louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00256581: Imaging Studies With GE C-Hawk Gamma Camera Compared to Routine Clinical Exam
Official title: Imaging Studies With GE C-Hawk Gamma Camera Compared to Routine Clinical Exam
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Chest Pain
Keywords: myocardial perfusion
Imaging
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: General Electric
First posted: 2005-11-21
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults undergoing SPECT Myocardial perfusion imaging

Brief summary: Comparison study of myocardial perfusion SPECT imaging with current clinical use camera and new camera.

Detailed description: Comparison study of myocardial perfusion SPECT imaging with current clinical use camera and new camera.

Eligibility criteria: Inclusion Criteria:

* Referral for cardiac stress testing with SPECT myocardial perfusion imaging

Exclusion Criteria:

* refusal to provide written informed consent or lack capacity to provide informed consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: UW Health
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Charles Hellman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01059981: Analysis of Emergency Department (ED) Volumes During Natural Disasters
Official title: Analysis of Emergency Department Volumes During Natural Disasters
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dialysis
Trauma Related Injuries
Carbon Monoxide Poisoning
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2010-02-01
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Three populations: Dialsysis patients, trauma patients, and patients experiencing carbon monoxide poisonings during natural disasters.

Brief summary: The 'Analysis of Emergency Department Volumes during Natural Disasters' retrospective study focuses on three specified populations including dialysis patients, trauma patients, and patients poisoned by carbon monoxide. These three populations have one commonality - hurricanes, ie. natural disasters, which is the exposure. Causal associations and significant correlations will be explored in all three subgroups.


Eligibility criteria: Inclusion Criteria:

* Patients with carbon monoxide poisoning in addition to trauma and dialysis patients admitted to the Memorial Hermann Health System's (MHHS) Emergency Department (ED) 1 week pre- and post-Hurricane Ike's landfall to the City of Houston, which was September 12, 2008.

Exclusion Criteria:

* Patients with the specified conditions that were not admitted during the time interval allotted.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Memorial Hermann Hospital - Medical Center
state: Texas
city: Houston
country: United States
facility: University of TX Health Science Center, Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: James J McCarthy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04107181: Pilot Study for Speculum Free Cervical Cancer Screening
Official title: A Pilot Study Continuation to Assess the Use of an Introducer "Calla" During Cervical Cancer Screening
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cervical Cancer
Keywords: Pap smear
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Korle-Bu Teaching Hospital, Accra, Ghana
name: National Cancer Institute (NCI)
First posted: 2019-09-27
Enrollment: 305
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The objective of the work described in this protocol is to determine the optical signatures of cervical dysplasia using optical technologies.

Detailed description: This project is to assess if the introducer, "calla", can be used in place of a speculum during a routine Pap smear. For the patient arm, the introducer will be used in conjunction with standard of care procedures. The healthy volunteer arm will include taking the introducer home for a week to determine if each person can find their cervix without the help of a physician. As well as completing surveys on ease of use and demographics related to their medial history.

Eligibility criteria: Inclusion Criteria:

Healthy female

* Aged 21-65 years
* Have had a pelvic exam
* Have conversational proficiency in English
* Highest level of education attained

Exclusion Criteria:

- Pregnant women

Primary outcomes:
measure: Assessment of introducer
timeFrame: Up to 1 week (at time of pap smear for patients and up to 1 week for healthy volunteers)
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke
name: Nimmi Ramanujam, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04095481: Obalon Navigation/Touch System Post-Approval Study
Official title: Obalon Navigation/Touch System Post-Approval Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity
Lead sponsor: Obalon Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2019-09-19
Enrollment: 1600
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients 22 years and older with a starting therapy BMI of 30.0-40.0 kg/m2 and who commercially purchased the Obalon Balloon device.

Brief summary: Post-approval study for the Obalon Navigation/Touch System (NTS)

Detailed description: The Obalon NTS PAS is a prospective, observational, open-label and multi-center study with an objective to collect continued safety and performance of the Obalon NTS in a commercial setting and confirm results observed in the supplemental PMA IDE study.

Eligibility criteria: Inclusion Criteria:

1. Ages 22 years and older
2. Starting or current therapy BMI of 30.0-40.0 kg/m2
3. Commercially purchased the Obalon Balloon Device

Exclusion Criteria:

1. Known history of structural or functional disorders of the esophagus that may impede passage of the device through the gastrointestinal tract or increase risk of esophageal damage during an endoscopic removal procedure, including, Barrett's esophagus, esophagitis, dysphagia, achalasia, stricture/stenosis, esophageal varices, esophageal diverticula, esophageal perforation or any other disorder of the esophagus.
2. Known history of structural or functional disorder of the esophagus, including any swallowing disorder, esophageal chest pain disorders, or drug refractory esophageal reflux symptoms.
3. Known history of structural or functional disorders of the stomach including, gastroparesis, gastric ulcer, chronic gastritis, gastric varices, hiatal hernia (\> 2 cm), cancer or any other disorder of the stomach.
4. Active implantable devices, such as a pacemaker of defibrillator, or with metal implants in the thoracic region.

Primary outcomes:
measure: Esophageal Inflation
timeFrame: Up to 20 Weeks
measure: System Success
timeFrame: Up to 20 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Flower Mound
country: United States
facility: Ultimate Bariatrics - Flower Mound
state: Texas
city: Fort Worth
country: United States
facility: Ultimate Bariatrics - Fort Worth
state: Texas
Study officials:
References:
Clinical trial NCT05760781: To Evaluate the Safety and Efficacy of STSG-0002 Injection in Patients With Chronic Hepatitis B
Official title: Phase Ib/II: Multicenter, Open, Dose-escalation Evaluation of the Safety and Efficacy of STSG-0002 Injection in Patients With Chronic Hepatitis B Treated With Oral Antiviral Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Chronic Hepatitis b
Lead sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Beijing Sanuo Jiayi Biotechnology Co. LTD
First posted: 2023-03-08
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This trial is a multi-center, open, single-dose, dose-increasing trial，to evaluate the safety and efficacy of STSG-0002 injection in patients with chronic hepatitis B treated with oral antiviral therapy.


Eligibility criteria: Inclusion Criteria:

* Patients with chronic HBV；
* Receiving anti-HB viral therapy;
* 10 IU/ml≤HBsAg≤3000 IU/ml.

Exclusion Criteria:

* Patients co-infected with hepatitis C virus, HIV, HAV, HDV, HEV;
* Liver cirrhosis;
* Hepatocellular carcinoma;
* Autoimmune liver disease;
* Clinical hepatic decompensation;
* Fibroscan\>12 kPa;
* a. hemoglobin\<110g/L（female）\<120 g/L（male），platelet\<ULN，white blood cell\<2.5×109/L；b. bilirubin\>1.5 ×ULN，ALT\>2 × ULN，serum albumin\<35 g/L；c. INR\>1.5；d. serum creatinine \>1.5×ULN.

Primary outcomes:
measure: Number of subjects of adverse events
timeFrame: Baseline to Day 180
measure: Number of subjects With Significant Abnormal Physical Examination
timeFrame: Baseline to Day 180
measure: Number of subjects of Significant Abnormal Vital Signs Findings
timeFrame: Baseline to Day 180
measure: Number of Participants With Significant Abnormal Laboratory Values
timeFrame: Baseline to Day 180
measure: Number of subjects With Significant Abnormal Electrocardiography (ECG) Findings
timeFrame: Baseline to Day 180
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Youan Hospital,Capital Medical
state: Beijing
city: Chongqing
country: China
facility: The Second Affiliated Hospital of Chongqing Medical
state: Chongqing
Study officials:
affiliation: Peking University First Hospital
name: Guiqiang Wang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03406481: The Impact of Preoperative Fasting Period on Cardiac Index Variability After Anesthesia Induction in Pediatric Patients
Official title: The Impact of Preoperative Fasting Period on Cardiac Index Variability After Anesthesia Induction in Pediatric Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fasting Period
Intravascular Volume
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2018-01-23
Enrollment: 85
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pediatric patients undergoing surgery

Brief summary: The minimum period of fasting recommended by the 'American Society of Anesthesiologists' for the preoperative period is 6 hours for solid foods and 2 hours for clear liquids. Knowing the effect of preoperative fasting time on intravascular volume status may lead us to determine the amount of fluid to be administered intraoperatively. Cardiac preload static indicators are often insufficient to predict the need for fluid and are often measured by invasive methods. Knowing the adequacy of the preload is important in anesthesia practice; there is no hemodynamic benefit of fluid replacement in non-responsive patients. In this study, the investigators aimed to determine the effect of preoperative fasting period on cardiac index change after anesthesia induction in pediatric patients aged 5-12 years. The primary implication of this study is to determine the fasting period of fluid evacuation by assessing patients' intravascular volume status.


Eligibility criteria: Inclusion Criteria: pediatric patients, aged between 5 to 12, undergoing surgery -

Exclusion Criteria: any comorbidity

-

Primary outcomes:
measure: the relationship between fasting period duration and fluid responsiveness
timeFrame: March 2018
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University
Study officials:
References:
Clinical trial NCT03396081: Efficacy of PRADO Heart Failure in Occitania
Official title: Efficacy of PRADO Heart Failure in Occitania
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Heart Failure
Care pathway
Transition program
Efficiency
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2018-01-10
Enrollment: 404
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Patients with heart failure (IC), after hospitalization, have a marked fragility: in France, in the first year, 29% die and 45% are readmitted to IC. Interventions improving the coordination of care providers at the time of discharge from hospitalization were tested; they showed a reduction in readmissions for IC (relative risk (RR) from 0.51 to 0.74) and all-cause mortality (RR 0.75 to 0.87). The Patient Return Program IC (PRADO IC), set up by the Health Insurance, offers assistance in the initiation of outpatient medical monitoring, and a nursing follow-up of 2 to 6 months depending on the patient's severity. The trial of PRADO began in the second half of 2013, and the first evaluation showed that the time to first treatment was significantly shorter, and that the readmissions rate and the 6-month death rate were unchanged.

This study was of epidemiological type, comparative before-elsewhere. The difficulty of controlling for confounders in this type of study limits the scope of these conclusions. The efficacy hypothesis of PRADO IC is therefore always posed in the French context


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Hospitalization for heart failure
* Subject living at home
* Informed consent

Exclusion criteria:

* discharge to a rehabilitation clinic or to medical home for elderly people
* subject without health insurance
* terminal kidney failure
* programmed heart surgery
* waiting for heart transplantation
* psycho-cognitive impairment
* patient not autonomous for mobility at home
* supportive care
* planned move to medical home for elderly people in the coming 6 months
* no fluent french
* not able to provide informed consent
* participating to other study

Primary outcomes:
measure: Cost-efficacy ratio
timeFrame: 12 months
Secondary outcomes:
measure: Cost-utility ratio
timeFrame: 12 months
measure: Number of hospitalization for heart failure
timeFrame: 12 months
measure: Number of all causes hospitalization
timeFrame: 12 months
measure: Rate of death from cardiovascular disease
timeFrame: 12 months
measure: Number of general practitionner
timeFrame: 12 months
measure: Number of cardiologist visits
timeFrame: 12 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHU Montpellier
Study officials:
References:
Clinical trial NCT00902681: A Bioequivalence Study Of 8 Mg Fesoterodine Extended-Release Tablets (Toviaz™) In Healthy Subjects
Official title: An Open-Label, Randomized, Single-Dose, Two-Way Crossover Bioequivalence Study Of 8 Mg Fesoterodine Extended-Release Tablets (Toviaz™), Manufactured At Zwickau Versus Vega Baja, In Healthy Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Treatment of Overactive Bladder
Keywords: Bioequivalence, Pharmacokinetics
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-05-15
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This bioequivalence (BE) study is to satisfy FDA regulatory requirements for extended releases drug product transfer from Zwickau, Germany to Vega Baja, Puerto-Rico.


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2

Exclusion Criteria:

* Subjects with evidence or history of clinically significant urologic diseases
* A positive urine drug screen
* Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method

Primary outcomes:
measure: AUCinf, AUClast, and Cmax of 5-HMT
timeFrame: 6 weeks
Secondary outcomes:
measure: Tmax and half-life of 5-HMT as data permit.
timeFrame: 6 weeks
measure: Safety laboratory tests and adverse events
timeFrame: 6 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00564681: Study to Evaluate Safety, Efficacy of Botulinum Toxin Type A in Patients With Cervical Dystonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cervical Dystonia
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2007-11-28
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study is to investigate the use of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) scale in a cervical dystonia population treated with botulinum toxin type A, and placebo.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of cervical dystonia

Exclusion Criteria:

* Current or previous botulinum toxin treatment of any type for any condition

Primary outcomes:
measure: Change From Baseline in Observed Total Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Score at Week 4 of Treatment Cycle 1
timeFrame: Baseline, Week 4
Secondary outcomes:
measure: Physician's Global Assessment of Response to Treatment at Week 4 of Treatment Cycle 1
timeFrame: Week 4
measure: Patient's Global Assessment of Response to Treatment at Week 4 of Treatment Cycle 1
timeFrame: Week 4
measure: Change From Baseline in Pain as Evaluated With the TWSTRS Pain Subscale at Week 4 of Treatment Cycle 1
timeFrame: Baseline, Week 4
measure: Duration of Treatment Effect for Treatment Responders
timeFrame: Up to 6 Months
Other outcomes:
Locations:
city: Winston-Salem
country: United States
state: North Carolina
city: Halifax
country: Canada
state: Nova Scotia
city: Prague
country: Czech Republic
city: Berlin
country: Germany
city: Budapest
country: Hungary
city: Mumbai
country: India
city: Manila
country: Philippines
city: Warsaw
country: Poland
city: Moscow
country: Russian Federation
city: Belgrade
country: Serbia
city: Singapore
country: Singapore
city: Spisska Nova
country: Slovakia
city: Cape Town
country: South Africa
city: Tainan
country: Taiwan
city: Bangkok
country: Thailand
city: Bristol
country: United Kingdom
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00289081: Primary TKA Cruciate Retaining vs Cruciate Substituting With Rotating Platform Knee Prostheses
Official title: Multi-center Prospective Clinical Evaluation of the P.F.C.® Sigma™ Rotating Platform Knee Primary Cases Cruciate Retaining Versus Cruciate Substituting
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Osteoarthritis
Arthritis, Rheumatoid
Avascular Necrosis of Bone
Post-traumatic Arthritis
Rheumatoid Arthritis
Keywords: Total Knee Replacement
Lead sponsor: DePuy Orthopaedics
Sponsor class: INDUSTRY
First posted: 2006-02-09
Enrollment: 399
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the clinical performance of the cruciate ligament retaining or cruciate ligament substituting implants by obtaining a series of primary TKAs. Outcome scoring and radiographic assessment will be the methods used to evaluate performance.

Detailed description: The study will evaluate the clinical performance of cruciate ligament retaining or cruciate ligament substituting implants through a series of primary TKAs. Patients will receive either the P.F.C.® Sigma™ Rotating Platform Cruciate Retaining Knee implant or the P.F.C.® Sigma™ Rotating Platform Cruciate Substituting Knee implant and assignment will be randomized.

Eligibility criteria: Inclusion Criteria:

* Osteoarthritis
* Rheumatoid arthritis
* Avascular necrosis (AVN) of bone
* Other inflammatory arthritis
* Post-traumatic arthritis
* Juvenile rheumatoid arthritis

Exclusion Criteria:

* Prior ipsilateral TKA
* Metabolic disorders
* Joint replacement due to autoimmune disorders
* History of recent/active joint sepsis
* Charcot neuropathy
* Psycho-social disorders that would limit rehabilitation
* Greater than 75 years of age at the time of surgery
* Severe diabetes mellitus
* Skeletal immaturity

Primary outcomes:
measure: Knee Society scores
timeFrame: Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.
Secondary outcomes:
measure: Complications
timeFrame: On-going to end of study
measure: Revisions
timeFrame: On-going to end of study
measure: Medical imaging
timeFrame: Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.
measure: SF-12 patient outcomes
timeFrame: Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.
Other outcomes:
Locations:
city: La Jolla
country: United States
state: California
city: Crystal River
country: United States
facility: West Coast Orthopaedic Specialists
state: Florida
city: Melbourne
country: United States
state: Florida
city: Cleveland Heights
country: United States
state: Ohio
Study officials:
affiliation: DePuy Orthopaedics
name: Tammy L O'Dell, EMT, CCRA
role: STUDY_DIRECTOR
References: