louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06965725: Paired-Ring Mitral Annuloplasty Ring Sizing Device
Official title: Evaluation of a Novel Paired-Ring Mitral Annuloplasty Sizing Method and Device
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Heart Valve Diseases
Keywords: Annuloplasty Ring
Sizing methods
Lead sponsor: Endeavor Health
Sponsor class: OTHER
First posted: 2025-05-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing mitral valve repair.

Brief summary: The purpose of this study is to evaluate a novel paired-ring mitral annuloplasty sizing system in humans.

Detailed description: This is a pilot feasibility study of an investigational device. The proposed device is designed to be used as a temporary, disposable tool that will guide final ring size selection during mitral valve repair surgery. This device enables the direct measurement of the mitral valve opening. Currently, sizing tools for mitral annuloplasty ring implantation has provide only a rough estimate. The field of cardiac surgery is in need of a precise technique to accomplish the important task of correctly selecting an annuloplasty ring for implantation.

Eligibility criteria: Inclusion Criteria:

1. All patients scheduled for mitral repair surgery
2. Age 18 years or older

Exclusion Criteria:

1. Adults unable to consent,
2. Pregnant women and prisoners.
3. Emergency operations and those patients in whom mitral repair is not performed in a meaningful way, requiring mitral replacement instead, will be excluded.
4. Presence of acute endocarditis infection during the initial screening process

Primary outcomes:
measure: Mitral leaflet coaptation length.
timeFrame: During surgery, immediately prior to prosthesis implantation.
measure: Post-procedure, echocardiography measurements - mitral coaptation length.
timeFrame: After separation from cardiopulmonary bypass.
Secondary outcomes:
Other outcomes:
Locations:
city: Glenview
country: United States
facility: Endeavor Health
state: Illinois
Study officials:
affiliation: Endeavor Health
name: Nikola Dobrilovic, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04633525: Defining Optimum Cup Orientation for Hip Replacements Taking Into Account the Individual's Anatomy and Movement Patterns
Official title: A Prospective Study to Define Optimum Cup Orientation in Hip Arthroplasty Accounting for the Individual's Anatomy and Movement Patterns
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hip Arthritis
Hip Osteoarthritis
Keywords: Hip Replacement
Hip Arthroplasty
Arthritis
Osteoarthritis
Hip dislocation
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2020-11-18
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate and determine the optimal zone for implanting the cup component (the ball that sits in the joint socket) in a total hip replacement. Enrolled participants will have a series of X-rays analyzed before surgery to identify their individual optimal zone or cup orientation. This information will be provided to the operating surgeon, who may use this information to influence the placement of the cup implant. Follow-up X-rays taken after surgery will determine if the cup is within the suggested optimal zone. Questionnaires will be completed before and after surgery, and data on complications or issues with the surgery (including incidents of dislocation) will be collected after surgery.


Eligibility criteria: Inclusion Criteria:

* Signed up for primary total hip arthroplasty procedures at the General Campus at The Ottawa Hospital.

Exclusion Criteria:

* Unwilling or unable to complete study requirements (either X-rays or questionnaires)
* Unwilling or unable to sign the informed consent form

Primary outcomes:
measure: Cup Orientation
timeFrame: 12 months after surgery
Secondary outcomes:
measure: Change in Patient Reported Function
timeFrame: 12 months
measure: Change in Patient Reported Pain
timeFrame: 12 months
measure: Change in Patient Reported Health
timeFrame: 12 months
measure: Change in Patient Reported Health
timeFrame: 12 months
measure: Incidence of Adverse Events
timeFrame: Up to 12 months after surgery
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
Study officials:
affiliation: Ottawa Hospital Research Institute
name: George Grammatopoulos
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00717925: Study Evaluating Safety and Tolerability of Inotuzumab Ozogamicin (CMC-544) in Japanese Patients With B-cell Non-Hodgkin's Lymphoma (NHL)
Official title: A Phase 1 Study Of CMC-544 Administered As A Single Agent In Subjects With B-Cell Non-Hodgkin's Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lymphoma, B-Cell
Keywords: B-cell Non-Hodgkin's Lymphoma
NHL
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2008-07-18
Enrollment: 13
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess the tolerability and the initial safety profile of Inotuzumab Ozogamicin (CMC-544) in patients with B-Cell Non-Hodgkin's Lymphoma (NHL).


Eligibility criteria: Inclusion Criteria:

* CD22-positive, B-cell NHL which has progressed after 1 or 2 prior therapies.
* Patients who have progressed after at least 1 prior chemotherapy regimen for indolent lymphoma, or 1/ 2 chemotherapy regimens, which include anthracylin or anthraquinon for aggressive lymphoma.
* Eastern Cooperative Oncology Group (ECOG) performance status: 0/ 1.

Exclusion Criteria:

* Patients must not have received monoclonal antibodies or radioimmunoconjugates within 3 months before first dose of test article.
* Patients must not have received bilateral pelvic irradiation.
* Patients must not have received chemotherapy, cancer immunosuppressive therapy, growth factors (except erythropoietin), or investigational agents within 4 weeks before first dose of test article.

Primary outcomes:
measure: Incidence and severity of adverse events, dose-limiting toxicities, and changes in laboratory test results.
timeFrame: 4 months
Secondary outcomes:
measure: Tumor response (according to the International Response Criteria for Non-Hodgkin's Lymphomas).
timeFrame: 4 months
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Ogura M, Tobinai K, Hatake K, Uchida T, Kasai M, Oyama T, Suzuki T, Kobayashi Y, Watanabe T, Azuma T, Mori M, Terui Y, Yokoyama M, Mishima Y, Takahashi S, Ono C, Ohata J. Phase I study of inotuzumab ozogamicin (CMC-544) in Japanese patients with follicular lymphoma pretreated with rituximab-based therapy. Cancer Sci. 2010 Aug;101(8):1840-5. doi: 10.1111/j.1349-7006.2010.01601.x. Epub 2010 Apr 23.
Clinical trial NCT05516225: Safety Study of Human Milk Oligosaccharides in Healthy Adults
Official title: Phase 1 Safety Study of Human Milk Oligosaccharide Concentrate PBCLN-003 in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Prolacta Bioscience
Sponsor class: INDUSTRY
First posted: 2022-08-25
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: First-in-human phase 1 study conducted in healthy adult male and female volunteers to determine the safety and tolerability of increasing doses of PBCLN-003, which are concentrated human milk oligosaccharides (HMO).


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) between 18.5 and 24.9 kg/m2
* Age between 18 and 50 years old
* No diagnosed medical conditions
* No significant change to diet in the 2 weeks prior to enrollment
* Agreement to use contraception for female subjects

Exclusion Criteria:

* Lactose intolerance
* Pregnancy
* Lactation
* Enrollment in another clinical study

Primary outcomes:
measure: Number of Adverse Events
timeFrame: 28 days
Secondary outcomes:
measure: Stool, saliva, and vaginal microbiome
timeFrame: 28 days
measure: Serum cytokine levels
timeFrame: 28 days
Other outcomes:
Locations:
city: Cypress
country: United States
facility: WCCT Global, LLC
state: California
Study officials:
References:
Clinical trial NCT02861625: CONDOL01: Evaluation on the Experience of Bereavement, of a Medical Consultation, Proposed by a Letter of CONDOLence to the Patients' Relatives Versus Standard Practice After the Death of the Patient
Official title: CONDOL01: Evaluation on the Experience of Bereavement, of a Medical Consultation, Proposed by a Letter of CONDOLence to the Patients' Relatives Versus Standard Practice After the Death of the Patient: A Multicenter, Randomized Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Caregivers
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2016-08-10
Enrollment: 432
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population consisted of the reliable person (a family member and/or caregiver, designed by the patient himself at each hospitalization) of cancer patients who have died in one of the participating center.

Brief summary: The aim of this randomized multicenter study is to evaluate the impact in offering the condolence letter to the family caregivers (indicated as the reliable person by the patient himself at each hospitalization) and a bereavement consultation with the reference physician.

Detailed description: The hypothesis is that offering the opportunity to clarify questions about the patients' terminal care will influence positively the grieving process. In particular, the study team hypothesized that psychological morbidity will be reduced (main objective) as well as some aspects of QOL (secondary objective). It is also assumed that the situations of conflict (solicitations for medical records, number of legal procedures) will be reduced.

Eligibility criteria: Inclusion Criteria:

* Patient died in the institution
* Patient for which the reliable person has been identified
* Acceptation of the reference physician to send a letter of condolence with the proposed consultation

Exclusion Criteria:

* The physician already met with the caregiver after the patient's death

Primary outcomes:
measure: Evolution of mental component score (MCS) of the SF-36 questionnaire
timeFrame: 3 months post death
Secondary outcomes:
measure: Quality of life of the caregivers after the death of the patient evaluated by specific caregivers CarGOQoL questionnaire
timeFrame: 1 year post death
measure: Quality of life of the caregivers after the death of the patient evaluated by SF36 questionnaire
timeFrame: 1 year post death
measure: Anxiety of the caregivers after the death of the patient
timeFrame: 1 year post death
measure: Depression of the caregivers after the death of the patient
timeFrame: 1 year post death
measure: Complicated grief
timeFrame: 1 year post death
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli Calmettes
state: Bouches Du Rhone
city: Marseille
country: France
facility: GRAVIS
Study officials:
affiliation: Institut Paoli-Calmettes
name: Gwenaelle Gravis, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02554825: Healthy Futures Evaluation
Official title: Healthy Futures Longitudinal School-Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Behavior
Lead sponsor: JSI Research & Training Institute, Inc.
Sponsor class: OTHER
Collaborators: name: Department of Health and Human Services
name: Black Ministerial Alliance of Greater Boston
name: Healthy Futures
First posted: 2015-09-18
Enrollment: 1344
Sex: ALL
Minimum age (years): 10
Maximum age (years): 15
Standard ages: CHILD
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study evaluated the impact of the three-year Healthy Futures program on teen sexual behaviors in three Massachusetts cities.

Detailed description: This study evaluated the impact of the three-year Healthy Futures program on teen sexual behaviors in three Massachusetts cities. This longitudinal school-cluster randomized controlled trial included 15 public middle schools (n=1,344). Participants were enrolled in the 6th grade in the 2011-2012 school year (Cohort 1) or 2012-2013 school year (Cohort 2). Outcome data sources included five student surveys: baseline; 6th, 7th, 8th grade follow-ups; and 9th grade follow-up (Cohort 1 only).

Eligibility criteria: Inclusion Criteria:

* Students attended one of the 15 participating public middle schools
* Students were enrolled in the 6th grade in the 2011-2012 school year (Cohort 1) or 2012-2013 school year (Cohort 2)
* Students were not withdrawn from Healthy Futures program participation by himself/herself, a parent, or school administrator(s) prior to the consent/assent process for the study

Exclusion Criteria:

* Students were were not in the 6th grade at the time of consent
* Students were not in the school after the consent/assent process occurred
* Students were withdrawn from Healthy Futures program participation by himself/herself, a parent, or school administrator(s) prior to the consent/assent process for the study.

Primary outcomes:
measure: Prevalence of participants who reported vaginal sex
timeFrame: 2 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: JSI Research & Training Institute, Inc.
state: Massachusetts
Study officials:
References:
Clinical trial NCT06091722: Quantitative Assessment of Lid Margin Vascularity Using SS-OCTA
Official title: Quantitative Assessment of Lid Margin Vascularity Using Swept-source Optical Coherence Tomographic Angiography
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Ss-octa
Lid Margin Blood Flow Density
MGD
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2023-10-19
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MGD or normal patients who could cooperate with dry eye evaluation and SSOCTA examination in the dry eye Clinic of the Eye Hospital of Wenzhou Medical University were enrolled.

Brief summary: To explore an optimized scan technique for the detection of lid margin vasculature

Detailed description: To investigate whether the SS-OCTA tool has the potential to characterize the lid margin vascularity in MGD patients. The repeatability and validity of OCTA in assessing eyelid margin blood flow density was evaluated。

Eligibility criteria: Inclusion Criteria:

The MGD patients were aged \>_20 years and were diagnosed according to Chinese MGD diagnostic criteria,11 including dry eye symptoms, and at least one of the following signs: (1) poor meibum expressibility or quality; (2) at least one of eyelid margin abnormalities (lid margin irregularity, plugging of the gland orifice, vascular engorgement/telangiectasia, and anterior replacement of the mucocutaneous junction. Normal subjects were defined as adults without any dry eye symptoms and lid margin abnormality.

Exclusion Criteria:

(1) subjects with ocular diseases or conditions known to affect the anatomy of the anterior segment, such as acute ocular inflammation, a history of eyelid surgery, contact lens wear within two weeks, and/or eyelid trauma; (2) subjects with of history of systemic or topical medications that might cause ocular congestion; (3) subjects with severe systemic illness or pregnancy; and (4) subjects who were difficult to cooperate with examination, resulting the obtained images were not sufficiently clear for automatic analysis.

Primary outcomes:
measure: LMBFD
timeFrame: Immediately after ssocta
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01779622: Rapid Versus Slow Ingestion of Mixed Meal: Influence on Islet and Incretin Hormone Secretion in Healthy Volunteers
Official title: Rapid Versus Slow Ingestion of Mixed Meal: Influence on Islet and Incretin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers Recruited From the General Population
Keywords: mixed meal¨
insulin
glucagon
GIP
GLP-1
Lead sponsor: Lund University
Sponsor class: OTHER
First posted: 2013-01-30
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: To test the influence of rapid versus slow ingestion of a mixed meal on insulin and incretin hormone secretion in healthy volunteers

Detailed description: A mixed meal (524 kcal) is ingested rapidly (within 5 min) or slowly (10-15 min) and changes in insulin, glucagon, GIP and GLP-1 levels are followed for subsequent 300 min

Eligibility criteria: Inclusion Criteria:

* Healthy subjects

Exclusion Criteria:

* Diabetes Liver disease Kidney disease Thyroid disease

Primary outcomes:
measure: Area under the curve for insulin
timeFrame: 300 min
Secondary outcomes:
measure: Area under the curve for glucose-dependent insuinotropic polypeptide
timeFrame: 300 min
measure: Area under the curve for glucagon-like peptide-1
timeFrame: 300 min
Other outcomes:
measure: Area under the curve for glucagon
timeFrame: 300 min
Locations:
city: Lund
country: Sweden
facility: Department of Clinical Sciences, Lund University
Study officials:
References:
Clinical trial NCT03894722: Effects of Polyvinylpyrrolidone Iodine on Postoperative Trismus and Swelling During Impacted Third Molar Surgery
Official title: Effects of Polyvinylpyrrolidone Iodine Concentrations on Postoperative Trismus and Swelling Using as an Irrigation Solution During Impacted Third Molar Surgery : a Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Impacted Third Molar Tooth
Keywords: third molar surgery
povidone iodine
Lead sponsor: Uşak University
Sponsor class: OTHER
First posted: 2019-03-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the present study was to evaluate the effects of different concentrations of povidone iodine (PVP-I) on postoperative swelling and trismus when used as a coolant and irrigation solution during the surgical removal of impacted mandibular third molars.


Eligibility criteria: Inclusion Criteria:

* Totally impacted mandibular third molars of class C, 1, 2, and 3 according to the Pell-Gregory classification;
* Has no systemic disease

Exclusion Criteria:

* The use of medications that could interfere with the healing process;
* Smoking;
* Pregnancy or lactation;
* Presence of any condition, such as inflammation, periodontitis, gingivitis and dental abscess in the area of the impacted teeth;
* Undergoing antibiotic or anti-inflammatory drugs therapies in the 7 days before surgery;
* History of hypersensitivity to iodine;
* Has any thyroid diseases.

Primary outcomes:
measure: Postoperative Facial Swelling (assessed 3 facial lines (in millimeters) for determination of difference in facial contours before and after surgery)
timeFrame: Preoperative (on the day of surgery)- postoperative 2nd day-postoperative 7th day
measure: Postoperative Trismus (difference in interincisal distance at the maximal mouth opening (in millimeters) before and after surgery)
timeFrame: Preoperative (on the day of surgery)- postoperative 2nd day-postoperative 7th day.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Yuce E, Dereci O, Altin N, Koca CE, Yazan M. Effects of different polyvinylpyrrolidone iodine concentrations on trismus and swelling following third molar surgery. J Pak Med Assoc. 2020 Dec;70(12(B)):2304-2309. doi: 10.5455/JPMA.130.
Clinical trial NCT06637722: Self-management in Patients With Adrenal Insufficiency.
Official title: Self-management in Patients With Adrenal Insufficiency.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Adrenal Insufficiency
Keywords: Adrenal insufficiency
self-management
Lead sponsor: Region Stockholm
Sponsor class: OTHER_GOV
First posted: 2024-10-15
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with adrenal insufficiency cared for at at the endocrinology department at Karolinska university hospital, Örebro university hospital, university hospital linköping or university hospital of Umeå and their relatives.

Brief summary: Background: Cortisol deficiency leads to a wide range of clinical consequences. Substitution with glucocorticoids is necessary and demands knowledge and ability to self-management from the patient.

Methods: Longitudinal questionnaire-based observational study including group education.

Research questions: To find out if education in group, enhances patients´ and relatives' knowledge about adequate dose adjustment of cortisone and increases the feeling of safety and QoL in patients with adrenal insufficiency.


Eligibility criteria: Inclusion Criteria:

Adrenal insufficiency or relative to a person with adrenal insufficiency

Exclusion Criteria:

-

Primary outcomes:
measure: Questionnaire
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: