey or Diathermy Excision for Prolapsed Haemorrhoids: an International Randomsed Trial (the STOPP-trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hemorrhoids
Keywords: Symptoms
Postoperative pain
Postoperative complications
Milligan
Anopxy
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: Karolinska University Hospital
name: Oxford University Hospitals NHS Trust
First posted: 2009-02-11
Enrollment: 207
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: Background: In an international randomised controlled trial we studied how patient self-reported symptoms improved after either a stapled anopexy operation or a diathermy excision of the haemorrhoids.

Methods: The study involved 18 hospitals in Sweden, Denmark and the UK. Two hundred and seven patients were randomised. After exclusion of 27 patients, 90 in both groups were operated and followed one year. Patients provided self-reported symptoms before surgery and after 1 year. A patient diary obtained daily self-reported postoperative pain scores (VAS). Surgeons evaluated the anal anatomy before surgery and after 1 year.


Eligibility criteria: Inclusion Criteria:

* Grades III and IV haemorrhoids

Exclusion Criteria:

* Previous operation for high anal fistula or injury to the anal sphincteres

Primary outcomes:
measure: Self-reported frequency of symptoms
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Odense C
country: Denmark
facility: Odense University Hospital
Study officials:
name: Niels Qvist, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01022320: Effect of Lateral Pharyngoplasty on Blood Pressure in Obstructive Sleep Apnea (OSA) Patients
Official title: Effect of Lateral Pharyngoplasty on Blood Pressure in Obstructive Sleep Apnea Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obstructive Sleep Apnea
High Blood Pressure
Keywords: OSA
Blood pressure
Lateral Pharyngoplasty
Lead sponsor: Hospital do Servidor Publico Estadual
Sponsor class: OTHER
First posted: 2009-12-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: * Describe blood pressure changes on patients with OSA treated with lateral pharyngoplasty
* Compare the mean of systolic and diastolic blood pressure in 24 hours, average systolic and diastolic pressure during daytime and night and changes in the nocturnal decrease.

Detailed description: The variables are:

Ambulatory blood pressure data Snoring scale BMI neck circumference abdominal circumference medications and life style changes

Eligibility criteria: Inclusion Criteria:

* Adult Patient
* BMI \< 35
* no Benzodiazepinec User

Exclusion Criteria:

* BMI \> 35
* Use of benzodiazepinecs
* Clinical contra-indications to surgery (ASA III or ASA IV)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital do Servidor Estadual de São Paulo
Study officials:
affiliation: HSPE
name: Carolina Soares, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02555020: Effect of Preoperative Oral Carbohydrates on Quality of Recovery
Official title: Effect of Preoperative Oral Carbohydrates on Quality of Recovery: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Evidence of Cholecystectomy
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-09-21
Enrollment: 153
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Carbohydrate loading is an important component of enhanced recovery pathways. Preoperative carbohydrate treatments have been widely adopted as part of enhanced recovery after surgery (ERAS) or fast-track surgery protocols. Although fast-track surgery protocols have been widely investigated and have been shown to be associated with improved postoperative outcomes, some individual constituents of these protocols, including preoperative carbohydrate treatment, have not been subject to such robust analysis.To assess the effects of preoperative carbohydrate treatment, compared with placebo or preoperative fasting, on postoperative recovery and insulin resistance in adult patients undergoing elective surgery.

Detailed description: Patients received 400 mL of oral isotonic glucose (No NPO®, Daesang, Korea) 12 hours before anesthesia and 400 mL 2 hours before. CHL composition was standard: 12.5 g of carbohydrate per 100 mL, 12% monosaccharide, 12% disaccharide, 76% polysaccharide, 250 mOsm/kg and 50 kcal.

Eligibility criteria: Inclusion Criteria:

1. ASA (I/II)
2. Laparoscopic cholecystectomy.
3. KAROFSKY PERFORMANCE SCALE \>70,
4. No history of major operation

Exclusion Criteria:

1. DM patients
2. GE reflux Hx patients.
3. No- compliance,
4. Previous Abdominal Surgery History

Primary outcomes:
measure: Quality of Recovery score using the QoR-40 Questionnaire
timeFrame: We check the QoR-40 at POD1 after cholecystectomy , an expected average 3days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Lee JS, Song Y, Kim JY, Park JS, Yoon DS. Effects of Preoperative Oral Carbohydrates on Quality of Recovery in Laparoscopic Cholecystectomy: A Randomized, Double Blind, Placebo-Controlled Trial. World J Surg. 2018 Oct;42(10):3150-3157. doi: 10.1007/s00268-018-4717-4.
Clinical trial NCT06200220: Patients Treated in Real Life With VEnetoclax for WAldenström Macroglobulinemia
Official title: Patients Treated in Real Life With VEnetoclax for WAldenström Macroglobulinemia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Waldenstrom's Macroglobulinaemia Refractory
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2024-01-10
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from university hospitals in France (16 center)

Brief summary: Waldenström macroglobulinemia (WM) is an incurable disease. BCL2 antagonist, an important anti-apoptosys molecule, is already approved for the treatment of chronic lymphocytic leukemia (CLL) and acute myeloid leukemia. Recently, a clinical trial including 32 patients with WM treated with Venetoclax showed an overall response rates of 84% and a major response rate of 81%. However, there is no in real life data, in the french population, of the efficiency of Venetoclax in WM. The aim of our multicentric retrospective study is to evaluate the efficiency and tolerance of Venetoclax in WM.


Eligibility criteria: Inclusion Criteria:

* Waldenstrom's macroglobulinemia
* Treatment with Venetoclax
* Non opposition

Exclusion Criteria: none

Primary outcomes:
measure: Efficiency
timeFrame: 2018 to 2025
Secondary outcomes:
measure: Tolerance
timeFrame: 2018 to 2025
measure: Efficiency in specific population
timeFrame: 2018 to 2025
Other outcomes:
Locations:
city: Poitiers
country: France
facility: CHU Poitiers
Study officials:
References:
Clinical trial NCT02219620: Examining the Effects of (MiM) Treatment on Emotional and Cognitive Functioning of Residents in Long-term Care
Official title: Examining the Effects of (MiM) Treatment on Emotional and Cognitive Functioning of Residents in Long-term Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emotion
Impaired Cognition
Keywords: creative arts
older adults
intervention study
Lead sponsor: George Mason University
Sponsor class: OTHER
First posted: 2014-08-19
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To examine the effects of a music, imagery, and movement (MiM) intervention on emotional and cognitive functioning in residents living in a community-based adult long-term care facility.

Hypothesis 1: Residents who participate in the MiM group will improve in emotional functioning, as compared to residents in the control group.

Hypothesis 2: Residents who participate in the MiM group will improve in cognitive functioning, as compared to residents in the control group.

Detailed description: To implement a community-based integrated music, art and imagery, and movement intervention to improve mood and promote cognitive functioning in older adult residents living in a long-term care facility.

Eligibility criteria: Inclusion Criteria:

* Resident in assisted living at long-term care facility with MMSE score above 20

Exclusion Criteria:

* co-morbid psychiatric diagnosis and/or staff clinical evaluation that determines inappropriateness for study inclusion

Primary outcomes:
measure: emotional functioning
timeFrame: pre-post 10 week treatment and 6 week FU
Secondary outcomes:
measure: cognitive functioning
timeFrame: pre-post 10 week intervention and 6 week FU
Other outcomes:
Locations:
city: Manassas
country: United States
facility: Assisted Living at Birmingham Green
state: Virginia
Study officials:
affiliation: George Mason University
name: Holly Matto, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: George Mason University
name: Cathy Tompkins, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: George Mason University
name: Emily Ihara, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03233620: Effectiveness of Contemporary Knee Arthroplasty in Working-age Patients
Official title: Effectiveness of Contemporary Knee Arthroplasty in Working-age Patients: a Prospective Study With 2-year Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: knee arthroplasty
working-age
patient related outcome measures
Lead sponsor: Coxa, Hospital for Joint Replacement
Sponsor class: OTHER
First posted: 2017-07-28
Enrollment: 250
Sex: ALL
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of our study was to assess the effectiveness of contemporary knee arthroplasty in working-age patients (\< 65 years) by conducting a prospective cohort study with 2-year follow up. Outcomes were measured comprehensively using various patient-reported outcome measures (PROMs) to provide information on the effect of knee arthroplasty on pain, satisfaction, physical activity, activities of daily living, and quality of life.


Eligibility criteria: Inclusion Criteria:

* Age 65 or less and
* Scheduled for either TKA or unicondylar knee arthroplasty (UKA)

Exclusion Criteria:

* rheumatoid arthritis or other inflammatory diseases
* unwilling to provide informed consent
* physical, mental, or neurological conditions that could comprise the patient´s ability and compliance with postoperative rehabilitation and follow-up (e.g., drug or alcohol abuse, serious mental illness, general neurological conditions such as Parkinson's disease, multiple sclerosis (MS), etc.)
* known sensitivity to materials in the devices.

Primary outcomes:
measure: Effectiveness of contemporary knee arthroplasty in working-age patients
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Leppanen S, Niemelainen M, Huhtala H, Eskelinen A. Mild knee osteoarthritis predicts dissatisfaction after total knee arthroplasty: a prospective study of 186 patients aged 65 years or less with 2-year follow-up. BMC Musculoskelet Disord. 2021 Aug 5;22(1):657. doi: 10.1186/s12891-021-04543-8.
Clinical trial NCT02822820: The Comparison of Conventional and Advanced Bipolar Energy Modalities During Laparoscopic Staging Surgery of Gynecologic Cancers
Official title: The Impact of Bipolar Energy Modalities on Peri-operative Outcome During Laparoscopic Staging Surgery of Gynecologic Cancers: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perioperative Period
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2016-07-04
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This single-institution prospective randomized clinical trial will be performed at the Gynecologic Oncology clinic of Ankara University. Patients with endometrial cancer and cervix cancer who will be operated for staging via laparoscopic approach will be included in the study. The included patients will be randomized to two groups before surgery. During the operation of first group instruments with advanced bipolar energy will be used during lymphadenectomy and hysterectomy and salpingo-oophorectomy. In the second group the operation will be performed by conventional bipolar energy forceps. The outcome parameters to be measured are intra-operative bleeding, duration of operation, intraoperative complications, postoperative pain score, postoperative complications, postoperative duration of hospitalization, late complications such as lymphocele formation and costs.


Eligibility criteria: Inclusion Criteria:

* Pathologic diagnosis of endometrial or cervix cancer
* Stage I, IB1, IIA1 cervix cancer or patients with partial or complete response to chemoradiotherapy
* Clinically stage I and II endometrial cancer

Exclusion Criteria:

* Hematologic abnormality
* Coagulation disorder
* Present or past thromboembolic disease
* ECOG performance \>2
* Advanced stage disease
* Fertility preserving surgery

Primary outcomes:
measure: Duration of operation
timeFrame: six months
measure: Perioperative complications
timeFrame: six months
Secondary outcomes:
measure: Pain measured by Visual Analog Scale
timeFrame: Postoperative pain scores at 8th and 24th hours
measure: Total cost of hospitalization, operation and complications
timeFrame: six months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University Medical Faculty Hospital
Study officials:
References:
citation: Taskin S, Sukur YE, Altin D, Turgay B, Varli B, Baytas V, Ortac F. Bipolar Energy Instruments in Laparoscopic Uterine Cancer Surgery: A Randomized Study. J Laparoendosc Adv Surg Tech A. 2018 Jun;28(6):645-649. doi: 10.1089/lap.2017.0639. Epub 2018 Jan 11.