louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01329120: Short and Long-term Effects of Surgical Repair of Pectus Deformities
Official title: Short and Long-term Effects of Surgical Repair of Pectus Excavatum and Pectus Carinatum - A Questionnaire Study of Persistent Post-surgical Pain, Health-related Quality of Life, Patient Satisfaction, and Aesthetic Outcome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pain, Postoperative
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2011-04-05
Enrollment: 1000
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All consecutive patients referred to the Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby for the purpose of pectus deformity repair from January 1, 2001 to December 31, 2010 are invited to participate in the study.

Brief summary: A large number of institutions have reported their early results with minimally invasive repair of pectus excavatum and open repair of pectus carinatum, but only few have addressed the outcomes relevant to the concerns of the patients and even fewer have reported long-term results following bar removal. Even fewer studies have investigated the prevalence and characteristics of long term persistent post-surgical pain following surgical repair of pectus deformities. The reasons as to why acute postoperative pain in some patients persists and becomes chronic whereas in others the pain dies down shortly after wound healing are largely unknown, and why some patients complain of loss of sensibility in wide regions of their chest following surgery also remains unclear.


Eligibility criteria: Inclusion Criteria:

* Minimally invasive repair of pectus excavatum from 2001 throughout 2010.
* Open surgical repair of pectus carinatum from 2001 throughout 2010.

Exclusion Criteria:

* Not being able to fill in detailed questionnaires in Danish

Primary outcomes:
measure: Persistent post-surgical pain
timeFrame: At least 4 months following surgery
Secondary outcomes:
measure: Health related quality of life
timeFrame: At least 4 months following surgery
measure: Patient satisfaction
timeFrame: At least 4 months following surgery
measure: Aesthetic outcome
timeFrame: At least 4 months following surgery
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital, Skejby, Department of Cardiothoracic and Vascular Surgery
Study officials:
affiliation: Aarhus University Hospital Skejby
name: Kasper Grosen, PhD Fellow
role: PRINCIPAL_INVESTIGATOR
affiliation: Aarhus University Hospital Skejby
name: Hans K Pilegaard, MD
role: STUDY_DIRECTOR
affiliation: Aarhus University Hospital, Aarhus Sygehus
name: Mogens Pfeiffer-Jensen, MD, PhD
role: STUDY_CHAIR
affiliation: Aarhus University Hospital Skejby
name: Vibeke E Hjortdal, Prof., MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00038220: Effectiveness of ABT-378/Ritonavir Plus Lamivudine Plus Efavirenz Plus Tenofovir DF in HIV-Infected Patients
Official title: A Phase I/II, Open Label Study to Evaluate the Ability of Combination Therapy With ABT-378/Ritonavir (Kaletra), Lamivudine (Epivir), Efavirenz (Sustiva)and Tenofovir DF to Completely Suppress Viral Replication in Subjects Infected With HIV-1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Keywords: HIV
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2002-05-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if a novel 4-drug anti-HIV combination can suppress the growth of HIV in patients infected with the virus.


Eligibility criteria: Inclusion Criteria:

* Have HIV Infection.
* Age 18 to 65 years old.
* Show no signs of recent illness other than HIV infection.
* Agree to use a barrier method of birth control during the study and for 30 days after study.

Exclusion Criteria:

* Are unable to follow study requirements (in the opinion of the investigator).
* Are pregnant or breast-feeding.
* Are unable to take medications by mouth.
* Have chronic nausea or vomiting.
* Have cancer other than Kaposi's sarcoma or basal cell carcinoma.
* Have active, serious infections (other than HIV) requiring antibiotic injections within 15 days prior to screening.
* Are taking any medications that are not allowed with ABT-378/r and efavirenz.
* Are taking or have taken any other experimental drugs, antiretroviral drugs, or drugs that affect the immune system within 30 days of start of study without consent of the medical monitor.
* Are receiving or have received radiation therapy within 30 days of start of study without consent of the medical monitor.
* Have a history of drug abuse or mental illness that would prevent the patient from following the protocol requirements.
* Have a history of kidney or bone disease.

Primary outcomes:
measure: Proportion of subjects in each group demonstrating complete suppression of viral replication at Week 144.
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Aaron Diamond AIDS Research Center - Rockefeller University
state: New York
Study officials:
affiliation: Head, Antiviral Global Project Team
name: Scott Brun, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05433220: PRagmatic Trial Of Messaging to Providers About Treatment of Heart Failure at Inova
Official title: PRagmatic Trial Of Messaging to Providers About Treatment of Heart Failure (PROMPT-HF) at Inova
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Keywords: Heart Failure
GDMT
NYHA
HFrEF
Implementation
Lead sponsor: Inova Health Care Services
Sponsor class: OTHER
First posted: 2022-06-27
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: A randomized, single-blind intervention trial to test the comparative effectiveness of an electronic health record best practice advisory system that informs clinicians of guideline-indicated and FDA-approved heart failure medications currently not prescribed to their patients with heart failure versus usual care (no alert and how things are done currently). The purpose of the alert is to stimulate appropriate medication prescription for patients with heart failure and a reduced ejection fraction. This will be done across outpatient Inova clinics and at the five Inova hospitals.


Eligibility criteria: Inclusion Criteria:

* Age\>18 Years
* Seen by a Cardiologist in an Inova clinic or Inova hospital setting
* Left Ventricular Ejection Fraction ≤40%

Exclusion Criteria:

* Opted out of EHR-based research
* Hospice care
* Already receiving maximally titrated doses of each of the four classes of evidence- based HFrEF medical therapy
* Prior heart transplant

Primary outcomes:
measure: Increased use of GDMT in patients with Heart Failure with Reduced Ejection Fraction
timeFrame: 30 days after randomization
Secondary outcomes:
measure: All-cause hospitalization and all-cause mortality at 30 days
timeFrame: 30 days
measure: All-cause hospitalization and all-cause mortality at 90 days
timeFrame: 90 days
measure: All-cause hospitalization and all-cause mortality at 180 days
timeFrame: 180 days
measure: All-cause hospitalization and all-cause mortality at 1 year
timeFrame: 1 year
Other outcomes:
Locations:
city: Falls Church
country: United States
facility: Inova Health System
state: Virginia
Study officials:
affiliation: Inova Health Care Services
name: Mitchell Psotka, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03452020: Evaluation of the Tyto Thermometer When Used in Clinical Care Setting
Official title: Evaluation of the Tyto Thermometer When Used in Clinical Care Setting
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Body Temperature Measurement
Lead sponsor: Tyto Care Ltd
Sponsor class: INDUSTRY
First posted: 2018-03-02
Enrollment: 124
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Patients who present to the Emergency Department will be evaluated for eligibility to the study. Those meeting all the inclusion criteria and none of the exclusion criteria will undergo an informed consent process and will sign a written consent. Within each age group both afebrile and febrile patients will be represented.

The patients will be divided into 3 study groups by age:

Group 1: up to 1 year Group 2: 1 to 5 years Group 3: older than 5 years

The following temperature measurements will be taken:

1. Three temperature measurements using the Tyto thermometer
2. Temperature measurement using the standard of care
3. Three temperature measurements using the predicate device


Eligibility criteria: Inclusion Criteria:

1. Male or female, of any age
2. Subject or Parent/Guardian: able to communicate with study personnel;
3. Subject or Parent/Guardian: able to understand the nature of the study and provide written informed consent
4. Subject or Parent/Guardian willing to comply with study procedures

Exclusion Criteria:

1. Cognitive impairment, history of dementia, psychiatric disorders, mental disorders or PDD.
2. Subject or legal guardian unwilling to sign informed consent form
3. Those with signs or recent history of inflammation or infection of the forehead or at the Reference Clinical Test site (site of temperature measurement in any one of the devices used).
4. Subjects currently using cooling blankets, ice on their forehead or fans.
5. Subjects receiving treatment with antipyretics, barbiturates, antipsychotics for the past 3 hours.
6. Subjects receiving current systemic treatment with thyroid preparations, corticosteroids or underwent immunizations during the past 7 days.
7. Subjects with documented illicit drug use or alcoholic intoxication
8. Those participating in a clinical trial of an investigational medicinal product
9. Carriers of multi drug resistant bacteria
10. Pregnancy
11. CTAS score of 1-2

Primary outcomes:
measure: Body temperature measurement
timeFrame: a period of no more than 12 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Petah Tikva
country: Israel
facility: Schneider Children's Medical Center of Israel
Study officials:
affiliation: Director, Department of Emergency Medicine, Schneider Children's Medical Center of Israel
name: Yehezkel Waisman, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02519920: Lower Fluorescein Sodium Dose on Confocal Laser Endoscopy Image Quality and Yellow Discoloration of the Skin
Official title: Lower Fluorescein Sodium Dose on Confocal Laser Endoscopy Image Quality and Yellow Discoloration of the Skin
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Image Quality
Skin Discoloration
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2015-08-11
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This study was to test an appropriate dose of fluorescein sodium which can provide high image quality to ensure endoscopy examination and have no yellow dye in the skin by a randomized blinded controlled trial.

Detailed description: Fluorescein sodium is one of the commonly used staining agents in confocal laser endoscopy, a device for in vivo real-time histological observation of the gastrointestinal mucosa. The conventional intravenous dosage of fluorescein sodium is in the range of 5ml to 10ml of 10% fluorescein. Image quality can be guaranteed with this range of fluorescein sodium, but yellow discoloration of the skin seriously influences daily life. This study was to test whether a lower dose of fluorescein sodium, which has minimal discoloration of skin, can provide satisfied image quality by a randomized blinded controlled trial.

Eligibility criteria: Inclusion Criteria:

* Only those with normal mucosa and minor gastritis from 18 were included.
* patients with aged 18 years to 80 years
* patients with normal mucosa and minor gastritis
* willing to provide informed consent

Exclusion Criteria:

* serious coagulopathy dysfunction, severe cardiopulmonary disease, bronchial asthma, liver and kidney dysfunction, allergy to fluorescein, pregnancy women or breast feeding.
* patients with peptic ulcer, gastric cancer, remnant stomach, acute serious gastritis were also excluded.
* unwilling to provide informed consent

Primary outcomes:
measure: Different ratios of high resolution CLE images among four different fluorescein sodium dose groups(0.01ml/kg,0.02ml/kg,0.05ml/kg,0.1ml/kg)
timeFrame: six months
Secondary outcomes:
measure: Different degrees of skin yellow dye of patients in four different fluorescein sodium dose groups(0.01ml/kg,0.02ml/kg,0.05ml/kg,0.1ml/kg)
timeFrame: six months
Other outcomes:
Locations:
city: Jinan
country: China
facility: Department of Gastroenterology, Qilu Hospital, Shandong University
state: Shandong
Study officials:
affiliation: Department of Gastroenterology,Qilu Hospital,Shandong University
name: Yanqing Li, PhD.MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05183620: Feeling Hot 2: Penile Skin Temperature Measurements of Nocturnal Erections
Official title: Feeling Hot 2: Evaluating Nocturnal Erection Detection With Penile Temperature Measurements in the Search of a Modern Erectile Dysfunction Diagnostic Tool
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Erectile Dysfunction
Keywords: Erectile Dysfunction
RigiScan
Nocturnal erection
Penile temperature
Lead sponsor: St. Antonius Hospital
Sponsor class: OTHER
First posted: 2022-01-10
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The Feeling Hot studies focus on the proof-of-principle of using temperature sensing as a tool to detect nocturnal erections. In the Feeling Hot 2 study the penile skin temperature is investigated during nocturnal erections during overnight ambulatory measurements. Simultaneous measurements with the RigiScan will be performed to detect the nocturnal erections and validate the principle of temperature measurements for erectile dysfunction diagnostics.

Detailed description: Differentiation in nature of erectile dysfunction (ED) is currently made by nocturnal erection detection with the RigiScan. The RigiScan uses outdated software, measurements are user unfriendly and system components are out of stock. In the search of modernizing erectile dysfunction diagnostics, the question has arisen whether temperature measurements can function as a tool for nocturnal erection detection. With the absence of a pressure component, the patient experience should improve. Literature and mathematical modelling studies have shown that the penile temperature increases significantly during erection. However, no studies have used penile skin temperature measurements to detect nocturnal erections. The Feeling Hot 2 study explores the validity of this measurement set-up for overnight ambulatory measurements of nocturnal erections in the search of modernizing erectile dysfunction diagnostics.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteer without (a history of) erectile dysfunction
* Male
* Aged 18 - 29 years

Exclusion Criteria:

* Test subjects who are unwilling to sign informed consent
* Test subjects with erectile dysfunction
* IIEF-5 score of below 17
* (History of) sickle cell aneamia, atherosclerosis and diabetes type I or II.
* (History of) REM-sleep behavior disorder or other sleep disorders such as restless legs syndrome, insomnia, and sleep apnea
* Usage of sleeping pills or benzodiazepines.

Primary outcomes:
measure: Temperature increase
timeFrame: 8 hours
measure: (De)tumescence duration
timeFrame: 8 hours
Secondary outcomes:
measure: Difference between sexual and nocturnal erections
timeFrame: 8 hours
Other outcomes:
Locations:
city: Nieuwegein
country: Netherlands
facility: Hille Torenvlied
Study officials:
affiliation: Urologist, St. Antonius Ziekenhuis
name: Jack Beck, Dr.,MD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02029820: RenalGuard System for Prevention of Contrast Induced Nephropathy
Official title: RenalGuard System for Prevention of Contrast Induced Nephropathy - A Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Radiographic Contrast Agent Nephropathy
Keywords: Contrast Nephropathy
Prevention
Renalguard
Lead sponsor: Hospital Sao Lucas da PUCRS
Sponsor class: OTHER
First posted: 2014-01-08
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether hydration with intravenous saline matched with urine output, using the device RenalGuard is superior to standard hydration with saline to prevent contrast-induced nephropathy.


Eligibility criteria: Inclusion Criteria:

* serum creatinine \>1.2mg/dl
* glomerular filtration rate (GFR) \< 60ml/min

Exclusion Criteria:

* acute renal failure
* use of radiological contrast in the latest 7 days
* Current use of N-acetylcysteine or hydration of sodium bicarbonate
* Patients in dialysis
* Emergency procedures

Primary outcomes:
measure: Incidence of contrast-induced nephropathy
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital São Lucas -PUCRS, Serviço de Hemodinâmica
state: RS
Study officials:
affiliation: Hospital Sao Lucas
name: Vitor O Gomes, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00702520: Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial 38833 (P05783)
Official title: Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established After Controlled Ovarian Stimulation in Clinical Trial 38833 for Org 36286 (Corifollitropin Alfa)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Neonates
Keywords: Neonatal outcome
Congenital malformations
In-Vitro fertilization
Controlled ovarian stimulation
Follow-up
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2008-06-20
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with an ongoing pregnancy at least 10 weeks after embryo transfer in Trial 38833 were enrolled in this trial.

Brief summary: The objective of this trial is to evaluate whether corifollitropin alfa (MK-8962, Org 36286) treatment for the induction of multifollicular growth in women undergoing Controlled Ovarian Stimulation (COS) prior to in vitro fertilization (IVF) or Intracytoplasmic Sperm Injection (ICSI) is safe for pregnant participants and their offspring.

Detailed description: This is a follow-up protocol to prospectively monitor pregnancy, delivery, and neonatal outcomes of all women who were treated with corifollitropin alfa and became pregnant during the base Trial 38833. For this follow-up trial (38834), no investigational products will be administered and no study specific assessments are required, but information will be obtained as per standard clinical practice.

Eligibility criteria: Inclusion Criteria:

* Participants who received one dose of corifollitropin alfa in Trial 38833;
* Ongoing pregnancy confirmed by ultrasound at least 10 weeks after embryo transfer in Trial 38833;
* Able and willing to give written informed consent.

Exclusion Criteria:

* None

Primary outcomes:
measure: Number of Expectant Mothers Experiencing Adverse Events (AEs)
timeFrame: Up to 1 Year
measure: Number of Expectant Mothers Experiencing Serious AEs (SAEs)
timeFrame: Up to 1 Year
measure: Number of Infants Experiencing AEs
timeFrame: Up to 1 Year
measure: Number of Infants Experiencing SAEs
timeFrame: Up to 1 Year
measure: Take-Home Baby Rate
timeFrame: Birth of a one or more live babies (Up to 1 year)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Bonduelle M, Mannaerts B, Leader A, Bergh C, Passier D, Devroey P. Prospective follow-up of 838 fetuses conceived after ovarian stimulation with corifollitropin alfa: comparative and overall neonatal outcome. Hum Reprod. 2012 Jul;27(7):2177-85. doi: 10.1093/humrep/des156. Epub 2012 May 15.
Clinical trial NCT06709820: A Study of LY4060874 in Healthy Participants
Official title: A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY4060874 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2024-11-29
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate safety and tolerability of LY4060874 in healthy participants.

Study participation may last up to 22 weeks and up to approximately 16 study visits.


Eligibility criteria: Inclusion Criteria:

* Are overtly healthy as determined by medical evaluation, including medical history and physical examination.
* Have a body mass index in the range of 20 to 29.9 kilogram per meter squared (kg/m²), inclusive, at screening.
* To qualify as Chinese for this study, all 4 of the participant's biological grandparents must be of exclusive Chinese descent and born in China.
* To qualify as a participant of first-generation Japanese origin, the participant, the participant's biological parents, and all the participants' biological grandparents must be of exclusive Japanese descent and born in Japan.

Exclusion Criteria:

* Have a history of or have been diagnosed with Type 1 or Type 2 diabetes mellitus.
* Have hemoglobin A1c (HbA1c) \> 6.4% or 46 millimoles/mole (mmol/mol) at screening.
* Have taken approved, including over the counter (OTC) or prescribed, medication or investigational medication for weight loss, including GLP-1 receptor agonists, within the previous 3 months of study screening.
* Have had surgical treatment for obesity.
* Are actively participating in a weight loss program or intend to initiate an intensive diet and/or exercise program during the study.

Primary outcomes:
measure: Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to 22 Weeks
Secondary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time (AUC) of LY4060874
timeFrame: PK: Part A: Baseline up to 13 weeks; Part B and C: Baseline up to 18 weeks
measure: PK: Maximum Observed Concentration of LY4060874
timeFrame: PK: Part A: Baseline up to 13 weeks; Part B and C: Baseline up to 18 weeks
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Fortrea, Inc.
state: Texas
city: Singapore
country: Singapore
facility: Lilly Centre for Clinical Pharmacology
Study officials:
affiliation: Eli Lilly and Company
name: 1-877-CTLILLY (1-877-285-4559) or 3176154559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: