louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05711108: Continuous Glucose Monitoring (CGM) in Long Term Care (LTC) Facilities
Official title: Continuous Glucose Monitoring (CGM) to Assess Hypoglycemia in Older Adults With Diabetes in Long Term Care (LTC) Facilities
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes
Hypoglycemia
Aging
Keywords: older adults
hypoglycemia
continuous glucose monitoring
long-term care facilities
Lead sponsor: Joslin Diabetes Center
Sponsor class: OTHER
Collaborators: name: Theoria Medical
First posted: 2023-02-02
Enrollment: 300
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Long term care residents using glucose lowering medications

Brief summary: To prospectively determine the burden of hypoglycemia (minutes spent below 70 mg/dl per day, measured by continuous glucose monitor (CGM)) among residents of long term care facilities (LTC) with a diagnosis of type 1 or type 2 diabetes including key clinical subgroups (living in skilled nursing facility (SNF) or nursing home (NH), on different hypoglycemic medications).

This aim will be achieved by recruiting 300 residents with diabetes in 4 LTC facilities. All participants will undergo masked CGM for 10 days.


Eligibility criteria: Inclusion Criteria:

* Adults \>64 years with diagnosis of type 1 or type 2 diabetes
* Using glucose-lowering medication or insulin

Exclusion Criteria:

* Currently taking or planning to take hydroxyurea
* Patient or Health care proxy refuses to sign consent form

Primary outcomes:
measure: Biochemical hypoglycemia
timeFrame: Baseline
Secondary outcomes:
measure: A1C
timeFrame: Baseline
measure: Time-in-range
timeFrame: Baseline
measure: Clinically significant hypoglycemia
timeFrame: Baseline
measure: Severe hypoglycemia
timeFrame: Baseline
measure: Falls, hospitalization
timeFrame: Baseline
measure: Symptoms of hypoglycemia reported to the staff by the resident in between or at the time of fingerstick glucose monitoring (information derived from nursing notes)
timeFrame: Baseline
Other outcomes:
Locations:
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
Study officials:
References:
Clinical trial NCT05344508: An Expanded Access Study to Assess Brensocatib for Participants With Non-Cystic Fibrosis Bronchiectasis
Official title: Brensocatib in Patients With Non-Cystic Fibrosis Bronchiectasis
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Non-Cystic Fibrosis Bronchiectasis
Keywords: Cathepsin G
CKD-EPI
NCFBE
Lead sponsor: Insmed Incorporated
Sponsor class: INDUSTRY
First posted: 2022-04-25
Sex: ALL
Minimum age (years): 12
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: The purpose of this study is to allow early access to brensocatib for participants with non-cystic fibrosis bronchiectasis (NCFBE) who have successfully completed the INS1007301 ASPEN Clinical trial.

Detailed description: Participants will receive brensocatib 10 mg, oral tablets, once daily.

Eligibility criteria: Inclusion Criteria:

* Participant had agreed to provide their informed consent to participate per local requirements.
* Participant had successfully completed Clinical Trial INS 1007-301 ASPEN, including the End of study Visit 12 prior to receiving treatment.
* Requests for Post-Trial access for brensocatib had come from ASPEN investigator.
* Had received brensocatib treatment.

Exclusion Criteria:

* Participant had experienced a serious adverse event deemed to be related to brensocatib during the study and required permanent participant is continuation.
* The participant is immunocompromised or chronically treated with any investigational or commercialized immunomodulatory agent that is directed to any component of the adaptive or innate immune systems.

Note: The use of any immunomodulatory agents (including but not limited to: bortezomib, ixazomib, thalidomide, cyclophosphamide, mycophenolate, Janus kinase inhibitors, IFN-γ, and azathioprine) is prohibited during the program.

* The participant had undergone continuous use of high dose non-steroidal anti-inflammatory drugs.
* The participant had undergone chronic use of systemic steroids for any chronic condition, except steroids with topical anti-inflammatory activities (ie, oral budesonide).
* Participant had planned to receive live attenuated vaccines during the program (treatment must be postponed until 4 weeks after the last dose of drug).
* Participant had planned to use investigational drugs.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04672408: His Bundle Pacing Versus Right Ventricular Pacing
Official title: His Bundle Pacing Versus Right Ventricular Pacing: a Randomized Crossover Study (His-PACE)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pacing-Induced Cardiomyopathy
Keywords: His bundle pacing
Right ventricular pacing
Left ventricular systolic function
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized crossover double-blind
Primary purpose: TREATMENT

Brief summary: This study will randomize cross-over periods of 6 months of right ventricular pacing and His bundle pacing in patients with baseline left ventricular ejection fraction (LVEF)\>40%. The primary outcome measure is LVEF.

Detailed description: Monocentric, randomized, double-blind comparative crossover clinical study.

Patients with a standard pacing indication with \>20% ventricular pacing, with a baseline LVEF \>40%, implanted with a functioning His bundle lead and a backup right ventricular lead, will be randomized to 6-months periods of right ventricular pacing and of His bundle pacing. The primary outcome is LVEF assessed by gated Equilibrium Radionuclide Angiography. Secondary outcomes are diastolic function, New York Heart Association (NYHA) functional class, quality of life, 6-minute walk test, heart failure hospitalisations and device electrical parameters.

Eligibility criteria: Inclusion Criteria:

* Baseline LVEF\>40%
* Standard pacing indication with \>20% VP
* Functional His bundle lead with confirmed His capture
* Functional right ventricular lead with myocardial capture

Exclusion Criteria:

* Unable to sign an informed consent form

Primary outcomes:
measure: Left ventricular ejection fraction
timeFrame: 6 months
Secondary outcomes:
measure: Left ventricular peak filling rate (EDV/s)
timeFrame: 6 months
measure: NYHA functional class
timeFrame: 6 months
measure: 6-minute walk test
timeFrame: 6 months
measure: Quality of life measure by SF-36 questionnaire
timeFrame: 6 months
measure: Right ventricular ejection fraction
timeFrame: 6 months
measure: Hospital admission for cardiovascular causes
timeFrame: 6 months
measure: Hospital admission for cardiovascular causes
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: University Hospital Geneva
state: GE
Study officials:
affiliation: University Hospital, Geneva
name: Haran Burri, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05804708: Phase 2 Clinical Trial of GH001 in Postpartum Depression
Official title: A Phase 2 Clinical Trial of GH001 in Patients with Postpartum Depression
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Postpartum Depression
Postnatal Depression
Keywords: Depression
Postpartum Depression
5-Methoxy-N,N-Dimethyltryptamine
5-MeO-DMT
Mebufotenin
Postnatal Depression
Lead sponsor: GH Research Ireland Limited
Sponsor class: INDUSTRY
First posted: 2023-04-07
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a multicenter, open-label, single-arm Phase 2 clinical trial. Approximately 15 female participants with clinically diagnosed postpartum depression (PPD) will be included in this study. The participants will receive an individualized dosing regimen (IDR) with at least one and up to three doses of GH001 administered within a single day.


Eligibility criteria: Inclusion Criteria:

* Is female and in the age range between 18 and 45 years (inclusive) at screening.
* Has a body mass index (BMI) in the range of 18.5 and 35 kg/m2 (inclusive) at screening.
* Meets the trial criteria for PPD as assessed by a trial psychiatrist or registered clinical psychologist.

Exclusion Criteria:

* Has one or more first or second degree relatives with a current or prior diagnosis of bipolar disorder, psychotic disorder or other mood disorder (including MDD) with psychotic features.
* Current pregnancy resulting in termination, still-birth, pre-term delivery (before week complete gestational week 37), need for intensive care therapy of mother or child, or adoption of child away from patient.
* Has taken prohibited medication or prohibited dietary supplements within the specified timeframe prior to dosing.
* Has previously experienced a significant adverse reaction to a hallucinogenic or psychedelic drug according to the investigator's judgment.
* Has a clinically significant abnormality in physical examination, vital signs, ECG, or clinical laboratory parameters which renders the patient unsuitable for the trial according to the investigator's judgment.
* Patient who has a positive pregnancy test at screening or on the pretest day, is pregnant, or plans to become pregnant during the course of the trial and up to 90 days after GH001 dosing.

Primary outcomes:
measure: The anti-depressive effects of GH001 evaluated by the change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) assessed at Day 7
timeFrame: From Baseline to Day 7
Secondary outcomes:
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
city: London
country: United Kingdom
facility: Clerkenwell Health
city: London
country: United Kingdom
facility: St. Pancras Clinical Research
city: Sheffield
country: United Kingdom
facility: Sheffield Health and Social Care NHS Foundation
Study officials:
References:
Clinical trial NCT04288908: Trait Injustice, Social Exclusion, and Anger
Official title: Trait Injustice and Its Effects on Anger Induced by Social Exclusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: General Population
Lead sponsor: Universitat Jaume I
Sponsor class: OTHER
First posted: 2020-02-28
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The two conditions, based on the experimental task called Cyberball, will be: social inclusion and social exclusion.
Primary purpose: BASIC_SCIENCE

Brief summary: Participants will be randomly allocated to one of two experimental conditions: social exclusion or social inclusion. Participants, but not experimenters will be blind to the assignment. Pre- and post-tests will be administered. Participants will be offered 7 euros in compensation for participating.


Eligibility criteria: Inclusion Criteria:

* Being over 18 years of age
* Signs the informed consent
* Can read and understand Spanish

Exclusion Criteria:

* Being younger than 18 years of age
* Does not sign the informed consent
* Cannot read or understand Spanish

Primary outcomes:
measure: Change in Anger State from baseline to end of the experiment
timeFrame: The STAXI-2 will be administered twice: at Baseline and at the same day of Baseline assessment just after the experimental task (end of study)
measure: Trait Injustice
timeFrame: This measure will be administered at Baseline
Secondary outcomes:
measure: Frustration Discomfort Scale
timeFrame: This measure will be administered at Baseline
measure: Change in State Injustice from baseline to end of the experiment
timeFrame: This measure will be administered twice: at Baseline and at the same day of Baseline assessment just after the experimental task (end of study)
measure: Change in State Anxiety from baseline to end of the experiment
timeFrame: This measure will be administered twice: at Baseline and at the same day of Baseline assessment just after the experimental task (end of study)
measure: Cyberball Experiences post-experimental check Questionnaire
timeFrame: This measure will be administered at the same day of Baseline assessment just after the experimental task (end of study)
Other outcomes:
Locations:
city: Castellón De La Plana
country: Spain
facility: Faculty of Psycholoy. Jaume I University
Study officials:
References:
Clinical trial NCT01937208: Comparable Study of Different Radiation Dose in Esophageal Carcinoma
Official title: A Prospective, Randomised Phase 3 Study of High-dose Versus Standard-dose Radiation of Inoperable Esophageal Carcinoma Treated With Concurrent Chemoradiation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Esophageal Carcinoma
Keywords: Esophageal Carcinoma
chemoradiation
radiation dose
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2013-09-09
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Radiation therapy plus concurrent chemotherapy is now the standard therapy for patients with localized carcinoma of the esophagus selected for nonsurgical treatment. The standard radiation dose is 50-50.4Gy/1.8-2.0Gy/F.All of this were based on 2D radiation technology. Entering new century, 3D-CRT or IMRT has used on esophageal cancer. In China,the recommend radiation dose of concurrent chemoradiation was 60Gy. The study is a clinical phase III, randomized trial to compare the different radiation dose(60Gy vs 50Gy) of concurrent chemoradiation using 3D-CRT or IMRT in patients with unresectable esophageal carcinoma.


Eligibility criteria: Inclusion Criteria:

* Histological or cytologic diagnosis of esophageal carcinoma
* ECOG performance status 0-1
* Age:18-70 years
* Joined the study voluntarily and signed informed consent form
* Patients must not have received any prior anticancer therapy
* Unresectable disease, or refuse surgery.Stage Ⅰ-ⅣA（AJCC 2009）
* Target lesions can be measured according to RECIST criteria
* No serious system dysfunction and immuno-deficiency, Adequate organ function including the following: Hemoglobin ≥9 g/dL, WBC≥3x109/L, Neutrophils (ANC )≥1.5x109/L, platelet count ≥100x 109/L, TBIL\<1.5 x ULN, ALT and AST ≦ 2.5 x ULN, creatinine ≦ 1.5 x ULN
* Use of an effective contraceptive for adults to prevent pregnancy
* Life expectancy of more than 3 months

Exclusion Criteria:

* Multiple carcinomas of the esophagus,
* Biopsy-proven invasion of the tracheobronchial tree or tracheoesophageal fistula,
* Metastatic disease (M1),
* A primary tumor that extended to within 2 cm of the gastroesophageal junction,
* Prior chemotherapy, prior thoracic radiation, surgical resection of the primary tumor,
* Concurrent pregnancy or lactation, history of a second malignancy other than nonmelanoma skin cancer

Primary outcomes:
measure: Progression-free survival
timeFrame: 5 years
Secondary outcomes:
measure: Overall survival
timeFrame: 5 years
Other outcomes:
measure: local control rate; relapse location; toxicity
timeFrame: 5 years
measure: radiation-related advent events
timeFrame: at least 3 years
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Zhejiang Cancer Hospital
name: Xiao Zheng, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01478308: Metformin With Standard Taxotere and Prednisone in the Treatment of Castration Resistant Prostate Cancer
Official title: Metformin With Standard Taxotere and Prednisone in the Treatment of Castration Resistant Prostate Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: prostate
castration resistant
hormone resistant
CRPC
Lead sponsor: New Mexico Cancer Research Alliance
Sponsor class: OTHER
First posted: 2011-11-23
Enrollment: 0
Sex: MALE
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 is being conducted to determine the effectiveness of standard 3 weekly treatments using docetaxel and prednisone with metformin in patients with castration-resistant metastatic prostate cancer.

It is also being conducted to determine the levels of toxicity of metformin when added to every 3 weekly docetaxel treatments in patients with endocrine resistent, metastatic prostate cancer.

Detailed description: This is a single-arm, non-randomized Phase II trial of docetaxel given every 3 weeks with metformin twice daily and Prednisone twice daily. The study duration of this trial is open ended. The patient would take the metformin only for as long as they are treated with docetaxel.

Eligibility criteria: Inclusion Criteria:

* All patients, 18 of age or older, with hormone refractory prostate cancer are eligible.
* Patients must have a life expectancy of at least 12 weeks.
* Patients must have a Zubrod performance status of 0-2.
* Patients must sign an informed consent.
* Patients should have adequate bone marrow function defined by an absolute peripheral granulocyte count of \> 1,500 or cells/mm3 and platelet count \>100,000/mm3 and absence of a regular red blood cell transfusion requirement.
* Patients should have adequate hepatic function with a total bilirubin \< 2 mg/dl and SGOT or SGPT \< two times the upper limit of normal, and adequate renal function as defined by a serum creatinine \< 1.5 x upper limit of normal.
* Patients must have pathologically confirmed prostate cancer with PSA increasing despite androgen deprivation therapy.
* Diabetic patients on therapy with Metformin are eligible provided that their Metformin dose is at least 850mg twice daily.

Exclusion Criteria:

* Patients with symptomatic brain metastases are excluded from this study.
* Patients on insulin are not eligible.
* Patients may receive no other concurrent chemotherapy or radiation therapy during this trial.
* Patients with severe medical problems such as uncontrolled diabetes mellitus, cardiovascular disease, and congestive heart failure defined as New York Heart Association Class III or IV, hepatic dysfunction, or active infections are not eligible for this trial.

Primary outcomes:
measure: Measure efficacy
timeFrame: 7 years
Secondary outcomes:
measure: Measure toxicity
timeFrame: 7 years
Other outcomes:
Locations:
Study officials:
affiliation: University of New Mexico Cancer Center
name: Richard Lauer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06736808: Patient Understanding of Handouts at Different Reading Levels
Official title: Assessment of Patient Understanding of Educational Material at Above and Below a Sixth Grade Reading Level
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Literacy
Keywords: readability
patient understanding
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2024-12-17
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of this randomized clinical trial is to learn if participants are better able to understand medical handouts written at below a sixth grade reading level compared to those written at above a sixth grade reading level. The main question it aims to answer is:

• Do participants score higher on a knowledge test after reading a handout written at below a sixth grade reading level compared to after reading a handout written at above a sixth grade reading level?

Researchers will compare knowledge scores on pelvic organ prolapse after participants read a handout written at an eight grade reading level compared to the same handout re-written to be at a fifth grade reading level.

Participants will:

* Read a one page handout (written at either above or below a sixth grade reading level) on pelvic organ prolapse
* Complete a one page multiple-choice test on pelvic organ prolapse

Detailed description: The secondary objective is to determine characteristics of patients whose knowledge levels are higher after reading educational material written below a sixth grade reading level compared to material written above a sixth grade reading level.

Eligibility criteria: Inclusion Criteria:

* Must be able to complete pen and paper questionnaire

Exclusion Criteria:

* Unable to understand or read English

Primary outcomes:
measure: Knowledge Assessment Score
timeFrame: Assessed during completion of a 5 minute survey after reading a one page informational handout for approximately 10 minutes
measure: Participant-reported Handout Utility
timeFrame: Assessed during completion of a 5 minute survey after reading a one page informational handout for approximately 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Raleigh
country: United States
facility: University of North Carolina Urogynecology and Reconstructive Pelvic Surgery at REX
state: North Carolina
Study officials:
affiliation: University of North Carolina
name: Bertie Geng, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shah AD, Massagli MP, Kohli N, Rajan SS, Braaten KP, Hoyte L. A reliable, valid instrument to assess patient knowledge about urinary incontinence and pelvic organ prolapse. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Sep;19(9):1283-9. doi: 10.1007/s00192-008-0631-x. Epub 2008 May 15.