louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04441866: Automated Analysis Algorithms in Second Trimester Obstetric Ultrasound
Official title: Automated Analysis Algorithms in Second Trimester Obstetric Ultrasound
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ultrasonography, Prenatal
Lead sponsor: Università degli Studi di Brescia
Sponsor class: OTHER
First posted: 2020-06-22
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study aims to evaluate the effect of the use of automated algorithms for the measurement of fetal biometry, and for the reconstruction of standard planes of fetal anatomy, compared with the standard ultrasound technique, during the second trimester ultrasound scan.

Detailed description: In recent years in many ultrasound equipment were fitted with automated algorithms for measuring fetal biometry, and for the reconstruction of standard planes of fetal anatomy. Although there are studies that have assessed the application of these algorithms in terms of repeatability of the measurements made, or of possibility of acquiring diagnostic planes, there are no randomized controlled studies that evaluated their impact on the second trimester ultrasound scan.

The aim of the study is to evaluate the effect of the use of automated algorithms for the measurement of fetal biometry, and for the reconstruction of standard planes of fetal anatomy, compared with the standard ultrasound technique, in terms of:

* duration of the ultrasound scan
* quality of biometric measurements
* quality of the diagnostic planes
* operator satisfaction

Eligibility criteria: Inclusion Criteria:

* Singleton pregnancy 19+0-21+6 weeks
* Live fetus
* No fetal abnormalities

Exclusion Criteria:

* Multiple pregnancy
* Intrauterine fetal death
* Fetal abnormalities

Primary outcomes:
measure: Duration of ultrasound examination
timeFrame: During ultrasound examination
Secondary outcomes:
measure: Quality score of fetal biometry
timeFrame: During ultrasound examination
measure: Quality score of fetal diagnostic planes
timeFrame: During ultrasound examination
measure: Operator satisfaction
timeFrame: During ultrasound examination
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: Spedali Ciivli
Study officials:
References:
Clinical trial NCT03313466: Trial of Internet-Based Cognitive Behavioral Therapy for Insomnia
Official title: Trial of Internet-Based Cognitive Behavioral Therapy for Insomnia in Patients Prescribed Insomnia Medications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: Big Health Inc.
First posted: 2017-10-18
Enrollment: 136630
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 investigators will conduct a randomized, controlled trial of internet-based cognitive behavioral therapy (iCBT) vs usual care for insomnia. The target population is patients prescribed medications for insomnia who have not had a dispensation of these medications in the preceding six months. The primary outcomes is dispensed days supply over the subsequent one year. Secondary outcomes include all types of health system clinical encounters. The investigators hypothesize that the group randomized into iCBT will have less insomnia medications dispensed than usual care controls, and less clinical encounters..


Eligibility criteria: Inclusion Criteria:

* A prescription for any of a set of selected insomnia medications.
* Age \>18 years at the time of the prescription.
* A recent (\<30 days before the prescription date) diagnosis of insomnia as determined by a set of selected International Classification of Disease (ICD) codes, to be used for medications that are not prescribed just for insomnia.
* Membership for \>365 days prior to the prescription date.
* No evidence of a dispensed insomnia medication within six months (183 days) of the current prescription.

Exclusion Criteria:

* Contained in inclusion criteria.

Primary outcomes:
measure: Days supply of dispensed insomnia medications
timeFrame: One year
Secondary outcomes:
measure: Health care inpatient and outpatient encounters
timeFrame: One year
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: Kaiser Permanente Southern California
state: California
Study officials:
affiliation: Kaiser Permanente
name: Stephen Derose, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Derose SF, Rozema E, Chen A, Shen E, Hwang D, Manthena P. A population health approach to insomnia using internet-based cognitive behavioral therapy for insomnia. J Clin Sleep Med. 2021 Aug 1;17(8):1675-1684. doi: 10.5664/jcsm.9280.
Clinical trial NCT03841266: Recurrence Risk Evaluation by 21-gene Detection
Official title: Postoperative Recurrence Risk Evaluation of Hormone Receptor Positive, Her-2 Negative Breast Cancer by Using Different 21-gene Detection Kits (REBCK)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Relationship and Consistency Analysis
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2019-02-15
Enrollment: 220
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Breast cancer patients with early breast cancer were enrolled according to the inclusion criteria. Baseline characteristics were recorded from medical record system. Recurrence score were obtained by 21-gene detection kits from different biological companies. Relationship between recurrence score and the prognosis was explored. Meanwhile, we analyzed the consistency of the results obtained from various 21-gene test kits and immunohistochemistry detection.

Brief summary: Breast cancer patients with early breast cancer were enrolled according to the inclusion criteria. Baseline characteristics were recorded from medical record system. Recurrence score were obtained by 21-gene detection kits from different biological companies. Relationship between recurrence score and the prognosis was explored. Meanwhile, the investigators analyzed the consistency of the results obtained from various 21-gene test kits and immunohistochemistry detection.


Eligibility criteria: Inclusion Criteria:

1. breast cancer in stage I-III, tumor size\>0.5cm
2. lymph nodes negative
3. hormone receptor positive （ER+/PR+,ER+/PR-,ER-/PR+）
4. HER2 negative（IHC 0 or +， FISH negative）
5. receive endocrine therapy only
6. enough FFPE samples within 10 years（3\~6 10μm ）
7. patients with integrated medical records

Exclusion Criteria:

1. Tumor cells \<5%
2. Isolated RNA\<500ng

Primary outcomes:
measure: correlation analysis
timeFrame: Janyary 1, 2019-December 31, 2019
Secondary outcomes:
measure: consistency analysis
timeFrame: Janyary 1, 2019-December 31, 2019
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing hoapital
Study officials:
References:
Clinical trial NCT01159366: Incidence of Occluded Culprit Arteries and Impact of Coronary Collaterals on Outcome in Patients With NSTEMI
Official title: Substudy of the Leipzig Immediate Versus Early and Late Percutaneous Coronary Intervention Trial in NSTEMI - LIPSIA-NSTEMI TRIAL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: NSTEMI
Keywords: myocardial infarction
coronary occlusion
myocardial revascularization
collaterals
prognosis
Lead sponsor: University of Jena
Sponsor class: OTHER
First posted: 2010-07-09
Enrollment: 602
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: It is assumed that patients with non-ST-elevation myocardial infarctions (NSTEMI) showing an infero- or posterolateral occluded culprit artery (OCA) during diagnostic angiography frequently elude standard 12-lead electrocardiogram diagnosis. In addition, coronary collaterals may have beneficial effects in patients with OCA.

Detailed description: We examined consecutive NSTEMI patients within 48 h of symptom onset. All patients underwent early invasive angiography plus optimal medical therapy. We compared baseline characteristics, procedural findings including analysis of TIMI-flow and collaterals using the Rentrop-classification, 30-day and 6-months major adverse cardiovascular events (MACE) in patients with and without totally OCA.

Eligibility criteria: Inclusion Criteria:

* age between 18 and 90 years,
* onset of angina pectoris at rest \<24 h or crescendo angina in recent weeks with symptoms under minimal exertion or at rest lasting \<24 h,
* elevated troponin T ≥0.03 µg/L and
* written informed consent.

Exclusion Criteria:

* persistent angina,
* ST-segment elevation myocardial infarction (STEMI),
* hemodynamic instability including cardiogenic shock,
* oral anticoagulation therapy,
* contraindications for glycoprotein IIb/IIIa inhibitors,
* other disease with life expectancy \<6 months,
* known coagulopathy,
* pregnancy,
* other suspected causes of troponin elevation as myocarditis, secondary to hypertensive crisis, or after cardiac decompensation,
* no ability to consent, and
* participation in another study.

Primary outcomes:
measure: MACE
timeFrame: 6 months
Secondary outcomes:
measure: CK and CK-MB
timeFrame: 48 hours
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: University of Leipzig
Study officials:
affiliation: University of Leipzig
name: Gerhard Schuler, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06489366: Efficacy of Semi-rigid Ureteroscopic Laser Lithotripsy in the Treatment of Proximal Ureteral Stones: a Randomized Controlled Trial
Official title: Efficacy of Semi-rigid Ureteroscopic Laser Lithotripsy in the Treatment of Proximal Ureteral Stones: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Urolithiasis
Proximal Ureteral Stone
Keywords: Proximal ureteral stones
Ho: YAG lithotripsy
Thulium Fiber laser (TFL) lithotripsy
Semirigid ureteroscopic lithotripsy
Lead sponsor: Zhongnan Hospital
Sponsor class: OTHER
First posted: 2024-07-05
Enrollment: 138
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 efficacy of Ho: YAG and TFL combined with semirigid ureteroscopic treatment of proximal ureteral stones will be compared.

Detailed description: The target population of this study is patients with proximal ureteral stones who are scheduled to undergo semirigid ureteroscopic laser lithotripsy. After enrollment, the subjects will be randomly assigned to the semirigid ureteroscopic holmium laser (Ho: YAG) lithotripsy group and the semirigid ureteroscopic thulium fiber laser (TFL) lithotripsy group for surgical treatment. The subjects will be followed up after surgery, and the collected data will be summarized and analyzed after the study.

Eligibility criteria: Inclusion Criteria:

1. ≥18 years old;
2. patients diagnosed with unilateral proximal ureteral stones ≤2cm by computed tomography (CT)/Kidney and upper bladder (KUB) radiography who required surgery;
3. patients who volunteered to participate in this study.

Exclusion Criteria:

1. Unable to give informed consent;
2. Untreated urinary tract infection;
3. Pregnant women;
4. Known anatomical abnormalities (such as urinary diversion or ureteral stenosis);
5. Urothelial tumors, transplanted kidney stones, irreversible coagulopathy;
6. The semi-rigid ureteroscope cannot reach the stone site, ureteroscopy-negative stones, and stones can be removed directly without laser lithotripsy;
7. The researchers believe that they are not suitable for participation in this study.

Primary outcomes:
measure: Stone-free rate (SFR)
timeFrame: 2-4 weeks after surgery
Secondary outcomes:
measure: Operative time
timeFrame: Immediately during surgery
measure: Intraoperative complications
timeFrame: Immediately during surgery
measure: Postoperative complications
timeFrame: 2-4 weeks after surgery
measure: Additional procedures
timeFrame: Intraoperatively and before removal of the Ureteral stents
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Zhongnan Hospital, Wuhan University,
state: Hubei
Study officials:
References:
Clinical trial NCT02413866: Weight Outlooks by Restriction of Diet and Sleep
Official title: Weight Outlooks by Restriction of Diet and Sleep
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight
Keywords: body composition
anthropometry
Lead sponsor: University of South Carolina
Sponsor class: OTHER
First posted: 2015-04-10
Enrollment: 36
Sex: ALL
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to examine whether chronic moderate sleep restriction effects the amount of body fat and lean mass loss, and calorie expenditure, in individuals who are participating in a dietary weight loss program.

Detailed description: Participants will be randomly assigned to an 8-week program of either restricted diet alone, or restricted diet with restricted sleep for 5 days a week. The total expected duration of participation is approximately 3 months.

Eligibility criteria: Inclusion Criteria:

* age between 35-55 years,
* BMI between 30-35 kg/meters squared,
* total sleep time between 6.5-8 hours

Exclusion Criteria:

* work requiring changing schedule,
* use of sleep aids or sleep medication

Primary outcomes:
measure: body composition measured via DXA scans
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of South Carolina
state: South Carolina
Study officials:
affiliation: University of South Carolina
name: Xuewen Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sparks JR, Porter RR, Youngstedt SD, Bowyer KP, Durstine JL, Wang X. Effects of moderate sleep restriction during 8-week calorie restriction on lipoprotein particles and glucose metabolism. Sleep Adv. 2021 Jan 28;1(1):zpab001. doi: 10.1093/sleepadvances/zpab001. eCollection 2020.
citation: Wang X, Sparks JR, Bowyer KP, Youngstedt SD. Influence of sleep restriction on weight loss outcomes associated with caloric restriction. Sleep. 2018 May 1;41(5):10.1093/sleep/zsy027. doi: 10.1093/sleep/zsy027.
Clinical trial NCT04543266: Predicting Metastatic Oral Squamous Cell Carcinomas With Molecular Biomarkers Using Machine Learning
Official title: Predicting Metastatic Oral Squamous Cell Carcinomas With Molecular Biomarkers Using Machine Learning
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Oral Squamous Cell Carcinoma
Keywords: OSCC; Oral cancer; Machine Learning
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2020-09-10
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a retrospective, cohort study of all oral SCC patients who were treated with surgery for their primary oral SCC tumours at Queen Mary Hospital, from 1st October 2000 to 1st October 2019. The investigation will involve retrieval of paraffin embedded tissue blocks, determination of biomarker profile in these tissues, and retrieval of patient data from the Clinical Management System. No new patients will be prospectively recruited into the study.

Brief summary: Application Management Team:

PI - Siu Wai Choi; email - htswchoi@hku.hk Delegates - Chui Shan Chu; email: sunshine.c@connect.hku.hk FollowUpUsers - Chui Shan Chu; email:sunshine.c@connect.hku.hk

Detailed description: Eligibility Criteria:

- patients were diagnosed with a baseline disease of oral squamous carcinoma.

Exclusion Criteria:

- N/A

Sample size:

- \~500 subjects

Source of Data:

- The data, such as age and medical records, would be obtained from Hospital Authority Clinical Management System (HACMS)

Statistical analysis:

- machine learning will be applied into analysis plan

Eligibility criteria: Inclusion Criteria:

* patients with oral squamous carcinoma
* received surgery from 1st October 2000 to 1st October 2019

Exclusion Criteria:

N/A

Primary outcomes:
measure: The primary outcomes of the study are metastasis and recurrent disease
timeFrame: Baseline of OSCC
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong
Study officials:
References:
Clinical trial NCT01583166: Voiding Function After Mid-Urethral Slings With and Without Local Anesthetic: Randomized Controlled Trial
Official title: Voiding Function After Mid-Urethral Slings With and Without Local Anesthetic: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
First posted: 2012-04-23
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine if there is a difference in post-operative voiding function between subjects receiving local anesthetic and those receiving placebo at the time of mid-urethral sling placement. The secondary objective is to evaluate pain after the procedure in the two groups.


Eligibility criteria: Inclusion Criteria:

* Scheduled to undergo mid-urethral sling for incontinence without concomitant procedures

Exclusion Criteria:

* Undergoing procedure in addition to the sling
* Not competent to give consent
* Using intermittent self catheterization pre-operatively
* Known allergy to local anesthetic
* Undergoing spinal anesthesia for the procedure
* Prisoners
* Non-English speaker
* Under 18 years of age
* Has a condition that would contra-indicate the use of local anesthetic or epinephrine

Primary outcomes:
measure: Number of Subjects Who Passed the Voiding Trial After a Midurethral Sling
timeFrame: 2 weeks
Secondary outcomes:
measure: Post-operative Pain Scores at 2-3 Hours Post op
timeFrame: 2-3 hours
measure: Post-operative Pain Scale at 6-7 Hours Post op
timeFrame: 6-7 hours
measure: Visual Analog Scale for Pain: Pre-operative.
timeFrame: At enrollment
Other outcomes:
Locations:
city: Worcester
country: United States
facility: University of Massachusetts
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Worcester
name: Michael Flynn, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Duenas-Garcia OF, Patterson D, De la Luz Nieto M, Leung K, Flynn MK. Voiding Function After Midurethral Slings With and Without Local Anesthetic: Randomized Controlled Trial. Female Pelvic Med Reconstr Surg. 2017 Jan/Feb;23(1):56-60. doi: 10.1097/SPV.0000000000000343.
Clinical trial NCT02871466: Stem Cells Therapy in Advanced Heart Failure
Official title: Intra Cardiac Autologous Stem Cells Infusion May Improve Clinical Outcomes in Failing Heart Subjects Refractory to Maximal Drug Therapy and Internal Cardioverter With a Defibrillator (ICD) Recipients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Congestive Heart Failure
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
First posted: 2016-08-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: stem cells therapy may be a choice therapy for advanced heart failure patients refractory to medical therapy, internal cardiovertor with a defibrillator (ICD) recipients, and a previous history of myocardial infarction and coronary artery revascularization. These patients, without indication to receive a cardiac resynchronization therapy (CRT), may have a worsening of heart failure, and symptoms of coronary artery disease. In this study we have evaluated in consecutive 30 selected patients the amelioration in failing heart NYHA class, hospitalization rate, echocardiographic left ventricle functionality, and associated to reduction of angina after a treatment with stem cells intra thoracic infusion.


Eligibility criteria: Inclusion Criteria:

* heart failure post coronary artery disease, refractory to maximal medical therapy, previous coronary artery surgical revascularization.

Exclusion Criteria:

* inflammatory chronic diseases, neoplastic diseases.

Primary outcomes:
measure: NYHA class improvement
timeFrame: 12 months
measure: reduction in hospitalization rate
timeFrame: 12 months
measure: reduction in angor symptoms
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Celestino Sardu
city: Naples
country: Italy
facility: Raffaele Marfella
city: Napoli
country: Italy
facility: Celestino Sardu
Study officials:
References: