louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00806260: A Study to Evaluate How VI-0521 Affect Psychomotor Performance in Healthy Overweight and Obese Subjects.
Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Cross-over Study to Evaluate the Psychomotor Effect of VI-0521 in Healthy Overweight and Obese Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Overweight
Obesity
Keywords: Overweight
Obesity
coordination
psychomotor
Lead sponsor: VIVUS LLC
Sponsor class: INDUSTRY
Collaborators: name: MDS Pharma Services
First posted: 2008-12-10
Enrollment: 80
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine how VI-0521 affect speed and reaction time on specific tasks that require eye and hand coordination, compared to placebo.


Eligibility criteria: Inclusion Criteria:

* Written consents;
* Adequate contraception from screening through 28 days after the last dose of study drug for female subjects;
* Healthy obese or overweight subjects with BMI between 27 and 35.

Exclusion Criteria:

* History of glaucoma or any past or present use of medications to treat increased intraocular pressure;
* Current use of any tobacco products, including cigarettes, cigars, pipes, or chewing tobacco, or use within the three months prior to screening;
* History of drug abuse during the three years prior to screening;
* History of alcohol abuse, or excessive alcohol consumption, or describes themselves as non-users of alcohol;
* Current depression of moderate or greater severity, or any presence or history of suicidal behavior or active suicidal ideation
* More than one lifetime episode of major depression;
* Currently working night shifts at a job;
* On average consumes greater than two cups of coffee or xanthine-containing beverages per day (\>200 mg/day) within the two weeks prior to screening;
* Any use of dietary, herbal, and/or fitness/body-building supplements (with the exception of vitamins) within one month prior to screening;
* Aspartate aminotransferase or alanine aminotransferase \>2.5 x ULN;
* Serum creatinine ≥1.5 mg/dL for men or ≥1.4 mg/dL for women.

Primary outcomes:
measure: Measure of Psychomotor Function Using Speed and Coordination on the CogScreen Pathfinder Number (PFN) Test in Subjects Treated With Alcohol Compared to Alcohol Placebo in Period 1.
timeFrame: at breath alcohol levels 0.10%, 0.07%, and 0.04%
measure: Measure of Psychomotor Function Using Speed and Coordination on the CogScreen Pathfinder Number (PFN) Test in Subjects Treated With VI-0521 Compared to Placebo in Periods 2 and 3.
timeFrame: Hour 2 and Hour 6
Secondary outcomes:
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Research Site
state: Nebraska
Study officials:
affiliation: VIVUS LLC
name: Craig Peterson
role: STUDY_DIRECTOR
affiliation: MDS Pharma Services
name: Alan Marion, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05894460: Constrained Balloon Combined With Drug-coated Balloon Angioplasty for Femoropopliteal Lesion
Official title: Constrained Balloon Combined With Drug-coated Balloon Angioplasty for Femoropopliteal Lesion: a Single-centre, Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Peripheral Arterial Disease
Keywords: Femoral artery
Popliteal artery
Peripheral artery disease
Chocolate percutaneous transluminal angioplasty balloon
Drug-coated balloon
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2023-06-08
Enrollment: 254
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 with femoropopliteal atherosclerotic occlusive disease

Brief summary: This study will assess the safety and efficacy of Chocolate balloons as a combination with drug-coated balloons in the treatment of popliteal artery lesions in lower limb atherosclerotic occlusive disease and will compare them with conventional balloons.


Eligibility criteria: Inclusion Criteria:

* Rutherford classification of 2-6 in patients with femoropopliteal atherosclerotic occlusive disease;
* primary cases with no previous surgical treatment of the target lesion;
* presence of at least one vessel with patency in the distal outflow tract;
* survival \>1 year.

Exclusion Criteria:

* planned stenting;
* presence of flow-limiting dissection prior to application of Chocolate balloon and conventional balloon dilation of the target lesion;
* combination of severe organ dysfunction of the heart, lungs and brain that cannot tolerate the procedure;
* allergy to contrast agents, anaesthetic drugs, anticoagulants and anti-platelet drugs;
* ineffective recanalization attempts;
* lesions within or adjacent to the aneurysm, or the presence of a popliteal aneurysm.

Primary outcomes:
measure: Primary patency
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital
state: None Selected
Study officials:
References:
Clinical trial NCT00076960: Compassionate Use of Stanate (TM) [Stannsoporfin]
Official title: Compassionate Use of Stannsoporfin as an Adjuvant to Phototherapy to Reduce the Need for Exchange Transfusions
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Neonatal Jaundice
Hyperbilirubinemia
Keywords: hyperbilirubinemia
jaundice
tin-mesoporphyrin
stannsoporfin
exchange transfusion
neonatal hyperbilirubinemia
Lead sponsor: Mallinckrodt
Sponsor class: INDUSTRY
First posted: 2004-02-10
Sex: ALL
Minimum age (years): 12
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no

Brief summary: The purpose of this protocol is to make Stanate (TM) \[stannsoporfin, tin-mesoporphyrin\] available to infants who meet the following criteria:

1. the infant has a very high level of bilirubin without an adequate clinical response to phototherapy;
2. the infant requires an exchange transfusion; and
3. the family refuses to allow the administration of blood products, particularly on religious grounds, such as within the Jehovah's Witness community.


Eligibility criteria: * Term or near term neonate
* Elevated serum bilirubin
* Failing phototherapy
* Requires exchange transfusion
* Family refuses exchange transfusion on religious grounds

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
Study officials:
References:
citation: Kappas A, Drummond GS, Munson DP, Marshall JR. Sn-Mesoporphyrin interdiction of severe hyperbilirubinemia in Jehovah's Witness newborns as an alternative to exchange transfusion. Pediatrics. 2001 Dec;108(6):1374-7. doi: 10.1542/peds.108.6.1374.
Clinical trial NCT05873660: A Study to Characterize the Prevalence of Overweight and Obesity Among Patients With Established Cardiovascular Disease
Official title: Multi-centre Cross-sectional Observational Study to Characterize the Prevalence of Overweight and Obesity Among Patients With Established Cardiovascular Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Overweight
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2023-05-24
Enrollment: 5360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of adults aged 18 years or older diagnosed with established cardiovascular disease (CVD) and are attending routine medical care or follow-up in a cardiology clinic.

Brief summary: The purpose of this observational study is to measure how many people are overweight or obese amongst patients with a diagnosed cardiovascular disease (CVD). The study also aims to characterise the population including the presence of cardiovascular (CV) risk factors in a number of countries across the globe representing different geographies, ethnicities, as well as different healthcare systems.


Eligibility criteria: Inclusion Criteria:

1. Informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
2. Adults, age above or equal to 18 years at the time of signing informed consent.
3. Have established CVD and equal to or greater than 1 follow up appointment following an acute event from at least one of the following:

   * Prior myocardial infarction
   * Prior stroke (ischemic or haemorrhagic stroke)
   * Symptomatic peripheral arterial disease (PAD), as evidenced by intermittent claudication with ankle-brachial index (ABI) below 85 (at rest), or peripheral arterial revascularization procedure, or amputation due to atherosclerotic disease

Exclusion Criteria:

1. Previous participation in this study. Participation is defined as having given informed consent in this study
2. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
3. Patients with known congenital heart disease/malformation

Primary outcomes:
measure: Overweight and obesity among patients with established CVD pooled across all countries
timeFrame: At the time of patient enrolment (Day 1/Visit 1)
Secondary outcomes:
Other outcomes:
Locations:
city: Plainsboro
country: United States
facility: Novo Nordisk Investigational Site
state: New Jersey
city: São Paulo
country: Brazil
facility: Novo Nordisk Investigational Site
city: Ontario
country: Canada
facility: Novo Nordisk Investigational Site
city: Riyadh
country: Saudi Arabia
facility: Novo Nordisk Investigational Site
city: Madrid
country: Spain
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References:
Clinical trial NCT03815760: Can Blood Flow Restriction Therapy Improve Strength for Shoulder External Rotators Better Than Exercise Alone
Official title: Can Blood Flow Restriction Therapy Improve Strength for Shoulder External Rotators Better Than Exercise Alone
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Muscular Weakness
Keywords: infraspinatus, external rotators, blood flow restriction
Lead sponsor: George Fox University
Sponsor class: OTHER
First posted: 2019-01-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the ability of blood flow restriction therapy to improve strength of shoulder muscles during the sidelying external rotation (ER) exercise versus a control group who only performs the sidelying ER exercise.

Detailed description: The purpose of this study is to determine if blood flow restriction (BFR) therapy is superior at increasing strength of the shoulder (supraspinatus, infraspinatus, posterior deltoid, and middle deltoid) and increasing tendon size of the supraspinatus and infraspinatus (as determined by diagnostic ultrasound) while performing the sidelying external rotation exercise compared to those who only perform the sideyling external rotation exercise without BFR.

Subjects will be randomized to one of two treatment groups: exercise with BFR or exercise alone. Recruitment will be a sample of convenience consisting of healthy adults (age range 22 to 45). Subjects will perform the sidelying external rotation exercise 2 times a week for an 8 week period.

Eligibility criteria: Inclusion Criteria:

1. Healthy adult (age 18 and older) with no current shoulder pathology

Exclusion Criteria:

1. Current neck, shoulder (or general upper extremity), and/or thoracic spine pathology
2. Shoulder surgery (or general upper extremity surgery) during the prior 6-month time period
3. Cervical/thoracic spine surgery during the prior 1 year
4. Subject having one or more contraindications for BFR training.

Primary outcomes:
measure: Muscular Strength as Measured by Dynamometry
timeFrame: Change from Baseline to 8-weeks
measure: Tendon Size as Measured by Diagnostic Ultrasound
timeFrame: Change from Baseline to 8-weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Newberg
country: United States
facility: George Fox University School of Physical Therapy
state: Oregon
Study officials:
affiliation: George Fox University
name: Jason Brumitt, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03323060: Post-Market Clinical Follow-Up to Access & Visualize the Anus, Rectum, & Distal Colon During Transanal Procedures
Official title: A Multicenter Post-Market Clinical Follow-Up of the Medrobotics Flex Robotic System and Flex Rectoscope Used for Accessing and Visualizing the Anus, Rectum, and Distal Colon During Transanal Procedures
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Disease or Lesions of the Anus, Rectum, or Distal Colon
Lead sponsor: Medrobotics Corporation
Sponsor class: OTHER
First posted: 2017-10-26
Enrollment: 20
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects ≥ 22 years of age requiring transanal procedures in the areas of the anus, rectum, and distal colon

Brief summary: To assess the safety and performance of the Medrobotics Flex Robotic System and Flex Rectoscope for accessing and visualizing the Anus, Rectum, and Distal Colon when used for Transanal procedures


Eligibility criteria: Inclusion Criteria:

* ≥ 22 years of age
* Candidate for transanal procedures in the areas of the anus, rectum, and distal colon.

Exclusion Criteria:

* Candidates are excluded if they \< 22 years of age and do not meet criteria for transanal surgery in the anus, rectum, and distal colon

Primary outcomes:
measure: Access and Visualization
timeFrame: 0-24 hours
Secondary outcomes:
measure: Performance of transanal surgical procedure
timeFrame: 0-24 hours
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: Univsersity of Nevada School of Medicine
state: Nevada
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
References:
Clinical trial NCT00450476: Aspiration of Subglottic Secretions Using Hi-Lo Evac Endotracheal Tube: Tube Size and Incidence of Suction Lumen Dysfunction
Official title: Aspiration of Subglottic Secretions in Intubated Critically Ill Patients Using Hi-Lo Evac Endotracheal Tube: Correlation Between Tube Size and Incidence of Suction Lumen Dysfunction
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aspiration of Subglottic Secretions
Keywords: ventilator associated pneumonia
prevention
endotracheal intubation
mechanical ventilation
Lead sponsor: University Hospital, Alexandroupolis
Sponsor class: OTHER
First posted: 2007-03-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: OTHER

Brief summary: To evaluate the correlation between endotracheal tube size and incidence of dysfunction of suction lumen of Hi-Lo Evac endotracheal tube in critically ill patients who required mechanical ventilation for more than 48 hours.

Detailed description: In mechanically ventilated patients, aspiration of subglottic secretions is a widely used intervention for prevention of ventilator-associated pneumonia. Using Hi-Lo® Evac endotracheal tube (Hi-Lo Evac; Mallinckrodt; Athlone, Ireland), dysfunction of suction lumen and subsequent failure to aspirate the subglottic secretions is not uncommon. The objective of this prospective observational study is to determine the causes and the incidence of suction lumen dysfunction of Evac endotracheal tube.

Eligibility criteria: Inclusion Criteria:

* Critically ill patients with orotracheal intubation and anticipated duration of intubation more than 48 hours

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandroupolis
country: Greece
facility: University General Hospital of Alexandroupolis
state: Evros
Study officials:
affiliation: Intensive Care Unit, University Hospital of Alexandroupolis
name: Christos K Dragoumanis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01686776: A Prospective Validation Study of Albumin Kinetics With Tracer 123 I-HSA
Official title: A Prospective Validation Study in Healthy Volunteers, Patients With Acute Inflammation and Patients Scheduled for Major Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy
SIRS
Keywords: Plasma albumine
Plasma volume
Transcapillary escape rate
Inflammation
Circulation
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2012-09-18
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3 parallell Groups were measured regarding plasma volume and transcapillary escape rate of albumin where commercial 125I-iodinated human serum albumin was compared to hospital manufactured 123I- iodinated human serum albumin
Primary purpose: OTHER

Brief summary: This is a prospective, validation study of a extempore made tracer compared with a commercial. Studies with tracer have no medical effects but are used for studying human physiology, in this case pharmacokinetic variables of endogenous albumin distribution and turnover at different levels of inflammation.

1. Primary Objective:

   - Do the extempore made tracer 123-iodine labeled albumin an commercially manufactured SERALB-125 give identical values of calculated blood plasma volume and capillary leakage measured as transcapillary escape rate of albumin?
2. Secondary Objective:

   * How do three different measures of albumin turnover correlate in volunteers?
   * How do the pharmacokinetic parameters of endogenous albumin vary between the three study groups?


Eligibility criteria: Inclusion Criteria:

* healthy volunteers (treatment arm I)
* on contraceptive agent and/or contraceptive device
* visual peripheral veins
* signed informed consent
* planned for elective larger interabdominal surgery (treatment arm II)
* patients with a acute pancreatitis or cholecystitis (treatment arm III)

Exclusion Criteria:

* pregnant women and/or lactating
* allergy towards excipients in 123 I HSA or 125 I HSA
* participates in another study involving radiation or stabile isotopes within a period of 60 days to study start
* it is the opinion of the principle investigator that the patient/subject should not participate for his/hers own good

Primary outcomes:
measure: Transcapillary Escape Rate (TER)of Albumin
timeFrame: 42 days
Secondary outcomes:
measure: Fractional catabolic rate (FCR)
timeFrame: 42 days
Other outcomes:
measure: plasma albumin turnover rate
timeFrame: 42 days
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital, Huddinge
Study officials:
affiliation: Karolinska University Hopsital
name: Olav Rooyackers, PhDProfessor
role: STUDY_CHAIR
References:
citation: Komaromi A, Estenberg U, Hammarqvist F, Rooyackers O, Wernerman J, Norberg A. Simultaneous assessment of the synthesis rate and transcapillary escape rate of albumin in inflammation and surgery. Crit Care. 2016 Nov 15;20(1):370. doi: 10.1186/s13054-016-1536-6.
Clinical trial NCT06348576: Phase III Study to Evaluate the Efficacy and Safety of AD-209
Official title: A Multicenter, Randomized, Double-blind, Active-control, Phase III Study to Evaluate the Efficacy and Safety of AD-209 in Patients With Essential Hypertension
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Hypertension,Essential
Lead sponsor: Addpharma Inc.
Sponsor class: INDUSTRY
First posted: 2024-04-04
Enrollment: 280
Sex: ALL
Minimum age (years): 19
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 efficacy and safety of AD-209

Detailed description: Condition or disease : hypertension

Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Other inclusions applied

Exclusion Criteria:

* Orthostatic hypotension with symptom
* Other exclusions applied

Primary outcomes:
measure: Change rate of MSSBP
timeFrame: Baseline, Week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
Study officials:
affiliation: Korea University Guro Hospital
name: Chang Gyu Park, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03488576: Foveal Sparing of the ILM
Official title: Macular Peeling With Foveal Sparing of the Internal Limiting Membrane: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retinal Sensitivity
Lead sponsor: Università degli Studi di Brescia
Sponsor class: OTHER
First posted: 2018-04-05
Enrollment: 190
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This was a prospective study including ninety-one eyes of 190 phakic patients scheduled to undergo vitrectomy for idiopathic macular pucker or macular hole, from July 2014 to December 2016. Patients were randomized in a 1:1 ratio to complete peeling of the ILM (CP group) or foveal sparing (FS group).
Primary purpose: TREATMENT

Brief summary: To compare the retinal sensitivity of complete internal limiting membrane (ILM) peeling versus foveal sparing ILM peeling during vitrectomy for epiretinal membrane or macular hole.


Eligibility criteria: Inclusion Criteria:

* provision of written informed consent
* age \> 60 years
* presence of idiopathic macular pucker or macular hole documented by OCT

Exclusion Criteria:

* any prior intraocular surgery
* pathologic myopia (\> 7 diopters)
* age related macular degeneration
* glaucoma and diabetic retinopathy or any other retinal vascular disease

Primary outcomes:
measure: Retinal Sensitivity (dB)
timeFrame: 12-month
measure: Visual Acuity (LogMAR)
timeFrame: 12-month
measure: Central Retinal Thickness (microns)
timeFrame: 12-month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: