louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04086940: Role of Intraoperative Beta Blocker for Morbid Obese Patients Undergoing Laparoscopic Bariatric Surgery
Official title: Lecturer of Anesthesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Intraoperative Awareness
Postoperative Pain
Keywords: role
INTRAOPERATIVE
beta blocker
bariatric surgery
morbid obese
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2019-09-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective randomized controlled study
Primary purpose: PREVENTION

Brief summary: Using esmolol during anesthetic maintenance of laparoscopic bariatric surgery significantly decreases anesthetic, analgesic requirements, postoperative pain, PNV and postoperative hypoxia.

Detailed description: Postoperative pain, nausea, vomiting (PNV) and hypoxia are common in relation to laparoscopic bariatric surgery. Sympatholytic drugs might decrease the need for intravenous or Inhalation anesthetics and opioids. In this study we wanted to analyze effects of esmolol on intraoperative anesthetic-analgesic requirements, postoperative analgesic requirements, postoperative pain, PNV and hypoxia.

Methods: Sixty patients have been included. Propofol, fentanyl and rocuronium were used for induction. Study groups were as follows; group E Esmolol infusion was added to maintenance anesthetics (Sevoflurane and fentanyl), group N only Sevoflurane and fentanyl was used during maintenance. They have been monitored during the intraoperative period and postoperatively for 24 h for analgesic requirements and PNV. Visual analog scale (VAS) scores for pain was also been assessed.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) I - II patients
* age between 18-59 years
* both genders
* body mass index (BMI) \> 45 kg/m2

Exclusion Criteria:

* Patients with -hepatic
* renal
* cardiac
* respiratory diseases
* patients with a history of drug abuse or who were dependent on opioid drugs.

Primary outcomes:
measure: intraoperative analgesic requirements
timeFrame: 6 months
measure: postoperative analgesic requirements
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ramymahrose
Study officials:
References:
Clinical trial NCT01024140: Open Trial of Escitalopram Treatment for Male Subjects With Posttraumatic Stress Disorder
Official title: Open Trial of Escitalopram Treatment for Male Subjects With Posttraumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Posttraumatic Stress Disorder
Keywords: Posttraumatic Stress Disorder
Escitalopram
Efficacy
Lead sponsor: Northern California Institute of Research and Education
Sponsor class: OTHER
First posted: 2009-12-02
Enrollment: 16
Sex: MALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary aim of this pilot study is to test the efficacy of the selective serotonin re-uptake inhibitor, Escitalopram, in the treatment of posttraumatic stress disorder (PTSD) in an open clinical trial.

A secondary aim is to determine whether treatment with escitalopram increases plasma allopregnanolone levels in patients with PTSD and if increases in allopregnanolone levels are correlated with treatment efficacy.


Eligibility criteria: Inclusion Criteria:

* Current DSM-IV TR PTSD and a score \> 40 on the CAPS, as a result of a traumatic event that occurred at least 6 months prior to evaluation.

Exclusion Criteria:

* Lifetime history of bipolar or any psychiatric disorder with psychotic features.
* Prominent suicidal or homicidal ideation.
* History of alcohol abuse/dependence within the past 3 months.
* History of drug abuse/dependence within the past 6 months.
* Subjects who plan to start a new form of psychotherapy during the protocol.
* History of sleep apnea, neurological disorder and/or current systemic illness affecting central nervous system function.
* History of myocardial infarction in the past year.
* Subjects on antipsychotic medications, systemic steroid medication, antidepressants, mood stabilizers, antianxiety medication, or benzodiazepines within the past 2 weeks.
* Use of Citalopram or Escitalopram within the past 6 months.

Primary outcomes:
measure: The Clinician Administered PTSD Scale
timeFrame: Administered at baseline (prior to treatment) and week 12
Secondary outcomes:
measure: PTSD Checklist
timeFrame: Each Visit: Week 0, 2, 4, 6, 8, & 12
measure: Beck Depression Inventory
timeFrame: Each Visit: Week 0, 2, 4, 6, 8, & 12
measure: Profile of Mood State
timeFrame: Each Visit: Week 0, 2, 4, 6, 8, & 12
measure: Social Adjustment Scale
timeFrame: Initial, Mid-Trial and Final Assessments
measure: Quality of Life Inventory
timeFrame: Initial, Mid-Trial and Final Assessments
Other outcomes:
Locations:
Study officials:
affiliation: UCSF / VAMC / NCIRE
name: Thomas C Neylan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02693340: Evolution of Lymphocyte Populations Under Biotherapy in Inflammatory Bowel Disease
Official title: Evolution of Lymphocyte Populations Under Biotherapy in Inflammatory Bowel Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Inflammatory Bowel Disease
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2016-02-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Crohn's Disease Diagnosis (CD) or ulcerative colitis (UC)

Brief summary: This is a monocentric prospective study for the collection of biological samples (blood and biopsies) to be used for in vitro biomarker assay(s) performed to identify predictive markers of response to biological treatments in inflammatory bowel disease (IBD).


Eligibility criteria: Inclusion Criteria:

* Patients aged 18 or more.
* Crohn's Disease Diagnosis (CD) or ulcerative colitis (UC) according to defined criteria (ECCO recommendations).
* Active disease as defined by clinical biological and/or morphological assessment.
* Initiation of an anti-Tumor Necrosis Factor (TNF) therapy (Infliximab, Adalimumab, Golimumab) or new biotherapy (Vedolizumab, Ustekinumab) provided in connection with the management of digestive disease.
* Patient (e) have signed and dated consent of the study before undertaking procedures related to the study.

Exclusion Criteria:

* Patients under guardianship / curators
* Following Situations

  * Persons unable to understand, read and / or sign an informed consent
  * Patient with the following functions: investigator or co-investigator, research assistant, pharmacist, study coordinator or having any involvement in the study
  * Uncooperative person or potentially non-compliant for the study and its procedures with predictable difficulties regular monitoring of over 1 year.
  * No affiliation to a social security scheme, a universal medical coverage or any similar plan.
* Pregnant or lactating women.

Primary outcomes:
measure: Response to biological treatments
timeFrame: 12 months
Secondary outcomes:
measure: Microbiota variation
timeFrame: 12 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Gastroenterology department
Study officials:
affiliation: APHP
name: Matthieu Allez, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06852040: Effect of TDCS Combined with Intraoral Electrical Stimulation
Official title: Analysis of the Therapeutic Effect of TDCS Combined with Intraoral Electrical Stimulation on Dysphagia After Pontine Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pontine Infarction
Keywords: pontine infarction
dysphagia
transcranial direct current stimulation
Inductive electrical stimulation in the mouth
Lead sponsor: Handan Central Hospital
Sponsor class: OTHER
First posted: 2025-02-28
Enrollment: 90
Sex: ALL
Minimum age (years): 1
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective: To investigate the clinical efficacy of transcranial direct current stimulation (tDCS) combined with intraoral electrical stimulation in patients with dysphagia after pontine infarction. Methods: This prospective study enrolled a total of 90 patients with dysphagia due to pontine infarction from October 2022 to November 2024, and they were divided into three groups according to the treatment method: control group A, control group B, and experimental group C. Control group A was given intraoral induction electrical stimulation, control group B was given transcranial direct current stimulation (tDCS), and experimental group C was given tDCS combined with intraoral induction electrical stimulation. The three groups were compared in terms of efficacy, modified Waffield Drinking Water Test Score (MWST), Penetration-aspiration scale (PAS), Functional Oral Intake Scale (FOIS), Hyoid-Larynx Complex mobility, maximum amplitude of surface electromyography, and swallowing time.


Eligibility criteria: Inclusion Criteria:

* Patients with dysphagia (able to cooperate with swallowing assessment) and consistent with the criteria of the "Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018"\[9\] or pontine infarction by clinical imaging examination;
* Age≥18 years or ≤80 years;
* The modified water swallow test (MWST) score is 3-5\[10\] or the Functional Oral Intake Scale score \<4

Exclusion Criteria:

* Those who are intolerant to electrical stimulation or allergic to auxiliary electrodes;
* Patients with implanted pacemakers, metal stents in the neck, or other reasons that cannot be treated with electrical stimulation;
* Patients who are critically ill or unable to cooperate with the assessment and treatment of patients with dysphagia due to other reasons.

Primary outcomes:
measure: MWST
timeFrame: 4 weeks
measure: FOIS
timeFrame: 4 weeks
measure: RAS
timeFrame: 4 weeks
measure: Hyoid laryngeal complex mobility
timeFrame: 4 weeks
measure: Maximum Amplitude and Swallowing Time of Surface Electromyography
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Handan City
country: China
facility: Handan Central Hospital
state: Hebei
Study officials:
affiliation: Handan Central Hospital
name: Xuehai Lv Lv
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05303740: Anlotinib Retrospective Study for Esophageal Cancer
Official title: Efficacy and Safety of Anlotinib in the First-line or Second-line Treatment of Locally Advanced or Metastatic Esophageal Cancer in China, a Retrospective, Multicenter, Real-world Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Neoplasms
Lead sponsor: The First Affiliated Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 300
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: Esophageal cancer patients previously treated with anlotinib

Brief summary: The efficacy of anlotinib in the treatment of esophageal cancer has been confirmed. The purpose of this study was to retrospectively observe the efficacy and safety of anlotinib in the first and second line of advanced esophageal cancer in the real world.


Eligibility criteria: Inclusion Criteria:

* Esophageal cancer diagnosed pathologically or clinically
* Patients who use anlotinib alone, or combined with chemoradiotherapy, or plus PD-1 inhibitors in first-line or second-line treatment

Exclusion Criteria:

None

Primary outcomes:
measure: PFS
timeFrame: From date of admission until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Secondary outcomes:
measure: OS
timeFrame: From date of admission until the date of death from any cause, assessed up to 24 months
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
Study officials:
References:
Clinical trial NCT04609540: Pyrotinib Combined With Trastuzumab And Chemotherapy in HER2-positive MBC
Official title: Pyrotinib Combined With Trastuzumab and Chemotherapy in HER2-positive Metastatic Breast Cancer Patients- a Multicenter Retrospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HER2-positive Breast Cancer
Metastatic Breast Cancer
Lead sponsor: Shandong Cancer Hospital and Institute
Sponsor class: OTHER
First posted: 2020-10-30
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HER2 positive Metastatic Breast Cancer

Brief summary: To explore the real world data of trastuzumab Combined With Trastuzumab And Chemotherapy in China, and to explore the relationship between progression free survival and treatment pattern.


Eligibility criteria: Inclusion Criteria:

* woman, age \> 18 years old
* Diagnosed with HER2 +Metastatic Breast Cancer
* Pyrotinib Combined With Trastuzumab And Chemotherapy for at least one cycle, starting from 2020.11.01-2021.10.31
* Available medical history

Exclusion Criteria:

* Incomplete medical history

Primary outcomes:
measure: Progression free survival(PFS)
timeFrame: 1 year
Secondary outcomes:
measure: Overall survival(OS)
timeFrame: 1 year
measure: Objective Response Rate(ORR)
timeFrame: 1 year
measure: Safety
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03126344: Nasal Intubation Using King Vision Video Laryngoscopy
Official title: Comparison King Vision Video Laryngoscopy 、McGrath MAC Video Laryngoscopy With Macintosh Laryngoscopy for Nasal Intubation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasal Intubation
Keywords: King Vision
Lead sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sponsor class: OTHER
First posted: 2017-04-24
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was designed to determine the comparison between the King Vision video laryngoscope 、 McGrath MAC video laryngoscope and Macintosh laryngoscope for nasotracheal intubation.Patients were divided into 3 groups of 30 patients each.Patients of King Vision group \[n=30\]、 McGrath MAC group \[n=30\] and Macintosh group\[n=30\]were intubated using respective devices.This study is the first to search the use of King Vision video laryngoscope for nasotracheal intubation.


Eligibility criteria: Inclusion Criteria:

* ASA physical status 1-2
* general anesthesia with nasotracheal intubation
* anticipated difficult airway

Exclusion Criteria:

* contraindications to nasal intubation
* Patients with a history of anti-hypertensive drugs

Primary outcomes:
measure: Time to Intubation
timeFrame: 0 min after nasal intubation
Secondary outcomes:
measure: Laryngoscopy Time
timeFrame: after expose the glottis
measure: Number of Participants With Complications
timeFrame: 24h after surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital,Affililated to Shanghai Jiaotong University School of Medicine
state: Shanghai
Study officials:
References:
citation: Zhu H, Liu J, Suo L, Zhou C, Sun Y, Jiang H. A randomized controlled comparison of non-channeled king vision, McGrath MAC video laryngoscope and Macintosh direct laryngoscope for nasotracheal intubation in patients with predicted difficult intubations. BMC Anesthesiol. 2019 Aug 31;19(1):166. doi: 10.1186/s12871-019-0838-z.
Clinical trial NCT00781144: Determination of Forces Used in Palpatory Diagnosis
Official title: The Effect of Experience and Gender on the Palpatory Forces Exerted by Novice and Experienced Osteopaths in Australia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Volunteers
Lead sponsor: Nova Southeastern University
Sponsor class: OTHER
First posted: 2008-10-28
Enrollment: 82
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: first year osteopathic students, fourth and fifth year osteopathic students and experienced osteopathic clinicians

Brief summary: In this study, we are experimentally investigating the assessment of forces used by skilled clinicians and beginning practitioners in palpatory techniques. The study will assess pressure used during palpatory diagnosis of the paraspinal region.

Detailed description: The study will assess pressure used during palpatory diagnosis of the paraspinal region. The research hypothesis is that both experience and gender will affect the amount of pressure exerted with diagnostic springing. The data will be valuable in characterizing practice parameters of novice and skilled osteopathic clinicians in palpation and will provide data on skill maturation from novice to experienced clinician. It will also allow far more precise teaching of these skills to students, who can use the transducers to determine how much pressure they are using compared to skilled clinicians. For measuring the palpatory forces, a thin film pressure transducer will be used in the hand of the clinician. Data will be collected on a portable computer via an analog to digital interface.

Eligibility criteria: Inclusion Criteria:

* osteopathic student first year or senior or experienced osteopathic clinician

Exclusion Criteria:

* none

Primary outcomes:
measure: palpatory force exerted with PA springing
timeFrame: 3 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Ft. Lauderdale
country: United States
facility: Nova Southeastern University
state: Florida
city: Melbourne
country: Australia
facility: Victoria University
state: Victoria
Study officials:
affiliation: Nova Southeastern University, Victoria University
name: Yasmin Qureshi, MHS. MPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00890344: Body Composition Assessment in Healthy Full-term Neonates by Anthropometry, Air Displacement Plethysmography and Multiple-frequency Bio-impedance Analysis
Official title: "Body Composition Assessment in Healthy Full-term Neonates by Anthropometry, Air Displacement Plethysmography (PeaPod) and Multiple-frequency Bio-impedance Analysis (BIA)"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neonates
Keywords: PeaPod
BIA
Anthropometry
Body Composition
Fat Mass
Total Body Water
Neonatology
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2009-04-29
Enrollment: 40
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Full-term infants 10th percentile for gestational age, according to the Audipog's growth chart

Brief summary: Low birth weight and prematurity are associated with adverse metabolic outcome in adult life. Yet it remains to be determined whether this outcome is the consequence of the low birth weight per se, or of the catch up growth achieved in Neonatology units using an early, 'aggressive' nutritional management. As a matter of fact, 'aggressive' nutrition may promote fat mass, rather than lean body mass accretion. Assessment of body composition therefore is key to evaluate the efficacy of the nutritional management of these infants. Scarce data is, however, available in the literature about the body composition of healthy full-term neonates in the first few days of life.

The aim of this study is to:

1. Evaluate the feasibility and reproducibility of a safe and non invasive method of measurement of infant body composition by Air Displacement Plethysmography (PeaPod). Anthropometry and BIA will be used as the reference techniques to assess the accuracy of the PeaPod
2. Describe the body composition (fat mass, fat free mass) of healthy full-term neonates in the first few weeks of life
3. Obtain data on the total body water content of healthy full term infants from BIA.


Eligibility criteria: Inclusion Criteria:

* Full-term infants
* 10th percentile for gestational age, according to the Audipog's growth chart

Exclusion Criteria:

* Congenital diseases
* Chromosomal abnormalities
* Any disease requiring intensive care

Primary outcomes:
measure: Accuracy and reproducibility of the PeaPod compared with Anthropometry and BIA. We defined that assessments are convergent if the difference between methods is less than 10 percent.
timeFrame: August 2009
Secondary outcomes:
measure: Describe the body composition (fat mass, fat free mass) of healthy full-term neonates To get data on the total body water that we can refer to from BIA.
timeFrame: August 2009
Other outcomes:
Locations:
city: Nantes
country: France
facility: Centre Hospitalier Universitaire
Study officials:
affiliation: Nantes University Hospital
name: Anne CA FRONDAS-CHAUTY, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03967444: Study to Evaluate Satisfaction After Treatment With Kysse
Official title: Post Marketing Study to Evaluate Lip Augmentation & Satisfaction With Restylane Kysse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lip Augmentation
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2019-05-30
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Open-label, phase IV, post-marketing study to evaluate aesthetic improvement and satisfaction after treatment with Kysse.


Eligibility criteria: Inclusion Criteria:

* Signed and dated informed consent to participate in the study
* Adult women and men who intend to undergo lip augmentation

Exclusion Criteria:

* Subjects presenting with known allergy to HA (hyaluronic acid) filler or amide local anesthetics
* Subjects with a previous implant other than HA in or near the intended treatment site
* Participation in any other clinical study within three (3) months before treatment

Primary outcomes:
measure: Assess Treatment With Restylane Kysse Using GAIS
timeFrame: 8 weeks after last treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Galderma Study Site
city: Toronto
country: Canada
facility: Galderma Study Site
Study officials:
affiliation: Galderma R&D
name: Study Director
role: STUDY_DIRECTOR
References: