louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01629953: Assessing Supported Employment With Veterans With Felony Convictions and Mental Illness or Substance Abuse
Official title: Assessing Supported Employment With Veterans With Felony Convictions and MI or SA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Employment
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: North Texas Veterans Healthcare System
First posted: 2012-06-28
Enrollment: 140
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: This study continues to develop and refine best practices in the delivery of vocational services to veterans with histories of felony convictions and mental health/substance abuse difficulties. There are currently over 225,000 incarcerated veterans and it is estimated 64,000 veterans are released from prisons annually. These veterans encounter significant difficulties in finding employment due to stigma, intrapersonal difficulties, and out-dated work skills. Additionally these veterans are more likely to be homeless than other population., Previous work has found that manual based, vocational groups led by trained vocational staff led to quicker employment compared to traditional vocational services and manual based self studies. To attempt to improve on previous results, this study adds principles and components of supported employment including ongoing follow-up, treatment team coordination, and community based assistance.


Eligibility criteria: Inclusion Criteria:

* history of at least one felony conviction
* diagnosis of a mental illness including substance use disorders

Exclusion Criteria:

* dementia
* active psychosis

Primary outcomes:
measure: Employment
timeFrame: within 6 months
measure: Total Employment
timeFrame: 1 years
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
state: Texas
Study officials:
affiliation: VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
name: James P. LePage, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02031653: Comparison Between Invasive Pressure Flow Study and Non-invasive Penile Cuff Test
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bladder Outlet Obstruction
Pressure Flow Study
Keywords: Penile Cuff Test
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2014-01-09
Enrollment: 335
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male patients with Low Urinary Tract Symptoms over 6 months.

Brief summary: To provide evidence of promising tests to noninvasively diagnose bladder outlet obstruction (BOO) in men with benign prostatic hyperplasia.

1. Penile cuff test provides a means of obtaining a urodynamic diagnosis with a high level of accuracy without the morbidity and expense of invasive Pressure flow study.
2. Penile cuff test may be particularly useful in the counseling of patients prior to benign prostatic hyperplasia operation. Patients diagnosed as obstructed following a penile cuff test can be reassured that surgery has a high chance of resulting in symptomatic benefit


Eligibility criteria: Inclusion Criteria:

1. Male patients with Low Urinary Tract Symptoms over 6 months. (International prostatic symptom score \>= 12)
2. Patients scheduled to have pressure flow study.
3. Able to give fully informed consent

Exclusion Criteria:

1. Patients with urologic malignancies such as prostate cancer and bladder cancer
2. Patients underwent urethral, prostate surgery
3. Patients with urethral stricture or bladder diverticulum or bladder neck contracture
4. seems not to be appropriate to this study by the decision of investigators because of any other reasons

Primary outcomes:
measure: The Positive/Negative Predictive Value of Penile cuff test
timeFrame: 5 hours
measure: The proportion comparison of Good responder between obstructed and unobstructed patients in penile cuff test
timeFrame: up to 3 months
Secondary outcomes:
measure: The correlation of intra-vesical Pressure between Pressure flow study and penile cuff test
timeFrame: 5 hours
measure: The difference of Pain visual analogue scale score between two diagnostic tests
timeFrame: 5 hours
measure: The categorical change of penile cuff test normogram after BPH operation
timeFrame: up to 3 months
measure: The PSA level change after benign prostatic hyperplasia operation in obstructed and non-obstructed patients.
timeFrame: up to 3 months .
measure: The changes of International Prostatic Symptom Scores after BPH operation.
timeFrame: up to 3 months
Other outcomes:
Locations:
city: Seoul,
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT06555653: The Effect of Video-based Multimedia Information Before Amniocentesis on Pain, Anxiety and Pregnancy Outcomes
Official title: The Effect of Video-based Multimedia Information Before Amniocentesis on Pain, Anxiety and Pregnancy Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amniocentesis
Video Information
Keywords: Video-based information, amniocentesis
Lead sponsor: Başakşehir Çam & Sakura City Hospital
Sponsor class: OTHER_GOV
First posted: 2024-08-15
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women who received video based multimedia information about amniocentesis

Brief summary: The goal of this clinical trial is to assess the effect of video-based multimedia information before amniocentesis on pain, anxiety and pregnancy outcomes

Detailed description: Amniocentesis is the most commonly used invasive prenatal diagnostic test. This study aimed to investigate the effect of video-based multimedia information (MMI) on the anxiety and pain levels of patients undergoing amniocentesis.

All consecutive women aged 18-45 years scheduled for amniocentesis were included in this prospective randomized controlled study. Subjects were assigned to receive video-based MMI or traditional written information (controls). Anxiety levels were assessed at the first admission using the State and Trait Anxiety Inventory-State (STAI-S). After MMI and written information, STAI-S was repeated before the procedure. A standard amniocentesis procedure was performed on all patients by the same perinatology physicians. After amniocentesis, a Likert scale was used to evaluate the ease of the procedure and patient satisfaction, and a visual analog scale was used to evaluate pain. Pregnancy results and amniocentesis results were noted

Eligibility criteria: Inclusion Criteria:

* All consecutive women aged 18-45 years scheduled for amniocentesis

Exclusion Criteria:

-

Primary outcomes:
measure: To assess the effect of video based information on pain levels
timeFrame: 01.12.2023- 01.04.2024
measure: To assess the effect of video based information on anxiety
timeFrame: 01.12.2023- 01.04.2024
measure: To assess the effect of video based information on ease of procedure
timeFrame: 01.12.2023- 01.04.2024
measure: To assess the effect of video based information on pregnancy outcome
timeFrame: 01.12.2023- 01.04.2024
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Basaksehir Cam and Sakura City Hospital
Study officials:
affiliation: Başakşehir Çam & Sakura City Hospital
name: Nihal Callıoglu
role: STUDY_DIRECTOR
References:
Clinical trial NCT01694953: The Natural History Study of Mitochondrial NeuroGastroIntestinal Encephalopathy (MNGIE)
Official title: The Rare Disease Clinical Research Network Natural History Study of MNGIE
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mitochondrial NeuroGastroIntestinal Encephalopathy (MNGIE)
Keywords: MNGIE
Mitochondrial
Mitochondrial Neurogastrointestinal encephalopathy
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2012-09-27
Enrollment: 20
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male or female, At least 5 years of age, with Thymidine Phosphorylase defect

Brief summary: This is a multi-center natural history study of Mitochondrial NeurogastroIntestinal Encephalopathy (MNGIE). Patients will be followed over time to assess clinical symptoms. The investigators hope to learn more about the disease of MNGIE as well as develop useful measures of disease status for use in future clinical trials.

Additional clinical centers will be listed as they become available.

Detailed description: The investigators will examine a total of 20 patients at six month intervals for up to five years. The investigators will evaluate gastrointestinal function, lean body mass, neuropathy, neuropsychological capability, quality of life, nutrition, motor function and biochemical parameters.

Eligibility criteria: Inclusion Criteria:

1. Thymidine Phosphorylase (TP) defect:

   1. homozygous or
   2. compound heterozygous mutations in the TYMP gene, and/or
   3. TP enzyme activity of \<20% of normal.
2. Increased plasma Thd \> 3 micromole/L
3. Increased plasma dUrd \> 7.5 micromole/L
4. Age requirement of at least 5 years of age.

Exclusion Criteria:

1. Participation in an interventional (study medication or other experimental intervention) study (within 1 month of participation in this study).
2. Unable to travel to site for research visits.
3. Unwillingness to sign informed consent form.
4. Substance abuser

Primary outcomes:
measure: Timed Water Swallow
timeFrame: 5 years
Secondary outcomes:
measure: Degree of Neuropathy
timeFrame: 5 years
Other outcomes:
measure: Score on Mini Mental State Exam
timeFrame: 5 years
Locations:
city: New York
country: United States
facility: Columbia University
state: New York
Study officials:
affiliation: Columbia University
name: Michio Hirano, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marti R, Lopez LC, Hirano M. Assessment of thymidine phosphorylase function: measurement of plasma thymidine (and deoxyuridine) and thymidine phosphorylase activity. Methods Mol Biol. 2012;837:121-33. doi: 10.1007/978-1-61779-504-6_8.
Clinical trial NCT04319653: Development of a Pelvic Cavity Characterization Algorithm Through the Acquisition of MRI Images and Pressure Measurement by an Intravaginal Probe
Official title: Development of a Pelvic Cavity Characterization Algorithm Through the Acquisition of MRI Images and Pressure Measurement by an Intravaginal Probe
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pelvic Floor Disorders
Keywords: Geometrical reconstruction
Pelvic Floor Disorders
FE models
Pelvic system
MRI
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2020-03-24
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The conditions such as childbirth or endometriosis can lead to a change in the mobility of the pelvic organs (bladder, vagina, rectum and uterus). The purpose of the study is to study in a personalized way each woman the characteristics of the tissues of their pelvis and to be able to personalize the treatments (surgery, injection, rehabilitation, etc.). Women requiring pelvic MRI may participate in the study. The pelvic dynamic MRI will be done with an intravaginal probe which will be inserted by the patient herself as well as gel in the anus and vagina which will allow to obtain the data on the characteristics of the pelvic tissues of each woman with a 3D reconstruction.


Eligibility criteria: Inclusion Criteria:

All:

* Understanding of the French language
* Signature of informed consent
* Insured social patient

For pregnant women:

* Primiparous women
* with no severe maternal-fetal pathology
* with no scheduled caesarean section at the time of the MRI

For women with prolapse:

- Requires pelvic MRI

Exclusion Criteria:

* Minor
* Person who does not have social security
* Person with ongoing vaginal infection
* Pregnant woman during the first or third trimester of pregnancy
* Pregnant woman with broken water pocket
* Bi-cicatricial uterus
* IVF
* Person wearing a pace maker or any intra-body metal implant (if "tube" MRI)
* Claustrophobic person (if "tube" MRI)

Primary outcomes:
measure: 3D reconstruction of the pelvic cavity
timeFrame: at 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Jeanne de Flandres, CHU
Study officials:
affiliation: University Hospital, Lille
name: Michel COSSON, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05389553: Fetal Doppler and Uterine Artery Blood Volume Correlation.
Official title: The Association Between Fetal Doppler and Uterine Artery Blood Volume at Term of Pregnancy: A Prospective Observational Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fetal Doppler
Uterine Blood Flow
Keywords: Doppler
Pregnancy
ultrasound
uterine blood flow
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
First posted: 2022-05-25
Enrollment: 49
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Full-term pregnancies (37-42 weeks) comprised all pregnant women who would give birth at our hospital.

Brief summary: To investigate the relationship between uterine artery blood volume and fetal doppler indices at the delivery.

Detailed description: Introduction: To investigate the relationship between uterine artery blood volume and fetal doppler indices at the delivery.

Materials and Methods: This was a prospective cohort study of 50 nulliparous women booking antenatal care at the University of Campania "Luigi Vanvitelli" between May 2022 and September 2022. All full-term pregnancies accepted for delivery will include. Pregnant women with antepartum haemorrhage, stillbirths, multiple gestations, or congenital abnormalities were excluded. Women underwent a transabdominal ultrasound examination of uterine arteries for measurement of Uterine artery blood volume. Pregnancy outcomes were recorded, and linear regression was used to study the relationship between uterine artery blood volume and fetal Doppler indices. SPSS version 25 (Chicago, IL, USA) was used to code, tabulate, and analyze the data. Quantitative data were analyzed using the student's t-test. Qualitative data were analyzed using the Mann-Whitney test. A statistically significant difference was defined as a p-value of 0.05.

Eligibility criteria: Inclusion Criteria:

* full-term pregnancies (37-42 weeks)

Exclusion Criteria:

* antepartum hemorrhage, fetal growth restriction, stillbirths, multiple gestations, or congenital abnormalities

Primary outcomes:
measure: We estimate the uterine volume and its correlation with the fetal doppler indices
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Università degli studi della Campania "Luigi Vanvitelli"- OB & Gyn -
state: Italia
Study officials:
References:
Clinical trial NCT06289153: Internal Bracing Following ACL Reconstruction
Official title: Effect of Internal Bracing on Outcomes Following ACL Reconstruction With Quadriceps Tendon: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: ACL Injury
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2024-03-01
Enrollment: 30
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 purpose of this study is to assess Anterior Cruciate Ligament (ACL) healing through analyzing clinical, radiographic, functional and patient-reported outcomes following ACL reconstruction with quadriceps graft with and without internal bracing.

Detailed description: The primary objective is to compare functional outcomes at one year in patients who underwent ACLR with or without internal bracing. The secondary outcomes are to characterize the evidence of ACL healing at 1 year by MRI imaging of the knee and obtain data on clinical and patient reported outcomes at 1 year follow-up.

Eligibility criteria: Inclusion Criteria:

• History of ACL injury indicated for isolated reconstruction, without concomitant ligament reconstruction or repair, cartilage repair procedure, or osteotomy.

Exclusion Criteria:

* Patients who underwent concomitant ligament reconstruction or repair, cartilage repair procedure, or osteotomy.
* History of blood-borne diseases including HIV, HBV, HCV, HTLV, and syphilis.

Primary outcomes:
measure: Change from Baseline in 2000 International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form at Month 6 Post-Operation
timeFrame: Baseline, Month 6 Post-Operation
measure: Change from Baseline in 2000 IKDC Subjective Knee Evaluation Form Score at Month 12 Post-Operation
timeFrame: Baseline, Month 12 Post-Operation
measure: Change from Baseline in Lysholm Knee Scoring System Score at Month 6 Post-Operation
timeFrame: Baseline, Month 6 Post-Operation
measure: Change from Baseline in Lysholm Knee Scoring System Score at Month 12 Post-Operation
timeFrame: Baseline, Month 12 Post-Operation
measure: Change from Baseline in Visual Analogue Scale (VAS) - Pain Score at Month 6 Post-Operation
timeFrame: Baseline, Month 6 Post-Operation
measure: Change from Baseline in Visual Analogue Scale (VAS) - Pain Score at Month 12 Post-Operation
timeFrame: Baseline, Month 12 Post-Operation
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Guillem Gonzalez-Lomas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02374853: Topical Use of Vancomycin in Reducing Sternal Wound Infection in Cardiac Surgery (SWI Trial)
Official title: Topical Use of Vancomycin in Reducing Sternal Wound Infection in Cardiac Surgery (SWI Trial)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: INFECTION
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2015-03-02
Enrollment: 1037
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this research is to determine if using the antibiotic vancomycin as a preventative topical (on the surface of the skin) treatment during open-heart surgery will reduce the risk of developing a sternal wound infection.

Detailed description: During open-heart surgery, an incision is made along the chest and the sternum (breastbone) is divided. The sternum is held open throughout the surgery so that the doctors can reach the heart. Sternal wound infection is an uncommon but serious complication of cardiac surgery that occurs when an infection develops at this site of entry. Sternal wound infections are associated with increased hospital stays, subsequent surgical procedures, and higher mortality rates.

The purpose of this research is to determine if using the antibiotic vancomycin as a preventative topical (on the surface of the skin) treatment during open-heart surgery will reduce the risk of developing a sternal wound infection. The results of this study could provide important information to guide new standards of practice in cardiac surgery. The ultimate goal of this research project is to improve patient care by reducing the number of sternal wound infections at our hospital.

Eligibility criteria: Inclusion Criteria:

* Able to sign Informed Consent and Release of Medical Information Form
* Age ≥ 18 years
* Undergoing cardiac surgery with complete sternotomy (including re-operations)

Exclusion Criteria:

* Evidence of active infection (any culture positive or blood positive infection)
* Undergoing organ transplantation
* Patients with known hypersensitivity to vancomycin
* Pregnant or nursing women
* Mental impairment or other conditions that may not allow participant to understand the nature, significance, and scope of study

Primary outcomes:
measure: Number of Sternal Wound Infections
timeFrame: 3 months postoperative
Secondary outcomes:
measure: Number of Sternal Wound Infections
timeFrame: 1 year postoperative
measure: Hospitalization
timeFrame: 1 year postoperative
measure: Number of Participants With Use of Prophylactic Antibiotics
timeFrame: Assessed before surgery
measure: Cost Analysis for Sternal Wound Infection Treatment
timeFrame: 1 year postoperative
measure: Adverse Events
timeFrame: 1 year postoperative
Other outcomes:
Locations:
Study officials:
affiliation: University of Alberta
name: Abbas Khani-Hanjani, MD
role: PRINCIPAL_INVESTIGATOR
References: