louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02433587: Short vs Long Duration Dual Antiplatelet Therapy in Patients Undergoing Lower Extremity Endovascular Revascularization
Official title: Evaluation of Short Versus Long Duration Dual Antiplatelet Therapy in Patients Undergoing Lower Extremity Endovascular Revascularization
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Peripheral Arterial Disease
Endovascular Procedures
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2015-05-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the trial is to evaluate short versus long duration dual antiplatelet therapy in patients undergoing lower extremity endovascular revascularization.


Eligibility criteria: Inclusion Criteria:

1. Provide signed informed consent before initiation of any study related procedures
2. Be at least 18 years of age
3. Successful percutaneous lower extremity (iliac and infrainguinal) endovascular revascularization (percutaneous transluminal angioplasty, and /or stent).
4. At least 1 vessel run-off in segment distal to the intervention
5. Rutherford Classification 2-5 that is unresponsive to medical therapy

Exclusion Criteria:

1. Acute limb ischemia
2. Procedure includes device deployment that has specific FDA regulations for anticoagulation/anti-platelet medication regimen.
3. Patient undergoing atherectomy procedure
4. Intervention includes deployment of drug eluted stent
5. Critical limb ischemia (Rutherford Classification 6)
6. Thrombocytopenia: Platelet count \<50k
7. Liver disease (Childs-Pugh B or C)
8. Existing need for on going clopidogrel therapy
9. Proton Pump Inhibitor Use (If unable to be switched)
10. Need for therapeutic anticoagulation
11. Known hypercoagulable disorder
12. Allergy or contraindication to aspirin or clopidogrel
13. Pregnancy
14. Patients enrolled in another investigational drug or device study within the past 30 days

Primary outcomes:
measure: Major Adverse Cardiovascular Event Rates
timeFrame: 12 months post-intervention
measure: Major Adverse Limb Event Rates
timeFrame: 12 months post-intervention
Secondary outcomes:
measure: Quality of Life Outcome
timeFrame: 12 Months post-intervention
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
Study officials:
References:
Clinical trial NCT03688087: Study of Programm Interest 'Bouge' to Improve the Daily Physical Activity at the Pregnant Women.
Official title: Study of Program Interest "Bouge" to Improve the Daily Physical Activity and Tolerance in Processings Treatment of Pregnant Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Physical Activity
Pregnant
Mobile Health Apps
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2018-09-28
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Evaluate the "Bouge" digital program (smartphone application) to increase the daily physical activity of pregnant patients beguining at 15 SA

Detailed description: Controlled, randomized, open, prospective, multicentric study, 250 pregnant patients aged between 18 and more, with 14 weeks of amenorrhea, possessing a smartphone, will be recruited and randomized into two groups:

125 in the control group (smartphone application "placebo" = number of steps) 125 will be equipped with the application "Bouge" = coached group

For three months, the patients do their daily physical activity. The "coached" group, through the smartphone application "Bouge", receives computer coaching to increase their physical activity (no direct medical intervention, only notifications and computer pusch).

The control group is not coached by the application (simple display of the number of step)

Eligibility criteria: Inclusion Criteria:

Pregnant \<14 weeks of amenorrhea Must have a compatible smartphone

Exclusion Criteria:

Multiple pregnancies Pre-existing pregnancy-related diseases Pregnancy complicated History of peripheral arterial disease History of IUGR History of cone biopsy History of delivery hemorrhage

Primary outcomes:
measure: Increased daily physical activity (number of steps) using the smartphone application "BOUGE"
timeFrame: 12 Weeks
Secondary outcomes:
measure: sleep,
timeFrame: 12 Weeks
measure: Well being
timeFrame: 12 Weeks
measure: - lumbago
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Brest
country: France
facility: Clinique KERAUDREN
city: Brest
country: France
facility: CHRU de Brest
city: Morlaix
country: France
facility: CH de Morlaix
city: Quimper
country: France
facility: Chic Quimper
Study officials:
References:
Clinical trial NCT04824287: Pelvic Floor Muscle Exercises Effect After Stoma Closure
Official title: The Effect of Pelvic Floor Muscle Exercises on Bowel Evacuation Problems and Quality of Life in Individuals With Closed Stoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stoma
Keywords: stoma
stoma and wound care nurse
pelvic floor exercises
bowel evacuation problems
quality of life
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 40
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: OTHER

Brief summary: This study was conducted to evaluate the effect of pelvic floor muscle exercises on bowel evacuation problems and quality of life in individuals after stoma closure.

Detailed description: Sample of study was calculated as 32 using G\*Power Software (ver. 3.1.9.2) for 80% power and medium effect size (f=0.25) at 95% confidence level in line with the data of Lin et al. Participants were assigned to the experimental and control groups by the stratified block randomization method. The locks were assigned to layers using Microsoft Excel.

The individuals in the experimental group received pelvic floor muscle exercises training from the researcher using the Roy Adaptation Model in addition to routine discharge training. The patients received a PFME training booklet prepared by the researcher. Face-to-face training was given to the individuals in the experimental group on the day before the operation, on the second and third postoperative days, and on the day of discharge. The training continued with phone calls at the first, second and third weeks and the first, second, third, and sixth months after the surgery. Data was collected a day before discharge, first, second, third, and sixth months after the surgery.

Eligibility criteria: Inclusion Criteria:

* Being between the ages of 18 and 75,
* Being literate,
* Having a stoma due to colorectal cancer,
* Having no previous anal trauma,
* Having no anal surgery other than colorectal cancer surgery,
* Having no congenital anorectal anomaly,
* Having no neurological problem,
* Having no physical disability,
* Having no previous experience of PFMEs before the surgery,
* Being cognitively able to answer questions

Exclusion Criteria:

* Wanting to leave the study,
* Having had previous biofeedback and electrical stimulation therapy applications,
* Having another stoma,
* Not being reachable by phone.

Primary outcomes:
measure: Bowel Evacuation Habits
timeFrame: 6 month
measure: Wexner Scale Score
timeFrame: 6 month
measure: Psychosocial Problems
timeFrame: 6 month
measure: Health-related Quality of Life
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Yıldırım Beyazıt University, Faculty of Health Sciences, Department of Nursing
Study officials:
affiliation: Ankara Yıldırım Beyazıt University, Faculty of Health Sciences, Department of Nursing
name: Dilek Aktaş
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00285987: Quality of Life After an Ambulatory Reconstruction of the Cruciate Ligament
Official title: Quality of Life After an Ambulatory Reconstruction of the Cruciate Ligament
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Rupture of the Cruciate Ligament
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2006-02-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study to compare the quality of life after reconstruction of the cruciate ligament in hospitalized versus day-clinic patient


Eligibility criteria: Inclusion Criteria:

* rupture of the cruciate ligament

Exclusion Criteria:

-

Primary outcomes:
measure: Quality of life
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Ghent
name: Rene Verdonk, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04271787: New Periodontal Classification
Official title: Periodontal Diseases Classification: Old is Gold or New is Bold
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontal Diseases
Peri-Implantitis
Gingival Diseases
Keywords: Classification
Periodontal diseases
Periodontitis
Peri-implantitis
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
Collaborators: name: Cairo University
First posted: 2020-02-17
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: periodontists in various universities

Brief summary: A new classification system of periodontal and peri-implant diseases and conditions was proposed by consensus of world experts in 2017. Since then there has been ongoing debates among periodontists regarding the application of the new classification. This study aims to shed light on the current understanding of the new classification among Egyptian periodontists.

Detailed description: This study was approved by the Research Ethics Committee of Faculty of Dentistry Beni-Suef University (ID #FDBSUREC/27022019/AM) and was conducted in full accordance with the World Medical Association Declaration of Helsinki 1975, revised in 2003. The questionnaire was anonymous with no personal identification data. Completion and submission of the questionnaire was considered an approved informed consent to participate in the study by the Research Ethic Committee.

The questionnaire was designed by the authors and pilot tested among a group of 12 periodontists for validation. Afterwards, adjustments were made to ensure a clear and comprehensive version of the questionnaire. The questionnaire had a cover letter explaining the nature and purpose of the survey and comprised 15 questions. The first six statements of the questionnaire were descriptive in nature addressing the participant's demographics, and the seventh was a question whether the participant is aware of the new PDL classification or not. Only those who were aware of it were asked to proceed to 13 multiple choice questions using Likert scale; ranging from strongly disagree to strongly agree or from excellent to poor, in addition to "I don't know" option (8). There were also three open ended questions for further comments at the end of the questionnaire.

Eligibility criteria: Inclusion Criteria:

* periodontists

Exclusion Criteria:

* non periodontists

Primary outcomes:
measure: significant predictors of satisfaction with the new classification.
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Maha Abdelkawy, Phd
Study officials:
References:
Clinical trial NCT02878187: Uterine Cavity and Blood Flow After Conservative Management of Placenta Previa/Accreta
Official title: Evaluation of the Uterine Cavity and Blood Flow After Conservative Management of Placenta Previa/Accreta
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Improving Quality of Life
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-08-25
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All women delivered by elective/emergency cesarean section due to placenta previa/accreta during the study period will be included in the study.

Brief summary: Bleeding is the most significant cause of maternal death worldwide with more than half of those occurring within the first day of delivery. About 10.5% (some estimate as high at 12-17%) of live births world-wide, or about 14 million births, are complicated by postpartum hemorrhage; a woman dies every 4 minutes from postpartum hemorrhage. Uterine atony and placenta accreta are the two leading causes of postpartum hysterectomies with up to 64% of Cesarean hysterectomies done for abnormally adherent placentation

Detailed description: No previous studies performed for evaluation of the effect of those procedures on the uterine cavity or uterine blood flow. Most of the studies in the literature evaluated the menstrual and fertility outcome after conservative measures for intraoperative hemorrhage due to placenta previa/accreta were retrospective and depend on the resumption of menses and pregnancy rate

Eligibility criteria: Inclusion Criteria:

1. Women Age 18-40 years
2. Gestational age of pregnancy 28-40 weeks
3. Diagnosed antenatally as placenta previa/accreta
4. Patients who will be managed by conservative surgical techniques for intraoperative hemorrhage
5. Women who will accept to participate in the study and are reliable for follow-up

Exclusion Criteria:

* 1- Patients who will be managed by hysterectomy 2- Patients who will be managed by conservative leaving the placenta in-situ 3- Diabetic or hypertensive women 4- Women who will refuse to participate in the study

Primary outcomes:
measure: The mean difference in the uterine arteries diameters in both groups
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Ahmed Abbas
state: Cairo
Study officials:
affiliation: Assiut University
name: Ahmed Abbas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00907309: Dental and Medical Office iMET to Reduce Teen Tobacco, Alcohol, and Drug Use
Official title: Dental and Medical Office Internet/Intranet Motivational Enhancement Therapy to Reduce Teen Tobacco, Alcohol, and Drug Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Use; Tobacco, Harmful
Alcohol Abuse
Drug Abuse
Keywords: alcohol abuse
marijuana abuse
drug abuse
tobacco use
tobacco dependence
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Cambridge Health Alliance
name: Tufts Medical Center
name: Harvard School of Dental Medicine
name: Fallon Clinic
First posted: 2009-05-22
Enrollment: 121
Sex: ALL
Minimum age (years): 12
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the project is to improve adolescent behavioral counseling services in healthcare settings with a new Internet/Intranet-based Motivational Enhancement Therapy (iMET) intervention that targets the use of tobacco, alcohol, and other drugs.

Detailed description: We have previously developed and tested in a treatment population a promising MET program for alcohol and drug use. We will broaden the MET intervention to also target tobacco use and convert the new materials into a self-administered format.

Eligibility criteria: Inclusion Criteria:

* 12-21 years old
* Coming for routine care

Exclusion Criteria:

* Medically or emotionally unstable day of visit
* Already receiving behavioral health services
* Cannot read/understand English
* Will not be available for post-tests

Primary outcomes:
measure: Frequency of tobacco, alcohol, marijuana, and other drug use
timeFrame: 3 months, 6 months
Secondary outcomes:
measure: Rates of initiation and cessation of tobacco, alcohol, marijuana and other drug use
timeFrame: 3 months, 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: John R. Knight, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Holliday R, Hong B, McColl E, Livingstone-Banks J, Preshaw PM. Interventions for tobacco cessation delivered by dental professionals. Cochrane Database Syst Rev. 2021 Feb 19;2(2):CD005084. doi: 10.1002/14651858.CD005084.pub4.
Clinical trial NCT04559009: COVID-19 Amyotrophic Lateral Sclerosis (ALS) Registry
Official title: COVID-19 Amyotrophic Lateral Sclerosis (ALS) Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Amyotrophic Lateral Sclerosis
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2020-09-22
Enrollment: 47
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: Our study population consists of qualifying cases of patients with ALS who have had a laboratory confirmed COVID-19 infection.

Brief summary: Amyotrophic lateral sclerosis (ALS) is a relentlessly progressive and fatal neurodegenerative disease characterized by progressive weakness involving limb, bulbar, and respiratory muscles.There is currently no information suggesting how COVID-19 affects patients diagnosed with amyotrophic lateral sclerosis (ALS). This is especially important as respiratory compromise is common in ALS patients and can complicate the clinical course as COVID-19 could lead to respiratory failure and need for intubation. We intend that this registry will guide our understanding of how COVID-19 affects patients with ALS.

Detailed description: The purpose of this registry is to assess the incidence and prevalence of COVID-19 in ALS patients, the effect of COVID-19 on ALS disease trajectory, and the impact, if any, of edaravone, riluzole and other concomitant medication used in ALS like Albuterol and dextromethorphan/quinidine (Nuedexta) on these parameters. COVID-19 incidence and prevalence in the ALS population will be assessed through outcomes reporting ranging from recovered infections to patient death reported in a patient facing registry.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of ALS and
* A confirmed COVID-19 infection determined by:

  1. positive SARS-CoV-2 viral RNA PCR test and/or
  2. positive serology antibody testing for SARS-CoV-2

Exclusion Criteria:

* No ALS diagnosis
* No confirmed COVID-19 infection

Primary outcomes:
measure: COVID-19 incidence and prevalence in the ALS population
timeFrame: Data will be collected through study completion, an average of 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Neurosciences Institute, Neurology - Charlotte
state: North Carolina
Study officials:
affiliation: Neurologist/ MDA Director
name: Urvi Desai, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01783509: Limb Girdle Muscular Dystrophy (LGMD) Natural History
Official title: Longitudinal Assessment and Genetic Understanding of Limb-Girdle Muscular Dystrophy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Muscular Dystrophies, Limb-Girdle (GENETICALLY CONFIRMED)
Keywords: GENETICALLY CONFIRMED limb girdle muscular dystrophy
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Muscular Dystrophy Association
First posted: 2013-02-05
Enrollment: 13
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of GENETICALLY CONFIRMED LGMD

Brief summary: The purpose of this study is to understand more about limb-girdle muscular dystrophy. Therefore, the investigators would like to track the following information collected once a year from patients with GENETICALLY CONFIRMED LGMD: quality of life questionnaires, muscle strength, motor function, routine examination, assessment of patient (or parent) understanding of LGMD, and serum (blood) for growth factors, cytokines, and biomarkers (all parts of your blood). By tracking this information, we hope to be able to understand more about the diagnosis, progression and natural history of this disorder.


Eligibility criteria: Inclusion Criteria:

* You have a GENETICALLY CONFIRMED diagnosis of Limb Girdle Muscular Dystrophy
* You must be at least 6 years of age or older (if under 18 you will need Parental consent)
* You must be able to travel to the study site
* You must be able to provide a DNA/Gene testing report that confirms a diagnosis of LGMD

Exclusion Criteria:

* You or your child do not have a diagnosis of LGMD
* Your child is under age 6
* You or your child are not able to travel to the study site

Primary outcomes:
measure: Comprehensive clinical evaluation of individuals with GENETICALLY CONFIRMED LGMD, according to the study protocol, in order to evaluate disease progression
timeFrame: yearly up to 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Carolinas Medical Center - Pediatrics
state: North Carolina
Study officials:
affiliation: Carolinas Medical Center - Pediatrics
name: Ibrahim Binalsheikh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04150809: A Study to Explore the Role of Gut Flora in ALS
Official title: A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Amyotrophic Lateral Sclerosis
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: ALS
Amyotrophic Lateral Sclerosis
Motor Neuron Disease
Lead sponsor: ProgenaBiome
Sponsor class: OTHER
First posted: 2019-11-05
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with ALS

Brief summary: This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding ALS

Detailed description: The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to the information provided in surveys and in medical records regarding ALS

Eligibility criteria: Inclusion Criteria:

1. Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study
2. Male or female patients of any age (interest is given to children to compare with mothers).
3. Diagnosis of ALS

Exclusion Criteria:

1. Refusal to sign informed consent form
2. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
3. Postoperative stoma, ostomy, or ileoanal pouch
4. Participation in any experimental drug protocol within the past 12 weeks
5. Treatment with total parenteral nutrition
6. Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial
7. Inability to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study

Primary outcomes:
measure: Correlation of Microbiome to ALS via Relative Abundance Found in Microbiome Sequencing
timeFrame: One year
Secondary outcomes:
measure: Validation of Sequencing Methods
timeFrame: One year
Other outcomes:
Locations:
city: Ventura
country: United States
facility: ProgenaBiome
state: California
Study officials:
affiliation: ProgenaBiome
name: Sabine Hazan, MD
role: PRINCIPAL_INVESTIGATOR
References: