louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00311376: Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Overactive Bladder
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2006-04-06
Enrollment: 416
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
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 the safety and effectiveness of botulinum toxin type A in treating overactive bladder in spinal cord injury or multiple sclerosis patients.


Eligibility criteria: Inclusion Criteria:

* Urinary incontinence as a result of neurogenic overactive bladder due to spinal cord injury or multiple sclerosis
* Inadequate response to anticholinergic medication used to treat overactive bladder

Exclusion Criteria:

* History of evidence of pelvic or urologic abnormality
* Previous or current diagnosis of bladder or prostate cancer
* Urinary tract infection at time of enrollment

Primary outcomes:
measure: Change From Baseline in Number of Weekly Episodes of Urinary Incontinence
timeFrame: Baseline, Week 6
Secondary outcomes:
measure: Change From Baseline in Maximum Cystometric Capacity (MCC)
timeFrame: Baseline, Week 6
measure: Change From Baseline in Maximum Detrusor Pressure (MDP)
timeFrame: Baseline, Week 6
measure: Change From Baseline in Total Score on Incontinence Quality of Life (I-QOL) Questionnaire
timeFrame: Baseline, Week 6
Other outcomes:
Locations:
city: Royal Oak
country: United States
state: Michigan
city: Randwick
country: Australia
state: New South Wales
city: Innsbruck
country: Austria
city: Gent
country: Belgium
city: Sherbrooke
country: Canada
city: Ostrava
country: Czech Republic
city: Garches
country: France
city: Halle (Saale)
country: Germany
city: Christchurch
country: New Zealand
city: Wroclaw
country: Poland
city: Moscow
country: Russian Federation
city: Martin
country: Slovakia
city: Lviv
country: Ukraine
city: London
country: United Kingdom
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Cuervo J, Castejon N, Khalaf KM, Waweru C, Globe D, Patrick DL. Development of the Incontinence Utility Index: estimating population-based utilities associated with urinary problems from the Incontinence Quality of Life Questionnaire and Neurogenic Module. Health Qual Life Outcomes. 2014 Oct 8;12:147. doi: 10.1186/s12955-014-0147-7.
citation: Chancellor MB, Patel V, Leng WW, Shenot PJ, Lam W, Globe DR, Loeb AL, Chapple CR. OnabotulinumtoxinA improves quality of life in patients with neurogenic detrusor overactivity. Neurology. 2013 Aug 27;81(9):841-8. doi: 10.1212/WNL.0b013e3182a2ca4d. Epub 2013 Jul 26.
citation: Ginsberg D, Gousse A, Keppenne V, Sievert KD, Thompson C, Lam W, Brin MF, Jenkins B, Haag-Molkenteller C. Phase 3 efficacy and tolerability study of onabotulinumtoxinA for urinary incontinence from neurogenic detrusor overactivity. J Urol. 2012 Jun;187(6):2131-9. doi: 10.1016/j.juro.2012.01.125. Epub 2012 Apr 12.
Clinical trial NCT06332976: PrefeRences And ChemoTherapy In Breast Cancer patiEnts
Official title: Patients' Preferences for Adjuvant or Neoadjuvant Chemotherapy in Breast Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Female Breast Cancer
Keywords: Early breast cancer
Locally advanced breast cancer
Lead sponsor: European Institute of Oncology
Sponsor class: OTHER
First posted: 2024-03-27
Enrollment: 450
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Breast cancer patients candidate to or who are receiving/have already redceived adjuvant or neoadjuvant chemotherapy

Brief summary: The aim of the present study is to ask women treated with adjuvant or neoadjuvant chemotherapy for breast cancer what survival benefit would justify the treatment.

The benefit should be evaluated in terms of Survival rate trade off and Survival time trade off value. The analyses will be conducted into three different groups of patients to value the survival benefit expected:

1. before to start the chemotherapy
2. during chemotherapy
3. after the end of chemotherapy

Detailed description: The chemotherapy is generally proposed a large number of early breast cancer patients to reduce the risk of recurrence and death. However chemotherapy is associated with side effects that impact the quality of life of the patients.

Patients are more likely to accept treatment on the basis of presented relative rather than absolute risks and so the question arises as to whether unrealistic improvements in outcome are expected by patients. The interviews with patients in the proposed trial will elicit the expected gains both in terms of survival and life years and will be able to assess the proportion of patients who considered an improvement of realistic size was sufficient to justify the treatment.

Eligibility criteria: Inclusion Criteria:

* Patients with early or locally advanced breast cancer
* Patients candidate to adjuvant/neoadjuvant chemotherapy or patients who are receiving adjuvant/neoadjuvant chemotherapy or patients who received adjuvant/neoadjuvant chemotherapy
* Sufficient literacy in Italian to complete the questionnaires
* Patients must provide signed, written or advanced electronic signature (AES or AdES), informed consent

Exclusion Criteria:

* None

Primary outcomes:
measure: Percentage of risk reduction needed to consider adjuvant or neoadjuvant chemotherapy worthwhile
timeFrame: 1 week
measure: Prolonged survival time gain needed to consider CT worthwhile
timeFrame: 1 week
Secondary outcomes:
measure: Behavior assessment
timeFrame: 1 week
measure: Reaction to uncertain situations assessment
timeFrame: 1 week
measure: Regret and disappointment assessment
timeFrame: 1 week
Other outcomes:
Locations:
city: Milan
country: Italy
facility: European Institute of Oncology
Study officials:
affiliation: European Institute of Oncology
name: Emilia Montagna, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05974176: Considering Racial and Acculturation Stress in Addressing Trauma
Official title: Evaluating the Effectiveness of Evidence-based Trauma Interventions (Trauma Focused CBT - TF-CBT; and Trauma Systems Therapy - TST), Baseline Index Trauma, and PTSD Symptoms in the Context of Contributing Stress From Racialized Trauma and Acculturation Stress
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Trauma-related PTSD
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Substance Abuse and Mental Health Services Administration (SAMHSA)
First posted: 2023-08-03
Enrollment: 475
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Investigators plan to offer two evidence based interventions - Trauma Focused Cognitive Behavioral Therapy (CBT) (TF-CBT) and Trauma Systems therapy (TST) to traumatized children and their families. The investigators are looking to evaluate the effectiveness of these interventions in the context of additional stress related to racialized trauma and acculturation stress


Eligibility criteria: Inclusion Criteria:

* Child/adolescent aged 5-17 years of age who has experienced trauma with associated and related emotional dysregulation (i.e PTSD) and one of their parent/guardian
* Have capacity and willingness to provide consent or age-appropriate assent

Exclusion Criteria:

* Individual with intellectual disability with an IQ\<70
* Individual with active suicidality, homicidality, or other symptoms at the time of enrollment that warrants hospitalization

Primary outcomes:
measure: Child and Adolescent Trauma Screen (CATS) Score at Baseline
timeFrame: Baseline (Day 1)
measure: CATS Score at Completion of Intervention
timeFrame: Completion of Intervention (Typically Month 3-4)
Secondary outcomes:
measure: Acculturative Stress Scale (SAFE) Score at Baseline
timeFrame: Baseline (Day 1)
measure: SAFE Score at Completion of Intervention
timeFrame: Completion of Intervention (Typically Month 3-4)
measure: Bidimensional Acculturation Scale (BAS) Score at Baseline
timeFrame: Baseline (Day 1)
measure: BAS Score at Completion of Intervention
timeFrame: Completion of Intervention (Typically Month 3-4)
measure: Multi-Group Ethnic Identity Measure (MEIM-6) Score at Baseline
timeFrame: Baseline (Day 1)
measure: Multi-Group Ethnic Identity Measure (MEIM-6) Score at Completion of Intervention
timeFrame: Completion of Intervention (Typically Month 3-4)
measure: Trauma Symptoms of Discrimination Scale (TSDS) at Baseline
timeFrame: Baseline (Day 1)
measure: Trauma Symptoms of Discrimination Scale (TSDS) at Completion of Intervention
timeFrame: Completion of Intervention (Typically Month 3-4)
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Aaron Reliford
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03662776: Effect of Treatment Modality on Psychosocial Functioning of Survivors of Unilateral Retinoblastoma
Official title: Effect of Treatment Modality on Psychosocial Functioning of Survivors of Unilateral Retinoblastoma
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Survivors of Unilateral Retinoblastoma
Keywords: Quality of Life
physical health
emotional health
18-397
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2018-09-07
Enrollment: 120
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible survivors of unilateral retinoblastoma will be identified via the MSK and TCH databases and offered participation in the study.

Brief summary: The purpose of this study is to find out about the quality of life and health in patients who had retinoblastoma in one eye (unilateral retinoblastoma), who either received treatment with chemotherapy injected directly into an artery leading to the eye (intra-arterial chemotherapy) or removal of the eye (enucleation). By quality of life, the investigators mean how the participants are feeling about being satisfied with things in their life, including, physical health, emotional health, and their ability to carry out daily activities. The investigators want to see if either treatment option would affect quality of life differently. The investigators hope that this information will help us provide better care to future children with retinoblastoma and better follow-up care for survivors of retinoblastoma.


Eligibility criteria: Inclusion Criteria:

* Ability to speak and understand English or Spanish
* Diagnosis of unilateral retinoblastoma at any age, confirmed by the enrolling institution
* Treatment of retinoblastoma between 2006 or later
* Patients must between the age of 8-17 years old
* At least 1 year since completion of all cancer-directed therapy
* Treatment with enucleation of the affected eye or intra-arterial chemotherapy

Parent of patient:

* Ability to speak and understand English or Spanish
* Ability to confirm that he or she is the parent of a child treated for unilateral retinoblastoma who meets the eligibility criteria listed above
* Ability to provide informed consent

Exclusion Criteria:

* Patients, or parents of patients, treated with both enucleation and intra-arterial chemotherapy are not eligible

Primary outcomes:
measure: social-emotional health
timeFrame: 2 years
measure: behavioral health
timeFrame: 2 year
measure: compare HRQoL
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Houston
country: United States
facility: Texas Children's Hospital (Data Collection)
state: Texas
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Laura Cimini, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03353376: Group Versus Individual Care in Diabetes Clinic
Official title: Group Versus Individual Care in Patients With Long Standing Type 1 and Type 2 Diabetes: Non Inferiority in a One Year Prospective Study in a Tertiary Diabetes Clinic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Group Meetings
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2017-11-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: In this prospective, randomized, non blinded, one center (University hospital) trial, 60 patients (28 with type 1 and 32 with type 2 diabetes) with a mean duration of diabetes of 22.5 ± 11.7 years were randomly assigned to group (6 patients per group) or individual usual care for one year. Primary end-point included change in Hba1c and visits to out-patients clinics, secondary endpoint included change in body mass index, blood pressure levels, waist circumference, non HDL Cholesterol, diabetes related and quality of life questionnaires and hospitalizations.

Detailed description: in the intervention arm patients attended 4 preplanned group visits in the study year and the empowerment model was used in the group care visits.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of type 1 or type 2 diabetes
* Fluency in Hebrew
* Attendance at least for the second time at the diabetes clinic
* Follow up of at least one year by a general practitioner
* Willingness to participate in the study and to give informed consent.

Exclusion Criteria:

* Uncontrolled psychiatric diseases
* Active cancer
* Pregnancy

Primary outcomes:
measure: change in in Hba1c levels
timeFrame: one year from date of randomization
Secondary outcomes:
measure: change in scores of diabetes specific questionnaire
timeFrame: one year from date of randomization
measure: change in BMI in kg/m2
timeFrame: one year from date of randomization
measure: change in non HDL Cholesterol
timeFrame: one year from date of randomization
Other outcomes:
measure: change in number of outpatients visits
timeFrame: one year from date of randomization
measure: change in number in hospital admission
timeFrame: one year from date of randomization
Locations:
Study officials:
affiliation: Rabin Medical Center
name: Noa Naftali, MA
role: STUDY_CHAIR
References:
Clinical trial NCT03079076: Ultrasound Guided Modified Thoracolumbar Interfascial Plane Block for Spinal Surgery
Official title: Ultrasound Guided Modified Thoracolumbar Interfascial Plane Block for Spinal Surgery: A New Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Spine Disease
Keywords: Postoperative Analgesia
Ultrasound guided thoracolumbar interfascial plane block
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2017-03-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ultrasound guided thoracolumbar interfascial plane (TLIP) block was first described in 2015 by Hand et al. TLIP block involves injection of local anesthetics between multifidus and longissimus muscles at the third lumbar vertebra level and can block the dorsal rami of thoracolumbar nerves. In new approach differently, the investigators made the injection between longissimus and iliocostalis muscles with a 15 degree angle from medial to lateral.

The aim of this study is to determine effectiveness of ultrasound guided thoracolumbar interfascial plane (TLIP) block in patients undergoing spinal surgery.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologist's physiologic state I-III patients undergoing spinal surgery

Exclusion Criteria:

* chronic pain
* bleeding disorders
* renal or hepatic insufficiency
* patients on chronic non-steroidal anti-inflammatory medications
* emergency cases

Primary outcomes:
measure: Opioid Consumption
timeFrame: First 24 hours total opioid consumption
Secondary outcomes:
measure: Visual analog pain score
timeFrame: postoperative first hour
measure: Visual analog pain score
timeFrame: postoperative second hour
measure: Visual analog pain score
timeFrame: postoperative 4th hour
measure: Visual analog pain score
timeFrame: postoperative 8th hour
measure: Visual analog pain score
timeFrame: postoperative 12th hour
measure: Visual analog pain score
timeFrame: postoperative 24th hour
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk University
Study officials:
References:
citation: Hand WR, Taylor JM, Harvey NR, Epperson TI, Gunselman RJ, Bolin ED, Whiteley J. Thoracolumbar interfascial plane (TLIP) block: a pilot study in volunteers. Can J Anaesth. 2015 Nov;62(11):1196-200. doi: 10.1007/s12630-015-0431-y. Epub 2015 Jul 7.
citation: Ahiskalioglu A, Alici HA, Selvitopi K, Yayik AM. Ultrasonography-guided modified thoracolumbar interfascial plane block: a new approach. Can J Anaesth. 2017 Jul;64(7):775-776. doi: 10.1007/s12630-017-0851-y. Epub 2017 Feb 27. No abstract available.
citation: Ueshima H, Oku K, Otake H. Ultrasound-guided thoracolumbar interfascial plane block: a cadaveric study of the spread of injectate. J Clin Anesth. 2016 Nov;34:259-60. doi: 10.1016/j.jclinane.2016.04.060. Epub 2016 May 13. No abstract available.
Clinical trial NCT04130776: 4Kscore Using Serum Stored Uncentrifuged
Official title: Demonstrating the Stability of the Analytes Measured for 4Kscore: Total PSA (tPSA), Free PSA (fPSA), Intact PSA (iPSA), and Human Kallikrein 2 (hk2) in Clinical Serum Samples Stored Uncentrifuged Before Testing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Lead sponsor: OPKO Health, Inc.
Sponsor class: INDUSTRY
First posted: 2019-10-17
Enrollment: 64
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be 40 to 80 years old male whom have met all eligibility criteria

Brief summary: The purpose of the study is to evaluate whether storage of serum uncentrifuged is an allowable preanalytical procedure


Eligibility criteria: Inclusion Criteria:

* Men capable of donating five 5 mL tubes of whole blood
* 40 to 80 years old
* No prior diagnosis of prostate cancer; prior negative prostate biopsy included
* Total PSA (tPSA) value measured within last year to be: at 1.5 ng/mL to 4 ng/mL, 4.1 ng/mL to 10 ng/mL and 10 ng/mL and above

Exclusion Criteria:

* In the previous 96 hours (4 days), underwent a digital rectal exam
* Any invasive urologic procedure in the 6 months prior to study participation
* Underwent any procedure to treat symptomatic benign prostatic hyperplasia in the last 6 months
* Radical prostatectomy since tPSA measurement
* Received within the previous 6 months 5-alpha reductase inhibitor (5-ARI) therapy such as Avodart (dutasteride) or Proscar (finasteride)

Primary outcomes:
measure: tPSA changes in 3 days
timeFrame: Day 0, 1, 2 and 3
measure: fPSA changes in 3 days
timeFrame: Day 0, 1, 2 and 3
measure: iPSA changes in 3 days
timeFrame: Day 0, 1, 2 and 3
measure: hK2 changes in 3 days
timeFrame: Day 0, 1, 2 and 3
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Sidney Kimmel Cancer Center at Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: James Ryan Mark
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01112176: Effect of Heart Rate on Left Ventricular Performance
Official title: Effect of Heart Rate on Left Ventricular Performance
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myocardial Function
Myocardial Strain
Keywords: Strain
Ejection fraction
Diastolic function
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-04-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The current study is aimed at determining the normal response to increasing heart rates. For this purpose, atrial pacing will be used to increase heart rate.

Detailed description: Participants will be patients with pacemakers and normal A-V node conduction with a possibility for right atrial pacing mode.

Detailed Echo studies will be performed at baseline. Echo studies will be repeated at each pacing stage, stages defined as 10 bpm increments in paced heart rate. Each stage will last 2-3 min or as long as it takes to record the echo study. Heart rate will be increased to 85% of predicted heart rate for age or at to appearance of signs of ischemia.

Hemodynamic parameters will be recorded and segmental longitudinal strain will be calculated (as well as other Echo data), for each stage.

Eligibility criteria: Inclusion Criteria:

1. Patients with AAI or DDD pacemaker with intact AV nodal conduction that can be set to work in AAI mode.
2. Stable rhythm (either sinus or paced).
3. Good quality baseline echo.
4. Able and willing to sign Informed Consent Form.

Exclusion Criteria:

1. Prior heart failure or ischemic heart disease.
2. Severe valvular lesions.
3. Severe pulmonary hypertension.
4. Known intolerance to rapid pacing.
5. Multiple extrasystoles (more than 1 per echo or monitor screen).
6. Age over 70.

Primary outcomes:
measure: Segmental Strain
timeFrame: approx. 20 minutes
Secondary outcomes:
measure: LV function
timeFrame: Approx. 20 minutes
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hille Yaffe Medical Ceter
Study officials:
affiliation: Hillel Yaffe Medical Center
name: David S. Blondheim, MD
role: PRINCIPAL_INVESTIGATOR
References: