louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02782572: Safety of Aerobic Exercise in Acute Heart Failure
Official title: Safety and Efficacy of Exercise Training in Patients With Acute Heart Failure: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Acute Heart Failure
Keywords: Exercise
Cardiac Rehabilitation
Non-invasive ventilation
Lead sponsor: Instituto Dante Pazzanese de Cardiologia
Sponsor class: OTHER
First posted: 2016-05-25
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This project deals with exercise in acute heart failure in three different groups (conventional medical treatment; exercise with non-invasive ventilation and exercise with placebo of non-invasive ventilation).

Detailed description: All of the subjects performed an individualized clinical evaluation right after hospital admission on day 1 (D1) by the cardiologist and physiotherapis involved in the study. Pulmonary function tests (spirometry), blood sample (brain natriuretic peptide \[NT-proBNP\] and high sensitive C-reactive protein \[hs-CRP\]), six-minute walk test (6MWT), and maximal inspiratory pressure (MIP) test were performed.

After the clinical tests were performed, the patients were randomized into three groups, and all received standard medical treatment.

The control group (CTL) received medical treatment and did not perform aerobic exercise training; the ET+NIV group performed aerobic exercise training associated with NIV once a day, for 8 consecutive days; and the ET+Sham group performed aerobic exercise with placebo NIV once a day, for 8 consecutive days. The ET+NIV and ET+Sham groups also received medical treatment.

After eight consecutive days, all of the patients underwent a new clinical evaluation (D10). After D10, all of the patients continued to receive only conventional treatment, and they were followed up for main outcomes (hospital discharge, worsening HF, or death). Worsening HF was considered when a patient needed to be transferred to the intensive care unit.

Eligibility criteria: Inclusion Criteria:

* established diagnosis of acute HF; previous Doppler echocardiography with left ventricle ejection fraction (LVEF) \<30%, and NYHA Class IV.

Exclusion Criteria:

* unstable angina, complex cardiac arrhythmias, pacemaker, cardiac resynchronization therapy or left ventricle assist device, myocardial infarction within the previous 12 months, oxygen saturation by pulse oximetry (SpO2) at rest \< 88% without oxygen supplementation, acute pulmonary edema with clinical indications for mechanical ventilation

Primary outcomes:
measure: Safety and efficacy of exercise in acute heart failure
timeFrame: Patients were followed up until hospital discharge. up to 60 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00348972: Lantus in Prediabetes
Official title: Assessment of Safety and Tolerability of Lantus® (Insulin Glargine) in Subjects With Impaired Fasting Glucose (IFG) or Impaired Glucose Tolerance (IGT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hyperglycemia
Diabetes Mellitus
Keywords: Glargine
prediabetes
impaired glucose tolerance
impaired fasting glucose
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-07-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the safety, tolerability, and efficacy of Lantus® (insulin glargine) in prediabetes (IFG or IGT).


Eligibility criteria: Inclusion Criteria:

* Hyperglycemia (either IGT , IFG, or untreated type 2 diabetes)
* HbA1c \< 7.0%
* BMI \< 40kg/m2
* Able to perform moderate stationary bicycle exercise

Exclusion Criteria:

* Chronic pharmacologic treatment for hyperglycemia, past or present
* CAD
* serum creatinine \> 2.0mg/dL
* BP \> 180/105
* History of hypoglycemia unawareness

Primary outcomes:
measure: Efficacy: 8-point blood glucose measurements.
measure: Safety / tolerability: hypoglycemia
Secondary outcomes:
measure: Blood glucose in response to exercise.
measure: Fasting supine levels of counterregulatory hormones
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Sanofi-Aventis
state: New Jersey
Study officials:
affiliation: Sanofi
name: Peter JOHNSTON, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03922672: Piano Training, Caregivers, and Parkinson's Disease
Official title: The Impact of Group Piano Training on Psychosocial Outcomes in Caregivers of Adults With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Depression
Mood
Burden, Dependency
Keywords: caregiver
Parkinson's disease
group piano training
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2019-04-22
Enrollment: 14
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
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 investigate the impact of group piano training on psychosocial outcomes in caregivers of adults with Parkinson's disease (PD). As well, the study is investigating the impact of group piano training on psychosocial outcomes in the care-recipient with PD.


Eligibility criteria: Inclusion Criteria:

* Caregiver:

  * Are currently a primary caregiver to an adult with PD
  * Are between the age of 40-80 years
  * Have less than 5 years of music training
  * Speak and read English fluently

Adult with PD:

* Stage 1-3 Parkinson's disease
* Are between the age of 40-80
* Have less than 5 years of music training
* Speak and read English fluently

Exclusion Criteria:

* Doesn't meet all the inclusion criteria

Primary outcomes:
measure: Change in caregiver burden as assessed by the Zarit Burden Interview.
timeFrame: Baseline to month 1, baseline to month 2, baseline to month 4
Secondary outcomes:
measure: Change in depression as assessed by the Center for Epidemiological Studies for Depression (CES-D).
timeFrame: Baseline to month 1, baseline to month 2, baseline to month 4
measure: Change in musical self-efficacy as assessed by the Musical Performance Self-Efficacy Scale (MPSE).
timeFrame: Baseline to month 1, baseline to month 2, baseline to month 4
measure: Change in mood by the Profile of Mood States - Brief Form (POMS-BF).
timeFrame: From month 1 to month 4.
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Teresa L Lesiuk, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04933344: Pharmacokinetics and Toxicodynamics of Daptomycin in Bone and Joint Infections
Official title: Pharmacokinetics and Toxicodynamics of Daptomycin in Bone and Joint Infections
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dactinomycin Adverse Reaction
Bone and Joint Infection
Keywords: bone and joint infection
adverse event
daptomycin
Eosinophilic pneumonia
CPK
rhabdomyolysis
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2021-06-21
Enrollment: 1130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients managed at the CRIOAc Lyon who have had an osteoarticular infection, treated with daptomycin, with at least one blood test for daptomycin performed

Brief summary: the aim of this study is to investigate the relationship between exposure to daptomycin and the occurrence of muscle toxicity or eosinophilic pneumonia in patients treated with daptomycin for bone and joint infection

Detailed description: Daptomycin is widely used in osteoarticular infections (IOA), as an alternative to vancomycin, and recommended for this use by various learned societies including the Infectious Diseases Society of America (IDSA) in 2013.

Tolerance to daptomycin is generally favorable, with in particular better renal tolerance than vancomycin. However, two rare and potentially severe side effects have been described with this antibiotics: muscle toxicity and eosinophilic pneumonia.

Eligibility criteria: Inclusion Criteria:

* Patients who have had an osteoarticular infection, treated with daptomycin, with at least one blood test for daptomycin performed

Exclusion Criteria:

* Patients who objected to participating in the study
* Absence of blood dosage of daptomycin

Primary outcomes:
measure: rate of patients having had a PJI or BJI treated by daptomycin
timeFrame: between 2010 and 2020
measure: description of BJI/PJI
timeFrame: between 2010 and 2020
measure: description of patients
timeFrame: between 2010 and 2020
measure: description of adverse event
timeFrame: between 2010 and 2020
measure: rate of patients having had an adverse event
timeFrame: between 2010 and 2020
measure: Evalutation of the adverse event due to daptomycin : dosage of daptomycine
timeFrame: between 2010 and 2020
measure: Evalutation of the adverse event due to daptomycin : duration of daptomycine
timeFrame: between 2010 and 2020
measure: Evalutation of the adverse event due to daptomycin : daptomycine plasma clearance
timeFrame: between 2010 and 2020
measure: Evalutation of the adverse event due to daptomycin : daptomycine volume distribution
timeFrame: between 2010 and 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon
Study officials:
References:
Clinical trial NCT03078244: Protocol for a Multicentre Survey of Patients With Treatment Resistant Hypertension
Official title: Protocol for a Multicentre Survey of Patients With Treatment Resistant Hypertension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Treatment Resistant Hypertension
Lead sponsor: George Clinical Pty Ltd
Sponsor class: INDUSTRY
Collaborators: name: The George Institute
name: Actelion
First posted: 2017-03-13
Enrollment: 1500
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult subjects with treatment resistant hypertension

Brief summary: Project aims to determine the number of individuals with treatment resistant hypertension and to define the characteristics of these patients and estimate disease frequency. The study will be a retrospective review of medical record data based upon de-identified information and will require no patient contact.


Eligibility criteria: Inclusion Criteria:

* \> = 18 years of age
* No known secondary cause of hypertension
* History of uncontrolled hypertension while using 3 or more anti-hypertensive agents
* Controlled blood pressure using 4 or more different anti-hypertensive agents

Exclusion Criteria:

N/A

Primary outcomes:
measure: Number of adult subjects with treatment resistant hypertension
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01688544: Pharmacokinetic/Pharmacodynamic Study of Ilaprazole to Evaluate the Effect of CYP Genetic Polymorphism
Official title: Phase 1 Study to Evaluate the Effect of CYP Polymorphism and Gender on the Pharmacokinetics and Pharmacodynamics of Ilaprazole After Multiple Dosing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Ilaprazole
Intragastric pH
Serum Gastrin
Pharmacokinetics
Lead sponsor: Inje University
Sponsor class: OTHER
First posted: 2012-09-20
Enrollment: 27
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Ilaprazole is a novel proton pump inhibitor and metabolized by CYP3A4 and 2C19. Thus genetic polymorphisms of CYP3A4 and 2C19 may have effect on the pharmacokinetics and pharmacodynamics of Ilaprazole.

Detailed description: Effects of genetic polymorphisms on the pharmacokinetics or pharmacodynamics were measured in healthy Korean volunteers

Eligibility criteria: Inclusion Criteria:

* healthy adult volunteer between 20 and 45 years of age and within 20% of ideal body weight
* No congenital or acquired chronic disease
* appropriate for the study judging from examinations (hematology, chemistry, urinalysis and so on), vital sign and ECG results
* sign the informed consent form prior to study participation

Exclusion Criteria:

* received any metabolizing enzymes or transporters inducing or inhibiting drugs like barbiturates within 1 month prior to the date of first drug administration
* history of hypersensitivity against drugs or clinically significant allergic diseases
* abnormal laboratory results
* positive result for helicobacter pylori infection from the Urea Breath Test
* alcohol or drug abuser
* pregnant or lactating
* donated whole blood within 60days prior to the study

Primary outcomes:
measure: 24 hour intragastric ph
timeFrame: After 7 days dosing of Ilaprazole 10 mg
Secondary outcomes:
measure: Pharmacokinetic parameters (Cmax, AUC) of Ilaprazole and its metabolite
timeFrame: After 7 days dosing of Ilaprazole
measure: Serum Gastrin level
timeFrame: After 7 days dosing of Ilaprazole
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hoapital Clinical Trial Center
Study officials:
affiliation: Inje University
name: JaeGook Shin, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01606644: Hyperbaric Oxygen - a New Treatment Modality in Patients With Radiation Damaged Salivary Gland Tissue
Official title: Hyperbaric Oxygen - a New Treatment Modality in Patients With Radiation Damaged Salivary Gland Tissue.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Late Effect of Radiation
Keywords: radiation sequelae
hyperbaric oxygen
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Danish Cancer Society
First posted: 2012-05-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Randomized clinical trial regarding the effect of hyperbaric oxygen on late radiation tissue injury to salivary gland tissue.


Eligibility criteria: Inclusion Criteria

* Head and neck cancer with planned radiation therapy
* Age \> 18 years

Exclusion Criteria:

* Surgical treatment of head and neck cancer
* Salivary gland disease
* Severe claustrophobia
* Pregnancy or lactation (fertile women must use safe contraceptives)
* Uncontrolled hypertension (\> 220/110)
* Epilepsy
* Lack of ability to equalize inner ear pressure
* Pneumothorax
* Thoracic surgery within one month before HBO treatment
* Abuse of alcohol, drugs or narcotics
* Exposed titanium surfaces or defect titanium in the oral cavity
* Previous HBO treatment

Primary outcomes:
measure: Salivation rate
timeFrame: 6 months
Secondary outcomes:
measure: Quality of life
timeFrame: 6 months
measure: Xerostomia
timeFrame: 6 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Anaesthesia and Department of Oral and Maxillofacial Surgery, Copenhagen University Hospital
Study officials:
affiliation: Copenhagen University Hospital at Herlev
name: Lone Forner, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01428544: Special Drug Use Investigation (Retrospective) for Arixtra® (Fondaparinux) Venous Thromboembolism Treatment (Over 100kg)
Official title: Special Drug Use Investigation (Retrospective) for Arixtra® (Fondaparinux) Venous Thromboembolism Treatment (Over 100kg)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ataxia
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-09-05
Enrollment: 5
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Japanese patients with acute pulmonary thromboembolism or acute deep venous thrombosis whose body weight is 100 kg or more, or to whom fondaparinux was injected 10 mg/day.

Brief summary: The purpose of this post-marketing surveillance study is to collect and assess information retrospectively on safety and effectiveness of fondaparinux injection in patients with venous thromboembolism (VTE) whose body weight is 100 kilograms (kg) or more, or to whom fondaparinux was injected 10 mg/day.

("Arixtra" is a trademark of the GlaxoSmithKline group of companies.)


Eligibility criteria: Inclusion Criteria:

* Patients with acute pulmonary thromboembolism or acute deep venous thrombosis
* Fondaparinux injection must be prescribed for the first time

Exclusion Criteria:

* Not applicable

Primary outcomes:
measure: Number of patients with adverse drug reaction
timeFrame: 3 months
measure: Number of patients with any serious adverse event
timeFrame: 3 months
measure: Number of patients with any hemorrhagic adverse event
timeFrame: 3 months
measure: Presence or absence of reoccurrence of VTE
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT03121144: Usability Validation of Patient Monitoring Device for Pressure Injury Prevention and Fall Detection
Official title: Usability Validation of Patient Monitoring Device for Pressure Injury Prevention and Fall Detection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pressure Ulcer
Pressure Injury
Falls Injury
Lead sponsor: Masimo Corporation
Sponsor class: INDUSTRY
First posted: 2017-04-19
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study describes a procedure to collect a subject's position, movement, physiological data and usability information using Masimo's investigational device.


Eligibility criteria: Inclusion Criteria:

1. At least 18 years of age
2. ICU patient
3. Primarily bedbound subjects
4. Able to be monitored for a minimum of approximately 8 hours

Exclusion Criteria:

1. Pregnancy
2. Prisoner status
3. Pressure injury stage 2, 3, or ungroupable
4. Has a pacemaker or internal defibrillator
5. Has a history of complications with a similar study
6. Has any medical condition which in the judgment of the Investigator, renders them inappropriate for participation in this study

Primary outcomes:
measure: Usability Validation of Masimo Centroid System
timeFrame: At least 8 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
Study officials:
References:
Clinical trial NCT06468644: Phase II Study of Different Doses of Radiotherapy Combined With Sintilimab in the Treatment of Locally Advanced Esophageal Squamous Cell Carcinoma
Official title: Phase II Study of Different Doses of Radiotherapy Combined With Sintilimab in the Treatment of Locally Advanced Esophageal Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Esophageal Squamous Cell Carcinoma
Lead sponsor: Fujian Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2024-06-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is aimed to evaluate the efficacy and safety of different doses of radiotherapy combined with sintilimab in locally advanced esophageal squamous cell carcinoma.

Detailed description: This study was designed as a two cohorts, phase II trial. Subjects will receive different doses of radiotherapy combined with sintilimab. The primary endpoint is progression-free survival.

Eligibility criteria: Inclusion Criteria:

* ≥18 years old
* Histopathological examination of the primary biopsy confirmed the diagnosis of locally advanced esophageal squamous cell carcinoma
* At least one measurable lesion
* Eastern cooperative oncology group (ECOG) performance status of 0 to 1
* With adequate organs function

Exclusion Criteria:

* Patients with active malignancy within 5 years other than the tumor studied in this study or a localized tumor that has been cured such as resected basal or squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, or breast cancer
* Patients who have a higher risk of bleeding or perforation due to the tumor\&#39;s obvious invasion of the adjacent organs (aorta or trachea) of the esophageal lesion, or patients who have formed a fistula
* Patients who have received any anti-tumor therapy for the research disease in the past, including radiotherapy, chemotherapy, immunotherapy (including but not limited to interleukin, interferon, thymus hormone) and traditional Chinese medicine therapy

Primary outcomes:
measure: progression free survival
timeFrame: 1 years
measure: Incidence rate of adverse events
timeFrame: 3 years
Secondary outcomes:
measure: overall survival
timeFrame: 3 years
measure: Objective Response Rate
timeFrame: 3 months after therapy
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03154944: A Clinical Investigation Evaluating Three New 1-piece Ostomy Products
Official title: A Clinical Investigation Evaluating Three New 1-piece Ostomy Products
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ileostomy - Stoma
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2017-05-16
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This investigation evaluates three new ostomy appliances and their impact on the peristomal skin.


Eligibility criteria: Inclusion Criteria:

1. Have given written informed consent and in DK: signed a letter of authority
2. Be at least 18 years of age and have full legal capacity
3. Have had their ileostomy for at least 3 months
4. Have an ileostomy with a diameter between 10 and 55 mm
5. Be able to handle the Clinical App. and product themselves
6. Must be able to use custom cut product
7. Minimum change of product every second day
8. If current product is SenSura Mio - Be willing to use Maxi bag during investigation
9. Subject using Sensura or Sensura Mio flat 1 pc. open for at least two weeks before inclusion in the study.
10. Negative result of a pregnancy test for women of childbearing age (only DK)

Exclusion Criteria:

1. Are currently receiving or have within the past 2 months received radio-and/or chemotherapy (low doses chemotherapy are allowed for other indications than cancer, e.g. below 15 mg methotrexate for rheumatoid arthritis)
2. Are currently receiving or have within the past month received topical steroid treatment in the peristomal skin area, e.g. lotion or spray. Systemic steroid treatment (e.g. injection, or tablet) are allowed.
3. Are pregnant or breastfeeding\*\*
4. Are participating in other interventional clinical investigations or have previously participated in this investigation
5. Are currently suffering from peristomal skin problems i.e. bleeding and/or broken skin (assessed by the investigator)
6. Have known hypersensitivity towards any of the products used in the investigation

Primary outcomes:
measure: Trans Epidermal Water Loss
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Humlebaek
country: Denmark
facility: Coloplast A/S
Study officials:
affiliation: Medial director
name: Birte P Jakosen, MD
role: PRINCIPAL_INVESTIGATOR
References: