louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00386490: Safety of Larazotide Acetate in Healthy Volunteers
Official title: A Phase 1, Randomized, Double-Blind, Placebo Controlled, Multi-Dose Study to Determine the Safety, Tolerance and Pharmacokinetics of 3 Dose Levels of Larazotide Acetate (AT-1001) in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: celiac disease
larazotide acetate
Lead sponsor: 9 Meters Biopharma, Inc.
Sponsor class: INDUSTRY
First posted: 2006-10-11
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Phase 1, randomized, double-blind, placebo controlled multi-dose study
Primary purpose: BASIC_SCIENCE

Brief summary: To demonstrate the safety, tolerance and pharmacokinetics of multiple, oral doses of larazotide acetate.

Detailed description: CLIN1001-003 was a Phase 1, randomized, double-blind, placebo controlled multi-dose study to determine the safety, tolerance, and pharmacokinetics (including food effect) of 3 dose levels of larazotide acetate in healthy volunteers. Three (3) cohorts of 8 subjects, in which six (6) subjects in each cohort received larazotide acetate in escalating doses of 0.25 mg, 1 mg, or 4 mg TID for 10 days and two (2) subjects received placebo TID for 10 days, were studied. Subjects maintained a standard gluten-free diet. Subjects were dosed three times a day 30 minutes prior to meals except for the morning dosing on Days 1, 5, and 10. For the morning dosing on Days 1, 5, and 10 subjects, fasted overnight prior to dosing and for 2 hours post dose. Subjects were evaluated for safety (medical history, physical examination, vital signs, clinical laboratory testing, and 12-lead electrocardiograms) throughout the study. Serial blood samples were collected or pharmacokinetic determinations at baseline and 2 hours post morning dose on Days 1, 2, 5, 6 and 10.

Eligibility criteria: Inclusion Criteria:

* Healthy male and female subjects
* BMI between 18 and 30.

Exclusion Criteria:

* Subjects with clinically significant abnormal clinical lab results
* Hemoglobin \< 12g/dL
* Subjects with diarrhea within 3 days prior to treatment visit

Primary outcomes:
measure: Demonstrate the safety and tolerance of multiple, oral doses of larazotide acetate
timeFrame: Subjects were evaluated for safety at screening, prior to administration of treatment, and following dosing of the study drug.
measure: Determine whether quantifiable concentrations of larazotide acetate are present in plasma following multiple oral doses and characterize the pharmacokinetic behavior of larazotide acetate in healthy subjects that are gluten-free and in remission
timeFrame: Serial blood samples were collected for pharmacokinetic determinations at baseline and 2 hours post morning dose on Days 1, 2, 5, 6 and 10.
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Parexel
state: Maryland
Study officials:
affiliation: Alba Therapeutics
name: Blake Paterson, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02361190: Effects of Fast Acting Testosterone Nasal Spray on Anxiety
Official title: Effects of Fast Acting Testosterone Nasal Spray on Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2015-02-11
Enrollment: 96
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

Brief summary: The proposed study will test the effects of a fast-acting testosterone nasal spray on the fear reactions of young men to two distinct anxiety challenges (social and nonsocial) using a double-blind randomized experimental design.

Detailed description: Aim 1: Test the hypothesis that men administered testosterone nasal spray will result in lower levels of anxiety (anticipatory and situational) and greater levels of approach behavior in response to two distinct (social and nonsocial) anxiety challenges relative to men administered placebo spray.

Aim 2: Test the hypothesis that anxiety challenge type (social versus nonsocial) will moderate the effects of testosterone administration on subjects' responses to challenge.

Aim 3: Test the hypothesis that rejection sensitivity - heightened sensitivity to evaluative threat - will moderate the effects of drug condition on response to the two anxiety challenge tests.

Eligibility criteria: Inclusion Criteria:

* Male, 18 years of age or older

Exclusion Criteria:

* Male breast cancer
* Obstructive sleep apnea
* Suspected or diagnosed prostate cancer
* Male breast cancer
* Obstructive sleep apnea
* Diabetes
* Heart Disease
* Liver disease (e.g., hepatitis)
* Kidney disease
* Thyroid disease
* Tuberculosis or history if positive TB test
* Infection or fever in the past 7 days
* Surgeries within the last 6 weeks
* Anemia
* Gastrointestinal disease
* Respiratory disease (e.g., asthma or chronic bronchitis)
* Other (Please list)
* Reynaud's Disease
* Type 2 diabetes
* Diagnosed hypersensitivity to cold
* Warfarin (Coumadin) for thinning blood
* Insulin or any oral drugs for diabetes
* Propranolol (Inderal)
* Oxyphenbutazone
* Imipramine
* Any kind of corticosteroid drug
* Insulin
* Steroids
* Statins (i.e.., cholesterol lowering drugs)
* Sleeping pills
* Drugs to treat hormone disorders
* Antibiotics in the past 7 days
* Gastrointestinal disease
* Pain Killers -

Primary outcomes:
measure: Magnitude of behavioral approach
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: University of Texas at Austin Department of Psychology
state: Texas
Study officials:
affiliation: University of Texas at Austin
name: Robert A Josephs, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00938990: The Effect of Etomidate on Outcomes of Trauma Patients
Official title: The Effect of Etomidate on Outcomes of Trauma Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Trauma
Lead sponsor: Advocate Hospital System
Sponsor class: OTHER
First posted: 2009-07-14
Enrollment: 0
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Rationale: The drug etomidate causes increased mortality if used for continuous sedation in mechanically ventilated patients; however, etomidate continues to be widely used as a single-bolus induction agent for endotracheal intubation because of its favorable hemodynamic properties. Recent data have raised questions regarding the safety of using etomidate for even a single bolus in patients at risk of adrenal insufficiency, emphasizing the fact that single bolus doses of etomidate cause measurable adrenal suppression, and consequently may cause increases in vasopressor requirements and in hospital length of stay. Alternative FDA-approved induction agents, such as midazolam, may be safer than etomidate; however, no studies have formally compared these agents.

Research Hypothesis: The investigators hypothesize that in critically ill trauma patients presenting to the emergency department requiring rapid sequence intubation, the hospital length of stay for patients given etomidate will be greater than for patients given midazolam for induction.

Specific Aims: The specific aim is to determine the difference in hospital length of stay between trauma patients given etomidate and those given midazolam for induction during rapid sequence intubation in the emergency department. The investigators plan to compare the two groups in terms of hospital length of hospital stay, length of stay in the intensive care unit, and duration of intubation by performing a prospective, randomized, trial of critically ill trauma patients presenting to the emergency department requiring intubation. The investigators will also compare the mortality rates in these two groups while controlling for severity of illness and the use of steroids while hospitalized.

Significance: If the use of etomidate to induce anesthesia prior to intubation adversely affects the hospital length of stay of trauma patients, this length of stay might be reduced in such patients by using alternative agents for induction. Since etomidate is currently in widespread use as an induction agent, the results of this study could have significant implications for patient management.


Eligibility criteria: Inclusion Criteria:

* All critically ill trauma patients (defined as patients over the age of 14 years requiring trauma team activation) who present to the ED in need of ventilatory support due to the severity of their illness and injuries.

Exclusion Criteria:

* Age less than 14, do-not-resuscitate status, or cardiopulmonary arrest prior to arrival in the ED.

Primary outcomes:
measure: Length of Stay
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06556290: Effect of a Casein and Gluten Free Diet in Mexican Children With Autism Spectrum Disorder
Official title: Effect of a Casein and Gluten Free Diet on Gastrointestinal Symptoms, Clinical Variables and Gut Microbiota Composition in Mexican Children With Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Gut microbiota
Gluten free diet
Casein free diet
Lead sponsor: University of Guadalajara
Sponsor class: OTHER
First posted: 2024-08-16
Enrollment: 20
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Assess the effect of a casein-free and gluten-free diet on gastrointestinal symptoms, clinical variables, and the composition of the intestinal microbiota in Mexican children with autism spectrum disorder.

Detailed description: The objective of this quasi-experimental pre-post study with time series is to evaluate the effect of a casein-free and gluten-free diet on gastrointestinal symptoms, clinical variables, and the composition of the intestinal microbiota in Mexican children with autism spectrum disorder. The main question it aims to answer is:

Does a casein free and gluten free diet promote a reduction in gastrointestinal symptoms, an improvement in clinical variables, and a state of eubiosis in the composition of the intestinal microbiota in Mexican children with autism spectrum disorder?

Participants will undergo:

An intervention of a casein-free and gluten-free diet for 3 months. Sample collection before and after the nutritional intervention. Clinical evaluations.

Eligibility criteria: Inclusion Criteria:

Children between 4-10 years old diagnosed with autism spectrum disorder using the criteria established in the ADOS scale and the CARS.

Exclusion Criteria:

Children who have received:

* Antibiotics
* Antimycotics
* Probiotic supplements
* Prebiotic supplements
* Any medication that may alter the microbial composition of the patient, minimum one month prior to sampling.
* Children on a strict dietary regimen other than a casein-free and gluten-free diet.
* Children with celiac disease or who present any gluten-related disorder.
* Children with allergy to dairy products.

Primary outcomes:
measure: Gut microbiota composition through Next Generation Sequencing (16SRNA) and bioinformatic analysis
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara
state: Jalisco
Study officials:
affiliation: University of Guadalajara
name: Nora M. Torres Carrillo, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02951403: Results of the Treatment of Patients With Elbow Osteoarthritis
Official title: Results of the Treatment of Patients With Elbow Osteoarthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Elbow Osteoarthritis
Keywords: elbow arthroscopy
DASH
elbow locking
elbow osteoarthritis
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
Collaborators: name: Central Finland Hospital District
First posted: 2016-11-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is a prospective case controlled clinical trial. The purpose of the study is to investigate the effect of elbow arthroscopy in the treatment for osteoarthritis of the elbow when compared to conservative treatment.

Detailed description: Patients will be recruited at departments of hand surgery and orthopedic surgery outpatient clinics. The control group will be patients to whom the conservative treatment continues. Patients who meet the inclusion criteria will be asked to participate and sign the informed consent. Therefore the investigators have two treatment groups: group 1 who receives an elbow joint debridement arthroscopically without physiotherapy and group 2 who receives only conservative treatment with physiotherapy.

Eligibility criteria: Inclusion Criteria:

* Symptomatic post-traumatic or primary osteoarthritis - mechanical locking and/or decreased range of motion ( \>30°)
* Radiographic evidence of at least mild primary or post-traumatic osteoarthritis according to Broberg - Morrey classification symptoms lasting at least 6 months
* Patients willingness to participate the study
* All patients 18-80 ages

Exclusion Criteria:

* Patients with previous severe soft tissue trauma at elbow region ( crush, burns etc - the elbow joint problems are not joint specific)
* Patients with crystal arthropathy or inflammatory arthritis
* Patient refuses to participate the study
* Patients with dementia or are institutionalized
* Patients with severe substance addiction
* Patient does not understand written and spoken guidance

Primary outcomes:
measure: Quick DASH score
timeFrame: 24 Months
Secondary outcomes:
measure: VAS score
timeFrame: 24 Months
measure: Range of motion
timeFrame: 24 Months
Other outcomes:
Locations:
city: Jyväskylä
country: Finland
facility: Central Finland Central Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital, Hatanpää
Study officials:
affiliation: professor
name: Ville Mattila, MD, PhD
role: STUDY_CHAIR
affiliation: hand surgeon
name: Margit Karelson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02586103: Prospective Study Assessing the Validity of Y-PAS (Yale Preoperative Anxiety Scale) to Predict Patients Undergoing Magnetic Resonance Imaging Without the Use of Sedation/General Anesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Magnetic Resonance Imaging
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2015-10-26
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for MRI with sedation or anesthesia.

Brief summary: The mYPAS (Modified Yale Preoperative Anxiety Scale) is a quick, easy, validated and "gold standard" assessment tool to measure pediatric anxiety in the perioperative period. Therefore the objective of the current prospective study is examine if the mY-PAS is an effective screening tool to differentiate patients who would succeed versus fail for MRI without sedation/anesthesia.


Eligibility criteria: Inclusion Criteria:

* all patients and parents who are willing to participate in the simulated practice MRI on the day of or prior to their scheduled MRI.

Exclusion Criteria:

* patients/parents who refuse to go through the practice MRI sessions.

Primary outcomes:
measure: Anxiety score
timeFrame: Immediately following MRI simulation
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT06162403: Exploring the Benefit of Peripheral Nerve Stimulation in Treating Pain From Chemo-induced Peripheral Neuropathy: A Longitudinal Single Center Feasibility Study
Official title: Exploring the Benefit of Peripheral Nerve Stimulation in Treating Pain From Chemo-induced Peripheral Neuropathy: A Longitudinal Single Center Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peripheral Nerve Stimulation
Chemotherapy-induced Peripheral Neuropathy
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2023-12-08
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: To learn if peripheral nerve stimulation (PNS) can help to improve pain in participants with CIPN.

Detailed description: Primary objective:

To assess Pain intensity (NRS) scores in chemotherapy induced peripheral neuropathy (CIPN) participants before and after use of peripheral nerve stimulation (PNS).

Secondary objectives:

To assess changes in quantitative sensory testing (QST), gait testing, and skin punch biopsy to compare the integrity of Meissner's corpuscles (MC), pain disability using the Oswestry Disability Index (ODI), pain interference using the Brief Pain Inventory (BPI), and Patient Global Impression of Change (PGIC) in CIPN patients before and after use of PNS.

Eligibility criteria: Inclusion Criteria:

* Participants diagnosed with chronic (≥90 days duration) CIPN (due to either vinca alkaloids, taxanes, bortezomib, thalidomide, platinum-based compounds or ionizing irradiation) of the lower extremity, seen at Pain Management Center at MD Anderson Cancer Center
* Participants reports baseline pain ≥ 4 (0-10 scale, NRS)
* Participants between ages 18-85 years old
* Participants who have completed chemotherapy within the previous year at the time of enrollment

Exclusion Criteria:

* Participants with cognitive dysfunction
* Participants with recent history (\<6 months) of drug or alcohol abuse
* Participants with open skin lesion or undergoing antibiotic therapy for local for systemic infection
* Participants with allergies to local anesthesia, steroids, or adhesives
* Participants with conditions that conflict with the SPRINT PNS System Indications for Use, including Contraindications and Warnings.

Primary outcomes:
measure: Safety and adverse events (AEs)
timeFrame: Through study completion; an average of 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Saba Javed, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00942903: Short-term Clinical Feasibility of the Provox XtraHMEs for Pulmonary Rehabilitation After Total Laryngectomy
Official title: Phase 1 Study. Short-term Feasibility of the Next Generation Provox HMEs for Pulmonary Rehabilitation After Total Laryngectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Total Laryngectomy
Keywords: HME
Provox
voice prosthesis
laryngectomy
Lead sponsor: Atos Medical AB
Sponsor class: INDUSTRY
Collaborators: name: The Netherlands Cancer Institute
First posted: 2009-07-21
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a short term feasibility study that aims to investigate patient satisfaction with and performance of new Provox Xtra HME in 20 laryngectomized patients. Aspects that are considered are for example performance for stoma occlusion, speaking, breathing, appearance, compliance, and short-term impact on pulmonary symptoms.


Eligibility criteria: Inclusion Criteria:

* total laryngectomy
* compliant Provox HME user (24/7 use)

Exclusion Criteria:

* current medical problems that might influence HME use

Primary outcomes:
measure: Patient Preference for Provox HME or Provox XtraHME
timeFrame: 3 weeks
Secondary outcomes:
measure: Noise at Stoma Occlusion
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Netherlands Cancer Institute
state: Noord Holland
Study officials:
affiliation: The Netherlands Cancer Institute
name: Frans JM Hilgers, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01890603: Enhancing Complex Care Through an Integrated Care Coordination Information System
Official title: Ambulatory Safety and Quality Program: Improving Management of Individuals With Complex Healthcare Needs Through Health It
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Nurse Based Care Management
Health Information Technology
Keywords: Care coordination, primary care
nurse care management
practice facilitation
Lead sponsor: Care Management Plus
Sponsor class: OTHER
First posted: 2013-07-02
Enrollment: 60000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Cluster randomized controlled trial comparing care coordination incentives to pay for performance (quality measure) incentives in clinics on utilization, cost, quality, and patient experience.


Eligibility criteria: Inclusion Criteria:

* Six Clinics participating whom Care Management Plus team has worked with before
* Patients belonging to one of these six clinics
* Picked based on an algorithm designed to identify high risk patients.
* Clinic will review potential patients list and issue a survey with consent form

Exclusion Criteria:

* Younger than 18
* Older than 90

Primary outcomes:
measure: Rate of Utilization
timeFrame: up to 18 months
Secondary outcomes:
measure: Patient Satisfaction/Experience
timeFrame: 0, 18 months
measure: Reduce Costs
timeFrame: 0, 12, 18 months
measure: Improve quality of care
timeFrame: 0,3,6,9,12,15,18 months
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: David Dorr, MD MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Oregon Health and Science University
name: Gwenivere Olsen, BS
role: STUDY_CHAIR
affiliation: Oregon Health and Science University
name: Kelli Radican
role: STUDY_CHAIR
References: