louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00130572: Efficacy of Elidel Cream on Erosive Oral Lichen Planus
Official title: Randomized Placebo-Controlled Clinical Pilot Trial Regarding the Efficacy of Elidel Cream on Erosive Oral Lichen Planus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lichen Planus, Oral
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2005-08-15
Enrollment: 20
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 is to investigate whether topical applied pimecrolimus will lead to improvement of erosive oral lichen planus. This effect will be monitored by reduction of erosive mucosal area and reduction of patient's pain symptoms.

Detailed description: Oral lichen planus is a mucosal inflammatory disease of unknown origin. It can be very painful especially if erosions appear on the oral mucosa.

In this study the efficacy of pimecrolimus compared to placebo in treatment of erosive oral lichen planus will be investigated. To this end the subjective pain and the amount of affected mucosa will be monitored before and after treatment.

Eligibility criteria: Inclusion Criteria:

* Clinically and histologically confirmed diagnosis of erosive oral lichen planus
* Spontaneous or meal related oral pain
* No topical therapy 2 weeks prior to study start
* No systemic therapy 4 weeks prior to study start
* Signed informed consent

Exclusion Criteria:

* Pregnant or breast-feeding women
* Known allergy to macrolide antibiotics
* Known current active malignant disease or in patient's history
* Known immunodeficiency or HIV infection
* Participation at another clinical trial within the last 6 months

Primary outcomes:
measure: Reduction of a symptom score consisting of involved mucosal area and appearance of pain before and after treatment
Secondary outcomes:
measure: Patient's and investigator's global assessment after 4 and 8 weeks
measure: Pimecrolimus blood level after 4 weeks
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: University Hospital, Department of Dermatology
Study officials:
affiliation: University of Tuebingen, Department of Dermatology
name: Tilo Biedermann, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01730872: Evaluation of Prednisolone in a Modified Conjunctival Allergen Challenge Model
Official title: A Single-Center, Double-Masked, Randomized, Placebo-Controlled Evaluation of Prednisolone Sodium Phosphate Ophthalmic Solution, 1% Compared to Placebo in a Modified Conjunctival Allergen Challenge (CAC) Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Allergic Conjunctivitis
Lead sponsor: ORA, Inc.
Sponsor class: INDUSTRY
First posted: 2012-11-21
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the effectiveness of the modified Conjunctival Allergen Challenge (CAC) and observe how the produced allergic inflammation reacts to treatment with a proven ocular anti-inflammatory medication,

Prednisolone, assessed by the following measures:

Chronic Allergic Inflammation assessed using confocal microscopy Ocular itching Conjunctival redness

Detailed description: Prospective, single center, randomized, double-masked, placebo controlled study. Subjects will be randomized to one of the following treatment arms to dose four times per day (QID) for 4 days between Visits 3 and 4.

Prednisolone phosphate Tears Naturale II Ophthalmic Solution (Placebo)

Duration:

Approximately 2 weeks

Controls:

Artificial Tears (Tears Naturale® II)

Eligibility criteria: Inclusion Criteria:

* At least 18 years of age \& either sex, any race
* Willing and able to follow all instructions
* Positive history of ocular allergies
* Reproducible positive ocular allergic reaction induced by conjunctival allergen challenge

Exclusion Criteria:

* Have planned surgery during trial period
* Female currently pregnant, planning a pregnancy or lactating
* Use of disallowed medications
* Have ocular infections, or ocular conditions that could affect study parameters
* Have moderate to severe dry eye
* Have used an investigational drug or device within 30 days of start of study
* Female that is currently pregnant, planning a pregnancy or lactating

Primary outcomes:
measure: Inflammation Change From Baseline to Day 6
timeFrame: 90 minutes post CAC
Secondary outcomes:
measure: Ocular Itching Change From Baseline to Day 6
timeFrame: 7 minutes post-CAC
measure: Ocular Redness Change From Baseline to Day 6
timeFrame: 7 minutes post-CAC
Other outcomes:
Locations:
city: Andover
country: United States
facility: Andover Eye Associates
state: Massachusetts
Study officials:
affiliation: Massachusetts Medical Society, Alpha Omega Alpha Honor Society, American Academy of Ophthalmology
name: Gail Torkildsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03136172: Monitoring of Systemic or Organ Perfusion for Preterm Infants
Official title: Observational Study on Monitoring of Systemic or Organ Blood Circulation and Perfusion for Preterm Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infant, Premature
Hypoperfusion in Newborn
Necrotizing Enterocolitis of Newborn
Sepsis Newborn
Oliguria
Hypotension
Lead sponsor: Inha University Hospital
Sponsor class: OTHER
First posted: 2017-05-02
Enrollment: 85
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: premature infants with 32 weeks or less of gestational age or 1,500 g or less of birth weight

Brief summary: To investigate biomarker reflects systemic or specific organ perfusion well, we are going to the observational comparison study using several hemodynamic monitoring methods in the premature infants. It includes near-infrared spectroscopy (NIRS), pulse oximetry with perfusion index (PI) and pleth variability index (PVI) and functional echocardiography.

Detailed description: Hemodynamic observational comparisons will be performed in 6 episodes below on each patient.

1. first 24 hours after birth
2. during red blood cell (RBC) transfusion: from 4 hours before to 4 hours after the transfusion
3. suspicion of necrotizing enterocolitis: from the suspicion point for 48 hours
4. suspicion of sepsis: from the suspicion point for 48 hours
5. oligouria (\< 1 mL/kg/hour of urine): for 48 hours
6. hypotension (mean blood pressure \< 30 mmHg): for 48 hours

Eligibility criteria: Inclusion Criteria:

* premature infants with 32 weeks or less of gestational age or 1,500 g or less of birth weight

Exclusion Criteria:

* infants without the consent of their guardians

Primary outcomes:
measure: Positive predictive value of each index on hypotension
timeFrame: first 24 hours after birth
Secondary outcomes:
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
Study officials:
References:
Clinical trial NCT01115972: A Study to Assess the Effect of ASP1585 on Pharmacokinetics of Valsartan in Healthy Volunteers
Official title: ASP1585 Pharmacokinetic Interaction Study - Pharmacokinetic Interaction With Valsartan -
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Pharmacokinetics of Valsartan
Keywords: ASP1585
Drug-drug interaction
valsartan
Healthy volunteer
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2010-05-04
Enrollment: 24
Sex: MALE
Minimum age (years): 20
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This study is to assess the effect of ASP1585 on pharmacokinetics of valsartan in 2x2 crossover method


Eligibility criteria: Inclusion Criteria:

* Body weight: =\<50.0kg, \<80.0kg
* Body mass index: =\<17.6, \<26.4
* Healthy as judged by investigator or caregiver from subjective and objective symptoms and physical examination data

Exclusion Criteria:

* Attending another clinical trial within 120 days before the study
* Blood donation within 90 days (400ml) or 30 days (200ml) before the study
* Receiving any drugs within 7 days before the study
* History of allergy to drugs
* Having GI disorders
* History or complication of liver diseases
* History or complication of heart disease
* History or complication of respiratory diseases
* History or complication of renal diseases
* History or complication of cerebrovascular diseases

Primary outcomes:
measure: Plasma concentration of valsartan
timeFrame: for 48 hours after administration
Secondary outcomes:
measure: Safety assessed by AE, vital signs 12-lead ECG and lab tests
timeFrame: for 5 days after administration
Other outcomes:
Locations:
city: Tokyo
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References:
Clinical trial NCT02128672: Spinal Stimulation to Treat Low Back Pain
Official title: Extraforaminal Spinal Stimulation Compared to Conventional Spinal Cord Stimulation to Treat Axial Low Back Pain-A Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Low Back Pain
Lumbar Back Pain
Lumbago
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2014-05-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Spinal cord stimulation (SCS) has been used for almost 30 years to treat many intractable back pain conditions. It has demonstrated efficacy in the co-called Failed Back Surgery Syndrome (FBSS) and a recent randomized controlled trial demonstrated significant superiority of SCS over conventional medical therapy to treat patients with FBSS. Another trial has demonstrated superiority of SCS over repeat surgery in the same patient population. However, the ability to reliably capture the low back with paresthesia coverage has remained challenging and elusive despite numerous strategies designed to overcome this limitation. Strategies that have been introduced but so far with limited success include transverse multiple lead stimulation, high frequency stimulation, peripheral field stimulation, and dorsal root ganglion (DRG) stimulation. To date, none of these strategies have been able to reliably overcome the long-term problems of paresthesia capture and pain relief of the low back.

This proposal describes a new spinal stimulation technique designed to improve the likelihood of low back stimulation by targeting the nerve supply to the two most commonly affected pain producing structures in the back, the facet joints and the intervertebral disks. The technique has proven to be feasible in a cadaver model with ease of lead placement at the desired targets


Eligibility criteria: Inclusion:

* Patients with one sided low back pain
* Failed standard conservative care including medications, physical therapy, and/or injections
* Pain greater than 6 months

Exclusion:

* Pregnancy
* Previous spine surgery
* Pain radiating beyond/below the knee

Primary outcomes:
measure: Did the participant have paresthesia coverage from the stimulation?
timeFrame: Baseline to 4 days
Secondary outcomes:
measure: Numeric Pain Rating Scale (NRS)
timeFrame: Baseline to 4 days
measure: Patient preferred stimulation-Likert Scale
timeFrame: baseline to 4 days
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Tim Lamer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00286572: Long-term Mortality in Diabetics Undergoing Major Surgery
Official title: Comparison in Survival in Patients With Insulin-dependent and Non-insulin-dependent Diabetes Mellitus With Known or Suspected Coronary Artery Disease Undergoing Major Non-cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Coronary Heart Disease
Major Non-cardiac Surgery
Keywords: insulin-dependent diabetes mellitus
non-insulin-dependent diabetes mellitus
coronary artery disease
long-term mortality
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2006-02-03
Enrollment: 380
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with treated diabetes mellitus undergoing surgery with major risk or patients with treated diabetes mellitus and known coronary artery disease undergoing surgery with major or intermediate risk

Brief summary: Patients with CAD and diabetes mellitus have a better prognosis than patients with CAD and no diabetes mellitus. In acute coronary syndrome patients with an insulin therapy had a better survival than patients with oral antidiabetics. But there is not known wether perioperative therapy with insulin or oral antidiabetics is associated with higher risk for higher perioperative cardiac morbidity and mortality and worse long-term survival.

Detailed description: Diabetes mellitus is an important risk factor for arteriosclerosis in general and for coronary artery disease. Patients with CAD have a worse prognosis if they have diabetes mellitus. But it is not known whether the treatment of Dm has an influence on mortality or morbidity.

In face of the high number of patients with Dm and the therapeutic consequences this prospective study wants to compare short-time and long-time morbidity in Patients with Dm undergoing major non-vascular surgery. Inclusion criteria are medically treated Dm (insulin or oral antidiabetics) and major non cardiac surgery.

The "normal" perioperative treatment of the study is not changed by the study itself.

Eligibility criteria: Inclusion Criteria:

* diabetes mellitus with insulin or oral antidiabetics
* proven coronary artery disease or very high risk for it
* major non-vascular surgery

Exclusion Criteria:

* emergency
* no consent

Primary outcomes:
measure: Death and/or major adverse cardiac events
timeFrame: 12 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital
state: CH
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Miodrag Filipovic, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01161472: A Study to Assess the Cognitive Effects of Fesoterodine in Elderly Subjects
Official title: A 4 Way Placebo And Active Controlled Study To Evaluate The Effects Of Fesoterodine On Cognitive Function In Healthy Elderly Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-07-13
Enrollment: 20
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The study is designed to evaluate elements of cognitive function in subjects receiving either fesoterodine or alprazolam.

Detailed description: Evaluation of cognitive function

Eligibility criteria: Inclusion Criteria:

* Adult healthy volunteers 65 years and over with minimum MMSE of 26

Exclusion Criteria:

* Prohibited concomitant medications
* Confounding medical conditions
* Clinically significant comorbid diseases
* Hypersensitivity or contraindications to fesoterodine or active control

Primary outcomes:
measure: Computer Based Objective Cognition Testing (CogState) Detection Speed
timeFrame: Baseline
measure: Change From Baseline in Computer Based Objective Cognition Testing (CogState) Detection Speed on Day 6
timeFrame: Baseline and Day 6
Secondary outcomes:
measure: CogState Identification Speed
timeFrame: Baseline
measure: Change From Baseline in CogState Identification Speed on Day 6
timeFrame: Baseline and Day 6
measure: CogState One Card Learning
timeFrame: Baseline
measure: Change From Baseline in CogState One Card Learning on Day 6
timeFrame: Baseline and Day 6
measure: CogState Continuous Paired Associate Learning (CPAL)
timeFrame: Baseline
measure: Change From Baseline in CogState CPAL on Day 6
timeFrame: Baseline and Day 6
measure: CogState Groton Maze Learning Task (GMLT)
timeFrame: Baseline
measure: Change From Baseline in CogState Groton Maze Learning Task on Day 6
timeFrame: Baseline and Day 6
measure: Rey Auditory Verbal Learning Test (RAVLT)
timeFrame: Baseline
measure: Rey Auditory Verbal Learning Test (RAVLT) on Day 6
timeFrame: Baseline and Day 6
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Overland Park
country: United States
facility: Pfizer Investigational Site
state: Kansas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01191372: First-in-Human and Proof-of-Mechanism Study of ARC19499 Administered to Hemophilia Patients
Official title: First-in-Human and Proof-of-Mechanism Study of ARC19499 Administered to Hemophilia Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Hemophilia
Keywords: Hemophilia A
Hemophilia B
pharmacokinetics
pharmacodynamics
Tissue Factor Pathway Inhibitor
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2010-08-30
Enrollment: 17
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the safety, tolerability and the way the body handles various single and multiple doses of ARC19499 in patients with hemophilia.


Eligibility criteria: Inclusion Criteria:

Adult male patients ≥18 to ≤75 years of age.

* Hemophilia of any type or severity.
* Patients who are negative for hepatitis B surface antigen (HBsAg), and human immunodeficiency virus (HIV) I and II antibody tests at screening.
* Male patients who, with their partners, are willing to use 2 effective, methods of contraception (i.e., for both self and partner) throughout the study and for at least 3 months after discontinuation of study drug treatment.
* All patients must be capable of understanding and complying with the protocol and must have signed the informed consent document.

Exclusion Criteria:

* Female patients;
* If on a prophylactic coagulation factor concentrate regimen, inability or unwillingness to discontinue prophylaxis during participation in this study.
* Existence of other co-existing bleeding disorder (e.g., von Willebrand Disease).
* Medical history of venous or arterial thromboembolism.
* Scheduled for elective surgical procedure during the conduct of this study.
* Use of an investigational drug within 30 days of study entry.
* Transaminase values \> 3 x upper limit of normal (ULN) at time of screening.
* Haemoglobin \<12.0 g/dL.
* Participants who, in the opinion of the Investigator, have a significant infection or known inflammatory process on screening.
* Participants who have a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders.
* Any medical condition the investigator believes would place the patient at increased risk as a result of participation in the study e.g. history of thromboembolic disease or stroke.
* Any medication the investigator considers may increase the risk of adverse effects during the study.

Primary outcomes:
measure: Pharmacokinetics (PK) of ARC19499
timeFrame: 2 weeks
Secondary outcomes:
measure: Coagulation system pharmacodynamic (PD) effects of ARC19499.
timeFrame: 2 weeks
Other outcomes:
Locations:
city: London
country: United Kingdom
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06226272: Clinical Outcome Measure at Stryker Spine
Official title: Clinical Outcome Measure at Stryker Spine: COMPASS
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Degenerative Disc Disease
Degenerative Scoliosis
Keywords: Device: Cervical or Thoracolumbar Spinal fusion
Device: Adult Spinal Deformities
Lead sponsor: Stryker Spine
Sponsor class: INDUSTRY
First posted: 2024-01-26
Enrollment: 5222
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population includes subjects who have undergone or will undergo surgery utilizing one or more Stryker devices according to Stryker cleared IFUs and Surgical Technique Guides (STGs) by a participating investigator and are willing to complete the following patient-reported outcome measures (PROMs) at the study-specific time points.

Brief summary: This is a multicenter, prospective, retrospective, Post Market Clinical Follow-up (PMCF) study in subjects who have undergone or will undergo surgery utilizing one or more Stryker devices according to Stryker cleared Instructions for Use (IFU).

Detailed description: Stryker Spine has a broad portfolio of spinal devices used to stabilize the spine. This PMCF study is designed to collect data on the performance and safety of the devices over their lifetime of 24 months post-implantation. Four protocols have been designed to aid in this process, a master and three sub-protocols. The sub-protocols are based on body region and indication:

* S-S-102-A Cervical: Interbody Devices (IBDs), Vertebral Body Replacement Devices (VBRs), Internal Fixation Devices, and Vitoss
* S-S-102-B Thoracolumbar: IBDs, VBRs, Internal Fixation Devices, and Vitoss
* S-S-102-C Adult Spinal Deformities: IBDs, Internal Fixation Devices, and Vitoss Each of the sub-protocols has its own specific performance endpoint and hypothesis, radiographical data assessments, and SAPs. Safety data will be collected throughout the study.

Eligibility criteria: Inclusion Criteria:

• To be eligible to participate in the study, the potential subject must meet all inclusion criteria specific to the Stryker system being evaluated, please contact one of the participating investigators or see the device-specific cleared IFU, for further details.

Exclusion Criteria:

• The exclusion criteria are based on the contraindications as presented in the Stryker device cleared IFUs, please contact one of the participating investigators or see the device-specific cleared IFU, for further details.

Primary outcomes:
measure: S-S-102-A
timeFrame: Baseline through 24-months post-op.
measure: S-S-102-B
timeFrame: Baseline through 24-months post-op.
measure: S-S-102-C
timeFrame: Baseline through 24-months post-op.
Secondary outcomes:
measure: S-S-102-A
timeFrame: Surgery through 24-months post-op.
measure: S-S-102-B
timeFrame: Surgery through 24-months post-op.
measure: S-S-102-C
timeFrame: Surgery through 24-months post-op.
Other outcomes:
Locations:
Study officials:
References: