louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02176538: Study Comparing Product 0405 to a Vehicle Control in the Treatment of Mild to Moderate Atopic Dermatitis in Pediatric Subjects
Official title: A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing Product 0405 To A Vehicle Control In The Treatment Of Mild To Moderate Atopic Dermatitis In Pediatric Subjects
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Atopic Dermatitis
Lead sponsor: Fougera Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2014-06-27
Enrollment: 0
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of product 0405 in pediatric subjects with Mild to Moderate Atopic Dermatitis.

Detailed description: Treatment medication will be administered topically twice daily for 28 days

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Atopic Dermatitis
* Good health with the exception of Atopic Dermatitis
* Percent body surface area minimum requirements

Exclusion Criteria:

* Subjects who are pregnant, nursing or planning a pregnancy

Primary outcomes:
measure: Statistically significant superiority of the test Product 0405 to the vehicle
timeFrame: 28 days
Secondary outcomes:
measure: Incidence of success based on the Investigators Static Global Assessment and the Clinical Signs and Symptoms (erythema, scaling) at the end of treatment.
timeFrame: 28 days
Other outcomes:
Locations:
Study officials:
affiliation: Fougera Pharmaceuticals Inc.
name: Angela C Kaplan
role: STUDY_DIRECTOR
References:
Clinical trial NCT03973138: Visual Outcomes and the Predictive Factors in Chinese Patients With Diabetic Macular Edema Treated With Ranibizumab
Official title: Visual Outcomes and the Predictive Factors in Chinese Patients With Diabetic Macular Edema Treated With Ranibizumab
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Diabetic Macular Edema
Keywords: Macular edema
ranibizumab
Mpredictive factor
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2019-06-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the one-year visual outcome and prognostic factors after intraocular injections of ranibizumab under pro re nata treatment regimen for the patients with diabetic macular edema (DME).

Detailed description: The aim of this study is to evaluate the one-year visual outcome and prognostic factors after intraocular injections of ranibizumab under pro re nata treatment regimen for the patients with diabetic macular edema (DME). Mean change of logarithm of the minimal angle of resolution (logMAR) visual acuity (VA), central foveal thickness (CFT), as well as predictive factors including best-corrected visual acuity (BCVA) were assessed.

Eligibility criteria: Inclusion Criteria:

* 1) patients (aged\>18 years) with DME who had a best-corrected visual acuity (BCVA) between 20/32 and 20/200, and CRT≥300μm; 2) clinically significant DME confirmed by both fundus fluorescein angiography (FFA) and optical coherence tomography (OCT) (Spectralis HRA+OCT; Heidelberg Engineering, Germany); 3) decreased vision caused by foveal thickening from DME, which could not be explained by any other cause.

Exclusion Criteria:

* 1) previous anti-VEGF or laser treatment; 2) proliferative diabetic retinopathy who required immediate panretinal photocoagulation; 3) active proliferative diabetic retinopathy; 4) other causes for macular edema, for example, branch retinal vein occlusion; 5) other causes of visual loss in the study; 6) unstable systemic conditions, for example, uncontrolled blood pressure, stroke, renal or kidney failure.

Primary outcomes:
measure: Best-corrected visual acuity
timeFrame: one year
Secondary outcomes:
measure: Central foveal thickness
timeFrame: one year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Kunbei Lai
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Chenjin Jin, ph.D.
role: STUDY_CHAIR
References:
citation: Lai K, Huang C, Li L, Gong Y, Xu F, Zhong X, Lu L, Jin C. Anatomical and functional responses in eyes with diabetic macular edema treated with "1 + PRN" ranibizumab: one-year outcomes in population of mainland China. BMC Ophthalmol. 2020 Jun 15;20(1):229. doi: 10.1186/s12886-020-01510-0.
Clinical trial NCT00442338: Study of MK-0476 in Adult Patients With Acute Asthma (0476-334)
Official title: MK-476 IV Formulation Phase III Open Label Exploratory Comparative Study - Acute Exacerbations of Asthma -
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2007-03-01
Enrollment: 91
Sex: ALL
Minimum age (years): 15
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study estimates the efficacy and safety of MK0476 and aminophylline intravenous administration in adult participants with acute asthma.


Eligibility criteria: Inclusion Criteria:

* Adult participants with acute asthma attacks

Exclusion Criteria:

* Participant has any known or suspected, acute or chronic cause for their pulmonary symptoms other than asthma (e.g., COPD, chronic heart failure, etc.).
* Participant has a smoking habit (15 cigarettes per day) within a month prior to screening period, and/or has a smoking history (20 cigarettes per day) of more than 15 years.
* Participant has a disease of the cardiovascular, hepatic, renal, hematologic systems, or other severe disease.

Primary outcomes:
measure: Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Within the First 60 Minutes After Administration
timeFrame: Baseline and 60 minutes after study drug administration
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06534138: Exercise Inhibit Innate Immune Response and Ameliorate Chronic Pancreatitis
Official title: An Observational Study on the Role of Exercise in the Disease Progression of Chronic Pancreatitis.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pancreatitis
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2024-08-02
Enrollment: 121
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The 105 patients with CP were categorized into the sedentary group (CP-Sed, n = 54) and exercise group (CP-Ex, n = 51) based on self-reported exercise time per day during the six-month follow-up post the diagnosis of CP. Physical exercise time was recorded at four levels: 15 min/d, 30 min/d, 45 min/d, and 60 min/d or more.

Brief summary: The goal of this observational study is to learn about the effects of different physical exercise on disease progression in patients with chronic pancreatitis. The main question it aims to answer is:

Can physical exercise alleviate the disease progression of chronic pancreatitis?

Currently, the investigators have followed up with participants through a telephone questionnaire for six months to investigate whether the participants have engaged in physical exercise and to assess the disease progression of chronic pancreatitis.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of chronic pancreatitis
* Must be adhere to the guidelines of the American Gastroenterological Association

Exclusion Criteria:

* Autoimmune pancreatitis
* Pancreatic cancer diagnosed within 2 years after the onset of CP
* Use of drugs or toxins, or presence of viral infections

Primary outcomes:
measure: Physical Exercise Can Alleviate the Disease Progression of Chronic Pancreatitis.
timeFrame: Six months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT00777608: A Study to Test the Performance of the CogState Computerized Neuropsychological Battery in Patients With Alzheimer's Disease (0000-086)(COMPLETED)
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial, With Placebo Run-In, and an Open-Label Treatment Period, to Evaluate the Performance of the CogState Computerized Neuropsychological Battery and the ADAS-Cog in Generally Cholinesterase-naive AD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-10-22
Enrollment: 106
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the performance of the CogState computerized neuropsychological battery, Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) and Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) in participants with mild-to-moderate Alzheimer's disease (AD).


Eligibility criteria: Inclusion Criteria:

* Participant is ambulatory, male or female and 55 years of age or older
* Participant has reliable informant/caregiver who can communicate effectively with the study site and personnel

Exclusion Criteria:

* Participant has a history within the last 6 months or current evidence of a psychotic disorder or an active major depressive disorder or participant has any history of schizophrenia
* Participant has a history of multiple and/or serious allergies to drugs or food or a history of an allergic reaction to more than 3 drug classes

Primary outcomes:
measure: Change in Mean Computer-based Cognitive Assessment (CogState) Composite Score at Week 4
timeFrame: Baseline and 4 weeks
Secondary outcomes:
measure: Evaluate the Efficacy of Donepezil by Determining the Change in Mean CogState Composite Score at Week 2, Week 8 and Week 12
timeFrame: Baseline and 2 weeks, 8 weeks and 12 weeks
measure: Evaluate the Efficacy of Donepezil by Determining the Change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Score at Week 4, Week 8 and Week 12
timeFrame: Baseline and 4 weeks, 8 weeks and 12 weeks.
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03016208: The Misoprostol Vaginal Insert for Labour Induction
Official title: The Misoprostol Vaginal Insert Used in Standard Compared With Adjusted Criteria for Labour Induction in Term Pregnancies: a Non-interventional Case Control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Labour Induction
Lead sponsor: Asklepios Kliniken Hamburg GmbH
Sponsor class: OTHER
First posted: 2017-01-10
Enrollment: 138
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A cohort of 138 pregnant women ≥ 37/0 weeks undergoing labour induction.

Brief summary: Objective: To compare the efficacy and safety of the misoprostol vaginal insert (MVI) for labour induction using standard (MVI-24) and adjusted (MVI-10) criteria.

Design: Non-interventional observational case control study.

Setting: Tertiary-care academic centre in Germany.

Population: A cohort of 138 pregnant women ≥ 37/0 weeks undergoing labour induction.

Methods: Induction of labour with MVI in a consecutive series of women using standard (MVI-24, n = 69) or adjusted (MVI-10, n = 69) criteria.

Main outcome measures: The primary outcomes were the time from induction to delivery and the caesarean section rate. The secondary outcomes included the need for additional measures to induce labour, uterine tachysystole, tocolysis, fetal scalp blood testing, meconium-stained amniotic fluid, umbilical arterial pH, and Apgar score.


Eligibility criteria: Inclusion Criteria:

* gynecologist's indication for induction
* informed consent
* ≥ 37 weeks of gestation
* singleton pregnancies
* cephalic presentation
* cervical Bishop score of \< 5 before priming reassuring fetal heart rate

Exclusion Criteria:

* known hypersensitivity to prostaglandins
* uterine scar
* parity \> 5
* any contraindication for vaginal delivery
* cephalopelvic disproportion
* placenta praevia
* chorioamnionitis
* antepartum bleeding of unknown etiology
* cardiopulmonary, renal, hepatic maternal disease
* glaucoma
* fetal congenital abnormalities

Primary outcomes:
measure: Time from induction to delivery in minutes
timeFrame: August 2016
measure: Rate of participants receiving a caesarean section compared to all participants being induced
timeFrame: August 2016
Secondary outcomes:
measure: Number of participants with treatment-related tachysystole as assessed by cardiotocography
timeFrame: August 2016
measure: Number of participants with treatment-related adverse events following tocolysis with Partusisten
timeFrame: August 2016
measure: Number of participants with fetal compromise assessed by the APGAR-Score and the postpartum fetal pH-value
timeFrame: August 2016
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04716608: Treatment for Osgood Schlatter Patients With a Physiotherapy Program
Official title: Treatment for Osgood Schlatter Patients With a Physiotherapy Program "TrOPhy-Study"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osgood-Schlatter Disease
Keywords: myofascial massage
stretching
home exercises
strengthening
KOOS-Child-Questionnaire
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2021-01-20
Enrollment: 36
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomised controlled parallel groups
Primary purpose: TREATMENT

Brief summary: This study is to compare the effect of a physiotherapy program to usual care treatment in patients with Osgood Schlatter disease (OSD). Patients will be randomly assigned into two groups. Group 1 will receive the physiotherapy program with myofascial massage, while group 2 (usual care group USC) will receive usual care treatment.


Eligibility criteria: Inclusion Criteria:

* Uni- or bilateral OSD
* ability to follow instructions
* sufficient knowledge of German
* availability: can participate in two exercise sessions per week for a period of 8 weeks

Exclusion Criteria:

* any history of knee surgery
* medication intake affecting the knee
* unstable fractures
* neurological disorders
* systematic diseases
* already in physiotherapeutic treatment because of the knee
* not possible to do any physiotherapy sessions at the Universitäts-Kinderspital Basel (UKBB)

Primary outcomes:
measure: change in Knee and Osteoarthritis Outcome Score for Children (KOOS-Child-Questionnaire Score)
timeFrame: at baseline and 8 weeks after baseline
Secondary outcomes:
measure: Change in Knee pain assessed by Visual Analogue Scale (VAS)
timeFrame: at baseline and 8 weeks after baseline
measure: Change in Range of motion (ROM) of knee
timeFrame: at baseline and 8 weeks after baseline
measure: Change in Y Balance Test (Lower Quarter)
timeFrame: at baseline and 8 weeks after baseline
measure: Time of return to sport activity (in days)
timeFrame: within 8 weeks after baseline
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department of Sport, Exercise and Health, Medical Faculty University of Basel
Study officials:
affiliation: Department of Sport, Exercise and Health, Medical Faculty University of Basel
name: Oliver Faude, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00342108: Cortical Visual Impairment and Visual Attentiveness
Official title: Cortical Visual Impairment and Visual Attentiveness: The Effect of Visual and Cross-Modal Environments on Children Diagnosed With Cerebral Palsy and Cortical Visual Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Cortical Visual Impairment
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2006-06-21
Enrollment: 60
Sex: ALL
Minimum age (years): 2
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will investigate the effect of enhanced visual and cross-modal environments upon the visual attentiveness of multiply handicapped children diagnosed with Cerebral Palsy (CP) and Cortical Visual Impairment (CVI).

Research Hypothesis

1. Adapted visual environments which present controlled auditory, tactile, proprioceptive or contrasting visual background stimulation will enhance the visual attentiveness to a given visual stimulus of children diagnosed with CP and CVI.
2. Systematic, repetitive, visual stimulation over time, improves the visual attentiveness and/or visual-motor responses of CP-CVI children.
3. The analysis of additional behavioral responses to visual stimuli is a critical component in evaluating the perceptual development of visual attention in CP-CVI children.

Use of Noldus: The Observer, an advanced objective computerized observation program, will enable precise detection of the neurobehavioral responses of the participants. Both overt and covert responses will be observed, analyzed and correlated to identify the level of attention of each participant.


Eligibility criteria: Inclusion Criteria:

* two to twelve years of age
* diagnosis of: CP, mental retardation (MR) and CVI (Control group participants without visual disability)

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Eye Movements
timeFrame: within the testing session
Secondary outcomes:
measure: Other behavioural responses
timeFrame: within the testing session
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba_Medical_Center
Study officials:
affiliation: Dept. of Pediatric Rehabilitation Sheba Medical Center Israel
name: Amichai Brezner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04196608: In Vitro Activity of Ceftolozane/Tazobactam and Imipenem/Relebactam in Clinical Isolates of Pseudomonas Aeruginosa and Enterobacterales Collected From Hematology and Oncology Patients
Official title: In Vitro Activity of Ceftolozane/Tazobactam and Imipenem/Relebactam in Clinical Isolates of Pseudomonas Aeruginosa and Enterobacterales Collected From Hematology and Oncology Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ceftolozane/Tazobactam
Imipenem/Relebactam
Hematology and Oncology
Lead sponsor: Hospital General Universitario Gregorio Marañon
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2019-12-12
Enrollment: 1005
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: Participating laboratories will prospectively collect the first 1,005 clinical isolates (510 P. aeruginosa isolates and 495 Enterobacterales isolates) starting in a preestablished date from patients with cIAIs, cUTIs, LRTIs, or BSIs

Brief summary: The purpose of the ACTHEON Study is to evaluate the in vitro activity of ceftolozane-tazobactam, imipenem-relebactam and comparator agents (amoxicillin- clavulanate, piperacillin-tazobactam, ceftazidime, cefotaxime, cefepime, imipenem, meropenem, levofloxacin and amikacin; see list more details on page 7) against clinical isolates of P. aeruginosa and Enterobacterales prospectively collected from hematology and oncology patients with complicated intra-abdominal infections (cIAIs), complicated urinary infections (cUTIs), lower respiratory tract infections (LRTIs), and blood stream infections (BSIs) from 15 participating centers in Spain


Eligibility criteria: Inclusion Criteria:

* P. aeruginosa isolates
* Enterobacterales isolates

Exclusion Criteria:

* Non P. aeruginosa isolates
* Non Enterobacterales isolates

Primary outcomes:
measure: Summary MIC and its distributions as susceptible, intermediate and resistant
timeFrame: 31 october 2020
measure: Summary of percentages of isolates
timeFrame: 31 october 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: HG Gregorio Marañón
Study officials:
References:
Clinical trial NCT02029508: The Treatment of Posterior Semicircular Canal Benign Paroxysmal Positional Vertigo
Official title: The Effectiveness Comparison of Three Different Methods for the Treatment of Posterior Semicircular Canal Benign Paroxysmal Positional Vertigo: Prospective, Double Blinded, Randomized, Multicenter Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Benign Paroxysmal Positional Vertigo
Keywords: PSCC(Posterior semicircular canal)
BPPV(Bening paroxysmal positional vertigo)
Vertigo
Otorhinolaryngologic Diseases
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2014-01-08
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to compare the treatment effectiveness of three different methods for posterior semicircular canal benign paroxysmal positional vertigo. The included methods are Modified Epley maneuver, Semont maneuver and Sham maneuver.

Detailed description: This study was a prospective, double blinded, randomized, multicenter clinical trial. The enrolled posterior semicircular canal benign paroxysmal positional vertigo patients were randomized to one of the three treatment regimens when they are diagnosed with the Dix-Hallpike test. An then the patient was treated with one of the three maneuvers. After 20 minutes, the patient was examined with the Dix-Hallpike test again. The resolution of nystagmus and symptoms were checked. When the nystagmus was sustained, the same treatment was applied once again. And after 20 minutes, the patient was examined with the Dix-Hallpike test too. 1 day after and 7 days after, the patient was re-examined with the Dix-Hallpike test.

Eligibility criteria: Inclusion Criteria:

* a symptom of positional vertigo
* rotational and upbeating nystagmus in Dix-Hallpike test
* the nystagmus should be disappear within 60 seconds
* no spontaneous nystagmus

Exclusion Criteria:

* ages under 18 years
* suspicious or verified a central nervous system lesion
* traumatic vertigo patients
* other otologic disease(acute/chronic otitis media, otosclerosis, etc)
* other vestibular disease(vestibular neuronitis, Meniere's disease, etc)
* congenital nystagmus patients
* the patients with spinal disease
* the patients with the limitation of cervical movement

Primary outcomes:
measure: Initial Effectiveness of Treatment for the Posterior Semicircular Canal Benign Paroxysmal Positional Vertigo
timeFrame: 20 minutes
Secondary outcomes:
measure: Delayed Effectiveness of Treatment for the Posterior Semicircular Canal Benign Paroxysmal Positional Vertigo
timeFrame: 1, 7 day
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Songpa-gu
Study officials:
affiliation: Asan Medical Center
name: Hongju Park, Professor
role: STUDY_DIRECTOR
References: