louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01979185: Effect of SSP-004184 (SPD602) on the Pharmacokinetics of Simvastatin in Healthy Adult Subjects
Official title: A Phase 1, Randomized, Open-label, Cross-over Study to Evaluate the Pharmacokinetic Interaction Between SSP-004184 (SPD602) and Simvastatin in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2013-11-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This is a randomized, open-label study to evaluate the effect of a single dose of SSP-004184 on the pharmacokinetics of a single dose of simvastatin in healthy adult subjects.


Eligibility criteria: Inclusion Criteria:

* Normal healthy male and female volunteers
* Serum ferritin, hemoglobin and erythrocyte indices within normal range

Exclusion Criteria:

* Evidence of any active or chronic disease

Primary outcomes:
measure: Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) for Simvastatin
timeFrame: Study Periods 1 & 2: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours.
measure: Area Under the Concentration-time Curve From Time Zero to the Time of the Last Measureable Concentration (AUClast) of Simvastatin
timeFrame: Study Periods 1 & 2: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours.
measure: Maximum Plasma Concentration (Cmax) of Simvastatin
timeFrame: Study Periods 1 & 2: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours.
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Clinical Pharmacology of Miami, Inc.
state: Florida
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04924985: Goal-directed CPR Using Cerebral Oximetry
Official title: Goal-Directed Cardiopulmonary Resuscitation in Cardiac Arrest Using a Novel Physiological Target
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Ischemia
Reperfusion Injury
Keywords: CPR
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2021-06-14
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The proposed study is a single-center, randomized controlled pilot trial of adults who suffer in-hospital cardiac arrests. Using cerebral oxygenation and end-tidal carbon dioxide physiological targets to predict survival and neurological outcome, the impact of physiological-feedback CPR will be assessed. 150 adult patients who have a cardiac arrest event at NYU Tisch Hospital will be randomized to one of two treatment groups: (1) Physiological-Feedback CPR or (2) Non-Physiological (Audiovisual) Feedback CPR.


Eligibility criteria: Inclusion Criteria:

1. In-hospital cardiac arrest patient
2. Age ≥18 years
3. Age \<80 years
4. CPR lasting ≥5 minutes

Exclusion Criteria:

1. Patients \< 18 years of age or \> 80 years of age
2. Out of hospital cardiac arrest patients
3. ≥3 acute organ failures (defined as acute renal failure requiring dialysis, fulminant liver failure i.e. liver failure with INR≥1.5, respiratory failure requiring mechanical ventilation)
4. Repeat in-hospital cardiac arrest event within 14 days of a prior cardiac arrest
5. Presence of known raised intracranial pressure
6. Presence of known traumatic brain injury or subarachnoid hemorrhage \<14 days old, frontal lobe brain tumors or subdural hemorrhage
7. Hyperbilirubinemia \>1.0 mg/dl (based on the absorption of near-infrared light by bilirubin)
8. Resuscitation using extra-corporeal membrane oxygenation (ECMO)

Primary outcomes:
measure: Rate of Return of Spontaneous Circulation (ROSC)
timeFrame: Day 0
Secondary outcomes:
measure: Cerebral Performance Category (CPC) Score
timeFrame: Day 1-2
measure: Cerebral Performance Category (CPC) Score
timeFrame: Day 30
measure: Change in mean rSO2 during CPR as markers of the quality of resuscitation
timeFrame: Day 0
measure: Change in mean ETCO2 during CPR as markers of the quality of resuscitation
timeFrame: Day 0
measure: Release of interleukin (IL)-6
timeFrame: Day 0
measure: Release of Lactate
timeFrame: Day 0
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Sam Parnia, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05568485: Telerehabilitation in Individuals With Rheumatic Disease
Official title: Biopsychosocial Exercise Model Via Telerehabilitation in Individuals With Rheumatic Disease During the COVID-19 Pandemic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatic Diseases
Keywords: Biopsychosocial, rheumatology, remote care, holistic
Lead sponsor: Eastern Mediterranean University
Sponsor class: OTHER
First posted: 2022-10-05
Enrollment: 28
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: increasing the prevalence of exercise models designed in accordance with the biopsychosocial model is very important in terms of ensuring the sustainability of these models with telerehabilitation in periods such as epidemics and pandemics. The aim of this study was to investigate the effects of a biopsychosocial exercise model provided via telerehabilitation in individuals with rheumatic diseases during the COVID-19 pandemic.

Detailed description: Telerehabilitation was applied to the group with rheumatism in 3 sessions a week for 24 weeks via a social texting program. The intervention sessions consisted of 10 minutes of dance therapy-authentic movement, 40 minutes of exercises, and 10 more minutes of dance therapy. This exercise content was based on a biopsychosocial model, named the Cognitive Exercise Therapy Approach (BETY) which was used in the study, and it was a method that patients already practiced before the pandemic. At the beginning, at the 12th week and 24th week, the Health Assessment Questionnaire (HAQ), the Hospital Anxiety and Depression Scale (HADS), the BETY Biopsychosocial Questionnaire (BETY-BQ) were applied.

Eligibility criteria: Inclusion Criteria:

members of an exercise group before the pandemic at the physiotherapy and rehabilitation department of a university.

Exclusion Criteria:

* Individuals who had difficulty in cooperation

Primary outcomes:
measure: BETY Biopsychosocial Questionnaire (BETY-BQ
timeFrame: change will be assessed at 12th week and 24th week
Secondary outcomes:
measure: Health assessment questionnaire
timeFrame: change will be assessed at 12th week and 24th week
measure: hospital qnxiety and depression scale
timeFrame: change will be assessed at 12th week and 24th week
Other outcomes:
Locations:
city: Famagusta
country: Cyprus
facility: Eastern Mediterranen University
Study officials:
affiliation: Hasan Kalyoncu University
name: Zeynep İrem Bulut, MSc. Pt.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Nur Banu Karaca, MSc. Pt.
role: PRINCIPAL_INVESTIGATOR
affiliation: İstanbul Yeni Yüzyıl University
name: Arzu Dağ
role: PRINCIPAL_INVESTIGATOR
affiliation: Hasan Kalyoncu University
name: Yavuz Yakut, Prof.Dr.
role: STUDY_DIRECTOR
affiliation: Hacettepe University
name: Sedat Kiraz, Prof. Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05582785: Low Field Magnetic Resonance Imaging Assessment With Outpatients
Official title: Low Field Magnetic Resonance Imaging Assessment With Outpatients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Conditions Requiring a Brain Magnetic Resonance Imaging, Head Computerized Tomography, or Head Ultrasound
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
First posted: 2022-10-17
Enrollment: 500
Sex: ALL
Minimum age (years): 0
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The objective of the study is to perform imaging assessments of an early stage magnetic resonance imaging (MRI) system on patients using low field magnetic strength.


Eligibility criteria: Inclusion Criteria

Outpatients at CMH Adele Hall Radiology ages 0 days to 22 years are eligible for enrollment.

Exclusion Criteria

No additional sedation will be given as part of this study and that sedation, if already administered, will not be altered for study purposes.

Any patient who has a contraindication to having an MRI, such as:

Non-MRI conditional implanted device or device that is not able to be removed for MRI examination

Primary outcomes:
measure: Sensitivity and specificity of hyperfine MRI versus conventional MRI, CT and/or US
timeFrame: Through study completion, an average of 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Kansas City
state: Missouri
Study officials:
affiliation: Children's Mercy
name: Sherwin Chan, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00464685: Safety and Efficacy of a New Treatment in Combination With Laser for Diabetic Macular Edema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Macular Edema
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2007-04-24
Enrollment: 253
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 study will evaluate the safety and efficacy of the intravitreal implant of dexamethasone with laser treatment vs. laser treatment alone in patients with diabetic macular edema.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older with diabetic macular edema
* Decrease in visual acuity in at least one eye as a result of macular edema (20/50 or worse)
* Visual acuity in other eye no worse than 20/200

Exclusion Criteria:

* Known anticipated need for ocular surgery within next 12 months
* History of glaucoma or current high eye pressure requiring more than 1 medication
* Uncontrolled systemic disease
* Known steroid-responder
* Use of systemic steroids - Use of Warfarin/Heparin

Primary outcomes:
measure: Percentage of Patients With at Least 10 Letters of Improvement in Best Corrected Visual Acuity (BCVA) From Baseline in the Study Eye
timeFrame: Baseline, Month 12
Secondary outcomes:
measure: Change From Baseline in BCVA in the Study Eye
timeFrame: Baseline, Month 12
measure: Change From Baseline in Central Subfield Retinal Thickness in the Study Eye
timeFrame: Baseline, Month 12
measure: Change From Baseline in the Focal Leakage Area in the Study Eye
timeFrame: Baseline, Month 12
measure: Time to Retreatment in the Study Eye
timeFrame: 12 Months
Other outcomes:
Locations:
city: Artesia
country: United States
state: California
city: Victoria
country: Canada
state: British Columbia
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Callanan DG, Gupta S, Boyer DS, Ciulla TA, Singer MA, Kuppermann BD, Liu CC, Li XY, Hollander DA, Schiffman RM, Whitcup SM; Ozurdex PLACID Study Group. Dexamethasone intravitreal implant in combination with laser photocoagulation for the treatment of diffuse diabetic macular edema. Ophthalmology. 2013 Sep;120(9):1843-51. doi: 10.1016/j.ophtha.2013.02.018. Epub 2013 May 22.
Clinical trial NCT01654185: Dimethyldiguanide Combined With Aromatase Inhibitor (AI) in Metastatic Breast Cancer
Official title: Phase II Study of Dimethyldiguanide Combined With AI Compared to AI in Postmenopausal HR(+) Metastatic Breast Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Breast Cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2012-07-31
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The addition of dimethyldiguanide might increase the efficacy of AI treatment in metastatic breast cancer.

Detailed description: The addition of dimethyldiguanide might increase the efficacy of AI in patients with metastatic breast cancer after the failure of the first line endocrine therapy.

Eligibility criteria: Inclusion Criteria:

* postmenopausal HR positive breast cancer patients;
* inoperable locally advanced or metastatic breast cancer patients;
* candidate for endocrine therapy;
* ECOG equal to or less than 1;
* adequate bone marrow function(Hb\>=90g/L, WBC \>=3.5×10\^9/L,ANC\>=1.5×10\^9/L, PLT\>=80×10\^9/L; adequate renal function(Ccr\<=ULN);adequate liver function(ALT,AST,AKP\<=2.5\*ULN,or \<=5\*ULN if liver metastases)
* life expectancy \>=12weeks;
* no severe history disease of liver,heart,lung or kidney;
* written informed consent form;

Exclusion Criteria:

* Her-2 overexpression;
* patients who has visceral endocrisis；

Primary outcomes:
measure: progression free survival
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Cancer Hospital
Study officials:
affiliation: Fudan University
name: Xichun Hu, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00891085: Synchronized Intermittent Mechanical Ventilation Versus Open Lung Ventilation With Spontaneous Respiration
Official title: Synchronized Intermittent Mechanical Ventilation vs Open Lung Ventilation With Spontaneous Respiration
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Trauma
Keywords: ventilation
ards
ali
trauma
Trauma Patients with ISS > 25
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2009-04-30
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult Trauma Patients with ISS\>/=25

Brief summary: The purpose of this study is to collect data on patients who are on breathing machines (ventilators) in the Trauma Surgical Intensive Care Unit (TSICU). This data may help us to determine if one form of assisted breathing is better than another. The two forms of assisted breathing being compared in this study are called BiVent and SIMV. (7) BiVent and SIMV are both delivered by a ventilator but differ in how they assist breathing. SIMV is an older form of mechanical breathing that blows air into the lungs to inflate the lungs. BiVent is a newer form of mechanical ventilation that permits the patient to pull air into the lungs as we normally do. Both BiVent and SIMV are currently being used on a regular basis in the TSICU. The investigators hope that this study will determine if one method of assisted breathing is better than another in preventing complications associated with mechanically assisted breathing.

Detailed description: SOLV Hypothesis:

A prospective, randomized trial directly comparing open lung ventilation (OLV) with spontaneous breathing (SB) utilizing BiVent on the Maquet Servo-I versus synchronized intermittent mechanical ventilation (SIMV) will be conducted in the trauma-surgical intensive care unit at the University Hospital (TSICU). Both OLV-SB and SIMV protocols have been designed according to lung protective strategies. The primary goal of the SOLV trial is to see determine if the early application of open lung ventilation will less ventilator days. In addition, several secondary endpoints will be evaluated. It is not anticipated that this study will be powered to show a mortality difference.

Eligibility criteria: Inclusion Criteria:

* \>/=18 years of age, ISS \>/=25, on ventilator for more than 48 hours

Exclusion Criteria:

* less than 18 years of age, die or come off ventilator in less than 48 hours

Primary outcomes:
measure: Reduction in ventilator days
timeFrame: 4 years
Secondary outcomes:
measure: Progression to acute lung injury/acute respiratory distress syndrome (ALI/ARDS)
timeFrame: 4 years
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico Hospital
state: New Mexico
Study officials:
References:
Clinical trial NCT00932685: Does Distraction With a Hand Held Video Game Reduce Preoperative and Emergence Anxiety in Children?
Official title: Is Preoperative Distraction With a Hand Held Video Game Boy as Effective as Midazolam in Reducing Preoperative Anxiety Levels in Children as Weel as Emergence Agitation?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Emergence Agitation and Pain
Keywords: pediatric emergence agitation and pain
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: Nintendo of North America
First posted: 2009-07-03
Enrollment: 119
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Preoperative anxiety is characterized by subjective feelings of tension, apprehension, nervousness and worry. In children, preoperative anxiety is reported to result in postoperative negative psychological effects, including nightmares, eating problems and increased fear of doctors. Previous studies have assessed anxiety in children during the preoperative period and the effects of premedication and parental presence. Midazolzam has been shown to reduce preoperative anxiety in children but post operative recovery maybe delayed for children undergoing a short operative procedure. Distraction may be particularly helpful in children ages 6-12 as these children are curious about their environment. An association between preoperative anxiety and emergence agitation has been suggested. Emergence agitation in children is not well understood but is a frightening experience for child and parent. A previous study demonstrated the efficacy of hand held video games used as an interactive distraction to allay preoperative anxiety. The purpose of this study is to treat preop anxiety with premedication, or video game and to evaluate the impact of these interventions on the incidence and severity of emergence agitation.


Eligibility criteria: Inclusion Criteria:

* ASA rating of I-II Mask induction of General Anesthesia

Exclusion Criteria:

* Emergency surgery Children who have developmental disabilities or chronic illness Children who have had repetitive surgeries Children who have excessive anxiety attacks or who are currently on benzopaines

Primary outcomes:
measure: postoperative pain
timeFrame: on arrival in PACU, at 10 min, at 30 min and 10 minutes prior to discharge
Secondary outcomes:
measure: emergence agitation
timeFrame: on arrival, at 5 minutes and every 10 min for one hour in PACU
Other outcomes:
Locations:
city: Newark
country: United States
facility: University Hospital
state: New Jersey
Study officials:
affiliation: Rutgers, The State University of New Jersey
name: Anuradha Patel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06039085: Microendoscopic EI Sensing for Real-time Intraoperative Surgical Margin Assessment
Official title: Microendoscopic Electrical Impedance Sensing for Real-time Intraoperative Surgical Margin Assessment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer
Keywords: Impedance
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: Dartmouth College
First posted: 2023-09-15
Enrollment: 200
Sex: MALE
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: Men with a diagnosis of prostate cancer who require surgery.

Brief summary: This research will study a custom device developed to detect if any prostate cancer tissue is left behind when the prostate is removed. This device is called an Electrical Impedance Imaging (EII) probe.

Detailed description: Two hundred men will be recruited to participate in this trial. Consent will be obtained from all participating men prior to surgery.

The trial will consist of recording EII data from:

1. In vivo pelvic floor and peri-prostatic tissues remaining after the prostate has been resected
2. Resected ex vivo prostate following extraction from the abdomen (in the OR)
3. Resected ex vivo prostate when transferred to Pathology, post-RARP

The study team will also track post-surgical complications due to the study's technology (e.g., infection) and additional time required to deploy the study technology used to assess feasibility of clinical integration of the EII device. Post-RARP pathological assessment of margin tissues will be used to train and evaluate the study's classification schemes for identifying Positive Surgical Margin (PSMs).

Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of prostate cancer requiring RARP.
2. Ability to understand and the willingness to sign a written informed consent document.
3. Age ≥ 18 years old

Exclusion Criteria:

1. Adults with implanted electrical devices such as pacemakers
2. Prisoners
3. Adults with impaired decision-making capacity
4. Any condition for which, in the opinion of the investigator, contraindicates study participation.

Primary outcomes:
measure: Electrical impedance difference between positive and negative surgical margins
timeFrame: 2023-2025
Secondary outcomes:
measure: Safety of EI sensing in vivo electrical sensing
timeFrame: 2023-2025
measure: Efficacy of EI sensing in vivo electrical sensing
timeFrame: 2023-2025
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock, Manchester
name: Ryan J Halter, PhD
role: PRINCIPAL_INVESTIGATOR
References: