louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05654870: Study to Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as an Adjunctive Treatment for Schizophrenia
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as Adjunctive Treatment in Subjects With Schizophrenia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: schizophrenia
valbenazine
antipsychotic
VMAT2
NBI-98854
dopamine
PANSS
Adjunctive
Lead sponsor: Neurocrine Biosciences
Sponsor class: INDUSTRY
First posted: 2022-12-16
Enrollment: 8
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This primary objective for this study is to evaluate the effect of adjunctive valbenazine versus placebo on symptoms of schizophrenia in participants who have inadequate response to antipsychotic treatment.


Eligibility criteria: Key Inclusion Criteria:

* Medically confirmed diagnosis of schizophrenia
* Participant is receiving a stable regimen of background antipsychotic medication
* Plasma levels for at least 1 of the participant's antipsychotic medications must be detectable by an available assay
* Participant is an outpatient with stable symptomatology
* Participant must have an adult informant (for example, a family member, relative, partner, social worker, caseworker, residential facility staff, or nurse)

Key Exclusion Criteria:

* Has a history of treatment resistant schizophrenia
* Have a clinically significant unstable medical condition in the judgement of the investigator or any laboratory value outside the normal range that is considered by the investigator to be clinically significant at the screening visit
* Prior (within 6 months of Screening) or concomitant use of any vesicular monoamine transporter 2 (VMAT2) inhibitor (that is, valbenazine, reserpine, tetrabenazine, deutetrabenazine); or a history of intolerance to VMAT2 inhibitors

Primary outcomes:
measure: Change in Positive and Negative Syndrome Scale (PANSS) Total Score from Baseline to Week 10
timeFrame: Baseline, Week 10
Secondary outcomes:
measure: Change in Clinical Global Impression of Severity (CGI-S) Score from Baseline to Week 10
timeFrame: Baseline, Week 10
measure: Change in Personal and Social Performance (PSP) Score from Baseline to Week 10
timeFrame: Baseline, Week 10
Other outcomes:
Locations:
city: San Jose
country: United States
facility: Neurocrine Clinical Site
state: California
city: Coral Gables
country: United States
facility: Neurocrine Clinical Site
state: Florida
city: Atlanta
country: United States
facility: Neurocrine Clinical Site
state: Georgia
Study officials:
affiliation: Neurocrine Biosciences
name: Clinical Development Lead
role: STUDY_DIRECTOR
References:
Clinical trial NCT02961270: Icotinib in Non-small Cell Lung Cancer Patients With Uncommon EGFR Mutation
Official title: Clinical Activity of Icotinib in Patients With Advanced Non-small-cell Lung Cancer Harbouring Uncommon EGFR Mutations: a Single-arm, Prospective, Phase 2 Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2016-11-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the efficacy of icotinib, a first generation EGFR TKI, in non-small cell lung cancer patients harboring uncommon EGFR mutation


Eligibility criteria: Inclusion Criteria:

* Patients with stage IIIB/IV non-small cell lung cancer
* Patients with uncommon epidermal growth factor receptor (EGFR) mutation
* Targeted-therapy-naive patients
* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
* Evaluable target lesions according to RECIST 1.1 for tumour response assessment

Exclusion Criteria:

* Wild-type EGFR
* Positive 19 del and/or 21 L858R mutation
* Previous treatment with EGFR TKIs such as gefitinib, erlotinib, and afatinib
* Patients who have documented history of interstitial lung disease

Primary outcomes:
measure: progression-free survival
timeFrame: 10 months
Secondary outcomes:
measure: tumor response rate
timeFrame: 2 months
measure: overall survival
timeFrame: 24 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Medical Oncology, Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College; Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs
Study officials:
affiliation: Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs
name: Shengyu Zhou, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00457470: A Phase 2 Study Exploring The Safety And Efficacy Of Novel Drug Treatment In Subjects With Diabetic Macular Edema (DME)
Official title: A Phase 2, Multi-Stage, Multi-Center Trial Exploring The Safety And Efficacy Of AG-014699 In Subjects With Diffuse Diabetic Macular Edema (DME) Involving The Center Of The Retina
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Diabetes Mellitus
Diabetic Retinopathy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-04-06
Enrollment: 0
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: This study will evaluate the safety and efficacy of AG-014699 in diabetic patients


Eligibility criteria: Inclusion Criteria:

* diabetic patients, either man or woman, with diabetic retinopathy, at least 18 years of age

Exclusion Criteria:

* patients treated with laser therapy within the last 90 days
* patients with likelyhood to require cataract surgery within 3 months
* Uncontrolled diabetes

Primary outcomes:
measure: Change of retinal thickness at Day 15 or Day 25 depending on dosing regimen
Secondary outcomes:
measure: Proportion of subjects with reduction in retinal thickness from baseline in 2 months
measure: Change in retinal thickness for 2 months
measure: Change in visual acuity for 2 months
measure: ; Proportion of eyes experiencing an improvement in the degree of retinopathy at Day 28
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05151770: Type 1 Diabetic Post Prandial Glycemia Evaluation Using an Algorithm
Official title: Type 1 Diabetic Post Prandial Glycemia Evaluation Using an Algorithm
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type I Diabetes
Keywords: Type I diabetes
Hyperglycemia
Post prandial glycemia
algorithm
Lead sponsor: M-DT1
Sponsor class: INDUSTRY
Collaborators: name: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
name: Assistance Publique Hopitaux De Marseille
First posted: 2021-12-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Type I diabetes

Brief summary: The aim of this study is to demonstrate the efficacy of an algorithm to anticipate the post prandial glycemic profile in type I diabetic patient.


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes
* ≥ 18 years old
* Hb1Ac\<12%

Exclusion Criteria:

* Patient without continuous glucose monitoring system
* Disease other than diabetes (bulimia, anorexia...)
* Dialysis patient
* Known history of drug or alcohol abuse
* Patient under judicial protection
* Person deprived of liberty
* Pregnant, parturient or breastfeeding woman
* Patient in psychiatric care
* Patient admitted to a health or social institution for purposes other than research
* Any reasons that might interfere with the evaluation of the study objectives

Primary outcomes:
measure: Algorithm efficacy
timeFrame: 15 days
Secondary outcomes:
measure: Algorithm efficacy (lower margin of error)
timeFrame: 15 days
measure: Algorithm efficacy versus meal composition
timeFrame: 15 days
measure: Influence of the age of the patients on algorithm results
timeFrame: 15 days
measure: Influence of the BMI on algorithms results
timeFrame: 15 days
measure: Influence of the insulin administration on algorithm results
timeFrame: 15 days
Other outcomes:
Locations:
city: Marseille
country: France
facility: APHM
city: Toulon
country: France
facility: Hopital Sainte Musse
Study officials:
References:
Clinical trial NCT00189670: Randomized Phase II Trial of Dose Dense Docetaxel in N+ Breast Cancer
Official title: A Phase II Randomized Trial of 6 TEC Every 3 Weeks, Versus 4 EC Followed by 4 Taxotere Every 2 Weeks, Versus 4 Taxotere Followed by 4 EC Every 2 Weeks in Node Positive Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Node Positive Breast Cancer
Lead sponsor: Association Européenne de Recherche en Oncologie
Sponsor class: OTHER
Collaborators: name: Aventis Pharmaceuticals
name: Amgen
First posted: 2005-09-19
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To screen a dose-dense arm to be used in a future large scale phase III trial. Primary endpoint is safety; secondary endpoints are disease free survival and overall survival. A total of 100 patients were included.


Eligibility criteria: Inclusion Criteria:

* Patient with histologically proven breast cancer
* Surgical resection performed with clear margins (R0 resection)
* At least 1 histologically proven involved axillary node
* ER + or ER-
* Interval between surgery (2nd surgical procedure in case of multiple procedures) and randomization inferior to 60 days
* Aged over 18 years, and more than 10-year life expectancy
* ECOG performance status 0-1
* Signed informed consent form prior to randomization

Exclusion Criteria:

* Bilateral breast cancer
* Inflammatory breast cancer
* Personal history of breast cancer
* Immunohistochemical only node involvement
* Intraductal breast cancer
* Distant metastases
* Contraindication to any drug contained in the chemotherapy regimens
* Any serious active disease or co-morbid medical condition including recent history of severe sepsis and digestive inflammatory disease
* Poor renal function (creatinin level \> 120 micromol/L), poor hepatic function (total bilirubin level \> 1 UNL), transaminases \> 2.5 UNL)
* Poor bone marrow reserve as defined by neutrophils \< 1.5 G/L or platelets \< 100 G/L; Hemoglobin \< 10 G/dL
* Poor contractile cardiac function (LVEF \< 50%)
* Coronary disease
* Any history of cancer during the last 5 years, with the exception of basal cell carcinomas or stage 0 (in situ) cervical carcinoma
* Pregnancy or breast feeding
* Absence of contraception in non menopausal women
* Adult patient unable to give informed consent because of intellectual impairment
* Concomitant participation to another trial

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Association Europeenne de Recherche en Oncologie
name: Pascal Piedbois, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02939170: Initial Performance of a Daily Disposable Contact Lens Featuring Molded Marks
Official title: Initial Performance of a Daily Disposable Contact Lens Featuring Molded Marks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Error
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2016-10-19
Enrollment: 87
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 evaluate the impact of back surface molded marks (MM) applied to delefilcon A contact lenses as measured by the incidence of ocular discomfort device-related adverse events with DAILIES TOTAL1® Multifocal contact lenses with molded marks (DT1 MF MM) and current DAILIES TOTAL1® Multifocal contact lenses (DT1 MF).


Eligibility criteria: Inclusion Criteria:

* Must sign an Informed Consent document;
* Current wearer of commercial DAILIES TOTAL1® contact lenses;
* Have spectacles in current prescription available to be worn in conjunction with the investigational product;
* Manifest astigmatism less than or equal to 0.75 diopter (D) (at screening)
* Best corrected distance visual acuity (BCVA) greater than or equal to 20/25 in each eye;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Eye injury in either eye within 12 weeks prior to study enrollment;
* Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear;
* Any use of systemic or ocular medications for which contact lens wear could be contraindicated;
* History of herpetic keratitis, refractive surgery or irregular cornea;
* A pathologically dry eye that precludes contact lens wear;
* Concurrent participation in a contact lens or contact lens care product clinical trial within the previous 30 days;
* Monocular (only 1 eye with functional vision);
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Incidence of Ocular Discomfort Device-related Adverse Events (AE)
timeFrame: Day 1 at Hour 9
Secondary outcomes:
measure: Ocular Staining
timeFrame: Day 1 at Hour 9
measure: Limbal Hyperemia
timeFrame: Day 1 at Hour 9
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon Call Center for Trial Locations
state: Texas
Study officials:
affiliation: Alcon, A Novartis Division
name: Clinical Manager, CTM
role: STUDY_DIRECTOR
References:
Clinical trial NCT03784170: FemPulse Therapy for Overactive Bladder in Women
Official title: Evaluation of a Non-Implanted Electrical Stimulation Continence Device for Overactive Bladder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urinary Bladder, Overactive
Keywords: Overactive Bladder
OAB
Women
Neuromodulation
Bioelectronic Medicine
Lead sponsor: FemPulse Corporation
Sponsor class: INDUSTRY
First posted: 2018-12-21
Enrollment: 21
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will wear a device and will be treated at 1 of 2 device settings for approximately 3 days.
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical trial is to investigate a new medical device treatment for Overactive Bladder (OAB) in women.

Detailed description: The FemPulse System is a vaginal ring intended to provide mild electrical stimulation to nerves that regulate bladder function. It is believed that stimulation of these nerves may help relieve the symptoms of OAB.

Eligibility criteria: Inclusion Criteria:

* Females 21 years or older with a diagnosis of Overactive Bladder
* If of reproductive age, must use a reliable form of contraception

Exclusion Criteria:

* Pregnant, was recently pregnant or is trying to conceive
* Has a metal pelvic implant or any electrically active implanted medical device
* Had a previous hysterectomy, pelvic radiation or pelvic cancer
* Has significant pelvic organ prolapse
* Had bladder treatment with onabotulinumtoxinA in the previous 12 months
* Has a significant heart condition

Primary outcomes:
measure: All device- and procedure-related adverse events will be collected and tabulated
timeFrame: Approximately 11 days in total
measure: Urinary frequency
timeFrame: Approximately 11 days in total
measure: Urinary urgency
timeFrame: Approximately 11 days in total
measure: Urge urinary incontinence (UUI)
timeFrame: Approximately 11 days in total
measure: OAB-q - Short Form
timeFrame: Approximately 11 days in total
measure: OAB Symptom Score
timeFrame: Approximately 11 days in total
measure: Urogenital Distress Inventory - Short Form
timeFrame: Approximately 11 days in total
measure: Incontinence Impact Questionnaire - Short Form
timeFrame: Approximately 11 days in total
Secondary outcomes:
Other outcomes:
Locations:
city: Woodbury
country: United States
facility: Minnesota Urology
state: Minnesota
city: Charlotte
country: United States
facility: McKay Urology
state: North Carolina
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
Study officials:
References:
Clinical trial NCT05881070: Effectiveness of Mobile-health Self Management on Quality of Life of Patients Undergoing Chemotherapy
Official title: Effectiveness of Mobile-health Self Management on Quality of Life of Patients Undergoing Chemotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer
Chemotherapy Effect
Quality of Life
Self Efficacy
Lead sponsor: Universitas Muhammadiyah Yogyakarta
Sponsor class: OTHER
First posted: 2023-05-30
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study will design and evaluate the use of mobile-health based self-management on self-efficacy and quality of life of patients undergoing chemotherapy.

Detailed description: The study will design and evaluate the use of mobile-health based self-management on self-efficacy and quality of life of patients undergoing chemotherapy.

Eligibility criteria: Inclusion Criteria:

* adult patients diagnosed with cancer
* patients who use smart phone

Exclusion Criteria:

* patients with cancer with comorbidity

Primary outcomes:
measure: Patient's Quality of life
timeFrame: Four weeks
measure: Patient's Self-efficacy
timeFrame: four weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04288570: Punch vs. Drill Tunnel Use for Anchor Tunnel Creation and Correlation With Post-operative Pain
Official title: Punch vs. Drill Tunnel Use for Anchor Tunnel Creation and Correlation With Post-operative Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Tears
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2020-02-28
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine if different techniques used in the creation of suture anchor socket creation can influence post-op pain following rotator cuff repair.


Eligibility criteria: Inclusion Criteria:

a. Patient's aged 18-80 years old with diagnosis of rotator cuff tear having failed non-operative management and being indicated for surgical intervention with use of suture anchors.

Exclusion Criteria:

1. Glenohumeral arthrosis
2. Previous shoulder surgery
3. Psychiatric diseasesMRI
4. Rheumatologic diseases
5. Fibromyalgia
6. Spine diseases

Primary outcomes:
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function Short Form
timeFrame: Preop, 2 Weeks, 6 Weeks, 3 Months, 6 Months
measure: Single Assessment Numeric Evaluation (SANE)
timeFrame: Preop, 2 Weeks, 6 Weeks, 3 Months, 6 Months
measure: Visual Analogue Scale
timeFrame: Preop, 2 Weeks, 6 Weeks, 3 Months, 6 Months
measure: PROMIS - Pain Interference
timeFrame: Preop, 2 Weeks, 6 Weeks, 3 Months, 6 Months
Secondary outcomes:
measure: Magnetic Resonance Imaging (MRI) of the Shoulder
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
Study officials:
affiliation: University of Missouri Health System, Department of Orthopaedic Surgery
name: Matthew J Smith
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01490970: Sarcoma Database at KFSH&RC
Official title: Sarcoma Database at KFSH&RC.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sarcoma Database
Keywords: Sarcoma Database
Lead sponsor: King Faisal Specialist Hospital & Research Center
Sponsor class: OTHER
First posted: 2011-12-13
Enrollment: 44
Sex: ALL
Minimum age (years): 14
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Sarcoma Database

Brief summary: Sarcoma Database

Detailed description: Sarcoma Database

Eligibility criteria: Inclusion Criteria:

* Patients with diagnosed Sarcoma

Exclusion Criteria:

* Patients with diagnosis other than Sarcoma

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Kfsh & Rc
Study officials:
affiliation: KFSH & RC
name: M Memon, M.D.
role: PRINCIPAL_INVESTIGATOR
References: