louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00000201: Pharmacological Modulation of Cocaine Effects - 1
Official title: Pharmacological Modulation of Cocaine Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cocaine-Related Disorders
Keywords: cocaine dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: Johns Hopkins University
First posted: 1999-09-21
Enrollment: 0
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to conduct human laboratory studies of possible cocaine interactions with various potential treatment medications.


Eligibility criteria: Please contact site for information.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University (BPRU) Bayview Campus
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: George Bigelow, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00294801: Effect of Flex-a-New on Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Osteoarthritis
Keywords: knee osteoarthritis
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2006-02-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: comparative trial of placebo versus flex-a-new (a food supplement) containing glucosamine an chondroitin sulfate for the symptom modification is knee osteoarthritis

Detailed description: comparative trial of placebo versus flex-a-new (a food supplement) containing glucosamine an chondroitin sulfate for the symptom modification is knee osteoarthritis

Eligibility criteria: Inclusion Criteria:

knee osteoarthritis grade 1 to 3 -

Exclusion Criteria:

ischemic heart disease with CHF -

Primary outcomes:
measure: KOOS
Secondary outcomes:
measure: VAS KSS
Other outcomes:
Locations:
city: Petah Tikwa
country: Israel
facility: Rabin Medical Center
Study officials:
affiliation: Rabin Medical Center
name: dror robinson
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05409001: Falls From Sitting to Standing
Official title: Falls From Sitting to Standing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Falls, Tomography of the Head, Cervical Spine, Chest, Abdomen, and Pelvis
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2022-06-07
Enrollment: 751
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A retrospective chart review was conducted using the trauma registry at a large, urban Level 1 trauma center. This registry was queried for consecutive elderly patients (age \>65 years) who presented with fall from sitting or standing from 01/01/2019-12/31/2019. This trauma registry includes all patients of which the trauma surgery team was notified as part of the insinuation's trauma notification protocol. It also includes patients who were ultimately admitted to the hospital with ICD 10 codes consistent with traumatic injuries, regardless of trauma team activation. Patients discharged from the Emergency Department with a traumatic injury may have limited data in the registry.

Brief summary: Background: When evaluating trauma patients, many centers perform computed tomography of the head, cervical spine, chest, abdomen, and pelvis, the so-called "pan-scan." Here, we evaluate the utility of pan-scan in geriatric patients who sustained ground-level falls.

Study Design: We performed a retrospective review of consecutive patients from the trauma registry of a large, urban Level 1 trauma center. Inclusion criteria were registration during the 2019 calendar year, age ≥ 65, mechanism of fall from either sitting or standing, and performance of "pan-scan" at time of assessment. Patient demographics, physical exam findings, CT results, injuries, and patient disposition were recorded. The sensitivity, specificity, positive and negative predictive values of the physical exam for significant injuries were calculated.


Eligibility criteria: Inclusion criteria

* age \>65
* presented with fall from sitting or standing from 01/01/2019-12/31/2019

Exclusion criteria included

* age \<65 years,
* falls from height,
* GCS less than 14,
* patients who did not undergo the complete pan-scan.

Primary outcomes:
measure: Sensitivity of physical exam compared to CT scan and identifying traumatic injuries
timeFrame: 2 years
measure: Prevalence of injury.
timeFrame: 2 years
measure: Disposition from ED
timeFrame: 2 years
measure: Disposition from hospital.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: SIUH Northwell Health
state: New York
Study officials:
References:
Clinical trial NCT00000301: Rapid Evaluation of Amantadine for Treatment of Cocaine Abuse/Dependence - 4
Official title: Rapid Evaluation of Cocaine Pharmacotherapies (Amantadine)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cocaine-Related Disorders
Keywords: Amantadine
Cocaine
Pharmacotherapy
Outpatient
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to empirically test a series of medications to: 1) determine each medication's efficacy in treatment of cocaine abuse/dependence; 2) find most effective dose range for each medication. In this study, amantadine is tested."

Detailed description: 16-week participation plus a 2 weekk lead-in period. Participants are assigned randomly to placebo or amantadine. Participants attend group meeting 3 times/week

Eligibility criteria: Inclusion Criteria:

M/F, ages 18-65. cocaine dependence according to DMS-IV criteria. Self-reported use within the last 30 days. Agreeable to conditions of the study and signed informed consent.

Exclusion Criteria:

Psychiatric disorder that requires medication therapy, history of seizures. Pregnant and/or nursing women. Dependence on ETOH or benzodiazepines or other sedative-hypnotics. Acute hepatitis. Other medical conditions that deem participation to be unsafe.

Primary outcomes:
measure: Retention
measure: Cocaine use
measure: Cocaine craving
measure: Psychosocial progress
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Friends Research Institute
state: California
Study officials:
affiliation: Friends Research Institute, Inc.
name: Walter Ling, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shoptaw S, Kintaudi PC, Charuvastra C, Ling W. A screening trial of amantadine as a medication for cocaine dependence. Drug Alcohol Depend. 2002 May 1;66(3):217-24. doi: 10.1016/s0376-8716(01)00205-8.
Clinical trial NCT03221101: Home Non Invasive Ventilation for COPD Patients
Official title: Home Non Invasive Ventilation Versus Long Term Oxygen Therapy Alone in COPD Survivors After Acute Hypercapnic Respiratory Failure. A French Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Hypercapnic Respiratory Failure
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
Collaborators: name: ADIR Association
First posted: 2017-07-18
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic Obstructive Pulmonary Disease (COPD) patients are more likely to develop acute hypercapnic respiratory failure. In the acute phase, non invasive ventilation has been shown to improve mortality and reduce intubation rate. Few studies are available about long term benefits of home non invasive ventilation in COPD patients with chronic hypercapnic respiratory failure who survived after an acute episode. The purpose of this study is to determine whether home non invasive ventilation can reduce recurrent acute hypercapnic respiratory failure in COPD patients who survived an acute hypercapnic respiratory failure episode treated by non invasive ventilation.


Eligibility criteria: Inclusion Criteria:

* COPD patients who survived after an acute episode of hypercapnic respiratory failure
* patients weaned from ventilation ( non invasive ventilation or mechanical ventilation) prescribed for acute episode since at least five days with following arterial blood gas : pH \> 7.35 and PCO2 \> = 45 mmHg

Exclusion Criteria:

* severe obstructive sleep apnea ( DI \> 30/h)
* Non COPD cause of respiratory failure
* Serious comorbidity
* Adverse psychological status

Primary outcomes:
measure: acute hypercapnic respiratory failure episode
timeFrame: up to 24 months
Secondary outcomes:
measure: acute hypercapnic respiratory failure episode rate
timeFrame: up to 24 months
measure: pulmonary function test
timeFrame: at one month and every six months up to 24 months
measure: Six Minute Walk Distance
timeFrame: at one month and every six months up to 24 months
measure: Quality of life
timeFrame: at one month and every six months up to 24 months
measure: Heart function
timeFrame: at one month and every six months up to 24 months
measure: Cost effectiveness
timeFrame: at one month and every six months up to 24 months
measure: mortality
timeFrame: at one month and every six months up to 24 months
measure: arterial blood gas
timeFrame: at one month and every six months up to 24 months
Other outcomes:
Locations:
city: Dieppe
country: France
facility: CH Dieppe
city: Elbeuf
country: France
facility: CH Elbeuf
city: Montivilliers
country: France
facility: Le Havre, Jacques Monod Hospital
city: Rouen
country: France
facility: CHU de Rouen
Study officials:
References:
Clinical trial NCT04031001: Vascular No-React Graft Against Infection
Official title: Vascular No-React Graft Against Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vascular Infections
Lead sponsor: Catharina Ziekenhuis Eindhoven
Sponsor class: OTHER
First posted: 2019-07-24
Enrollment: 43
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with (a high risk for) infection.

Brief summary: This study seeks to demonstrate the effectiveness and safety of the Non-valved Conduit for CE marking on the basis of infection. The rationale for infection resistance with the conduit is that BioIntegral Surgical No-React® treated products have a well-documented history of infection resistance in hybrid vascular settings.


Eligibility criteria: Inclusion Criteria:

* Infected prosthetic graft and/or bifurcation
* High risk of infection at graft implantation
* Mycotic aneurysm
* No alternative available

Exclusion Criteria:

* Below-knee procedure
* AV access

Primary outcomes:
measure: Percentage of graft infection 3 months after implantation
timeFrame: 3 months after implantation
Secondary outcomes:
measure: Percentage of patency 12 months after implantation
timeFrame: 12 months after implantation
Other outcomes:
Locations:
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
Study officials:
References:
Clinical trial NCT00489801: Trial Comparing Home-based Cardiac Rehabilitation With Comprehensive Centre-based Cardiac Rehabilitation in Patients Older Than 65 Years With Coronary Heart Disease. The HOMEBASE Trial
Official title: RCT Comparing Home-based Cardiac Rehabilitation With Comprehensive Centre-based Cardiac Rehabilitation and Usual Care in Patients Older Than 65 Years With Coronary Heart Disease. The HOMEBASE Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Heart Disease
Keywords: Cardiac Rehabilitation
Exercise
Heart failure
Coronary heart disease
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: Velux Fonden
First posted: 2007-06-21
Enrollment: 115
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Hypothesis: Home-based cardiac rehabilitation is as effective as comprehensive centre-based cardiac rehabilitation in patients older than 65 years.

Detailed description: Participation in cardiac rehabilitation is known to reduce mortality and morbidity and increase health related quality of life. However, participation rate are low among elderly cardiac patients with coronary heart disease. Home-based cardiac rehabilitation could be an attractive alternative to the centre-based programmes but studies investigating the effect of these programmes are limited and even less is known about the effect among the elderly.

Eligibility criteria: Inclusion Criteria:

1. Event of coronary heart disease (new myocardial infarction, CABG or PCI)

Exclusion Criteria:

1. Care home patients.
2. Serious disability incompatible with rehabilitation.
3. Social circumstances incompatible with participation.

Primary outcomes:
measure: Exercise capacity
timeFrame: At baseline and after 3,6 and 12 months
Secondary outcomes:
measure: Blood pressure, cholesterol, body composition, HRQL
timeFrame: At baseline and after 3, 6 and 12 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjeg Hospital
Study officials:
name: Bodil Oerkild, MD, ph.d fellow
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05139901: Usefulness of DORNASE in COVID-19 on HFNO
Official title: Usefulness of DORNASE (Pulmozyme®) in Patients With COVID-19 Respiratory Insufficiency on High-Flow Oxygen Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: COVID-19 Pneumonia
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2021-12-01
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blind randomised
Primary purpose: TREATMENT

Brief summary: COVID-19 pneumonia manifests among others with a thick bronhial secretion. It contains an increased number of neutrophil extracellular traps (NETs), formed during netosis. DNA is a major component in NETs. DNAse alfa (Pulmozyme®, Roche) is a recombinant human enzyme, registered for inhalations in patients with Cystic fibrosis, in which NETs are also a typical characteristic. DNAse alfa inhalations are typically well tolerated and with no major side effects. Some initial reports exist of using DNAse alfa inhalations in COVID-19 patients, that had benefitial effects. There are some trials registered with ClinicalTrials, investigating the usufulness of DNAse alfa in intubated patients, but the investigators have no knowledge of a trial, investigating the usufulness of this drug in patients receiving High Flow Nasal Oxygen therapy.


Eligibility criteria: Inclusion Criteria:

* Positive SARS-CoV-2 RNA PCR swab
* inflamatory phase of infection
* HFNO

Exclusion Criteria:

* pregnancy
* previous treatment with DNAse alfa

Primary outcomes:
measure: Intubations
timeFrame: 7 days
Secondary outcomes:
measure: PaO2/FiO2
timeFrame: 7 days
measure: inflamation
timeFrame: 7 days
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Medical Centre Ljubljana
Study officials:
References:
Clinical trial NCT00649701: Novel Internet-Based Interventions to Reduce Sexual Risk Among Men Who Have Sex With Men
Official title: Phase 1 Online Intervention to Reduce Sexual Risk Among Men Who Have Sex With Men
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: HIV Infections
Keywords: HIV
Internet
MSM
Condom Use
Disclosure
Lead sponsor: Public Health Solutions
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2008-04-01
Enrollment: 3097
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to develop and test the efficacy of online HIV risk reduction interventions among men who have sex with men.

Detailed description: This is an Internet-based, five-branch randomized controlled intervention, enrolling 3,000 adult MSM. The five branches include 1) a control condition receiving no intervention content, 2) a standard text-based prevention webpage, 3) an 8 minute dramatic video addressing sexual risk reduction within the context of alcohol use, 4) a 5 minute documentary video addressing HIV disclosure, HIV testing, and condom use with the sub-context of drug use, and 5) both videos. After completing the baseline survey, eligible participants who consent to participate in the intervention will be randomly assigned to the control condition or one of the four intervention conditions. The control condition will not include the delivery of any intervention content. All participants (branches 1-5) will be asked to complete a brief post-intervention survey (to measure intentions). All intervention participants will be invited to complete a final 60-day follow-up survey.

Eligibility criteria: Inclusion Criteria:

* Male;
* Age 18 and over;
* Ability to read and respond in English;
* Reside within the United States;
* Report oral or anal sex with any male (new partner or not) in the past 60 days AND report oral, anal or vaginal sex for the first time with any partner (male or female) in the past 60 days;
* Complete baseline survey
* Provide an email address;

Exclusion Criteria:

* Women and transgender persons

Primary outcomes:
measure: HIV disclosure, HIV testing, and condom use
timeFrame: 60 days
Secondary outcomes:
measure: drug and/or alcohol use before sex, and depressive and/or anxiety symptomatology (past 2 weeks)
timeFrame: 60 days
Other outcomes:
Locations:
city: New York
country: United States
facility: Public Health Solutions
state: New York
Study officials:
affiliation: Public Health Solutions
name: Sabina Hirshfield, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hirshfield S, Chiasson MA, Joseph H, Scheinmann R, Johnson WD, Remien RH, Shaw FS, Emmons R, Yu G, Margolis AD. An online randomized controlled trial evaluating HIV prevention digital media interventions for men who have sex with men. PLoS One. 2012;7(10):e46252. doi: 10.1371/journal.pone.0046252. Epub 2012 Oct 2.
Clinical trial NCT06529601: Comparison Between CAD/CAM and Conventional Mandibular Fixed Retainers.
Official title: Comparison Between CAD/CAM and Conventional Mandibular Fixed Retainers: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Orthodontic Retainers
Lead sponsor: Azienda Ospedaliero-Universitaria Careggi
Sponsor class: OTHER
First posted: 2024-07-31
Enrollment: 54
Sex: ALL
Minimum age (years): 13
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The devices compared in this study are 'retainers', i.e. fixed orthodontic retainers applied to the lingual surface of the central and lateral incisors and lower canines bilaterally. Their function is to maintain dental alignment once fixed orthodontic therapy has ended. In particular, the CAD/CAM device Keeppy patented by the company Leone SpA (Via Ponte a Quaracchi 50, Sesto Fiorentino, Florence) will be compared with the standard retainer made from a steel braided wire (Ortho FlexTech, Reliance Orthodontic Products Inc., 1540 West Thorndale Ave, Itasca, Illinois, USA).

This is a single-center, national, controlled, superiority, randomized, crossover, open-label study.

The aim of this study is to evaluate whether the CAD/CAM retainer results in fewer failures (fractures or detachments) over a period of 6 months and 2 years compared to the standard retainer. In addition, the aim of the study is to evaluate whether the Keeppy device results in the maintenance of better periodontal health as judged by the use of plaque and bleeding indices on the surfaces of the lower six anterior teeth compared to the standard retainer. Other objectives consist of the patient's assessment of pain, difficulty in speaking and esthetic satisfaction and the stability of the lower anterior tooth sector.


Eligibility criteria: Inclusion Criteria:

* Patients who have completed fixed orthodontic therapy between the ages of 13 and 20 years;
* Patients whose parents will sign the informed consent

Exclusion Criteria:

* Presence of dental anomalies in number (excess or deficiency) in the lower anterior teeth
* Patients with metal allergies.

Primary outcomes:
measure: Retainer failure at 6-month and 2-year follow-ups
timeFrame: At 6 months and at 2 years
Secondary outcomes:
measure: Assessment of the plaque and gingival bleeding index at the central and lateral incisors and lower canines.
timeFrame: At baseline, at 6 months and at 2 years
measure: Pain reported by patients
timeFrame: At baseline, at one month, at 6 months and at 2 years
measure: Difficulty in speaking reported by patients
timeFrame: At baseline, at one month, at 6 months and at 2 years
measure: Aesthetic satisfaction reported by patients
timeFrame: At baseline, at one month, at 6 months and at 2 years
measure: Stability of the alignment of the lower anterior teeth
timeFrame: At 6 months and at 2 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00540501: A Study to Evaluate Orally-Administered Oseltamivir and Intravenous Zanamivir in Healthy Subjects
Official title: Phase 1, Open-Label Study to Evaluate Potential Pharmacokinetic Interactions Between Orally-Administered Oseltamivir and Intravenous Zanamivir in Healthy Thai Adult Subjects
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Healthy Subjects
Keywords: zanamivir,
influenza virus,
healthy volunteer,
PK, drug interaction,
IV, and oseltamivir.
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-10-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a 4 period study to see if there is any interaction between Orally-Administered Oseltamivir and Intravenous Zanamivir in Healthy Thai Adult Subjects


Eligibility criteria: Inclusion criteria:

* Healthy Volunteer(s)confirmed by physical exam, clinical labs, ECGs, and vitals
* Must be woman of non-childbearing potential or willing to abstain from intercourse for two weeks prior to study drug administration and throughout the study or be willing to use two acceptable methods of birth control.

Exclusion criteria:

* Subjects with history of certain heart problems or subjects with Hepatitis B, C or HIV.

Primary outcomes:
measure: Oseltamivir carboxylate levels: Cmax and AUC(0-12)-
timeFrame: Period 2: Day 1, 2 & 3. Period 3: Day 1, 2 & 3. Period 4: Day 1, 2 & 3.
Secondary outcomes:
measure: Oseltamivir: Cmax, AUC(0-12)& C12. Oseltamivir carboxylate: C12, AUC(0-24)& t1/2.
timeFrame: Period 2-4 Day 1-3
measure: Zanamivir: Cmax, AUC(0-12), C12, t1/2, CL, tmax & V2 .
timeFrame: Period 1, 3 & 4 Day 1-3
measure: Safety:labs, vitals, ECGs & AEs.
timeFrame: Period 1-4, Days 1-4.
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: