louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02041988: Preemptive Analgesia With Morphine Sulphate in Major Urological Surgery
Official title: Influence of Premedication With Oral Morphine Sulphate on Analgesic Consumption in Patient Undergoing Major Urological Surgery. Comparison Between Two Different Doses
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pain
Keywords: premedication
oral morphine
preemptive analgesia
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2014-01-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients selected for major urological surgery

Brief summary: In this study safety and efficacy of oral morphine sulphate is evaluated in order to reduce opioids administration during major urological surgery

Detailed description: The administration of oral morphine sulfate could be useful to reduce the use of opioids in major urological surgery. This study aims to assess the safety and efficacy of two different oral morphine sulphate doses 0,2 mg/kg vs 0,4mg/kg in major urological surgery.

Eligibility criteria: Inclusion Criteria:

American Society of Anaesthesiologists physical status classification I/ II, age between 18 - 75, BMI 18 -30

Exclusion Criteria:

American Society of Anaesthesiologists physical status classification III/ IV, renal and hepatic insufficiency, postoperative nausea and vomiting after oral opioids administrations, neurological and psychiatric disorders.

Primary outcomes:
measure: morphine sulphate consumption
timeFrame: six months
Secondary outcomes:
measure: vital signs
timeFrame: six months
Other outcomes:
measure: VAS score
timeFrame: six months
measure: side effects
timeFrame: six months
Locations:
city: Rome
country: Italy
facility: Francesco Cannata
city: Rome
country: Italy
facility: Policlinico Umberto I
Study officials:
affiliation: Policlinico Umberto I
name: Francesco MD Cannata, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05999188: Clinical Characteristics and Prognosis of Aortic Dissection in China (CLASSIC)
Official title: Clinical Characteristics and Prognosis of Aortic Dissection in China (CLASSIC): a National, Multicenter, Retrospective-prospective, Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aortic Dissection
Keywords: aortic dissection
clinical characteristics
prognosis
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
Collaborators: name: 521 Hospital of NORINCO Group
name: Shaanxi Provincial People's Hospital
name: Xiangyang Central Hospital
name: Henan Provincial People's Hospital
First posted: 2023-08-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are aged 18-80 years and diagnosed with aortic dissection at any of the centre can be enrolled.

Brief summary: This study will construct a retrospective-prospective long-term follow-up cohort and management system for aortic dissection through a multicentre collaborative network. This study aims to investigate the disease characteristics, progression patterns, clinical features, natural course and factors affecting the disease course and prognosis of patients with aortic dissection by retrospectively collecting data and prospectively enrolling patients.

Detailed description: This study aims to construct a retrospective-prospective long-term follow-up cohort and management system for aortic dissection through a multicentre collaborative network. The duration of the study will be divided into retrospective and prospective components. The retrospective study will collect cases of aortic dissection of different aetiologies from 2003-2022; the prospective study is expected to collect cases of aortic dissection from 2022-2030. The study is expected to assess the disease characteristics, progression patterns, clinical features, natural course and long-term prognosis of aortic coarctation.

Eligibility criteria: Inclusion Criteria:

* Age 18-80 years;
* Meet diagnostic criteria for aortic dissection.

Exclusion Criteria:

* Age \<18 years or \>80 years;
* Women who are pregnant and breastfeeding;
* Patients and their families refuse or are unable to sign the informed consent form.

Primary outcomes:
measure: Change of post-operative survival rate
timeFrame: 3, 6, 9 month and 1, 2, 3, 4, 5 year after the surgery.
Secondary outcomes:
measure: Change of the incidence of MACCE
timeFrame: 3, 6, 9 month and 1, 2, 3, 4, 5 year after the surgery.
measure: Incidence of any complications
timeFrame: 5 years after the surgery.
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xian Jiantong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Guoliang Li
role: PRINCIPAL_INVESTIGATOR
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Yang Yan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02959788: Heart Rate Variability as a Predictor of Ischemic Heart Disease
Official title: Heart Rate Variability as a Predictor of Ischemic Heart Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Keywords: Heart rate variability
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2016-11-09
Enrollment: 62
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: All adults who present to the emergency department with chest pain.

Brief summary: Identification of patients who are at highest risk for heart attack is an important task for emergency medicine physicians. Currently, physicians use a variety of different scoring systems to stratify their risk for having a heart attack. Heart rate variability (HRV) is a measure derived from noninvasive cardiac monitoring. This data is collected from a simple, non-invasive chest strap during a 10-minute recording session. The purpose of this proposal is to collect heart rate variability data on patients admitted to the emergency department with chest pain. The intent is to measure the association between heart rate variability and the various risk stratification scoring systems for chest pain.

Detailed description: Identification of patients who are at highest risk for heart attack is an important task for emergency medicine physicians. Currently, physicians use a variety of different scoring systems to stratify their risk for having a heart attack. Heart rate variability (HRV) is a measure derived from noninvasive cardiac monitoring. This data is collected from a simple, non-invasive chest strap during a 10-minute recording session. The purpose of this proposal is to collect heart rate variability data on patients admitted to the emergency department with chest pain. The intent is to measure the association between heart rate variability and the various risk stratification scoring systems for chest pain.

The investigators propose to enroll patients admitted to the emergency department with chest pain. In addition to HRV data, clinical risk factors will be obtained, using validated clinical risk scoring systems. The team will follow patient's clinical course in order to include information about the determined cause of chest pain. The goal is to understand how HRV can augment common risk stratification scoring systems for patient presenting to the ED with chest pain.

Eligibility criteria: Inclusion Criteria:

* Chest pain in ED

Exclusion Criteria:

* STEMI
* Prisoners
* Pregnant women
* Unable to consent

Primary outcomes:
measure: Major adverse cardiac events
timeFrame: 30 days
Secondary outcomes:
measure: HEART score
timeFrame: 1 day
measure: Coronary heart disease risk factors
timeFrame: 1 day
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
Study officials:
affiliation: University of Iowa
name: Nicholas M Mohr, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05301088: Pain and Fear of Venous Blood Collection in Children
Official title: The Effect of Chocolate Smell and Stress Ball on Pain and Fear in Venous Blood Collection in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Fear
Lead sponsor: Ataturk University
Sponsor class: OTHER
Collaborators: name: MSc Eylem Nazan KAPAN
First posted: 2022-03-29
Enrollment: 126
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Nurses are in the position of primary health care provider in relieving children's pain and fears of bloodletting in the wards where they work. As a result of this study, it is aimed to encourage nurses to apply non-pharmacological interventions during painful medical procedures, to facilitate the provision of necessary and different means of distraction to blood collection services, and to contribute to the development of in-house health policies and the preparation of appropriate clinical guides and to add an innovative perspective.


Eligibility criteria: Inclusion Criteria:

* 6-12 age group,
* children who need blood drawn for any reason
* have no disease that can cause chronic pain,
* no olfactory disorder
* no mental or neurological problems
* able to communicate
* speaks Turkish

Exclusion Criteria:

* those who did not give consent to the research by both the child and the parent

Primary outcomes:
measure: Wong-Baker Faces Pain Rating Scale
timeFrame: 12 week
measure: Child Fear Scale
timeFrame: 12 week
Secondary outcomes:
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk University
Study officials:
References:
Clinical trial NCT06432088: Safety and Feasibility of Liver Retraction With the Levita Magnetic Surgical System: Extended Magnetic Grasper Device
Official title: Prospective, Multi-center, Single-arm, Open Label Study Designed to Assess the Safety and Feasibility of Liver Retraction With the Levita Magnetic Surgical System: Extended Magnetic Grasper Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bariatric Surgery Candidate
Hiatal Hernia
Lead sponsor: Levita Magnetics
Sponsor class: INDUSTRY
First posted: 2024-05-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate the safety and effectiveness of the Extended Magnetic Grasper Device in patients undergoing bariatric and/or hiatal hernia procedures, as a liver retractor grasping the liver and/or the tissue surrounding the crus of the diaphragm.

Detailed description: The purpose of this study is to evaluate the safety and effectiveness of the Levita Magnetic Surgical System Version 2 in patients undergoing bariatric and/or hiatal hernia procedures.

Eligibility criteria: Inclusion Criteria:

* At least 18 years of age.
* Scheduled to undergo elective bariatric and/or hiatal hernia procedures.
* Willing and able to provide a written Informed Consent Form (ICF) to participate in the study prior to any study required procedures.

Exclusion Criteria:

* Individuals with pacemakers, defibrillators, or other electromedical implants.
* Individuals with ferromagnetic implants.
* American Society of Anesthesiologists (ASA) score of III or IV.
* Significant comorbidities: cardiovascular, neuromuscular, chronic obstructive pulmonary disease, and urological disease (renal failure).
* Clinical history of impaired coagulation confirmed by abnormal blood tests.
* Individuals has signs of hepatic abnormality (e.g.: cirrhosis, liver failure, increase in liver enzymes, etc.).
* Anatomical abnormality or disease of intended target tissue noted after initiation of index procedure that would prevent device use.
* Pregnant or wishes to become pregnant during the length of study participation.
* Individual is not likely to comply with the follow-up evaluation schedule.
* Participating in a clinical trial of another investigational drug or device.
* Prisoner or under incarceration.

Primary outcomes:
measure: Number of Device Related Adverse Events
timeFrame: 30 days
measure: Mobilization Requiring Additional Retractors
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Hospital Santiago Oriente Dr. Luis Tisné Brousse
state: Metropolitana
Study officials:
References:
Clinical trial NCT02993588: Impact of Melatonin on IVF/ICSI Outcomes in Prospective Poor Responders
Official title: Impact of Melatonin Adjuvant Therapy on IVF/ICSI Outcomes in Prospective Poor Responders: A Double-blind, Randomized, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: In Vitro Fertilization
Poor Ovarian Response
Keywords: Melatonin
IVF/ICSI
Poor ovarian response
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-12-15
Enrollment: 100
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the impact of melatonin administration on in vitro fertilization (IVF/ICSI) outcomes namely the total number and quality of the oocytes and embryos in the prospective poor responders.

Detailed description: The prospective poor responders have been associated with lower number and poorer oocyte quality. Melatonin is suggested to have antioxidative effects which may contribute to improving the IVF/ICSI outcomes in this group of patients who expected to have poor outcomes. However, the expected beneficial effects of melatonin have not yet been investigated. The purpose of this study is to investigate the impact of melatonin administration on IVF/ICSI outcomes namely the total number and quality of the oocytes and embryos in the prospective poor responders. A randomized, double-blinded, placebo-controlled study is used to investigate the impact of melatonin on the IVF/ICSI outcomes.

Eligibility criteria: Inclusion Criteria:

* Prospective poor responder with AMH \< 1 ng/ml and AFC \< 8 (in both ovaries).

Exclusion Criteria:

* Severe male factor infertility.

Primary outcomes:
measure: Total number of retrieved mature oocytes
timeFrame: On the day of oocyte retrieval procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Osama Abdalmageed
state: Non-US/Non-Canadian
city: Assiut
country: Egypt
facility: Osama Abdalmageed
Study officials:
affiliation: Women health center
name: Osama Abdalmageed, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fernando S, Rombauts L. Melatonin: shedding light on infertility?--A review of the recent literature. J Ovarian Res. 2014 Oct 21;7:98. doi: 10.1186/s13048-014-0098-y.
Clinical trial NCT04372888: Examining Choice Architecture for Genetic Testing Decisions
Official title: Examining Choice Architecture for Genetic Testing Decisions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Decision Making
Lead sponsor: Boston College
Sponsor class: OTHER
First posted: 2020-05-04
Enrollment: 1012
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization to 1 of 6 decision frames for two disease testing scenarios (arms)
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this application is to gain a deeper understanding of decision-making for genetic testing and identify effective choice-architecture-based strategies to improve decisions in genetic testing. The investigators hypothesize that choice architecture (i.e. framing) affects decision-making for hypothetical genetic testing scenarios.

Detailed description: After providing opt-in electronic consent, eligible consented participants will be randomized to one of two hypothetical genetic testing scenarios (rare, life-altering genetic condition or common, life-threatening genetic condition). The genetic testing scenarios include brief detailed information about genetic testing (i.e. how results may influence treatment decisions) as well as information about standard approaches to treatment. Subjects will be randomized to receive a framing conditions (e.g. choice, opt-in, opt-out, enhanced choice). Participants will select a preferred testing option to the hypothetical scenario and will complete several validated instruments.

Eligibility criteria: Inclusion Criteria:

* Adult participants (18-64 yrs) residing in North America (who are members of the Amazon Mechanical Turk platform)

Exclusion Criteria:

* age \<18yrs or \>65yrs or residing outside of North America

Primary outcomes:
measure: Genetic testing decision
timeFrame: after reading the scenario and viewing frame (approximately 10 minutes)
measure: Satisfaction with Decision Scale (SWD)
timeFrame: study completion (approximately 30 minutes)
measure: Decisional Regret Scale (DRS)
timeFrame: study completion (approximately 30 minutes)
Secondary outcomes:
measure: Newest Vital Sign (NVS)
timeFrame: study completion (approximately 30 minutes)
measure: Experience with genetic disease
timeFrame: Baseline (study onset)
Other outcomes:
Locations:
city: Chestnut Hill
country: United States
facility: Boston College
state: Massachusetts
Study officials:
affiliation: Boston College
name: Andrew A Dwyer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dwyer AA, Shen H, Zeng Z, Gregas M, Zhao M. Framing Effects on Decision-Making for Diagnostic Genetic Testing: Results from a Randomized Trial. Genes (Basel). 2021 Jun 20;12(6):941. doi: 10.3390/genes12060941.
Clinical trial NCT05728788: Correlation Between Myocardial Injury and Intestinal Flora Changes Associated With Oncology Drug Therapy
Official title: Correlation Between Early Myocardial Injury and Intestinal Flora Changes Associated With Oncology Drug Therapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer Therapy-related Cardiovascular Toxicity
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2023-02-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with antineoplastic agents

Brief summary: The purpose of this study was to explore the relationship between early myocardial injury caused by tumor drug therapy and intestinal microbial structure changes by echocardiographic two-dimensional speckle tracking technique and intestinal microflora structure detection.

Detailed description: This is a monocentric prospective cohort study in which 50 patients treated for malignant tumors will be included. All participants will be followed for 6 months after the initiation of oncology drug therapy. Echocardiography and 2D speckle tracking will be performed and stool and blood samples will be tested before treatment initiation and at 3 and 6 months after initiation.

Eligibility criteria: Inclusion Criteria:

* With malignant tumors
* Will receive antitumor drugs
* Could receive regular follow-up for 6 months
* Written informed consent

Exclusion Criteria:

* Satisfactory echocardiographic images could not be obtained
* Cardiomyopathy
* Coronary artery disease
* Heart failure
* Arrhythmia requiring intervention
* Moderate or severe valvular disease
* Acute myocarditis
* Refractory hypertension
* Participating in other studies of drug intervention

Primary outcomes:
measure: At least a 10% decrease in the global longitudinal strain
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Zhenyu Tian
Study officials:
affiliation: Peking University Third Hospital
name: Ming Cui, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05792488: Lifestyle Guidance Methods in NAFLD
Official title: The Investigation of Different Guidance Methods to Facilitate Lifestyle Changes in Patients With NAFLD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Non-Alcoholic Fatty Liver Disease
Lead sponsor: Ziekenhuis Oost-Limburg
Sponsor class: OTHER
First posted: 2023-03-31
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the efficiency of lifestyle modification (due to a dietitian or digital application) compared to standard of care.


Eligibility criteria: Inclusion Criteria:

* NAFLD based in FibroScan measurements

Exclusion Criteria:

* excessive alcohol use
* other causes of liver disease
* secondary causes of liver steatosis

Primary outcomes:
measure: A change in liver fat
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
state: Limburg
Study officials:
affiliation: Hasselt University
name: Geert Robaeys, MD. PhD
role: PRINCIPAL_INVESTIGATOR
References: