louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05762861: Exploring Clinical Predictors of COPD Exacerbation in a Community Cohort
Official title: Exploring Clinical Predictors of COPD Exacerbation in a Community Cohort
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COPD Exacerbation
Lead sponsor: University of Minho
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2023-03-10
Enrollment: 200
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of our study is to assess the feasibility and benefits of the implementation of an interactive telemonitoring system for earlier detection of COPD exacerbations in a community cohort preventing further deterioration requiring hospital admissions.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of COPD
* Aged 40 years or above
* Must be enrolled in health centres from Braga

Primary outcomes:
measure: Number of COPD exacerbation with hospital admission
timeFrame: 18 months
measure: Number of COPD exacerbation managed at home
timeFrame: 18 months
measure: Quality of Life using St. George's Respiratory Questionnaire
timeFrame: 18 months
measure: Impact of COPD on patient's life using COPD Assessment Test (CAT)
timeFrame: 18 months
measure: Impact of the programme - rate of compliance
timeFrame: 18 months
measure: Impact of the programme - satisfaction level
timeFrame: 18 months
measure: Impact of the programme - % of retention of participating patients
timeFrame: 18 months
Secondary outcomes:
measure: Pulmonary function (FEV1 and FEV1/ FVC ratio after BD)
timeFrame: 18 months
measure: Dyspnoea level (mMRC)
timeFrame: 18 months
measure: Changes in GOLD classification
timeFrame: 18 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02300961: Feasibility Neurocognitive Outcome After Transplant
Official title: A Risk Stratification Model for Neurocognitive Outcome After Transplant and Feasibility of an Early Cognitive Intervention Program
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Stem Cell Transplantation
Pediatric Cancer
Acute Lymphoblastic Leukemia
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2014-11-25
Enrollment: 35
Sex: ALL
Minimum age (years): 6
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This pilot study will primarily be evaluated by feasibility and adherence to an iPad-based neurocognitive intervention program. It will secondarily be evaluated by performance on the neurocognitive testing post-transplant and change in performance in subsequent years.


Eligibility criteria: Inclusion Criteria:

* All patients must have a histologic or cytological diagnosis of ALL treated with stem cell transplantation. There are no restrictions on prior therapy.
* Patients must be between the ages of 6 years and 21 years of age (inclusive), but there will be no discrimination based on gender, race, creed, or ethnic background. The age limits are set at 6 years of age in order to ensure that patients will be able to participate in these specific cognitive rehabilitation tasks. ECOG/KPS will not be employed.
* Patient and/or parents/guardians as appropriate must sign an informed consent, be mentally responsible, able to understand and willing to sign a written informed consent.

Exclusion Criteria:

* Subjects with significant concurrent medical complications that in the judgment of the Principal Investigator(s) could affect the patient's ability to complete the planned trial. There are no therapy restrictions or restrictions regarding the use of other Investigational Agents.
* Pregnant patients will be excluded.

Primary outcomes:
measure: Number of participants who complete the post-transplant neurocognitive intervention program
timeFrame: 26 weeks after transplant
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University, School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Susan Hiniker
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03946761: Fluorescence Imaging in Hepatobiliary Surgery
Official title: Evaluation of Fluorescence Imaging in Hepatobiliary Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hepatobiliary Surgery
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2019-05-13
Enrollment: 0
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: A current gap in the use indocyanine green fluorescence to isolate the biliary system is the dosing amount necessary to fluoresce the biliary system without "over" fluorescing the liver and gallbladder. Over fluorescing surrounding structures such as the liver and gallbladder saturates the image and makes it impossible to identify biliary leaks or differentiate branches of the common bile duct using fluorescent imaging devices. The over dosing does not affect the standard of care procedure, but eliminates the added benefit of the fluorescent imaging technology. The use of "microdoses" (approximately 0.1 mg) of indocyanine green has been trialed and shown promise in some patients. This study aims to do an in depth study utilizing the Cancer goggle systems fluorescent imaging system to determine the correct dose needed to isolate the biliary system without over fluorescing surrounding structures. This dosing study could additionally serve as a pilot study for follow on research using indocyanine green and fluorescent imaging in hepatobiliary surgery.


Eligibility criteria: Inclusion Criteria:

* Planned open liver resection or ablation.
* At least 18 years of age.
* Able to understand and willing to sign a written informed consent document.

Exclusion Criteria:

-History of allergic reactions attributed to ICG, iodine, iodine dye, or other agents used in the study.

Primary outcomes:
measure: The minimum dose of the ICG that causes initial fluorescence of the liver
timeFrame: Through completion of surgery for all participants enrolled (estimated to take 1 year)
Secondary outcomes:
measure: The visible status of the bile ducts and/or bile leaks from the cut surface of the liver at ICG doses administered in our dosing regimen
timeFrame: Through completion of surgery for all participants enrolled (estimated to take 1 year)
Other outcomes:
Locations:
Study officials:
affiliation: Washington University School of Medicine
name: Chet Hammill, M.D., FACS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02026661: Effectiveness of Intracytoplasmic Sperm Injection and Laser Assisted Hatching on in Vitro Fertilization Outcomes of Patients With Different Causes of Infertility
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2014-01-03
Enrollment: 375
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the patients with different causes of infertility

Brief summary: To determine the association of factors affecting the clinical pregnancy and live birth rates in patients undergoing in vitro fertilization (IVF) who received intracytoplasmic sperm injection (ICSI) and/or laser assisted hatching (LAH) or neither.

After applying the inclusion and exclusion criteria, a total of 400 women who underwent IVF between January 2007 and December 2010 were included in the analysis. Patients were divided into 4 groups; 1) those that did not receive ICSI or LAH, 2) those that received ICSI only, 3) those that received LAH only, and 4) those that received both ICSI and LAH. Univariate and multivariate analyses were performed.


Eligibility criteria: Inclusion Criteria:

* The present study was a retrospective review of the outcomes of women who underwent IVF with or without intracytoplasmic sperm injection (ICSI) at the Far Eastern Memorial Hospital, Taipei, Taiwan, between January 2007 and December 2010.

Exclusion Criteria:

* Cases in which estradiol levels exceeded 50 pg/mL on the second day of the menstrual cycle were excluded.
* Female minors or disabled persons.

Primary outcomes:
measure: Clinical pregnancy rate of intracytoplasmic sperm injection and laser assisted hatching on in vitro fertilization outcomes of patients with different causes of infertility
timeFrame: 3 months
Secondary outcomes:
measure: Live birth rate of intracytoplasmic sperm injection and laser assisted hatching on in vitro fertilization outcomes of patients with different causes of infertility
timeFrame: 1 year
Other outcomes:
Locations:
city: Banqiao
country: Taiwan
facility: Far Eastern Memorial Hospital
state: New Taipei
Study officials:
References:
Clinical trial NCT06609161: A Study to Compare Oral Formulations of Tedizolid Phosphate in Healthy Adults (MK-1986-044)
Official title: A Study to Evaluate the Definitive Bioequivalence of Tedizolid Phosphate Single-Unit-Dose Sachet Powder for Oral Suspension Compared to Tedizolid Phosphate Powder for Oral Suspension Bottle Used in Pediatric Clinical Studies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2024-09-24
Enrollment: 18
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of the study is to learn what happens to different oral formulations of tedizolid phosphate (MK-1986) in a healthy person's body over time. Researchers want to know if there is a difference in the oral formulations absorption and elimination from the healthy persons body.


Eligibility criteria: Inclusion Criteria:

The key inclusion criteria include but are not limited to the following:

* Has body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m\^2

Exclusion Criteria:

The key exclusion criteria include but are not limited to the following:

* Has a history of or presence of risk factors for Torsades de Pointes (e.g., heart failure/cardiomyopathy or family history of long QT syndrome), or uncorrected hypokalemia or hypomagnesemia
* Has a history of clostridium difficile-associated diarrhea

Primary outcomes:
measure: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Tedizolid
timeFrame: At designated time points (up to 3 days postdose)
measure: Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Tedizolid
timeFrame: At designated time points (up to 3 days postdose)
measure: Maximum Plasma Concentration (Cmax) of Tedizolid
timeFrame: At designated time points (up to 3 days postdose)
Secondary outcomes:
measure: Number of Participants Who Experienced an Adverse Event (AE)
timeFrame: Up to approximately 2 weeks postdose
measure: Number of Participants Who Discontinue Study Drug Due to an AE
timeFrame: Up to approximately 2 weeks postdose
measure: Time to Maximum Plasma Concentration (Tmax) of Tedizolid
timeFrame: At designated time points (up to 3 days postdose)
measure: Apparent Terminal Half-Life (t1/2) of Tedizolid
timeFrame: At designated time points (up to 3 days postdose)
measure: Apparent Volume of Distribution of Tedizolid During Terminal Phase (Vz/F)
timeFrame: At designated time points (up to 3 days postdose)
measure: Apparent Clearance (CL/F) of Tedizolid
timeFrame: At designated time points (up to 3 days postdose)
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Celerion (Site 0001)
state: Nebraska
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04416061: The Role of a Private Hospital in Hong Kong Amid COVID-19 Pandemic
Official title: The Role of a Private Hospital in Hong Kong Amid COVID-19 Pandemic: A Descriptive Study of Patients With SARS-CoV-2 RT-PCR Performed
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID
Lead sponsor: Hong Kong Sanatorium & Hospital
Sponsor class: INDUSTRY
First posted: 2020-06-04
Enrollment: 2510
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects who underwent COVID-19 test in HKSH during the study period

Brief summary: Hong Kong public healthcare system is facing tremendous pressure under the COVID-19 pandemic. As the virus spread in Hong Kong, Hong Kong Sanatorium \& Hospital (HKSH) is one of the first private hospitals which immediately provide reliable and rapid COVID-19 test -- Reverse Transcription Polymerase Chain Reaction (RT-PCR). Early provision of the RT-PCR screening test for COVID-19 not only facilitates identification of COVID-19 but also contains the spread of the virus in the community and frontline medical staff.

Since description of role of private hospital in Hong Kong amid COVID-19 pandemic is lacking, this study will describe COVID-19 screening algorithm and methodology. A retrospective analysis on clinical characteristics, laboratory findings as well as outcome of patients who underwent COVID-19 test in HKSH is also performed.


Eligibility criteria: Inclusion Criteria:

* Subjects who underwent COVID-19 test in HKSH during the study period

Exclusion Criteria:

-

Primary outcomes:
measure: Proportion of asymptomatic subjects
timeFrame: 1 Feb 2020 until the 14th consecutive day without any local infection in Hong Kong
Secondary outcomes:
measure: Proportion of subjects with recent contact history
timeFrame: 1 Feb 2020 until the 14th consecutive day without any local infection in Hong Kong
measure: Proportion of subjects with recent travel history
timeFrame: 1 Feb 2020 until the 14th consecutive day without any local infection in Hong Kong
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Hong Kong Sanatorium & Hospital
Study officials:
affiliation: Hong Kong Sanatorium & Hospital
name: Jonpaul Sze Tsing Zee, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00646061: Pain Control in Renal Colic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Colic
Keywords: renal colic
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2008-03-28
Sex: ALL
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Renal colic is very common in emergency department patients. Our aim of this study is which combination of drug is more effective in renal colic.


Eligibility criteria: Inclusion Criteria:

* adult, clinical suspicion of renal colic

Exclusion Criteria:

* under 15
* do not consent
* contraindication of morphine, ketorolac, or buscopan
* previously pain controlled

Primary outcomes:
measure: pain control
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Kyeongi-do
Study officials:
References:
Clinical trial NCT01202461: Triple Therapy of Pars Plana Vitrectomy and Grid/Focal Laser for Diabetic Macular Edema (DME)
Official title: Three-year Result of Triple Therapy of Vitrectomy, Intravitreal Triamcinolone and Macular Laser Photocoagulation for Intractable Diabetic Macular Edema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetic Retinopathy
Macular Edema
Keywords: Diabetic macular edema
Combination therapy for DME
DME
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2010-09-15
Enrollment: 41
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is designed to report 3-year result of triple therapy of vitrectomy, intravitreal triamcinolone and macular laser photocoagulation for intractable diabetic macular edema.

Previously author reported 1-year result(Am J Ophthalmol. 2007 Dec;144(6):878-885. Epub 2007 Oct 15.).


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of diabetes mellitus
* intractable diffuse DME (diffuse DME which did not respond to or recurred after the previous IVTA and/or macular focal laser photocoagulation)
* central subfield macular thickness (CST) greater than 250μm

Exclusion Criteria:

* presence of vitreomacular traction
* a prior history of treatment for the DME within 3 months or vitreoretinal surgery

Primary outcomes:
measure: Best-corrected visual acuity
timeFrame: At baseline, 6,12,24,36 months after surgery
Secondary outcomes:
measure: Central subfield macular thickness
timeFrame: 0,6,12,24,36 months after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: S. Korea
Study officials:
References:
Clinical trial NCT05242861: Retrospective Study of Brachytherapy
Official title: A Retrospective Study of Brachytherapy in Gynecological Cancers
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Brachytherapy
Uterine Cervical Neoplasms
Uterine Neoplasms
Vulvar Cancer
Vaginal Cancer
Ovarian Neoplasms
Gynecologic Neoplasm
Keywords: Brachytherapy
Cervical Cancer
Endometrial Cancer
Vaginal Cancer
Vulvar Cancer
Image Guided
3D Print
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2022-02-16
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 18 to 80 years old female who diagnosed as gynecological cancer and underwent brachytherapy will be enrolled in this study.

Brief summary: Brachytherapy for gynecological cancers will be studied retrospectively.


Eligibility criteria: Inclusion Criteria:

* 18 - 80 female
* Underwent brachytherapy
* With gynecological cancer

Exclusion Criteria:

* Refusal to enter this trial

Primary outcomes:
measure: Overall survival rate
timeFrame: 5-year
Secondary outcomes:
measure: Progression-free survival rate
timeFrame: 5-year
measure: Side effects
timeFrame: 5-year
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
References:
citation: Sturdza A, Potter R, Fokdal LU, Haie-Meder C, Tan LT, Mazeron R, Petric P, Segedin B, Jurgenliemk-Schulz IM, Nomden C, Gillham C, McArdle O, Van Limbergen E, Janssen H, Hoskin P, Lowe G, Tharavichitkul E, Villafranca E, Mahantshetty U, Georg P, Kirchheiner K, Kirisits C, Tanderup K, Lindegaard JC. Image guided brachytherapy in locally advanced cervical cancer: Improved pelvic control and survival in RetroEMBRACE, a multicenter cohort study. Radiother Oncol. 2016 Sep;120(3):428-433. doi: 10.1016/j.radonc.2016.03.011. Epub 2016 Apr 29.
citation: Lindegaard JC, Madsen ML, Traberg A, Meisner B, Nielsen SK, Tanderup K, Spejlborg H, Fokdal LU, Norrevang O. Individualised 3D printed vaginal template for MRI guided brachytherapy in locally advanced cervical cancer. Radiother Oncol. 2016 Jan;118(1):173-5. doi: 10.1016/j.radonc.2015.12.012. Epub 2015 Dec 29.
citation: Sekii S, Tsujino K, Kosaka K, Yamaguchi S, Kubota H, Matsumoto Y, Ota Y, Sasaki R, Soejima T. Inversely designed, 3D-printed personalized template-guided interstitial brachytherapy for vaginal tumors. J Contemp Brachytherapy. 2018 Oct;10(5):470-477. doi: 10.5114/jcb.2018.78832. Epub 2018 Oct 9.
citation: Harris BD, Nilsson S, Poole CM. A feasibility study for using ABS plastic and a low-cost 3D printer for patient-specific brachytherapy mould design. Australas Phys Eng Sci Med. 2015 Sep;38(3):399-412. doi: 10.1007/s13246-015-0356-3. Epub 2015 Jun 25.
citation: Han K, Milosevic M, Fyles A, Pintilie M, Viswanathan AN. Trends in the utilization of brachytherapy in cervical cancer in the United States. Int J Radiat Oncol Biol Phys. 2013 Sep 1;87(1):111-9. doi: 10.1016/j.ijrobp.2013.05.033. Epub 2013 Jul 9.
Clinical trial NCT01836861: IPI-145 ADME and Absolute Bioavailability Study
Official title: A Phase 1, Open-Label Study of the Absorption, Distribution, Metabolism and Excretion of 14C-Labeled IPI-145 and the Absolute Bioavailability of IPI-145 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Phase I
healthy male volunteers
ADME
Bioavailability
PI3K inhibitor
Absorption
Distribution
Metabolism
Excretion
safety
Lead sponsor: SecuraBio
Sponsor class: INDUSTRY
First posted: 2013-04-22
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This is an open-label, 2-period, absorption, distribution, metabolism and excretion (ADME) and absolute bioavailability study in 6 healthy adult male subjects.

Detailed description: In Period 1, subjects will receive a single oral dose of 25 mg IPI-145, followed by a 15-minute IV infusion of approximately 2.8 μg 14C-IPI-145 containing 14.8 kBq of radioactivity.

In Period 2, the same subjects will receive a single dose of 25 mg 14C-IPI-145 as an oral suspension, containing approximately 3.15 MBq of radioactivity.

There will be a washout period of at least 14 days between Period 1 and Period 2.

Eligibility criteria: Inclusion Criteria:

* Males, between 18 and 45 years of age, inclusive Body Mass Index (BMI) : 18.0-30.0 kg/m2
* In good health, determined by no clinically significant findings from medical history, physical examination (Check-in), 12-lead ECG, and vital signs
* Provision of signed and dated, written informed consent prior to any study specific procedures

Exclusion Criteria:

* Evidence of clinically significant medical conditions
* History of gastrointestinal surgery that may affect drug absorption
* Positive or indeterminate QuantiFERON-TB Gold test at screening
* Any active infection at the time of screening or admission
* Participation in another ADME study with a radiation burden \>0.1 mSv in the period of 1 year before screening
* Irregular defecation pattern (less than once per 2 days)

Primary outcomes:
measure: PK parameters (AUC) of IPI-145 in plasma
timeFrame: over 48 hours
measure: PK parameters (AUC) and radioactivity excreted in urine and feces
timeFrame: over 144 hours
measure: PK parameters (Cmax) of IPI-145 in plasma
timeFrame: over 48 hours
measure: PK parameters (t1/2) of IPI-145 in plasma
timeFrame: over 48 hours
measure: PK parameters (Cmax) and radioactivity excreted in urine and feces
timeFrame: over 144 hours
measure: PK parameters (t1/2) and radioactivity excreted in urine and feces
timeFrame: over 144 hours
Secondary outcomes:
measure: Number of participants with adverse events following a single dose administration of IPI-145
timeFrame: over 4 weeks
Other outcomes:
Locations:
city: Zuidlaren
country: Netherlands
facility: Pharmaceuticals Research Association (PRA)
Study officials:
affiliation: Verastem, Inc.
name: Hagop Youssoufian, MD
role: STUDY_CHAIR
References: