louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04271124: COPD and Inflammatory Mediators
Official title: Comparison of Exercise Training
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COPD
Lead sponsor: Faculty of Medicine, Sousse
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 40
Sex: MALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Chronic obstructive pulmonary disease (COPD) is widely spread all over the world. It is predicted to be the third leading cause of death by 2020.

Detailed description: COPD is a common, preventable treatable disease that is characterized by an airflow limitation which is not fully reversible.Not only the long-term exposition to noxious particles and gases contributes to the development of COPD, but also many others factors such as genetics and cigarette smoking. Cigarettes are harmful and contribute to different extra pulmonary disorders. Although COPD affects lungs some extrapulmonary manifestations are prescribed such as muscle dysfunction, abnormal respiratory muscles and systemic inflammation. Indeed, the systemic inflammation\[6, 8\] is considered as a key process in the pathogenesis of COPD. It involves different cells and molecules; high levels of circulating of white blood cells, increased plasma c-reactive proteins (CRP), interleukin 6 (Il6) have been reported in.those patients.Likewise, systemic inflammation could worsen the comorbidities (cardiovascular, osteoporosis..) and may lead to the exercise limitation.

Eligibility criteria: Inclusion Criteria:

* COPD diagnosed by pulmonary function testing
* Clinically stable
* Abscence of other obstructive diseases
* Signed written consent

Exclusion Criteria:

* Neuromuscular diseases -Severe psychiatric, neurologic or musculoskeletal conditions
* cardiovascular diseases.
* Contre-indications to physical therapy
* Acute exacerbations a month before the intervention

Primary outcomes:
measure: Change of Interleukins concentrations
timeFrame: Before the training, 2 months
Secondary outcomes:
measure: 6Minutes Walk test
timeFrame: Before the training, 2 months
Other outcomes:
Locations:
city: Sousse
country: Tunisia
facility: Laboratoire de Recherche : Physiologie de l'Exercice et Physiopathologie
Study officials:
affiliation: Laboratoire de recherche:Physiologie de l'Exercice et Physiopathologie
name: Yassine Trabelsi, professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01628224: Enhanced Critical Care Air Transport Team Training for Mitigation of Task Saturation
Official title: Enhanced Critical Care Air Transport Team Training for Mitigation of Task Saturation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Task Saturation
Keywords: Task saturation
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: United States Air Force
First posted: 2012-06-26
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population for the first task will consist of 4 CCATT teams (of 3 members each)

Brief summary: This study involves two tasks. The first involves observation of patient care during simulated aeroevacuation missions in order to gauge task saturation. The second involves review of records from actual evacuation flights in order to determine the effects of task saturation on patient care.


Eligibility criteria: Inclusion Criteria:

* Enrollment in a US Air Force CCATT Advanced Class at University Hospital, Cincinnati

Primary outcomes:
measure: Incidence of task saturation
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University Hospital
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Tim Pritts, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01897324: IVF/ICSI Protocols in Poor Responders With Growth Hormone
Official title: Which is the Best IVF/ICSI Protocol to be Used in Poor Responders Receiving Growth Hormone as an Adjuvant Treatment ? A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Female Infertility Due to Diminished Ovarian Reserve
Keywords: Poor Ovarian Response
Poor Responders
IVF/ICSI
Growth Hormone
Lead sponsor: Woman's Health University Hospital, Egypt
Sponsor class: OTHER
First posted: 2013-07-11
Enrollment: 287
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: in this study, we are trying to monitor the effect of the addition of growth hormone on the different down regulation protocols ( long, short, antagonist and microflare). The outcome will be primarily assessed by the clinical pregnancy rates.

Detailed description: Poor responders undergoing IVF/ICSI cycles have emerged as a major problem. the need to find a proper stimulation protocol is a must. in this study we are trying to detect the best stimulation protocol ,in addition to growth hormone ,that can give the highest pregnancy rates in these patients.

Eligibility criteria: Inclusion Criteria:

ESHRE consensus 2011,At least two of the following three features must be present:

* Advanced maternal age (≥40 years) or any other risk factor for POR;
* A previous POR (≤3 oocytes with a conventional stimulation protocol);
* An abnormal ovarian reserve test (i.e. AFC \< 5-7 follicles or AMH \< 0.5 -1.1 ng/ml).

Exclusion Criteria:

* female patients with causes of infertility other than poor ovarian reserve
* females suffering from congenital or acquired uterine anomalies
* females with focal uterine lesions
* females who had previous ovarian surgeries
* females with history of previous exposure to radiotherapy , or chemotherapy
* females refusing to get enrolled in the study

Primary outcomes:
measure: Numbers of oocytes retrieved and number of fertilized oocytes
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: private IVF medical center
state: Cairo
Study officials:
affiliation: Cairo University
name: Dina M Dakhly, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dakhly DM, Bayoumi YA, Gad Allah SH. Which is the best IVF/ICSI protocol to be used in poor responders receiving growth hormone as an adjuvant treatment? A prospective randomized trial. Gynecol Endocrinol. 2016;32(2):116-9. doi: 10.3109/09513590.2015.1092136. Epub 2015 Sep 29.
Clinical trial NCT03337334: Effects of High Amplitude and Focused tACS on Entraining Physiological Tremor
Official title: Effects of High Amplitude and Focused tACS on Entraining Physiological Tremor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tremor, Limb
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2017-11-09
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Transcranial alternating current stimulation (tACS) is a noninvasive neuromodulation method that works by passing alternating electric current between electrodes where at least one of them is attached to the head. While tACS applied over the motor cortex at the general applied amplitude (1 mA) and using patch electrodes has been shown to entrain physiological tremor in healthy volunteers, the aim of this study is to test the feasibility of using high-amplitude tACS and to assess the effect of different electrode montages and stimulation sites in entraining physiological tremor. First, 10 subjects (arm 1) will be stimulated with 2 mA current amplitude applied between saline soaked patch square electrodes and comparison will be done between motor cortex stimulation and peripheral cortex stimulation. Then, 10 subjects (arm 2) will be stimulated using focused 4x1 montage with gel-filled cup-electrodes and 5 mA amplitude and comparison will be made between motor cortex and occipital cortex stimulation. Three outcome measurements will be measured during the experiments which are: tremor entrainment, phosphene intensity and phosphene threshold.


Eligibility criteria: Inclusion Criteria:

* Above 18
* signed informed written consent

Exclusion Criteria:

* Pregnancy
* History of Epilepsy
* Family history of Epilepsy

Primary outcomes:
measure: Tremor-stimulation phase entrainment
timeFrame: During the 36 minutes of all sessions (3 sessions each of is 12 minutes)
Secondary outcomes:
measure: Phosphene rating
timeFrame: Measured up to 5 minutes before the start of the stimulation sessions and lasts for 10 seconds of stimulation after which the subject gives the rating
measure: Phosphene threshold
timeFrame: Measured 3 minutes before the start of the stimulation sessions and lasts up to 2 minutes. Stimulation at each amplitude lasts for 10 sec.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05231434: Influence of Hydration and Functional Aerobic Capacity on the Nonlinear Dynamics of Heart Rate in Healthy Individuals
Official title: Influence of Hydration and Functional Capacity on the Recovery of Nonlinear Heart Rate Dynamics in Healthy Individuals: Crossover Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: exercise
hydration
non-linear dynamic
Autonomic nervous system
Lead sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho
Sponsor class: OTHER
First posted: 2022-02-09
Enrollment: 31
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of this study is to analyze the influence of hydration and functional aerobic capacity in young and healthy individuals on non-linear heart rate dynamics as a technique that favor faster and more efficient recovery cardiac autonomic modulation.


Eligibility criteria: Inclusion Criteria:

* include healthy and male individuals, age between 18 and 30 years and physically active.

Exclusion Criteria:

* individuals who smoke and drink, those who have infections, metabolic and respiratory diseases that may interfere in the results and orthopedic problems.

Primary outcomes:
measure: Blood Pressure
timeFrame: up to 3 weeks
measure: Heart Rate
timeFrame: up to 3 weeks
measure: Autonomic Modulation - SD1 index
timeFrame: up to 3 weeks
measure: Autonomic Modulation - SD2 index
timeFrame: up to 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Presidente Prudente
country: Brazil
facility: Universidade Estadual Júlio de Mesquita Filho
state: SP
Study officials:
affiliation: Universidade Estadual Júlio de Mesquita Filho
name: thamyres rangel R barros
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01272934: Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Applied Four Times Daily in Subjects With Acute Ankle Sprain
Official title: A Randomized, Double-blind, Multi-center, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Diclofenac Sodium Topical Gel (DSG) 1% Applied Four Times Daily in Subjects With Acute Ankle Sprain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Ankle Sprain
Keywords: Ankle Sprain, soft tissue injury
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-01-10
Enrollment: 205
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: The purpose of this study is to evaluate the efficacy of DSG 1% compared with placebo applied four times a day in subjects with acute ankle sprains under 'in-use' conditions, in particular with regard to pain relief.


Eligibility criteria: Inclusion Criteria:

* Male or female aged 18 years and over.Acute sprain of the lateral ankle, Grade I-II, meeting baseline pain intensity level. Injury within past 12 hours.

Exclusion Criteria:

* Pain medication was taken within the 6 hours that precede randomization.During the past 3 months: Grade I-III sprain of the same ankle.During the past 6 months: Grade II-III sprain, any other significant injury (such as fracture or torn ligament), or surgery (except for skin or nails) of the same ankle or foot.Pain or instability in the same ankle attributable to previous ankle sprain or any other trauma.Ankle sprain attributable to a known disease affecting the ligaments, such as ligament hyperlaxity due to connective tissue disease (e.g., Marfan's syndrome, Down's syndrome, Ehlers-Danlos syndrome).

Primary outcomes:
measure: Pain on Movement
timeFrame: 72 hours
Secondary outcomes:
measure: Onset of Pain Relief
timeFrame: On day 1
Other outcomes:
Locations:
city: Bad Nauheim
country: Germany
facility: NCH investigative site
city: Brühl
country: Germany
facility: NCH investigative site
city: Cologne
country: Germany
facility: NCH investigative site
city: Essen
country: Germany
facility: NCH investigative site
city: Gilching
country: Germany
facility: NCH investigative site
city: Munich
country: Germany
facility: NCH investigative site, Munich, Germany.
Study officials:
References:
Clinical trial NCT01435434: Mononucleotide Autologous Stem Cells and Demineralized Bone Matrix in the Treatment of Non Union/Delayed Fractures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non Union/Delayed Fractures
Keywords: subjects sustaining Non union/delayed fractures and requiring surgical intervention for treatment
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2011-09-16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study is a prospective, trial to test the safety and feasibility of injecting autologous, isolated, sterile centrifuged NBMC, and Ignite® DBM in the treatment of high risk non union/delayed fractures. Another objective is to turn this procedure to a standard care protocol in our department .


Eligibility criteria: Inclusion Criteria:

1. Ages: 18 to 65
2. Males- not involved in active military duty.
3. Females-non child bearing potential, or females of child-bearing potential who have a negative pregnancy test (hCG urine) within 72 hours of informed consent.
4. Subjects must be available for follow-up for 1 year. 5"Hard to heal" fracture include the following: A. Fracture of the distal third of the tibial bone B. Segmental or open (II, IIIa an IIIB) fractures of the the tibia or femur diaphysis C.Articular fracture of the lower extremity (distal femur, tibial plateau and tibial pilon fractures) with significant metaphyseal comminution and/or bone loss.

Exclusion Criteria:

1. Active systemic or local infection.
2. History of malignancy, radiotherapy, or chemotherapy for malignancy (except BCC of the skin)
3. Pathological Fractures.
4. Prior Fracture or Prior operation in the current fracture

Primary outcomes:
measure: clinical and radiological bony union at 3 months and 6 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
Study officials:
References:
Clinical trial NCT02227134: Ultrasound to Predict a Pediatric Difficult Airway and Obstructive Sleep Apnea Syndrome in Children
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Difficult Airway
Obstructive Sleep Apnea
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2014-08-27
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a prospective study to see whether ultrasonography can predict difficult airway and/or predict obstructive sleep apnea syndrome (OSAS) in children.


Eligibility criteria: Inclusion Criteria:

* Children with known or suspected difficult direct laryngoscopy identified by either ENT or anesthesiologist.
* Children with difficult tracheal intubation aged 1 month - 18 years old
* Children with obstructive sleep apnea aged 1 year - 8 years old

Exclusion Criteria:

* Parent/ patient refusal to participate in study

Primary outcomes:
measure: Hyo-mental distance
timeFrame: intraoperative
Secondary outcomes:
measure: Tongue width
timeFrame: intraoperative
measure: Tonsil Size
timeFrame: intraoperative
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT02288234: Telavancin Observational Use Registry (TOUR)
Official title: Telavancin Observational Use Registry (TOUR)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hospital Acquired Bacterial Pneumonia
Complicated Skin and Skin Structure Infections
Ventilator Associated Bacterial Pneumonia
Gram Positive Infection
Keywords: Registry
Lead sponsor: Cumberland Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2014-11-11
Enrollment: 1063
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will aim to enroll approximately 1,000 patients from 50-60 hospital sites or outpatient infusion centers.

Brief summary: The telavancin observational use registry (TOUR) will collect data to support study of the efficacy, safety, and pattern of use of telavancin in hospital-based inpatients and in outpatients being treated in infusion centers who are receiving clinician directed telavancin therapy.

Detailed description: This is a retrospective medical chart review, multicenter, observational study to examine telavancin efficacy and safety in a real-word setting and to characterize the pattern of use of telavancin in hospital-based inpatients and in outpatient infusion centers. All treatment decisions and clinical assessment will be made at the discretion of the treating physician per usual care and are not mandated by study design or protocol.

Eligibility criteria: Inclusion Criteria:

-received at least 1 dose of telavancin since January 1, 2015

Exclusion Criteria:

* Participation in an interventional research study or clinical trial involving telavancin after January 01, 2015

Primary outcomes:
measure: Time to clinical response
timeFrame: 6 months
Secondary outcomes:
measure: Frequency and Proportion of Patients experiencing Renal Adverse Events (AEs)
timeFrame: 30 days
Other outcomes:
Locations:
city: Southfield
country: United States
facility: Newland Medical Associates
state: Michigan
Study officials:
affiliation: Cumberland Pharmaceuticals, Inc.
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Sims CR, Bressler AM, Graham DR, Lacy MK, Lombardi DA, Castaneda-Ruiz B. Real-World Clinical Use and Outcomes of Telavancin for the Treatment of Bone and Joint Infections: Results from the Telavancin Observational Use Registry (TOUR). Drugs Real World Outcomes. 2021 Dec;8(4):509-518. doi: 10.1007/s40801-021-00255-6. Epub 2021 May 26.
citation: Reilly J, Jacobs MA, Friedman B, Cleveland KO, Lombardi DA, Castaneda-Ruiz B. Clinical Experience with Telavancin for the Treatment of Patients with Bacteremia and Endocarditis: Real-World Results from the Telavancin Observational Use Registry (TOUR). Drugs Real World Outcomes. 2020 Sep;7(3):179-189. doi: 10.1007/s40801-020-00191-x.
Clinical trial NCT01648634: Nebivolol for the Prevention of Left Ventricular Systolic Dysfunction in Patients With Duchenne Muscular Dystrophy
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multi-center Study to Examine the Effect of Nebivolol, a Beta-Blockade Drug, for the Prevention of Ventricular Systolic Dysfunction in Patients With Duchenne Muscular Dystrophy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Duchenne Muscular Dystrophy
Cardiomyopathy
Heart Failure
Keywords: Nebivolol
beta-blockade treatment
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Association Française contre les Myopathies (AFM), Paris
First posted: 2012-07-24
Enrollment: 51
Sex: MALE
Minimum age (years): 10
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective is to determine whether nebivolol, a beta-blockade drug, can prevent the development of heart disease in patients with Duchenne muscular dystrophy aged 10 to 15 year-old.

Detailed description: A 1.25 mg-test dose will be administrated to assess the treatment tolerance before randomization. A forced titration of nebivolol and placebo will be performed with 2 weeks periods. Full dose of nebivolol and placebo is 5mg/day (7.5mg/day for patients whose weight is\>60kg).

Eligibility criteria: Inclusion Criteria:

* Duchenne muscular dystrophy genetically proven
* Age between 10 and 15 years
* Left ventricular ejection fraction assessed by radionuclide angiography or echocardiography ≥50% and measured within 3 months
* Systolic blood pressure ≥80 mmHg
* Diastolic blood pressure ≥70 mmHg

Exclusion Criteria:

* Heart rate \<50 bpm
* 2nd or 3rd degree atrioventricular blocks, sinus node dysfunction
* Asthma or bronchospasm
* Severe peripheral circulatory disease
* Hypersensitivity to nebivolol or excipients
* Metabolic acidosis
* Blood urea \>7 mmol/l
* Liver transaminases enzymes \>6 fold the upper limit of normal
* Formal indication for beta-blockade treatment
* Cardiac treatments except angiotensin-converting enzyme inhibitors
* Participation to another clinical trial within 3 months

Primary outcomes:
measure: Left ventricular systolic dysfunction
timeFrame: at 5 years
Secondary outcomes:
measure: Right ventricular ejection fraction
timeFrame: at 5 years
measure: NT-ProBNP
timeFrame: at 1, 2, 3, 4, and 5 years
measure: Left ventricular dysfunction
timeFrame: at 10 years
measure: Hospitalizations
timeFrame: at 10 years
measure: Mortality
timeFrame: at 10 years ((5-years open label extension)
Other outcomes:
Locations:
city: Paris
country: France
facility: Armand Trousseau Hospital
Study officials:
affiliation: Armand Trousseau Hospital
name: Henri-Marc BECANE, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: