louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06305156: Protocol Optimization in CT for the Quantification of BMD
Official title: Protocol-optimization in Computed Tomography for the Quantification of Bone Mineral Density (BMD)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoporosis, Osteopenia
Bone Loss
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Bone mineral density is an important measurement to detect osteoporosis.

The goal of this clinical trial is to compare bone mineral density measurements in CT examinations and DXA scans. The main question it aims to answer is:

* How good is the measurement of bone mineral density in the new photon-counting CT in comparison to DXA
* How can we optimize the CT scan for bone mineral density

Participants will undergo:

* Clinically indicated CT scan on day of inclusion
* Study related DXA scan on a separate appointment


Eligibility criteria: Inclusion Criteria:

* Informed Consent signed by the subject
* Referral to a regular clinically indicated CT examination covering the lumbar area (e.g., Abdomen, Thorax + Abdomen, Neck + Thorax +Abdomen)
* Informed written and oral consent (interpreter present in case of foreign language patients)
* No contraindication to the clinically indicated CT examination

Exclusion Criteria:

* Patients \< 18 years
* Pregnant women
* Vulnerable subjects
* Contraindications to the clinically indicated CT scan
* Multiple Myeloma
* Diffuse bone metastasis
* Fixateur interne in the lumbar spine
* Kyphoplasty in the lumbar spine
* Enterally administrated contrast agent
* Obtaining informed consent is not possible
* Withdrawal of consent orally or in writing
* Inability to follow the procedures of the investigation, e.g., due to language problems, psychological disorders, dementia, etc. of the subject
* Immobility (patients confined to a wheelchair or to bed)

Primary outcomes:
measure: Bone mineral density CT
timeFrame: Immediately after CT scan of the participant.
measure: Bone mineral density Dual-energy x-ray absorptiometry (DXA)
timeFrame: Immediately after DXA scan of the participant.
Secondary outcomes:
measure: Correlation between age and bone mineral density
timeFrame: 1 year
measure: Correlation between sex and bone mineral density
timeFrame: 1 year
measure: Correlation between height and bone mineral density
timeFrame: 1 year
measure: Correlation between weight and bone mineral density
timeFrame: 1 year
measure: Correlation between body mass index (BMI) and bone mineral density
timeFrame: 1 year
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Diagnostic and Interventional Radiology, University Hospital Zurich
Study officials:
affiliation: Diagnostic and Interventional Radiology, University Hospital Zurich
name: Hatem Alkadhi, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03759756: Artificial Intelligence for Early Diagnosis of Esophageal Squamous Cell Carcinoma
Official title: Application of Artificial Intelligence for Early Diagnosis of Esophageal Squamous Cell Carcinoma During Optical Enhancement Magnifying Endoscopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Artificial Intelligence
Optical Enhancement Endoscopy
Magnifying Endoscopy
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2018-11-30
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients who came to Qilu Hospital of Shandong University and received optical magnifying OE endoscopy examination

Brief summary: Esophageal squamous cell carcinoma is one of the most common malignant tumor of upper digestive tract. However, the detection rate and diagnosis accuracy of early esophageal squamous cell cancer is low. The aim of this study is to develop a computer-assisted diagnosis tool combining with optical magnifying endoscopy for early detection and accurate diagnosis of it.


Eligibility criteria: Inclusion Criteria:

* high risk patients for esophageal cancer aged 18 years or older;
* Histologically verified early esophageal squamous cell cancer.

Exclusion Criteria:

* patients whose images of esophagus not suitable for the training, validation and testing the computer-assist diagnosis tool.

Primary outcomes:
measure: the diagnosis efficiency of the AI model
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Department of Gastroenterology, Qilu Hospital, Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital, Shandong University
name: Yanqing Li, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02762656: The Effect of Perioperative Lidocaine Intravenous Infusion on Postoperative Recovery After Spine Surgery.
Official title: The Effect of Perioperative Lidocaine Intravenous Infusion on Postoperative Recovery After Spine Surgery.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Spinal Diseases
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2016-05-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effectiveness of perioperative Lidocaine intravenous infusion in reducing postoperative pain for spine surgery patients.

Detailed description: Study design: this study used a prospective, randomized, double-blinded, and placebo-controlled clinical trial.

Sixty patients scheduled for a spine surgery will be randomly assigned to two groups. Lidocaine group will receive an intravenous bolus injection of lidocaine 1.5 mg/kg before intubation, followed by 2 mg/kg/h continuous infusion during the operation. Placebo group will receive the same dosage of saline at the same time. Analgesic requirement will be monitored using patient-controlled Analgesia (PCA protocol: demand dose is 2 mg of morphine, lockout 5 min, maximum dose 15 mg per hour). Forty-eight hours after surgery, we will check the morphine consumption in two groups. Quality of recovery after surgery will be assessed using Q0R15 questionnaire.

Eligibility criteria: Inclusion Criteria:

* spine surgery with general anesthesia

Exclusion Criteria:

* lidocaine allergy
* hepatic disease
* dementia or cognitive decline

Primary outcomes:
measure: Postoperative pain
timeFrame: 24 hours postop
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
References:
Clinical trial NCT04134156: Sleeve Gastrectomy Versus One-anastomosis Gastric Bypass: Randomized Trial
Official title: Weight Loss and Change in Ghrelin and GLP-1 Levels After Sleeve Gastrectomy and One-anastomosis Gastric Bypass: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Morbid Obesity
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2019-10-22
Enrollment: 40
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hormonal changes after SG and OAGB involve alterations in the levels of many enteric hormones, among these hormones are ghrelin and glucagon-like peptide-1 (GLP-1). Ghrelin is an orexigenic hormone that stimulates food intake and has a documented role in the development of obesity. While ghrelin levels decrease significantly after SG as the fundus, which is the main source of that hormone, is completely removed, they tend to increase after OAGB GLP-1 plays an important role in glucose homeostasis via affecting food intake and satiety. It enhances insulin secretion, stimulates the proliferation and growth of pancreatic beta cells, inhibits food and water intake, and promotes satiety. Some studies reported that both OAGB and SG are followed by increased GLP-1 levels. We conducted this randomized study to compare SG and OAGB with regards to weight loss, comorbidity resolution, changes in ghrelin and GLP-1 hormones, and complications.


Eligibility criteria: Inclusion Criteria:

* Adult patients of both genders with morbid obesity (defined as BMI \> 40 kg/m2 or \> 35 Kg/m2 with at least one associated comorbidity) were included. Patients who underwent previous surgery for morbid obesity were also included.

Exclusion Criteria:

* patients ageing more than 60 years
* patients with endocrine disorders
* patients with psychiatric disorders that influence perception of the study protocol
* patients unfit for general anesthesia.

Primary outcomes:
measure: excess weight loss
timeFrame: 12 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Mansoura university hospital
state: Dakahlia
Study officials:
References:
Clinical trial NCT00756756: The Effect of Granulocyte Colony Stimulating Factor (G-CSF) on Myocardial Function After Acute Anterior Myocardial Infarction, a Prospective Double Blind Randomized Placebo Controlled Study
Official title: The Effect of Granulocyte Colony Stimulating Factor (G-CSF) on Myocardial Function After Acute Anterior Myocardial Infarction, a Prospective Double Blind Randomized Placebo Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Infarction
Keywords: G-CSF
Myocardial infarction
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2008-09-22
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators applied G-CSF to patients 2 weeks after acute anterior MI and successful PCI to evaluate the efficacy and safety of G-CSF in improving myocardial function as cytokine which improve inflammation and mobilize stem cells from bone marrow for regeneration of myocardium.

Detailed description: Ten patients in the treatment group and 10 patients in the control group were enrolled in this prospective, randomized, double blinded study. Two weeks after myocardial infarction that was accompanied by successful recanalization and stent implantation, the patients of the treatment group received 10 μg/kg body weight per day (divided BID) G-CSF subcutaneously for treatment duration of maximum 5.0 days. In both groups, ejection fraction was evaluated with echocardiography and cardiac scan (Gated SPECT method) 10 days after myocardial infarction and after 6 months. Tei index was measured by echocardiography.

Results: No severe side effects of G-CSF treatment were observed. Ejection fraction determined by cardiac scan increased in the treatment group from 0.428 to 0.462 and from 0.470 to 0.496 in the control group but there was no significant improvement of left ventricular ejection fraction when the G-CSF treated group was compared to the controls (p=0.821 for cardiac scan and p=0.705 for echocardiography). Changes in Tei index was not significant in the treatment group (p=0.815) however it reached significant level in the control group (p=0.005), respectively.

Eligibility criteria: Inclusion Criteria:

* First anterior myocardial infarction.
* Low systolic ventricular function.

Exclusion Criteria:

* Bleeding tendency
* Contraindication to G-CSF
* Cardiogenic shock
* Hemodynamic instability
* Hepatic or renal disease
* Multivessel disease

Primary outcomes:
measure: Ejection fraction
timeFrame: 6 months
measure: Diastolic function(Tei index)
timeFrame: 6 months
Secondary outcomes:
measure: Drug complication
timeFrame: acute and 6 months
measure: Mortality
timeFrame: 6 months
measure: New revascularization and MACE
timeFrame: 6 months
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Shiraz University of Medical Sciences/Cardiology Ward/Namazi and Shahid Faghihi Hospital
state: Fars
Study officials:
References:
Clinical trial NCT03289715: Evaluation of an On-Demand Humidifier on Neuromuscular Patients Requiring Mechanical Ventilation
Official title: Evaluation of an On-Demand Humidifier on Neuromuscular Patients Requiring Mechanical Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuromuscular Diseases
Lead sponsor: Philips Electronics Nederland B.V. acting through Philips CTO organization
Sponsor class: INDUSTRY
First posted: 2017-09-21
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Monocenter study to determine and evaluate the optimal amount of humidification doses delivered by the On-Demand humidification system in neuromuscular patients requiring home mechanical ventilation. The patient's perception will be monitored with subjective as well as with objective measurements of the optimum comfortable on-demand humidification doses.


Eligibility criteria: Inclusion Criteria:

1. Age \> 18 of age; \< 85 years of age
2. Participants with a neuromuscular disorder who:

   1. Require 24 hour mechanical ventilation in some form through tracheostomy, mask or mouth piece
   2. Can be ambulatory for at least a few hours during the day while using a heat and moisture exchange device (HME) or no humidification
   3. Can part of the day use a heated pass-over humidification system while on their ventilator (overnight, for example).
3. Able to provide feedback/articulate via some form of communication
4. Patients using a Trilogy ventilator
5. Invasively ventilated patients that are willing to use a HME device on their way to participate in the study (from home to hospital).
6. Patients that are willing to participate and are able to consent and sign the informed consent form. (Patients with the functional capacity for medical decision-making).

Exclusion Criteria:

1. Clinically unstable, i.e.,

   1. Acute respiratory failure
   2. Participants with refractory hypotension (defined as systolic blood pressure less than 90 mm Hg despite inotropic agents)
   3. Uncontrolled cardiac ischemia or arrhythmias
   4. Any participant determined as inappropriate for the study by the Principal Investigator
2. Patients suffering from metastatic or terminal cancer
3. Patients lacking the functional capacity for medical decision-making.

Primary outcomes:
measure: optimum comfortable amount of on-demand humidification
timeFrame: 3 hours
measure: optimum comfortable amount of on-demand humidification
timeFrame: 3 hours
measure: optimum comfortable amount of on-demand humidification
timeFrame: 3 hours
measure: optimum comfortable amount of on-demand humidification
timeFrame: 3 hours
measure: optimum comfortable amount of on-demand humidification
timeFrame: 3 hours
measure: optimum comfortable amount of on-demand humidification
timeFrame: 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
References:
Clinical trial NCT02703415: Immune Response of Caudally Administrated Tramadol In Pediatric Lower Abdominal Surgery
Official title: Comparison Of Immune Response And Analgesic Effects Of Caudally Administrated Tramadol In Pediatric Lower Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Pain
Keywords: immune
interleukin
tramadol
postoperartive analgesia
pediatric
caudal bupivacaine
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-03-09
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Management of acute pain is one of the most important tasks of perioperative pediatric anesthesia. The alleviation of pain has been defined by the Society of Pediatric Anesthesia, on its 15th annual meeting as a basic human right, irrespective of age, treatment primary service responsible for the patient care. Pro-inflammatory cytokines increased by surgical trauma indirectly modulate pain through the release of substances like nitric oxide, oxygen free radicals, prostaglandins, and excitatory amino acids, inducing peripheral and central sensitivity and hyperalgesia. There has been growing interest in determining the possible immune consequences of analgesic administration for the management of postoperative pain

Detailed description: 60 children aged 3-10 years undergoing lower abdominal surgery will be randomized into 2 groups (30 patients in each group) to receive caudal block with bupivacaine (0.25%) 1mg/kg (group 1) plus tramadol 1mg/kg (group 2) just after the induction of general anesthesia without premedication. All children will be assessed for the post operative immune response by measuring interleukin 6 and 10 (IL-6 and IL-10) and Tumour Necrosing Factor-α (TNF-α) using enzyme-linked immunosorbent assay (ELISA) technique one hour preoperatively and three hours after incision.

Eligibility criteria: Inclusion Criteria:

lower abdominal operation

Exclusion Criteria:

Any systemic disease that might compromise the immune system severe coagulation disorder true allergy to local anesthetics patients with major malformations of the lower spine or meninges any cutaneous or subcutaneous lesion at the site of injection unplanned reoperation, or reoperation within three months Diabetes Melliutes

Primary outcomes:
measure: post operative immune response
timeFrame: within the first three days postoperatiely
Secondary outcomes:
measure: . Post operative pain intensity
timeFrame: within the first postoperative day
measure: Time of first supplemental analgesia
timeFrame: within the first postoperative day
measure: sedation score
timeFrame: Within the first 24 hours
measure: side effects
timeFrame: Within the first 24 hours
measure: Leucocyte count
timeFrame: within the first three days postoperatiely
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of Medicine
Study officials:
affiliation: associate professor
name: sayed abd elshafy
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05016115: Longitudinal Study of Empathy Levels in Physiotherapy Students
Official title: A Four-Year Longitudinal Study of Empathy Levels in Undergraduate Physiotherapy Students
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Longitudinal Study of Empathy Levels in Physiotherapy Students
Keywords: empathy
longitudinal studies
students
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2021-08-23
Enrollment: 120
Sex: ALL
Minimum age (years): 19
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: physiotherapy students

Brief summary: 'Empathy' is a core term of occupations related to health sciences like physiotherapy. In physiotherapy education programs, empathy is necessary to have a successful cooperation with the clients. This study was planned to follow the changes of empathy levels in physiotherapy students of a four-year bachelor program and therefore enhance the curriculum related to the results. To the best of our knowledge, this research is the first longitudinal study about empathy levels of students in Turkey. Hypotheses: Empathy levels of the students increase year by year (1). Female students are more empathetic than male ones (2).

Detailed description: Totally 120 physiotherapy students at a non-governmental university in Istanbul participated in this study. The Turkish reworded student version of the Jefferson scale of physician empathy was used. Empathy scores were compared related to study years and gender. Empathy scores relevant to gender were compared using Mann-Whitney U test. The Kruskal-Wallis one-way analysis of variance was used for differences among the four study years.

Eligibility criteria: Inclusion Criteria:

* attending the first through fourth year of physiotherapy department
* being willing to participate in the study

Exclusion Criteria:

do not continue in physiotherapy department

Primary outcomes:
measure: Empathy levels of the students
timeFrame: 5 minutes
Secondary outcomes:
measure: Empathy levels of female students
timeFrame: 5 minutes
Other outcomes:
Locations:
Study officials:
References:
citation: Chen PJ, Huang CD, Yeh SJ. Impact of a narrative medicine programme on healthcare providers' empathy scores over time. BMC Med Educ. 2017 Jul 5;17(1):108. doi: 10.1186/s12909-017-0952-x.
citation: Hojat M, Gonnella JS. Eleven Years of Data on the Jefferson Scale of Empathy-Medical Student Version (JSE-S): Proxy Norm Data and Tentative Cutoff Scores. Med Princ Pract. 2015;24(4):344-50. doi: 10.1159/000381954. Epub 2015 Apr 28.
Clinical trial NCT03133715: Laparoscopic Versus Robot-assisted Ventral Hernia Repair: a Single Institution Randomized Controlled Trial
Official title: Laparoscopic Versus Robot-assisted Ventral Hernia Repair: The Immediate, Intermediate, and Long Term Outcome Differences. A Single Institution Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Ventral Hernia
Keywords: robot-assisted
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2017-04-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to receive either laparoscopic or robot-assisted repair of ventral hernia.
Primary purpose: TREATMENT

Brief summary: Randomized trial to compare outcomes of robot-assisted and laparoscopic ventral hernia repair surgery.

Detailed description: Ventral hernia repair is a very common surgical operation. Both laparoscopic and robot-assisted operations are considered acceptable. However, there is no clear indication for a particular approach. No prospective trial has been conducted so far to establish superiority of one approach over the other. The Investigator believes each approach has unique characteristics and may offer advantages over the other in the right population group. The Investigator will randomly assign patients in two arms according to the surgical approach, whether laparoscopic or robot-assisted. The Investigator will collect preoperative characteristics, intraoperative variables, and postoperative outcomes. The Investigator will compare all variables to establish differences between the two groups.

Eligibility criteria: Inclusion Criteria:

* surgeon determined need for ventral hernia repair

Exclusion Criteria:

* \<18 \& \>99 years of age
* Pregnant
* Medical indication for open repair

Primary outcomes:
measure: Operative time
timeFrame: perioperative time
Secondary outcomes:
measure: Post operative pain score
timeFrame: until year five post-operative
Other outcomes:
measure: Complications
timeFrame: From immediately post-operative until year five following surgical ventral hernia repair.
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Michael Latzko, MD
role: PRINCIPAL_INVESTIGATOR
References: