louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00645671: Loteprednol Etabonate Ophthalmic Ointment vs. Vehicle in the Treatment of Inflammation Following Cataract Surgery
Official title: A Randomized Multicenter, Double-Masked, Parallel-Group Clinical Safety and Efficacy Evaluation of Loteprednol Etabonate Ophthalmic Ointment, 0.5% Versus Vehicle for the Treatment of Inflammation Following Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ocular Inflammation
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2008-03-28
Enrollment: 400
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: To evaluate the clinical safety and efficacy of Loteprednol Etabonate Ophthalmic Ointment, 0.5% vs. vehicle for the treatment of inflammation following cataract surgery


Eligibility criteria: Inclusion Criteria:

1. Subjects who are candidate for routine, uncomplicated cataract surgery
2. Subjects who, in the Investigator's opinion, have potential postoperative pinholed Snellen visual acuity (VA) of at least 20/200 in the study eye.

Exclusion Criteria:

1. Subjects who will require concurrent ocular therapy with NSAIDs, mast cell stabilizers, antihistamines, decongestants, or immunosuppressants (e.g., Restasis), or with ocular or systemic corticosteroids
2. Subjects who have known hypersensitivity or contraindication to the study drug(s) or their components
3. Subjects who are monocular or have pinholed Snellen VA 20/200 or worse in the non-study eye
4. Subjects who have had ocular surgery (including laser surgery) in the study eye within 3 months or in the fellow eye within 2 weeks prior to the Screening Visit

Primary outcomes:
measure: Subjects With Complete Resolution of Anterior Chamber Cells and Flare. Grade=0.
timeFrame: Postoperative Day 8 (Visit 5)
measure: Grade 0 for Pain
timeFrame: Postoperative Day 8 (Visit 5)
Secondary outcomes:
measure: Subjects With Complete Resolution of Anterior Chamber Cells and Flare. At Each Follow-up Visit.
timeFrame: At each follow-up visit through day18 (Visit 7)
measure: Change From Baseline to Each Follow-up Visit in Anterior Chamber Cells and Flare
timeFrame: Baseline and each follow-up visit through day18 (Visit 7)
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: John Hunkeler, MD
state: Kansas
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Alyson J Berliner, MD/PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02115971: Jumping Exercises Approach in Individuals With Chronic Ankle Instability
Official title: The Effect of a 12-week Training Jumping Exercises Program in Individuals With Chronic Ankle Instability: Randomized Controlled Trial Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Joint Instability
Chronic Disease
Sprains
Keywords: chronic
functional
instability
ankle
Lead sponsor: Balgrist University Hospital
Sponsor class: OTHER
First posted: 2014-04-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this pilot study is to analyze the effect of a 12-week specific jump training compared with conventional therapy in patients with chronic functional instability of the ankle. It is to be evaluated to what extent the symptoms in of chronic functional instability of the ankle can be influenced in everyday life.

Detailed description: There is a need for;

1. more homogeneous sub- groups with chronic functional instability of the ankle.
2. Studies are needed that older patients (up to 50 years) and also take into account women.
3. In addition, studies should be performed in a clinical environment and also at the same time clinically adapted test can be used as a form measurement.

( Hiller et al. , 2011).

Eligibility criteria: Inclusion Criteria:

* Ankle injury more than 6 months ago
* Chronic instability
* Functional instability of the ankle
* Experience with proprioceptive exercises

Exclusion Criteria:

* Foot surgery
* Fresh ankle injury
* Acute foot pain with signs of inflammation
* Mechanical / anatomical ankle instability
* Athletes with regularly jumping exercise (eg volleyball, basketball)
* Taking medications which affect balance and coordination
* Diseases that affect the balance
* Serious diseases such as tumors, infections, neuropathies, severe articular degeneration
* Non-German-speaking patients

Primary outcomes:
measure: Change from Baseline in Gait variables
timeFrame: Change from Baseline in Gait variables at week 3, week 7, and at the end of therapy (week 12)
Secondary outcomes:
measure: Balance
timeFrame: Baseline, week 3, week 7, and at the end of therapy (week 12)
measure: Health questionnaire
timeFrame: Baseline, week 3, week 7, and at the end of therapy (week 12), followup 12 months
measure: Foot function questionnaire
timeFrame: Baseline, week 3, week 7, and at the end of therapy (week 12)
measure: Personal calendar
timeFrame: 12 months
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Balgrist Univeresty Hospital
state: ZH
Study officials:
affiliation: Balgrist Univeresty Hospital
name: Jaap Swanneburg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03824171: Evaluating the Pharmacokinetic Characteristics of AD-102 in Healthy Volunteers
Official title: A Randomized, Open Label, Single Dose, Crossover Study to Evaluate the Safety and Pharmacokinetic Characteristics After Administration of AD-102 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteoporosis
Lead sponsor: Addpharma Inc.
Sponsor class: INDUSTRY
First posted: 2019-01-31
Enrollment: 52
Sex: MALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the pharmacokinetic characteristics of AD-102 in healthy male subjects

Detailed description: This study is to evaluate the pharmacokinetic characteristics and safety of AD-102 compared with administration of raloxifen 60 mg + Cholecalciferol 800IU in healthy male subjects

Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) between 17.5 kg/m2 and 30.5 kg/m2 at the time of screening visit
* The Age between 19 and 50 in healthy male volunteers at the time of screening visit

Exclusion Criteria:

* As a result of laboratory tests, the following figures: ALT or AST\> 2 times upper limit of normal range
* As a result of laboratory tests, the following figures: 25-OH vitamin D total \<9 ng/mL

Primary outcomes:
measure: Peak Plasma Concentration (Cmax)
timeFrame: pre-dose to 96 hours
measure: Peak Plasma Concentration (Cmax)
timeFrame: pre-dose to 72 hours
measure: Area under the curve in time plot (AUCt)
timeFrame: pre-dose to 96 hours
measure: Area under the curve in time plot (AUCt)
timeFrame: pre-dose to 72 hours
Secondary outcomes:
measure: Area under the curve in time plot (AUCinf)
timeFrame: pre-dose to 96 hours
measure: Area under the curve in time plot (AUCinf)
timeFrame: pre-dose to 72 hours
measure: Time to reach Cmax
timeFrame: pre-dose to 96 hours
measure: Time to reach Cmax
timeFrame: pre-dose to 72 hours
measure: Effective half-life
timeFrame: pre-dose to 96 hours
measure: Effective half-life
timeFrame: pre-dose to 72 hours
Other outcomes:
measure: Number of participants with adverse events
timeFrame: From Day 1 until 32 Days
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hosptial
Study officials:
References:
Clinical trial NCT05160571: A Retrospective Multicenter Review to Evaluate the Performance of the Ion Endoluminal System in Sampling Pulmonary Lesions
Official title: A Retrospective Multicenter Review to Evaluate the Performance of the Ion Endoluminal System in Sampling Pulmonary Lesions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Pulmonary Nodule
Lead sponsor: Intuitive Surgical
Sponsor class: INDUSTRY
First posted: 2021-12-16
Enrollment: 279
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who underwent an Ion Endoluminal Procedure with a pulmonary nodule, 18 years or older

Brief summary: This study is a retrospective multi-center chart review of patients who underwent an attempted biopsy of one or more pulmonary lesion(s) with the Ion Endoluminal System with the aim of assessing the overall performance of the system.

Detailed description: This study is a retrospective multi-center chart review of patients who underwent an attempted biopsy of one or more pulmonary lesion(s) with the Ion Endoluminal System with the aim of assessing the overall performance of the system. The primary objectives of the study will be performance (evaluated by diagnostic yield and sensitivity for malignancy) and safety (assessed by rate of pneumothoraces and bleeding events).

Eligibility criteria: Inclusion Criteria:

* Subject was 18 years or older at the time of the procedure
* Biopsy procedure attempted/performed using the Ion Endoluminal System

Exclusion Criteria:

* Biopsy procedure was not attempted with the Ion Endoluminal System
* Biopsy procedure attempted with the Ion Endoluminal System occurred less than 12 months prior to IRB approval

Primary outcomes:
measure: Diagnostic yield
timeFrame: Intra-operative through the one year follow up period
measure: Sensitivity for malignancy
timeFrame: Intra-operative through the one year follow up period
measure: Pneumothorax
timeFrame: Intra-operative
measure: Bleeding
timeFrame: Intra-operative
Secondary outcomes:
measure: Adverse events
timeFrame: Intra-operative through 30 days
measure: Conversion to alternate approach or termination of procedure
timeFrame: Intra-operative
Other outcomes:
Locations:
city: Winchester
country: United States
facility: Winchester Medical Center
state: Virginia
Study officials:
affiliation: Winchester Medical Center
name: Glen Bouder, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02420171: Adding Insulin to IVF Culture Media Significantly Improve Outcome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: In Vitro
embryo quality
Intracytoplasmic sperm injection
Lead sponsor: Ibn Sina Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Banon IVF Center Assiut, Egypt
First posted: 2015-04-17
Enrollment: 360
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Add insulin to a single step culture media for IVF embryo culture from day 0 to day 5/6 of In Vitro culture and detect the the effect upon embryo quality and implantation potential.

Detailed description: The IVF culture media design and upgrade underwent many ideas during the last 3 decades, we suppose that adding insulin as a hormon and growth factor might improve embryo development in vitro so we decide to design a trial to compare the embryogenesis by sibling Oocytes of the same patient between to arm of the same culture media and yhe same culture condition but with one arm with insulin and the other is traditional one and closely monitor the outcome within the 2 arms abd record the results

Eligibility criteria: Inclusion Criteria:

* normal responder
* PCOS
* Tubal factor infertility
* mild asthenozoospermia

Exclusion Criteria:

* patient over 40

Primary outcomes:
measure: clinical Pregnancy rate ( % )
timeFrame: 6 months
Secondary outcomes:
measure: Blastocyst rate ( % )
timeFrame: 6 months
measure: Blastocyst quality rate ( % )
timeFrame: 6 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Banon IVF Center
city: Sohag
country: Egypt
facility: Ibnsina IVF center
Study officials:
References:
Clinical trial NCT01090271: Effects of Eccentric Training for Shoulder Abductors in Subjects With Shoulder Impingement Syndrome
Official title: Eccentric Training for Shoulder Abductors Improves Pain, Function and Isokinetic Performance Steadiness in Subjects With Shoulder Impingement Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Impingement Syndrome
Keywords: Subacromial impingement syndrome
Muscle Strength
Resistance Training
Lead sponsor: Universidade Federal de Sao Carlos
Sponsor class: OTHER
Collaborators: name: Coordenaçao de Aperfeiçoamento de Pessoal de Nível Superior
First posted: 2010-03-19
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study was to evaluate the effect of eccentric strength training for shoulder abductors on force steadiness in subjects with subacromial impingement syndrome (SIS).

Detailed description: Although it is known that shoulder abduction in subjects with subacromial impingement syndrome (SIS) presents alterations in several parameters, as for example, in scapular and glenohumeral kinematics, the strengthening of the shoulder abductors as an intervention strategy is controversial in literature.

Strength training has been shown to be effective in reducing the fluctuations in force and had a positive effect on isometric steadiness in old adults and in healthy young subjects during bed rest. However, there are no studies that evaluated the effects of strength training on the force steadiness in subjects with SIS.

Eligibility criteria: Inclusion Criteria:

* subjects diagnosed with Subacromial impingement syndrome by a physical therapist (the diagnosis was confirmed by an orthopaedic physician).

Exclusion Criteria:

* pregnancy
* torn rotator cuff or long head biceps tendons
* ligamentous laxity based on positive Sulcus test or a positive apprehension test
* previous shoulder or neck surgery
* hooked acromion
* systemic illnesses
* corticosteroid injection 3 months prior to evaluation
* physical therapy 6 months prior to evaluation

Primary outcomes:
measure: Isokinetic evaluation
timeFrame: 2 months
Secondary outcomes:
measure: Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire
timeFrame: 2 months
Other outcomes:
Locations:
city: Sao Carlos
country: Brazil
facility: Universidade Federal de Sao Carlos
state: Sao Paulo
Study officials:
affiliation: Universidade Federal de Sao Carlos (Sao Paulo - Brazil)
name: Tânia TS Salvini, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04345471: A Study of MD-120 in Patients With Depression
Official title: A Placebo-controlled Study of MD-120 in Patients With Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Lead sponsor: Mochida Pharmaceutical Company, Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2020-04-14
Enrollment: 615
Sex: ALL
Minimum age (years): 20
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 verify the efficacy and evaluate the safety of 8-week once-daily oral administration of MD-120 in Japanese patients with depression.


Eligibility criteria: Inclusion Criteria:

* Patient with diagnosis of Major Depressive Disorder (MDD) based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5).
* Hamilton Depression Rating Scale-17 (HAM-D17) total score of ≥20.

Exclusion Criteria:

* Patient who meets DSM-5 criteria of the following disorders for current or past history.

Schizophrenia spectrum and other psychotic disorders Bipolar and related disorders Substance use disorders (exclusive of tobacco and caffeine)

* Patient who had suicidal behavior in Columbia-Suicide Severity Rating Scale (C-SSRS) within 1 year before start of screening phase.

Primary outcomes:
measure: Changes in Total MADRS Score From the Baseline to Week 8 Visit During the Treatment Period
timeFrame: 8 weeks
measure: Number of Participants With Adverse Events (AEs)
timeFrame: 10 weeks
Secondary outcomes:
measure: Changes in Total HAM-D17 Score From the Baseline to Week 8 Visit During the Treatment Period
timeFrame: 8 weeks
measure: Number of Participants With Adverse Drug Reactions (ADRs)
timeFrame: 10 weeks
measure: Plasma Concentration of Desvenlafaxine
timeFrame: Week 2 through week 8
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Mochida Investigational sites
Study officials:
affiliation: Mochida Pharmaceutical Company, Ltd.
name: Koichi Hayashi
role: STUDY_DIRECTOR
References:
Clinical trial NCT00004471: Phase I Pilot Study of Gene Therapy for Cystic Fibrosis Using Cationic Liposome Mediated Gene Transfer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cystic Fibrosis
Keywords: cardiovascular and respiratory diseases
cystic fibrosis
genetic diseases and dysmorphic syndromes
rare disease
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 1999-10-19
Enrollment: 9
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: OBJECTIVES:

Determine whether copies of the cystic fibrosis gene (pGT-1) can be delivered to the cells lining the nose of cystic fibrosis patients using cationic liposome (DMRIE/DOPE) mediated gene transfer.

Detailed description: PROTOCOL OUTLINE: Under direct visualization, patients receive lipid/DNA formulation (pGT-1 lipid complex) by syringe instillation over 30 minutes to the right inferior nasal turbinate.

Patients are followed daily for 7 days, twice a week for 3 weeks, every 2-3 weeks for 10 weeks, then every 3 months thereafter.

Eligibility criteria: * Cystic fibrosis patients
* Not pregnant Fertile patients must use effective contraception

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Alabama at Birmingham
name: Eric J. Sorscher
role: STUDY_CHAIR
References:
Clinical trial NCT00956371: ONO-7746 Study in Healthy Adult Subjects
Official title: A Double-Blind, Placebo-Controlled, SIngle Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONO-7746 in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Adult Subjects
Keywords: ONO-7746
Healthy adult subjects
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2009-08-11
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the safety and tolerability of ONO-7746 in healthy adult subjects. The secondary objectives are to characterize the pharmacokinetic and pharmacodynamic profiles of ONO-7746.


Eligibility criteria: Inclusion Criteria:

* Healthy non-smoking male or female subjects (18-55 years inclusive)
* Body mass index (BMI) of 19-35 kg/m² (inclusive)
* For females: postmenopausal, non-lactating and non-pregnant

Exclusion Criteria:

* History or presence of clinically significant disease

Primary outcomes:
measure: Safety and tolerability of ONO-7746 across ascending single doses
timeFrame: study duration
Secondary outcomes:
measure: Characterization of PK and PD profiles of ONO-7746
timeFrame: study duration
Other outcomes:
Locations:
city: Austin
country: United States
facility: Austin
state: Texas
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Ono Pharma USA, Inc.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04437771: Long-Term Follow-up of Subjects With Fanconi Anaemia Subtype A Treated With ex Vivo Gene Therapy
Official title: Long-Term Follow-up: Phase I/II Clinical Study to Evaluate the Safety and Efficacy of the Infusion of Autologous CD34+ Cells Transduced With a Lentiviral Vector Carrying the FANCA Gene in Patients With Fanconi Anaemia Subtype A: FANCOLEN-I
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Fanconi Anemia Complementation Group A
Fanconi Anemia
Keywords: gene therapy
anaemia
autologous hematopoeitic stem cell transplant
safety
bone marrow failure
genetic diseases
anemia
Lead sponsor: Rocket Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2020-06-18
Enrollment: 9
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with Fanconi anemia subtype A who have been treated with ex vivo gene therapy product in FANCOLEN-I study

Brief summary: This is a long-term safety and efficacy follow-up study for subjects with Fanconi Anaemia Subtype A who have been treated with ex vivo gene therapy on the FANCOLEN-I trial. After completion of the FANCOLEN-I study, eligible subjects will be followed for a total of 15 years post gene therapy treatment. No investigational drug product will be administered during this study.

Detailed description: This long-term follow-up protocol will evaluate the long term safety and efficacy of the infusion of autologous CD34+ cells transduced with lentiviral vector (LV) carrying the FANCA gene.

Eligibility criteria: Inclusion Criteria:

1. Enrolled in the FANCOLEN-I study
2. Treated with gene therapy in the FANCOLEN-I study
3. Able to adhere to the study visit schedule and protocol requirements
4. Provided written informed consent and, as applicable, assent to participate

Exclusion Criteria:

* There are no exclusion criteria for this study

Primary outcomes:
measure: Monitor long term safety of patients through blood laboratory evaluations and general health status
timeFrame: 15 years post-drug product infusion
measure: Long term genetic correction assessed in bone marrow and blood
timeFrame: 15 years post-drug product infusion
measure: Replication competent lentivirus (RCL)
timeFrame: 15 years post-drug product infusion
measure: Insertion site analysis in blood
timeFrame: 15 years post-drug product infusion
measure: Phenotypic correction
timeFrame: 15 years post-drug product infusion
measure: Assessment for Malignancies
timeFrame: 15 years post-drug product infusion
measure: Hematologic stabilization
timeFrame: 15 years post-drug product infusion
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Infantil Universitario Niño Jesús (HIUNJ)
Study officials:
References: