louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01535560: Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa
Official title: Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Otitis Externa
Keywords: Acute otitis externa
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2012-02-17
Enrollment: 589
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to demonstrate superiority of AL-60371 relative to Vehicle based on clinical cures at test-of-cure (TOC) for the treatment of acute otitis externa (AOE).

Detailed description: Participants or legal guardians completed a telephone diary twice daily to record assessments of ear pain, ear medication use, and impact of ear pain on sleep and other daily activities.

Eligibility criteria: Inclusion Criteria:

* At least 6 months of age.
* Clinical diagnosis of acute otitis externa (AOE) based on clinical observation and of presumed bacterial origin in at least one ear.
* Combined numerical score of ≥4 in at least one affected ear at the Day 1 exam for tenderness, erythema, and edema.
* Agree to refrain from water immersion of the ears during the conduct of the entire study.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Duration of signs or symptoms of AOE greater than 28 days in the affected ear(s) as reported by patient or parent/guardian.
* Presence of a tympanostomy tube or perforated tympanic membrane in the affected ear(s).
* Clinically diagnosed otic disease other than AOE (eg, malignant otitis externa) in the affected ear(s).
* Known or suspected ear infection of yeast, fungal or mycobacterial origin in the affected ear(s).
* Prior otologic surgery within 6 months of study entry in the affected ear(s).
* Known or suspected allergy or hypersensitivity to quinolones or other ingredients present in the medications to be used in the study.
* Patients who use ear plugs, head phones or ear buds and are unwilling to discontinue their use during the study period.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Proportion of Patients With Clinical Cures at the Day 11 (TOC) Visit
timeFrame: Day 11
Secondary outcomes:
measure: Proportion of Patients With Microbiological Successes at the Day 11 (TOC) Visit
timeFrame: Day 11
measure: Median Time (in Days) to Cessation of Ear Pain as Reported by the Patient or Parent/Legal Guadian Via the Telephone Diary
timeFrame: Time to event (Day 1 to Day 11)
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Sally Schieb
role: STUDY_DIRECTOR
References:
Clinical trial NCT03060460: Ultrasound Guided Insertion of Sheath Before Angiography or Angioplasty
Official title: Randomized Evaluation of Traditional Versus Ultrasound Guided Insertion of Sheath Before Angiography or Angioplasty
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Radial
Angioplasty
Angiography
Ultrasound
Randomized
Lead sponsor: Aarhus University Hospital Skejby
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: historical control cohort (Group A) and then a randomized prospective study (Group B and C).
Primary purpose: DIAGNOSTIC

Brief summary: The study evaluates whether routine use of ultrasound for sheath insertion during radial or femoral angiography or angioplasty has any impact on: number of punctures, patient discomfort, procedural length, successfull procedure or ideal vessel puncture.

Detailed description: A randomised study with an historical control group.

Initially data on prespecified endpoints are collected for an historical control group of 200 patients (100 radial and 100 femoral procedures). Hereafter 400 patients are randomized to ultrasound guided or conventional sheath insertion (200 radial and 200 femoral procedures).

Only high-volume physicians who have passed a ultrasound course are allowed to include patients.

Eligibility criteria: Inclusion Criteria:

* All patients scheduled for angiography or angioplasty in whom both radial and femoral access is possible

Exclusion Criteria:

* Abnormal pulse oxymetry test
* If severe lower-extremity calcification is known to exclude femoral access

Primary outcomes:
measure: number of puncture attempts
timeFrame: during the procedure
measure: time of procedure
timeFrame: during the procedure
measure: Placement of sheath
timeFrame: during the procedure
measure: Pain during sheath insertion and during the procedure
timeFrame: during the procedure
measure: Successfull procedure
timeFrame: during the procedure
Secondary outcomes:
measure: Use of analgetics
timeFrame: during the procedure
measure: Use of sedatives
timeFrame: during the procedure
measure: Use of calcium blocker
timeFrame: during the procedure
measure: Radial artery patency
timeFrame: during the procedure
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of cardiology, Aarhus University Hospital in Skejby
Study officials:
affiliation: Department of anaestesiology, Aarhus University Hospital, DK-8200 Aarhus N
name: erik sloth, professor
role: STUDY_CHAIR
References:
Clinical trial NCT01321060: Fluid Collections Management in Severe Acute Pancreatitis
Official title: Management of Sterile Fluid Collections in Patients With Severe Acute Pancreatitis:a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Pancreatitis
Acute Pancreatic Fluid Collection
Keywords: severe acute pancreatitis
acute fluid collection
catheter drainage
repeated aspiration
Lead sponsor: Nanjing University School of Medicine
Sponsor class: OTHER
Collaborators: name: Jinling Hospital, China
First posted: 2011-03-23
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Acute fluid collections is common in patients with severe acute pancreatitis (SAP). But the treatment for this is controversial. In this study, the investigators aim to evaluate the different effects of three different treatment protocols which is repeated aspiration, continuous catheter drainage and conservative treatment. The investigators suppose repeated aspiration could not only solve acute fluid collections, but also lower the rate of pancreatic infection.


Eligibility criteria: Inclusion Criteria:

* Symptoms and signs of acute pancreatitis according to Atlanta criteria and if pancreatic or/and peripancreatic fluid collections were confirmed by ultrasound and computed tomography examination
* CT density \< 30Hu
* Within 7 days from the onset of the disease
* Available approach for percutaneous penetrate

Exclusion Criteria:

* Pregnant pancreatitis
* Receiving surgery or aspiration before;need of early surgery
* Infected fluid collection

Primary outcomes:
measure: pancreatic infection
timeFrame: 28 days
measure: mortality
timeFrame: 28 days
Secondary outcomes:
measure: inflammation parameters
timeFrame: 28 days
measure: intra abdominal pressure
timeFrame: 28 days
measure: complications
timeFrame: 28 days
measure: ICU duration
timeFrame: day one until discharge
measure: hospital duration
timeFrame: day one until discharge
measure: SIRS
timeFrame: 28 days
measure: MODS
timeFrame: 28 days
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Department of SICU, Research Institute of General Surgery Jinling Hospital,
state: Jiangsu
Study officials:
References:
Clinical trial NCT03874260: Cinical Trial to Explore the Efficacy of Statin/Choline Fenofibrate Combination Therapy vs Statin Monotherapy in Patients With Inadequately Controlled TG Despite Receiving Statin Monotherapy
Official title: A Multi-center, Randomized, Double-blind, Parallel Phase Ⅳ Study to Explore the Efficacy of Statin/Choline Fenofibrate Combination Therapy vs Statin Monotherapy in Patients With Inadequately Controlled TG Despite Receiving Statin Monotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Dyslipidemias
Lead sponsor: Daewon Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-03-14
Enrollment: 180
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Multi-center, Randomized, Double-blind, Parallel Phase Ⅳ Study to Explore the Efficacy of Statin/Choline Fenofibrate Combination Therapy vs Statin Monotherapy in Patients With Inadequately Controlled TG Despite Receiving Statin Monotherapy


Eligibility criteria: Inclusion Criteria:

* both male and female who are over 19-year-old
* 200mg/dl≤TG\<500mg/dl
* Desired value of LDL-c

  1. very high risk \< 70
  2. high risk \< 100
  3. moderate risk \<130
  4. low risk \< 160

Exclusion Criteria:

* patient who is going to have an operation during this study
* patient who has allergy or hypersensitivity of fenofibrate
* patient who has abnormal ECG

Primary outcomes:
measure: rate of change for Triglyceride based on baseline
timeFrame: 8week
Secondary outcomes:
Other outcomes:
Locations:
city: Hwaseong-si
country: Korea, Republic of
facility: Hallym University Dongtan Sacred Heart Hospital
Study officials:
References:
citation: Park MS, Youn JC, Kim EJ, Han KH, Lee SH, Kim SH, Kim BJ, Kwon SU, Ryu KH. Efficacy and Safety of Fenofibrate-Statin Combination Therapy in Patients With Inadequately Controlled Triglyceride Levels Despite Previous Statin Monotherapy: A Multicenter, Randomized, Double-blind, Phase IV Study. Clin Ther. 2021 Oct;43(10):1735-1747. doi: 10.1016/j.clinthera.2021.08.005. Epub 2021 Sep 10.
Clinical trial NCT01153360: Peri-operative Oral Triiodothyronine Replacement Therapy to Decrease the Risk of Transient Atrial Fibrillation After Off-pump Coronary Artery Bypass Surgery
Official title: Peri-operative Oral Triiodothyronine Replacement Therapy to Decrease the Risk of Transient Atrial Fibrillation After Off-pump Coronary Artery Bypass Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-thyroidal Illness Syndrome
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2010-06-30
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is planned to medicate oral T3(Liothyronine)to the patients who are planned to have OPCAB(off- pump coronary bypass graft surgery. The aim of this study was to assess the effects of oral triiodothyronine (T3) therapy on postoperative thyroid hormone concentrations, hemodynamic variables and outcomes in patients undergoing OPCAB in a randomized, controlled trial.


Eligibility criteria: Inclusion Criteria:

* Patients who are undergoing Off-pump coronary artery bypass graft

Exclusion Criteria:

* No normal sinus rhythm,
* History of thyroid disease
* Abnormal thyroid hormone
* Renal dysfunction
* Hepatic dysfunction
* LVEF \<30%
* Recent MI
* Active infection 1\~15

Primary outcomes:
measure: compare the serum T3 concentrations and the number of patients with serum T3 concentrations below the normal range between the groups
timeFrame: until 36 hours after surgery
Secondary outcomes:
measure: difference of hemodynamic performance and myocardial injury
timeFrame: during surgery and 36 hr after surgery
Other outcomes:
measure: major morbidity endpoints including acute renal failure, cardiovascular failure, stroke, mediastinitis, need for ventilator support for >48 h, and new onset atrial fibrillation
timeFrame: until discharge of hospital
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
affiliation: Anesthesiology & Pain Medicine, Severance Hospital
name: Yong-Sun Choi, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03671460: CD19 CAR-T Cells for Patients With Relapse and Refractory CD19+ B-ALL.
Official title: Phase I Study of the Safety and Efficacy of CD19 CAR-T Cells in Patients With Relapsed or Refractory Acute B-cell Lymphoblastic Leukemia (R/R B-ALL)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: B-cell Acute Lymphoblastic Leukemia
Keywords: B-cell acute lymphoblastic leukemia
CD19 CAR-T
Lead sponsor: Tianjin Mycure Medical Technology Co., Ltd
Sponsor class: INDUSTRY
First posted: 2018-09-14
Enrollment: 18
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single-center, open-label, nonrandomized, no control, prospective clinical trial
Primary purpose: TREATMENT

Brief summary: This is a single center, single arm, open-lable phase 1 study to determine the safety and efficacy of CD19-CAR-T cells in patients with relapsed or refractory acute B-cell lymphoblastic leukemia (R/R B-ALL).

Detailed description: In this single-center, open-label, nonrandomized, no control, prospective clinical trial, no less than 18 CD19+ B-cell relapsed or refractory acute B-cell lymphoblastic leukemia (R/R B-ALL) patients will be enrolled. Side effects of CD19 CAR T cells therapy will be monitored. The purpose of current study is to determine the clinical efficacy and safety of CD19 CAR T cells therapy in patients with R/R B-ALL.

Eligibility criteria: Inclusion Criteria:

1. More than 1 year;
2. CD19 positive B-cell acute lymphoblastic leukemia;
3. Important organ function is satisfied: cardiac ultrasound indicates cardiac ejection fraction ≥50%, no obvious abnormality in ECG; blood oxygen saturation ≥90%; creatinine clearance calculated by Cockcroft-Gault formula ≥40ml/min; ALT and AST≤ 5 times normal range, total bilirubin ≤ 34.2 μmol / L.
4. Expected to survive for more than 3 months;
5. Informed consent is signed by a subject or his lineal relation.

Exclusion Criteria:

1. Recent or current use of glucocorticoid or other immunosuppressor;
2. Uncontrolled active infection, HIV infection, syphilis serology reaction positive;
3. Has a graft-versus-host response and requires the use of immunosuppressants；
4. Drug uncontrollable central nervous system leukemia；
5. Pregnant or lactating female；
6. The patient did not agree to use effective contraception during the treatment period and for the following 1 year；
7. A history of other malignant tumors;
8. The investigator believes that there are other factors that are not suitable for inclusion or influence the subject's participation or completion of the study.

Primary outcomes:
measure: Percentage of adverse events
timeFrame: 6 months
Secondary outcomes:
measure: complete remission rate
timeFrame: 6 months
measure: objective remission rate
timeFrame: 6 months
Other outcomes:
Locations:
city: Langfang
country: China
facility: Hebei Yanda Ludaopei Hospital
state: Hebei
Study officials:
affiliation: Hebei Yanda Ludaopei Hospital
name: Peihua Lu, PhD,MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05482360: Testing Implementation Strategies to Improve Delivery of PrEP for Pregnant and Postpartum Women in Kenya
Official title: Testing Implementation Strategies to Improve Delivery of Pre-exposure Prophylaxis (PrEP) for Pregnant and Postpartum Women in Kenya (K01)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-Exposure Prophylaxis
HIV Infections
Pregnancy Related
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2022-08-01
Enrollment: 5173
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A difference-in-difference design will be used; this is a quasi-experimental design that compares data before an intervention is introduced to data after the intervention is introduced and compares that with the expected change before and after in comparison clinics. Three rounds of difference-in-differences tests will be used to evaluate three PrEP optimization interventions, identified by stakeholders based on qualitative information. Each of the three rounds will include 4 facilities receiving the intervention and 4 facilities serving as an ongoing concurrent comparator group; these 4 facilities will not receive any of the packages of interventions, but will undergo the same data collection procedures.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study tests strategies for improving PrEP implementation in maternal and child health clinics using an interrupted time series.

Detailed description: This study aims to improve integrated delivery of PrEP to women seeking health services in maternal and child health clinics by piloting and evaluating four strategies or bundles of strategies for optimized PrEP delivery. Strategies to be tested include three packages of strategies identified by stakeholders.

Eligibility criteria: Inclusion Criteria:

* Women receiving Maternal and Child Health (MCH) services HCW participating in satisfaction surveys

Exclusion Criteria:

* Unwilling or unable to provide informed consent

Primary outcomes:
measure: Change in PrEP Penetration
timeFrame: 6 months
measure: Change in PrEP Fidelity
timeFrame: 6 months
measure: Timeliness of Services
timeFrame: 6 months
measure: Waiting Time
timeFrame: 6 months
measure: HCW Acceptability
timeFrame: 6 months
measure: Health Care Worker (HCW) Appropriateness
timeFrame: 6 months
measure: Client Satisfaction
timeFrame: 6 months
Secondary outcomes:
measure: PrEP Uptake
timeFrame: 6 months
measure: PrEP Continuation
timeFrame: 6 months
measure: Client PrEP Knowledge
timeFrame: 6 months
measure: PrEP Adherence
timeFrame: 6 months
measure: PrEP Efficiency
timeFrame: 6 months
Other outcomes:
Locations:
city: Homa Bay
country: Kenya
facility: Ober Health Center
Study officials:
affiliation: University of Washington
name: Anjuli Wagner, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01042860: The Influence of Lutein Supplements on Age-related Macular Degeneration
Official title: The Influence of Lutein Supplements on Age-related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Age-Related Macular Degeneration
Keywords: macular pigment
lutein
age-related macular degeneration
AMD
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Cognis Deutschland GmbH & Co. KG
First posted: 2010-01-06
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: Rationale: Age-related macular degeneration is the most common cause of blindness in the industrialized world. Macular pigment is hypothesized to protect against the vision loss in this disease.

Objective: 1. To study if the macular pigment optical density can be raised by lutein supplementation. 2. To study if lutein supplementation can stop or slow down the decrease in visual functions.

Study design: Randomized, double blind, placebo controlled intervention study.

Study population: Eighty patients with early signs of age-related macular degeneration Intervention: The intervention group (40 subjects) receives 10 mg lutein per day, while the control group (40 subjects) gets a placebo.


Eligibility criteria: Inclusion Criteria:

* AMD grade 2 or 3
* visual acuity \> 0.5
* BMI \< 30

Exclusion Criteria:

* using lutein supplements
* smoking
* diabetes
* diseases that interfere with lipid absorption
* other eye diseases

Primary outcomes:
measure: Macular Pigment Optical Density
timeFrame: Baseline, 4 months, 8 months, 12 months
Secondary outcomes:
measure: Visual Acuity
timeFrame: Baseline, 4 months, 8 months, 12 months
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: University Eye Clinic Maastricht
city: Manchester
country: United Kingdom
facility: Faculty of Life Sciences, University of Manchester
Study officials:
affiliation: University Eye Clinic Maastricht
name: Tos TJM Berendschot, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Manchester
name: Ian J Murray, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Murray IJ, Makridaki M, van der Veen RL, Carden D, Parry NR, Berendschot TT. Lutein supplementation over a one-year period in early AMD might have a mild beneficial effect on visual acuity: the CLEAR study. Invest Ophthalmol Vis Sci. 2013 Mar 11;54(3):1781-8. doi: 10.1167/iovs.12-10715.
Clinical trial NCT05882760: Postoperative Sensitivity Following Placement with Different Restorative Materials in Vital Posterior Teeth
Official title: Comparison of Postoperative Sensitivity Following Placement with Different Restorative Materials in Vital Posterior Teeth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sensitivity, Tooth
Lead sponsor: Liaquat University of Medical & Health Sciences
Sponsor class: OTHER
First posted: 2023-05-31
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There is a lack of long-term clinical studies comparing different restorative materials; most of the available studies have only looked at class I cavities or examined post-operative sensitivity in non-caries cervical lesions. The purpose of this study is to measure postoperative sensitivity in clinical settings at 3-month intervals for class 1 and 2 direct posterior restoration


Eligibility criteria: Inclusion Criteria:

Either gender Minimum age 18 years, maximum age 40 years. Class I \& II Cavity on maxillary and mandibular 1st and 2nd molars. Vital maxillary and mandibular molar teeth that had occlusal contact with antagonist teeth.

Exclusion Criteria:

Irreversible Pulpitis diagnosed clinically and radiographically. Class I \& Class II cavity of premolars and third molars Patients taking analgesic prior to treatment. History of allergic reaction to any dental material used in the study. History of parafunctional habits (bruxism and/or clenching) Malocclusion

Primary outcomes:
measure: Post Operative Sensitivity
timeFrame: 3 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Hyderabad
country: Pakistan
facility: Institute of Dentistry, Liaquat University of Medical and Health Sciences
state: Sindh
Study officials:
affiliation: Liaquat University of Medical and Health Science
name: Priya Rani, BDS
role: PRINCIPAL_INVESTIGATOR
References: