louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00875875: Single Daily Dose Rifaximin for the Treatment of Travelers' Diarrhea
Official title: Single Daily Dose Rifaximin vs. Standard Thrice Daily Dosing for the 3-Day Treatment of Travelers' Diarrhea
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Travelers' Diarrhea
Keywords: Diarrhea, travelers
Acute travelers' diarrhea
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2009-04-06
Enrollment: 0
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 study will compare durations of diarrhea among subjects who report to clinic for treatment and who receive either:

1. standard rifaximin therapy at a dose of 200 mg three times a day for 3 days, OR
2. a single 600 mg dose of rifaximin daily for 3 days.


Eligibility criteria: Inclusion Criteria:

* passage of 3 or more unformed stools in 24 hours plus an additional symptom of enteric disease such as abdominal cramps, nausea, vomiting, or fever; and investigator verification that an unformed stool has been submitted.
* is \> 18 years of age
* has diarrhea (at least three unformed stools in 24 hrs) plus at least one additional sign or symptom of enteric illness
* has acute diarrhea less than 1 week's duration
* willingness to provide a diarrhea stool sample
* willingness to keep a daily diary for 5 days
* signed informed consent

Exclusion Criteria:

* fever or bloody diarrhea
* has taken predictably effective antibiotics in the past week (e.g. quinolones, TMP/SMX, azalide or doxycycline)
* is pregnant now, likely to become pregnant, or breast-feeding
* has duration of diarrhea of greater than 1 weeks
* is allergic to Rifampin or Rifaximin
* has a history of significant underlying enteric, pulmonary, cardiac, renal disease, or any CNS disorder
* is more than moderately dehydrated

Primary outcomes:
measure: Time from beginning therapy to passage of last unformed stool
timeFrame: 5 days
Secondary outcomes:
measure: Side effects as reported by the subjects on diaries
timeFrame: 5 days
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Enteric Disease Clinic
state: Jalisco
Study officials:
affiliation: University of Texas Medical School at Houston
name: Charles D Ericsson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05902975: Evaluation of the Antimicrobial Fiber Reinforced Composite Resin Space Maintainer Modified With Silver Nano Particles
Official title: Evaluation of the Antimicrobial Fiber Reinforced Composite Resin Space Maintainer Modified With Silver Nano Particles
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Caries in Children
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 24
Sex: ALL
Minimum age (years): 4
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Fiber reinforced composite resin space maintainer

Detailed description: Evaluation of the antimicrobial fiber reinforced composite resin space maintainer modified by silver nano particles.

Eligibility criteria: Inclusion Criteria:

* Premature loss of primary molar.
* Presence of teeth on the mesial and distal sides of the extraction space.
* Normal primary molar relation.
* No root resorption of abutment teeth.
* Presence of a succedaneous tooth bud.
* Absence of pathology on the eruption track of the succedaneous tooth.
* The age will be ranged from 4 to 9 years.

Exclusion Criteria:

* Carious buccal and lingual surface of abutment teeth.
* Absence of teeth on the mesial and distal sides of the extraction.

Primary outcomes:
measure: Evaluation of strepetoccous mutant and lactobacilli from sample of saliva
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Alazhar university
Study officials:
affiliation: Associate professior
name: Alaa eldin Mahmoud Abdallah
role: STUDY_DIRECTOR
affiliation: Lecture
name: Hamdy Mahmoud Badereldin
role: STUDY_DIRECTOR
affiliation: Lecture
name: Ahmed Akram Elawady
role: STUDY_DIRECTOR
References:
Clinical trial NCT02847975: Sodium Nitrate to Improve Blood Flow
Official title: Sodium Nitrate to Improve Blood Flow
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Becker Muscular Dystrophy
Keywords: Becker
dystrophy
sympatholysis
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2016-07-28
Enrollment: 11
Sex: MALE
Minimum age (years): 15
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Investigators recently showed that tadalafil restores functional sympatholysis in patients with Becker muscular dystrophy (BMD). If tadalafil restores functional sympatholysis in BMD via the NO-cyclic guanosine monophosphate pathway, then functional sympatholysis should also be restored by sodium nitrite- which is an indirect nitric oxide donor.


Eligibility criteria: Inclusion Criteria:

* Becker muscular dystrophy
* age 15-55 years of age
* ambulatory

Exclusion Criteria:

* hypertension, diabetes, or heart failure by standard clinical criteria
* elevated brain natriuretic peptide level (\>100 pg/ml)
* Left ventricular ejection fraction \< 50%
* cardiac rhythm disorder, specifically: rhythm other than sinus, supraventricular tachycardia, atrial fibrillation, ventricular tachycardia, heart block
* continuous ventilatory support
* liver disease
* renal impairment
* history of asthma or bronchospasm
* use of any medications other than common supplements
* unable to perform handgrip exercise

Primary outcomes:
measure: change in muscle tissue oxygenation
timeFrame: change from baseline to post treatment (3-4 hours)
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Heart Institute
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Ronald G Victor, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Martin EA, Barresi R, Byrne BJ, Tsimerinov EI, Scott BL, Walker AE, Gurudevan SV, Anene F, Elashoff RM, Thomas GD, Victor RG. Tadalafil alleviates muscle ischemia in patients with Becker muscular dystrophy. Sci Transl Med. 2012 Nov 28;4(162):162ra155. doi: 10.1126/scitranslmed.3004327.
Clinical trial NCT05229575: Breast Stereotactic Radiotherapy to Primary Tumors in Metastatic Patients
Official title: Breast Stereotactic Radiotherapy to Primary Tumors in Metastatic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stage IV Breast Cancer
Lead sponsor: Campus Bio-Medico University
Sponsor class: OTHER
First posted: 2022-02-08
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a dose escalation study involving stage IV breast cancer patients not progressing after 6 months of first line systemic treatment. Potential advantages of stereotactic body radiotherapy (SBRT) in treating breast primary tumor in metastatic breast cancer are:

* radio-biological advantage of a short highly effective treatment schedule
* possibility of preventing lesions to become symptomatic
* possibility of continuing systemic treatment without interruption


Eligibility criteria: Inclusion Criteria:

* Age: 18 years or older
* Histologically confirmed diagnosis of invasive breast carcinoma (biological immunohistochemical profile: luminal and/or human epidermal growth factor receptor 2 positive)
* Distant metastatic disease not progressing after 6 months of systemic therapy
* Zubrod Performance status of 0-1
* Unifocal tumour \< 5 cm tumor size
* Tumor CT or 18-labeled fluorodeoxyglucose positron emission tomography (5FDG-PET) detectable
* No surgery being recommended at time of enrollment.

Exclusion Criteria:

* prior radiotherapy
* active systemic lupus erythematosus, or any history of scleroderma, dermatomyositis with active rash
* Women who are pregnant or lactating.
* Psychiatric or addictive disorders that preclude obtaining informed consent or adherence to protocol

Primary outcomes:
measure: Maximum tolerated dose of stereotactic body radiotherapy (SBRT)
timeFrame: 6 months
Secondary outcomes:
measure: Rate of long-term adverse events
timeFrame: 2 years
measure: Breast Cosmesis
timeFrame: 2 years
measure: QoL
timeFrame: 2 years
measure: Primary breast tumor best response
timeFrame: 2 years
Other outcomes:
measure: Primary breast tumor local failure
timeFrame: 2 years
Locations:
city: Roma
country: Italy
facility: Università Campus Biomedico
Study officials:
References:
Clinical trial NCT05471375: C-STAR Movement Database
Official title: Center for Smart Use of Technologies to Assess Real World Outcomes Movement Database
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke
Parkinson Disease
Lower Limb Amputation Above Knee (Injury)
Lower Limb Amputation Below Knee (Injury)
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
First posted: 2022-07-22
Enrollment: 250
Sex: ALL
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: By building the C-STAR database, the intent is to create a database that can serve as a hub for data sets that researchers and clinicians with appropriate access may use to support their research questions related to movement and physical rehabilitation.

Brief summary: The purpose of this study is to develop a database that contains movement and rehabilitation-related data collected through the use of wearable sensors and video. This database will serve as a resource for clinicians and researchers interested in the investigation of movement or rehabilitation-related research ideas.

Detailed description: Scholarly research in the field of physical rehabilitation helps to aid in maximizing outcomes for individuals that require these services due to orthopedic and neurologic injuries. To produce quality research results, large cohorts of individuals are often required for data analysis. Some research facilities or labs do not have adequate access to large cohorts or may not have the means to recruit them. By building the C-STAR database, the intent is to create a database that can serve as a hub for data sets that researchers and clinicians with appropriate access may use to support their research questions related to movement and physical rehabilitation.

Eligibility criteria: Inclusion Criteria:

1. Age 0 to 99 years old
2. Able and willing to give written consent and comply with study procedures

Exclusion Criteria:

1. Unable to give written consent or comply with study procedures
2. Any condition that would prevent safe completion of study activities, as determined by the Principal Investigator

Primary outcomes:
measure: Database development
timeFrame: Data will be collected and added to the C-STAR database for 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Shirley Ryan AbilityLab
state: Illinois
Study officials:
affiliation: Shirley Ryan AbilityLab
name: Arun Jayaraman, PT, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shirley Ryan AbilityLab
name: Levi Hargrove, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shirley Ryan AbilityLab
name: Richard Lieber, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00991575: Long Term Vascular Changes in Type 1 Diabetes
Official title: Long Term Vascular Changes in Type 1 Diabetes, Clinical Aspects and Biological Markers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 1
Complications
Coronary Heart Disease
Keywords: Diabetes mellitus, type1
cardiovascular disease
diabetes complications
Glycation end products, advanced
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University Hospital, Aker
First posted: 2009-10-08
Enrollment: 33
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This project will be a continuation of the previous cohort performed originally from 1982. The group or cohorts will be selected from primary care clinic.

Brief summary: The main purpose of this study is to investigate progression of late complications of diabetes during the last ten years in a well characterized cohort of type 1 diabetes with a long duration of the disease, and to define factors responsible for the progression of late complications.

Detailed description: Despite intensively research in the field of hyperglycaemia and coronary heart disease in type 1 diabetes it is still not known in detail how hyperglycaemia leads to damage of the vessels.

The aims of the present proposal are therefore two-fold:

1. To study in detail the progression of atherosclerosis (and micro vascular complications) in a well characterized cohort of type 1 diabetes with a long duration of the disease. This project will be a continuation of the Oslo study, a cohort started in 1982, with the last follow-up study in 1999/2000.
2. To define factors responsible for the progression of coronary heart disease (and micro vascular complications) in this cohort.

Eligibility criteria: The original criteria from 1982:

Inclusion Criteria:

* Age 18-45 years
* Diagnosis of type 1 diabetes at \< 30 years of age, disease duration \> 7 but \< 30 years
* C-peptide \< 0, 1 nmol/l

Exclusion Criteria:

* Serum creatinine \> 150 µmol/l
* Diastolic blood pressure \<100mmHg
* Overt nephropathy
* Proliferative retinopathy
* Pregnancy
* A history of neuropathy
* Other chronical disease
* Treatment with other drugs except insulin and oral contraceptives

Primary outcomes:
measure: Fatal and non fatal cardiovascular disease (CVD) and stroke
timeFrame: One year
Secondary outcomes:
measure: Vessel area stenosis
timeFrame: One year
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University hospital, Aker
Study officials:
affiliation: Oslo university hospital, Aker, Norway
name: Kristian F Hanssen, Professor MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03618875: Reduction of Post Intravitreal Injection Bleeding and Pain by Ice
Official title: Reduction of Post Intravitreal Injection Bleeding and Pain by Ice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Lead sponsor: Wolfson Medical Center
Sponsor class: OTHER_GOV
First posted: 2018-08-07
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: Intravitreal injections are an efficient method for delivering intraocular therapeutic agents in numerous ophthalmologic diseases. However, side effects, such as pain and subconjunctival hemorrhage remain a major concern.

Prevention or alleviation of those side effects might shorten the healing duration and improve patients' quality of life.

Detailed description: cooling the eye using ice patched prior to Intravitreal injections may ameliorated pain and subconjunctival hemorrhage incidences.

Eligibility criteria: Inclusion Criteria:

patients receiving intravitreal injection

Exclusion Criteria:

Primary outcomes:
measure: pain
timeFrame: change between VAS pain score at baseline and 10 minutes
Secondary outcomes:
measure: size of subconjunctival hemorrhage
timeFrame: change between subconjunctival hemorrhage at baseline and 10 minutes
Other outcomes:
Locations:
city: Holon
country: Israel
facility: The E.Wolfson Medical Center
Study officials:
References:
Clinical trial NCT05399875: AR Ruler to Improve Safety and Clinical Workflow During PICC Placement
Official title: Augmented Reality Ruler to Improve Safety and Clinical Workflow During Placement of Peripherally Inserted Central Catheters
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insertion of Peripherally Inserted Central Catheter
Keywords: Catheters
Augmented Reality
Radiology, Interventional
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2022-06-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to assess the utility of an augmented reality virtual ruler during placement of peripherally inserted central catheters.

Detailed description: After being informed about the study, patients who give consent will have their peripheral inserted central catheter placed by a physician wearing mixed reality smart glasses. The mixed reality smart glasses will have an application that allows the physician to measure distances with their hands. This application will be used to measure the appropriate length for which to trim the central catheter.

Eligibility criteria: Inclusion Criteria:

* Scheduled for a non-emergent peripherally inserted central catheter placement in Interventional Radiology
* Over 18 years

Exclusion Criteria:

* Undergoing an emergent peripherally inserted central catheter placement
* Younger than 18 years old

Primary outcomes:
measure: Number of participants with appropriate catheter tip location
timeFrame: End of procedure
Secondary outcomes:
measure: Radiation dose
timeFrame: End of procedure
measure: Procedure time
timeFrame: End of procedure
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Ali H Dhanaliwala, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03357575: The Comparison of Efficacy and Safety of the Mesenchymal Stem Cells From Adipose and Hyaluronic Acid
Official title: The Comparison of Efficacy and Safety of the Mesenchymal Stem Cells From Adipose and Hyaluronic Acid in the Treatment of Adult Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Knee Osteoarthritis
adipose
mesenchymal stem cells
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2017-11-30
Enrollment: 14
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: The aim of this study was to evaluate the efficacy and safety of Mesenchymal Stem Cells (MSCs) from adipose anticular injection in comparison with hyaluronic acid anticular injection in the treatment of human knee osteoarthritis(OA).

Detailed description: This is a single-centre, quadruple blined, randomized controlled clinical trials with a total of 14 knee osteoarthrits patients as participants, who will be randomly assigned into experiment group or compare group.Participants in experiment group will receive the treatment of MSCs from adipose anticular injection, while participants in compare group will receive hyaluronic acid. Unexplained local and systemic symptoms as well as visual analog scale pain score, WesternOntario McMasterUniversities (WOMAC) Osteoarthritis Index scorewill be assessed at baseline and 2 years after the injection.

Eligibility criteria: Inclusion Criteria:

* K / L score of 2-3;
* chronic knee pain;
* no local or systemic infection;
* without obvious contraindication of the joint puncture from hematology and biochemical tests;
* informed consent.

Exclusion Criteria:

* older than 75 years old or less than 18 years old, or without full capacity for civil conduct;
* HIV, hepatitis virus or syphilis virus infection or their serology is positive;
* BMI index is greater than 30;
* congenital or acquired knee deformity;
* pregnant or lactating women;
* tumor patients;
* immunodeficiency patients;
* intra-articular drug injection history within 3 months;
* participating in other clinical trials;
* other patients who researchers believe are not eligible for inclusion such as suffering from other concomitant diseases.

Primary outcomes:
measure: Unexplained local and systemic symptoms or death
timeFrame: 2 years
Secondary outcomes:
measure: VAS score
timeFrame: 2 years
measure: WOMAC score
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: arthritis clinic and research center
name: Ziyi Yang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01368575: Surgical Treatment of Ischemic Mitral Regurgitation
Official title: The Effect of Different Surgical Methods in the Treatment of Patients With Ischemic Mitral Regurgitation and Assess the Dynamics of Heart Failure and the Effectiveness of Surgical Treatment of Mitral Valve.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Mitral Valve Insufficiency
Keywords: Ischemic
Mitral
Valve
Insufficiency
SVR
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2011-06-08
Enrollment: 420
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective is to estimate surgical treatment (prosthesis or plastic) of moderate and severe ischemic mitral regurgitation combined with CABG in patients with CAD and impact on heart failure and progress of mitral regurgitation.


Eligibility criteria: Inclusion Criteria:

* Patient is a male or female between 30 to 75 years of age (inclusive) on the day of signing the informed consent.
* Patients with a verified diagnosis of CAD, including post myocardial infarction scar.
* Coronary artery pathology to be coronary artery bypasses grafting.
* The presence of moderate or severe ischemic mitral regurgitation.

Exclusion Criteria:

* The patient did not sign the informed consent.
* Aortic valve disease requiring prosthetic or aortic valve repair.
* Organic lesion of valve and subvalvular structures (endocarditis and degenerative processes of the mitral valve).

  а) separation of the mitral valve chords; б) rupture and perforation of the mitral valve; в) myxomatous degeneration and calcification of the mitral valve
* Patients with acute coronary syndrome.
* The presence of the indications for angioplasty of the coronary arteries.
* Coronary artery bypasses grafting in history.
* Parallel patient participation in other studies.
* The organs diseases, which can be reason to death after surgery during the first 3 years.

Primary outcomes:
measure: Assess the degree of mitral regurgitation in the early and late term of the study. Identify the cause of the return of IMR. Determine the dynamics of heart failure in patients with IMR.
timeFrame: 3,6,12,24,36 months
Secondary outcomes:
measure: Assessment of IMR
timeFrame: 3 years
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: State Research Institute of Circulation Patholody
Study officials:
affiliation: State Research Institute of Circulation Patholody Novosibirsk, 630055 Russian Federation
name: Alexander Cherniavskiy, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: