louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05498350: Randomized Trial Comparing Early "Trigger" Versus Delayed "Trigger" Timing in Cycles of Controlled Ovarian Stimulation.
Official title: Randomized Trial Comparing Early "Trigger" Versus Delayed "Trigger" Timing in Cycles of Controlled Ovarian Stimulation.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infertility, Female
Lead sponsor: Fertility Center of Las Vegas
Sponsor class: INDUSTRY
First posted: 2022-08-12
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized trial will compare the efficacy of two different times of administration of medications for final oocyte maturation, commonly called a "trigger", in cycles of controlled ovarian stimulation (COS) for cycles in which all embryos will be cryopreserved ("freeze-all cycles").

Detailed description: This randomized trial will compare the efficacy of two different times of administration of medications for final oocyte maturation, commonly called a "trigger", in cycles of controlled ovarian stimulation (COS) for cycles in which all embryos will be cryopreserved ("freeze-all cycles").

1. The early trigger timing will be based on sonographic observation of at least three follicles reaching at least 17mm in diameter.
2. The delayed trigger timing will be based on at least three follicles reaching at least 22mm in diameter.

Eligibility criteria: Inclusion Criteria:

1. Adult female at least 18 years of age and less than 35 years of age intending to undergo ovarian stimulation for a cycle of IVF with all embryos to be frozen that attain the blastocyst stage.
2. Anticipated at least normal ovarian response evidenced by at least 8 antral follicles observed on ultrasound or a serum level of at least 1.5 ng/ml AMH.
3. Ability read and understand English sufficiently to obtain informed consent.
4. Patients with prior IVF cycles are allowed, but no patient can undergo more than one cycle with oocyte collection under this study.

Exclusion Criteria:

1. Any cycle type that would preclude immediate culture to blastocyst stage (e.g. oocyte banking).
2. Any condition that, in the opinion of the physician or principal investigator, would place the patient at undue risk under this protocol or would otherwise make the protocol inappropriate for that subject.

Primary outcomes:
measure: Good-quality blastocysts
timeFrame: Within 7 days of oocyte retrieval
measure: Delayed blastocyst formation
timeFrame: Within 7 days of oocyte retrieval
Secondary outcomes:
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: Fertility center of Las Vegas
state: Nevada
Study officials:
References:
Clinical trial NCT00739050: Effect of Simvastatin on Endothelial Function in Premenopausal Women With Systemic Lupus Erythematosus (0733-271)(TERMINATED)
Official title: Effect of Simvastatin on Endothelial Function in Premenopausal Women With Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Systemic Lupus Erythematosus
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2008-08-21
Enrollment: 4
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Women with Systemic Lupus Erythematosus (SLE) are prone to cardiovascular disease. Early detection of improvement of endothelial function with simvastatin could be a clue for future intervention trials.


Eligibility criteria: Inclusion Criteria:

* Female Patients Over 18 Years Old
* Confirmed Systemic Lupus Erythematosus (SLE) diagnosis according to American College of Rheumatology (ACR)
* Signed Informed Consent Form (ICF)

Exclusion Criteria:

* Patients With LDL-C Below 90 mg/dL
* Pregnant Or Breast Feeding
* Diabetes Mellitus
* Or Any Clinically Relevant Organ Disfunction

Primary outcomes:
measure: Change From Baseline in Endothelial Thickness After 12 Weeks of Treatment.
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Change in Total Cholesterol From Baseline at Week 12
timeFrame: Baseline and 12 weeks
measure: Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) After 12 Weeks of Treatment
timeFrame: Baseline and 12 weeks
measure: Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) After 12 Weeks of Treatment
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00714350: Evaluation of Information Displays A Paper & Pencil, Computer, Simulator, and ICU Based Study
Official title: Evaluation of Information Displays A Paper & Pencil, Computer, Simulator, and ICU Based Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Information Display
situational awareness
Create intuitive visualization
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2008-07-14
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ICU nurses

Brief summary: Our objective is to develop intuitive, meaningful and ergonomically efficient informative displays specific to the user's domain. Specifically we aim to enhance and refine the display prototype of ABG information to include gas-exchange, acid-base balance, lung mechanics, ventilation, oxygenation, and metabolism information.

Detailed description: To create an intuitive and meaningful visualization of Arterial Blood Gas (ABG) variables, it is necessary to address usability, ergonomics, domain specific, and expertise specific issues and concerns. Our objective is to develop intuitive, meaningful and ergonomically efficient informative displays specific to the user's domain. Specifically we aim to enhance and refine the display prototype of ABG information to include gas-exchange, acid-base balance, lung mechanics, ventilation, oxygenation, and metabolism information.

Eligibility criteria: Inclusion Criteria: ICU nurses Exclusion Criteria: All participants were screened and excluded from participation if they had previously participated in any of graphical display design and feedback sessions when developing the ICU display.

Primary outcomes:
measure: Nurses using the new ICU display will detect and communicate to an attending physician (confederate) more abnormal patient physiological states than when using the tabular (control) display.
timeFrame: At time of observation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Utah
name: Michael Behrens
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02232750: Evaluation of CPD MNV as an Aid in the Diagnosis and Risk Assessment of Sepsis (Protocol # Sepsis 1-14)
Official title: Evaluation of CPD (Cell Population Data) MNV (Mean Neutrophil Volume) as an Aid in the Diagnosis and Risk Assessment of Sepsis (Protocol # Sepsis 1-14)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis, Severe Sepsis and Septic Shock
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2014-09-05
Enrollment: 1320
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Emergency Department

Brief summary: The investigators hypothesize that CPD parameters will provide improved prediction of sepsis compared to currently employed laboratory parameters. These studies hold the potential to shape practitioner guidelines and improve the timeliness and accuracy with which patients with sepsis are treated today.


Eligibility criteria: Inclusion Criteria:

* Adult (≥18 to 90 years)
* Patients presenting to the Emergency Department
* CBC (Complete Blood Count) with differential testing performed and CPD data retrieved

Exclusion Criteria:

* Previously enrolled in this study

Primary outcomes:
measure: We are measuring CBC (complete blood count) and MNV (Mean Neutrophil Volume)
timeFrame: approximately 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Wexner Medical Center at The Ohio State University
state: Ohio
Study officials:
References:
citation: Crouser ED, Parrillo JE, Seymour C, Angus DC, Bicking K, Tejidor L, Magari R, Careaga D, Williams J, Closser DR, Samoszuk M, Herren L, Robart E, Chaves F. Improved Early Detection of Sepsis in the ED With a Novel Monocyte Distribution Width Biomarker. Chest. 2017 Sep;152(3):518-526. doi: 10.1016/j.chest.2017.05.039. Epub 2017 Jun 15.
Clinical trial NCT02297750: Optimal Timing of Double-Wire Technique For Biliary Cannulation at ERCP
Official title: Optimal Timing of Double-Wire Technique For Biliary Cannulation at ERCP
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endoscopic Retrograde Cholangiopancreatography
Keywords: The focus of the study is double-wire technique versus single wire technique in patients undergoing ERCP with biliary cannulation as the primary objective.
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2014-11-21
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to give doctors who perform Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures a better idea as to the best techniques to use in order to examine the bile duct as quickly and safely as possible.

Detailed description: Sometimes, in the course of a regular ERCP procedure, techniques used by the doctor to pass a wire into the bile duct can result in the pancreas duct being entered instead. When this happens, the doctor may either remove the wire (known as "single wire" technique) or leave it in and use a second wire ("double wire") to enter the bile duct. This study will try to determine whether the "double wire" technique or the "single wire" technique removing the wire is the safest and most efficient.

Eligibility criteria: Inclusion Criteria:

1. Patients undergoing ERCP with primary intent to cannulate the bile duct
2. Written informed consent

Exclusion Criteria:

1. Age \< 18 years
2. Non-naive papilla (previous sphincterotomy)
3. Surgically altered anatomy
4. Known/suspected pancreas divisum
5. Suspected SOD/biliary manometry
6. Prior ERCP/stent within 3 months
7. ERCP performed in the Operating Room or at Duke North
8. Pregnancy/breast-feeding

Primary outcomes:
measure: Success of biliary cannulation
timeFrame: 10 minutes after randomization
Secondary outcomes:
measure: Success of biliary cannulation
timeFrame: 2 days after the procedure
measure: Time to successful biliary cannulation
timeFrame: 2 days after the procedure
measure: Post-ERCP pancreatitis
timeFrame: 2 days after the procedure
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Mahfuzul Haque, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00021723: Randomized Safety, Tolerability and Pilot Efficacy of AN-1792 in Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Alzheimer's Disease
Keywords: Alzheimer's
AN-1792
AIP-001
Lead sponsor: JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Sponsor class: INDUSTRY
Collaborators: name: Wyeth is now a wholly owned subsidiary of Pfizer
First posted: 2001-08-06
Enrollment: 375
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A multi-center, double-blind, placebo-controlled out-patient, safety, tolerability, and pilot efficacy study of intramuscular AN-1792 in patients with mild to moderate Alzheimer's disease.

Detailed description: The study will enroll approximately 375 patients with mild to moderate Alzheimer's disease at investigational sites in the United States and Europe. Patients will receive either AN-1792 or placebo, and they will be evaluated using standard clinical assessments of cognition and memory as well as experimental surrogate markers of Alzheimer's disease pathology. The goal of the study is to evaluate the clinical impact of eliciting an immune response (formation of antibodies) to the A-beta peptide in patients with Alzheimer's disease.

Eligibility criteria: Mild to moderate Alzheimer's disease. Ability to cooperate with MRI scanning and neuropsychological testing. Live at home or in the community and a caregiver capable of accompanying the patient on all clinic visits and visiting the patient at least 5 times per week.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Peoria
country: United States
facility: Pivotal Research Centers
state: Arizona
city: Phoenix
country: United States
facility: 21st Century Neurology
state: Arizona
city: Beverly Hills
country: United States
facility: California Clinical Trials
state: California
city: La Jolla
country: United States
facility: UCSD Medical Center
state: California
city: Northridge
country: United States
facility: Pharmacology Research Institute
state: California
city: Bay Harbor Islands
country: United States
facility: Baumel-Eisner Neuromedical Institute
state: Florida
city: Boca Raton
country: United States
facility: Baumel-Eisner Neuromedical Institute
state: Florida
city: Ft. Lauderdale
country: United States
facility: Baumel-Eisner Neuromedical Institute
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Tulsa
country: United States
facility: Clinical Pharmaceutical Trials, Inc.
state: Oklahoma
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
References:
Clinical trial NCT03672123: GDF-15 Levels in Risk Stratification in Acute Pulmonary Embolism
Official title: GDF-15 Levels in Risk Stratification in Acute Pulmonary Embolism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Embolism
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
Collaborators: name: National Science Center, Poland
First posted: 2018-09-14
Enrollment: 270
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: The study will recruit 270 patients.

Brief summary: Prospective observational study evaluating serum GDF-15 levels in patients with acute pulmonary embolism.

Detailed description: Prospective observational study evaluating serum GDF-15 levels in patients with acute pulmonary embolism (APE).

In APE right ventricle failure developing due to ischemia and myocarditis is considered the primary cause of death, however, its pathomechanism has not been fully established yet. Growth differentiation factor 15 (GDF-15) is a chemokine secreted by activated macrophages in response to oxidative stress. It has now been shown that ischemic injury, mechanical stretch, and pro-inflammatory cytokines also stimulate the expression of GDF-15 in cardiac myocytes. The objective of this project is to describe the role of GDF-15 in the pathomechanism of acute right ventricle failure in the setting of acute pulmonary embolism and to verify the hypothesis that higher serum concentrations of GDF-15 are associated with more advanced right ventricle dysfunction and failure.

Eligibility criteria: Inclusion Criteria:

* Adult patients with APE hospitalized who give written consent.

Exclusion Criteria:

* lack of informed consent
* APE with symptoms lasting above 14 days before the admission
* acute coronary syndrome, diagnosed pulmonary hypertension
* severe valve disease
* sepsis
* active malignancy
* diagnosed mitochondrial diseases
* chronic kidney disease at least stage 4 (KDIGO)
* pregnancy.

Primary outcomes:
measure: hemodynamic deterioration
timeFrame: assessed daily through study completion, average of 10 days
Secondary outcomes:
measure: Hemorrhagic complications
timeFrame: assessed daily through study completion, average of 10 days
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Department of Internal Medicine & Cardiology with the Centre for Management of Venous Thromboembolic Disease, Medical University of Warsaw
Study officials:
affiliation: Medical University of Warsaw
name: Marta Z Skowronska, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of Warsaw
name: Piotr Pruszczyk, Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05653323: A Phase 1 Dose Escalation Study of VX-993 in Healthy Participants
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple-dose Escalation Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of VX-993 in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2022-12-16
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of VX-993 at different doses in healthy participants.

Detailed description: This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Eligibility criteria: Key Inclusion Criteria:

* Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (kg/m\^2)
* A total body weight of more than (\>) 50 kg
* Participants of non-childbearing potential
* Nonsmoker or ex-smoker for at least 3 months before screening

Key Exclusion Criteria:

* History of febrile illness or other acute illness within 14 days before the first dose of study drug
* Any condition possibly affecting drug absorption

Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Day 1 up to Day 25
measure: Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Day 1 up to Day 25
measure: Part B: Safety and Tolerability as Assessed by Number of Participants With Clinically Meaningful Findings in Columbia Suicide Severity Rating Scale (C-SSRS) Responses
timeFrame: Pre-dose up to Day 25
Secondary outcomes:
measure: Part A: Maximum Observed Plasma Concentration (Cmax) of VX-993
timeFrame: Pre-dose up to Day 25
measure: Part B: Maximum Observed Plasma Concentration (Cmax) of VX-993
timeFrame: Pre-dose up to Day 25
measure: Part A: Area Under the Concentration Versus Time Curve (AUC) of VX-993
timeFrame: Pre-dose up to Day 25
measure: Part B: Area Under the Concentration Versus Time Curve (AUC) of VX-993
timeFrame: Pre-dose up to Day 25
measure: Part B: Pain Tolerance Threshold (PTT) for the Cold Pressor Test
timeFrame: Day 1, Day 10, and Day 11
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: MAC Clinical Research
Study officials:
References:
Clinical trial NCT04725123: Addressing Personalized Needs in Clostridioides Difficile Infection
Official title: Bezlotoxumab Yielded Outcomes by Addressing Personalized Needs in Clostridioides Difficile Infection: Study Phase 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Clostridioides Difficile Infection
Keywords: Clostridioides difficile
Microbiome
Prediction
Unfavorable outcome
Lead sponsor: Hellenic Institute for the Study of Sepsis
Sponsor class: OTHER
First posted: 2021-01-26
Enrollment: 153
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: BEYOND is aiming to demonstrate how by enrichment of the available SPECIFY score, patients at great likelihood for CDI with unfavorable outcome are early detected

Detailed description: In a previous project, following GWAS analysis of the DNA and measurement of serum biomarkers coming from 134 patients a prediction score named SPECIFY was developed. The SPECIFY score comprises four elements: low hemoglobin, increased urea, increased IL-8 and carriage of G alleles of rs2091172. The score has 80% positive predictive value and 95.8% specificity for the early detection of unfavorable outcome but the sensitivity is low. Unfavorable outcome is defined as any of: presentation or progression into severe CDI, relapse; and death. Stool samples of day 1 before start of therapy of the patients are stored refrigerated. Microbiome analysis will be done aiming to the integration of the Shannon diversity index to the already developed score in order to improve sensitivity.

Eligibility criteria: Inclusion Criteria:

* Age more than or equal to 18 years
* Both genders
* Diarrhea defined as at least 3 episodes of unformed stools in the last 24hours according to the Bristol stool chart
* Presence of C.difficile in stool. This is defined as any stool sample positive for the presence of glutamate dehydrogenase (GDH) and for the presence of toxin A and/or B.

Exclusion Criteria:

• No exclusion criteria apply

Primary outcomes:
measure: Prediction of unfavorable outcome
timeFrame: 40 days
Secondary outcomes:
measure: Diagnostic PCR reaction in stool
timeFrame: 40 days
Other outcomes:
Locations:
city: Athens
country: Greece
facility: 4th Department of Internal Medicine, ATTIKON University General Hospital
Study officials:
affiliation: National and Kapodistrian University of Athens
name: Evangelos J Giamarellos-Bourboulis, MD, PhD
role: STUDY_CHAIR
References: