louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01649154: Clinical Trial on Harmonic Focus Shears Versus Ligasure Small Jaw and Clamp-and-tie Technique for Total Thyroidectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Thoroid Disease Requiring Total Thyroidectomy
Lead sponsor: Ospedale Regina Apostolorum
Sponsor class: OTHER
First posted: 2012-07-25
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The Harmonic Focus and Ligasure small-Jaw are the last device designed for thyroid surgery. The aim is to assess: 1. decrease of operative time (minutes); 2. decrease of post-operative blood loss (milliliters); 3. decrease of post-operative stay (days); decrease of post-operative complications (%, hypocalcemia, laringeal nerve demage), compared to traditional dissection in a prospective randomized trial of total thyroidectomy procedures, for benign disease.

Detailed description: A single-blinded prospective randomized controlled trial was conducted at a tertiary referral center. A total of 120 patients who required a thyroidectomy for thyroid benign disease, will be randomized to either Harmonic Focus or Ligasure small-Jaw or clamp-and-tie technique during thyroidectomy. The operative time (minutes), morbidity rate (%), post-operative blood loss (milliliters), hospital stay (days), post-operative hypocalcemia (%), and cost of thyroidectomy (euros) were compared between the three groups.

Eligibility criteria: Inclusion Criteria:

* thyroid benign disease

Exclusion Criteria:

* malignant disease
* thyroid malign disease requiring lymphadenectomy
* coagulatory disease

Primary outcomes:
measure: Improvement of post-operative outcomes (morbidity, hospital stay, costs) with new generation devices for total thyroidectomy.
Secondary outcomes:
measure: Cost assessment of new generation devices in thyroid surgery
Other outcomes:
Locations:
city: Albano Laziale
country: Italy
facility: Ospedale Regina Apostolorum
state: Rome
Study officials:
References:
Clinical trial NCT05690854: Cardiovascular Magnetic Resonance in Adults With SysTemic Right Ventricle (STAR)
Official title: Cardiovascular Magnetic Resonance in Adults With SysTemic Right Ventricle (STAR): From Pathophysiology to Clinical Application
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Transposition of Great Arteries
Lead sponsor: IRCCS Policlinico S. Donato
Sponsor class: OTHER
First posted: 2023-01-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with diagnosis of L-loop transposition of great arteries (L-TGA) and D-loop transposition of great arteries (D-TGA) after atrial switch operation (ASO).

Brief summary: The main aim of the study is to explore HFs in SRV, comparing their magnitude and direction with that of subpulmonary RV and systemic LV. As a secondary aim, possible association or correlation will be investigated between SRV energetics and: i) patient functional parameters, e.g., the results from cardiopulmonary exercise test (CPET), ii) patient clinical status, including the occurrence of adverse outcome (a composite of death, hospitalization for heart failure, cardiovascular arrest, sustained arrhythmias).


Eligibility criteria: Inclusion Criteria:Case group:

The study will include patients aged ≥ 18 years with the diagnosis of L-TGA and D-TGA, who:

* are admitted to UNICCA, the Adult Congenital Heart Unit or
* are scheduled for a Cardiovascular Magnetic Resonance examination in this Institution

Control group:

The study will include subjects aged ≥ 18 years who will invited for a Cardiovascular Magnetic Resonance examination in our Institution. This group of control will include n=15 of adult healthy subjects. A further inclusion criteria for the control subjects are age and male proportion comparable to those of the TGA group.

Exclusion Criteria:

* (case and control group)

  * Subjects with intrabody ferromagnetic material precluding subject's safety
  * Subjects with non CMR-conditional devices
  * Subjects with claustrophobia or breath-holding precluding an adequate CMR and 4D Flow images quality
  * Pregnant women

Primary outcomes:
measure: Adverse Outcome definition
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: San Donato Milanese
country: Italy
facility: IRCCS Policlinico San Donato
state: Milano
Study officials:
References:
Clinical trial NCT01246154: An Evaluation of Exercise Tolerance in Asthmatic Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: To Evaluate
Keywords: ASTHMA
Lead sponsor: Physio Care
Sponsor class: INDUSTRY
First posted: 2010-11-23
Enrollment: 15
Sex: ALL
Minimum age (years): 40
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: KNOWN ASTHMATIC PATIENTS

Brief summary: To evaluate exercise tolerance.


Eligibility criteria: Inclusion Criteria:

- 40-50 YEARS

Exclusion Criteria:

* NO EXCERBATIONS

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Thanjavur
country: India
facility: Physio Care
state: Tamilnadu
Study officials:
References:
Clinical trial NCT04493554: The Effects of Vasopressin on Attention Control
Official title: The Effects of Vasopressin on Attention Control: An Eye-tracking Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: University of Electronic Science and Technology of China
Sponsor class: OTHER
First posted: 2020-07-30
Enrollment: 89
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Between-subject randomized placebo-controlled double-blind pharmacological eye-tracking design
Primary purpose: BASIC_SCIENCE

Brief summary: The main aim of the present study is to investigate whether intranasal vasopressin (20IU) could influence attention control in a social-emotional saccade/antisaccade eye-tracking paradigm.

Detailed description: A number of previous studies have reported vasopressin's effect on human social behavior and social cognition, although it remains unclear whether vasopressin could modulate attention allocation including stimulus-driven bottom-up control and goal-directed top-down control. In the current randomized, between-subject, placebo controlled study, 89 healthy male subjects will be recruited and receive either vasopressin (20 IU) or placebo control administered intranasally. 45 minutes after treatment subjects will be required to complete a social-emotional saccade /antisaccade eye-tracking paradigm. The paradigm uses social (happy, sad, angry, fear, and neutral faces) as well as non-social (oval shapes) stimuli to explore social- and emotion-specific effects of vasopressin.

Eligibility criteria: Inclusion Criteria:

* Healthy participants
* Non smokers

Exclusion Criteria:

* Previous or current medical, psychiatric, neurological disorder
* Regular medication
* Use of any psychoactive substances in the 24 hours before experiment
* Contra-indications for vasopressin
* Contra-indications for eye-tracking data acquisition

Primary outcomes:
measure: Effect of vasopressin administration on saccade/antisaccade latencies towards social (facial) versus non-social (shape) stimuli
timeFrame: 45 minutes - 100 minutes after treatment
measure: Effect of vasopressin administration on error rates of saccade/antisaccade for social (facial) versus non-social (shape) stimuli
timeFrame: 45 minutes - 100 minutes after treatment
Secondary outcomes:
measure: Emotion-specific effects of vasopressin administration on saccade/antisaccade latencies towards the separate facial emotions
timeFrame: 45 minutes - 100 minutes after treatment
measure: Emotion-specific effects of vasopressin administration on saccade/antisaccade error rates for the separate facial emotions
timeFrame: 45 minutes - 100 minutes after treatment
Other outcomes:
Locations:
city: Chengdu
country: China
facility: University of Electronic Science and Technology of China(UESTC)
state: Sichuan
Study officials:
affiliation: University of Electronic Science and Technology of China (UESTC)
name: Keith Kendrick, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04752254: Investigating Racing Thoughts in Patients With Insomnia Disorder
Official title: Cognitive Hyperarousal in Insomnia Disorder
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Insomnia Disorder
Keywords: Insomnia
Hyperarousal
Rumination
Racing thoughts
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2021-02-12
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Major subject with a diagnosis of chronic primary insomnia according to the criteria of ICSD-3

Brief summary: Cognitive arousal has been identified as playing a key role in the inability to fall asleep or stay asleep. However, although people with insomnia frequently complain about racing thoughts appearing as soon as they get into bed, studies focusing on racing thoughts in insomnia are lacking. The aim of the present study is to investigate racing thoughts in insomnia disorder using a self-report questionnaire, the Racing and Crowded Thoughts Questionnaire. Specifically, the researchers seek to address three related goals: the comparison of RCTQ scores in adults with primary insomnia, healthy individuals, and patients with bipolar disorder in a manic/hypomanic episode; the variation of RCTQ scores relative to time of day; and the specific contribution of racing thoughts to insomnia severity, as compared to worry and rumination.


Eligibility criteria: Inclusion Criteria:

* Major subject from 18 to 70 years old)
* with a diagnosis of chronic primary insomnia according to the criteria of ICSD-3
* Subject not having expressed his opposition, after information, to the reuse of his data for the purposes of this research

Exclusion Criteria:

* Subject having expressed opposition to participating in the study
* Subject under guardianship or guardianship
* Subject under safeguard of justice
* Patient with secondary insomnia (OSA, circadian rhythm disorder, severe restless legs syndrome, bipolar disorder, ADD +/- H)
* Subject under psychotropic treatment other than hypnotics
* Incomplete data concerning the main endpoint

Primary outcomes:
measure: A retrospective evaluation of self-reported tachypsychia in primary insomnia
timeFrame: Files analysed retrospectively from Jun 01, 2014 to March 13, 2020 will be examined]
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Center for Sleep Disorders - CIRCSom - Strasbourg University Hospitals
Study officials:
References:
citation: Weiner L, Martz E, Kilic-Huck U, Siegel N, Bertschy G, Geoffroy PA, Weibel S, Bourgin P. Investigating racing thoughts in insomnia: A neglected piece of the mood-sleep puzzle? Compr Psychiatry. 2021 Nov;111:152271. doi: 10.1016/j.comppsych.2021.152271. Epub 2021 Sep 17.
Clinical trial NCT00658554: Bioequivalence Study of ARQ 197 Amorphous and Crystalline Polymorphs A and B in Normal Healthy Volunteers
Official title: Bioequivalence Study of ARQ 197 Amorphous and Crystalline Polymorphs A and B in Normal Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
Sponsor class: INDUSTRY
First posted: 2008-04-15
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This is a bioequivalence study designed to compare three solid states of ARQ 197 in normal healthy volunteers using a randomized crossover design.

Detailed description: This is a bioequivalence study designed to compare three solid states of ARQ 197 in normal healthy volunteers using a randomized crossover design.

The primary objective is to obtain pharmacokinetic data to assess bioequivalence among three solid states of ARQ 197: amorphous, crystalline polymorph A and crystalline polymorph B.

Eligibility criteria: Inclusion Criteria:

* Subject must provide written informed consent prior to any study related procedures
* Subjects must be between the ages of 18 and 65 years
* Male participants must have been surgically sterilized
* Female participants must have been surgically sterilized or be post menopausal and must have a negative serum pregnancy test
* All participants will be phenotypically extensive metabolizers based on their CYP C19 genotype.

Exclusion Criteria:

* Males who are not surgically sterilized
* Females of child-bearing potential who are not surgically sterilized
* Any clinically significant acute or unstable physical or psychological disease based on medical history or screening physical examination
* Any clinically significant abnormality in the screening laboratory tests or ECG
* Received any investigational drugs within four weeks
* Human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection

Primary outcomes:
measure: To obtain pharmacokinetic data to assess bioequivalence among three solid states of ARQ 197: amorphous, crystalline polymorph A and crystalline polymorph B.
timeFrame: May 2008
Secondary outcomes:
measure: To monitor safety of the three solid states of ARQ 197.
timeFrame: May 2008
Other outcomes:
Locations:
city: Evansville
country: United States
facility: Covance Clinical Research Unit, Inc.
state: Indiana
Study officials:
affiliation: Covance Clinical Research Unit
name: Ronald M Kimberlin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05956054: A Comparison of Intravascular Penetration With Curved Needle and Straight Needle During S1 STE
Official title: A Comparison of Intravascular Penetration With Curved Needle and Straight Needle During Sacral 1 Transforaminal Epidural Block
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: S1 Transforaminal Epidural Injection
Keywords: S1 transforaminal epidural injection
curved needle
Lead sponsor: Kyungpook National University Chilgok Hospital
Sponsor class: OTHER
First posted: 2023-07-21
Enrollment: 240
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: OTHER

Brief summary: The goal of this observational study is to compare in intravasation rate during S1 transforaminal epidural injection between using a straight needle and a curved needle. The main question it aims to answer are:

The main question it aims to answer is:

• whether there is a difference in intravascular rate between using a straight needle and a curved needle in S1 transforaminal epidural injection

Participants in this study will be randomly assigned to receive an S1 transforaminal epidural injection using either a straight needle or a curved needle. The researchers will then observe the intravasation rate and compare it between the two groups.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for a lumbar 1 epidural nerve block in the outpatient department of anesthesiology and pain medicine at Kyungpook National University Hospital.

Exclusion Criteria:

1. Patients with a history of allergy to local anesthetics or steroids
2. Patients with a history of allergy to contrast media
3. Patients with a bleeding tendency
4. Patients with symptoms of infection in the sacroiliac region
5. Patients under 18 years of age or over 80 years of age
6. Patients who are pregnant or planning to become pregnant
7. Other medically incapable of consent, such as the mentally retarded.

Translated with www.DeepL.com/Translator (free version)

Primary outcomes:
measure: Intravasation rate
timeFrame: in the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
Study officials:
References:
Clinical trial NCT04640454: Assessment of Nipple Sparing Mastectomy as a Treatment Option for Breast Cancer
Official title: Assessment of Nipple Sparing Mastectomy as a Treatment Option for Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: breast cancer
mastectomy
breast reconstruction
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2020-11-23
Enrollment: 35
Sex: FEMALE
Minimum age (years): 28
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The mean age of the studied patients was 44.00±9.47 years old; the youngest patient was 28 years old and the oldest one was 68 years old, the majority of patients were 40-50 years of age (54%) As regard the patients' marital status; 31 patients were married constituting 88.57 % and only 4 (11.4 %) patients were single The main complaint of 25 of them (71.42%) was painless breast lump while 8 cases (22.85%) presented with local recurrence after previous breast conservative surgery and only two case (5.7%) presented by extensive mammographic calcifications on screening mammography

Brief summary: Nipple-sparing mastectomy (NSM) with immediate breast reconstruction (IBR) is a form of mastectomy that achieves optimal disease control and facilitates reconstruction. The study aimed to assess the oncological safety and aesthetic outcomes of nipple-sparing mastectomy and immediate breast reconstruction.

35 female patients with breast cancer were included in the study. The investigators categorized the incisions into radial, inframammary, and periareolar incisions with planned reconstruction types; direct to implant (DTI), transversus rectus abdominis myocutaneous (TRAM) flap, latissimus dorsi myocutaneous (LD) flap, or LD with implant.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of ductal in situ carcinoma or infiltrating ductal carcinoma with a tumor diameter up to 3 cm
* Distance of the tumor from the nipple ≥ 2 cm
* Cancer or microcalcifications not localized in the central field.
* No blood secretions or other (nipple-areola complex) NAC disturbances
* Absence of skin involvement
* Indication to mastectomy for multifocal or diffuse microcalcifications
* Negative intraoperative assessment of NAC-bottom

Exclusion Criteria:

* Tumor or microcalcifications localized in the central quadrant or in the retroareolar region
* Blood secretions or other NAC alterations
* Positive intraoperative assessment of NAC-bottom
* Inflammatory carcinoma
* Paget's disease of the nipple

Primary outcomes:
measure: patients complications after nipple sparing mastectomy
timeFrame: 2017-2019
Secondary outcomes:
measure: Aesthetic results assessed by Tzafetta et al scoring system
timeFrame: 2017-2019
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria faculty of medicine
Study officials:
References:
Clinical trial NCT00922454: Acute Technical Outcomes of the Talent Abdominal Aortic Aneurysm (AAA) Stent-Graft Versus Cook Zenith Stent-Graft
Official title: Acute Technical Outcomes of the Talent AAA Stent -Graft vs. Cook Zenith Stent- Graft: A Case-Control Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Abdominal Aortic Aneurysm
Keywords: patients will be matched based on AAA neck length and neck and iliac angulation
Lead sponsor: Center for Vascular Awareness, Albany, New York
Sponsor class: OTHER
First posted: 2009-06-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to compare acute technical outcomes of the Talent AAA Stent Graft system versus Cook Zenith Endograft at two high volume institutions, Albany Medical Center and St. Peter's Hospital in Albany, NY.

The investigators are comparing the two devices as part of the evolution of endovascular repair (EVAR) for AAAs. The Zenith AAA Endovascular Graft received FDA approval on May 23, 2003, the Talent Abdominal Stent Graft System on April 15, 2008.


Eligibility criteria: Inclusion Criteria:

* subject with abdominal aortic aneurysm, with or without iliac involvement
* iliac/femoral access vessel morphology that is compatible with vascular access techniques, devices, and/or accessories

Exclusion Criteria:

* less than 18 years of age
* pregnant or lactating
* have contraindications for use of contrast medium or anticoagulation drugs
* are patients who have a condition that threatens to infect the graft
* are patients with sensitivities or allergies to the device materials

Primary outcomes:
measure: Acute technical success, successful exclusion of the aneurysm
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Albany
country: United States
facility: Albany Medical Center, 47 New Scotland Ave.
state: New York
Study officials:
affiliation: The Vascular Group, PLLC
name: Manish Mehta, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01763554: Review of Medical Records of Patients Who Have Been Treated With Lutetium at the Cross Cancer Institute Between January 2010 and April 30, 2014
Official title: Review of Medical Records of Patients Who Have Been Treated With Lutetium at the Cross Cancer Institute Between January 2010 and April 30, 2014
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Neuroendocrine Tumors, NET
Keywords: Lu-177
Lutetium-177
DOTA-TATE
Neuroendocrine tumors
radiopharmaceutical
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
Collaborators: name: Cross Cancer Institute
First posted: 2013-01-09
Enrollment: 115
Sex: ALL
Minimum age (years): 14
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Limited to those subjects with neuroendocrine tumors who received Lu-177 DOTA-TATE treatment under SAP at the Cross Cancer Institute between January 2010 and April 30, 2014.

Brief summary: Retrospective review of the medical files of 115 patients with neuroendocrine tumours who were treated with Lutetium-177 DOTA-TATE under Health Canada's Special Access Programme (SAP) at the Cross Cancer Institute between January 2010 and April 30, 2014. Efficacy, safety, and other relevant data will be collected to support a separate clinical trial application.


Eligibility criteria: Subjects with neuroendocrine tumours who received Lu-177 DOTA-TATE treatment under SAP at the Cross Cancer Institute between January 2010 and April 30, 2014.

Primary outcomes:
measure: Efficacy data on subjects with neuroendocrine tumours (NET) treated with Lu-177 DOTA-TATE
timeFrame: Retrospective data January 2010 - April 30, 2014
Secondary outcomes:
measure: Safety and other relevant information on subjects treated with Lu-177 DOTA-TATE
timeFrame: Retrospective data January 2010 - April 30, 2014
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
Study officials:
affiliation: Endocrinology & Oncology, University of Alberta, Cross Cancer Institute
name: Donald Morrish, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: