louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02120066: Submacular Hemorrhage Associated With Retinal Arterial Macro Aneurysm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Submacular Hemorrhage
Ruptured Retinal Arterial Macro Aneurysms
Keywords: Submacular hemorrhage
Vitrectomy
tissue- plasminogen activator
Lead sponsor: Kyorin University
Sponsor class: OTHER
First posted: 2014-04-22
Enrollment: 22
Sex: ALL
Minimum age (years): 40
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluation of surgical outcome of vitrectomy with subretinal injection of recombinant tissue-plasminogen activator for submacular hemorrhage associated with retinal arterial macroanuerysms.


Eligibility criteria: Inclusion Criteria:

* The patients with sub macular hemorrhage associated with ruptured retinal arterial macro aneurysms

Exclusion Criteria:

* The eyes with preretinal or intraretinal hemorrhage at the fovea
* The patients with follow-up less than 3 months

Primary outcomes:
measure: Displacement of sub macular hemorrhage
timeFrame: one year
Secondary outcomes:
measure: Visual acuity
timeFrame: one year
Other outcomes:
Locations:
city: Mitaka
country: Japan
facility: Kyorin Eye Center
state: Tokyo
Study officials:
References:
Clinical trial NCT02330666: Parent-child Communication and Health-risk Behavior
Official title: Parent-child Communication and Health-risk Behavior
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parent-Child Relations
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Loyola University Chicago
name: Iowa State University
First posted: 2015-01-05
Enrollment: 604
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Engaging in health-risk behaviors such as tobacco and alcohol use put youth at risk for health problems that may compromise their futures and are extremely costly to society. Positive parent-child communication, characterized by openness, satisfaction with the family, caring, and effective problem-solving, has been found to be protective against a youth's involvement in health-risk behaviors. To promote positive adult-youth communication, in earlier work we developed, tested, and found efficacious an intervention, Mission Possible: Parents and Kids Who Listen (MP). This study is designed to test the following hypotheses: (a) Adults and youth who participate in MP will demonstrate more positive communication when compared with adults who did not participate; (b) Youth who participate in MP will have a lower incidence of health-risk behavior when compared with youth who did not participate; and (c) Positive adult-youth communication will mediate childhood health-risk behavior in the presence of risk processes that predict participation. The experimental design is a 2-group (intervention and comparison) pre-test repeated measures design with six waves of data collection over three years and two booster sessions of the intervention. Elementary school and community centers in Madison and Chicago served as recruitment sites for parent-child dyads.


Eligibility criteria: Inclusion Criteria:

* Adults and youth must be English speakers
* Youth must be 10 years old

Exclusion Criteria:

* Severe mental or physical illness that could preclude involvement in data collection procedures
* Family plans to move from the metropolitan areas prior to study completion

Primary outcomes:
measure: Youth Health Risk Behavior
timeFrame: 3 years
Secondary outcomes:
measure: Openness of Communication
timeFrame: 3 years
measure: Family Satisfaction
timeFrame: 3 years
measure: Problem-Solving Skill
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
affiliation: University of Wisconsin, Madison
name: Susan K Riesch, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06068166: Thoracic Epidural Anesthesia Reduces Mortality and Rehospitalization for Patients With Heart Failure With Reduced Ejection Fraction
Official title: Thoracic Epidural Anesthesia Reduces Mortality and Rehospitalization for Patients With Heart Failure With Reduced Ejection Fraction：a Retrospective Matched Case-control Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure With Reduced Ejection Fraction
Thoracic Epidural Anesthesia
Lead sponsor: First Affiliated Hospital of Harbin Medical University
Sponsor class: OTHER
First posted: 2023-10-05
Enrollment: 1840
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Despite significant scientific breakthrough in management, patients with heart failure with reduced ejection fraction (HFrEF) remain high morbidity and mortality, with a 5-year survival rate of 25% after hospitalization for HFrEF. The autonomic nervous system (ANS), particularly the sympathetic nervous system (SNS), plays a critical compensatory role in maintaining cardiovascular homeostasis in the failing heart. This is critical given the huge unmet need for novel treatment strategies for HFrEF.

Thoracic epidural anesthesia (TEA), the infusion of anesthetic agents (eg, lidocaine or ropivacaine) into the epidural space, is used to achieve sympathetic block at the T1 to T4 levels in thoracic and abdominal surgical procedures. Since 1995, Professor Liu Fengqi has pioneered the use of TEA to treat end-stage HFrEF and achieved surprising results. TEA could reduce the enlarged heart cavity, halt and reverse cardiac remodeling, and improve cardiac systolic and diastolic function. Currently, thousands of HFrEF patients have received TEA procedure. However, it is unclear whether TEA could positively impact the clinical outcomes of patients with HFrEF.


Eligibility criteria: Inclusion Criteria:

* The present study was a retrospective, observational, matched case-control study of 1,840 consecutive inpatients, in New York Heart Association functional class II-IV with a left ventricular ejection fraction (LVEF) ≤40%, who were hospitalized from July 2013 to August 2019.

Exclusion Criteria:

* Patients were excluded because of insufficient patient information, refusal to participate, or loss to follow-up by telephone. In patients with multiple hospitalizations during the time period, the first hospitalization was utilized in the analysis.

Primary outcomes:
measure: Rate of heart failure mortality in the patients with HFrEF
timeFrame: 8.5 years
Secondary outcomes:
measure: Rate of heart failure rehospitalization in the patients with HFrEF
timeFrame: 8.5 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00441766: Safety and Efficacy of Oral AGN 203818 for the Relief of Irritable Bowel Syndrome Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Irritable Bowel Syndrome
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2007-03-01
Enrollment: 213
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: This study will explore the safety and effectiveness of different doses of AGN 203818 in relieving Irritable Bowel Syndrome pain. The study is being conducted in 2 parts. Part A enrolled 213 pts dosed with either 3, 20, 60 mg AGN 203818 or placebo over 4 week treatment duration. Part B will enroll 320 pts and dose with either 60, 100, 160 mg BID AGN 203818 or placebo over 12 week treatment duration.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Irritable Bowel Syndrome
* Moderate or severe IBS pain

Exclusion Criteria:

* Any other uncontrolled disease
* Pregnant or nursing females

Primary outcomes:
measure: Change From Baseline in Mean Highest-Average-Pain Score at Week 4
timeFrame: Baseline, Week 4
Secondary outcomes:
measure: Percentage of Patients Who Rated Their Condition as Improved on the Subject Global Impression of Change (SGIC) at Week 4
timeFrame: Week 4
measure: Percentage of Patients Who Experienced Adequate Relief of Irritable Bowel Syndrome (IBS) Pain (AR-IBS) at Week 4
timeFrame: Week 4
measure: Change From Baseline in Frequency of Bowel Movements at Week 4 Using the Bristol Stool Scale (BSS)
timeFrame: Baseline, Week 4
Other outcomes:
Locations:
city: Orange
country: United States
state: California
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00335426: Influence of Spinal Manipulative Therapy Upon Stroop Task Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Motor Response Time
Lead sponsor: Logan College of Chiropractic
Sponsor class: OTHER
First posted: 2006-06-09
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if spinal manipulative therapy can affect cognitive processing as determined by performance on a Stroop task. It is specifically hypothesized that number of errors and response times will decrease as a result of spinal manipulative therapy.


Eligibility criteria: Inclusion Criteria:

Normal healthy

Exclusion Criteria:

No spinal manipulation one week proceeding trial No stimulants or depressants

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chesterfield
country: United States
facility: Logan College of Chiropractic
state: Missouri
Study officials:
affiliation: Logan College of Chiropractic
name: Kristan J Giggey, DC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00417326: Controlled Study of ONO-5046Na in Patients With Acute Respiratory Failure Associated With Community-Acquired Pneumonia
Official title: ONO-5046Na Phase II Study - A Pilot Study for Patients With Acute Respiratory Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Community-acquired Pneumonia
Keywords: ONO-5046Na
acute respiratory failure
community-acquired pneumonia
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2007-01-01
Enrollment: 174
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
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 determine the safety and efficacy of ONO-5046Na in patients with acute respiratory failure associated with community-acquired pneumonia


Eligibility criteria: Inclusion Criteria:

* Patients with community-acquired pneumonia
* Patients with acute respiratory failure

Exclusion Criteria:

* Patients with nosocomial pneumonia
* Patients on mechanical ventilation

Primary outcomes:
measure: pulmonary function
timeFrame: 14 days
Secondary outcomes:
measure: mortality
timeFrame: 28 days
measure: ventilator status
timeFrame: 28 days
Other outcomes:
Locations:
city: Chubu
country: Japan
facility: Chubu Region
city: Chugoku
country: Japan
facility: Chugoku Region
city: Hokkaido
country: Japan
facility: Hokkaido Region
city: Hokuriku
country: Japan
facility: Hokuriku Region
city: Kanto
country: Japan
facility: Kanto Region
city: Kinki
country: Japan
facility: Kinki Region
city: Kyushu
country: Japan
facility: Kyushu Region
city: Shikoku
country: Japan
facility: Shikoku Region
city: Tohuku
country: Japan
facility: Tohoku Region
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Koji Takehara
role: STUDY_DIRECTOR
References:
Clinical trial NCT01398826: Glycemic Response to Road Cycling in Type 1 Diabetes
Official title: A Pilot Study Assessing the Glycemic Response and Its Relationship to Performance During Road Cycling in Elite Athletes With Type 1 Diabetes and Non-Diabetic Controls
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type 1 Diabetes
Keywords: Type 1 Diabetes
Exercise
Continuous glucose monitoring
Lead sponsor: Team Type 1, Inc.
Sponsor class: OTHER
First posted: 2011-07-21
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Professional cyclists on TeamType 1 cycling teams

Brief summary: The purpose of this study is to assess the glycemic response to cycling road races (using continuous glucose monitoring ) in elite athletes with type 1 diabetes and non-diabetic controls. The investigators will also assess the relationship between power/work during cycling (using a power meter) and the subject's glucose profile.


Eligibility criteria: Inclusion Criteria:

* ≥18 years of age
* A1C ≤8.0% if diagnosed with type 1 DM

Exclusion Criteria:

* If diagnosed with type 1 diabetes, has had recurrent severe hypoglycemia (greater than 2 episodes in previous 6 months requiring assistance by a third party)
* Has any medical condition or medical history that may affect successful completion of the study and/or personal well-being (as assessed by the PI)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Team Type 1, Inc.
name: Juan P Frias, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01531426: Cerebral Oxygenation in Cardiac Arrest and Hypothermia
Official title: Cerebral Oxygen Saturation as Outcome Predictor in Cardiac Arrest Patients Undergoing Mild Therapeutic Hypothermia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Arrest
Keywords: resuscitation
hypothermia
outcome
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Medtronic - MITG
First posted: 2012-02-13
Enrollment: 94
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: Patients after cardiac arrest

Brief summary: Data indicate that neurological prognostication is difficult after cardiac arrest if mild therapeutic hypothermia is part of the post resuscitation care. Cerebral oxygenation detected by near-infrared spectroscopy, could be a new, non-invasive index marker for outcome assessment after cardiac arrest. The investigators hypothesize that cardiac arrest survivors with a continuously low cerebral oxygenation index have a poor prognosis.

Detailed description: The measurement of cerebral oxygen saturation by a non-invasive near-infrared monitor, INVOS® (In-Vivo Optical Spectroscopy; Covidien) can detect changes in oxygen levels reflecting regional blood oxygen saturation of the brain tissue beneath the sensor. If this monitoring can add further information towards reliable prognostication after cardiac arrest is unknown so far.

Eligibility criteria: Inclusion Criteria:

* over 18 years

Exclusion Criteria:

* under 18 years

Primary outcomes:
measure: neurological outcome (death; CPC: 5)
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 3-6 weeks
Secondary outcomes:
measure: neurological outcome CPC 1-5
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 3-6 weeks and a 12 month follow up will be performed
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Universitätsmedizin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Christian Storm, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01610726: Economic and Clinical Evaluation of Enhanced Recovery in Colorectal Surgery
Official title: Economic and Clinical Evaluation of Enhanced Recovery in Colorectal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonic Diseases
Keywords: colon
rectum
recovery
surgery
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
First posted: 2012-06-04
Enrollment: 484
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 health cost and clinical outcome by introducing enhanced recovery (ERAS) compared to conventional recovery in colorectal surgery.

Detailed description: Aim of the sudy:

1. Clinical evaluation: To investigate if patients treated with enhanced recovery have a shorter hospital stay and less morbidity than the patients treated conventionally. Other clinical questions witch might be answered in this study are clinical surgical stress response (insulin resistent), amount of analgetics used and time to normal activity.
2. Evaluation of quality of life: Instruments used in this sudy to evaluate quality of life are 15 D and qualitative interview.
3. Economic evaluation: Cost-utility analysis of the clinical studies
4. Compare patients who received a fast track program with dedicated fast track- and stoma nurse specialist and special focus on counselling and stoma education, compared with patients receiving existing current practice of stoma-education in a traditional care pathway, could reduce the length of hospital stay, readmission and stoma related complications
5. Further we will tray to generate additional insights into the impact of counselling when groups of patients are otherwise equal in terms of fast-track criteria. We are therefore continuing the enrolling of our colorectal patients in which both study arms contain the same ERAS items; the arms will only differ in terms of perioperative information and guidance as well as follow-up by dedicated nurses.

Eligibility criteria: Inclusion Criteria:

* Planed elective colorectal surgery, written consent and age above 18 years

Exclusion Criteria:

* Patients below 18 years, pregnancy, surgical emergency and no informed consent

Primary outcomes:
measure: Length of stay
timeFrame: 30 days
Secondary outcomes:
measure: Morbidity
timeFrame: 30 days
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Helse Bergen, Haukeland University Hospital
Study officials:
affiliation: Helse Bergen, Haukeland University Hospital
name: Christian Erichsen, PhD
role: STUDY_CHAIR
affiliation: Helse Bergen, Haukeland University Hospital
name: Håvard Forsmo, MD
role: STUDY_CHAIR
References:
citation: Forsmo HM, Erichsen C, Rasdal A, Tvinnereim JM, Korner H, Pfeffer F. Randomized Controlled Trial of Extended Perioperative Counseling in Enhanced Recovery After Colorectal Surgery. Dis Colon Rectum. 2018 Jun;61(6):724-732. doi: 10.1097/DCR.0000000000001007.
Clinical trial NCT00874926: EFFEKT - Efficacy and Safety of Long-term Treatment With KOGENATE Bayer/FS
Official title: Efficacy and Safety of Long-term Treatment With KOGENATE Bayer/FS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemophilia A
Keywords: Octocog alfa
Haemophilia A
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-04-03
Enrollment: 405
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Haemophilia A patients, no specific study population

Brief summary: The aim of this international prospective, non-interventional post-marketing surveillance study is to obtain data on treatment procedures, long-term safety and efficacy and patient acceptance of KOGENATE Bayer in treatment of patients with haemophilia A under daily-life treatment conditions.


Eligibility criteria: Inclusion Criteria:

* Patients with diagnosis of haemophilia A, treated with KOGENATE Bayer/FS as their only source of FVIII, decision taken by the investigator to administer KOGENATE Bayer/FS. For pretreated patients with more than 100 exposure days an inhibitor assessment within three months prior to enrollment should be available; for pretreated patients with less than 100 exposure days an inhibitor assessment at baseline should be available.

Exclusion Criteria:

* Exclusion criteria must be read in conjunction with the local product information.

Primary outcomes:
measure: Efficacy and Safety of Kogenate Bayer/FS
timeFrame: After 12 months, after 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Many Locations
country: Bahrain
city: Many Locations
country: Bosnia and Herzegovina
city: Many Locations
country: Croatia
city: Many Locations
country: Germany
city: Many Locations
country: Israel
city: Many Locations
country: Kazakhstan
city: Many Locations
country: Kuwait
city: Many Locations
country: Libyan Arab Jamahiriya
city: Many Locations
country: Morocco
city: Many Locations
country: Oman
city: Many Locations
country: Qatar
city: Many Locations
country: Romania
city: Many Locations
country: Russian Federation
city: Many Locations
country: Saudi Arabia
city: Many Locations
country: Slovenia
city: Many Locations
country: Tunisia
city: Many Locations
country: United Arab Emirates
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03530826: A Crowd Sourcing Platform for Patients With Cancer
Official title: A Crowd Sourcing Platform for Patients With Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Lead sponsor: All4Cure
Sponsor class: INDUSTRY
First posted: 2018-05-21
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult cancer patients

Brief summary: All4Cure aims to accelerate learning about cancer by sharing medical information and research results from cancer patients with fellow cancer patients, oncologists, and scientists on the All4Cure website with the hope that together patients, clinicians and researchers can cure cancer faster.

Detailed description: The core hypothesis tested by this study is that engaging researchers, clinicians and patients in an online knowledge sharing platform will enable patients to better understand cancer, better inform treatment decisions made by oncologists and accelerate cancer research. Leftover samples from patients with cancer (blood, bodily fluids and/or tissues collected for clinical purposes) will be obtained and sent for various types of analyses and results will be shared on the All4Cure website.

Eligibility criteria: Inclusion Criteria:

* Have been diagnosed with cancer.
* Be under the care of a physician.
* Be 18 years of age or older.

Exclusion Criteria:

Primary outcomes:
measure: Change in tumor tissue molecular profiles
timeFrame: 6 years
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: All4Cure
state: Washington
Study officials:
affiliation: All4Cure
name: Carl A Blau, MD
role: PRINCIPAL_INVESTIGATOR
References: