louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06125327: SC1011 Twice Daily vs Placebo in Patients Diagnosed With Idiopathic Pulmonary Fibrosis (IPF)
Official title: A Randomized, Double-blind, Placebo-controlled Phase II/III Trial Evaluating the Efficacy and Safety of Sufenidone (SC1011) Tablets in Patients With Idiopathic Pulmonary Fibrosis (IPF).
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Idiopathic Pulmonary Fibrosis
Keywords: Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Lung Diseases
Respiratory Tract Diseases
Lead sponsor: Guangzhou JOYO Pharma Co., Ltd
Sponsor class: INDUSTRY
First posted: 2023-11-09
Enrollment: 210
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluating Sufenidone (SC1011) in IPF patients for efficacy and safety. Includes screening, treatment, and follow-up, with FVC decline and health checks.

Detailed description: Randomized, double-blind study comparing Sufenidone (SC1011) and placebo in IPF patients, with interim analysis at 26 weeks to select the optimal dose for a 52-week treatment period followed by 4-week safety monitoring

Eligibility criteria: Inclusion Criteria:

* Ability to understand and sign written informed consent.
* The diagnosis time of IPF before enrollment was less than 5 years.
* Combination of High Resolution Computerized Tomography (HRCT) pattern, and if available surgical lung biopsy pattern, as assessed by central reviewers, are consistent with diagnosis of IPF.
* Dlco (corrected for Hb): 30%-90% predicted of normal.
* FVC\>= 50% predicted of normal.

Exclusion Criteria:

* Forced expiratory volume in one second (FEV1)/FVC ratio \<0.7 after administration of bronchodilator at Screening
* Expected to receive a lung transplant within 1 year from randomization or, for patients at sites in the United States, on a lung transplant waiting list at randomization.
* Known explanation for interstitial lung disease
* History of asthma or chronic obstructive pulmonary disease
* Active infection
* Ongoing IPF treatments including investigational therapy, immunosuppressants, and cytokine modulating agents
* History of unstable or deteriorating cardiac or pulmonary disease (other than IPF) within the previous 6 months

Primary outcomes:
measure: Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks
timeFrame: Primary Outcome measures will be assessed at baseline and again at 52 weeks.
Secondary outcomes:
measure: Change From Baseline in Saint-George's Respiratory Questionnaire (SGRQ) Total Score at 52 Weeks
timeFrame: Baseline and 52 weeks
measure: Time to First Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation.
timeFrame: Secondary outcome measures will be assessed at baseline and again at 52 weeks.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT06165627: Comparison of Clinical Performance of Two Monthly Replacement Toric Soft Contact Lenses
Official title: Comparison of Clinical Performance of Two Monthly Replacement Toric Soft Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ametropia
Astigmatism
Keywords: Contact lenses
Myopia
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2023-12-11
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the clinical performance of TOTAL30 for Astigmatism (T30fA) soft contact lenses with Biofinity Toric soft contact lenses.

Detailed description: Subjects will be expected to attend 5 office visits and will be dispensed study lenses (per randomization sequence) for 30-day duration of bilateral wear with each study lens (approximately 60 days of lens wear). The total duration of the subject's participation in the study will be approximately 74 days.

Eligibility criteria: Key Inclusion Criteria:

* Successful wearer of toric soft contact lenses in both eyes for a minimum of 5 days per week and at least 12 hours per day during the past 3 months;
* Best corrected distance visual acuity (as determined by manifest refraction at screening) better than or equal to 0.10 logMAR in each eye;
* Willing and able to wear the study lenses as specified in the protocol;
* Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

* Biomicroscopy findings at screening that are moderate (Grade 3) or higher and/or corneal vascularization that is mild (Grade 2) or higher; presence of corneal infiltrates;
* Monovision and multifocal contact lens wearers;
* Habitual Biofinity Toric soft contact lens wearers, daily disposable contact lens wearers, and Alcon Toric contact lens wearers in the past 3 months prior to consent;
* Wearing habitual contact lenses in extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Mean Distance Visual Acuity With Study Lenses at Day 30
timeFrame: Day 30 of each wear period. A wear period was 30 days [-1/+3 days] according to randomization assignment.
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Kurata Eye Care Center
state: California
city: Oakland
country: United States
facility: Elsa Pao, OD
state: California
city: San Francisco
country: United States
facility: Pacific Rims Optometry
state: California
city: Orlando
country: United States
facility: Vision Health Institute
state: Florida
city: Granville
country: United States
facility: ProCare Vision Center
state: Ohio
Study officials:
affiliation: Alcon Research, LLC
name: Clinical Trial Lead, Vision Care
role: STUDY_DIRECTOR
References:
Clinical trial NCT04990427: CLBS201 in Patients with Chronic Kidney Disease (CKD) and Type 2 Diabetes Mellitus (T2DM)
Official title: A Phase 1 Open-Label, Proof-of-Concept Study to Evaluate the Safety and Efficacy of CLBS201 Autologous Peripheral Blood-Derived CD34+ Cells in Subjects with Chronic Kidney Disease and Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Kidney Diseases
Keywords: Chronic Kidney disease
Type 2 Diabetes Mellitus
Diabetic Kidney disease
Lead sponsor: Lisata Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2021-08-04
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: CLBS201 will evaluate the safety, tolerability, and therapeutic effect in subjects with CKD and T2DM.


Eligibility criteria: Inclusion Criteria:

1. Adults aged 18 to 75 years, inclusive
2. Documented diagnosis of type 2 diabetes
3. eGFR of 30 to \<45 mL/min/1.73m at the screening visit.
4. UACR 300 mg/g to ≤ 5000 mg/g

Exclusion Criteria:

1. Hemoglobin \< 10 g/dL
2. Hemoglobin A1c ≥8% at the time of screening
3. Acute kidney injury within 6 months prior to screening

Primary outcomes:
measure: Serious Adverse Events
timeFrame: 6 Months
Secondary outcomes:
measure: Estimated Glomerular Filtration Rate (eGFR)
timeFrame: 6 Months
measure: UACR & UPCR
timeFrame: 6 Months
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Clinical Advancement Center, PLLC
state: Texas
Study officials:
affiliation: Lisata Therapeutics, Inc.
name: Kristen K Buck, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03815227: Outpatient Birth: Pilot Study
Official title: Outpatient Birth: Pilot Study to Assess the Feasibility of Maternity Out the Same Date or the Next Day of the Birth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Outpatient Birth
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
First posted: 2019-01-24
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The diminution of the average length stay (ALS) in French maternity is a clear evolution, the objective of the draft law on social security is to reduce the ALS to equal other OECD countries. The over-medicalization of maternal health raises the question of relevant and iatrogeny of Professional practices. Furthermore, pregnant woman, future parents expressed their wish for an individual support and more physiological respectful. A more-effective Professional coordination is expected where the midwife is a major player.

Detailed description: The aim of the study is to identify and evaluate an outpatient birth path during the first 24 hours after the birth.

Eligibility criteria: Inclusion Criteria:

* With no multiple pregnancy, of less than 20 weeks of gestation
* With a BMI between 17,5 and 35 kg/m²
* is able to understand research's informations
* affiliated member of the social security system
* Have given an informed consent

Exclusion Criteria:

* With psychological vulnerability, social vulnerability, addictions and high dependency
* With an unbalanced chronic pathology or susceptible to contraindicated a physiologic birth
* With history of caesarean, foeto-maternal incompatibility, gestational hypertension, pre-eclampsia, HELLP syndrome or retro-placental hematoma, sphincter tear
* With history of birth with perinatal asphyxia and sequelae or an unexplained perinatal death
* With history of puerperal psychosis
* Under guardianship

Primary outcomes:
measure: Output rate
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Thionville
country: France
facility: CHR Metz Thionville
state: Moselle
Study officials:
References:
Clinical trial NCT05604027: Pain Types and Pain Severity in Chronic Low Back Pain
Official title: The Effects of Pain Types on Pain Severity and Quality of Life in Chronic Low Back Pain
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Low-back Pain
Lead sponsor: Konya Beyhekim Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2022-11-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who come to the hospital for chronic low back pain

Brief summary: The aim of this study is to characterize the distribution of pain phenotypes in people with chronic low back pain and to determine the effects of pain phenotypes on pain severity, functional status and quality of life.

Participants will be examined to determine the type of pain and questions will be asked to identify the effects.


Eligibility criteria: Inclusion Criteria:

* having chronic low back pain
* be over 18 years old

Exclusion Criteria:

* Those under the age of 18
* Those with major psychiatric illness,
* Those with communication problems

Primary outcomes:
measure: identification of pain types(determination of nociceptive, neuropathic, nociplastic pain rates)
timeFrame: 01.03.2023
measure: Pain levels of those with nociplastic, neuropathic and nociceptive pain
timeFrame: 01.03.2023
measure: pain effect
timeFrame: 01.03.2023
measure: disability,
timeFrame: 01.03.2023
measure: patient's feelings, thoughts, and feelings about pain and disaster.
timeFrame: 01.03.2023
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Konya Beyhekim Research and Training Hospital
state: Selçuklu
Study officials:
References:
Clinical trial NCT02260427: A Comparison of the I-gel and Self-pressurised Air-Q Intubating Laryngeal Airway (Air-Q sp) in the Elderly Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Supraglottic Airway Device
Keywords: elective surgery
undergoing general anesthesia
elderly adult patients
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-10-09
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Supraglottic airway devices (SADs) are well established in anesthetic practice. Among these devices, the i-gel has been typically widely used. The self-pressurised air-Q intubating laryngeal airway (air-Q sp) is newly developed supraglottic airway devices. It is a new single-use device that may optimise the airway sealing while reducing the potential for postoperative complications such as sore throat. The overall structure of the air-Q sp is similar to the original air-Q, except the inflatable cuff. The aim of this randomized trial was to compare the clinical performance of the i-gel and the air-Q sp in elderly patients


Eligibility criteria: Inclusion Criteria:

1. elderly adult patients (65-90 of age) scheduled for elective surgery undergoing general anesthesia using supraglottic airway

Exclusion Criteria:

1. Patients with a potentially difficult airway, risk of aspiration such as gastroesophageal reflux disease, or active upper respiratory tract infection

Primary outcomes:
measure: airway leak pressure measured after device insertion
timeFrame: within 5min after insertion of each device
Secondary outcomes:
measure: insertion parameters (insertion time and ease of insertion)
timeFrame: During and 1 min after insertion of each device
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University College of Medicine, Gangnam Severance Hospital, 211 Eonju-ro, Gangnam-gu
Study officials:
affiliation: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research institute, Yonsei University College of Medicine, Seoul
name: Min-Soo Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee JS, Kim DH, Choi SH, Ha SH, Kim S, Kim MS. Prospective, Randomized Comparison of the i-gel and the Self-Pressurized air-Q Intubating Laryngeal Airway in Elderly Anesthetized Patients. Anesth Analg. 2020 Feb;130(2):480-487. doi: 10.1213/ANE.0000000000003849.
Clinical trial NCT02628327: Factors Influencing Patient Satisfaction in a Glaucoma Population
Official title: Factors Influencing Patient Satisfaction in a Glaucoma Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Keywords: glaucoma care
quality of life
patient satisfaction
Lead sponsor: Wills Eye
Sponsor class: OTHER
First posted: 2015-12-11
Enrollment: 250
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: Glaucoma or glaucoma suspect

Brief summary: 1. To administer a questionnaire to patients seen by Wills Eye Glaucoma Department physicians at Wills Eye Hospital assessing satisfaction with their office visit, vision related quality of life, and related issues.
2. To collect and de-identify information from each participant's medical chart related to their care including information pertaining to demographics, disease severity, and prior and current treatment
3. To assess the correlations between demographic factors, vision related quality of life, eye disease, and treatments with patient satisfaction survey responses.

Detailed description: This prospective study aims to recruit up to 250 patients being seen by glaucoma specialists at Wills Eye Hospital. Informed consent will be obtained prior to the office visit. Patients will complete a satisfaction survey with a few additional questions about themselves and their vision. Electronic health records (EHR) will be used to collect race, gender, age, glaucoma diagnosis, current and prior treatments, timing of appointment and care, visual acuity and field data, and distance to patient's home. Additional information captured will include weather, time of day, day of week.

In addition to completing the questionnaire subjects will be asked to provide their name and date of birth. Trained research staff members will use this information to find patients on the EHR system. A research assistant will later abstract information from the patient's EHR. This information will be tagged to the survey by a unique identifier, but all patient identity related information will be removed, including name and date of birth. Patients will be made aware that research staff will be retrieving their protected health information (PHI) for the purpose of this study through the consent form.

Eligibility criteria: Inclusion Criteria:

Age \> 18 years; patients who have a scheduled appointment at with a glaucoma specialist at Wills Eye Hospital; diagnosis of glaucoma or glaucoma suspect

Exclusion Criteria:

Children under the age of 18; inability to give informed consent; patients who are physically and/or mentally incapable of filling out a paper survey; patients who are not literate in English.

Primary outcomes:
measure: Quality of Life assessment
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Wills Eye Hospital
state: Pennsylvania
Study officials:
affiliation: Wills Eye Hospital
name: Jonathan Myers, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02100527: Study Of Safety, Tolerability And Effects Of PF-05175157 In Adults With Moderate To Severe Acne Vulgaris
Official title: A Phase 2a Randomized, Double-blind, Placebo-Controlled Study To Evaluate The Safety, Tolerability And Effects Of PF-05175157 On Moderate To Severe Acne Vulgaris In Adult Subjects
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Acne Vulgaris
Keywords: safety
tolerability
pharmacokinetics
oral dosing
moderate to severe acne vulgaris
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-04-01
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a 6 week study to characterize the safety, tolerability and effects of PF-05175157 administered for 6 weeks in subjects with moderate to severe acne vulgaris.


Eligibility criteria: Inclusion Criteria:

* Males 18 years or older diagnosed with moderate to severe acne vulgaris who are otherwise healthy.
* Normal spirometry at screening (FEV1 and FVC (Forced Vital Capacity)at least 80% predicted).
* Minimum of 20 inflammatory lesions on the face.
* Willing to discontinue other acne treatments prior to and during the study period through follow-up.

Exclusion Criteria:

* Subjects with active nodulocystic acne.
* Subjects unwilling to comply with lifestyle guidelines, commit to study visits, and perform study procedures.
* History of dry eye or other known disease that affects the sclera or cornea.
* History of pulmonary disease or inability to adequately perform testing.

Primary outcomes:
measure: Safety and tolerability
timeFrame: Weeks 2, 4, and 6
Secondary outcomes:
measure: Sebum measurements
timeFrame: Weeks 2, 4, and 6
measure: Pharmacokinetics of PF-05175157
timeFrame: Weeks 2, 4, and 6
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06295627: The Analysis of Factors Causing Indwelling Urinary Catheter-related Infections in ICU Patients and Their Nursing Strategies
Official title: The Analysis of Factors Causing Indwelling Urinary Catheter-related Infections in ICU Patients and Their Nursing Strategies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Catheter-associated Urinary Tract Infection
Keywords: ICU
Catheter-associated
Factors
NursingCountermeasures
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2024-03-06
Enrollment: 291
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 291 patients with indwelling urinary catheters in the second area of ICU of our hospital from January 1, 2023 to September 30, 2023 were selected as research subjects.

Brief summary: To explore the analysis of factors causing indwelling urinary catheter-related infections in ICU patients and their nursing strategies, and to provide reference for clinical nursing work. 291 patients with indwelling urinary catheters in the second area of ICU of our hospital from January 1, 2023 to September 30, 2023 were selected as research subjects. They were divided into infection group and non-infection group according to the presence or absence of urinary tract infection. Non-infection group The first group consisted of patients without urinary tract infection (278 cases), and the infection group consisted of patients with urinary tract infection (13 cases). A retrospective analysis method was used to analyze the causes of catheter-related urinary tract infection and the infecting bacteria of the two groups of patients. A single factor analysis was performed on various factors and other related factors, and corresponding nursing strategies were summarized and proposed.


Eligibility criteria: Inclusion Criteria:

* Age \> 14 years
* Patients with indwelling urinary tube during hospitalization
* Length of stay in ICU \> 48h
* Complete hospitalization data

Exclusion Criteria:

* Had urinary tract infection before hospitalization
* Indwelling catheter \< 72h
* Severe liver and kidney failure and death within 48 hours of admission

Primary outcomes:
measure: How many patients in the infected group and how many patients in the non-infected group had bladder irrigation
timeFrame: 2023.1.1-2023.9.30
measure: How many patients in the infected group and how many patients in the non-infected group were given enema
timeFrame: 2023.1.1-2023.9.30
measure: How many times the indwelling catheter was changed in patients in the infected group and patients in the non-infected group respectively
timeFrame: 2023.1.1-2023.9.30
measure: How many patients in the infected group and the non-infected group had co-diabetes
timeFrame: 2023.1.1-2023.9.30
Secondary outcomes:
Other outcomes:
Locations:
city: Canton
country: China
facility: Sun Yat-Sen Memorial Hospital
state: Guangdong
Study officials:
References: