louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05715775: Learning Curve and Optimization of Robotic Gastrectomy
Official title: Enlightenment of Robotic Gastrectomy From 527 Patients With Gastric Cancer in the Minimally Invasive Era: 5 Years of Optimizing Surgical Performance in a High-volume Center
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 527
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: 527 patients who underwent RG between August 2016 and June 2021.

Brief summary: we explore the learning curve and the impact of technique optimization on surgical outcomes and the first to construct a referenceable learning phase for performing robotic gastric cancer surgery.


Eligibility criteria: Inclusion Criteria:

* Case inclusion criteria: (1) patients with pathologically confirmed gastric adenocarcinoma; (2) no distant metastases; and (3) R0 resection was performed.

Exclusion Criteria:

* Case exclusion criteria: (1) the presence of distant metastases was found ; (2) preoperative neoadjuvant chemotherapy was administered; and (3) clinical information was incomplete.

Primary outcomes:
measure: The LN dissection rate
timeFrame: 36 months
Secondary outcomes:
measure: LN noncompliance
timeFrame: 30 days
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
Study officials:
References:
Clinical trial NCT02188875: Fitbit One and Text Messaging Prompts to Promote Physical Activity in Overweight/Obese Adults
Official title: Wearable Sensor/Device With Website (Fitbit One) and SMS Text Messaging Prompts to Increase Physical Activity in Overweight/Obese Adults: A Randomized Controlled Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behavior
Obesity
Keywords: Fitbit One
wearable sensor
wearable device
web-based intervention
SMS text messages
randomized controlled trial
physical activity
behavioral intervention
text message prompts
text messaging
technology
exercise
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Carol Vassiliadis Family
First posted: 2014-07-14
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Previous studies suggest self-regulatory techniques including self-monitoring, and SMS text-messaging as an intervention modality, can modify health behaviors including physical activity (PA). The primary purpose of this study was to examine change in objectively measured PA in a randomized controlled pilot trial that tested a wearable sensor/device (Fitbit One) for self-monitoring and SMS text-messaging prompts to promote PA in overweight/obese adults. In a 2-group design, 67 participants were provided the Fitbit One and half were randomized to receive 3 daily SMS-based PA prompts. A Fitbit One was provided to facilitate self-monitoring with a wearable tracker for instant feedback and website of daily PA summaries. Outcome measures were number of steps and minutes of PA by intensity-level using two accelerometers: Actigraph GT3X+ (primary) at baseline and 6-week follow-up and Fitbit One (secondary) at baseline and weeks 1-6. The main hypothesis was that text messaging plus the Fitbit One would show a greater increase in steps and minutes of PA compared to only the Fitbit One at 6-week follow-up.


Eligibility criteria: Inclusion Criteria:

* 18-69 years of age
* overweight or obese (otherwise healthy)
* does not meet recommended levels of PA (\>150 min/wk of MVPA)
* owns a personal mobile phone and able to use SMS text-messaging
* owns a personal computer, has access to Internet, able to operate the Fitbit One
* fluent in English

Primary outcomes:
measure: steps per day (Actigraph GT3X+)
timeFrame: up to 6 weeks
Secondary outcomes:
measure: Minutes per week of physical activity by intensity level (Actigraph GT3X+)
timeFrame: up to 6 weeks
Other outcomes:
measure: Physical activity levels (Fitbit One)
timeFrame: up to 6 weeks
measure: Steps per a day (Fitbit One)
timeFrame: up to 6 weeks
Locations:
city: La Jolla
country: United States
facility: UCSD Moores Cancer Center
state: California
Study officials:
affiliation: University of California, San Francisco
name: Julie Wang, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Diego
name: John Pierce, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03869775: Perfusion Index Changes in Cardiovascular Autonom Neuropathia Type-2 Dm Whit Spinal Anesthesia
Official title: Observational Study Relationship Between Perfusion Index Changes and Intraoperative Complications in Cardiovascular Autonom Neuropathia Type-2 DM Patients With Spinal Anesthesia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anesthesia; Adverse Effect
Lead sponsor: Erzincan University
Sponsor class: OTHER
First posted: 2019-03-11
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients over 18 years old

Brief summary: Cardiovascular autonomic neuropathy in diabetic patients, hypertension, sympathovagal imbalance, orthostatic hypotension, painless myocardial infarction, ischemia, left ventricular dysfunction, cardiac sympathetic and parasympathetic innervation disturbances, qt interval prolongation and sudden deaths observed. The purpose of this study is to evaluate the relationship between cardiovascular autonomic neuropathy and perfusion index in spinal anesthesia

Detailed description: Cardiovascular autonomic neuropathy in diabetic patients, hypertension, sympathovagal imbalance, orthostatic hypotension, painless myocardial infarction, ischemia, left ventricular dysfunction, cardiac sympathetic and parasympathetic innervation disturbances, qt interval prolongation and sudden deaths observed. The purpose of this study is to evaluate the relationship between cardiovascular autonomic neuropathy and perfusion index in spinal anesthesia

Eligibility criteria: Inclusion Criteria:

* the patient will be operated with spinal anesthesia
* over 18 years
* no additional disease and only DM

Exclusion Criteria:

* patients with additional disease
* patients under 18 years of age
* patients contraindicated in spinal anesthesia

Primary outcomes:
measure: Perfusion index change
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Erzincan
country: Turkey
facility: Erzincanu
state: Merkez
Study officials:
References:
Clinical trial NCT03989375: Transcutaneous Electrical Stimulation of the Vagus Nerve
Official title: The Effect of Transcutaneous Electrical Stimulation of the Vagus Nerve on Reduction of Postoperative Cognitive Dysfunction in Elderly Patients After Hip or Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cognitive Dysfunction
Keywords: postoperative Cognitive Dysfunction
hip- and knee arthroplasty
transcutaneous vagus nerve stimulation
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2019-06-18
Enrollment: 110
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study evaluate the cognitive functions of patient after hip or kneel replacement.Half of the patient will receive transcutaneous vagus nerve electrical stimulation during the surgery while the other half will get placebo therapy


Eligibility criteria: Inclusion Criteria:

* over 65 years old
* ability to communication
* hip or kneel replacement
* willing to participate in the study
* ASA I-II

Exclusion Criteria:

* with cerebral disorders or disease
* cognitive impairment before surgery
* with mental disease
* unable to communication
* severe eyes or ears impairment
* surgery performed in the past 30 days
* Bradycardia，II°AVB，III°AVB，severe heart, liver and kidney dysfunction
* severe skin disease
* refuse to enter the study

Primary outcomes:
measure: Incidence of perioperative neurocognitive disorders
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Diansan Su
state: Shanghai
Study officials:
References:
Clinical trial NCT01224275: Group Based Care Versus Individual Care
Official title: Group Based Care Versus Individual Care- Effects on Parents Satisfaction and Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Satisfaction
Keywords: group based care
antenatal care
parents satisfaction
Antenatal care´s organization and patient satisfaction
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2010-10-20
Enrollment: 1150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The Study compares group based care versus individual given care-effects on patient satisfaction and health. Midwives will be randomized to either traditional antenatal care (Individual care) or group based antenatal care(intervention).

Detailed description: In the RCT the midwife is randomized.There are a multicenter study. Before the study started the midwives received education about the study. Then they randomized with simple randomization per site(clinics). The midwives also have follow up meeting with the research team during the recruting period. The parents are informed about the study at the booking appointment, after that they can choose if they want to participate in the study and are allocated to either intervention or control, based on the woman's date of birth. The main aim is to investigate parents' satisfaction of antenatal group based care. The RCT is based on three questionnaires which both women and their partners receive, the first at baseline before they receive different models of care, and the second questionnaire distributed four to six months after birth and the last one year after birth. Descriptive and inferential statistics will be used in the analysis.A power calculation is made and the study schould have a total number of 350 partners.

Eligibility criteria: Inclusion Criteria:

* Must be able to Speak Swedish

Exclusion Criteria:

* Non speaking Swedish

Primary outcomes:
measure: Group based antenatal care versus Individual care- parent´s satisfaction with care
timeFrame: 6 years
Secondary outcomes:
measure: socialization with other parents
timeFrame: 4 years
measure: Self reported health effect on mother and child
timeFrame: 6 years
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institut-Woman and childrens health
Study officials:
affiliation: eva andersson
name: Eva andersson, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02179775: Effect of "Sekanjabin e Safarjali" (Quince Oxymel) in the Prevention of Migraine Attacks
Official title: Comparison of Effectiveness of "Sekanjabin e Safarjali" (Quince Oxymel), Propranolol and Placebo in the Prevention of Migraine Attacks in Patients With Simultaneous Upper Gastrointestinal Dysfunction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Migraine Headache
Gastric Diseases
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2014-07-02
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether Quince Oxymel is effective in the prevention of Migraine attacks in patients with simultaneous upper gastrointestinal dysfunction.

Detailed description: This is a randomized, placebo-controlled, triple blinded clinical study to evaluate the effects of oral use of "Sekanjebin e Safarjali" (Quince Oxymel) in the Prevention of Migraine attacks in patients with simultaneous upper gastrointestinal dysfunction.45 patients with Migraine headache aged between 15-70, after taking signed informed consent, according to the International headache society criteria for headache \[2\] are included in this trial. 45 cases with Migraine headache with simultaneous upper gastrointestinal dysfunction will allocate to three arms by using simple randomization. Quince Oxymel, propranolol and placebo will be given as encoded, innominate bottles with the same shape and color. Quince oxymel and placebo will be prescribed as 10 cc, three times a day for 4 weeks. Frequency, duration and intensity of Migraine Attacks at the beginning time and during 4 weeks of trial, will be evaluated, as the primary outcome measures.

Eligibility criteria: Inclusion Criteria:

* minimum age of 18 years old
* giving a written informed consent
* having at least 2 migraine attacks per month

Exclusion Criteria:

* patients older than 70 years old
* patients with Diabetes mellitus
* patients with chronic obstructive pulmonary disease and asthma
* pregnancy
* severe depression
* patients affected by sexual disorders
* bradyarrhythmic patients
* positive history of hypersensitivity reactions to quince, ginger, propranolol or naproxen

Primary outcomes:
measure: frequency of headache attacks
timeFrame: 4 weeks
measure: duration of headache attacks
timeFrame: 4 weeks
measure: Pain Scores as assessed by the Visual Analog Scale
timeFrame: 4 weeks
Secondary outcomes:
measure: self-reported improvement of upper gastrointestinal symptoms (by percent)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Shiraz University of Medical Sciences
state: Fars
city: Shiraz
country: Iran, Islamic Republic of
facility: Shiraz University of Medical Sciences
state: Fars
Study officials:
affiliation: Shiraz University of Medical Sciences
name: Abdolhamid Shariat, MD, Assistant Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00817375: Pharmacogenomic Study to Predict Antidepressant Responsiveness in Depressed Patients
Official title: Pharmacogenomic Study to Predict Antidepressant Responsiveness in Depressed Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Adverse Reaction to Drug
Keywords: Pharmacogenomics
Prediction of Antidepressant Response
Depressed Patients
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2009-01-06
Enrollment: 1000
Sex: ALL
Minimum age (years): 19
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether pharmacogenomic study predict antidepressant responsiveness in advance before the appearance of the drug effects until 4\~6 weeks after drug administration.

Detailed description: The purpose of this study is

1. to determine whether genomic effects on antidepressant response differed by class of drug,
2. whether genomic differences between drug responders and nonresponders predict the response of antidepressant and
3. to construct the prediction model for antidepressant treatment in order to aid to select the their genetically matching drugs.

Eligibility criteria: Inclusion Criteria:

1. Eligible patients were enrolled in the clinical trials program of hte Samsung Medical Center Geropsychiatry and Affective Disorder Clinics(Seoul, Korea). They received a semistructured diagnostic interview, the Samsung Psychiatric Evaluation Schedule. The affective disorder section of the Samsung Psychiatric Evaluation Schedule uses the Korean version of the structured clinical interview for the diagnostic and statistical manual of mental disorders, Fourth edition.
2. interview with one more patient's family member for objective diagnosis and final diagnosis decision by agreements of two more psychiatric physicians

Exclusion Criteria:

1. received psychotropic medication within 2 weeks of the study or fluoxetine within 4 weeks
2. potential study participants for pregnancy, significant medical conditions, abnormal laboratory baseline values, unstable psychiatric features(eg.suicidal), history of alcohol of drug dependence, seizures, head trauma with loss of consciousness, neurological illness, or concomitant Axis I psychiatric disorder.

Primary outcomes:
measure: Antidepressant Response at 2,4,6 weeks A/E monitoring at 1,2,4,6 weeks
timeFrame: 6 weeks
Secondary outcomes:
measure: Biological value at 0 and 6 weeks
timeFrame: 6weeks
Other outcomes:
Locations:
city: Kangnam
country: Korea, Republic of
facility: Samsung Medical Center
state: Seoul
Study officials:
affiliation: Samsung Medical Center
name: Doh Kwan Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03131375: Dexmedetomidine Reduces Emergence Delirium in Children Undergoing Tonsillectomy With Propofol Anesthesia
Official title: Dexmedetomidine Reduces Emergence Delirium in Children Undergoing Tonsillectomy With Propofol Anesthesia: a Prospective, Randomized, Double-blind, Single-center Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Emergence Delirium
Extubation Time
Heart Rate
Postoperative Analgesia
Blood Pressure
Keywords: dexmedetomidine
emergence delirium
anesthesia
propofol
children
Lead sponsor: Athens General Children's Hospital "Pan. & Aglaia Kyriakou"
Sponsor class: OTHER
First posted: 2017-04-27
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Dexmedetomidine (DEX) is safe and effective in reducing ED following sevoflurane anesthesia. The investigators intend to study the efficacy of DEX in reducing ED in children undergoing tonsillectomy with and without adenoidectomy using total intravenous anesthesia (TIVA) with propofol .


Eligibility criteria: Inclusion Criteria:

* Children
* ASA I or II
* tonsillectomy with or without adenoidectomy

Exclusion Criteria:

* Allergy to dexmedetomidine
* Allergy to anesthetic drugs
* History of neurological disease
* History of neuromuscular disease
* History of renal disease
* History of hepatic disease
* craniofacial anomalies
* History of cardiac disease
* History of respiratory disease

Primary outcomes:
measure: Emergence delirium in PACU
timeFrame: up to 30 min
Secondary outcomes:
measure: Emergence delirium severity, assessed in PACU
timeFrame: up to 30 min
measure: Extubation time
timeFrame: up to15 min
measure: Heart rate
timeFrame: up to 45 min
measure: Blood pressure
timeFrame: up to 45 min
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Childrens Hospital P. and A. Kyriakou Anesthesiology Department
Study officials:
affiliation: Director of the Anesthesiology Dept.
name: Evangelia Kalliardou, Consultant
role: STUDY_DIRECTOR
References:
Clinical trial NCT04588675: Stress Cardiac MRI in Ischemic Patients
Official title: Assessment of Myocardial Viability by Cardiac Magnetic Resonance Feature Tracking at Rest and During Stress by Low Dose Dobutamine
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ischemic Cardiomyopathy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 50 patients with chronic LV systolic dysfunction due to coronary artery disease (CAD)

Brief summary: The aim of this study is to assess the diagnostic accuracy of CMR feature-tracking (FT) at rest \& during stress with low dose dobutamine (LDD) in the evaluation of viability in ischemic cardiomyopathy (ICM) patients and compare it with delayed gadolinium enhancement (DGE).


Eligibility criteria: Inclusion Criteria:

* All patients recruited into the study have chronic LV systolic dysfunction due to coronary artery disease (CAD)

Exclusion Criteria:

* All patients with a contraindication to MR study:

  * Patients with implanted non-MRI compatible electronic devices (e.g. Cardiac pacemakers, intracranial metallic clips, implanted hearing aids, etc.)
  * Patients with foreign bodies in the eye.
  * Claustrophobic patients.
* Patients diagnosed with recent acute coronary syndrome within 4 weeks.
* Patients who had contraindications for MRI or contrast agents, and those with poor image quality due to either inadequate breath holding or arrhythmias

Primary outcomes:
measure: comparison of myocardial strain with late gadolinium enhancement
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Bhutani M, Vatsa D, Rahatekar P, Verma D, Nath RK, Pandit N. Role of strain imaging for assessment of myocardial viability in symptomatic myocardial infarction with single vessel disease: An observational study. Echocardiography. 2020 Jan;37(1):55-61. doi: 10.1111/echo.14567. Epub 2019 Dec 23.
citation: Schuster A, Paul M, Bettencourt N, Morton G, Chiribiri A, Ishida M, Hussain S, Jogiya R, Kutty S, Bigalke B, Perera D, Nagel E. Cardiovascular magnetic resonance myocardial feature tracking for quantitative viability assessment in ischemic cardiomyopathy. Int J Cardiol. 2013 Jun 20;166(2):413-20. doi: 10.1016/j.ijcard.2011.10.137. Epub 2011 Nov 29.
Clinical trial NCT05445375: STEPUP Clinical Trial
Official title: STrategic Education for Patients Undergoing PAD Surgery (STEPUP Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Artery Disease
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2022-07-06
Enrollment: 125
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will test whether, among patients undergoing surgery for peripheral artery disease (PAD), the addition of an online multimedia patient education video to the current education regimen will improve PAD knowledge, activation, and self-care engagement. The study will randomize 150 participants to one of 2 groups: current education regimen vs. current education regiment with video. The primary outcome is stage of self-care engagement. Secondary outcomes are PAD knowledge, self-efficacy, and activation. A subset of participants will also be randomly selected to participate in semi-structured interviews. Study duration for participants is 6 months.


Eligibility criteria: Inclusion Criteria:

* Patient undergoing surgery for PAD in Division of Vascular Surgery at Northwestern Memorial Hospital

Exclusion Criteria:

* Inability to provide informed consent
* Inability to complete study protocol
* Previously viewed the PAD education video
* Participation in pilot study

Primary outcomes:
measure: Readiness to change self-care engagement
timeFrame: Baseline to six-month follow-up
Secondary outcomes:
measure: PAD knowledge and beliefs
timeFrame: Baseline to six-month follow-up
measure: Self-efficacy
timeFrame: Baseline to six-month follow-up
measure: Activation level
timeFrame: Baseline to six-month follow-up
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
References: