louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01265108: Effects of Iron on Exercise Capacity During Hypoxia
Official title: Effects of Intravenous Iron Supplementation on Exercise Capacity During Sustained Alveolar Hypoxia in Healthy Humans.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: University of Oxford
Sponsor class: OTHER
First posted: 2010-12-22
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: During alveolar hypoxia, for example at high altitude or in patients with respiratory disease, there is evidence to suggest that hypoxia-induced pulmonary hypertension might limit exercise performance. Intravenous iron supplementation has recently been shown to reverse pulmonary hypertension in healthy humans at high altitude, and to prevent pulmonary hypertension in volunteers exposed to hypoxia at sea level. The investigators hypothesized that intravenous iron supplementation would enhance exercise capacity during alveolar hypoxia.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 60 years
* Sea level natives with no recent exposure to high altitude
* Baseline iron indices within the normal range
* Detectable tricuspid regurgitation on echocardiography

Exclusion Criteria:

* Significant cardiorespiratory disease
* Known susceptibility to high altitude-related illness
* Taking medications or iron supplementation
* Pregnancy

Primary outcomes:
measure: Maximal exercise capacity during hypoxia, assessed by maximal oxygen consumption.
timeFrame: After 8-h exposure to alveolar hypoxia.
Secondary outcomes:
measure: Maximal exercise capacity, assessed by peak power output.
timeFrame: After 8-h exposure to alveolar hypoxia.
measure: Pulmonary artery systolic pressure.
timeFrame: After 8-h exposure to alveolar hypoxia.
measure: Blood levels of oxygen-regulated proteins.
timeFrame: After 8-h exposure to alveolar hypoxia
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Department of Physiology, Anatomy & Genetics, University of Oxford
Study officials:
affiliation: University of Oxford
name: Nick P Talbot, DPhil MRCP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01669408: Prehospital COOLing 1 (PreCOOL 1)
Official title: A Randomized Controlled Trial Evaluating Cold Infusions for Prehospital Induction of Cooling in Awake Stroke Patients (PreCOOL 1)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Stroke
Keywords: ischemic stroke
hemorrhagic stroke
prehospital cooling
induction of cooling
ambulance
emergency room
cold infusions
hypothermia
normothermia
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
First posted: 2012-08-21
Enrollment: 40
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: Elevated body temperature was shown to be associated with worse outcome in acute stroke patients. PreCOOL 1 aims to investigate efficacy, feasibility and safety of prehospital cooling with cold infusions in stroke patients.


Eligibility criteria: Inclusion Criteria:

* Suspected stroke
* Symptom onset ≤ 7 days
* Tympanic temperature ≥ 36.7°C
* Informed consent by the patient
* Age ≥ 18 years

Exclusion Criteria:

* Severe cardiac insufficiency (NYHA ≥ III)
* New anisocoria, severe nausea, vomiting or headache
* High-grade heart valve stenosis or insufficiency
* Acute pulmonary embolism
* Acute myocardial infarction
* Threatening ventricular dysrhythmia
* Known hematologic disease with increased risk of thrombosis (e.g. cryoglobulinemia, cold agglutinins, sickle cell anemia)
* Known vasospastic vascular disorder (e.g. Raynaud's phenomenon or thromboangiitis obliterans)
* Severe renal insufficiency with reduced diuresis
* Pregnancy

Primary outcomes:
measure: Tympanic Temperature
timeFrame: from randomization (prehospital) until arrival in the ER, an expected average of 45min
Secondary outcomes:
measure: Efficacy
timeFrame: single measurement at arrival in the ER
measure: Vital parameters
timeFrame: from randomization (prehospital) until arrival in the ER, an expected average of 45min
measure: Tolerability
timeFrame: from randomization (prehospital) until arrival in the ER, an expected average of 45min
measure: Safety
timeFrame: from randomization (prehospital) until first neuroimaging (ER), an expected average of 80min
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Rescue service, Dept. of Anesthesiology, University Hospital Heidelberg
Study officials:
affiliation: University Hospital Heidelberg
name: Sven Poli, Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Heidelberg
name: Erik Popp, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01071408: Trial of a Secondary Stroke Prevention Program
Official title: Development of a Stroke Prevention Program for an Underserved Minority Community
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Stroke
Transient Ischemic Attack
Keywords: chronic care model
stroke prevention
health services research
Lead sponsor: Sepulveda Research Corporation
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2010-02-19
Enrollment: 54
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether an outpatient program can reduce the risk of recurrent stroke.

Detailed description: Stroke is a major cause of death and disability. A history of stroke is the strongest predictor of a future stroke. Control of risk factors lowers the risk of future stroke, yet most persons with stroke do not have their risk factors controlled.

In this randomized-controlled trial, we will test whether an outpatient stroke prevention program consisting of group clinics, patient self-management, and telephone care coordination can lower the risk of recurrent stroke by improving patient knowledge, medication adherence, and lifestyle habits. If successful, this program may be adapted to other settings.

Eligibility criteria: Inclusion Criteria:

* ischemic stroke within the past 30 days
* transient ischemic attack within the past 30 days
* person receiving care at VA Long Beach Healthcare System

Exclusion Criteria:

* unable to understand informed consent
* already enrolled in another research study

Primary outcomes:
measure: Blood pressure control
timeFrame: baseline, 3 months, 7 months
Secondary outcomes:
measure: control of other stroke risk factors including lipids, smoking, and exercise
timeFrame: baseline, 3 months, 7 months
measure: patient perceptions of care quality
timeFrame: baseline, 3 months, 7 months
measure: medication adherence
timeFrame: baseline, 3 months, 7 months
measure: Stroke knowledge
timeFrame: baseline, 3 months, 7 months
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: VA Long Beach Health Care System
state: California
Study officials:
affiliation: VA Long Beach Healthcare System
name: Eric M Cheng, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03319108: Comorbidity and Pulmonary Rehabilitation in COPD
Official title: The Effect of Severity of Co-morbidity on Outcomes of Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Lead sponsor: Izmir Katip Celebi University
Sponsor class: OTHER
First posted: 2017-10-24
Enrollment: 173
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Our aim in this study is to determine the distribution of comorbidity in patients with COPD participating in the pulmonary rehabilitation program and to examine the effect of severity of comorbidy on pulmonary rehabilitation outcomes.

Detailed description: Chronic Obstructive Pulmonary Disease (COPD) is associated not only with respiratory system effects but also with systemic outcomes leading to numerous chronic comorbidities, and it is well known that patients benefit from pulmonary rehabilitation programs. However, the effect of presence of comorbidity on the outcome of pulmonary rehabilitation in patients with COPD is not clear. Therefore, our aim in this study is to determine the distribution of comorbidity in patients with COPD participating in the pulmonary rehabilitation program and to examine the effect of severity of comorbidy on pulmonary rehabilitation outcomes We included a total of 173 patients referred to the Izmir Suat Seren Chest Diseases and Surgery Training and Research Hospital Pulmonary Rehabilitation Unit. Comorbidities were recorded based on self reports. Charlson Comorbid Indexes (CCI) were calculated. Patients who defined at least one comorbidity were divided into two groups according to CCI; 1-3 as Group 1 and 4 and above as Group 2. Six minute walk test, mMRC dyspnea scale, SGRQ Respiratory Disease Questionnaire, respiratory function tests and arterial blood gases performed for assessment of patients before and after 16 sessions of pulmonary rehabilitation program.


Primary outcomes:
measure: Exercise Capacity
timeFrame: 6 minute
Secondary outcomes:
measure: Respiratory Functions
timeFrame: 30 minutes
measure: Dyspnea
timeFrame: 5 minutes
measure: Disease Specific Quality of Life
timeFrame: 20 minutes
measure: Health Related Quality of Life
timeFrame: 20 minutes
Other outcomes:
Locations:
Study officials:
References:
citation: Naz I, Sahin H, Varol Y, Komurcuoglu B. The effect of comorbidity severity on pulmonary rehabilitation outcomes in chronic obstructive pulmonary disease patients. Chron Respir Dis. 2019 Jan-Dec;16:1479972318809472. doi: 10.1177/1479972318809472.
Clinical trial NCT03451708: OKS for the Treatment of Hemispatial Neglect
Official title: Optokinetic Stimulation for the Treatment of Hemispatial Neglect - Safety and Efficacy Studies
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Neglect, Hemispatial
Neglect, Sensory
Neglect, Hemisensory
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
name: National Eye Institute (NEI)
First posted: 2018-03-02
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Hemispatial neglect is a disorder where the patient has difficulty attending to objects and information in the left side of space, which occurs following strokes to the right side of the brain. This project is designed to help us understand how optokinetic stimulation treats the symptoms of hemispatial neglect.


Eligibility criteria: Inclusion Criteria:

* Patients with right hemispheric lesions resulting in hemispatial neglect as confirmed by Behavioral Inattention Test or Center of Cancellation Test

Exclusion Criteria:

* Reduced vision
* Documented vestibular disorder

Primary outcomes:
measure: Change in Hemispatial neglect scores
timeFrame: After 1 hour of OKS
measure: Change in Hemispatial neglect scores
timeFrame: After 1 hour of OKS
measure: Effect of OKS on vision
timeFrame: After 1 hour of OKS
measure: Effect of OKS on vision
timeFrame: After 1 hour of OKS
Secondary outcomes:
measure: Changes in secondary hemispatial neglect scores
timeFrame: After 1 hour of OKS
measure: Changes in secondary hemispatial neglect scores
timeFrame: After 1 hour of OKS
measure: Changes in secondary hemispatial neglect scores
timeFrame: After 1 hour of OKS
measure: Effect of OKS on gait
timeFrame: After 1 hour of OKS
measure: Effect of OKS on gait
timeFrame: After 1 hour of OKS
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Chun Lim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Longley V, Hazelton C, Heal C, Pollock A, Woodward-Nutt K, Mitchell C, Pobric G, Vail A, Bowen A. Non-pharmacological interventions for spatial neglect or inattention following stroke and other non-progressive brain injury. Cochrane Database Syst Rev. 2021 Jul 1;7(7):CD003586. doi: 10.1002/14651858.CD003586.pub4.
Clinical trial NCT00890708: Therapeutic Drug Monitoring of Voriconazole
Official title: Influence of Therapeutic Drug Monitoring of Voriconazole on Incidence of Drug Adverse Reaction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mycoses
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2009-04-30
Enrollment: 110
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether therapeutic drug monitoring of voriconazole is useful in the treatment of invasive fungal infection.

Detailed description: Voriconazole is an anti-fungal agent, which is used in the treatment of invasive fungal infection, especially aspergillosis. The serious side effects of voriconazole include liver function abnormality, encephalopathy, etc. Recently, the several studies showed that the blood level of voriconazole is variable and it is associated with drug side effect and treatment outcome. However, there is no randomized controlled study which proves that therapeutic drug monitoring of voriconazole can improve the clinical outcome in routine clinical practice.

Eligibility criteria: Inclusion Criteria:

* patients who were 16 years of age or older
* receiving voriconazole in order to treat invasive fungal infections or for empirical use

Exclusion Criteria:

* who experienced the serious side effect of voriconazole
* were hypersensitive to azoles
* had an aminotransferase, bilirubin, or alkaline phosphatase level higher than five times the upper limit of normal

Primary outcomes:
measure: side effects
timeFrame: during 3 months
Secondary outcomes:
measure: treatment response to voriconazole
timeFrame: at 3 months
measure: drug discontinuation of adverse events
timeFrame: within 3 month
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Wan Beom Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Park WB, Kim NH, Kim KH, Lee SH, Nam WS, Yoon SH, Song KH, Choe PG, Kim NJ, Jang IJ, Oh MD, Yu KS. The effect of therapeutic drug monitoring on safety and efficacy of voriconazole in invasive fungal infections: a randomized controlled trial. Clin Infect Dis. 2012 Oct;55(8):1080-7. doi: 10.1093/cid/cis599. Epub 2012 Jul 3.
Clinical trial NCT01162408: The Study of Clinical Value of Acute Physiologic and Chronic Health Evaluation (APACHE) Scoring System in Medical Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: APACHE Scoring Systems
Intensive Care Units
Outcome Prediction
Mortality
Keywords: ICU
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2010-07-14
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted between July 2010 and July 2013 to the medical intensive care unit of the First Affiliated Hospital of Sun Yat-sen University in Guangzhou, China.

Brief summary: Objective: To evaluate and compare the outcome predictive power of Acute Physiologic and Chronic Health Evaluation (APACHE) Ⅳ、Ⅲ、Ⅱ scoring systems for intensive ill patients in an independent medical intensive care unit (MICU), and explore the best time point when they can most accurately predict outcome.

Design: Retrospective analysis of medical records. Methods and Materials: Collect data of patients admitted between July 2010 and July 2013 to the medical intensive care unit of the First Affiliated Hospital of Sun Yat-sen University in Guangzhou, China. Patients with an ICU stay less than 4 hours and age less than 16 years were excluded. Calculate the APACHE Ⅳ、Ⅲ、Ⅱ scores and corresponding predictive mortality risks in the first 24 hours of ICU admission and the 3th, 5th, 7th, 14th, 21 th, 28th day or the day of transferred out of ICU or death. The predictive power of each model was assessed through the ratio of observed death rates and predictive death rates (Standardized mortality ratios, SMR), the calibration of observed and predictive death rates and the discriminative ability between survivors and non-survivors. Hosmer-Lemeshow test was employed for assessing the calibration and the discriminative ability was assessed by the area under the receiver operating curve. Compare the predictive power of the three models at different time points and explore the the best time point when they can most accurately predict outcome.


Eligibility criteria: Inclusion Criteria:

* Patients with an ICU stay more than 4 hours and age older than 16 years.

Exclusion Criteria:

* Patients with an ICU stay less than 4 hours and age less than 16 years.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01912508: Preterm Labor Prediction by Cervical Contour in Ultrasound
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Preterm Labor
Keywords: cervical length
cervical curvature
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2013-07-31
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Sampling method: PROBABILITY_SAMPLE
Study population: pregnant women 14-34w

Brief summary: Cervical length is a already known predictor for preterm labor. In this study the investigators want to examining the hypothesis that cervical curvature is also a predictor for preterm labor and that moderate transducer pressure influence cervical length.

study population: 200 consecutive pregnant women between 14-34w, visiting in the ultrasound unit ether for routine screening or because of preterm labor.

During their examination cervical length and curvature measurements will be taken. Another measurement will be taken after applying moderate cervical pressure.

The investigators will compere cervical contour and pressure influence between groups and according to cervical length Demographic data will be taken at the time of recruitment and pregnancy outcome measures in a later telephone interview.


Eligibility criteria: Inclusion Criteria:

* pregnancy

Exclusion Criteria:

* cervical cerclage
* pre term rupture on membrane in current pregnancy
* unknown dating of pregnancy

Primary outcomes:
measure: cervical curvature
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir hospital
Study officials:
References:
Clinical trial NCT00292708: Trial of Antibiotic Prophylaxis in Elective Colorectal Surgery
Official title: Randomized Multicenter Trial of Antibiotic Prophylaxis in Elective Colorectal Surgery: Single-Dose Vs. Three Doses of Second-Generation Cephalosporin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colorectal Surgery
Keywords: Antibiotics
Prophylaxis
Surgical wound infection
Lead sponsor: National Cancer Center, Japan
Sponsor class: OTHER_GOV
First posted: 2006-02-16
Enrollment: 500
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the optimal prophylactic antibiotics administration method in elective colorectal surgery

Detailed description: Use of prophylactic antibiotics in elective colorectal surgery is essential. Although single-dose prophylactic antibiotics are recommended, the efficacy of single-dose cephalosporin without metronidazole and oral antibiotics is not fully proven. We conducted a multicenter randomized trial of single-dose vs. three doses of the second-generation cephalosporin, cefmetazole.

Eligibility criteria: Inclusion Criteria:

* Colorectal diseases (cancer, large polyp, carcinoid, lymphoma,sarcoma and so on)
* Elective colorectal resection

Exclusion Criteria:

* Emergent operation
* Ileus
* No resection
* Preoperative infectious diseases
* Penicillin or cephalosporin allergy
* Antibiotics administration before surgery
* Inflammatory bowel diseases
* Angina or myocardial infarction
* Renal dysfunction
* Diabetes mellitus
* Steroid administration before surgery

Primary outcomes:
measure: Incidence of incisional surgical site infection (SSI)
Secondary outcomes:
measure: Incidences of organ/space SSI and other infectious diseases. Other postoperative complications and postoperative hospital stay
Other outcomes:
Locations:
city: Kanazawa
country: Japan
facility: Ishikawa Prefectural Central Hospital
city: Kashiwa
country: Japan
facility: National Cancer Center East Hospital
city: Nagoya
country: Japan
facility: Nagoya Medical Center
city: Niigata
country: Japan
facility: Niigata Cancer Center Hospital
city: Osaka
country: Japan
facility: Osaka Medical Center for Cancer and Cardiovascular Diseases
city: Tokyo
country: Japan
facility: National Cancer Center Hospital
city: Yamagata
country: Japan
facility: Yamagata Prefectural Central Hospital
Study officials:
affiliation: Japan National Cancer Center Hospital
name: Shin Fujita, MD. PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fujita S, Saito N, Yamada T, Takii Y, Kondo K, Ohue M, Ikeda E, Moriya Y. Randomized, multicenter trial of antibiotic prophylaxis in elective colorectal surgery: single dose vs 3 doses of a second-generation cephalosporin without metronidazole and oral antibiotics. Arch Surg. 2007 Jul;142(7):657-61. doi: 10.1001/archsurg.142.7.657.