louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02891629: Safety and Feasibility of the EyeControl Device
Official title: Safety and Feasibility of the EyeControl Device (Eye-based Communication Device) for ALS Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ALS (Amyotrophic Lateral Sclerosis)
Lead sponsor: Eyefree Assisting Communication Ltd
Sponsor class: INDUSTRY
First posted: 2016-09-07
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The EyeControl device is an eye movement-based communication device in the form of wearable glasses with connected infrared cam-era that tracks the pupil and translates blinks and movements into commands.This study is aimed to demonstrate the safety and feasibility of the EyeControl device in healthy volunteers, and ALS patients in early stages.


Eligibility criteria: Inclusion Criteria:

1. Subjects 18 to 65 years old
2. Subject with understandable speaking communication
3. Subject fluent in Hebrew (speech and writing skills)

   Additional inclusion criteria for Stage 2 of the study:
4. Subjects with early stage ALS diagnosis - whose speech capability is unaffected

Exclusion Criteria:

1. Subjects with glasses or contact lenses
2. Subjects with eye conditions such as Ptosis, Strabismus And Crossed Eyes
3. Medical history of epilepsy
4. Subjects who according to investigator's judgement, unable to comply with the requirements of this protocol
5. Pregnant or lactating women

Primary outcomes:
measure: Feasibility - Successful Performance Rate of Device Features
timeFrame: 2 weeks
Secondary outcomes:
measure: Safety Assessment - Number of Device Related Adverse Events
timeFrame: 2 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00773929: Safety Study of TAK-593 Given Orally in Subjects With Nonhematologic Advanced Cancer
Official title: A Multicenter Phase I Clinical and Pharmacokinetic Study of Oral TAK-593 in Subjects With Nonhematologic Advanced Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumors
Lead sponsor: Millennium Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2008-10-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety and toxicity profile of TAK-593 and determine the maximum tolerated dose of TAK-593.


Eligibility criteria: Inclusion Criteria:

* ≥ 18 years of age diagnosed with advanced solid tumor cancer that failed to respond to standard therapies and where no other treatment options are available.
* No prior chemotherapy
* Able to understand and follow study requirements
* Subject or subject's legal representative signs a written, informed consent form prior to beginning any study procedures.
* Women who are post-menopausal for at least 1 year before screening or surgically sterile
* Women of childbearing potential agree to practice two effective methods of birth control from the time of signing the informed consent form through 30 days after the last dose of the study drug or agree to completely abstain from heterosexual intercourse.
* Men who agree to practice an effective method of birth control for the entire study treatment period and through 30 days after the last dose of study drug or completely agree to abstain from heterosexual intercourse.
* Ability to swallow and retain oral medication
* Meet study specific laboratory test standards for bone marrow function, liver function, blood pressure, and renal function.

Exclusion Criteria:

* Cancer has spread to the brain
* History of another cancer diagnosed or treated within the past 3 years.
* Severe cardiovascular issues including heart attack within the past 6 months, unstable angina or arrhythmias that require treatments.
* Severe thyroid disease
* Unstable angina
* Arrhythmia issues
* History of bleeding issues
* Serious wounds, ulcers or bone fractures that do not heal
* Subject is pregnant or breast feeding
* Subject has illnesses or conditions that may affect their ability to participate in the study
* Subject participated in another clinical study/post marketing clinical study within 4 weeks prior to the start of this trial.

Primary outcomes:
measure: Toxicities of TAK-593 Pharmacokinetic parameters of TAK-593
timeFrame: 18-24 months
Secondary outcomes:
measure: Response outcomes including objective response and clinical benefit response.
timeFrame: 18-24 months
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
Study officials:
affiliation: Millennium Pharmaceuticals, Inc.
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00263029: Preoperative Radiotherapy/ Oxaliplatin/ Capecitabine Treatment For Unresectable Locally-advanced Rectal Cancer
Official title: Pre-operative Radiotherapy/ Oxaliplatin/ Capecitabine Treatment For Unresectable Locally-advanced Rectal Cancer (PROCTFUL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rectal Neoplasms
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2005-12-07
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this phase II trial is to determine the efficacy and safety of the combination of oxaliplatin, capecitabine and radiotherapy as preoperative therapy in locally advanced cancers of the rectum.


Eligibility criteria: Inclusion Criteria:

* ECOG performance status score 0-1.
* Chemo-naïve patients.
* Histologically/cytologically confirmed diagnosis of rectal adenocarcinoma (clinically stage mT3 or mT4), either considered (1)inoperable, or (2)locally advanced, where histologically confirmed curative resection is considered unlikely.
* Evaluable measurable disease on imaging with MRI/CT to allow for response assessment.
* Adequate haematological, renal and liver functions as follows:

  * ANC \> 3000ml
  * Platelet count \> 100,000 ml
  * Urea \& Serum Creatinine \< 1.5 X upper limit of normal value
  * Total serum bilirubin \< 1.5 X upper limit of normal value
  * ALT \& AST \< 3 X upper limit of normal value

Exclusion Criteria:

* Prior chemotherapy.
* Documented allergy to oxaliplatin or capecitabine.
* Prior radiotherapy to pelvis.
* Previous or concurrent malignancies at other sites with the exception of basal or squamous cell carcinoma of the skin.
* Pregnant or lactating females (with negative pregnancy test documentation in pre-menopausal female patients).
* Currently participating into another clinical trial with any investigational drug in the previous 30 days.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Response rate (both clinical and pathological) of the primary rectal cancer observed after the chemoradiotherapy. Histologically confirmed complete resection rate (R0 rate).
timeFrame: 3-years disease- free-survival or 3-years overall survival
Secondary outcomes:
measure: Adverse events collection
timeFrame: From the signature of the informed consent up to the end of the study
Other outcomes:
Locations:
Study officials:
affiliation: Sanofi
name: Iris CHAN, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01975129: A Pharmacokinetic Study of Vaginally and Intravenously Administered Oxytocin
Official title: A Pharmacokinetic Study of Vaginally and Intravenously Administered Oxytocin in Postmenopausal Women With Vaginal Atrophy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Vaginal Atrophy
Lead sponsor: PepTonic Medical AB
Sponsor class: INDUSTRY
First posted: 2013-11-03
Enrollment: 12
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the uptake of oxytocin following intravaginal administration of Vagitocin 400IU over a period of 15 days and also to compare oxytocin bioavailability after vaginal and intravenous administration. 12 healthy postmenopausal female volunteers, 40 to 70 years old with vaginal atrophy will be included and will self-administer Vagitocin intravaginally on day 2-14 (day 1 and 15 Vagitocin is given in the clinic). On day 22 a single intravenous dose of oxytocin 10 IU Syntocinon® will be given. Oxytocin plasma levels after intravaginal and intravenous administration will be analysed day 1, 15 and 22 at timepoints: -1.0, -0.5, 0, 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 6.0 and 8.0 hours, relative to dosing. Based on the obtained plasma levels for oxytocin, pharmakokinetic variables will be calculated. The % of oxytocin which was absorbed following vaginal administration (bioavailability)will also be calculated.


Eligibility criteria: Inclusion Criteria:

* Post-menopausal women with vaginal atrophy as judged by the investigator
* Willing to participate in the study as indicated by signing the informed consent
* Healthy post-menopausal women between the ages of 40 and 70 years, inclusive
* Body mass index (BMI) less than or equal to 32 kg/m2 but greater than or equal to 19 kg/m2
* Judged by the Investigator to be healthy on the basis of medical evaluation

Exclusion Criteria:

* Hospitalized subjects
* Symptoms of any significant acute illnesses at the screening visit
* History of significant allergies (including food, asthma, or drug allergies including allergies to any ingredient of the trial product)
* Known history of sensitivity to oxytocin or related derivatives
* Follicle-stimulating hormone level \< 40 pmol/mL
* Known history of narcotic addiction, drug abuse or alcoholism
* Simultaneously participate in another clinical study
* Use of any sex steroids including phytoestrogens, hormonal intrauterine device or herbal medicinal products with known estrogenic effects within 3 months prior to baseline
* Uncontrolled hypertension and/or hypercholesterolemia

Primary outcomes:
measure: Oxytocin plasma levels
timeFrame: Day 1 to 26
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Women's health clinic
state: Huddinge
Study officials:
affiliation: Karolinska University Hopsital, Womens Health
name: Aino Fianu Jonasson, MD Ass Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00285129: Primary Ceramic-on-Ceramic Total Hip Replacement Versus Metal-on-Metal Hip Resurfacing in Young Active Patients
Official title: Primary Ceramic-on-Ceramic Total Hip Replacement Versus Metal-on-Metal Hip Resurfacing in Young Active Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Indications for a Total Hip Prosthesis
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2006-02-01
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Comparison of the functional result and speed of rehabilitation between two types of hip prostheses: primary ceramic-on-ceramic total hip replacement versus metal-on-metal hip resurfacing.


Eligibility criteria: Inclusion Criteria:

* Total hip replacement

Exclusion Criteria:

-

Primary outcomes:
measure: Functional result
measure: Speed of rehabilitation
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Rene Verdonk, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03498729: Autoimmunity in the Pathogenesis of AF
Official title: The Role of Autoimmune Mechanisms in the Pathogenesis of Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: Autoimmune Diseases
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2018-04-17
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients 18 years and older.

Brief summary: This research study is being done to find out whether autoimmune mechanisms are associated with the development of atrial fibrillation.

Detailed description: The study sets out to identify an explanation for the pathogenesis of AF, potentially forming the basis for designing novel targeted therapies to prevent or reverse this prevalent human disease. The overall objectives are to determine whether autoimmune diseases are associated with AF development and to identify specific diagnostic and prognostic biomarkers that will improve the ability to accurately predict risk of AF development. The study will prospectively enroll patients with and without AF and determine their serum cytokine levels and assess the functional responses of T cells on the basis of cytokine production after in vitro T-cell specific stimulation, using Luminex bead-based multiplex technology.

Eligibility criteria: Inclusion Criteria:

* Cases: AF (Persistent, paroxysmal AF)
* Controls 1: (No prior history of AF or inflammatory or autoimmune diseases)
* Controls 2: (biopsy proven Psoriasis)

Exclusion Criteria:

* Clinically apparent acute infections over the past 4 weeks
* Chronic infections
* Recent malignancies
* Recent Radiation or chemotherapy
* Chronic kidney disease (≥ stage 2)
* Organ transplantation
* History of chronic liver disease
* Major surgery or invasive procedure in the past 6 months
* Internal prosthesis
* Receiving immunosuppressive therapy
* Known rheumatologic diseases (except for the participants with psoriasis)
* Females who are known to be pregnant

Primary outcomes:
measure: Cytokines Levels
timeFrame: through study completion, approximately 3 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Rowlens M. Melduni, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00950729: The Effects of Lower Right Limb Orthopedic Immobilization on Driving Performance
Official title: The Effects of Lower Right Limb Orthopedic Immobilization on Driving Performance: an Experimental Study During Simulated Driving in Healthy Volunteers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Walking Cast Right Leg Immobilisation Effects
Aircast Right Leg Immobilisation Effects
Keywords: car driving simulator
orthopedic leg immobilisation
braking time
braking force
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
Collaborators: name: BSN Medical Inc
First posted: 2009-08-03
Enrollment: 48
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Abstract Background: Effects of orthopedic immobilizations of the lower right limb on driving performances are unknown. Therefore, clinicians and legislators cannot put forth recommendations for road safety for patients requiring such immobilizations. The objective of the present study was to evaluate the effects of different orthopedic immobilizations on braking performances in simulated driving conditions.

Methods: The braking performances of 48 healthy volunteers were evaluated under 3 conditions: wearing their running shoes, and 2 types of orthopedic immobilizations of the lower right limb, a walking cast and an Aircast walker. A computerized driving simulator was used to measure the maximum force applied on the brake pedal during braking, the braking reaction time and the total braking time during emergency braking with and without a distracter.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects between 25 and 60 years old
* Valid Québec driving license
* Driving for at least five years
* Must used exclusively the right foot for accelerating and braking

Exclusion Criteria:

* Non-compensated visual acuity deficits or other visual problems
* Drug or alcohol abuse
* Use of psychotropic drugs
* Central nervous system illnesses such as epilepsy
* Sleep issues
* Metabolic problems
* Cardiovascular disease
* Cerebrovascular disease
* Peripheral vascular disease
* Psychiatric illness
* Renal disease
* Musculoskeletal disease
* Motion sickness and
* Simulator sickness

Primary outcomes:
measure: Mean Breaking Time Measured on a Driving Car Simulator
timeFrame: June 2007 to September 2007
measure: Mean Breaking Force Measured on a Driving Car Simulator
timeFrame: June 2007 to September 2007
Secondary outcomes:
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Research Centre on Aging, Sherbrooke Geriatric University Institute (IUGS),
state: Quebec
Study officials:
affiliation: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
name: François Cabana, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00035529: A Study to Evaluate the Preliminary Efficacy Pharmacokinetics and Immunogenicity of BMS-188667 Administered to Subjects With Relapsing-remitting Multiple Sclerosis
Official title: A Phase II,Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Preliminary Efficacy, Pharmacokinetics and Immunogenicity of BMS-188667 Administered to Subjects With Relapsing-Remitting Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Multiple Sclerosis
Keywords: MS
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2002-05-06
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether BMS-188667 will decrease multiple sclerosis disease activity on MRI examinations, as well as decrease the rate of clinical MS exacerbations, compared to placebo


Eligibility criteria: Inclusion

* relapsing-remitting MS
* at least 1 exacerbation in preceding 2 years
* at least 1 MRI lesion
* stable for 2 months prior to dosing

Exclusion

* progressive MS
* currently treated with an immunomodulatory therapy
* previously treated with an approved MS drug where treatment was discontinued for lack of efficacy
* active bacterial or viral infections

Primary outcomes:
measure: Preliminary efficacy- Reduction in cumulative nr of new or recurrent Gd-enhancing lesions.
Secondary outcomes:
measure: Preliminary efficacy: 1) Decrease in annualized relapse rate and 2) Reduction in cumulative nr of new or enlarging T2-weighted MRI lesions.
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Local Institution
state: Connecticut
city: Louisville
country: United States
facility: Local Institution
state: Kentucky
city: Worcester
country: United States
facility: Local Institution
state: Massachusetts
city: Newark
country: United States
facility: Local Institution
state: New Jersey
city: New York
country: United States
facility: Local Institution
state: New York
city: Charlotte
country: United States
facility: Local Institution
state: North Carolina
city: Philadelphia
country: United States
facility: Local Institution
state: Pennsylvania
city: Dallas
country: United States
facility: Local Institution
state: Texas
city: Burlington
country: United States
facility: Local Institution
state: Vermont
city: Madison
country: United States
facility: Local Institution
state: Wisconsin
Study officials:
References:
Clinical trial NCT04711629: Clinical Features of Smoker Patients With Chronic Obstructive Pulmonary Disease
Official title: Clinical Characteristics of Chronic Obstructive Pulmonary Patients Who Continue to Smoke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Copd
Smoking
Keywords: copd
smoking
Lead sponsor: Izmir Katip Celebi University
Sponsor class: OTHER
First posted: 2021-01-15
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Smoker COPD Ex Smoker COPD
Primary purpose: SUPPORTIVE_CARE

Brief summary: Smoking is the most important factor in the etiology of COPD. Some of the patients with COPD continue to smoke despite knowing this situation or they cannot quit even if they want.

The aim of this study is; To examine patients with COPD who continue to smoke in terms of perception of dyspnea, exercise capacity, psychological symptoms and quality of life.

Detailed description: The study was designed prospectively. Patients with COPD who apply to the pulmonary rehabilitation outpatient clinic will be included.

The data of patients with COPD who are eligible for PR and have been pre-evaluated will be scanned. Respiratory function test, arterial blood gas analysis, six-minute walking test (6-MWT), mMRC Dyspnea Scale, St George Quality of Life Questionnaire and Hospital Anxiety Depression Scale will be used in the study. Patients with COPD who smoke will constitute the study group, and those who quit smoking will constitute the control group.

Eligibility criteria: Inclusion Criteria:

* Smoker COPD Patients who smoker

Exclusion Criteria:

* Not volunteer to participate the study

Primary outcomes:
measure: Exercise Capacity
timeFrame: 6 minutes
Secondary outcomes:
measure: Respiratory Functions
timeFrame: 30 minutes
measure: Dyspnea Sensation
timeFrame: 20 minutes
measure: Disease Specific Quality of Life
timeFrame: 20 minutes
measure: Anxiety
timeFrame: 20 minutes
measure: Depression
timeFrame: 20 minutes
measure: Body Mass Index
timeFrame: 5 minutes
Other outcomes:
Locations:
Study officials:
References: