louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06206187: Blinded Randomized Controlled Trial of Artificial Intelligence Guided Detection of Intracardiac Thrombus
Official title: ICE Detector-RCT: Blinded, Randomized Controlled Trial of Electrophysiologist vs. Artificial Intelligence Detection of Intracardiac Thrombus
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
Collaborators: name: Johnson & Johnson
First posted: 2024-01-16
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: To determine whether an integrated AI decision support can save time and improve the accuracy of detection of intracardiac thrombus, the investigators are conducting a blinded, randomized controlled study of AI-guided detection of intracardiac thrombus to electrophysiologist judgment in preliminary readings of echocardiograms.


Eligibility criteria: Inclusion Criteria:

1. Aged 18-80 years.
2. Willing to sign informed consent.
3. Patients diagnosed with atrial fibrillation Paroxysmal AF and Persistent AF according to the latest clinical guidelines

Exclusion Criteria:

1. End-stage disease with a mean life expectancy less than 1 year
2. New York Heart Association (NYHA) class III or IV, or last known left ventricular ejection fraction less than 30%
3. Previous surgical or catheter ablation for AF
4. Bradycardia and presence of implanted ICD
5. Uncontrolled hypertension: Systolic blood pressure (SBP) \>180 mmHg or diastolic blood pressure (DBP) \> 110 mmHg
6. Patients with Cardiovascular events including acute myocardial infarction, any PCI, valvular cardiac surgical, or percutaneous procedure within the past 3 months
7. Women of childbearing potential who are, or plan to become, pregnant during the time of the study
8. Have been enrolled in an investigational study evaluating devices or drugs.

Primary outcomes:
measure: Degree of change from initial (AI vs EP doctor) assessment to final cardiologist assessment
timeFrame: 10 Minutes
Secondary outcomes:
measure: Perioperative adverse event rates
timeFrame: 10 Minutes
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: 上海市
Study officials:
References:
Clinical trial NCT00153387: Illinois WISEWOMAN Project
Official title: Illinois WISEWOMAN Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: CVD Risk
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
First posted: 2005-09-12
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 64
Standard ages: ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To provide low-income, under- or uninsured 40- to 64-year-old women with the knowledge, skills, and opportunities to improve diet, physical activity, and other lifestyle behaviors to prevent, delay and control cardiovascular and other chronic diseases.


Eligibility criteria: Inclusion Criteria:

* NBCCEDP

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Centers for Disease Control and Prevention
name: Julie Will
role: STUDY_CHAIR
References:
Clinical trial NCT00383487: A Phase II Trial of Calcitriol and Naproxen in Patients With Recurrent Prostate Cancer
Official title: A Phase II Trial of Calcitriol and Naproxen in Patients With Recurrent Prostate Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Prostatic Neoplasms
Prostate Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Novacea
First posted: 2006-10-03
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine whether, in this patient population, treatment with calcitriol and Naproxen is more effective in delaying the growth of prostate cancer than treatment with calcitriol alone as seen in historical controls.

Detailed description: In summary, in vitro and in vivo studies, as well as early phase clinical trial, have shown a promising role for both calcitriol and NSAIDs in the treatment of prostate cancer. Moreover, calcitriol and NSAIDs both exert their antiproliferative effect by decreasing prostaglandin levels, but they do so by different mechanisms. Thus, there is reason to believe that their combined effects on prostaglandins may be synergistic. Preliminary in vitro assays in which calcitriol is given in combination with one of two different NSAIDs (Naprosyn or sulindac) to LNCaP cell lines have indicated such synergy. This observation provides the rational for using them in combination for the treatment of prostate cancer. In addition, it is hoped that any synergy noted would allow for the use of lower doses of NSAIDs.

Eligibility criteria: Inclusion Criteria:

* Must give written informed consent
* Histologically confirmed adenocarcinoma of the prostate
* Biochemical relapse after primary radiation therapy or surgery
* Normal testosterone levels
* 3 rising PSA after nadir, with interval between PSA determinations \> 2 weeks

Exclusion Criteria:

* Local recurrence by CT scan
* Distant metastases by bone scan
* Hypercalcemia
* Nephrolithiasis
* Renal insufficiency (serum creatinine \> 1.8 mg/dl)
* Pancreatitis
* History of ulcer or gastrointestinal bleeding
* More than 6 months of hormone ablation therapy
* Concurrent therapy for prostate cancer
* Uncontrolled HTN
* H/O MI, CVA, TIA
* Known coronary disease/cerebrovascular disease
* Platelet counts \<50
* Patients on anticoagulants
* Patients on lithium

Primary outcomes:
measure: PSA response - 50% PSA decline, PSA progression, PSA response duration, progressive disease, time to PSA progression.
Secondary outcomes:
measure: Progressive disease in this study's patients, who would be treated with calcitriol and naprosyn, will be compared to that in historical controls of patients treated with calcitriol alone.
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Dr. Sandy Srinivas
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00101387: Effects of Lumbar PENS and Exercise in Older Adults With Chronic Low Back Pain
Official title: Functional Impact of PENS for 65+ Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Low Back Pain
Keywords: Aged
Acupuncture
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
name: National Institute on Aging (NIA)
First posted: 2005-01-11
Enrollment: 200
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether a form of electrical acupuncture, called percutaneous electrical nerve stimulation (PENS), can reduce pain and disability in older adults with chronic low back pain (LBP). This study will also determine the effects of general conditioning and aerobic exercise (GCAE) on chronic LBP.

Detailed description: Each year, a significant number of elderly individuals experience at least one episode of LBP. When LBP becomes chronic, it can lead to functional and emotional impairment, increased health care utilization, and decreased quality of life. Standard treatment for LBP typically consists of non-opioid analgesics and physical therapy; however, analgesic-associated morbidity in older adults often limits their utility. This study will determine the efficacy of PENS treatment, a neuroanatomically guided form of electroacupuncture, and exercise in reducing pain in older adults with chronic LBP.

Participants will be randomly assigned to one of four treatment groups: PENS alone, PENS placebo, PENS plus GCAE, or PENS placebo plus GCAE. The treatments will be given twice weekly for 6 weeks. Pain intensity, physical function, health care utilization, and psychosocial function will be assessed with self-report and performance-based measures. These assessments will be conducted at study start, immediately after the last treatment session, and 6 months after study completion.

Eligibility criteria: Inclusion Criteria:

* Low back pain for at least 3 months
* Able to walk without an assistive device (e.g., cane or walker)

Exclusion Criteria:

* Serious underlying illness causing back pain
* Nerve root compression
* History of back surgery
* Has pacemaker
* Current use of blood thinners
* Major psychiatric disorder
* Chest pains or heart problems that interfere with daily activity
* Fibromyalgia

Primary outcomes:
measure: Roland and Morris questionnaire
timeFrame: Baseline, post-intervention, 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pain Evaluation and Treatment Institute
name: Debra K. Weiner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02081287: Inositol Hexaphosphate: A Novel Treatment Strategy for Bipolar Disorder?
Official title: Inositol Hexaphosphate: A Novel Treatment Strategy for Bipolar Disorder?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bipolar Disorder
Manic Depression
Keywords: Bipolar Disorder
Depression
Inositol
Inositol Hexaphosphate
Phytic Acid
IP6
Lithium
Lamotrigine
Lead sponsor: San Diego Veterans Healthcare System
Sponsor class: FED
Collaborators: name: The Depressive and Bipolar Disorder Alternative Treatment Foundation
First posted: 2014-03-07
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Inositol hexaphosphate (IP6, also called inositol hexakisphosphate, and phytic acid) is a naturally occurring phosphorylated derivative of myo-inositol. Myo-inositol has shown preliminary evidence of efficacy in controlling mood symptoms, and good tolerability in bipolar disorder in some studies, but failed to establish efficacy in subsequent meta-analyses. In the investigators proposed work, the investigators plan to orally administer the calcium/magnesium salt of IP6 (2,000-3,000 mg daily in two divided doses) to paid research subjects with a diagnosis of bipolar disorder who are in a depressed state, and who have failed an adequate course of treatment with lithium monotherapy. The investigators hypothesis is that IP6 may be similar to myo-inositol in terms of relieving depression, but more potent and effective. Our aim is conduct a preliminary pilot study in 30 subjects (15 treated with IP6, 15 treated with lamotrigine, an active comparator) to assess the efficacy and tolerability of IP6 as an adjunctive treatment to lithium, the mood stabilizer most commonly used to treat bipolar disorder.


Eligibility criteria: Inclusion Criteria:

* must have bipolar disorder
* must be currently depressed
* must have failed adequate trial of lithium monotherapy
* must have shown partial response of depression to lithium

Exclusion Criteria:

* diagnoses of schizophrenia, major depression, or other psychotic disorder
* currently pregnant
* unstable medical condition
* active drug or alcohol dependence
* concurrent use of antidepressant or mood stabilizer other than lithium
* active suicidal or homicidal ideation
* past adverse reaction to lamotrigine or current skin rash (lamotrigine arm only)
* history of dietary malabsorption or nutritional deficiency (IP6 arm only)

Primary outcomes:
measure: Depression
timeFrame: 10 weeks
Secondary outcomes:
measure: Sleep Quality
timeFrame: 10 weeks
measure: Global Function
timeFrame: 10 weeks
measure: Side Effect Burden
timeFrame: 10 weeks
measure: Mania
timeFrame: 10 weeks
Other outcomes:
measure: Morning vs Evening Preference
timeFrame: 10 weeks
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System
state: California
Study officials:
affiliation: VA San Diego Healthcare, UCSD
name: Michael J. McCarthy, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03610087: Technology-Enabled Collaborative Care for Youth
Official title: Technology-Enabled Collaborative Care for Youth (TECC-Y): A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychosis
Metabolic Disease
Cardiovascular Risk Factor
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
Collaborators: name: Medical Psychiatry Alliance
name: Trillium Health Centre
name: The Hospital for Sick Children
name: University of Toronto
First posted: 2018-08-01
Enrollment: 70
Sex: ALL
Minimum age (years): 16
Maximum age (years): 29
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The overall objective is to develop scalable interventions to address the physical health needs of patients affected by early psychosis. The objective of this project is to conduct a feasibility study of a high intensity technology-enabled collaborative care model (CCM) compared to lower intensity self-help modules and email support for early identification and treatment of cardio-metabolic risk factors in youth, ages 16-29, affected by early psychosis.


Eligibility criteria: Inclusion Criteria:

* Ages 16 - 29 years
* Clinician diagnosis of early psychosis (diagnosed in last 5 years)
* Prescribed psychiatric medication, stable for 4 weeks
* Access to telephone or internet through computer or mobile

Exclusion Criteria:

* Unable to provide consent
* Unable to understand English

Primary outcomes:
measure: Change in patient engagement
timeFrame: Baseline, 6-weeks, 12-weeks, and 24-weeks.
Secondary outcomes:
measure: Healthy Behaviour Change
timeFrame: Baseline, 6-weeks, 12-weeks, and 24-weeks.
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
References:
citation: Selby P, Vojtila L, Ashfaq I, Dragonetti R, Melamed OC, Carriere R, LaChance L, Kohut SA, Hahn M, Mulsant BH. Technology-enabled collaborative care for youth with early psychosis: A protocol for a feasibility study to improve physical health behaviours. Early Interv Psychiatry. 2021 Aug;15(4):828-836. doi: 10.1111/eip.13018. Epub 2020 Aug 3.
Clinical trial NCT06273787: Effect of Diaphragmatic Release in Sleep Quality During Pregnancy
Official title: Effect of Diaphragmatic Release in Sleep Quality During Pregnancy, Randomized Controlled Trail
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: SLEEP APNEA PREGNANCY
Lead sponsor: MTI University
Sponsor class: OTHER
First posted: 2024-02-23
Enrollment: 44
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment group a : Diaphragmatic Release in addition to positioning instruction group b: positioning instruction
Primary purpose: TREATMENT

Brief summary: Sleep disordered breathing (SDB) is very common during pregnancy, and is most likely explained by hormonal, physiological and physical changes. Maternal obesity, one of the major risk factors for SDB, together with physiological changes in pregnancy may predispose women to develop SDB. SDB has been associated with poor maternal and fetal outcomes. Thus, early identification, diagnosis and treatment of SDB are important in pregnancy.

Detailed description: The present study will be conducted to add a new information to the body of knowledge of physical therapy profession as it will provide scientific basis for the clinical application of diaphragmatic release in sleep disordered breathing during pregnancy

Eligibility criteria: Inclusion Criteria:

* Pregnant women (at third trimester), diagnosed with sleep disordered breathing by the gynaecologist.
* Their ages will range from 30- 40 years old .
* Their BMI will be 25 to 30kg/m2.
* All are multipara.

Exclusion criteria:

Women will be excluded from the study if they have:

* Previous pulmonary surgery.
* any pulmonary diseases.
* Asthma.
* Neurological disorders
* Musculoskeletal disorders (severe osteoarthritis, osteoporosis)

Primary outcomes:
measure: pittshurgh sleep quality index
timeFrame: 1 month
Secondary outcomes:
measure: diaphragmatic excursion assessment
timeFrame: 1 month
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: MTI
Study officials:
References:
Clinical trial NCT02584270: Prosthesis Guided Speech Rehabilitation of T1/T2 Cancers of the Tongue
Official title: Prosthesis Guided Speech Rehabilitation of T1/T2 Cancers of the Tongue (PGSRT): a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tongue Neoplasms
Tongue Cancer
Oral Cancer
Keywords: palatal drop prosthesis
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2015-10-22
Enrollment: 40
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: This study will fill a scientific gap in the current knowledge providing data for evaluation of the palatal augmentation prosthesis (PAP) as a therapeutic modality post-surgery. This is a robust scientific randomized prospective clinical trial.

Positive outcomes from this study have the potential to dramatically alter the most common issues of oral cancer therapy, namely speech and swallowing functions. Patients will have been diagnosed with a cancer lesion of the tongue requiring surgery and removal of part of the tongue. Smaller cancers of the tongue are sized as T1 or T2. For patients with smaller lesions, a PAP, which can aid in speaking and swallowing, is not routinely provided.

Detailed description: This study will randomize patients into two arms; one for oral cancer patients that receive a small device, similar to a denture, called a PAP. The other arm will be patients who serve as a control and will not receive a PAP.

The PAP requires patients to have a dental mold created. A dentist customizes the PAP to specifically fit the individual's mouth.

The study will investigate whether the PAP improves speech following tongue cancer as measured by three different scales. Both groups will see a speech language therapist for additional measures of speech evaluation.

Eligibility criteria: Inclusion Criteria:

* Patients with a new diagnosis of a T1/T2 tongue cancer

Exclusion Criteria:

* Patients with recurrent disease
* Patients with a history of prior head and neck radiation therapy
* Patients who lack adequate maxillary dentition to support a palatal augmentation prosthesis

Primary outcomes:
measure: Word intelligibility
timeFrame: 6 months
Secondary outcomes:
measure: Sentence intelligibility
timeFrame: 6 months
measure: Articulation at the word level of phonemes (consonant sounds)
timeFrame: 6 months
measure: Patient satisfaction with speech
timeFrame: 6 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Department of Oral and Maxillofacial Surgery and Hospital Dentistry
state: Michigan
Study officials:
affiliation: University of Michigan
name: Stephanie M Munz, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04148170: Recanalization of Congenital Nasolacrimal Duct Obstruction by Endodiathermy Probe and Intubation Versus Intubation Only
Official title: Recanalization of Congenital Nasolacrimal Duct Obstruction by Endodiathermy Probe and Intubation Versus Intubation Only
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Congenital Nasolacrimal Duct Obstruction
Keywords: Endodiathermy Probe and Intubation Versus Intubation Only
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-11-01
Enrollment: 80
Sex: ALL
Minimum age (years): 2
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group (I): 80 eyes of children suffer from congenital nasolacrimal duct obstruction will have probing with metal probe and then intubation with bicanlicular silicon tube.

Group (II): 80 eyes of children suffer from congenital nasolacrimal duct obstruction will have probing with endodiathermy probe and then intubation with bicanlicular silicon tube.
Primary purpose: TREATMENT

Brief summary: The purpose of the current work is to assess the efficiency and success rate of endodiathermy probe followed by intubation in children more than 2 years compared to the success rate of intubation (as a standard method) which varies from 75% to 85% in several studies

Detailed description: The study will be conducted on children above 2 year and will be divided randomly into two groups:

Group (I): 80 eyes of children suffer from congenital nasolacrimal duct obstruction will have probing with metal probe and then intubation with bicanlicular silicon tube.

Group (II): 80 eyes of children suffer from congenital nasolacrimal duct obstruction will have probing with endodiathermy probe and then intubation with bicanlicular silicon tube

Eligibility criteria: Inclusion Criteria:

1. Children in the age group above 2 years old
2. No history of previous probing.
3. No history of previous intubation.
4. Children with no any other association or congenital anomalies cause watery eye.
5. children suffer from congenital nasolacrimal duct obstruction.

Exclusion Criteria:

1. children less than 2 years old.
2. previous probing.
3. previous intubation.
4. children with any other congenital anomalies as congenital ectropion , congenital entropion
5. children suffer from any upper lacrimal anomalies as obstruction or stenosis.

Primary outcomes:
measure: recanalization of nasolacrimal duct
timeFrame: 6 months
Secondary outcomes:
measure: complication
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Abo El Resh Pedriatric Hospital Cairo University
Study officials:
affiliation: professor of ophthalmology cairo university
name: tamer gawdat, professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Suranagi PV, Poornima MS; Smruthi; Banagar B. Regarding a novel technique to recanalize the nasolacrimal duct with endodiathermy bipolar probe. Indian J Ophthalmol. 2014 Sep;62(9):971. doi: 10.4103/0301-4738.143956. No abstract available.