louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01048242: Treatment of Insomnia in Elderly Sleep Apnea Patients With Ramelteon (TAK 375)
Official title: Treatment of Insomnia in Elderly Sleep Apnea Patients With Ramelteon (TAK 375)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Insomnia
Obstructive Sleep Apnea
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Takeda
First posted: 2010-01-13
Enrollment: 27
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the study is to determine if treatment with Ramelteon will help to improve insomnia in older adults with co-existent insomnia and sleep apnea. The primary study objective is sleep latency (a measure of insomnia). The hypothesis is that sleep latency will be reduced in subjects taking Ramelteon relative to the placebo arm. The secondary study objective is to determine if subject compliance with CPAP treatment of their sleep apnea is improved in subjects taking Ramelteon (their compliance may be improved because they would have less insomnia due to Ramelteon treatment when using their CPAP). The hypothesis is that compliance with CPAP will be improved in subjects taking Ramelteon relative to the placebo arm.

Detailed description: Randomized, double-blind, placebo-controlled, parallel arm clinical trial with two study arms.

Eligibility criteria: Inclusion Criteria:

* Obstructive sleep apnea
* Insomnia
* Age\>60

Exclusion Criteria:

* Cognitive impairment
* Active alcohol or substance abuse
* Active use of other sedative-hypnotic agents
* Active use of fluvoxamine (drug interaction with Ramelteon
* Evidence of hepatic dysfunction (Ramelteon contraindicated) on liver function panel
* Presence of Periodic Limb Movement Disorder or Restless Legs Syndrome
* Severe Chronic Obstructive Pulmonary Disease

Primary outcomes:
measure: Sleep Onset Latency
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Nalaka Gooneratne, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06106542: Muscle Oxygenation in Stroke Patients
Official title: How Does Motor Imagery Affect Lower Extremity Muscle Oxygenation in Stroke Patients?
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Stroke
Keywords: motor imagery
Muscle oxygenation
Lead sponsor: Bandırma Onyedi Eylül University
Sponsor class: OTHER
First posted: 2023-10-30
Enrollment: 32
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals between the ages of 40-75 who are diagnosed with stroke and meet the inclusion criteria who volunteer to participate in the research constitute the sample of the study.

Brief summary: In addition to its many effects, physical movement is known to change both systemic blood circulation and muscle blood flow. In a study examining the effects of motor imagery, which produces effects similar to physical movement, on muscle oxygenation, no change in muscle oxygenation was detected with motor imagery. However, no study has been found examining muscle oxygenation along with motor imagery in stroke patients. However, it has not been investigated whether there is a difference in muscle oxygenation between the affected and less affected extremities after stroke. For this reason, our study was planned to examine the effect of motor imagery on lower extremity muscle oxygenation in stroke patients. In addition, in our study, we will examine whether there is a difference in muscle oxygenation between the affected and less affected extremities in stroke patients under different conditions (rest / physical movement / motor imagery (mental movement)). Since there are insufficient studies in this field in the literature, we think that our study will lead to future studies.


Eligibility criteria: Inclusion Criteria:

* Being between the ages of 40-75
* Being diagnosed with stroke
* BMI \<30kg/cm2
* Subcutaneous fat thickness \<12mm
* Mini Mental State Test Score being 24 or above

Exclusion Criteria:

* Having another musculoskeletal, cardiovascular, pulmonary, metabolic or neurological disease that is serious enough to prevent participation in the study
* Having serious vision and hearing problems
* Presence of serious cognitive impairment determined by the physician that would prevent the tests from being performed
* Presence of an open wound or infection in the area to be measured

Primary outcomes:
measure: muscle oxygenation
timeFrame: baseline
measure: Kinesthetic and Visual Imagery Questionnaire
timeFrame: baseline
measure: Movement imagery questionnaire 3
timeFrame: baseline
measure: Mental Stopwatch/ Mental Chronometer
timeFrame: baseline
measure: Timed Up and Go Test
timeFrame: baseline
measure: Five Times Sit to Stand Test
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04025242: Objective Assessment of Adherence to Inhalers by COPD Patients
Official title: Objective Assessment of Adherence to Inhalers by COPD Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Lead sponsor: Beaumont Hospital
Sponsor class: OTHER
First posted: 2019-07-18
Enrollment: 244
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients admitted to an acute hospital with exacerbation of COPD.

Brief summary: Rationale: Objective adherence to inhaled therapy by patients with chronic obstructive pulmonary disease (COPD) has not been reported.

Objectives: To objectively quantify adherence to preventer Diskus inhaler therapy by patients with COPD with an electronic audio recording device (INCA).

Methods: This was a prospective observational study. On discharge from hospital patients were given a salmeterol/fluticasone inhaler with an INCA device attached. Analysis of this audio quantified the frequency and proficiency of inhaler use.


Eligibility criteria: Inclusion Criteria:

* Patients hospitalised with an exacerbation of COPD
* FEV1/FVC \<70% or FEV1 \<80%
* Age\>40 years
* smoking history
* Previously prescribed fluticasone/salmeterol inhaler

Exclusion Criteria:

* No exacerbations in previous year
* Outpatients

Primary outcomes:
measure: Actual rate of inhaler adherence
timeFrame: Three months post hospitalisation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02426242: Evaluation of Risk Factors Regarding Extubation Failure in Severe Brain Injured Patients.
Official title: Observational Evaluation of Risk Factors Regarding Extubation Failure in Severe Brain-injured Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Brain Injury
Keywords: brain-injury
extubation
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2015-04-24
Enrollment: 450
Sex: ALL
Minimum age (years): 15
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized in ICU for severe brain injury

Brief summary: Severe brain-injured patients require prolonged mechanical ventilation. Weaning these patients from mechanical ventilation is challenging. During neurologic recovery, brain injured patients usually present satisfactory respiratory autonomy. However, the exact timing of extubation is unknown and is frequently delayed because of potential inhalation.

To date, there are no clinical signs available in the current literature that can help the attending physician in the decision-making process of extubation in brain-injured-patients


Eligibility criteria: Inclusion Criteria:

* Patients with brain-injury (traumatic brain injury, subarachnoid haemorrhage, stroke, intracerebral hemorrhage, brain tumour) requiring ≥ 48 hours of mechanical ventilation after admission

Exclusion Criteria:

* Pregnant women
* Patient consent withdrawal

Primary outcomes:
measure: Extubation failure
timeFrame: In the 48 hours following extubation
Secondary outcomes:
measure: Impact of extubation failure
timeFrame: Median 14 days after Intensive Care Unit (ICU) admission
Other outcomes:
Locations:
city: Angers
country: France
facility: Angers University Hospital
city: Nantes
country: France
facility: Nantes University Hospital
city: Rennes
country: France
facility: Rennes University Hospital
Study officials:
affiliation: Nantes University Hospital
name: Raphaël Cinotti, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01018342: Fed Study of Mylan Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg and Macrobid® Capsules 100 mg
Official title: Single-Dose Food In Vivo Bioequivalence Study of Mylan Nitrofurantoin Monohydrate/Macrocrystals Capsules (100 mg; Mylan) and Macrobid® Capsules (100 mg; Procter & Gamble) in Healthy Volunteers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
First posted: 2009-11-23
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The objective of this study was to investigate the bioequivalence of Mylan nitrofurantoin monohydrate/macrocrystals capsules to Procter \& Gamble Macrobid® capsules following a single, oral 100 mg (1 x 100 mg) dose under fed conditions.


Eligibility criteria: Inclusion Criteria:

* healthy, adult subjects, 18 years and older
* able to swallow medication

Exclusion Criteria:

* institutionalized subjects
* history of any significant disease
* use of any prescription or OTC medications within 14 days of start of study
* received any investigational products within 30 days prior to start of study

Primary outcomes:
measure: The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data.
timeFrame: blood collection through 28 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: Kendle International Inc.
state: West Virginia
Study officials:
affiliation: Kendle International Inc.
name: Thomas S Clark, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00900042: SWOG-9023, DNA Analysis of Tumor Tissue From Patients With Metastatic Kidney Cancer
Official title: Cytogenetic and Flow Cytometric Analysis of : Renal Cell Carcinoma: A Companion Protocol to SWOG-8949
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Cancer
Keywords: stage IV renal cell cancer
Lead sponsor: SWOG Cancer Research Network
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 34
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: RATIONALE: DNA analysis of tumor tissue may help doctors predict how well patients will respond to treatment.

PURPOSE: This laboratory study is analyzing the DNA in tumor tissue from patients with metastatic kidney cancer.

Detailed description: OBJECTIVES:

* Determine if cytogenetic abnormalities can predict clinical outcome, in terms of response to treatment and survival, in patients with metastatic renal cell carcinoma registered to the nephrectomy arm (arm I) of SWOG-8949.
* Correlate cytogenetic abnormalities and DNA content analysis (DNA index and S-phase fraction) with clinical outcome.

OUTLINE: This is a partially prospective, partially retrospective, multicenter, companion study.

Paraffin-embedded tumor tissue specimens from patients enrolled in SWOG-8949 are evaluated by cytogenetic analysis (e.g., presence of trisomy and loss of Y chromosome) and flow cytometric analysis (e.g., presence of nondiploid cells and presence of abnormal proliferation index).

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of renal cell carcinoma

  * Any T, any N, M1 disease as specified in SWOG-8949
* Eligible for and registered on the nephrectomy arm\* (arm I) of SWOG-8949 NOTE: \*Patients must be registered on this study before undergoing nephrectomy on SWOG-8949

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
measure: Number of successes per number of evaluable samples
timeFrame: up to 4 years after registration
measure: Number of abnormalities per number of successes
timeFrame: up to 4 years after registration
measure: Correlation of tumor response to treatment with the type and number of abnormalities
timeFrame: up to 4 years after registration
measure: Correlation of time from diagnosis to development of metastatic disease with the type and number of abnormalities
timeFrame: up to 4 years after registration
measure: Correlation of time from first diagnosis of metastatic disease until death with the type and number of abnormalities
timeFrame: up to 4 years after registration
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Texas
name: Robert P. Whitehead, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00845442: Dynamic Laryngeal Opening for Bilateral Vocal Fold Paralysis by an Implanted Stimulator
Official title: Dynamic Vocal Fold Abduction for Bilateral Paralysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vocal Cord Paralysis
Keywords: Bilateral vocal cord paralyses
Implanted laryngeal stimulator
vocal cord opening
pulmonary function tests
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2009-02-18
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: People who had paralysis of the vocal cords are often prevented from breathing by this problem because the cords will not open, and the patients have to wear a tracheostomy (neck breathing tube) to bypass this airway obstruction. This study examines the effects of vocal cord opening triggered by a pacemaker implanted over the chest wall. The device is connected to a nerve taken from a muscle close to the larynx (voice box) and implanted into the paralysed laryngeal muscle so it can reinnervate it. When this process is complete after a few weeks, the stimulator is turned on and the level of vocal cord opening is assessed. Airway improvement is checked by pulmonary function tests and measurements of vocal cord opening. The ultimate goal of the study is to lead to situations where patients with bilateral vocal fold paralyses could get rid of the neck breathing tube to have less complications, be more comfortable and socially acceptable.

Detailed description: Data pending

Eligibility criteria: Inclusion Criteria:

* Breathing difficulties from vocal cord paralyses
* Tracheostomy tube
* Ability to understand the purpose of the research
* Appropriate hand motor coordination

Exclusion Criteria:

* Lack of understanding the research
* Poor hand motor coordination
* Non-acceptance of tracheostomy
* Inability to passively move the paralyzed vocal cords

Primary outcomes:
Secondary outcomes:
measure: Tolerance of implanted device
timeFrame: 3-6 months
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland
name: Michael Broniatowski, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02235142: Prostatic Cancer Versus Androgen Deficiency
Official title: Localised Cancer of Prostate and Androgen Deficiency.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer of Prostate
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2014-09-09
Enrollment: 1614
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Open study to make a comparison between hypogonadism and euogonadism patients regarding the severity of prostate cancer. The purpose of this study is to determine the importance of the relationship between the hormonal status and the type of the tumor at the time of surgical intervention as well as follow up of the patients.


Eligibility criteria: Inclusion Criteria:

* Male patients over than 18 years of age, with localized, stage I or II prostate cancer, not receiving local treatment (radiation, phototherapy, thermotherapy,...) or hormonal therapy, showing indication of radical prostatectomy.

Exclusion Criteria:

* Absence of radical prostatectomy indication
* Patient received local or hormonal therapy prior to surgery
* Patients already enrolled in other clinical study incompatible with the study
* Patients on a treatment which can affect hormonal level (Prednisone, Ketoconazole, Abiraterone, Finasteride, Dutasteride)

Primary outcomes:
measure: Testosteron Serum level
timeFrame: The day prior to surgery
measure: Gleason score
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hôpital Foch
state: Ile De France
city: Bordeaux
country: France
facility: Clinique Saint Augustin
city: Colmar
country: France
facility: Hôpitaux Civils de Colmar
city: Créteil
country: France
facility: Hôpital Henri Mondor
city: Paris
country: France
facility: La Pitié-Salpêtrière (AP-HP)
city: Paris
country: France
facility: Institut Mutualiste Montsouris
city: Pointe-à-Pitre
country: Guadeloupe
facility: CHU Pointe à Pitre
city: Fort-de-France
country: Martinique
facility: CHU Fort de France
Study officials:
References:
citation: Neuzillet Y, Raynaud JP, Dreyfus JF, Radulescu C, Rouanne M, Schneider M, Krish S, Roupret M, Drouin SJ, Comperat E, Galiano M, Cathelineau X, Validire P, Molinie V, Fiet J, Giton F, Lebret T, Botto H. Aggressiveness of Localized Prostate Cancer: the Key Value of Testosterone Deficiency Evaluated by Both Total and Bioavailable Testosterone: AndroCan Study Results. Horm Cancer. 2019 Feb;10(1):36-44. doi: 10.1007/s12672-018-0351-8. Epub 2018 Oct 6.
Clinical trial NCT00482742: Safety & Performance Randomized Study of the CiTop™ Guidewire for Peripheral CTO
Official title: A Feasibility, Multi Center Multinational Randomized Open Label Study, to Evaluate the Safety and Performance of the CiTop™ Guidewire for Crossing Total Occlusion in Peripheral Arteries.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Catheterization, Peripheral
Keywords: Chronic Total Occlusion
Lead sponsor: Ovalum
Sponsor class: INDUSTRY
First posted: 2007-06-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The main objectives of the study are:

To evaluate the performance and safety of the CiTop guidewire, while attempting to cross thru total occlusions of various dimensions and morphology.

To compare the safety and efficacy of the CiTop guidewire with standard guidewires in terms of impact on the treated artery. Following operation of the CiTop device, angiography demonstrated successful crossing of the occlusion with no visible evidence of arterial wall injury, dissection, or distal embolization.

To assess ease of operation and the level of integration of the CiTop with standard interventional angiography procedure: Balloon angioplasty, placement of stent.


Eligibility criteria: Clinical Inclusion Criteria:

* Patient with symptomatic peripheral vascular disease, intermittent claudication less than 30 meters, rest pain or tissue ischemia.(Fontain grade 3-4)
* Critical limb Ischemia
* The patient has Chronic Total Occlusion in limb arteries, aged at least 3 months.
* Patient has chronic total occlusion (CTO) that is:
* Documented angiographically, by the investigator or co-investigator.
* CTO was defined as an obstruction of a main peripheral artery with no luminal continuity and with TIMI (Thrombolysis In Myocardial Infraction) flow grade of 0 or 1.
* CTO location suitable for endovascular treatment (not in parallel location with the hip or knee joints).
* Lesion ≤ 8cm in length
* Lesion located in a segment with diameter more than 1.5 mm
* Adequate compliance with follow-up and/or repeat angiography
* No Contra-indication to treatment with aspirin or ticlopidine or clopidogrel and/or Heparin
* Visible entry point of target lesion
* NO cancer or other life threatening diseases or conditions
* NO diagnosis or suspected renal failure (2 x ULN of creatinine)
* Not suspected intolerance of the contrast agent
* NO Drug abuse or alcoholism
* Patients is NOT under custodial care
* Women with childbearing potential are NOT pregnant (positive pregnancy test at the time of procedure).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Split
country: Croatia
facility: University Hospital Split
city: Zagreb
country: Croatia
facility: Clinical Hospital Centre Zagreb
city: Petah-Tikva
country: Israel
facility: Rabin Campus, Belinson Hospital
Study officials:
affiliation: Research Fund, Belinson Hospital
name: Alexander Belenky, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02404142: Curarisation and Intubation Conditions During Videolaryngoscopy With Glidescope Titanium
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tracheal Intubation
Keywords: Trachel intubation
IDS score
Videoaryngoscopy
Glidescope® Titanium®
NMBA
Curare (Atracurium)
Lead sponsor: CHU de Reims
Sponsor class: OTHER
Collaborators: name: Verathon
First posted: 2015-03-31
Enrollment: 64
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: In this prospective, randomized study, the investigators assess the intubation conditions during videolaryngoscopy with Glidescope Titanium whether patients receive (curare (Atracurium) group) or no (control group) within elective surgery patients with no difficult intubation prediction

Detailed description: In this prospective, randomized study, the investigators assess the intubation conditions during videolaryngoscopy with Glidescope Titanium whether patients receive (curare (Atracurium)group) or no (control group) within elective surgery patients with no difficult intubation prediction. The IDS score assessed by an anesthesiologist from the video-recording is the primary outcome. All general anesthesias are standardized using Target Control Infusion of propofol and sufentanil. The investigators also compare IDS scores as assessed by intubators, time for tracheal intubation, and laryngeal morbidity in both groups.

Eligibility criteria: Inclusion Criteria:

* Elective Surgery Adult Patients
* no difficult intubation prediction

Exclusion Criteria:

Primary outcomes:
measure: IDS score video-assessed as described by Adnet et al. Measurement will be made by 2 experts anesthesiologists for centralized reading
timeFrame: Assessment will be done at the end of the inclusions period (9 months)
Secondary outcomes:
measure: IDS score assesed by the intubator anesthesiologist
timeFrame: 3 days post intubation
Other outcomes:
Locations:
city: Reims
country: France
facility: Chu de Reims
Study officials:
References: