louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00854061: Study of T-PRED(TM) Compared to Pred Forte(R) II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cataract
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2009-03-02
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Study of T-PRED(TM) Compared to Pred Forte(R)

Detailed description: This study was a multi-center, randomized, double-masked, bioequivalence study. A total of 172 participants undergoing bilateral cataract surgery were assigned investigational product to each eye according to a computer-generated randomization list for each of 2 study variables: treatment with T-PRED or Pred Forte in the first eye undergoing cataract extraction and the aqueous humor sampling time point.

The investigator determined which eye was clinically suited for the first operative procedure; treatment of this eye was randomized to either T-PRED or Pred Forte. The second eye received the other study treatment (RP if the first eye received T-PRED; T-PRED if the first eye received Pred Forte) at the time of the second cataract extraction.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older

Exclusion Criteria:

* No active or adverse disease

Primary outcomes:
measure: Means Aqueous Humor Prednisolone Acetate Concentration
timeFrame: 35 days
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: ISTA Pharmaceuticals, Inc.
state: California
Study officials:
affiliation: ISTA Pharmaceuticals, Inc.
name: Tim McNamara, PharmD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03444961: Computer-Assisted Rehabilitation Environment Training After Argus Retinal Prosthesis
Official title: Comprehensive Visual and Mobility Training Using Computer-Assisted Rehabilitation Environment (CAREN) After Argus Retinal Prosthesis Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retinitis Pigmentosa
Keywords: Argus II Retinal Prosthesis System
Rehabilitation
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2018-02-26
Enrollment: 4
Sex: ALL
Minimum age (years): 25
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of the current project is to fill the unmet clinical needs around the objective assessment of visual function and develop outcome-oriented visual rehabilitation approach using the computer assisted rehabilitation environment (CAREN) system for Argus recipients.


Eligibility criteria: Inclusion Criteria:

* Recipient of the Argus II Retinal Prosthesis System
* Ability to provide informed consent
* Ability to follow two-step commands
* Ability to ambulate 300+ feet with or without visual assistance
* Able to tolerate Argus device turned on for \>20 continuous minutes.

Exclusion Criteria:

* Dementia
* Musculoskeletal contraindication to exercise or walking
* Cardiopulmonary contraindication exercise (i.e. uncontrolled heart failure, cardiac arrhythmia, or pulmonary disease).

Primary outcomes:
measure: Effects of CAREN Virtual Reality System on Obstacle Course Navigation
timeFrame: 6 wks
measure: Time to Complete the Timed Up and Go Test Before and After CAREN Virtual Reality System Training
timeFrame: 6 wks
measure: Effects of CAREN Virtual Reality System on Square Localization Visual Function Test
timeFrame: 6 wks
measure: Effects of CAREN Virtual Reality System on Direction of Motion Visual Function Test.
timeFrame: 6 wks
measure: Effects of CAREN Virtual Reality System on Grating Visual Acuity Visual Function Test
timeFrame: 6 wks
measure: Effects of CAREN Virtual Reality System on Gait Assessment
timeFrame: 6 wks
Secondary outcomes:
Other outcomes:
measure: Effects of CAREN Virtual Reality System on Activities-specific Balance Confidence (ABC) Scale Questionnaire
timeFrame: 6 wks
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Aleksandra Rachitskaya, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rachitskaya A, Yuan A, Davidson S, Streicher M, DeBenedictis M, Rosenfeldt AB, Alberts J. Computer-Assisted Immersive Visual Rehabilitation in Argus II Retinal Prosthesis Recipients. Ophthalmol Retina. 2020 Jun;4(6):613-619. doi: 10.1016/j.oret.2019.11.007. Epub 2019 Nov 15.
Clinical trial NCT02307461: Bioequivalence of Duvelisib and Food Effect on Pharmacokinetics of IPI-145
Official title: A Phase 1, Open-label, 2-Part Study to Evaluate the Bioequivalence of the Duvelisib Marker-Image Formulation to the Duvelisib Clinical-Trial Formulation and to Assess the Effect of Food on the Pharmacokinetics of IP Duvelisib in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Phase 1
Bioequivalence
Pharmacokinetics
Food
Healthy Adult
Lead sponsor: SecuraBio
Sponsor class: INDUSTRY
First posted: 2014-12-04
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: To Evaluate the Bioequivalence of the two formulations of IPI-145 and the Effect of Food on the Pharmacokinetics of IPI-145

Detailed description: This Phase 1, randomized, open-label study of IPI-145 will be conducted in 2 parts.

Part 1 will be conducted in 2 cohorts. Cohort 1 will consist of 32 healthy subjects, and Cohort 2 will consist of 52 healthy subjects. Subjects in each cohort will receive 2 doses of IPI under fasted conditions in a 2-period, 2-sequence crossover design. Dosing in Period 1 and Period 2 will be separated by at least 7 days.

Part 2 is a 2-period, 2-sequence crossover design to assess the effect of a high-fat meal on the PK of the IPI-145 in 20 subjects. Subjects will receive single oral doses under fed (high-fat meal) and fasted conditions, separated by at least 7 days.

Eligibility criteria: Inclusion Criteria:

* Men or women of non-child bearing potential between 18-50 years of age
* Body Mass Index (BMI): 18.0 - 32.0 kg/m2.
* Healthy subjects: in good health, determined by no clinically significant findings from clinical evaluations
* Provided written informed consent prior to any study specific procedures

Exclusion Criteria:

* Women of childbearing potential
* Healthy subjects: positive screening test for hepatitis B surface antigen, hepatitis C antibody, or HIV-1/HIV-2 antibodies
* ECG at screening showing QTcF ≥ 450 msec
* Evidence of clinically significant medical conditions
* History of gastrointestinal disease or surgery that may affect drug absorption
* Positive T-Spot (tuberculosis)TB test at screening
* Any active infection at the time of screening or admission

Primary outcomes:
measure: Assessment of bioequivalence of the IPI-145 test and reference formulations
timeFrame: 24 Hours
measure: Pharmacokinetic Parameter (AUClast ) of IPI-145
timeFrame: Over 24 hours
measure: Pharmacokinetic Parameter (AUCinf ) of IPI-145
timeFrame: Over 24 hours
measure: Pharmacokinetic Parameter (Cmax) of IPI-145
timeFrame: Over 24 hours
Secondary outcomes:
measure: Incidence of adverse events following administration of IPI-145
timeFrame: 7 weeks
Other outcomes:
Locations:
city: Lenexa
country: United States
state: Kansas
Study officials:
affiliation: Verastem, Inc.
name: Hagop Youssoufian, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05051761: Study to Evaluate the Safety and Efficacy of Jaktinib in Adults With Alopecia Areata
Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Jaktinib in Adult Patients With Severe Alopecia Areata
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alopecia Areata
Lead sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2021-09-21
Enrollment: 425
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multi-center Phase 3 study to evaluate the safety and effectiveness of an investigational study drug (called Jaktinib) in adults (≥18 years and \<65 years) who have 50% or greater scalp hair loss. The study is placebo-controlled, meaning that some patients entering the study will not receive active study drug but will receive tablets with no active ingredients (a placebo). It is double-blinded, meaning that the Sponsor, the study doctors, the staff, and the patients will not know whether a patient is on active study drug (or the dose) or placebo.


Eligibility criteria: Inclusion Criteria:

* participants voluntarily sign the informed consent form (ICF);
* Age ≥ 18 years and \<65 years, either male or female;
* Clinical presentation compatible with alopecia areata with a current episode lasting not exceeding ≤8 years.
* At least 50% scalp hair loss.
* Willing to comply with the study visits and requirements of the study protocol.

Exclusion Criteria:

* participants has taken a JAK inhibitor prior to randomization;
* participants who are unsuitable to the trial, as identified by the investigator.

Primary outcomes:
measure: Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: Percentage of Participants Achieving 50% Improvement of SALT (SALT50)
timeFrame: Week 24
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Nanjing
country: China
facility: Hospital for Skin Diseases, Chinese Academy of medical Sciences
state: Jiangsu
Study officials:
affiliation: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
name: Jason Wu
role: STUDY_CHAIR
References:
Clinical trial NCT03689361: Interest of the T2 * Sequence in MRI for the Diagnosis of Migraine Aura in the Acute Phase.
Official title: Interest of the T2 * Sequence in MRI for the Diagnosis of Migraine Aura in the Acute Phase.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Migraine Aura
Keywords: migraine aura
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2018-09-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: investigators hypothesize that T2 \* vein abnormalities are frequent and are specific to the migraine aura.

Detailed description: The diagnosis of migraine aura is now based solely on clinical criteria and the assertion of the diagnosis on these clinical criteria alone proves difficult in the acute phase. Added to this difficulty, the symptomatology of a migraine aura can sometimes be similar to that of a stroke, so a diagnosis can be poorly established, resulting in poor patient care. The possibility of making the positive diagnosis of migraine aura on a routine MRI sequence, T2 \*, would be an important advance for the management of these patients

Eligibility criteria: Inclusion Criteria:

* Patients aged 18 to 55 years
* Admitted to the Neuro-Vascular Intensive Care Unit for Acute Focused Neurological Symptoms and MRI

  * less than 4 hours 30 minutes after onset of symptoms if symptoms persist during admission
  * less than two hours after the disappearance of symptoms if the patient arrives asymptomatic
* Affiliated to a social protection scheme.
* Having given their informed consent

Exclusion Criteria:

* Patients with neurological signs pointing to vertebrobasilar localization (vertigo, diplopia) or with a disorder of consciousness
* Presence of recent explanatory abnormalities on the MRI to make a diagnosis compatible with the initial neurological symptomatology (visible stroke in diffusion, cerebral hemorrhage, tumor, arteriovenous malformations).
* Potential strong cause of stroke known or discovered at the arrival of the patient, in particular stenosis of a cervical or intracranial artery upstream of the cerebral zone may correspond to the symptoms and emboligenic heart disease type atrial fibrillation.
* Pregnant women - Patients with a contraindication for MRI.
* Patients benefiting from a system of legal protection (tutelage,

Primary outcomes:
measure: frequency of the presence of visible brain vein abnormalities
timeFrame: Day 0
Secondary outcomes:
measure: perfusion parameters
timeFrame: Day 0
measure: asymmetry of visualization of the 3 intracranial arteries in MRI
timeFrame: Day 0
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Hôpital Pierre Paul Riquet - CHU de Toulouse
Study officials:
affiliation: Uuniversity Hospital Toulouse
name: Alain Viguier, PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00378261: APART Advanced Profiling of Anti-Rheumatic Therapies
Official title: A Multicenter, Randomized, Open Study to Evaluate the Impact of an Electronic Data Capture System on the Care of Patients With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Arthritis, Rheumatoid
Keywords: Rheumatoid Arthritis
Lead sponsor: Centocor Ortho Biotech Services, L.L.C.
Sponsor class: INDUSTRY
First posted: 2006-09-19
Enrollment: 1079
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to evaluate the utility of an electronic data capture system (EDCS) in a rheumatology clinical practice setting and to assess the impact of this system on patient satisfaction with patient-physician interaction.

Detailed description: This is a randomized, multicenter observational study to assess the impact of the EDCS in a rheumatology clinical practice setting on patient satisfaction with patient-physician communication using the Health Tracker electronic data capture system . Patients will be randomly assigned in a 2:1 ratio to the Health Tracker-user or non-user groups, respectively. The primary outcomes of this study will be the impact that information gathered and analyzed by an electronic data capture system has on patient satisfaction with arthritis care and patient physician interactions in clinical practice. Patient satisfaction will be assessed using a questionnaire developed specifically for this study.

This study does not involve the use of any investigational drugs, and the protocol does not mandate the treatment regimen patients will receive. Physicians will prescribe antirheumatic medications in accordance with usual clinical practice. The planned duration of subject participation is 12 months

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with active rheumatoid arthritis according to the revised criteria of the ACR (1987)
* Have rheumatoid arthritis that requires regularly scheduled visits with their rheumatologist at least every 3 months
* Willing and able to adhere to protocol requirements and participate in a study, lasting 12 months

Exclusion Criteria:

* Patients currently receiving investigational drugs
* Currently participating in other clinical trials or safety registries for rheumatoid arthritis or rheumatoid arthritis -related therapies

Primary outcomes:
measure: Primary endpoints for the Health Tracker-user group are the change in the patient satisfaction and patient-physician interaction surveys between the pre- and post-randomization phases.
Secondary outcomes:
measure: Changes between the pre- and post-randomization phases in the following clinical evaluations: HAQ scores, SF-12 scores, Patient assessed painful and/or swollen joint counts, Health care professional assessed tender and swollen joint counts
Other outcomes:
Locations:
Study officials:
affiliation: Centocor, Inc.
name: Centocor, Inc. Clinical Trial
role: STUDY_DIRECTOR
References:
Clinical trial NCT00703261: Evaluate the Utility of 18FDG-PET as a Tool to Quantify Atherosclerotic Plaque (MK-0000-081 AM3)(COMPLETED)
Official title: A Randomized, Double-Blind, Parallel Group Study to Evaluate the Effects of High Dose Statin Therapy on 18Fluorine Fluorodeoxyglucose (18FDG) Uptake in Arteries of Patients With Atherosclerotic Vascular Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Atherosclerotic Vascular Disease
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-06-23
Enrollment: 83
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
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 evaluate the utility of 18Fluorine Fluorodeoxyglucose Positron Emission Tomography (18FDG-PET) as a tool to quantify atherosclerotic plaque.


Eligibility criteria: Inclusion Criteria:

* Male or Female ages 30 to 80
* Participant is on a low dose statin for at least 6 weeks prior to screening or is statin-naive at screening

Exclusion Criteria:

* Participant has human immunodeficiency virus (HIV), Hepatitis B or C
* Participant uses illegal drugs
* Participant has Type I diabetes
* Participant has a history of claustrophobia

Primary outcomes:
measure: Percent Reduction From Baseline in TBRmeanmax of the Qualifying Segment
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Percent Reduction From Baseline in TBRmeanmax of the Qualifying Segment in Statin-naive Participants
timeFrame: Baseline and Week 12
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Singh P, Emami H, Subramanian S, Maurovich-Horvat P, Marincheva-Savcheva G, Medina HM, Abdelbaky A, Alon A, Shankar SS, Rudd JH, Fayad ZA, Hoffmann U, Tawakol A. Coronary Plaque Morphology and the Anti-Inflammatory Impact of Atorvastatin: A Multicenter 18F-Fluorodeoxyglucose Positron Emission Tomographic/Computed Tomographic Study. Circ Cardiovasc Imaging. 2016 Dec;9(12):e004195. doi: 10.1161/CIRCIMAGING.115.004195.
citation: Subramanian S, Emami H, Vucic E, Singh P, Vijayakumar J, Fifer KM, Alon A, Shankar SS, Farkouh M, Rudd JHF, Fayad ZA, Van Dyke TE, Tawakol A. High-dose atorvastatin reduces periodontal inflammation: a novel pleiotropic effect of statins. J Am Coll Cardiol. 2013 Dec 24;62(25):2382-2391. doi: 10.1016/j.jacc.2013.08.1627. Epub 2013 Sep 24.
citation: Tawakol A, Fayad ZA, Mogg R, Alon A, Klimas MT, Dansky H, Subramanian SS, Abdelbaky A, Rudd JH, Farkouh ME, Nunes IO, Beals CR, Shankar SS. Intensification of statin therapy results in a rapid reduction in atherosclerotic inflammation: results of a multicenter fluorodeoxyglucose-positron emission tomography/computed tomography feasibility study. J Am Coll Cardiol. 2013 Sep 3;62(10):909-17. doi: 10.1016/j.jacc.2013.04.066. Epub 2013 May 30.
Clinical trial NCT02477761: Sustained Effects of a Non-glucidic Nutrient Preload on Glucose Tolerance in Type 2 Diabetes
Official title: Sustained Effects of a Non-glucidic Nutrient Preload on Glucose Tolerance in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes
Lead sponsor: Azienda Ospedaliero, Universitaria Pisana
Sponsor class: OTHER
First posted: 2015-06-23
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The investigators aimed at evaluating the effects of a small non-glucidic nutrient preload on plasma glucose, insulin, C-peptide, glucagon-like peptide-1, and glucose-dependent insulinotropic polypeptide concentrations after the meal consumption and for 300 min after a 75 g glucose ingestion in diet-controlled type 2 diabetic patients.

Detailed description: As supported by experimental and clinical data, oral carbohydrate tolerance is influenced by the coingestion of nutrients through multiple mechanisms. The ingestion itself, the contact with the gastric mucosa, the arrival into the intestine and the subsequent digestion are known to produce neural reflexes, hormonal responses and plasma substrates gradients which, by modulating gastric emptying, insulin secretion and insulin clearance participate in the regulation of postprandial glycaemia. The size of this effect is influenced by a number of factors: the specific nutrient chemical characteristics (fat vs protein and composition) and their physical properties (solid vs liquid), the timing (pre-load vs coingestion) and finally the individual glucose tolerance status. The effect on 5 h glucose excursions of a combination of protein and fat given before carbohydrate is still unknown.

Eligibility criteria: Inclusion Criteria:

* Diet-controlled type 2 diabetic patients
* Subjects ≥ 18 and ≤65 years of age
* Lean, Overweight or Obese (BMI: 18 to 35 kg/m2)
* Normal liver and kidney function
* Normal thyroid function
* Read and understood the informed consent form and signed it voluntarily

Exclusion Criteria:

* Liver, heart, kidney, lung, infectious, neurological, psychiatric, immunological or neoplastic diseases.
* Type 1 or insulin treated diabetes.
* Pregnancy or lactation
* Illicit drug abuse or alcoholism
* Subjects taking anoretic drugs
* Subjects on steroid treatment
* Subjects after bariatric surgery.

Primary outcomes:
measure: Plasma glucose concentration
timeFrame: 330 minutes
Secondary outcomes:
measure: Plasma Insulin concentration
timeFrame: 330 minutes
measure: Plasma C-peptide concentration
timeFrame: 330 minutes
measure: Plasma glucagon-like peptide-1 concentration
timeFrame: 330 minutes
measure: Plasma glucose-dependent insulinotropic polypeptide concentration
timeFrame: 330 minutes
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: Azienda Ospedaliero-Universitaria Pisana
state: PI
Study officials:
affiliation: Azienda Ospedaliero, Universitaria Pisana
name: Andrea Natali, Prof
role: STUDY_CHAIR
References: