louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00348829: Mitral Valve Reconstruction in Chronic Heart Failure (CHF): Identification of Predictors for a Successful Therapy
Official title: Mitral Valve Reconstruction in Patients With Chronic Heart Failure and Secondary Mitral Insufficiency: Identification of Predictors for a Successful Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Chronic Heart Failure
Mitral Insufficiency
Keywords: CHF
mitral insufficiency
conductance catheter
mitral valve repair
Lead sponsor: University of Leipzig
Sponsor class: OTHER
First posted: 2006-07-06
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the study is to evaluate hemodynamic and echocardiographic parameters in patients with secondary mitral insufficiency and CHF.

1. Identification of hemodynamic parameters as predictor for a successful mitral valve reconstruction in CHF patients.
2. Collection of clinical factors for the assessment of the postoperative course after mitral valve reconstruction in CHF patient.


Eligibility criteria: Inclusion Criteria:

1. Age \> 18 years old
2. Dilatative Cardiomyopathy with LVEF \< 35%
3. NYHA III oder IV under maximal medical treatment
4. Angiographic and hemodynamic MI \> II° (LAP- mean pressure \> 15-20 mmHg; LA v-wave-oder PCWP v-wave \> 35 mmHg under exercise)
5. Echocardiographic MI \> II°
6. At least 1 hospitalization for heart failure before OP

Exclusion Criteria:

1. Secondary Cardiomyopathy by vitium cordis
2. Planned secondary procedure like CABG, aortic valve surgery, surgery of the tricuspid valve etc
3. Inclusion in another trial
4. Euro-Score \> 30%
5. Former valve operation or CABG

Primary outcomes:
measure: Identification of hemodynamic parameters as predictor for a successful mitral valve reconstruction in patients with congestive heart failure
timeFrame: 3 months
Secondary outcomes:
measure: Identification of clinical factors for the postoperative outcome
timeFrame: 3 months
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Heart Center Leipzig GmbH, University Leipzig
Study officials:
affiliation: Chair of the Dep. of Cardiology
name: Gerhard Schuler, Prof.
role: STUDY_CHAIR
affiliation: Consultant of the dep. of Cardiology
name: Sven Möbius-Winkler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01204229: Motivational and Cognitive Intervention for College Drinkers
Official title: Motivational and Cognitive Intervention for College Drinkers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Alcohol Consumption
Anxiety
Depression
Keywords: Alcohol Consumption
Social Anxiety
Depression
Brief Intervention
Motivational Interviewing
Cognitive Behavioral Therapy
Sub-Clinical Social Anxiety
Sub-Clinical Depression
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2010-09-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In the proposed project the investigators will develop and test a novel brief intervention targeting college students who drink heavily to cope with anxiety and depression, a behavior that increases risk for the development of alcohol dependence.


Eligibility criteria: Inclusion Criteria:

- 1. At least 1 heavy drinking episode (4 or more drinks for women; 5 or more drinks for men).

2. Sub-clinical anxiety or depression 3. Occasional to frequent drinking related problems

Exclusion Criteria:

* 1. Clinical Axis I diagnosis 2. Current suicidal ideation, pregnancy, major medical illness, severe alcohol dependence, current hallucinations

Primary outcomes:
measure: Alcohol Consumption and Drinking-Related Negative Consequences
timeFrame: Pre-Treatment, 2-month follow-up, 4-month follow-up, 6-month follow-up
measure: Anxiety
timeFrame: Pre-Treatment, 2-month follow-up, 4-month follow-up, 6-month follow-up
measure: Depression
timeFrame: Pre-Treatment, 2-month follow-up, 4-month follow-up, 6-month follow-up
Secondary outcomes:
measure: Cost efficacy data
timeFrame: 2-3 months post completion
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Psychology Department, University of Cincinnati
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Giao Q. Tran, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05617729: A Clinical Simulation Study of a Test Material on the Anterior Nares
Official title: A Clinical Simulation Study of a Test Material on the Anterior Nares
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonization, Asymptomatic
Lead sponsor: Center for Innovation and Research Organization
Sponsor class: NETWORK
First posted: 2022-11-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is simulate the clinical use of a test material within a 24h window. Efficacy will be simulated as the capacity of the material to reduce or clear the anterior nares bacterial population from opportunistic pathogens (e.g. Staphylococcus Aureus, Escherichia Coli, etc).


Eligibility criteria: Inclusion Criteria:

1. Subject is male or female between 18 to 55 years of age;
2. Subject has normal nasal passage;
3. Subject has not history of chronic nasal passage disease (chronic rhinitis, chronic sinusitis).
4. Subject is willing to have materials applied and follow the protocol;
5. Subject agrees to avoid exposure of the test sites to any chemical product and to refrain from touching the area of application.
6. Subject agrees to refrain from getting the application site wet and scrubbing or washing the test area with soap or applying powders, lotions or personal care products to the area during the course of the study;
7. Subject agrees not to introduce any new cosmetic or toiletry products during the study;
8. Subject is dependable and able to follow directions as outlined in the protocol and anticipates being available for all study visits;
9. Subject is willing to participate in all study evaluations;
10. Subject is in generally good health;
11. Subject understands and is willing to sign an Informed Consent Form

Exclusion Criteria:

1. Female subject is pregnant, nursing, planning a pregnancy, or not using adequate birth control;
2. Subject has a chronic nasal disease (e.g sinusitis, rhinitis);
3. Subject has a bleeding disorder, immunologically compromised, recent illness/vaccination or currently febrile;
4. Subject reports a history of allergies to antiseptics;
5. Subject is currently taking certain medications which, in the opinion of the Principal Investigator, may interfere with the study;
6. Subject has known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs

Primary outcomes:
measure: Colony Forming Units
timeFrame: up to 24 hours following application
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Center for Innovation and Research Organization
state: Pennsylvania
Study officials:
References:
Clinical trial NCT05117229: Correlation of Spinopelvic Movement With Lateral Radiographs
Official title: Correlation of Spinopelvic Movement With Lateral Radiographs to Assess Spine Motion Prior to Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinopelvic Relationships as They Relate to Total Hip Arthroplasty's
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-11-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will have the MetaWear Sensors used on them
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this research is to compare a novel pelvic MetaWear sensor that looks at spine and pelvic movements when taking lateral sit-to-stand radiographs.


Eligibility criteria: Inclusion Criteria:

* Ability to provide informed consent.
* Hip pathology: 20 presenting for total hip arthroplasty, 20 presenting for joint preservation procedures.

Exclusion Criteria:

- Patients with lumbosacral hardware, contralateral THA, or DJD in the contralateral hip.

Primary outcomes:
measure: Pelvic Tilt (PT)
timeFrame: Baseline
measure: Sacral Slope (SS)
timeFrame: Baseline
measure: Pelvic Incidence (PI)
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Rafael J Sierra, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02949089: ACH04 to Assess the Safety and Tolerability in Healthy Adults Subjects
Official title: An Open Label, Dose Escalation Study of ACH04 to Assess the Safety and Tolerability in Healthy Adults Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diarrhea
Keywords: safety
tolerability
rising multiple doses
ACH04
adult
male
Lead sponsor: Ache Laboratorios Farmaceuticos S.A.
Sponsor class: INDUSTRY
First posted: 2016-10-31
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study intends to provide information on the safety and tolerability of repeated oral doses of ACH04. A phase I, single-center, first in human, open-label, dose escalation study of ACH04 to assess the safety and tolerability in healthy adults subjects is selected to best address the study goals.


Eligibility criteria: Inclusion Criteria:

* Subjects will be healthy males subjects between 18 and 50 years of age;
* Subjects must be in good healthy as determined by a medical history, physical examination and clinical laboratory evaluations;
* Subjects will, prior to any study related activities, have given their written informed consent to participate in the study and to abide by the stdy restrictions.

Exclusion Criteria:

* Subjects with hypersensitivity known to Psidium guajava L. or history of serious adverse events;
* Subjects who have a significant history of alcoholism or drug/chemical abuse;
* Subjects who have body mass index \< 18 or \> 30;
* Subjects who have received any medications that is known to have a toxic potential well defined in large organs within the past 3 months prior the study start;
* Subjets who doesn´t agree to use, for the duration of the study, a barrier contraceptive;
* Subjects who were hospitalized for any reason in the six week prior the study start;
* Subjects who, in the opinion of the investigator, should not participate in the study, including subjects suspected for whatever reason of not being able to comply with the requirements of the protocol;
* Subjects who are participating in a clinical trial or have participated in a clinical study involving administration of an investigational drug, within one year;
* Subjects who are relatives of employees from the sponsor and the site, respectively;
* Subjects with, or with a history of, any clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, haematological, dermatological or other major disorders as determined by the Investigator;
* Any finding of clinical observation (anamnesis and physical evaluation), laboratory abnormality, who in the investigator opinion, may jeopardize the subjects or interfere with the study goals.

Primary outcomes:
measure: Evaluate the safety of rising multiple doses of ACH04
timeFrame: up to 39 days
Secondary outcomes:
Other outcomes:
Locations:
city: Fortaleza
country: Brazil
facility: UNIFAC
state: Ceará
Study officials:
References:
Clinical trial NCT00592189: Study of Donated Amnion, Fetal Placental Membrane, as Skin Substitute for Burn Patients
Official title: Fetal Membrane as a New Coverage Material
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Wounds
Keywords: Burns
Wound healing
Amnion
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2008-01-11
Enrollment: 1164
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Is the use of fetal membrane (human amnion) as a transient wound coverage in wound repair safe and efficacious.

Will the incorporation of liposomal gene constructs to amnion enhance the functionality of human amnion and improve wound repair.


Eligibility criteria: Inclusion Criteria:

* Women
* Pregnant, delivery expected within the month

Exclusion Criteria:

* Known history of hepatitis, HIV, or active transmissable diseases

Primary outcomes:
measure: Safe method of obtaining and processing amnion
timeFrame: 0-21 days post harvest
Secondary outcomes:
Other outcomes:
Locations:
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
Study officials:
affiliation: University of Texas
name: David N Herndon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00313989: Evaluation of Osseo-integration After Placement of Dental Implants With Patients Receiving Radiotherapy for Buccopharyngeal Oncology
Official title: Evaluation of Osseo-integration After Placement of Dental Implants With Patients Receiving Radiotherapy for Buccopharyngeal Oncology
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Dental Implants
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2006-04-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Follow up of implants with patients receiving radiotherapy for buccopharyngeal oncology. Implants will be placed 6 weeks before start of the radiotherapy or at least 3 months after the end of the radiotherapy


Eligibility criteria: Inclusion Criteria:

* Patients receiving radiotherapy (6 weeks later or at least 3 months before) for buccopharyngeal oncology

Primary outcomes:
measure: Recovering and ingrowing of dental implants
timeFrame: 4 to 6 months
measure: Success rate of dental implants
timeFrame: 4 to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Hugo De Bruyn, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03011229: Endoscopic Ultrasound (EUS) Fine Needle Biopsy (FNB) Submucosal Nodule
Official title: Endoscopic Ultrasound Fine Needle Biopsy of Submucosal Lesions of the GI Tract; Finding the Right Needle - A Randomized Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: GI Lesions
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2017-01-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to compare the diagnostic accuracy of a novel endoscopic ultrasound (EUS) biopsy needle to the current standard EUS needle.

The investigators hypothesize that with the SharkcoreTM needle a diagnostic yield of 90% is possible for subepithelial lesions (SEL) within the Gastrointestinal (GI) tract versus 60% yield with the current needle.


Eligibility criteria: Inclusion Criteria:

* Patients age 18 or older referred for EUS found to have a hypoechoic lesion \> 8 mm within the GI lumen arising from the muscularis propria, as determined by EUS.
* Women that have a negative pregnant test

Exclusion Criteria:

* Patients under the age of 18.
* Uncorrectable coagulopathy (INR\>1.5)
* Uncorrectable thrombocytopenia (platelet count \<50,000)
* Patient who is unable to comply with study requirements
* Pregnant women
* Female patients who are not tested per our current unit protocol
* Refusal to consent or unable to provide informed consent

Primary outcomes:
measure: diagnostic accuracy of biopsy needle
timeFrame: end of biopsy, approximately 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke
state: North Carolina
Study officials:
affiliation: Duke Health System
name: Joshua Spaete
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02727829: The Assessment of Microcirculation in Brachial Plexus Block Using Perfusion Index and Capillary Filling Time
Official title: The Assessment of Microcirculation in Brachial Plexus Block Using Perfusion Index and Capillary Filling Time
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Circulatory; Change
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2016-04-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: * American Society of Anesthesiologists score of I and III
* ages between 18 and 70
* upper extremity surgery

Brief summary: The aim of the present study is to assess the effects of brachial plexus block on microcirculation using pefusion index and capillary filling time.

Detailed description: Microcirculation is very crucial to evaluate the organ function those working properly in human body. The aim of the present study is to assess the effects of brachial plexus block on microcirculation using pefusion index and capillary filling time. A total of 50 patients whose planned to underwent surgery are performed brachial plexus block using ultrasound, and pefusion index, heart rate, blood pressure, capillary filling time are measured at 0, 10th and 20th minutes interval and at postoperative 24th hours. All measures will be recorded.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists score of I and III
* ages between 18 and 70
* upper extremity surgery

Exclusion Criteria:

* not to participate in the study
* reject to perform the intervention
* infection in injection cite
* allergy to local anesthetics
* peripherical vasculary diseases
* psychiatric diseases
* coagulation anomalies

Primary outcomes:
measure: perfusion index
timeFrame: five times in one year
Secondary outcomes:
measure: capillary filing time
timeFrame: five times in one year
measure: heart rate
timeFrame: five times in one year
measure: blood pressure
timeFrame: five times in one year
measure: oxygen saturation
timeFrame: five times in one year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02978729: Telephone Versus Videoconference Communication for Remote Genetic Disclosure in the APOE4 Trial
Official title: A Randomized Study of Telephone Versus Videoconference Communication for Remote Genetic Disclosure in the APOE4 Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Genetic Predisposition to Disease
Keywords: Telemedicine
Counseling, Genetic
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2016-12-01
Enrollment: 613
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to compare two methods for remote genetic counseling (telephone and two-way videoconferencing) for patients who are receiving disclosure of their APOE (apolipoprotein E) genotype. The target population will consist of males and females in the age range of 60-75 years who, as potential participants in a study (Generation Study), will need to receive genetic counseling and disclosure of APOE genotype. Subjects must be willing to receive genetic counseling and disclosure remotely. Subjects must be willing to be randomized to either telephone arm or videoconference arm.


Eligibility criteria: Inclusion Criteria:

1. Eligible to participate in the Generation Study
2. Ability to provide consent
3. Ability to communicate and hear in English

Exclusion Criteria:

-

Primary outcomes:
measure: Satisfaction with genetic counseling services as measured by the Satisfaction with Genetic Services Scale
timeFrame: 2-7 days
measure: Satisfaction with genetic counseling services as measured by the Satisfaction with Remote Counseling Scale
timeFrame: 2-7 days
Secondary outcomes:
measure: Knowledge of Genetic Disease as measured by the Cancer Genetics Knowledge Scale
timeFrame: 2-7 days, 6 weeks, 6 months, 12 months
measure: Disease-specific distress as measured by the Impact of Events Scale
timeFrame: 2-7 days, 6 weeks, 6 months, 12 months
measure: Perceived risk of Alzheimers Disease as measured by questionnaire items measuring perceived risk in quantitative, qualitative, and relative terms
timeFrame: 2-7 days, 6 weeks, 6 months, 12 months
measure: Responses to Genetic Testing as measured by the Impact of Genetic Testing for Alzheimer's disease (IGT-AD) scale
timeFrame: 2-7 days, 6 weeks, 6 months, 12 months
measure: Depression as measured by the GDS Short Form
timeFrame: 2-7 days, 6 weeks, 6 months, 12 months
measure: Anxiety as measured by the Mini State Trait Anxiety Inventory (mSTAI):
timeFrame: 2-7 days, 6 weeks, 6 months, 12 months
measure: Knowledge of Genetic Disease as measured by the ClinSeq Knowledge Scale
timeFrame: 2-7 days, 6 weeks, 6 months, 12 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Pennsylvania
name: Angela R Bradbury, MD
role: PRINCIPAL_INVESTIGATOR
References: