louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03348540: Attention Control Training for PTSD in Children
Official title: Randomized Clinical Trial of Attention Control Training for Symptoms of PTSD in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PTSD
Lead sponsor: Creighton University
Sponsor class: OTHER
First posted: 2017-11-21
Enrollment: 89
Sex: ALL
Minimum age (years): 7
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Participants will complete a pre and post training psychological assessment. Participants will be assigned to attention control training or the comparison stimuli computer task in a double-blind randomized control trial design. Both computerized dot probe tasks display two faces on a computer screen, one above the other, followed by a small right or left arrow appearing in the location vacated by one of the faces. Participants are required to respond as quickly as they can by pressing the indicated right or left arrow on their computer keyboard without compromising accuracy. Participants complete 6 training sessions.


Eligibility criteria: Inclusion Criteria:

* significant symptoms of PTSD and qualifying traumatic event

Exclusion Criteria:

* new traumatic event within one month of beginning the trial

Primary outcomes:
measure: Change in posttraumatic stress disorder (PTSD) symptoms from pre to post test
timeFrame: 10 minute long administration, given twice to measure change scores from pre and post training approximately 1 month apart
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Creighton Univeristy
state: Nebraska
Study officials:
References:
citation: Badura-Brack AS, Naim R, Ryan TJ, Levy O, Abend R, Khanna MM, McDermott TJ, Pine DS, Bar-Haim Y. Effect of Attention Training on Attention Bias Variability and PTSD Symptoms: Randomized Controlled Trials in Israeli and U.S. Combat Veterans. Am J Psychiatry. 2015 Dec;172(12):1233-41. doi: 10.1176/appi.ajp.2015.14121578. Epub 2015 Jul 24.
Clinical trial NCT00631540: REFORM Clinical Study: Treatment of Renal Artery Stenosis With the Formula Balloon-Expandable Stent
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Artery Stenosis
Keywords: renal artery stenosis
hypertension
renovascular
renal artery blockage
renal artery disease
renal arteries
angioplasty renal artery
renal artery stent
renal artery doppler
renovascular hypertension
kidney stenosis
renal artery
stent
stenting
kidney disease
renal failure
atherosclerosis
arterial hypertension
stenosis
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2008-03-07
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: TREATMENT

Brief summary: The purpose of the study is to evaluate the safety and effectiveness of the Formula Balloon-Expandable Stent in treatment of renal artery stenosis.


Eligibility criteria: Key Inclusion Criteria:

* renal artery stenosis
* appropriate size and location of the lesion
* suboptimal angioplasty

Key Exclusion Criteria:

* less than 18 years old
* failure or inability to give informed consent
* simultaneously participating in another drug or device study

Primary outcomes:
measure: Primary Patency of the Treated Renal Artery
timeFrame: 9 Months
Secondary outcomes:
measure: Number of Participants With 30-day Major Adverse Events
timeFrame: 30 Days
measure: Number of Participants With 9-month Major Adverse Events
timeFrame: 9 Months
measure: Technical Success
timeFrame: Prior to Discharge
measure: Acute Procedural Success
timeFrame: Prior to Discharge
measure: 30-day Clinical Success
timeFrame: 30 Days
Other outcomes:
Locations:
city: Ocala
country: United States
facility: Munroe Regional Medical Center
state: Florida
city: Orlando
country: United States
facility: Orlando Regional Medical Center
state: Florida
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: Raleigh
country: United States
facility: Wake Med Raleigh Campus
state: North Carolina
city: Lancaster
country: United States
facility: Fairfield Medical Center
state: Ohio
city: Harrisburg
country: United States
facility: Pinnacle Health at Harrisburg
state: Pennsylvania
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
Study officials:
affiliation: Swedish Medical Center
name: Robert Bersin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bersin RM, Ansel G, Rizzo A, Bob Smouse H, Sinha S, Sachar R, Dave R, Weinstock BS, Feldman R, Roubin GS. Nine-month results of the REFORM study: a prospective, single-arm, multicenter clinical study of the safety and effectiveness of the Formula balloon-expandable stent for treatment of renal artery stenosis. Catheter Cardiovasc Interv. 2013 Aug 1;82(2):266-73. doi: 10.1002/ccd.24481. Epub 2013 Mar 25.
Clinical trial NCT01865240: Renal Denervation for Resistant Hypertension
Official title: Renal Denervation for Resistant Hypertension
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hypertension
Keywords: renal denervation
blood pressure
cardiovascular risk
target organ damage
sympathetic activity
Lead sponsor: Baker Heart and Diabetes Institute
Sponsor class: OTHER
First posted: 2013-05-30
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study investigating the effectiveness of renal denervation in lowering blood pressure in people whose blood pressure is not adequately controlled despite treatment with 3 or more blood pressure lowering drugs. The study is designed to compare the effects of renal denervation to a usual care group receiving additional blood pressure lowering drugs.

Detailed description: Previous studies have shown that the renal denervation procedure is safe and effective in reducing blood pressure in patients with resistant hypertension. A total of 100 participants with uncontrolled blood pressure, treated with three or more blood pressure lowering medications will be recruited into the study. Patients will be assigned to one (1) of two (2) groups with the aim of attaining blood pressure control. Participants in group 1 will be assigned to renal denervation, participants in group 2 will receive additional antihypertensive medication according to current guidelines and best practice in an attempt to reach blood pressure targets.

Eligibility criteria: Inclusion Criteria:

* systolic BP ≥140mmHg or ≥130mmHg for patients with diabetes
* concurrent treatment with ≥3 anti-hypertensive drugs

Exclusion Criteria:

* renal artery anatomy ineligible for treatment
* eGFR \<15mL/min/1.73m2 (using Modification of Diet in Renal Disease (MDRD) calculation)
* female participants of childbearing potential must have negative pregnancy test prior to treatment

Primary outcomes:
measure: blood pressure control
timeFrame: 6 months post procedure
Secondary outcomes:
measure: number of drugs required to reach blood pressure target
timeFrame: baseline to 6 months
measure: time to achieve blood pressure target
timeFrame: baseline to 6 months
measure: Change in markers of sympathetic nerve activity
timeFrame: baseline to 6 months
measure: Change in Left Ventricular Structure and Function
timeFrame: baseline to 6 months
measure: Change in Quality of Life
timeFrame: baseline to 6 months
measure: Serum and Urine Biochemistry
timeFrame: baseline to 6 months
measure: Change in markers of arterial stiffness
timeFrame: baseline to 6 months
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Baker IDI Heart & Diabetes Inst
state: Victoria
Study officials:
affiliation: Baker IDI Heart & Diabetes Institute
name: Markus Schlaich, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00940940: Safety and Immunogenicity of Zostavax Vaccine in Patients Undergoing Living Donor Kidney Transplantation
Official title: Safety and Immunogenicity of Live Attenuated Herpes Zoster Vaccine in Patients Undergoing Living Donor Kidney Transplantations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Transplant
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2009-07-17
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Varicella zoster virus is part of the herpesvirus group and causes chickenpox in exposed individuals. The majority of the population is seropositive for this virus. Reactivation of varicella zoster virus occurs in up to 30% of the general population over 60 years old.

Solid organ transplant recipients receive lifelong immunosuppression drugs and are at great risk of reactivation of all herpesviruses including the varicella zoster virus regardless of age. The vaccine has been shown to be effective in preventing shingles in the general population. The investigators' purpose is to determine how well the vaccine works in patients on renal replacement therapy and post-transplant.


Eligibility criteria: Inclusion Criteria:

1. Age 18-65 years
2. Listed or will likely be listed for live donor kidney transplant within one month

Exclusion Criteria:

1. Previous receipt of Zostavax

Primary outcomes:
measure: Immunogenicity
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
Study officials:
affiliation: University of Alberta
name: Deepali Kumar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04115540: Penile Nerve Stimulation for Treatment of Delayed Ejaculation
Official title: Transcutaneous Electrical Nerve Stimulation of Penile Nerves for Treatment of Delayed Ejaculation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Delayed Ejaculation
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2019-10-04
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this clinical trial is to test the safety and feasibility of using transcutaneous electrical nerve stimulation (TENS) of the penile nerves to reduce intra-vaginal ejaculatory latency time in men with delayed ejaculation (DE). We hypothesize that this type of stimulation, either before or during sexual activity, will reduce latency time. The primary objective of this study is to determine if TENS of the penile nerve helps men with DE subjectively reduce their ejaculatory latency time. The secondary objective is to determine whether their International Index of Erectile Function (IIEF) score improves with treatment.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Sexually active
* Diagnosed with delayed ejaculation

Exclusion Criteria:

* Less than 18 years old
* Any condition effecting the participant that would make them unable to operate the interventional device

Primary outcomes:
measure: International Index of Erectile Function (IIEF) Scale Score
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Count of Participants With Treatment-related Adverse Events as Assessed by Survey
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Healthcare
state: California
Study officials:
affiliation: Stanford University
name: Michael Eisenberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06033040: Medical Imaging in Bladder Tumors by MRI
Official title: Clinical Study on the Diagnostic and Predictive Value of MRI Multifunctional Imaging in Bladder Tumors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bladder Tumor
Magnetic Resonance Imaging
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 178
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with bladder neoplasm planned to undergo surgery

Brief summary: This study prospectively included 178 patients with bladder neoplastic lesions who planned to undergo surgery (with or without preoperative neoadjuvant chemotherapy). Inclusion criteria: Patients with pathologically confirmed bladder cancer after radical or partial cystectomy or TURBT (\< 2 weeks between surgical resection and imaging). Exclusion criteria: 1) Prior history of chemotherapy and/or radiotherapy; 2) No surgical resection; 3) The interval between surgical resection and imaging examination is \> 2 weeks; 4) Obvious artifacts; 5)MRI scan contraindications. All subjects underwent pelvic MRI. Data was collected using a Siemens VIDA 3TMR scanner (Siemens Healthcare, Erlangen, Germany). All subjects underwent standardized scanning protocols. The obtained images are post-processed and the experimental results are analyzed statistically.


Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of bladder neoplasm
2. Must undergo radical or partial cystectomy or TURBT surgery within 2 weeks between surgical resection and imaging

Exclusion Criteria:

1. A history of pelvic radiotherapy or chemotherapy;
2. Lack of pathological findings or no surgery;
3. The interval between surgical resection and imaging examination \> 2 weeks;
4. Poor image quality due to poor coordination or motion artifacts;
5. MRI scan contraindications

Primary outcomes:
measure: quantitative parameters by MRI
timeFrame: From the time the participants completed the MRI scan to the post-processing of the resulting images,assessed up to 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
state: Guang Dong
Study officials:
References:
Clinical trial NCT05100940: Progress Complication
Official title: Prospective Global Registry of Complications of Percutaneous Coronary Interventions
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Keywords: complications
Percutaneous Coronary intervention
Lead sponsor: Minneapolis Heart Institute Foundation
Sponsor class: OTHER
First posted: 2021-10-29
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Over 18 years of age and undergoing coronary angiography or PCI and a complication occurred during or after the procedure at each of the participating centers.

Brief summary: Coronary angiography and percutaneous coronary intervention (PCI) is often performed in patients with ischemic heart disease. The safety of PCI has improved with new devices and strategies, but complications still occur, especially during complex procedures. The objectives of this multi-center observational registry are to examine frequency of complications occuring during cardiac catheterization and PCI, examine procedural strategies utilized for complication management, and evaluate the clinical outcomes (both immediate and during follow-up.)

Detailed description: The safety of PCI has improved with new devices and strategies, but complications still occur, especially during complex procedures. Systematic study of cardiac procedure complications can improve procedural safety and optimize short and long-term patient outcomes. The objectives of this multi-center observational registry are to

1-Examine the frequency and types of complications occurring during cardiac catheterization and PCI among participating sites, 2-Examine the procedural strategies (techniques and devices) utilized for complication management, 3-Evaluate the clinical outcomes (both immediate and during follow-up) after each complication type.

Eligibility criteria: * Over 18 years of age
* undergoing coronary angiography or PCI
* A complication occurred during or after the procedure

Primary outcomes:
measure: in-hospital major cardiac adverse events (MACE)
timeFrame: From Date of Procedure to Date of Hospital Discharge, approximately 48-72 hrs after index procedure
measure: Technical Success of PCI
timeFrame: From Date of Procedure to Date of Hospital Discharge, approximately 48-72 hrs after index procedure
measure: Procedural success of PCI
timeFrame: From Date of Procedure to Date of Hospital Discharge, approximately 48-72 hrs after index procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute Foundation
state: Minnesota
Study officials:
References:
Clinical trial NCT05863767: Effects of Baduanjin Sequential Therapy on Post CABG Patients.
Official title: Effect of Baduanjin Sequential Therapy on Physical Functioning and Quality of Life Among Post CABG Patients.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post-cardiac Surgery
Keywords: Baduanjin sequential therapy
CABG
Physical functioning
Quality of life
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-05-18
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the effects of Baduanjin sequential therapy (BST) on physical functioning and quality of life among post-CABG patients. Many studies have focused on the effects of standing Baduanjin on chronic diseases and it's an evidence-based therapy.

Detailed description: There exists limited data from large-scale randomized trials that have addressed the effect of Baduanjin exercise on the quality of life and cardiac function in the patient with CABG. Therefore, this study aims to determine the effects of Baduanjin sequential therapy (BST) on physical functioning and quality of life among post-CABG patients.

Eligibility criteria: Inclusion Criteria:

* Vitally Open heart surgery patients Discharged from the hospital and enrolled as outpatient Able to perform 6MWT

Exclusion Criteria:

* Prolonged intubation Unstable vitals Patient needs maximum assistance for mobility Decline consent

Primary outcomes:
measure: Functional capacity
timeFrame: 4 weeks
measure: Functional performance
timeFrame: 4 weeks
measure: Health related Quality of Life (QOL)
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: Peshawar Institute of cardiology
state: KPK
Study officials:
affiliation: Riphah International University
name: Mehwish Waseem, MSPT(CPPT)
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mao S, Zhang X, Chen M, Wang C, Chen Q, Guo L, Zhang M, Hinek A. Beneficial Effects of Baduanjin Exercise on Left Ventricular Remodelling in Patients after Acute Myocardial Infarction: an Exploratory Clinical Trial and Proteomic Analysis. Cardiovasc Drugs Ther. 2021 Feb;35(1):21-32. doi: 10.1007/s10557-020-07047-0. Epub 2020 Aug 6.
citation: Chen MG, Liang X, Kong L, Wang J, Wang F, Hu X, He J, Zeng RX, Mao S, Guo L, Zhang MZ, Zhang X. Effect of Baduanjin Sequential Therapy on the Quality of Life and Cardiac Function in Patients with AMI After PCI: A Randomized Controlled Trial. Evid Based Complement Alternat Med. 2020 Jul 4;2020:8171549. doi: 10.1155/2020/8171549. eCollection 2020.
citation: Chen DM, Yu WC, Hung HF, Tsai JC, Wu HY, Chiou AF. The effects of Baduanjin exercise on fatigue and quality of life in patients with heart failure: A randomized controlled trial. Eur J Cardiovasc Nurs. 2018 Jun;17(5):456-466. doi: 10.1177/1474515117744770. Epub 2017 Nov 30.
Clinical trial NCT00540267: Bone Density in Patients With Schizophrenia
Official title: Bone Mineral Density in the Korean Patients With Chronic Schizophrenia With Alcohol Abuse
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Alcohol Abuse
Keywords: Schizophrenia
Alcohol Abuse
Bone Density
Lead sponsor: Inje University
Sponsor class: OTHER
First posted: 2007-10-05
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: people with schizophrenia, gaed between 18-80 years, with no endocrine disorder

Brief summary: People with chronic mental disorder such as schizophrenia and alcohol abuse are high risk groups for developing osteoporosis.

To evaluate the prevalence of bone mineral density in men patients with schizophrenia with alcohol abuse, the investigators will compare bone mineral density between patient with schizophrenia with and without alcohol abuse.

Detailed description: People with schizophrenia has been known as a high risk groups for developing osteoporosis, because of lack of exercise, poor nutrition and high rate of smoking. Those with alcohol abuse may be higher risk group than one with schizophrenia without alcohol abuse, because they frequently have several medical problems such as liver dysfunction, Vitamin D deficiency, hyperparathyroidism and those medical condition increase risk for developing osteoporosis. Also alcohol itself can increase bone loss too by disturbing bone remodeling and enhancing bone fragility. To compare the prevalence of bone mineral density in patients with schizophrenia with alcohol abuse to those without alcohol problem, we will investigate BMD in large population of Korean patients with those illnesses.

Eligibility criteria: Inclusion Criteria:

* DSM-IV diagnosis of schizophrenia
* Onset of illness more than 5 years.

Exclusion Criteria:

* No severe Medical and endocrinological disorder

Primary outcomes:
measure: The change of bone mineral density
timeFrame: cross sectional and prospective
Secondary outcomes:
measure: The effects of Smoking and antipsychotic drug on BMD
timeFrame: Cross sectional Study
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Joo-Cheol Shim
Study officials:
affiliation: Inje University
name: Joo-Cheol Shim, MD,PhD
role: STUDY_DIRECTOR
References: