louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01252212: Adherence, Improvement Measure (AIM) System
Official title: Adherence, Improvement Measure (AIM) System; Challenge Topic: 10-MH-101
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Patient Compliance
AIDS
Keywords: HIV, antiretroviral, adherence, SMS, cell phone
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: The Commonwealth Fund
name: National Institute of Mental Health (NIMH)
name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2010-12-02
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: In this project, we will work directly with underserved patients in a safety-net setting to conduct a randomized clinical trial of standard-of-care adherence counseling versus a novel adherence intervention embedded in an existing PHR that uses cellular phone short message service (SMS) reminders and patient responses to the reminders. We will compare adherence rates in both arms as assessed by antiretroviral medication concentrations in hair samples and self-report; clinical outcomes will also be compared in the two arms. The project will examine medication adherence for antiretroviral medications and treatments of common conditions such as depression, hypertension, diabetes and hypercholesterolemia.


Eligibility criteria: Inclusion Criteria:

* Older than 18
* Evidence of HIV-1 infection, based on patient's medical history or results of laboratory tests
* Detectable Viral Load, based on patient's medical record
* Receiving primary medical care at the AIDS Program at SFGH
* Able and willing to give informed consent to be randomized to study arms
* Willing to use the patient portal
* Has a cell phone with ability to receive and send unlimited SMS texts, Patient of the HIV/AIDS Clinic at ward 86, SFGH

Exclusion Criteria:

Failure to meet inclusion criteria

-

Primary outcomes:
measure: HIV viral load
timeFrame: 12 month
Secondary outcomes:
measure: Level of antiretroviral medication in hair
timeFrame: 12 month
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Ward 86, San Francisco General Hospital
state: California
Study officials:
affiliation: University of California, San Francisco
name: James Kahn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00542412: CARE Canadian ALS Riluzole Evaluation
Official title: Care (Canadian ALS Riluzole Evaluation) Multicentre Phase IV Comparative Study of the Effects of Riluzole 50mg Bid on the Survival of ALS Subjects Compared to Historical Controls
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Amyotrophic Lateral Sclerosis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-10-11
Enrollment: 414
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluate the efficacy of riluzole 50-mg bid defined by comparing the percentage of riluzole-treated subjects who experienced death, permanently assisted ventilation (PAV) or tracheostomy, to a group of recent historical controls for the treatment of amyotrophic lateral sclerosis (ALS).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of ALS confirmed by the following definition:

  (a)"Probable" or "Definite" Amyotrophic Lateral Sclerosis (ALS) according to the El Escorial criteria(b)"Peripheral" onset form (limb involvement) or a "Bulbar" form of ALS with a duration of five years, based on inquiry for the earliest symptoms of the disease
* A subject who simultaneously presents with bulbar and peripheral signs at onset of ALS disease should be stratified to the bulbar onset group. The neurologic progression of such subjects matches that of the bulbar onset ALS subjects.
* Pulmonary Function: forced vital capacity (FVC) must be 3 60% at study entry.
* Females of childbearing potential must be documented to be using acceptable birth control methods such as an IUD or oral contraceptives.

Exclusion Criteria:

* Previous treatment with riluzole
* Tracheostomy, or expected to undergo a tracheostomy within two months after study inclusion
* Signs of clinical dementia and/or major psychiatric disorders
* Serious concomitant disease or handicap likely to interfere with the subject's assessments or impact on the subject's survival
* A multiple conduction block has been shown on nerve conduction studies by electromyogram

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

Primary outcomes:
measure: The primary efficacy endpoint was the time to the occurrence of an ALS-related event (PAV, tracheostomy or ALS-related death)
Secondary outcomes:
Other outcomes:
Locations:
city: Laval
country: Canada
facility: Sanofi-Aventis
state: Quebec
Study officials:
affiliation: Sanofi
name: Laurent-Didier Jacobs
role: STUDY_DIRECTOR
References:
Clinical trial NCT04459312: National Covid-19 Surveillance Physicians
Official title: National Covid-Surveillance Physicians
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Antibody COVID-19
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
Collaborators: name: Dr. Wetzchewald
First posted: 2020-07-07
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All physicians working in german hospitals in emergency or intensive care medicine

Brief summary: The investigators will analyze the presence of antibodies against SARS-COV2 in physicians working in emergency and intensive care medicine and in those who treat Covid 19 patients.


Eligibility criteria: Inclusion Criteria:

* Qualified as physician

Exclusion Criteria:

* none

Primary outcomes:
measure: Presence of antibodies against SARS-COV2
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Duesseldorf
country: Germany
facility: University Hospital Duesseldorf, Dept. of Anesthesiology
Study officials:
References:
Clinical trial NCT02487212: Treatment of Hypertrophic Scars Using Fractional Laser and Fractional Laser-assisted Topical Corticosteroid Delivery
Official title: Treatment of Hypertrophic Scars Using Fractional Laser and Fractional Laser-assisted Topical Corticosteroid Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertrophic Scars
Keywords: fractional laser
hypertrophic scar
topical corticosteroid
laser assisted delivery systems
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2015-07-01
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the efficacy and safety of using ablative fractional laser- assisted topical corticosteroid delivery for the treatment of hypertrophic scar.

Detailed description: Hypertrophic scars are common conditions that cause persistent symptom and can lead to severe psychosocial impairment. Intralesional corticosteroid have been a mainstay in the treatment of hypertrophic scars. However, there are many disadvantages of corticosteroid injection such as severe pain, skin atrophy, skin thinning, steroid acne, telangiectasia and hypopigmentation.

Recent reports propose new treatment methods for hypertrophic scars with the use of fractional ablative lasers to create zones of ablation of the skin that may assisted the penetration of drugs to the skin.

Eligibility criteria: Inclusion Criteria:

* Female subjects with age range 18-60 years;
* Subject with hypertrophic scar from abdominal surgery for at least 3 months;
* Discontinued using oral isotretinoin for 6 months, alpha hydroxy acid or topical retinoic acid for 3 months

Exclusion Criteria:

* Subject who has skin Infection, photosensitive dermatosis or inflammatory acne on the treated area;
* Subject who smoke cigarette;
* Subject who was treated with Intralesional corticosteroid

Primary outcomes:
measure: Scar thickness measured by digital calliper
timeFrame: change from baseline in scar thickness at 6 months
Secondary outcomes:
measure: Patient and observer scar assessment scale
timeFrame: Baseline, 1 month after first treatment, 1,3 and 6 months after fourth treatment
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine Siriraj Hospital, Mahidol University
Study officials:
References:
Clinical trial NCT01720212: Study to Assess the Safety and Plasma Concentration of YM178 OCAS Tablet (Mirabegron) in Healthy Chinese Volunteers
Official title: An Open-Label, Single and Multiple Dose Study to Assess the Safety and Pharmacokinetics of YM178 OCAS Tablet (Mirabegron) in Healthy Chinese Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Chinese Volunteers
Keywords: YM178
Mirabegron
OCAS
Chinese Healthy Volunteers
PK
Safety
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2012-11-02
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: To evaluate the safety and plasma concentration change of YM178 after single- and repeated-administration as oral absorption controlled tablet in healthy Chinese subjects.


Eligibility criteria: Inclusion Criteria:

1. Body Mass Index (BMI) between 19 and 24, the weight is no less than 50 kg.
2. Good health status
3. The female subject must be either post-menopausal or surgically sterile. All women of child bearing potential will be required to use adequate contraception, must not be lactating, and must not be breastfeeding.

Exclusion Criteria:

1. The subject who has a known or suspected hypersensitivity to test drug or any of the constituents of the formulation used.
2. Drug abusers and alcoholics.
3. The subject who has consumed alcohol within 36 hours before administration.
4. The subject who is positive for hepatitis B surface antigen (HBs- Ag) or hepatitis C virus (HCV) antibody.
5. The subject who is positive for human immunodeficiency virus (HIV).
6. The subject who consumes more than 1L tea and coffee per day.
7. Smokers.
8. The subject who has donated or lost over 200 mL blood
9. The subject who has participated in other clinical trials
10. The subject who has taken other drugs that prototype and its main metabolites had not completely eliminated
11. The subject who has taken drugs repeatedly that may affect the metabolism of the test drug
12. Psychopath.

Primary outcomes:
measure: AUC of YM178 assessed by the plasma concentration changes
timeFrame: Up to 96 hours after administration
measure: Cmax of YM178 assessed by the plasma concentration changes
timeFrame: Up to 96 hours after administration
measure: t1/2 of YM178 assessed by the plasma concentration changes
timeFrame: Up to 96 hours after administration
Secondary outcomes:
measure: Safety assessment of YM178
timeFrame: Up to 33 days
Other outcomes:
Locations:
city: Shanghai
country: China
Study officials:
affiliation: Astellas Pharma Inc
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01270412: Platelet Rich Plasma (PRP) as a Treatment for Knee Osteoarthritis PRP as a Treatment for Knee Osteoarthritis
Official title: Platelet Rich Plasma (PRP) as a Treatment for Knee Osteoarthritis - A Randomized-Double-Blind Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Osteoarthritis of the Knee
Keywords: Osteoarthritis
PRP
PRGF
Hyaluronic acid
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2011-01-05
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Autologous platelet-secreted growth factors (GFs) may have therapeutic effects in osteoarthritis (OA) capsular joints via multiple mechanisms. The aim is to examine the effect of a platelet-derived preparation rich in growth factors (PRGFs) in OA of the knee.

Detailed description: Autologous platelet-secreted growth factors (GFs) may have therapeutic effects in osteoarthritis (OA) capsular joints via multiple mechanisms. The investigators aim is to examine the effect of a platelet-derived preparation rich in growth factors(PRGFs) in OA of the knee, using parameters of pain, function, quality of life and safety.

Eligibility criteria: Inclusion Criteria:

* age 40-75 years old
* diagnosed Oa of the knee more then 1 year
* no knee deformation

Exclusion Criteria:

* mental of physical disabilities
* pregnancy
* deformities of the knee

Primary outcomes:
measure: Improvement in pain, function, quality of life and activity level in knee osteoarthritis
timeFrame: 1 -2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar-Saba
country: Israel
facility: Meir Medical Center
Study officials:
affiliation: Meir Medical Center
name: Lior Laver, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06343012: Caring Leadership Intervention Program for First-Line Nurse Managers
Official title: Effect of Caring Leadership Intervention Program for First-Line Nurse Managers on Their Managerial Actions and Nurse Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intervention
Behavior
Keywords: Caring
Leadership
Management
Actions
Nurse
Outcmes
Lead sponsor: Matrouh University
Sponsor class: OTHER
First posted: 2024-04-02
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A quasi-experimental study design utilized two groups, study and control groups
Primary purpose: OTHER

Brief summary: Caring leadership can help first-line nurse managers create a healthy environment, resulting in a positive outcome for nurse staff, patients, and healthcare organizations.

Detailed description: Developing caring behaviors among nurse managers is critical for establishing an effective nursing care environment. Enhancing the caring leadership of nurse managers would lead to improving nurses' perception regarding nurse manager caring behaviors and positive nurse outcomes. This study aimed to Examine the effect of a caring leadership intervention program for first-line nurse managers on their caring knowledge and managerial actions as well as nurses' perceived first-line nurse managers' nurse outcomes..

Eligibility criteria: Inclusion Criteria:

First nurse managers

* Work in inpatient wards and intensive care units
* Sign the informed consent

Exclusion Criteria:

First nurse managers

* Refuse to provide consent
* Decline to participate in the study

Primary outcomes:
measure: Questionnaire to measure first-line nurse managers' knowledge
timeFrame: one month
measure: Questionnaire to measure the managerial actions of first-line nurse managers
timeFrame: Two months
measure: Questionnaire to assess nurses' perceived first-line nurse managers' caring behavior
timeFrame: one month
measure: questionnaire to measure nurse outcomes
timeFrame: two months
Secondary outcomes:
Other outcomes:
Locations:
city: Marsa Matruh
country: Egypt
facility: Faculty of Nursing, Matrouh University
Study officials:
affiliation: Faculty of Nursing, Matrouh University, Egypt
name: Nagah Abd El-Fattah Mohamed Aly, Ph.D
role: STUDY_CHAIR
affiliation: Faculty of Nursing, Matrouh University, Egypt
name: Wael M. Lotfy, Ph.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT05771012: Topical Cyclosporin A 0.05% Eye Drops for Management of Symptomatic Acquired Punctal Stenosis. A Prospective, Controlled Clinical Study.
Official title: Topical Cyclosporin A 0.05% Eye Drops for Management of Symptomatic Acquired Punctal Stenosis. A Prospective, Controlled Clinical Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Management of Punctal Stenosis
Keywords: cyclosporin,
punctal stenosis,
Restasis,
mini-Monoka.
Lead sponsor: Farwaniya Hospital
Sponsor class: OTHER_GOV
First posted: 2023-03-16
Enrollment: 42
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A prospective, controlled, interventional clinical study, includes all patients (16 years) with symptomatic epiphora and diagnosed with grade 1 or grade 2 acquired punctal stenosis. All patients undergo punctal dilatation, canalicular probing and nasolacrimal duct irrigation. Afterwards, patients are divided into two groups: Group A: patients receive only medical treatment in the form of topical 0.05% cyclosporin (Restasis®, Allergan Inc) twice daily for 6 months. Group B: patients receive mini-Monoka stent insertion in the lower canaliculus for 6 months. Outcome measures are changes in Munk scoring, grading of the punctum, functional and anatomical success. Functional success is defined as Munk score 0 to 1. Anatomical success is defined as grade 3 punctum.


Eligibility criteria: Inclusion Criteria:

* The study includes all patients (more than 16 years) with symptomatic epiphora and diagnosed with grade 1 or grade 2 acquired punctal stenosis

Exclusion Criteria:

* Patients presented with congenital epiphora, previous eyelid surgeries, neoplastic or traumatic causes of punctual or canalicular obstruction, or any other causes of lacrimal passage obstruction such as canalicular, common canalicular or nasolacrimal duct obstruction NLDO are excluded from this study.

Primary outcomes:
measure: functional success
timeFrame: 6 months
measure: anatomical success
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Al Farwānīyah
country: Kuwait
facility: Farwanyia Hospital
state: Farwanyia
Study officials:
affiliation: Farwaniya Hospital
name: Mona Nassief
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02042612: Pharmacokinetic Study of 48-hour Sevoflurane Inhalation Using a Disposable Delivery System (AnaConDa©) in Obese ICU Patients
Official title: Pharmacokinetic Study of 48-hour Sevoflurane Inhalation Using a Disposable Delivery System (AnaConDa©) in Obese ICU Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Keywords: Pharmacokinetics
Sevoflurane
Obesity
Sedation
ICU patients
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2014-01-23
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Describing a pharmacokinetic model of 48-h sevoflurane sedation in obese ICU patients

Detailed description: Prospective clinical monocentric study in ICU with sedated ventilated obese patients with sevoflurane during 48 h with the AnaConda® system, establishing pharmacokinetic model of sévoflurane and its metabolites (hydroxyfluroisopropanol, fluoride)

Eligibility criteria: Inclusion Criteria:

* Adult patients ventilated more than 48 h Stable respiratory and hemodynamic conditions Consent of patients or family Arterial line BMI \>30

Exclusion Criteria:

* Acute kidney injury BMI \<30 Sevoflurane anaphylaxia

Primary outcomes:
measure: Determination of plasmatic concentrations of sevoflurane before using AnaConda® system
timeFrame: at 5min, 60 min, 24 hrs and just before the end of sedation.
Secondary outcomes:
measure: Determination of plasmatic concentrations of HFIP and fluoride before using AnaConda® system
timeFrame: at 5min, 60 min, 24 hrs and just before the end of sedation.
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Sébastien PERBET
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01884012: Effect of Long-term Oxygen Therapy on Exercise Capacity and Quality of Life in Patients With Pulmonary Arterial and Chronic Thromboembolic Pulmonary Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Arterial and Chronic Thromboembolic Pulmonary Hypertension
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2013-06-21
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: In this randomized-controlled, cross-over trial the investigators test the effect of long-term oxygen therapy (\> 16h/day) given for 5 weeks with a wash-out period between phases of 2 weeks on exercise performance and quality of life and many physiological parameters in patients with pulmonary arterial and chronic thromboembolic pulmonary hypertension.


Eligibility criteria: Inclusion criteria:

- Adult patients with established diagnosis of pulmonary arterial or chronic thromboembolic pulmonary hypertension (class I and IV according to the latest WHO classification scheme of Dana Point 2008) on optimized medical therapy and in stable condition for at least 4 weeks, who desaturate in the 6 minute walking test by =4% to values \<92%.

Exclusion criteria:

* Patients in unstable conditions requiring frequent therapeutic adaption
* pregnant women
* patients with pulmonary venous hypertension due to left heart diseases
* patients with relevant concomitant lung disease and severe daytime hypoxemia

Primary outcomes:
measure: 6 minute walk test
timeFrame: 5 weeks
measure: Quality of life
timeFrame: 5 weeks
Secondary outcomes:
measure: Daily activity
timeFrame: 5 week
measure: hemodynamics by echocardiography
timeFrame: 5 weeks
measure: quality of life
timeFrame: 5 weeks
measure: arterial blood gas
timeFrame: 5 weeks
measure: operating hours of oxygen concentrator
timeFrame: 5 weeks
measure: mean nocturnal oxygen saturation
timeFrame: 5 weeks
measure: tests of cognitive performance
timeFrame: 5 weeks
measure: Quality of life
timeFrame: 5 weeks
measure: Venous blood
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Division of Pneumology
state: ZH
Study officials:
affiliation: University Hospital Zurich, Division of Pneumology
name: Silvia Ulrich Somaini, MD
role: PRINCIPAL_INVESTIGATOR
References: